@Article{info:doi/10.2196/60488, author="Stanimirovic, Aleksandra and Francis, Troy and Meerai, Sonia and Mathew, Suja and Ibrahim, Sarah and Bowen, M. James and PIkula, Aleksandra and Rac, Valeria", title="Diabetic Retinopathy Screening Among at Risk Populations: Protocol for Distributional Cost-Effectiveness Analysis", journal="JMIR Res Protoc", year="2025", month="Apr", day="30", volume="14", pages="e60488", keywords="diabetic retinopathy", keywords="equity of care", keywords="distributional cost-effectiveness analysis", keywords="health equity", keywords="health care disparities", keywords="intersectionality", keywords="telehealth", keywords="telemedicine", keywords="retinopathy screening", abstract="Background: Diabetic retinopathy (DR) remains the primary vision complication of diabetes and the leading cause of blindness among adults, with up to 30\% prevalence among low-income populations. Tele-retina is a cost-effective screening alternative to vision loss prevention, yet there is an adverse association between screening and income. Intersectionality theory notes that barriers to achieving health equity result from the intersection of personal and social characteristics. Experiences at this intersection are influenced by interpersonal and structural systems of oppression. Studies have found that tele-retina is the preferred strategy over standard of care screening for at-risk populations. No study has assessed the economic equity impact of DR screening using a theoretical foundation. Objective: This study aims to address shortcomings related to the utilization of intersectionality theory in the economic evaluation of DR screening. We propose conducting a distributional cost-effectiveness analysis (DCEA) of the tele-retina program. Methods: The study will be undertaken using a deductive theoretical drive sequential multimethod approach, consisting of two studies: (1) a modified Delphi study and (2) DCEA. The Delphi panel (patient partners, field experts, and decision makers; N=35-50) will select the social constructs (eg, age, gender) for at-risk populations and potential trade-offs between health maximization and equity. The research will be guided by a social theory framework (intersectionality theory) to understand the impact of social constructs on economic outcomes. Social constructs that are selected by the Delphi panel will be integrated into the validated tele-retina cost-effectiveness analysis model, which will serve as a case study for DCEA. Results: We have submitted the research ethics board application to the University Health Network Research Ethics Board and are expecting to begin recruitment for the Delphi study in Spring 2025. We anticipate beginning work on the model in the summer of 2025 and completing it by early 2026. Conclusions: The Delphi study will provide an understanding of which social factors are deemed necessary by the stakeholders for guiding the inequity in care access. Study results will offer information related to the net health benefit of the intervention and the health equity impact of the tele-retina program, hence providing a more comprehensive valuation of the tele-retina program, which is informative to policy makers and governments whose goal is to mitigate the drivers of health inequities. We anticipate that each of these drivers will raise important questions regarding the implications for decision-making that may have not yet been addressed by Canadian health technology assessment bodies, such as the Canada Drug Agency. This is the first Canadian study to (1) have social constructs for DCEA selected by the Delphi panel, (2) mainstream how health equity framework and social constructs are used in economic assessment, (3) improve DR screening programs by using health equity lens, and (4) scale and adopt ``de-novo'' integration of social constructs in economic models for program evaluation. International Registered Report Identifier (IRRID): PRR1-10.2196/60488 ", doi="10.2196/60488", url="https://www.researchprotocols.org/2025/1/e60488", url="http://www.ncbi.nlm.nih.gov/pubmed/40305086" } @Article{info:doi/10.2196/62756, author="Yau, Yui Sarah Tsz and Hung, Tim Chi and Leung, Man Eman Yee and Lee, Albert and Yeoh, Kiong Eng", title="Survival Tree Analysis of Interactions Among Factors Associated With Colorectal Cancer Risk in Patients With Type 2 Diabetes: Retrospective Cohort Study", journal="JMIR Public Health Surveill", year="2025", month="Apr", day="29", volume="11", pages="e62756", keywords="colorectal cancer", keywords="risk factor", keywords="interaction", keywords="type 2 diabetes", keywords="survival analysis", keywords="decision tree", keywords="recursive partitioning", keywords="segmentation", keywords="risk stratification", keywords="public health", abstract="Background: Colorectal cancer (CRC) and diabetes share many common lifestyle risk factors, such as obesity. However, it remains largely unknown how different factors interact to influence the risk of CRC development among patients with diabetes. Objective: This study aimed to identify the interaction patterns among factors associated with the risk of CRC incidence among patients with diabetes. Methods: This is a retrospective cohort study conducted using electronic health records from Hong Kong. Patients who were diagnosed with type 2 diabetes and received care in general outpatient clinics between 2010 and 2019 without cancer history were included and followed up until December 2019. A conditional inference survival tree was applied to examine the interaction patterns among factors associated with the risk of CRC. Results: A total of 386,325 patients were included. During a median follow-up of 6.2 years (IQR 3.3-8.0), 4199 patients developed CRC. Patients were first partitioned into 4 age groups by increased levels of CRC risk (?54 vs 55 to 61 vs 62 to 73 vs >73 years). Among patients aged more than 54 years, male sex was the dominant risk factor for CRC within each age stratum and the associations lessened with age. Abdominal obesity (waist-to-hip ratio >0.95) and longer duration of diabetes (median 12, IQR 7-18 vs median 4, IQR 1-11 years) were identified as key risk factor for CRC among men aged between 62 and 73 years and women aged more than 73 years, respectively. Conclusions: This study suggests the interaction patterns among age, sex, waist-to-hip ratio, and duration of diabetes on the risk of CRC incidence among patients with diabetes. Findings of the study may help identify target groups for public health intervention strategies. ", doi="10.2196/62756", url="https://publichealth.jmir.org/2025/1/e62756" } @Article{info:doi/10.2196/72542, author="Price, L. Sarah A. and Koye, N. Digsu and Lewin, Alice and Nankervis, Alison and Kane, C. Stefan", title="Maternal Metabolic Health and Mother and Baby Health Outcomes (MAMBO): Protocol of a Prospective Observational Study", journal="JMIR Res Protoc", year="2025", month="Apr", day="11", volume="14", pages="e72542", keywords="preconception", keywords="large for gestational age", keywords="small for gestational age", keywords="pregnancy outcomes", keywords="metabolic disease", keywords="diabetes", keywords="obesity", keywords="hypertension", abstract="Background: Metabolic disease is increasingly impacting women of reproductive age. In pregnancy, uncontrolled metabolic disease can result in offspring with major congenital anomalies, preterm birth, and abnormal fetal growth. Pregnancy also accelerates the complications of metabolic diseases in mothers resulting in an increased risk of premature cardiovascular events. Despite the convincing evidence that preconception care can largely mitigate the risks of metabolic disease in pregnancy, there are few data about how to identify the highest-risk women so that they can be connected with appropriate preconception care services. Objective: The aim of the study is to determine the maternal phenotype that represents the highest risk of having adverse neonatal and maternal pregnancy outcomes. Methods: This will be a prospective cohort study of 500 women recruited in early pregnancy. The primary outcome is a composite of offspring born small for gestational age (SGA) or large for gestational age (LGA) (customized birthweight ?10th and ?90th centile for gestational age). Secondary outcomes are (1) composite of adverse neonatal birth outcomes (SGA, LGA, major congenital abnormalities, preterm birth [<37 weeks' gestation]) and (2) composite of new maternal metabolic outcomes (gestational diabetes, diabetes in pregnancy, type 2 diabetes [T2D] or prediabetes; gestational hypertension, preeclampsia, eclampsia or new essential hypertension after pregnancy; and gestational weight gain ?20kg or new overweight/obesity at the 12-18 months postpartum visit). A multivariable logistic regression analysis will be conducted to identify candidate predictors of poor pregnancy outcomes due to metabolic disease. From this model, model coefficients and the associated 95\% CIs will be extracted to derive the risk score for predicting the delivery of LGA/SGA offspring (primary outcome) and composites of adverse neonatal outcomes and maternal outcomes (secondary outcomes). Results: Seed funding for the project was acquired in November 2022 and subsequent funding was acquired in May 2024. The first participant was recruited on March 23, 2023. At the time of manuscript submission, 402 participants have been recruited. Data analysis has not yet been performed. Results are expected to be published in the first half of 2027. Conclusions: This is a prospective observational cohort study that intends to identify the metabolic disease risk factors, or combination of factors, that are most likely to cause adverse maternal and fetal health outcomes. These characteristics will be used to develop a risk calculator which will assist in identifying the highest risk women and in triaging them to appropriate services. The study has been approved by the institutional Human Research Ethics Committee (HREC/90080/MH-2022). Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12623000037606; https://tinyurl.com/yeytsxtp International Registered Report Identifier (IRRID): DERR1-10.2196/72542 ", doi="10.2196/72542", url="https://www.researchprotocols.org/2025/1/e72542", url="http://www.ncbi.nlm.nih.gov/pubmed/40215105" } @Article{info:doi/10.2196/60758, author="Caballero Mateos, Irene and Morales Portillo, Crist{\'o}bal and Lainez L{\'o}pez, Mar{\'i}a and Vilches-Arenas, {\'A}ngel", title="Efficacy of a Digital Educational Intervention for Patients With Type 2 Diabetes Mellitus: Multicenter, Randomized, Prospective, 6-Month Follow-Up Study", journal="J Med Internet Res", year="2025", month="Apr", day="10", volume="27", pages="e60758", keywords="body composition", keywords="type 2 diabetes mellitus", keywords="digital", keywords="metabolic control", keywords="social networks", keywords="satisfaction", keywords="telemedicine", abstract="Background: Adherence to therapies and metabolic control among patients with type 2 diabetes mellitus (T2DM) remain challenging. The use of new technologies, such as telemedicine, digitalized systems, and social networks, could improve self-management and disease control. Objective: We evaluated the efficacy of a digital educational intervention for patients with T2DM, expressed as changes in glycated hemoglobin (HbA1c) and body composition and evaluation of the response using validated questionnaires of satisfaction with health care professionals (Instrument for Evaluation of the Experience of Chronic Patients), Diabetes Knowledge Scale (ECODI), and adherence to treatment over 6 months of follow-up (Morisky, Green, Levine Medication Assessment Questionnaire). Methods: This multicenter, randomized, prospective study included adults with T2DM with poor metabolic control who started treatment with glucagon-like peptide-1 receptor agonists. Patients were randomized to digital intervention or usual care. The intervention group received education through social networks and digital tools in a structured program of healthy lifestyle changes. This was provided by a ``Digital Coach'' for weekly and on-demand advice and individualized support. Baseline and follow-up demographic, clinical parameter, adherence, and quality of life data were collected. Results: We included 85 patients (control: n=41; intervention: n=44). Both groups were matched regarding demographics, physical examination, insulin, and biochemical parameters. We observed a reduction in body weight (intervention: --8.7, SD 6.1 kg vs control: --4.9, SD 5.0 kg; t83=--3.13; P=.002), BMI (intervention: --3.0, SD 2.1 kg/m2 vs control: --1.8, SD 1.8 kg/m2; t83=--2.82; P=.006), and fast mass in both groups but greater in the intervention group. There were greater reductions in fasting plasma glucose (intervention: 122.6, SD 81.5 mg/dL vs control: 70.5, SD 72.9 mg/dL; t83=3.10; P=.004) and HbA1c (intervention: 3.7\%, SD 1.9\% vs control: 2.6\%, SD 2.1\%; t83=2.54; P=.006) in the intervention group. Although there was no significant change in the Spanish version of the Diabetes Quality of Life Questionnaire (EsDQOL) satisfaction score in the control group after 6 months of follow-up (0.7, SD 19.8), there was a marked reduction in EsDQOL satisfaction score in the intervention group (--13.7, SD 23.1; t83=--3.08; P=.02). According to the ECODI scale, knowledge about diabetes increased more in the intervention group (intervention: 0.3, SD 1.8 vs control: 1.5, SD 1.5; t83=--3.33; P=.001). Although the medication adherence score worsened in the control group after 6 months, it significantly improved with the intervention (control: --8\% vs intervention: 13.8\%; $\chi$21=0.35; P=.01). Patients' health care experiences improved with the intervention but not with the control. Conclusions: The digital educational intervention was effective at improving glycemic control, body composition, adherence, and patient satisfaction compared with usual care in patients with T2DM. The implementation of digital tools and social media could highly improve the multidisciplinary approach to the management of this population. Trial Registration: ClinicalTrials.gov NCT06850129; https://clinicaltrials.gov/study/NCT06850129 ", doi="10.2196/60758", url="https://www.jmir.org/2025/1/e60758" } @Article{info:doi/10.2196/68936, author="Fundoiano-Hershcovitz, Yifat and Lee, Felix and Stanger, Catherine and Breuer Asher, Inbar and Horwitz, L. David and Manejwala, Omar and Liska, Jan and Kerr, David", title="Digital Health Intervention on Awareness of Vaccination Against Influenza Among Adults With Diabetes: Pragmatic Randomized Follow-Up Study", journal="J Med Internet Res", year="2025", month="Apr", day="10", volume="27", pages="e68936", keywords="digital health", keywords="diabetes management", keywords="influenza vaccination", keywords="flu vaccination awareness", keywords="mobile health", abstract="Background: Diabetes mellitus significantly increases the risk of severe complications from influenza, necessitating targeted vaccination efforts. Despite vaccination being the most effective preventive measure, coverage remains below the World Health Organization's targets, partly due to limited awareness among patients. This study evaluated a digital health intervention aimed at improving influenza vaccination rates among adults with diabetes. Objective: This study aimed to demonstrate the effectiveness of digital health platforms in increasing vaccination rates among people with diabetes and to emphasize the impact of tailored messaging frequency on patient engagement and health behavior change. We hypothesized that digital tools providing empirical evidence of increased health risk awareness can effectively drive preventive actions. Methods: The study leveraged the Dario (Dario Health Corp) digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: (1) Group A received previously studied monthly flu nudge messages; (2) Group B received an adapted intervention with 2-3 monthly messages; (3) Group C served as the control with no intervention. Surveys were conducted at baseline, 3 months, and 6 months to assess vaccination status, awareness of influenza risks, and recollection of educational content. Statistical analyses, including logistic regression, chi-square tests, and t tests, were used to evaluate differences between groups. Results: Out of 64,904 users, 8431 completed the surveys. Vaccination rates were 71.0\% in group A, 71.9\% in group B, and 70.5\% in group C. Group B showed significantly higher awareness of influenza risks compared with the control group odds ratio (OR; OR 1.35, 95\% CI 1.12-1.63; P=.001), while group A did not (OR 1.10, 95\% CI 0.92-1.32; P=.27). Recollection of educational content was also higher in groups A (OR 1.29, 95\% CI 1.07-1.56; P=.008) and B (OR 1.92, 95\% CI 1.59-2.33; P<.001) compared with the control. In addition, a significant correlation between awareness and vaccination rates was found only in group B ($\chi$2(df=1)=6.12, P=.01). Conclusions: The adapted digital intervention (group B) effectively increased awareness of influenza risks and recollection of educational content, which correlated with the higher trend in vaccination rates. This study demonstrates the potential of digital health tools to enhance influenza vaccination among people with diabetes by improving risk awareness and education. Further research should focus on optimizing these interventions to achieve significant improvements in vaccination uptake and overall public health outcomes. Trial Registration: ClinicalTrials.gov NCT06840236; https://clinicaltrials.gov/study/NCT06840236 ", doi="10.2196/68936", url="https://www.jmir.org/2025/1/e68936", url="http://www.ncbi.nlm.nih.gov/pubmed/40209214" } @Article{info:doi/10.2196/60703, author="Seng, Benjamin Jun Jie and Nyanavoli, Hosea and Decruz, Moses Glenn and Kwan, Heng Yu and Low, Leng Lian", title="Health Coaching and Its Impact in the Remote Management of Patients With Type 2 Diabetes Mellitus: Scoping Review of the Literature", journal="J Med Internet Res", year="2025", month="Apr", day="9", volume="27", pages="e60703", keywords="diabetes mellitus", keywords="type 2", keywords="remote consultation", keywords="telenursing", keywords="education", keywords="health coaching", keywords="scoping review", keywords="telemonitoring", keywords="PRISMA", abstract="Background: Health coaching refers to the practice of health education and promotion to drive goal-directed behavioral changes and improve an individual's well-being. Remote patient monitoring systems, which employ health coaching interventions, have been gaining interest and may aid in the management of patients with type 2 diabetes mellitus (T2DM). Objective: This scoping review aims to summarize the impact of health coaching in the remote monitoring of patients with T2DM. Methods: A scoping review was performed in MEDLINE, Embase, CINAHL, PsychInfo, and Web of Science up to September 2024 and was reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The initial abstract screening, full-text review, and data extraction were performed by 2 independent reviewers. Studies that evaluated the impact of health coaching on the remote management of patients with T2DM were included. Outcomes evaluated were grouped into clinical, humanistic, psychiatric, behavioral, knowledge, and economic domains. A narrative review was performed for the impact of health coaching on the remote management of patients with T2DM. Results: Among 168,888 citations identified, 104 studies were included. Majority of the studies were conducted in North America (56/104, 53.8\%) and Asia (30/104, 28.8\%). Approximately half of the studies (48/104, 46.2\%) were conducted in primary health care settings, and one-third of the studies (37/104, 35.6\%) employed nurses as health coaches. Phone consultations were the most common modality of remote monitoring (45/104, 43.3\%). The follow-up duration of most studies (64/104, 61.5\%) was less than 1 year. Regarding clinical outcomes, majority of the studies (68/92, 73\%) showed improvements in diabetes-related parameters, but there was no improvement in blood pressure (21/32, 66\%) or hyperlipidemia control (19/32, 59\%). For humanistic outcomes, health coaching was associated with higher satisfaction with diabetes-related care (10/11, 91\%), but there was no improvement in quality of life (12/20, 60\%). Regarding psychiatric outcomes, there was no association with improvement in depressive (8/14, 57\%) or anxiety symptoms (4/5, 80\%). For behavioral outcomes, most studies (12/19, 63\%) showed improvement in diabetes-related self-efficacy. For knowledge outcomes, evidence was mixed, with half of the studies (5/9, 56\%) showing improvement in diabetes-related knowledge. For economic outcomes, majority of the studies (8/11, 73\%) did not show a reduction in health care use. Conclusions: Health coaching was associated with improved diabetes control and self-management among patients with T2DM on remote monitoring. Its role appears limited in improving health care use, lipid parameters, and quality of life; however, this may have been confounded by the short duration of follow-up in the studies. More studies are required to identify the optimal modality and duration of digital health coaching for patients with T2DM. ", doi="10.2196/60703", url="https://www.jmir.org/2025/1/e60703", url="http://www.ncbi.nlm.nih.gov/pubmed/40202791" } @Article{info:doi/10.2196/62916, author="Kostiuk, Marisa and Moore, L. Susan and Kramer, Seth E. and Gilens, Felton Joshua and Sarwal, Ashwin and Saxon, David and Thomas, F. John and Oser, K. Tamara", title="Assessment and Intervention for Diabetes Distress in Primary Care Using Clinical and Technological Interventions: Protocol for a Single-Arm Pilot Trial", journal="JMIR Res Protoc", year="2025", month="Mar", day="31", volume="14", pages="e62916", keywords="diabetes care", keywords="diabetes distress", keywords="primary care", keywords="healthcare chatbot", keywords="artificial intelligence", keywords="eConsult", keywords="care pathways", keywords="clinical workflows", abstract="Background: Diabetes distress (DD) is a common emotional response to living with diabetes. If not addressed, DD can have negative impacts on diabetes management, including the progression to mental health conditions such as depression and anxiety. Routine screening and treatment for DD is recommended, with primary care being an ideal setting given that the majority of people with diabetes receive their diabetes care from primary care providers. However, consistent screening of DD does not routinely occur in primary care settings. Research is needed to understand how to effectively and feasibly integrate DD screening and treatment into routine diabetes care. Objective: This study aims to (1) design and implement individualized technology-supported DD workflows, (2) evaluate the primary outcome of determining the acceptability and feasibility of integrating technology-based workflows to provide treatment for DD, and (3) evaluate the secondary outcomes of changes in DD, depression, and anxiety (baseline, 3 months, and 6 months) in patients receiving screening and personalized treatment. Methods: In total, 30 English and Spanish-speaking primary care patients with either type 1 or type 2 diabetes will receive screening for DD during clinical visits and subsequent support from an artificial intelligence (AI)--based health care chatbot with interactive tailored messaging. In addition, the use of electronic consultation with a specialist or referral to a behavioral health provider could occur depending on the severity and source of DD. The use of electronic consultations allows providers convenient and timely asynchronous access to a range of specialty care providers. Health outcomes will be measured through changes in validated screening measures for DD, depression, and anxiety. Digital outcomes will be measured through surveys assessing user experience with technology and system usability, and by system performance data. Qualitative data on acceptability and satisfaction with the clinical workflows and technological interventions will be collected through interviews with patients and clinical providers. Descriptive statistics will summarize quantitative outcome measures and responses to closed-ended survey items, and rapid thematic and content analysis will be conducted on open-ended survey and interview data. Results: Workflows for screening and treating DD have been approved and clinical staff have received training on the process. Electronic surveys for screening measure collection have been created. Data from visit screeners will be entered into the electronic medical record during the medical appointment. Recruitment will begin late June-July 2024. Conclusions: This study is expected to demonstrate the feasibility and acceptability of integrating individualized workflows for DD into primary care. Improving clinical and digital interventions for addressing DD in primary care can provide alternative care options for busy clinical providers. This study is intended to deliver whole-person diabetes care to people with diabetes within a primary care setting. International Registered Report Identifier (IRRID): PRR1-10.2196/62916 ", doi="10.2196/62916", url="https://www.researchprotocols.org/2025/1/e62916" } @Article{info:doi/10.2196/58951, author="Zhao, Yanchun and Huang, Ting and Chen, Yanli and Li, Songmei and Zhao, Juan and Han, Xu and Ni, Qing and Su, Ning", title="Evaluation of the Clinical Nursing Effects of a Traditional Chinese Medicine Nursing Program Based on Care Pathways for Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Clinical Trial", journal="JMIR Res Protoc", year="2025", month="Mar", day="31", volume="14", pages="e58951", keywords="type 2 diabetes", keywords="traditional Chinese medicine", keywords="TCM nursing program", keywords="clinical pathway", keywords="application research", keywords="diabetes", keywords="diabetes mellitus", keywords="research protocol", keywords="nursing", keywords="nursing program", keywords="nursing care", keywords="chronic disease", keywords="disease monitoring", keywords="prevalence", keywords="China", keywords="adult", keywords="patient recovery", keywords="psychological care", keywords="health education", keywords="quality of life", keywords="blood glucose", keywords="self-care", keywords="medication", keywords="control group", keywords="patient satisfaction", abstract="Background: To improve the performance of health care institutions, reduce overmedication, and minimize the waste of medical resources, China is committed to implementing a clinical pathway management model. This study aims to standardize nursing practices, foster clinical thinking in nurses, and promote patient recovery. Objective: The purpose of this study is to evaluate the clinical effects of a traditional Chinese medicine (TCM) nursing program based on nursing pathways for patients with type 2 diabetes mellitus (T2DM). Methods: This study uses a prospective, randomized, single-blind, parallel-controlled design. Based on sample size calculations, the study will include 594 patients with diabetes, with 2 groups of 297 patients: an observation group will receive a TCM nursing program based on clinical pathways, while a control group will receive routine care. Both groups will be evaluated before and after the intervention using assessment indicators. The primary outcome is the quality of life score, measured by a diabetes-specific quality of life questionnaire. Secondary outcomes include hospital stay duration, medical expenses, health knowledge, blood glucose control, symptom scores, and patient satisfaction. Results: This study was funded in August 2021 and has received approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2022-022-KY-01). The trial is ongoing, with the first patient enrolled in September 2022. The study is expected to conclude in April 2025. To date, 380 patients have been recruited, with 202 randomized into the study, though no statistical analysis of the data has yet been conducted. A single-blind method is used; nurses are aware of group assignments and intervention plans, while patients remain blinded. Final results are planned for release in the first quarter of 2025. Conclusions: This study seeks to integrate existing national standardized nursing protocols with clinical pathways to implement more efficient and higher-quality nursing practices. The goal is to standardize nursing procedures, enhance patients' quality of life, and improve self-care and medication adherence after discharge. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2022000048; https://tinyurl.com/y4jd68h4 International Registered Report Identifier (IRRID): DERR1-10.2196/58951 ", doi="10.2196/58951", url="https://www.researchprotocols.org/2025/1/e58951" } @Article{info:doi/10.2196/64400, author="Zhou, Jinyan and Ding, Shanni and Xu, Yihong and Pan, Hongying", title="Effects of Digital Intelligent Interventions on Self-Management of Patients With Diabetic Foot: Systematic Review", journal="J Med Internet Res", year="2025", month="Mar", day="25", volume="27", pages="e64400", keywords="diabetic foot", keywords="self-management", keywords="digital intelligent intervention", keywords="systematic review", keywords="mobile phone", abstract="Background: Diabetic foot (DF) is one of the most common and serious complications of diabetes. Effective self-management by patients can delay disease progression and improve quality of life. Digital intelligent technologies have emerged as advantageous in assisting patients with chronic diseases in self-management. However, the impact of digital intelligent technologies on self-management of patients with DF remains unclear. Objective: This systematic review aimed to determine the effects of digital intelligent interventions on self-management in patients with DF. Methods: A systematic literature search was conducted across PubMed, Web of Science, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Cochrane Central Register of Controlled Trial, ProQuest, China National Knowledge Internet, WanFang, China Science and Technology Journal Database, and SinoMed up to February 6, 2025, to identify eligible articles. Randomized controlled trials (RCTs) that assessed the effects of digital intelligent interventions on self-management of patients with DF were included. In total, 2 researchers independently conducted literature screening, quality assessment, and data extraction. The Cochrane Risk of Bias 2.0 tool (revised version 2019) for RCTs was used to assess the quality of the studies. A qualitative synthesis was conducted on the extracted data. Results: In total, 1079 articles were retrieved, and 18 RCTs were included. All studies were rated as having a high risk of bias. The digital intelligent interventions in the included studies varied in forms, components, and durations. The intervention forms included WeChat (Tencent Holdings Limited; 7/18, 39\%), apps (4/18, 22\%), electronic platforms (3/18, 17\%), mixed interventions (3/18, 17\%), and smartphone thermography (1/18, 6\%). The intervention components included self-management education (17/18, 94\%), blood glucose and foot condition monitoring (8/18, 44\%), self-management supervision and follow-up (6/18, 33\%), and other components like foot risk assessment, foot care reminders, visit reminders, and remote consultations. Intervention durations ranged from 5 weeks to 12 months, with the majority (10/18, 56\%) lasting 6 months. Among the 18 included studies, 17 studies (17/18, 94\%) indicated that, compared with routine care, digital intelligent interventions significantly improved the self-management behaviors of patients with DF, including diabetes control, foot care behaviors, and blood glucose monitoring. Only 1 study (1/18, 6\%) showed that the effects of digital intelligent interventions were not significantly different from those of routine care. Conclusions: In this systematic review, evidence suggests that digital intelligent interventions can improve self-management behaviors and capabilities in patients with DF. However, due to the overall low quality of the included studies, current evidence should be interpreted and applied with caution. This field is still in the exploratory stage, with significant heterogeneity among different studies and a lack of consensus on intervention strategies, necessitating further exploration tailored to different populations. Future RCTs with large sample sizes and rigorous design are needed to develop high-quality evidence. Trial Registration: PROSPERO CRD42024524473; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024524473 ", doi="10.2196/64400", url="https://www.jmir.org/2025/1/e64400" } @Article{info:doi/10.2196/64635, author="Shih, J. Jonathan and Kuznia, Magdalene and Nouri, Sarah and Sherwin, B. Elizabeth and Kemper, E. Kathryn and Rubinsky, D. Anna and Lyles, R. Courtney and Khoong, C. Elaine", title="Differences in Telemedicine Use for Patients With Diabetes in an Academic Versus Safety Net Health System: Retrospective Cohort Study", journal="J Med Internet Res", year="2025", month="Mar", day="24", volume="27", pages="e64635", keywords="telehealth", keywords="telemedicine", keywords="diabetes", keywords="delivery of health care", keywords="primary health care", keywords="health care utilization", keywords="health care disparities", keywords="chronic disease", keywords="COVID-19", keywords="safety net providers", keywords="public health emergency", keywords="older adults", abstract="Background: The COVID-19 public health emergency catalyzed widespread adoption of both video- and audio-only telemedicine visits. This proliferation highlighted inequities in use by age, race and ethnicity, and preferred language. Few studies have investigated how differences in health system telemedicine implementation affected these inequities. Objective: This study aims to describe patients who used telemedicine during the public health emergency and identify predictors of telemedicine use across 2 health systems with different telemedicine implementations. Methods: This retrospective cohort study included adults with diabetes receiving primary care between July 2020 and March 2021 at 2 independent health systems in San Francisco, California. Participant sociodemographic characteristics, health information, and telemedicine utilization were acquired from electronic health records. The primary outcome was visit type (any audio or video telemedicine vs in-person only) during the study period. We used multivariable logistic regression to assess the association between visit type and key predictors associated with digital exclusion (age, race and ethnicity, preferred language, and neighborhood socioeconomic status), adjusting for baseline health. We included an interaction term to evaluate health system impact on each predictor and then stratified by health system (academic, which prioritized video-enabled visits, vs safety net, which prioritized audio-only visits). Results: Among 10,201 patients, we found higher odds of telemedicine use in the safety net system compared with the academic system (adjusted odds ratio [aOR] 2.94, 95\% CI 2.48-3.48). Patients with younger age (18-34 years: aOR 2.55, 95\% CI 1.63-3.97; 35-49 years: aOR 1.39, 95\% CI 1.12-1.73 vs 75+ years) and Chinese-language preference (aOR 2.04, 95\% CI 1.66-2.5 vs English) had higher odds of having a telemedicine visit. Non-Hispanic Asian (aOR 0.67, 95\% CI 0.56-0.79), non-Hispanic Black (aOR 0.83, 95\% CI 0.68-1), and Hispanic or Latine (aOR 0.76, 95\% CI 0.61-0.95) patients had lower odds of having a telemedicine visit than non-Hispanic White patients. We found significant interactions between health system and age, race and ethnicity, and preferred language (P<.05). After stratifying by health system, several differences persisted in the academic system: non-Hispanic Asian (aOR 0.57, 95\% CI 0.46-0.70) and Latine (aOR 0.67, 95\% CI 0.50-0.91) patients had lower odds of a telemedicine visit, and younger age groups had higher odds (18-34 years: aOR 3.97, 95\% CI 1.99-7.93; 35-49 years: aOR 1.86, 95\% CI 1.36-2.56). In the safety net system, Chinese-speaking patients had higher odds of having a telemedicine visit (aOR 2.52, 95\% CI 1.85-3.42). Conclusions: We found disparities in telemedicine utilization by age, race and ethnicity, and preferred language, primarily in the health system that used more video visits. While telemedicine expanded rapidly recently, certain populations remain at risk for digital exclusion. These findings suggest that system-level factors influence telemedicine adoption and implementation decisions impact accessibility for populations at risk for digital exclusion. ", doi="10.2196/64635", url="https://www.jmir.org/2025/1/e64635", url="http://www.ncbi.nlm.nih.gov/pubmed/40126552" } @Article{info:doi/10.2196/51154, author="Nagpal, Meghan and Jalali, Niloofar and Sherifali, Diana and Morita, Plinio and Cafazzo, A. Joseph", title="Investigating Reddit Data on Type 2 Diabetes Management During the COVID-19 Pandemic Using Latent Dirichlet Allocation Topic Modeling and Valence Aware Dictionary for Sentiment Reasoning Analysis: Content Analysis", journal="JMIR Form Res", year="2025", month="Feb", day="21", volume="9", pages="e51154", keywords="diabetes", keywords="diabetes mellitus", keywords="DM", keywords="COVID-19", keywords="pandemics", keywords="social media", keywords="health behavior", keywords="health knowledge", keywords="attitudes", keywords="practice", keywords="self-management", keywords="patient-generated health data", keywords="perspective", keywords="T2DM", abstract="Background: Type 2 diabetes (T2D) is a chronic disease that can be partially managed through healthy behaviors. However, the COVID-19 pandemic impacted how people managed T2D due to work and school closures and social isolation. Moreover, individuals with T2D were at increased risk of complications from COVID-19 and experienced worsened mental health due to stress and anxiety. Objective: This study aims to synthesize emerging themes related to the health behaviors of people living with T2D, and how they were affected during the early stages of the COVID-19 pandemic by examining Reddit forums dedicated to people living with T2D. Methods: Data from Reddit forums related to T2D, from January 2018 to early March 2021, were downloaded using the Pushshift API; support vector machines were used to classify whether a post was made in the context of the pandemic. Latent Dirichlet allocation topic modelling was performed to identify topics of discussion across the entire dataset and a subsequent iteration was performed to identify topics specific to the COVID-19 pandemic. Sentiment analysis using the VADER (Valence Aware Dictionary for Sentiment Reasoning) algorithm was performed to assess attitudes towards the pandemic. Results: From all posts, the identified topics of discussion were classified into the following themes: managing lifestyle (sentiment score 0.25, 95\% CI 0.25-0.26), managing blood glucose (sentiment score 0.19, 95\% CI 0.18-0.19), obtaining diabetes care (sentiment score 0.19, 95\% CI 0.18-0.20), and coping and receiving support (sentiment score 0.34, 95\% CI 0.33-0.35). Among the COVID-19--specific posts, the topics of discussion were coping with poor mental health (sentiment score 0.04, 95\% CI ?0.01 to0.11), accessing doctor and medications and controlling blood glucose (sentiment score 0.14, 95\% CI 0.09-0.20), changing food habits during the pandemic (sentiment score 0.25, 95\% CI 0.20-0.31), impact of stress on blood glucose levels (sentiment score 0.03, 95\% CI ?0.03 to 0.08), changing status of employment and insurance (sentiment score 0.17, 95\% CI 0.13-0.22), and risk of COVID-19 complications (sentiment score 0.09, 95\% CI 0.03-0.14). Overall, posts classified as COVID-19--related (0.12, 95\% CI 0.01-0.15) were associated with a lower sentiment score than those classified as nonCOVID (0.25, 95\% CI 0.24-0.25). This study was limited due to the lack of a method for assessing the demographics of users and verifying whether users had T2D. Conclusions: Themes identified from Reddit data suggested that the COVID-19 pandemic significantly influenced how people with T2D managed their disease, particularly in terms of accessing care and dealing with the complications of the virus. Overall, the early stages of the pandemic negatively impacted the attitudes of people living with T2D. This study demonstrates that social media data can be a qualitative data source for understanding patient perspectives. ", doi="10.2196/51154", url="https://formative.jmir.org/2025/1/e51154" } @Article{info:doi/10.2196/60246, author="Mueller, Christian and Neusser, Thomas and Thate-Waschke, Inga and Nowicki, Julia and Plominski, Tomasz and Griesinger, Regine and Kessner, Stefanie and Martin, Stephan", title="Disease Awareness in Patients With Type 2 Diabetes: Analysis of Baseline Data From the SMART-Finder Observational Study", journal="JMIR Form Res", year="2025", month="Feb", day="18", volume="9", pages="e60246", keywords="app-based documentation", keywords="chronic kidney disease", keywords="CKD", keywords="disease awareness", keywords="MyTherapy", keywords="type 2 diabetes", keywords="type 2 diabetes mellitus", keywords="urine albumin-to-creatinine ratio screening", keywords="patient", keywords="observational study", keywords="Germany", keywords="quality of life", keywords="treatment", keywords="therapy", keywords="physician-patient communication", abstract="Background: Chronic kidney disease (CKD) is a common comorbidity of type 2 diabetes mellitus (T2DM). Data on the determination of CKD-related biomarkers among patients with T2DM in a real-life setting within Germany are limited. Objective: We aimed to determine the prevalence of CKD and risk factors, availability of urine albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) values, treatment satisfaction, and quality of life among patients with T2DM in Germany. Methods: SMART-Finder is a retrospective and prospective, observational, digital, patient-centered cohort study being performed as part of the routine use of an adherence-supporting app. This baseline analysis' observation period was from August to November 2023. Patients with T2DM in Germany who actively used the MyTherapy app; allowed push notifications; and documented use of diabetes medications, renin-angiotensin system inhibitors, finerenone, and/or blood glucose test strips were eligible for inclusion. Study materials (background information, electronic consent form, and laboratory and electronic questionnaires) were provided to eligible patients via app push notifications. Participants completed an electronic case report form that included questions on their blood pressure; their most recent UACR, eGFR, and glycated hemoglobin (HbA1c) values in the past 12 months; the EQ-5D-5L; and the Diabetes Treatment Satisfaction Questionnaire. The primary outcome was the proportion of patients with a UACR of ?30 mg/g. Results: Of 9527 invited eligible patients, 101 completed the electronic case report form (male: n=61; female: n=40; age: mean 54.2, SD 11.4 y). Of these, 1 female patient and 5 male patients reported their UACR values; 3 (all male) had a UACR of ?30 mg/g. The remaining 95 patients reported that their health care professionals had not provided UACR measurements. Only 9 (8.9\%) patients were aware of their latest eGFR values (3 patients: 15?44 mL/min/1.73 m2; 6 patients: 45?89 mL/min/1.73 m2), 90 provided HbA1c values (80 patients: ?6.0\%), 46 had a systolic blood pressure of ?130 mm Hg, and 83 reported former or current nephrotoxic medication intake. The mean EQ-5D-5L index score was 0.7 (SD 0.3; range --0.1 to 1.0; 50 patients). The mean Diabetes Treatment Satisfaction Questionnaire score was 28.8 (SD 6.8; range 9.0-36.0; 49 patients). Conclusions: Patients with T2DM who were using an adherence-supporting app in Germany lacked awareness of CKD-related biomarkers but had high knowledge of self-manageable biomarkers (eg, blood pressure, serum fasting glucose, and HbA1c values). Our results suggest that treating physicians either do not test for UACRs and eGFRs or do not inform patients about the results. Nonadherence to diagnostic testing guidelines and a lack of physician-patient communication put patients at risk. Another reason for this health literacy imbalance may be the focus on HbA1c instead of kidney comorbidity in patient education material. Future goals for diabetes management must include guideline-compliant testing of CKD-related biomarkers and open physician-patient communication. International Registered Report Identifier (IRRID): RR2-10.2196/44996 ", doi="10.2196/60246", url="https://formative.jmir.org/2025/1/e60246" } @Article{info:doi/10.2196/59608, author="Corser, Jenny and Yoldi, Irantzu and Reeves, D. Neil and Culmer, Pete and Venkatraman, D. Prabhuraj and Orlando, Giorgio and Turnbull, Peter Rory and Boakes, Paul and Woodin, Eric and Lightup, Roger and Ponton, Graham and Bradbury, Katherine", title="Developing a Smart Sensing Sock to Prevent Diabetic Foot Ulcers: Qualitative Focus Group and Interview Study", journal="J Particip Med", year="2025", month="Feb", day="14", volume="17", pages="e59608", keywords="diabetes", keywords="diabetic neuropathy", keywords="diabetic foot ulcer", keywords="podiatry", keywords="prevention", keywords="health technology", keywords="behavior change", abstract="Background: Diabetic foot ulcers are common and costly. Most cases are preventable, although few interventions exist to reliably support patients in performing self-care. Emerging technologies are showing promise in this domain, although patient and health care provider perspectives are rarely incorporated into digital intervention designs. Objective: This study explored patient and health care provider feedback on a smart sensing sock to detect shear strain and alert the wearer to change their behavior (ie, pause activity and check their feet) and considered how patient experience and attitudes toward self-care are likely to impact uptake and long-term effective engagement with the device to curate guiding principles for successful future intervention development. Methods: This qualitative study combined semistructured interviews and a focus group alongside a participant advisory group that was consulted throughout the study. In total, 20 people with diabetic neuropathy (n=16, 80\% with history of diabetic foot ulcers) and 2 carers were recruited directly from podiatry clinics as well as via a recruitment network and national health mobile app for one-to-one interviews either in person or via landline or video call. A total of 6 podiatrists were recruited via professional networks for 1 virtual focus group. Participants were asked about their experience of diabetic foot health and for feedback on the proposed device, including how it might work for them in daily life or clinical practice. The data were analyzed thematically. Results: Three main themes were generated, each raising a barrier to the use of the sock complemented by potential solutions: (1) patient buy-in---challenged by lack of awareness of risk and potentially addressed through using the device to collect and record evidence to enhance clinical messaging; (2) effective engagement---challenged by difficulties accepting and actioning information and requiring simple, specific, and supportive instructions in line with podiatrist advice; and (3) sustained use---challenged by difficulties coping, with the possibility to gain control through an early warning system. Conclusions: While both patients and podiatrists were interested in the concept, it would need to be packaged as part of a wider health intervention to overcome barriers to uptake and longer-term effective engagement. This study recommends specific considerations for the framing of feedback messages and instructions as well as provision of support for health care providers to integrate the use of such smart devices into practice. The guiding principles generated by this study can orient future research and development of smart sensing devices for diabetic foot care to help optimize patient engagement and improve health outcomes. ", doi="10.2196/59608", url="https://jopm.jmir.org/2025/1/e59608" } @Article{info:doi/10.2196/60275, author="Ray, Katherine Mary and Fleming, Jorie and Aschenbrenner, Andrew and Hassenstab, Jason and Redwine, Brooke and Burns, Carissa and Arbelaez, Maria Ana and Vajravelu, Ellen Mary and Hershey, Tamara", title="Assessing Dynamic Cognitive Function in the Daily Lives of Youths With and Without Type 1 Diabetes: Usability Study", journal="JMIR Form Res", year="2025", month="Feb", day="11", volume="9", pages="e60275", keywords="ecological momentary assessment", keywords="EMA", keywords="ambulatory", keywords="smartphone", keywords="continuous glucose monitoring", keywords="CGM", keywords="assessment", keywords="daily lives", keywords="youth", keywords="type 1 diabetes", keywords="diabetes", keywords="feasibility study", keywords="pilot study", keywords="glycemic control", keywords="environmental factor", keywords="phone", keywords="acceptability", keywords="young", keywords="cognitive test", keywords="app", keywords="application", keywords="mobile phone", abstract="Background: Studies have shown a relationship between worse glycemic control and lower cognitive scores in youths with type 1 diabetes (T1D). However, most studies assess long-term glucose control (eg, years-decades) and cognition at a single time point. Understanding this relationship at a higher temporal resolution (eg, minutes-hours) and in naturalistic settings has potential clinical implications. Newer technology (eg, continuous glucose monitoring [CGM] and ecological momentary assessment) provides a unique opportunity to explore the glucose dynamics that influence dynamic cognition; that is, cognitive functions that fluctuate short-term and are influenced by environmental factors. Objective: Before we can assess this relationship, we need to determine the feasibility of measuring cognition in youths in daily life and determine the plausibility of obtaining glucose variation with CGM to be integrated with real-time cognition measures. This study's purpose was to assess the acceptability of measuring dynamic cognition using a smartphone app and adherence to cognitive testing in daily life in youths with and without T1D. Further, we assessed CGM-derived glucose measures at temporally related timeframes to cognitive testing in naturalistic settings. Methods: Data were obtained from 3 studies including one in-laboratory study and 2 remote studies. For all studies, youths were asked to complete cognitive tests on the Ambulatory Research in Cognition (ARC) smartphone app that measured processing speed, associative memory, and working memory. For the in-laboratory study, youths completed testing 4 times during 1 session. For the remote studies, youths were asked to complete cognitive tests 5 times per day for either 10 or 14 consecutive days in daily life. Youths were asked to rate their impressions of the app. Youths with T1D wore a CGM. Results: 74 youths (n=53 control; n=21 T1D) aged 4?16 years participated. Youths generally reported liking or understanding the ARC app tasks in a laboratory and remote setting. Youths had high testing adherence in daily life (2350/3080 to 721/900, 76.3\%?80.2\%) and none dropped out. The percentage of measurements within each glycemic range taken immediately before the app's cognitive testing was 3\% (28/942) low glucose, 51\% (484/942) euglycemia, 23\% (221/942) high glucose, and 22\% (210/942) very high glucose. In the 2-hour window before each cognitive task, mean glucose was 182.5 (SD 76.2) mg/dL, SD in glucose was 27.1 mg/dL (SD 18.7), and the mean maximum difference between the highest and lowest glucose was 85.5 (SD 53.7) mg/dL. Conclusions: The results suggest that using the ARC smartphone app to assess dynamic cognitive functions in youths with and without T1D is feasible. Further, we showed CGM-derived glycemic variability at temporally associated timeframes of dynamic cognitive assessments. The next steps include using ecological momentary assessment in a fully powered study to determine the relationship between short-term glycemic control and cognition in youths with T1D. ", doi="10.2196/60275", url="https://formative.jmir.org/2025/1/e60275" } @Article{info:doi/10.2196/58107, author="Kim, Sunyoung and Park, Jaeyu and Son, Yejun and Lee, Hojae and Woo, Selin and Lee, Myeongcheol and Lee, Hayeon and Sang, Hyunji and Yon, Keon Dong and Rhee, Youl Sang", title="Development and Validation of a Machine Learning Algorithm for Predicting Diabetes Retinopathy in Patients With Type 2 Diabetes: Algorithm Development Study", journal="JMIR Med Inform", year="2025", month="Feb", day="7", volume="13", pages="e58107", keywords="type 2 diabetes", keywords="diabetes retinopathy", keywords="algorithm", keywords="machine learning", keywords="prediction", keywords="comorbidities", keywords="retinal", keywords="ophthalmology", abstract="Background: Diabetic retinopathy (DR) is the leading cause of preventable blindness worldwide. Machine learning (ML) systems can enhance DR in community-based screening. However, predictive power models for usability and performance are still being determined. Objective: This study used data from 3 university hospitals in South Korea to conduct a simple and accurate assessment of ML-based risk prediction for the development of DR that can be universally applied to adults with type 2 diabetes mellitus (T2DM). Methods: DR was predicted using data from 2 independent electronic medical records: a discovery cohort (one hospital, n=14,694) and a validation cohort (2 hospitals, n=1856). The primary outcome was the presence of DR at 3 years. Different ML-based models were selected through hyperparameter tuning in the discovery cohort, and the area under the receiver operating characteristic (ROC) curve was analyzed in both cohorts. Results: Among 14,694 patients screened for inclusion, 348 (2.37\%) were diagnosed with DR. For DR, the extreme gradient boosting (XGBoost) system had an accuracy of 75.13\% (95\% CI 74.10?76.17), a sensitivity of 71.00\% (95\% CI 66.83?75.17), and a specificity of 75.23\% (95\% CI 74.16?76.31) in the original dataset. Among the validation datasets, XGBoost had an accuracy of 65.14\%, a sensitivity of 64.96\%, and a specificity of 65.15\%. The most common feature in the XGBoost model is dyslipidemia, followed by cancer, hypertension, chronic kidney disease, neuropathy, and cardiovascular disease. Conclusions: This approach shows the potential to enhance patient outcomes by enabling timely interventions in patients with T2DM, improving our understanding of contributing factors, and reducing DR-related complications. The proposed prediction model is expected to be both competitive and cost-effective, particularly for primary care settings in South Korea. ", doi="10.2196/58107", url="https://medinform.jmir.org/2025/1/e58107" } @Article{info:doi/10.2196/68914, author="Thiagarajan, Nishanth and Tan, Chang Hong and Rama Chandran, Suresh and Lee, Ching Phong and Chin, Ann Yun and Zeng, Wanling and Ho, Lin Emily Tse and Carmody, David and Goh, Su-Yen and Bee, Mong Yong", title="Web-Based, Algorithm-Guided Insulin Titration in Insulin-Treated Type 2 Diabetes: Pre-Post Intervention Study", journal="JMIR Form Res", year="2025", month="Feb", day="7", volume="9", pages="e68914", keywords="diabetes", keywords="insulin", keywords="monitoring", keywords="technology", keywords="mobile", keywords="app", keywords="intervention", abstract="Background: Self-monitoring of blood glucose (SMBG) using web-based diabetes management platforms has demonstrated promise in managing type 2 diabetes (T2D). However, the effectiveness of such systems incorporating algorithm-guided insulin titration has not been extensively studied in Asian populations. Objective: This study evaluates the efficacy and safety of the ALRT telehealth solution---a US Food and Drug Administration--cleared, web-based platform that integrates SMBG with algorithm-driven insulin dose adjustments---in improving glycemia in insulin-treated T2D. Methods: This 24-week, pre-post intervention study enrolled 25 adults with T2D (mean age 58.9, SD 7.0 y; n=14, 56\% male) on twice-daily premixed insulin. Inclusion criteria included a baseline hemoglobin A1c (HbA1c) level between 7.5\% to 9.9\% (58?86 mmol/mol), a BMI ?40 kg/m{\texttwosuperior}, and experience with SMBG. Participants uploaded twice-daily SMBG data weekly via a mobile app, which generated insulin titration recommendations based on a predefined algorithm. Physicians reviewed and approved the recommendations, which were then communicated back to participants via the app. The primary outcome was the change in HbA1c level from baseline to 24 weeks. Secondary outcomes included changes in fasting plasma glucose, insulin dose, hypoglycemia incidence, and SMBG adherence. Results: Participants achieved significant reductions in HbA1c level from 8.6\% (70 mmol/mol) at baseline to 7.4\% (57 mmol/mol) at 24 weeks (P<.001), with reductions of 0.8\% and 0.4\% in the first and second 12 weeks, respectively. Fasting plasma glucose decreased from 8.7 (SD 2.0) mmol/L to 7.1 (SD 1.4) mmol/L (P<.001). Mean total daily insulin dose increased modestly from 0.73 (SD 0.31) units/kg/day to 0.79 (SD 0.34) units/kg/day (P=.007). Participants demonstrated high adherence, completing 97.3\% (327/336) of prescribed SMBG measurements. During the study, 48\% (12/25) of participants experienced at least 1 hypoglycemia episode, predominantly mild hypoglycemia (85/96, 88.5\%; glucose 3.0?3.9 mmol/L). Hypoglycemia episodes increased from 24 during weeks 0?12 to 72 during weeks 13?24. There were no episodes of severe hypoglycemia requiring external assistance. BMI increased slightly from 29.0 (SD 3.6) kg/m{\texttwosuperior} to 29.5 (SD 3.6) kg/m{\texttwosuperior} (P=.03), reflecting a modest weight gain associated with improved glycemia. Conclusions: In conclusion, patients with insulin-treated T2D initiated on a web-based glucose monitoring system with algorithm-guided dosing recommendations showed significant improvement in glycemic control compared to baseline. High adherence rates underscore the feasibility of integrating algorithm-guided insulin titration into routine care. While hypoglycemia incidence rose slightly, episodes were predominantly mild, and no severe events occurred. This intervention shows promise for broader adoption in T2D management, particularly in resource-constrained settings. ", doi="10.2196/68914", url="https://formative.jmir.org/2025/1/e68914" } @Article{info:doi/10.2196/57526, author="Reichert, Matthew and De La Cruz, A. Barbara and Gardiner, Paula and Mitchell, Suzanne", title="Diabetes Medical Group Visits and Type 2 Diabetes Outcomes: Mediation Analysis of Diabetes Distress", journal="JMIR Diabetes", year="2025", month="Feb", day="6", volume="10", pages="e57526", keywords="diabetes", keywords="diabetic", keywords="diabetes mellitus", keywords="DM", keywords="type 1 diabetes", keywords="type 2 diabetes", keywords="diabetes mellitus type 2", keywords="diabetes outcomes", keywords="diabetes medical group visit", keywords="DMGVs", keywords="psychosocial functioning", keywords="psychosocial", keywords="glycemic control", keywords="glycemic", keywords="shared medical appointments", keywords="self-management", keywords="mediation analysis", keywords="social support", keywords="minority women", keywords="minority", abstract="Background: Group-based diabetes care, both technology-enabled and in-person, can improve diabetes outcomes in low-income minority women, but the mechanism remains unclear. Objective: We tested whether diabetes group medical visits (GMVs) reduced hemoglobin A1c (HbA1c) by mitigating diabetes distress (DD), an emotional response affecting nearly half of adults with type 2 diabetes in community settings. Methods: We conducted a mediation and moderation analysis of data from the Women in Control 2.0 comparative effectiveness study, which showed that both technology-enabled and in-person diabetes GMVs improve HbA1c. We tested whether DD mediated the relationship between diabetes GMV engagement and reductions in HbA1c. We also tested whether this relationship was moderated by depressive symptoms and social support. Participants were 309 low-income and minority women. Diabetes GMV engagement was measured using the Group Climate Questionnaire. The mediator, DD, was measured using the Diabetes Distress Screening Scale. The outcome was the 6-month change in HbA1c. Social support was measured using the Medical Outcomes Study Social Support Survey. Results: DD mediated the relationship between engagement and 6-month HbA1c. Specifically, group engagement affected HbA1c by reducing distress associated with the regimen of diabetes self-management (P=.04), and possibly the emotional burden of diabetes (P=.09). The relationship between engagement and 6-month HbA1c was moderated by depressive symptoms (P=.02), and possibly social support (P=.08). Conclusions: Engagement in diabetes GMVs improved HbA1c because it helped reduce diabetes-related distress, especially related to the regimen of diabetes management and possibly related to its emotional burden, and especially for women without depressive symptoms and possibly for women who lacked social support. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/study/NCT02726425 ", doi="10.2196/57526", url="https://diabetes.jmir.org/2025/1/e57526" } @Article{info:doi/10.2196/51718, author="Sa'id, Mohd Iklil Iman and Hotung, Natasha and Benton, Madeleine and Nadal, Papachristou Iliatha and Baharom, Anisah and Prina, Matthew and Nisak Mohd Yusof, Barakatun and Goldsmith, Kimberley and Birts, Samantha and Siew Mooi, Ching and Forbes, Angus and Ismail, Khalida and Chew, How Boon", title="Process Evaluations of Interventions for the Prevention of Type 2 Diabetes in Women With Gestational Diabetes Mellitus: Systematic Review", journal="Interact J Med Res", year="2025", month="Feb", day="6", volume="14", pages="e51718", keywords="gestational diabetes mellitus", keywords="randomized controlled trial", keywords="process evaluation", keywords="implementation", keywords="complex interventions", abstract="Background: Gestational diabetes mellitus (GDM) is characterized by hyperglycemia in pregnancy and typically resolves after birth. Women with GDM have an increased risk of developing type 2 diabetes mellitus (T2DM) later in life compared to those with normoglycemic pregnancy. While diabetes prevention interventions (DPIs) have been developed to delay or prevent the onset of T2DM, few studies have provided process evaluation (PE) data to assess the mechanisms of impact, quality of implementation, or contextual factors that may influence the effectiveness of the intervention. Objective: This study aims to identify and evaluate PE data and how these link to outcomes of randomized controlled trials (RCTs) of T2DM prevention interventions for women with GDM. Methods: A systematic review was conducted to identify studies published from 2005 to 2020 aiming to capture the most recent DPIs. Five electronic bibliographic databases (Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, Embase, PubMed, and MEDLINE) were searched to identify relevant studies. Inclusion criteria were published (peer-reviewed) RCTs of DPIs in women with a current diagnosis or history of GDM. Exclusion criteria were studies not published in English; studies where the target population was women who had a family history of T2D or women who were menopausal or postmenopausal; and gray literature, including abstracts in conference proceedings. The Medical Research Council's PE framework of complex interventions was used to identify key PE components. The Mixed Method Appraisal Tool was used to assess the quality of included studies. Results: A total of 24 studies were included; however, only 5 studies explicitly reported a PE theoretical framework. The studies involved 3 methods of intervention delivery, including in person (n=7), digital (n=7), and hybrid (n=9). Two of the studies conducted pilot RCTs assessing the feasibility and acceptability of their interventions, including recruitment, participation, retention, program implementation, adherence, and satisfaction, and 1 study assessed the efficacy of a questionnaire to promote food and vegetable intake. While most studies linked PE data with study outcomes, it was unclear which of the reported PE components were specifically linked to the positive outcomes. Conclusions: While the Medical Research Council's framework is a valuable source for conducting systematic reviews on PEs, it has been criticized for lacking practical advice on how to conduct them. The lack of information on PE frameworks in our review also made it difficult to categorize individual PE components against the framework. We need clearer guidance and robust frameworks for conducting PEs for the development and reporting of DPIs for women with GDM. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020208212; https://www.crd.york.ac.uk/PROSPERO/display\_record.php?RecordID=208212 International Registered Report Identifier (IRRID): RR2-https://doi.org/10.1177/16094069211034010 ", doi="10.2196/51718", url="https://www.i-jmr.org/2025/1/e51718" } @Article{info:doi/10.2196/64479, author="Beuken, JM Maik and Kleynen, Melanie and Braun, Susy and Van Berkel, Kees and van der Kallen, Carla and Koster, Annemarie and Bosma, Hans and Berendschot, TJM Tos and Houben, JHM Alfons and Dukers-Muijrers, Nicole and van den Bergh, P. Joop and Kroon, A. Abraham and and Kanera, M. Iris", title="Identification of Clusters in a Population With Obesity Using Machine Learning: Secondary Analysis of The Maastricht Study", journal="JMIR Med Inform", year="2025", month="Feb", day="5", volume="13", pages="e64479", keywords="Maastricht Study", keywords="participant clusters", keywords="cluster analysis", keywords="factor probabilistic distance clustering", keywords="FPDC algorithm", keywords="statistically equivalent signature", keywords="SES feature selection", keywords="unsupervised machine learning", keywords="obesity", keywords="hypothesis free", keywords="risk factor", keywords="physical inactivity", keywords="poor nutrition", keywords="physical activity", keywords="chronic disease", keywords="type 2 diabetes", keywords="diabetes", keywords="heart disease", keywords="long-term behavior change", abstract="Background: Modern lifestyle risk factors, like physical inactivity and poor nutrition, contribute to rising rates of obesity and chronic diseases like type 2 diabetes and heart disease. Particularly personalized interventions have been shown to be effective for long-term behavior change. Machine learning can be used to uncover insights without predefined hypotheses, revealing complex relationships and distinct population clusters. New data-driven approaches, such as the factor probabilistic distance clustering algorithm, provide opportunities to identify potentially meaningful clusters within large and complex datasets. Objective: This study aimed to identify potential clusters and relevant variables among individuals with obesity using a data-driven and hypothesis-free machine learning approach. Methods: We used cross-sectional data from individuals with abdominal obesity from The Maastricht Study. Data (2971 variables) included demographics, lifestyle, biomedical aspects, advanced phenotyping, and social factors (cohort 2010). The factor probabilistic distance clustering algorithm was applied in order to detect clusters within this high-dimensional data. To identify a subset of distinct, minimally redundant, predictive variables, we used the statistically equivalent signature algorithm. To describe the clusters, we applied measures of central tendency and variability, and we assessed the distinctiveness of the clusters through the emerged variables using the F test for continuous variables and the chi-square test for categorical variables at a confidence level of $\alpha$=.001 Results: We identified 3 distinct clusters (including 4128/9188, 44.93\% of all data points) among individuals with obesity (n=4128). The most significant continuous variable for distinguishing cluster 1 (n=1458) from clusters 2 and 3 combined (n=2670) was the lower energy intake (mean 1684, SD 393 kcal/day vs mean 2358, SD 635 kcal/day; P<.001). The most significant categorical variable was occupation (P<.001). A significantly higher proportion (1236/1458, 84.77\%) in cluster 1 did not work compared to clusters 2 and 3 combined (1486/2670, 55.66\%; P<.001). For cluster 2 (n=1521), the most significant continuous variable was a higher energy intake (mean 2755, SD 506.2 kcal/day vs mean 1749, SD 375 kcal/day; P<.001). The most significant categorical variable was sex (P<.001). A significantly higher proportion (997/1521, 65.55\%) in cluster 2 were male compared to the other 2 clusters (885/2607, 33.95\%; P<.001). For cluster 3 (n=1149), the most significant continuous variable was overall higher cognitive functioning (mean 0.2349, SD 0.5702 vs mean --0.3088, SD 0.7212; P<.001), and educational level was the most significant categorical variable (P<.001). A significantly higher proportion (475/1149, 41.34\%) in cluster 3 received higher vocational or university education in comparison to clusters 1 and 2 combined (729/2979, 24.47\%; P<.001). Conclusions: This study demonstrates that a hypothesis-free and fully data-driven approach can be used to identify distinguishable participant clusters in large and complex datasets and find relevant variables that differ within populations with obesity. ", doi="10.2196/64479", url="https://medinform.jmir.org/2025/1/e64479" } @Article{info:doi/10.2196/63975, author="Wang, Yachen and Chai, Xin and Wang, Yueqing and Yin, Xuejun and Huang, Xinying and Gong, Qiuhong and Zhang, Juan and Shao, Ruitai and Li, Guangwei", title="Effectiveness of Different Intervention Modes in Lifestyle Intervention for the Prevention of Type 2 Diabetes and the Reversion to Normoglycemia in Adults With Prediabetes: Systematic Review and Meta-Analysis of Randomized Controlled Trials", journal="J Med Internet Res", year="2025", month="Jan", day="29", volume="27", pages="e63975", keywords="mobile phone", keywords="prediabetic state", keywords="digital health intervention", keywords="intervention mode", keywords="lifestyle intervention", keywords="type 2 diabetes mellitus", keywords="meta-analysis", keywords="systematic review", keywords="review", abstract="Background: Lifestyle interventions have been acknowledged as effective strategies for preventing type 2 diabetes mellitus (T2DM). However, the accessibility of conventional face-to-face interventions is often limited. Digital health intervention has been suggested as a potential solution to overcome the limitation. Despite this, there remains a significant gap in understanding the effectiveness of digital health for individuals with prediabetes, particularly in reducing T2DM incidence and reverting to normoglycemia. Objective: This study aimed to assess the effectiveness of different intervention modes of digital health, face-to-face, and blended interventions, particularly the benefits of digital health intervention, in reducing T2DM incidence and facilitating the reversion to normoglycemia in adults with prediabetes compared to the usual care. Methods: We conducted a comprehensive search in 9 electronic databases, namely MEDLINE, Embase, ACP Journal Club, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Cochrane Clinical Answers, Cochrane Methodology Register, Health Technology Assessment, and NHS Economic Evaluation Database through Ovid, from the inception to October 2024. This review included randomized controlled trials (RCTs) that studied the effectiveness of lifestyle interventions in adults with prediabetes. The overall intervention effect was synthesized using a random-effects model. The I{\texttwosuperior} statistic was used to assess heterogeneity across the RCTs. We performed a subgroup analysis to explore the effectiveness of digital health, face-to-face, and blended interventions compared with the control group, which received usual care. Results: From an initial 7868 records retrieved from 9 databases, we identified 54 articles from 31 RCTs. Our analysis showed that face-to-face interventions demonstrated a significant 46\% risk reduction in T2DM incidence (risk ratio [RR] 0.54, 95\% CI 0.47-0.63; I{\texttwosuperior}=43\%; P<.001), and a 46\% increase in the reversion to normoglycemia (RR 1.46, 95\% CI 1.11-1.91; I{\texttwosuperior}=82\%; P=.006), when compared with the control group. On the other hand, digital health interventions, compared with the control group, were associated with a 12\% risk reduction in T2DM incidence (RR 0.88, 95\% CI 0.77-1.01; I{\texttwosuperior}=0.6\%; P=.06). Moreover, the blended interventions combining digital and face-to-face interventions suggested a 37\% risk reduction in T2DM incidence (RR 0.63, 95\% CI 0.49-0.81;I{\texttwosuperior}<0.01\%; P<.001) and an 87\% increase in the reversion to normoglycemia (RR 1.87, 95\% CI 1.30-2.69; I{\texttwosuperior}=23\%; P=.001). However, no significant effect on the reversal of prediabetes to normoglycemia was observed from the digital health interventions. Conclusions: Face-to-face interventions have consistently demonstrated promising effectiveness in both reductions in T2DM incidence and reversion to normoglycemia in adults with prediabetes. However, the effectiveness of digital health interventions in these areas has not been sufficiently proven. Given these results, further research is required to provide more definitive evidence of digital health and blended interventions in T2DM prevention in the future. Trial Registration: PROSPERO CRD42023414313; https://tinyurl.com/55ac4j4n ", doi="10.2196/63975", url="https://www.jmir.org/2025/1/e63975" } @Article{info:doi/10.2196/62931, author="Moumjid, Nora and Gotte, Constance and Hommey, Sophie and Poupon Bourdy, St{\'e}phanie and Haesebaert, Julie and Durieu, Isabelle and Reynaud, Quitterie", title="Mixed Comparative Evaluation of a Training Program Dedicated to Cystic Fibrosis Reference Centers: Protocol for the Pilot Implementation of Shared Decision-Making in the Treatment of Diabetes in Adult Patients With Cystic Fibrosis", journal="JMIR Res Protoc", year="2025", month="Jan", day="28", volume="14", pages="e62931", keywords="shared decision-making", keywords="implementation", keywords="training", keywords="decision aid", keywords="cystic fibrosis", abstract="Background: Diabetes affects half of the patients with cystic fibrosis who are aged 30 years and older. Diabetes progresses asymptomatically over a long period of time. Two treatment options are possible: start insulin as soon as cystic fibrosis diagnosis is made with the additional constraints of cystic fibrosis or wait while monitoring the patient's clinical condition and start insulin when diabetes symptoms develop and therefore later. This situation is particularly well suited to shared decision-making (SDM) between the physician (health care team) and patient/relatives. Objective: The aim of this study was to perform qualitative and quantitative analyses for evaluating the outcomes and experience of SDM implementation between the physician/health care team trained for SDM and patients/their relatives for cystic fibrosis--related diabetes. Methods: A quasi-experimental with a comparison study will be developed. Three cystic fibrosis reference centers (CFRCs) will be trained in SDM by using a web-based training, including a validated decision aid and coaching for physicians and the medical team. Two control CFRCs will maintain their usual practices. A qualitative analysis through observation of consultations, individual semistructured interviews with patients, and focus groups in CFRCs will be conducted based on a thematic content analysis. Questionnaires related to decision-making and experience of decision-making with and without SDM implementation will be administered to patients and physicians. Results: Forty patients will be included (8 patients in each center), that is, 60 consultation observations (2 consultations per patient in the intervention groups given the modalities of the SDM process) will be conducted in 2025. Eight focus groups will be conducted in the 5 centers (2 groups in each intervention CFRC and 1 group in each control CFRC). This qualitative corpus plus responses to the patient and physician questionnaires will make it possible to know whether the practice of SDM in CFRCs is increased by an implementation strategy and to analyze the experience of patients and their relatives regarding decision-making modalities. Analysis of the outcomes and experience of the implementation of SDM are of importance to identify the facilitators and barriers to SDM from patients' and CFRCs' point of views. Conclusions: Our study will give us keys to adapt, improve, and disseminate SDM more widely in the context of cystic fibrosis therapy. SDM could thus be used in routine clinical practice in CFRCs at the national level. Trial Registration: ClinicalTrials.gov NCT04891159; https://clinicaltrials.gov/study/NCT04891159?id=NCT04891159 International Registered Report Identifier (IRRID): PRR1-10.2196/62931 ", doi="10.2196/62931", url="https://www.researchprotocols.org/2025/1/e62931" } @Article{info:doi/10.2196/54324, author="Bodner, Emma and Roth, Lena and Wiencke, Kathleen and Bischoff, Christian and Schwarz, EH Peter", title="Effect of Multimodal App-Based Interventions on Glycemic Control in Patients With Type 2 Diabetes: Systematic Review and Meta-Analysis", journal="J Med Internet Res", year="2025", month="Jan", day="24", volume="27", pages="e54324", keywords="app-based interventions", keywords="diabetes mellitus type 2", keywords="digital health", keywords="real world evidence", keywords="pragmatic trials", keywords="ehealth", keywords="mhealth", keywords="HbA1c", keywords="systematic review", keywords="meta-analysis", keywords="interventions", keywords="app", keywords="glycemic", keywords="patients", keywords="type 2 diabetes", abstract="Background: Digital technologies for type 2 diabetes mellitus (T2DM) care hold great potential to improve patients' health in the long term. Only a subset of telemedicine offerings are digital interventions that meet the criteria for prescribable digitale Gesundheitsanwendung (digital health apps; DiGAs) in Germany. Digital treatments further provide vast amounts of patient data that are important to generate evidence. Objective: This systematic review aims to analyze the efficacy of multimodal digital therapies that mainly meet the DiGA criteria for patients with T2DM and to elicit the potential of such therapies. This includes evidence from randomized controlled trials (RCTs) as well as from real-world data. The outcome of interest was a reduction in glycated hemoglobin (hemoglobin A1c [HbA1c]; long-term blood glucose measurements). Methods: A systematic literature search was conducted in the literature bases PubMed, LIVIVO, and Cochrane, based on the predefined PICO (Population; Intervention; Control; Outcome) scheme. Identified studies were assessed for risk of bias, pragmatism, and overall quality of evidence. Meta-analyses were conducted for between group differences using RCTs only, and for within-group differences using RCTs and non-RCTs, to examine the effect of the interventions on HbA1c. Results: In total, 795 records were identified, of which 24 were eligible for this systematic review and 23 studies were eligible for the meta-analysis. The results of the meta-analyses showed significant and clinically relevant reductions in HbA1c in patients with T2DM. Regarding the between-group difference for HbA1c reduction, the pooled effect of the RCTs showed a reduction of --0.36\% (95\% CI --0.59\% to --0.14\%; P<.001), favoring app-based interventions. The average mean within-group reduction in HbA1c was --0.79 (95\% CI --1.02 to --0.55), with no significant difference between RCTs (--0.69, 95\% CI --1.13 to --0.24) and non-RCTs (--0.87, 95\% CI --1.16 to --0.57; P<.01, differences between RCTs and RCTs P=.44). A pragmatism rating showed that both study types were on average (very) pragmatic, that is, close to usual care. However, the overall quality of evidence was low to very low. Conclusions: This systematic review shows that digital therapies that mainly meet the DiGA criteria can effectively improve HbA1c in patients with T2DM. The integration of digital health care into usual care holds great potential and should be considered as a complementary option to usual care in the future. Trial Registration: PROSPERO CRD42023440203; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=440203 ", doi="10.2196/54324", url="https://www.jmir.org/2025/1/e54324" } @Article{info:doi/10.2196/59308, author="Choudhry, K. Niteesh and Priyadarshini, Shweta and Swamy, Jaganath and Mehta, Mridul", title="Use of Machine Learning to Predict Individual Postprandial Glycemic Responses to Food Among Individuals With Type 2 Diabetes in India: Protocol for a Prospective Cohort Study", journal="JMIR Res Protoc", year="2025", month="Jan", day="23", volume="14", pages="e59308", keywords="diabetes", keywords="T2DM", keywords="diabetes management", keywords="food responsiveness", keywords="postprandial glucose response", keywords="food intake", keywords="diet logs", keywords="dietary intake", keywords="machine learning", abstract="Background: Type 2 diabetes (T2D) is a leading cause of premature morbidity and mortality globally and affects more than 100 million people in the world's most populous country, India. Nutrition is a critical and evidence-based component of effective blood glucose control and most dietary advice emphasizes carbohydrate and calorie reduction. Emerging global evidence demonstrates marked interindividual differences in postprandial glucose response (PPGR) although no such data exists in India and previous studies have primarily evaluated PPGR variation in individuals without diabetes. Objective: This prospective cohort study seeks to characterize the PPGR variability among individuals with diabetes living in India and to identify factors associated with these differences. Methods: Adults with T2D and a hemoglobin A1c of ?7 are being enrolled from 14 sites around India. Participants wear a continuous glucose monitor, eat a series of standardized meals, and record all free-living foods, activities, and medication use for a 14-day period. The study's primary outcome is PPGR, calculated as the incremental area under the curve 2 hours after each logged meal. Results: Data collection commenced in May 2022, and the results will be ready for publication by September 2025. Results from our study will generate data to facilitate the creation of machine learning models to predict individual PPGR responses and to facilitate the prescription of personalized diets for individuals with T2D. Conclusions: This study will provide the first large scale examination variability in blood glucose responses to food in India and will be among the first to estimate PPGR variability for individuals with T2D in any jurisdiction. Trial Registration: Clinical Trials Registry-India CTRI/2022/02/040619; https://tinyurl.com/mrywf6bf International Registered Report Identifier (IRRID): DERR1-10.2196/59308 ", doi="10.2196/59308", url="https://www.researchprotocols.org/2025/1/e59308", url="http://www.ncbi.nlm.nih.gov/pubmed/39847416" } @Article{info:doi/10.2196/58319, author="Ruiz-Leon, Maria Ana and Casas, Rosa and Castro-Barquero, Sara and Alfaro-Gonz{\'a}lez, Sofia and Radeva, Petia and Sacanella, Emilio and Casanovas-Garriga, Francesc and P{\'e}rez-Gesal{\'i}, Ainhoa and Estruch, Ramon", title="Efficacy of a Mobile Health--Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Jan", day="22", volume="27", pages="e58319", keywords="type 2 diabetes", keywords="cardiovascular health", keywords="lifestyle intervention", keywords="mHealth", keywords="artificial intelligence", keywords="mobile health", keywords="mobile application", keywords="diabetes", keywords="DM", keywords="self-management", keywords="randomized controlled trial", keywords="RCT", keywords="health care", keywords="self-care", keywords="Greenhabit", keywords="behavioral health", keywords="treatment", keywords="medication", keywords="analysis of covariance", keywords="intervention", keywords="work-life balance", keywords="cardiovascular", keywords="cardiovascular risk", abstract="Background: Enhancing self-management in health care through digital tools is a promising strategy to empower patients with type 2 diabetes (T2D) to improve self-care. Objective: This study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatment enhances T2D outcomes compared with standard care. Methods: A 12-week, parallel, single-blind randomized controlled trial was conducted with 123 participants (62/123, 50\%, female; mean age 58.25 years, SD 9.46 years) recently diagnosed with T2D. Participants were recruited face-to-face from primary care centers in Barcelona, Spain, between July 2021 and March 2022. They were randomly assigned to 1 of 2 groups: (1) an intervention group (n=61) instructed to use the Greenhabit mobile app alongside standard care, or (2) a control group (n=62) who received advice on maintaining a healthy diet and followed standard care. The Greenhabit app incorporates serious gaming technology. Participants received daily messages and challenges focused on promoting a healthy lifestyle, including nutrition, exercise, relaxation, a positive mindset, and a supportive social environment. The app encouraged participants to set weekly goals and awarded points for completing challenges. Data on nutrition, anthropometrics, and blood and urine samples were collected at baseline, 6 weeks, and 12 weeks. Questionnaires assessing quality of life, work-life balance, and social environment were administered at baseline and during the final visit. The primary outcomes were HbA1c and fasting plasma glucose (FPG). Repeated-measures analysis of variance was used to compare changes over time (baseline to 6 weeks and baseline to 12 weeks) between the 2 intervention groups. Analysis of covariance was performed to evaluate changes at 6 and 12 weeks, adjusted for baseline levels of each variable. Multiple contrasts were corrected using a Bonferroni post hoc test. Results: Both groups showed significant reductions in HbA1c after 6 and 12 weeks (mean change in the intervention group [n=50] --0.4\%, P<.001 vs --0.3\% in the control group [n=53], P=.001) and in FPG after 6 weeks (mean change in the intervention group --5.3 mg/dL, P=.01 vs control group --5.8 mg/dL, P=.01). At 12 weeks, the intervention group also showed significant reductions in systolic and diastolic blood pressures (mean change --4.5, P=.049 and --2.4 mmHg, P=.03, respectively), body weight (mean change --0.8 kg, P=.03), BMI (mean change --0.3 kg/m2, P=.03), waist circumference (mean change --1.0 cm, P=.046), and triglyceride concentration (mean change --20.0 mg/dL, P=.03). There was also a significant increase in high-density lipoprotein-cholesterol concentrations (mean change 2 mg/dL, P=.049). Finally, improvements were noted in 3 out of the 5 elements of balance: positivity, social environment, and work-life balance. Conclusions: The 12-week intervention with the Greenhabit behavioral treatment mHealth app showed beneficial effects on T2D outcomes and reduced the burden of cardiovascular risk factors. Although larger studies are warranted, these results suggest that mHealth apps can be a promising tool for improving T2D self-management. Trial Registration: ISRCTN Registry ISRCTN13456652; http://www.isrctn.com/ISRCTN13456652 ", doi="10.2196/58319", url="https://www.jmir.org/2025/1/e58319" } @Article{info:doi/10.2196/62772, author="Inagaki, Keigo and Tsuriya, Daisuke and Hashimoto, Takuya and Nakamura, Katsumasa", title="Verification of the Reliability of an Automated Urine Test Strip Colorimetric Program Using Colorimetric Analysis: Survey Study", journal="JMIR Form Res", year="2025", month="Jan", day="14", volume="9", pages="e62772", keywords="urine test strip", keywords="reliability", keywords="automatic urine analyzer", keywords="quasi-experimental study", keywords="colorimetric analysis", keywords="colorimetric", keywords="urinalysis", keywords="urinary", keywords="urine", keywords="evaluation", keywords="mobile phone", abstract="Background: One method for noninvasive and simple urinary microalbumin testing is urine test strips. However, when visually assessing urine test strips, accurate assessment may be difficult due to environmental influences---such as lighting color and intensity---and the physical and psychological influences of the assessor. These complicate the formation of an objective assessment. Objectives: This study developed an ``automated urine test strip colorimetric program'' (hereinafter referred to as ``this program'') to objectively assess urine test strips. Using this program may allow urine tests to be conducted at home. In this study, urine samples from hospitalized or outpatient patients were randomly obtained, and the reliability of this program was verified by comparing the agreement rate between this program and an automatic urine analyzer (US-3500 [Eiken Chemical Co, Ltd] and LABOSPECT 006 [Hitachi High-Tech Co, Ltd]). Furthermore, the sensitivity and specificity of the urine albumin test were investigated, and its applicability to screening for microalbuminuria was verified. Methods: A urine test strip was placed in a photography box with constant light intensity and color temperature conditions. The image taken with a smartphone camera on top of the photography box was judged by this program. This program used Accelerated KAZE to perform image-matching processing to reduce the effect of misalignment during photography. It also calculated and judged the item with the smallest color difference between the color chart and the urine test strip using the CIEDE2000 color difference formula. The agreement rate of the results of this program was investigated using the results of an automatic urine analyzer as the gold standard. Results: Compared with the judgments of an automatic urine analyzer, the average agreement rate for 12 items (protein, glucose, urobilinogen, bilirubin, ketone bodies, specific gravity, occult blood, pH, white blood cells, nitrite, creatinine, and albumin) was 78.6\%. Furthermore, the average agreement rate of the 12 items within {\textpm}1 rank was 95.4\%. The results showed a sensitivity of 100\% and a specificity of 58.6\% in determining albumin in urine, which is important for determining the stage of diabetic nephropathy. Finally, the area under the curve (0.907) derived from the receiver operating characteristic curve was satisfactory. Conclusions: The program developed by the authors can determine urine test strips without requiring calibration in a certain shooting environment. If this program can be used at home to perform urinary microalbumin tests, the early detection and treatment of diabetic nephropathy may prevent the condition from becoming severe. ", doi="10.2196/62772", url="https://formative.jmir.org/2025/1/e62772" } @Article{info:doi/10.2196/67554, author="Li, Chenxi and Guo, Lixin and Shi, Lixin and Chen, Li and Chen, Liming and Xue, Yaoming and Li, Hong and Liang, Yuzhen and Yang, Jing and Wang, Weimin and Zhu, Dalong", title="Effectiveness and Safety of the TRIO Optimal Health Management Program in Patients With Type 2 Diabetes Mellitus Initiating Basal Insulin Therapy: Prospective Observational Real-World Study", journal="J Med Internet Res", year="2025", month="Jan", day="13", volume="27", pages="e67554", keywords="type 2 diabetes", keywords="TRIO optimal health management program", keywords="initiating basal insulin therapy", keywords="glycemic control", keywords="real-world study", abstract="Background: Diabetes, a chronic disease necessitating long-term treatment and self-management, presents significant challenges for patients who spend most of their treatment time outside of hospitals. The potential of digital therapeutics for diabetes has garnered recognition from different organizations. Although some prior studies have demonstrated successful reductions in patients' blood glucose levels and body weight through digital diabetes programs, many studies were limited by including patients with prediabetes, including patients treated with mostly premixed insulin, or evaluating user engagement outcomes rather than clinical outcomes. Consequently, limited evidence remains regarding the effectiveness of health management mobile apps specifically designed for patients with type 2 diabetes mellitus (T2DM) initiating basal insulin (BI). Based on this, a data-based and artificial intelligence management system named ``TRIO'' was developed to provide patients with more personalized intervention methods in stages, in groups, and around the clock. TRIO assists doctors and nurses in achieving better blood glucose controls, truly carries out standardized management around patients, and allows them to have a higher quality of life. TRIO represents the 3 essential pillars in comprehensive diabetes management: physician, nurse, and patient. Objective: This prospective observational study evaluated the effectiveness and safety of the TRIO optimal health management program for patients with T2DM initiating BI therapy in a real-world setting. Methods: Patients aged 18-85 years with inadequate glycemic control (baseline hemoglobin A1c [HbA1c] ?7\%) starting BI therapy were enrolled in outpatient and inpatient settings. The study lasted 3 months, with health education and phone-based follow-up assessments. Data collected included patient characteristics, medical history, baseline diabetes conditions, treatment compliance, glycemic control, and safety indicators. Results: A total of 199,431 patients were included, and 118,134 patients completed the 3-month follow-up between December 1, 2019, and December 31, 2021, involving 574 hospitals in China. The mean baseline HbA1c was 9.2\%, the mean duration of diabetes was 7.3 years, and 80.4\% (1,59,930/1,98,969) of patients were using BI with oral antihyperglycemic drugs. After the intervention, mean HbA1c decreased by --2.59\% from baseline, with 55.6\% (28,858/51,912) achieving the target HbA1c level of <7\%. Patients who set lower fasting plasma glucose goals (<6.1 mmol/L) showed more significant HbA1c reductions (P<.001) and higher target achievement than those with fasting plasma glucose goals of ?6.1 mmol/L. Factors such as complications, diabetes duration, and baseline HbA1c levels influenced the magnitude of HbA1c reduction. The presence of complications, shorter diabetes duration, and higher baseline HbA1c were significantly associated with increased hypoglycemia incidence risk (all P<.05). Conclusions: The TRIO optimal health management program effectively improved glycemic control in patients with T2DM initiating BI therapy. Individualized treatment approaches considering patient characteristics and glycemic goals are vital for optimal outcomes. ", doi="10.2196/67554", url="https://www.jmir.org/2025/1/e67554" } @Article{info:doi/10.2196/67636, author="Willis, J. Holly and Henderson, G. Maren S. and Zibley, J. Laura and JaKa, M. Meghan", title="``Now I can see it works!'' Perspectives on Using a Nutrition-Focused Approach When Initiating Continuous Glucose Monitoring in People with Type 2 Diabetes: Qualitative Interview Study", journal="JMIR Diabetes", year="2025", month="Jan", day="10", volume="10", pages="e67636", keywords="diabetic", keywords="diabetes mellitus", keywords="DM", keywords="type 2 diabetes", keywords="T2D", keywords="endocrinology", keywords="nutrition", keywords="diet", keywords="continuous glucose monitoring", keywords="glucose monitor", keywords="glucose", keywords="glycemic control", keywords="time in range", keywords="self-care", keywords="education", keywords="mHealth", abstract="Background: Food choices play a significant role in achieving glycemic goals and optimizing overall health for people with type 2 diabetes (T2D). Continuous glucose monitoring (CGM) can provide a comprehensive look at the impact of foods and other behaviors on glucose in real time and over the course of time. The impact of using a nutrition-focused approach (NFA) when initiating CGM in people with T2D is unknown. Objective: This study aims to understand the perspectives and behaviors of people with T2D who participated in an NFA during CGM initiation. Methods: Semistructured qualitative interviews were conducted with UNITE (Using Nutrition to Improve Time in Range) study participants. UNITE was a 2-session intervention designed to introduce and initiate CGM using an NFA in people with T2D who do not use insulin. The intervention included CGM initiation materials that emphasized the continuous glucose monitor as a tool to guide evidence-based food choices. The materials were designed to support conversation between the CGM user and diabetes care provider conducting the sessions. A rapid matrix analysis approach was designed to answer two main questions: (1) How do people who participate in an NFA during CGM initiation describe this experience? and (2) How do people who participate in an NFA during CGM initiation use CGM data to make food-related decisions, and what food-related changes do they make? Results: Overall, 15 people completed interviews after completion of the UNITE study intervention: 87\% (n=13) identified as White, 60\% (n=9) identified as male, mean age of 64 (SD 7.4) years, mean T2D duration of 7.5 (SD 3.8) years, and mean hemoglobin A1c level of 7.5\% (SD 0.4\%). Participants fluently discussed glycemic metrics such as time in range (percent time with glucose 70-180 mg/dL) and reported regularly using real-time and retrospective CGM data. Participants liked the simplicity of the intervention materials (eg, images and messaging), which demonstrated how to use CGM data to learn the glycemic impact of food choices and suggested how to adjust food choices for improved glycemia. Participants reported that CGM data impacted how they thought about food, and most participants made changes because of seeing these data. Many of the reported changes aligned with evidence-based guidance for a healthy lifestyle, including prioritizing nonstarchy vegetables, reducing foods with added sugar, or walking more; however, some people reported behavior changes, such as skipping or delaying meals to stay in the target glucose range. A few participants reported that the CGM amplified negative feelings about food or eating. Conclusions: Participants agreed that pairing nutrition information with CGM initiation instructions was helpful for their diabetes care. In general, the NFA during CGM initiation was well received and led to positive changes in food choices and behaviors during a 2-month intervention. ", doi="10.2196/67636", url="https://diabetes.jmir.org/2025/1/e67636" } @Article{info:doi/10.2196/60066, author="Hodgson, William and Kirk, Alison and Lennon, Marilyn and Janssen, Xanne", title="Exploring the Use of Activity Trackers to Support Physical Activity and Reduce Sedentary Behavior in Adults Diagnosed With Type 2 Diabetes: Qualitative Interview Study Using the RE-AIM Framework", journal="JMIR Diabetes", year="2024", month="Dec", day="30", volume="9", pages="e60066", keywords="type 2 diabetes", keywords="physical activity", keywords="sedentary behavior", keywords="Fitbit", keywords="activity tracker", keywords="My Diabetes My Way", keywords="RE-AIM framework", keywords="diabetes care", keywords="clinical care", keywords="thematic analysis", keywords="health promotion", abstract="Background: The prevalence of type 2 diabetes in adults worldwide is increasing. Low levels of physical activity and sedentary behavior are major risk factors for developing the disease. Physical activity interventions incorporating activity trackers can reduce blood glucose levels in adults diagnosed with type 2 diabetes. The My Diabetes My Way website is a support and educational platform for people diagnosed with diabetes and health care professionals. Users of the My Diabetes My Way website can upload their Fitbit (Google Inc) activity data into the system but this is not presently being analyzed and used routinely within clinical care. Developers of the My Diabetes My Way system are planning to allow different makes of activity trackers to be integrated with the platform. Objective: This qualitative study aimed to explore (through the RE-AIM [reach, effectiveness, adoption, implementation, and maintenance] framework) views from adults diagnosed with type 2 diabetes and health care professionals on the integration of activity trackers into type 2 diabetes care. Methods: Overall, 12 adults diagnosed with type 2 diabetes and 9 health care professionals (4 general practitioners, 1 consultant, 2 diabetes nurses, 1 practice nurse, and 1 physical activity advisor) were recruited through social media and professional contacts. Semistructured one-to-one interviews were conducted. Abductive thematic analysis was undertaken, and main themes and subthemes were identified. The RE-AIM framework was used to evaluate the themes with respect to the wider use of activity trackers and the My Diabetes My Way platform within type 2 diabetes clinical care. Results: Overall, 6 main themes (awareness, access, cost, promotion, support, and technology and data) and 20 subthemes were identified. Evaluation using the 5 RE-AIM dimensions found that reach could be improved by raising awareness of the My Diabetes My Way platform and the ability to upload activity tracker data into the system. Effectiveness could be improved by implementing appropriate personalized measures of health benefits and providing appropriate support for patients and health care staff. Adoption could be improved by better promotion of the intervention among stakeholders and the development of joint procedures. Implementation could be improved through the development of an agreed protocol, staff training, and introducing measurements of costs. Maintenance could be improved by supporting all patients for long-term engagement and measuring improvements to patients' health. Conclusions: Through this study, we identified how the reach, effectiveness, adoption, implementation, and maintenance of integrating activity trackers into adult type 2 diabetes care could be improved. ", doi="10.2196/60066", url="https://diabetes.jmir.org/2024/1/e60066" } @Article{info:doi/10.2196/58038, author="Naruse, Aki and Yamada, Yuka and Miyamoto, Takeshi", title="Skeletal Muscle Mass Loss and Physical Function in Young to Middle-Aged Adult Patients With Diabetes: Cross-Sectional Observational Study", journal="Interact J Med Res", year="2024", month="Dec", day="18", volume="13", pages="e58038", keywords="type 2 diabetes mellitus", keywords="middle-aged adults", keywords="physical function", keywords="skeletal muscle mass", keywords="sarcopenia", abstract="Background: Recently, it has been reported that older adults with type 2 diabetes mellitus (T2DM) have lower skeletal muscle mass than healthy individuals. Although skeletal muscle mass in older adults with diabetes is occasionally reported, similar reports on young to middle-aged adults are limited. Objective: This study aims to assess the prevalence of skeletal muscle loss in young to middle-aged adults with diabetes, examine the relationship between skeletal muscle loss and physical function in these patients, and examine whether there are differences in these characteristics between men and women. Methods: This cross-sectional, observational study included patients younger than 65 years with T2DM who were admitted to our hospital between 2014 and 2022 for educational admission for glycemic control and requested rehabilitation by the Department of Metabolic Medicine. The control group consisted of patients who received rehabilitation during their hospitalization at our hospital and did not have diabetes. The main parameters included skeletal muscle mass, muscle strength, physical function, and activities of daily living. Results: The prevalence of skeletal muscle mass loss in this study was 18.2\% (10/55) in men and 7.7\% (4/52) in women. The skeletal muscle mass index (SMI) was 7.7 (SD 0.8) and 8.4 (SD 0.5) for men in the T2DM and control groups, respectively, and 7.0 (SD 0.9) and 6.8 (SD 0.7) for women in the T2DM and control groups, respectively. Therefore, compared with the nondiabetes group, a significant difference was observed in men but not in women (men: P<.001, women: P=.35). Nonetheless, the diabetes group exhibited significantly lower physical functions, such as a walking speed of 1.3 (SD 0.2) m/s and 1.2 (SD 0.43) m/s for men and women in the T2DM group and 1.6 (SD 0.2) m/s and 1.5 (SD 0.1) m/s for men and women in the control group, respectively (men: P<.001, women: P<.001). One-leg standing time was measured as 30.7 (SD 26.9) seconds and 29.4 (SD 25.5) seconds for men and women in the T2DM group, compared with 100.5 (SD 30.6) seconds and 82.5 (SD 39.8) seconds for men and women in the control group, respectively, with the T2DM group's times being significantly lower (men: P<.001, women: P<.001). Univariate logistic regression analysis showed that SMI was significantly associated with age, BMI, and peripheral neuropathy (all P?.002). Multiple logistic regression analysis showed that BMI exhibited the strongest association (odds ratio 1.15, 95\% CI 1.07-1.23; P<.001), and peripheral neuropathy was also significantly associated with SMI (P=.009). Conclusions: Patients with diabetes, even those who are not older adults, face an elevated rate of skeletal muscle mass loss, muscle weakness, and a decline in physical function; moreover, they are susceptible to dynapenia and presarcopenia. Therefore, early intervention focusing on muscle evaluation and exercise is crucial. ", doi="10.2196/58038", url="https://www.i-jmr.org/2024/1/e58038", url="http://www.ncbi.nlm.nih.gov/pubmed/39693147" } @Article{info:doi/10.2196/60004, author="Allen, A. Nancy and Berg, A. Cynthia and Iacob, Eli and Gonzales, Rodriguez Bruno and Butner, E. Jonathan and Litchman, L. Michelle", title="Examining Share plus---A Continuous Glucose Monitoring Plus Data-Sharing Intervention in Older Adults and Their Care Partners: Protocol for a Randomized Control Study", journal="JMIR Res Protoc", year="2024", month="Dec", day="16", volume="13", pages="e60004", keywords="type 1 diabetes", keywords="T1D", keywords="older adults", keywords="continuous glucose monitoring", keywords="data sharing", keywords="dyadic coping", keywords="diabetes management", keywords="diabetes self-care", keywords="glucose monitoring", keywords="quality of life", keywords="mobile phone", abstract="Background: Older adults with type 1 diabetes (T1D) are increasingly turning to care partners (CPs) as resources to support their diabetes management. With the rise in diabetes technologies, such as continuous glucose monitoring (CGM), there is great potential for CGM data sharing to increase CP involvement in a way that improves persons with diabetes' glucose management and reduces distress. Objective: The specific aims of this paper are to (1) evaluate the feasibility, usability, and acceptability of the Share plus intervention compared to the CGM Follow app plus diabetes self-management education and support; (2) evaluate the effect of the Share plus intervention on time-in-range (TIR; primary outcome) and diabetes distress (secondary outcome); and (3) explore differences between groups in person with diabetes and CP dyadic appraisal and coping, quality of life, diabetes self-care, and CP burden at 12 and 24 weeks and associations of dyadic variables on outcomes. Methods: This is a protocol for a feasibility, pilot randomized controlled trial. Older adults with T1D and their CP (N=80 dyads) will be randomized 1:1 to the Share plus intervention or Follow app plus diabetes self-management education. The trial will include a 12-week active intervention to determine the change in primary (TIR) and secondary (diabetes distress) outcomes, followed by a 12-week, observation-only phase to examine maintenance effects. The evaluation is guided by the Dyadic Coping Model. Patient-level effectiveness outcomes (TIR, hemoglobin A1c [HbA1c], diabetes distress, diabetes appraisal, coping, quality of life, diabetes self-care behaviors, and CP burden) will be assessed, using patient-reported outcomes measures and a home HbA1c?test kit. Patient- and CP-level acceptability and feasibility will be assessed using surveys and interviews. Quantitative feasibility, acceptability, and usability data will be described using frequencies and percentages. Acceptability will be summarized based on Likert questions and open-ended questions. Usability will be examined separately for the intervention and control groups based on the System Usability Scale, with a study benchmark of ?68 indicating good usability. TIR will be computed based on 2 weeks' worth of data at baseline (prior to intervention) and 2 weeks each after the intervention (week 12) and at follow-up (week 24). Results: Recruitment started in August 2023 and enrollment began in?November 2023. To date, 24 participants have been enrolled in this study. We expect to conclude this study in March 2026 and expect to disseminate results in March 2026. Conclusions: To our knowledge, this will be the first pilot randomized controlled trial to evaluate both feasibility and effectiveness outcomes for the web-based, platform-delivered Share plus intervention for older adults with T1D and their CP. This research has implications for CGM data sharing in other age groups with T1D and type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT05937321; https://clinicaltrials.gov/study/NCT05937321 International Registered Report Identifier (IRRID): DERR1-10.2196/60004 ", doi="10.2196/60004", url="https://www.researchprotocols.org/2024/1/e60004" } @Article{info:doi/10.2196/58327, author="Jones, Catherine and Cui, Yi and Jeminiwa, Ruth and Bajracharya, Elina and Chang, Katie and Ma, Tony", title="Personalized and Culturally Tailored Features of Mobile Apps for Gestational Diabetes Mellitus and Their Impact on Patient Self-Management: Scoping Review", journal="JMIR Diabetes", year="2024", month="Dec", day="12", volume="9", pages="e58327", keywords="gestational diabetes", keywords="pregnancy", keywords="cultural tailoring", keywords="cultural adaptation", keywords="personalization", keywords="maternal health", keywords="mobile health", keywords="mHealth", keywords="smartphone", keywords="mobile app", keywords="mobile phone", keywords="self management; social determinants of health", abstract="Background: Gestational diabetes mellitus (GDM) is an increasingly common high-risk pregnancy condition requiring intensive daily self-management, placing the burden of care directly on the patient. Understanding personal and cultural differences among patients is critical for delivering optimal support for GDM self-management, particularly in high-risk populations. Although mobile apps for GDM self-management are being used, limited research has been done on the personalized and culturally tailored features of these apps and their impact on patient self-management. Objective: This scoping review aims to explore the extent to which published studies report the integration and effectiveness of personalized and culturally tailored features in GDM mobile apps for patient self-management support. Methods: We examined English-language peer-reviewed articles published between October 2016 and May 2023 from PubMed, CINAHL, PsycINFO, ClinicalTrials.gov, Proquest Research Library, and Google Scholar using search terms related to digital tools, diabetes, pregnancy, and cultural tailoring. We reviewed eligible articles and extracted data using the Arskey and O'Malley methodological framework. Results: Our search yielded a total of 1772 articles after the removal of duplicates and 158 articles for full-text review. A total of 21 articles that researched 15 GDM mobile apps were selected for data extraction. Our results demonstrated the stark contrast between the number of GDM mobile apps with personalized features for the individual user (all 15 mobile apps) and those culturally tailored for a specific population (only 3 of the 15 mobile apps). Our findings showed that GDM mobile apps with personalized and culturally tailored features were perceived to be useful to patients and had the potential to improve patients' adherence to glycemic control and nutrition plans. Conclusions: There is a strong need for increased research and development to foster the implementation of personalized and culturally tailored features in GDM mobile apps for self-management that cater to patients from diverse backgrounds and ethnicities. Personalized and culturally tailored features have the potential to serve the unique needs of patients more efficiently and effectively than generic features alone; however, the impacts of such features still need to be adequately studied. Recommendations for future research include examining the cultural needs of different ethnicities within the increasingly diverse US population in the context of GDM self-management, conducting participatory-based research with these groups, and designing human-centered mobile health solutions for both patients and providers. ", doi="10.2196/58327", url="https://diabetes.jmir.org/2024/1/e58327" } @Article{info:doi/10.2196/52107, author="Thanh Phuc, Phan and Nguyen, Phung-Anh and Nguyen, Nhat Nam and Hsu, Min-Huei and Le, Khanh Nguyen Quoc and Tran, Quoc-Viet and Huang, Chih-Wei and Yang, Hsuan-Chia and Chen, Cheng-Yu and Le, Hoa Thi Anh and Le, Khoi Minh and Nguyen, Bac Hoang and Lu, Y. Christine and Hsu, C. Jason", title="Early Detection of Dementia in Populations With Type 2 Diabetes: Predictive Analytics Using Machine Learning Approach", journal="J Med Internet Res", year="2024", month="Dec", day="11", volume="26", pages="e52107", keywords="diabetes", keywords="dementia", keywords="machine learning", keywords="prediction model", keywords="TMUCRD", keywords="Taipei Medical University Clinical Research Database", abstract="Background: The possible association between diabetes mellitus and dementia has raised concerns, given the observed coincidental occurrences. Objective: This study aimed to develop a personalized predictive model, using artificial intelligence, to assess the 5-year and 10-year dementia risk among patients with type 2 diabetes mellitus (T2DM) who are prescribed antidiabetic medications. Methods: This retrospective multicenter study used data from the Taipei Medical University Clinical Research Database, which comprises electronic medical records from 3 hospitals in Taiwan. This study applied 8 machine learning algorithms to develop prediction models, including logistic regression, linear discriminant analysis, gradient boosting machine, light gradient boosting machine, AdaBoost, random forest, extreme gradient boosting, and artificial neural network (ANN). These models incorporated a range of variables, encompassing patient characteristics, comorbidities, medication usage, laboratory results, and examination data. Results: This study involved a cohort of 43,068 patients diagnosed with type 2 diabetes mellitus, which accounted for a total of 1,937,692 visits. For model development and validation, 1,300,829 visits were used, while an additional 636,863 visits were reserved for external testing. The area under the curve of the prediction models range from 0.67 for the logistic regression to 0.98 for the ANNs. Based on the external test results, the model built using the ANN algorithm had the best area under the curve (0.97 for 5-year follow-up period and 0.98 for 10-year follow-up period). Based on the best model (ANN), age, gender, triglyceride, hemoglobin A1c, antidiabetic agents, stroke history, and other long-term medications were the most important predictors. Conclusions: We have successfully developed a novel, computer-aided, dementia risk prediction model that can facilitate the clinical diagnosis and management of patients prescribed with antidiabetic medications. However, further investigation is required to assess the model's feasibility and external validity. ", doi="10.2196/52107", url="https://www.jmir.org/2024/1/e52107", url="http://www.ncbi.nlm.nih.gov/pubmed/39434474" } @Article{info:doi/10.2196/55925, author="Gagnon, Marie-Pierre and Ouellet, Steven and Attisso, Eug{\`e}ne and Supper, Wilfried and Amil, Samira and Rh{\'e}aume, Caroline and Paquette, Jean-S{\'e}bastien and Chabot, Christian and Laferri{\`e}re, Marie-Claude and Sasseville, Maxime", title="Wearable Devices for Supporting Chronic Disease Self-Management: Scoping Review", journal="Interact J Med Res", year="2024", month="Dec", day="9", volume="13", pages="e55925", keywords="chronic diseases", keywords="self-care", keywords="self-management", keywords="empowerment", keywords="mobile health", keywords="mHealth", keywords="wearable", keywords="devices", keywords="scoping", keywords="review", keywords="mobile phone", keywords="PRISMA", abstract="Background: People with chronic diseases can benefit from wearable devices in managing their health and encouraging healthy lifestyle habits. Wearables such as activity trackers or blood glucose monitoring devices can lead to positive health impacts, including improved physical activity adherence or better management of type 2 diabetes. Few literature reviews have focused on the intersection of various chronic diseases, the wearable devices used, and the outcomes evaluated in intervention studies, particularly in the context of primary health care. Objective: This study aims to identify and describe (1) the chronic diseases represented in intervention studies, (2) the types or combinations of wearables used, and (3) the health or health care outcomes assessed and measured. Methods: We conducted a scoping review following the Joanna Briggs Institute guidelines, searching the MEDLINE and Web of Science databases for studies published between 2012 and 2022. Pairs of reviewers independently screened titles and abstracts, applied the selection criteria, and performed full-text screening. We included interventions using wearables that automatically collected and transmitted data to adult populations with at least one chronic disease. We excluded studies with participants with only a predisposition to develop a chronic disease, hospitalized patients, patients with acute diseases, patients with active cancer, and cancer survivors. We included randomized controlled trials and cohort, pretest-posttest, observational, mixed methods, and qualitative studies. Results: After the removal of 1987 duplicates, we screened 4540 titles and abstracts. Of the remaining 304 articles after exclusions, we excluded 215 (70.7\%) full texts and included 89 (29.3\%). Of these 89 texts, 10 (11\%) were related to the same interventions as those in the included studies, resulting in 79 studies being included. We structured the results according to chronic disease clusters: (1) diabetes, (2) heart failure, (3) other cardiovascular conditions, (4) hypertension, (5) multimorbidity and other combinations of chronic conditions, (6) chronic obstructive pulmonary disease, (7) chronic pain, (8) musculoskeletal conditions, and (9) asthma. Diabetes was the most frequent health condition (18/79, 23\% of the studies), and wearable activity trackers were the most used (42/79, 53\% of the studies). In the 79 included studies, 74 clinical, 73 behavioral, 36 patient technology experience, 28 health care system, and 25 holistic or biopsychosocial outcomes were reported. Conclusions: This scoping review provides an overview of the wearable devices used in chronic disease self-management intervention studies, revealing disparities in both the range of chronic diseases studied and the variety of wearable devices used. These findings offer researchers valuable insights to further explore health care outcomes, validate the impact of concomitant device use, and expand their use to other chronic diseases. Trial Registration: Open Science Framework Registries (OSF) s4wfm; https://osf.io/s4wfm ", doi="10.2196/55925", url="https://www.i-jmr.org/2024/1/e55925" } @Article{info:doi/10.2196/55473, author="Yan, Z. Allie and Staab, M. Erin and Nu{\~n}ez, Daisy and Zhu, Mengqi and Wan, Wen and Schaefer, T. Cynthia and Campbell, Amanda and Quinn, T. Michael and Baig, A. Arshiya", title="Impact of a Text Messaging Intervention as an In-Between Support to Diabetes Group Visits in Federally Qualified Health Centers: Cluster Randomized Controlled Study", journal="JMIR Diabetes", year="2024", month="Nov", day="28", volume="9", pages="e55473", keywords="diabetes", keywords="diabetes mellitus", keywords="type 2 diabetes", keywords="mHealth", keywords="mobile health", keywords="digital health", keywords="digital technology", keywords="digital intervention", keywords="text messaging intervention", keywords="text message", keywords="text messaging", keywords="texting", keywords="federally qualified health center", keywords="FQHC", keywords="mobile phone", abstract="Background: In the United States, 1 in 11 people receive primary care from a federally qualified health center (FQHC). Text messaging interventions (TMIs) are accessible ways to deliver health information, engage patients, and improve health outcomes in the health center setting. Objective: We aimed to evaluate the impact of a TMI implemented with a group visit (GV) intervention among patients with type 2 diabetes mellitus (T2DM) at FQHCs on patient-reported outcomes and clinical outcomes based on patient TMI engagement. Methods: A TMI was implemented for 11 health centers participating in a cluster randomized study of diabetes GVs in Midwestern FQHCs targeting adults with T2DM. FQHC patients participated in 6 monthly GVs either in person or online and a concurrent 25-week TMI. Outcome measures included clinical markers such as glycated hemoglobin A1c and patient-reported diabetes distress, diabetes self-care, diabetes self-efficacy, diabetes care knowledge, diabetes quality of life, diabetes social support, and TMI use and satisfaction. TMI response rate was calculated as responses to an SMS text message requesting a response divided by total messages requesting a response sent. Patients were grouped as high responders if their response rate was greater than or equal to the median response rate and low responders if their response rate was below the median. We conducted linear mixed models to compare high and low responders and within a group, adjusting for age, gender, GV attendance, and depression/anxiety at baseline. Results: In total, 101 of 124 GV patients (81.5\%) enrolled in the TMI. The average age of the population in the TMI was 53 years. Of the 101 respondents, 61 (60\%) were racial or ethnic minorities, while 42 of 82 respondents (51\%) had a high school diploma/General Education Development or less, and 56 of 80 respondents (71\%) reported an annual income less than US \$30,000. In addition, 70 of 81 respondents (86\%) owned a smartphone and 74 of 80 respondents (93\%) had an unlimited texting plan. The median response rate was 41\% and the mean response rate was 41.6\%. Adjusted models showed significantly improved diabetes knowledge (P<.001), foot care (P<.001), and exercise (P=.002) in high responders (n=34) compared to low responders (n=23) at 6 months. No group difference was found in glycated hemoglobin A1c. Within high responders, diabetes distress (P=.001), social support (P<.001), quality of life (P<.001), diabetes knowledge (P<.001), foot care (P<.001), and diet (P=.003) improved from baseline to 6 months. Low responders only improved in diabetes quality of life (P=.003) from baseline to 6 months. Conclusions: In a FQHC safety net population participating in a combined TMI and GV intervention, our study showed improved diabetes distress, social support, knowledge, self-care, self-efficacy, and quality of life among patients highly engaged in the SMS text messaging program. Trial Registration: ClinicalTrials.gov NCT03487692; https://clinicaltrials.gov/study/NCT03487692 ", doi="10.2196/55473", url="https://diabetes.jmir.org/2024/1/e55473" } @Article{info:doi/10.2196/60942, author="Chun, Elizabeth and Joseph, Richard and Pojednic, Rachele", title="Whole-Body Cryotherapy Reduces Systemic Inflammation in Healthy Adults: Pilot Cohort Study", journal="Interact J Med Res", year="2024", month="Nov", day="22", volume="13", pages="e60942", keywords="cold therapy", keywords="C-reactive protein", keywords="fasting glucose", keywords="HbA1c", keywords="inflammation", keywords="lipid metabolism", keywords="whole-body cryotherapy", keywords="cryotherapy", keywords="retrospective", keywords="reactive protein", keywords="biomarker", keywords="adult", keywords="systemic inflammation", abstract="Background: Chronically elevated inflammation is implicated in many conditions, including obesity, metabolic syndrome, and cardiovascular disease, and has been associated with increased mortality risk. Whole-body cryotherapy (W-BC) is a promising modality to treat inflammation with demonstrated benefits for clinical subpopulations including those with arthritis, obesity, and type 2 diabetes. However, it is unclear whether the benefit from W-BC extends to healthy individuals prior to chronic disease--related inflammation. In addition, the long-term durability of W-BC effect is unknown. Objective: This study investigates the inflammatory response to W-BC in healthy adults with a biomarker of inflammation, high-sensitivity C-reactive protein (hsCRP), and clinical biomarkers of metabolism including fasting glucose, hemoglobin A1c (HbA1c), low-density lipoprotein (LDL) and high-density lipoprotein (HDL), and triglycerides. Methods: Fifteen individuals (n=9 female) participated in frequent recreational W-BC (3 minutes of cold exposure at --110 {\textcelcius}) over approximately 9 months and had blood draws at baseline plus follow-up visits. Biomarkers were modeled as linear functions of W-BC sessions received in the month prior to blood draw. Results: The mean amount of W-BC received was 6.78 (SD 4.26) times per month with the cumulative total ranging from 13 to 157 W-BC sessions over the course of the study. On average, participants completed 1-2 sessions per week throughout the intervention. The number of W-BC sessions were associated with decreased hsCRP (--0.14 mg/L in hsCRP per W-BC session; P<.01) and with durability of up to 9 months. Increased W-BC was also associated with a downward trend in fasting glucose. This trend failed to reach significance at 1 month (--0.73 mg/dL in fasting glucose per W-BC session; P<.10) but was significant for 2- and 3-month windows (P<.05). HbA1c was increased significantly after 9 months (P<.01); however, the change occurred within normal ranges (difference=0.13\% and <5.7\%) and was not clinically significant. There was no association between W-BC and LDL cholesterol, HDL cholesterol, or triglycerides (P>.10), although LDL trended lower over the time period examined (P=.07). Conclusions: These results suggest that W-BC beneficially impacts systemic inflammation by lowering hsCRP levels in healthy individuals and may also have some modulating effect on fasting glucose. ", doi="10.2196/60942", url="https://www.i-jmr.org/2024/1/e60942", url="http://www.ncbi.nlm.nih.gov/pubmed/39576692" } @Article{info:doi/10.2196/65455, author="Hu, Lu and Lin, Nelson?F and Shi, Yun and Cao, Jiepin and Sevick, Ann Mary and Li, Huilin and Beasley, M. Jeannette and Levy, Natalie and Tamura, Kosuke and Xu, Xinyi and Jiang, Yulin and Ong, Iris and Yang, Ximin and Bai, Yujie and Su, Liwen and Chan, Wan Sze and Yi, S. Stella", title="The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Nov", day="19", volume="13", pages="e65455", keywords="mHealth", keywords="mobile health", keywords="prediabetes", keywords="immigrants", keywords="prevention", keywords="diabetes", keywords="INCLUDE", keywords="T2DM", keywords="social determinants of health", abstract="Background: Type 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods, and low health literacy. Objective: The goal of the Integrating Cultural Aspects into Diabetes Education (INCLUDE) study is to test a social media--based intervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted, community-supported agriculture program. Here, we report the protocol for the INCLUDE study. Methods: INCLUDE is a 3-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolled and randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3 culturally tailored, in-language DPP videos weekly for 12 weeks, as well as biweekly phone calls from bilingual study staff to review video content, support goal setting, and assess and address SDOH-related barriers such as food insecurity. Intervention participants will also be given produce for 10 weeks as part of the community-supported agriculture program. Weight (primary outcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and 6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and other secondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School of Medicine. Results: Recruitment started in May 2023, with the first cohort of 75 participants enrolled and randomized into 2 groups in July 2023. The 3-month and 6-month assessment of the first-year cohort has been completed. We have recruited 75 participants for the second cohort as of July 2024. Conclusions: The INCLUDE study will serve as an innovative model for culturally adapted, multilevel interventions for underserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with several national calls for multilevel interventions, the INCLUDE intervention will provide critical data that will inform how researchers and public health professionals address SDOH barriers faced by underserved populations and prevent diabetes. Trial Registration: ClinicalTrials.gov NCT05492916; https://clinicaltrials.gov/study/NCT05492916 International Registered Report Identifier (IRRID): DERR1-10.2196/65455 ", doi="10.2196/65455", url="https://www.researchprotocols.org/2024/1/e65455" } @Article{info:doi/10.2196/60713, author="Malinovsk{\'a}, Jana and Michalec, Juraj and Bro?, Jan", title="Considerations for Future Research and Methodological Clarifications on Smoking Behavior Change and Heart Failure Risk in Patients With Type 2 Diabetes", journal="JMIR Public Health Surveill", year="2024", month="Nov", day="12", volume="10", pages="e60713", keywords="type 2 diabetes", keywords="smoking", keywords="heart failure", keywords="cardiovascular disease", keywords="smoking cessation", doi="10.2196/60713", url="https://publichealth.jmir.org/2024/1/e60713" } @Article{info:doi/10.2196/59824, author="Podwojniak, Alicia and Flemming, Joseph and Tan, J. Isabella and Ghani, Hira and Neubauer, Zachary and Jones, Anne", title="Cutaneous Adverse Effects From Diabetes Devices in Pediatric Patients With Type 1 Diabetes Mellitus: Systematic Review", journal="JMIR Dermatol", year="2024", month="Nov", day="7", volume="7", pages="e59824", keywords="insulin pumps", keywords="continuous glucose monitoring", keywords="type 1 diabetes", keywords="lipohypertrophy", keywords="contact dermatitis", keywords="lipodystrophy", abstract="Background: Continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusions (CSIIs) are the current standard treatment devices for type 1 diabetes (T1D) management. With a high prevalence of T1D beginning in pediatrics and carrying into adulthood, insufficient glycemic control leads to poor patient outcomes. Dermatologic complications such as contact dermatitis, lipodystrophies, and inflammatory lesions are among those associated with CGM and CSII, which reduce glycemic control and patient compliance. Objective: This systematic review aims to explore the current literature surrounding dermatologic complications of CGM and CSII as well as the impact on patient outcomes. Methods: A systematic review of the literature was carried out using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines using 5 online databases. Included articles were those containing primary data relevant to human participants and adverse reactions to CGM and CSII devices in pediatric populations, of which greater than 50\% of the sample size were aged 0?21 years. Qualitative analysis was chosen due to the heterogeneity of outcomes. Results: Following the application of exclusion criteria, 25 studies were analyzed and discussed. An additional 5 studies were identified after the initial search and inclusion. The most common complication covered is contact dermatitis, with 13 identified studies. Further, 7 studies concerned lipodystrophies, 5 covered nonspecific cutaneous changes, 3 covered unique cutaneous findings such as granulomatous reactions and panniculitis, and 2 discussed user acceptability. Conclusions: The dermatologic complications of CGM and CSII pose a potential risk to long-term glycemic control in T1D, especially in young patients where skin lesions can lead to discontinuation. Increased manufacturer transparency is critical and further studies are needed to expand upon the current preventative measures such as device site rotation and steroid creams, which lack consistent effectiveness. ", doi="10.2196/59824", url="https://derma.jmir.org/2024/1/e59824" } @Article{info:doi/10.2196/50456, author="Hashim, Jumana and Luna Puerta, Lidia and Foong, Sym Pin and Tai, Shyong E. and Yi, Huso and Smith, Elizabeth Helen", title="Codesigning a Digital Type 2 Diabetes Risk Communication Tool in Singapore: Qualitative Participatory Action Research Approach", journal="JMIR Form Res", year="2024", month="Nov", day="5", volume="8", pages="e50456", keywords="type 2 diabetes", keywords="risk perception", keywords="co-design", keywords="risk communication tool", keywords="diabetes prevention", abstract="Background: Diabetes is a serious public health concern worldwide. Despite public health efforts encouraging early screening and improving knowledge of effective interventions for those at increased risk of type 2 diabetes (T2D), the incorporation of preventative behaviors into an individual's daily life remains suboptimal. Successfully and accurately increasing risk perception has been demonstrated to increase behavioral intention. Objective: The study aims to codesign a T2D risk communication tool by engaging public participants to (1) identify key characteristics that contribute to an effective risk communication tool and (2) test and iterate to develop a culturally sensitive and meaningful risk communication tool that can motivate T2D preventative behaviors. Methods: We adopted a novel methodology, ``Patient and Public Involvement (PPI) Hawkers,'' where we approached patrons at hawker centers and public eateries frequented by all local residents to evaluate and test 3 prototypes for the tool. The three prototypes were (1) ``Diabetes Onset''---estimated age of diabetes onset of T2D based on one's risk factors, (2) ``Relative Risk''---the relative risk of T2D is presented in a 1-10 scale indicating where one's risk score lie in relation to others, and (3) ``Metabolic Age''---the median age of the risk category based on one's risk factors, presented to be compared against their chronological age. We gathered reactions and feedback through rapid testing and iteration to understand which risk result presentation would be received the best. All the collected data were revisited and analyzed using an inductive thematic analysis to identify the key characteristics contributing to an effective risk communication tool. Results: We engaged with 112 participants (female: n=59, 56\%) across 6 hawker centers. The key characteristics that were important to participants emerged in four main themes: (1) appeal and user experience, in terms of format and readability; (2) trust and validity of the institution providing the tool and the accuracy of the risk result; (3) threat appraisal: salience of risk information, which influenced their risk perception; and (4) coping appraisal: facilitators for behavior change, which impacted their intention for implementing T2D preventative behaviors. The predictive nature of the prototype entitled ``Diabetes Onset'' was poorly received and removed after the first iteration. The Relative Risk prototype was valued for being straightforward but feared to be boring. The Metabolic Age prototype was anticipated to be more motivating for behavior change, but there were some concerns that the terminology may not be understood by everyone. Conclusions: Participants were divided on which of the 2 prototypes, ``Metabolic Age'' or ``Relative Risk,'' they would favor adopting. Further testing is now required to determine which prototype will be more effective in motivating behavior change. This study's insights on the design process and valued characteristics of a risk communication tool will inform future development of such interventions. ", doi="10.2196/50456", url="https://formative.jmir.org/2024/1/e50456" } @Article{info:doi/10.2196/63598, author="Ramirez, Marissa and Gebauer, Maja and Mermier, Christine and Little, Peter Jonathan and Lin, Luotao and Palley, Gabriel and Hsiao, Yu Yu and Mota Alvidrez, Ivan Roberto and Mang, A. Zach and Amorim, Trigueiro Fabiano and Tricoli, Valmor and De Castro Magalhaes, Flavio", title="The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals Living With Prediabetes or Type 2 Diabetes: Protocol for a Crossover Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Nov", day="5", volume="13", pages="e63598", keywords="diabetes", keywords="resistance exercise", keywords="weight training", keywords="glucose", keywords="insulin resistance", abstract="Background: Type 2 diabetes (T2D) is preceded by prediabetes, and these conditions place a great burden on patients and society. These conditions are significantly associated with poor glycemic control, which is improved by resistance exercise. It has been suggested that resistance exercise should be performed with a high degree of effort to improve glucose metabolism, but this is associated with negative psychological responses that might lead to lower long-term adherence. Objective: This study aimed to investigate the effect of the degree of effort during a resistance exercise session on glycemic control and psychological responses in individuals living with prediabetes or T2D. Methods: This study will be a crossover, 3-arm, randomized controlled trial. A total of 15 participants living with prediabetes or T2D will be thoroughly familiarized with 7 resistance exercises; afterward, they will perform 3 randomized experimental sessions, each lasting approximately 48 hours each, separated by at least 4 washout days. In 2 of these sessions, supervised resistance exercise will be performed, but the sessions will differ in the degree of effort in each set (high vs low) and will be equalized in terms of total weight lifted and session duration. For this, proximity to failure will be manipulated by changing the number of sets per exercise, the number of repetitions per set, and the resting interval between sets and exercises. Participants will also complete a sedentary (control) session, where they will not perform any exercise. In response to each session, psychological responses will be assessed (exertion, affect, enjoyment, self-efficacy, and discomfort). Glycemic control will be assessed by a continuous glucose monitoring device every 5 minutes, throughout the approximately 48 hours of each experimental session. Food and drink will be individually prescribed by a registered dietitian nutritionist and provided to participants, in order to control for the confounding effect of energy intake and diet composition. Physical activity levels will be assessed by accelerometry. Randomization will be done using the opaque, sequentially numbered envelopes technique. Participants and researchers will be blinded for continuous glucose monitoring and accelerometry data, and data will be analyzed by a blinded statistician. Results: This study has been funded, and data collection is expected to take place between June 2024 and May 2025. Final manuscript submission should happen by August 2025. Conclusions: The results of this project might encourage individuals living with prediabetes and T2D to engage in resistance exercise while better informing exercise specialists on how to best incorporate resistance exercise in their client's or patient's routine. Trial Registration: ClinicalTrials.gov NCT06208189; https://clinicaltrials.gov/study/NCT06208189 International Registered Report Identifier (IRRID): PRR1-10.2196/63598 ", doi="10.2196/63598", url="https://www.researchprotocols.org/2024/1/e63598" } @Article{info:doi/10.2196/59142, author="Yan, Man and Yu, Yingchun and Li, Shuping and Zhang, Peiling and Yu, Jiaxiang", title="Effectiveness of King's Theory of Goal Attainment in Blood Glucose Management for Newly Diagnosed Patients With Type 2 Diabetes: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Oct", day="31", volume="26", pages="e59142", keywords="King's Theory of Goal Attainment", keywords="online feedback approach", keywords="newly diagnosed patients with type 2 diabetes mellitus", keywords="blood glucose control", keywords="type 2 diabetes", keywords="diabetes mellitus", keywords="blood glucose", abstract="Background: Diabetes poses a significant public health challenge in China and globally, with the number of patients expected to reach 592 million by 2035, notably in Asia. In China alone, an estimated 140 million individuals are living with diabetes, and a significant portion is nonadherent to medications, underscoring the urgency of effective management strategies. Recognizing the necessity of early and comprehensive management for newly diagnosed patients with type 2 diabetes, this study leverages an online teach-back method and ``Internet + Nursing'' platform based on King's Theory of Goal Attainment. The approach aims to enhance glycemic control and reduce fear and misconceptions about the disease, addressing both the educational and emotional needs of the patients. Objective: The primary aim of this study was to assess the effectiveness of King's Goal Attainment Theory in the management of newly diagnosed patients with type 2 diabetes. This research sought to develop a collaborative model for blood glucose management, integrating the expertise and roles of physicians, nurses, and patients. The model is designed to enhance the synergy in health care provision, ensuring a comprehensive approach to diabetes management. Methods: In this study conducted at Changzhou Traditional Chinese Medicine Hospital between January 2022 and February 2023, eligible patients were randomized into a control group or an online feedback group. The control group received standard care, while the online feedback group participated in a King's Theory of Goal Attainment--based online teach-back program, enhanced by ``Internet + Nursing'' strategies. This included an interactive platform for goal planning, video content sharing, comprehension assessment, misconception correction, and patient-driven recaps of disease information. Health monitoring was facilitated through the ``Internet + Nursing'' platform. The study focused on comparing changes in glucose metabolism and emotional disorder symptoms between the groups to evaluate the intervention's effectiveness. Results: Following a 24-week intervention, we observed significant differences in key metrics between the online feedback group and the control group, each comprising 60 participants. The online feedback group demonstrated significant reductions in fasting plasma glucose, 2-hour postprandial glucose, and hemoglobin A1c (P<.05). Additionally, there was a notable decrease in hypoglycemia-related anxiety and alexithymia within this group. Conversely, the control group maintained relatively higher values for these metrics at the same time point (P<.05). These findings underscore the efficacy of online feedback in managing glycemic control and reducing psychological distress associated with hypoglycemia. Conclusions: The online teaching-back method, guided by King's Theory of Goal Attainment, effectively enhances glycemic control, reducing fasting plasma glucose, 2-hour postprandial glucose, and hemoglobin A1c levels in newly diagnosed patients with type 2 diabetes. Simultaneously, it alleviates hypoglycemia-related anxiety and mitigates alexithymia. This approach merits widespread promotion and implementation in clinical settings. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400079547; https://www.chictr.org.cn/showproj.html?proj=208223 ", doi="10.2196/59142", url="https://www.jmir.org/2024/1/e59142" } @Article{info:doi/10.2196/46983, author="Erdt, Mojisola and Yusof, Binte Sakinah and Chai, Liquan and Md Salleh, Umairah Siti and Liu, Zhengyuan and Sarim, Binte Halimah and Lim, Choo Geok and Lim, Hazel and Suhaimi, Ain Nur Farah and Yulong, Lin and Guo, Yang and Ng, Angela and Ong, Sharon and Choo, Peide Bryan and Lee, Sheldon and Weiliang, Huang and Oh, Choon Hong and Wolters, Klara Maria and Chen, F. Nancy and Krishnaswamy, Pavitra", title="Characterization of Telecare Conversations on Lifestyle Management and Their Relation to Health Care Utilization for Patients with Heart Failure: Mixed Methods Study", journal="J Med Internet Res", year="2024", month="Oct", day="30", volume="26", pages="e46983", keywords="telehealth", keywords="telecare", keywords="heart failure", keywords="chronic disease", keywords="self-management", keywords="lifestyle management", keywords="behavior", keywords="health care utilization", keywords="conversation", keywords="dialogue", keywords="medical informatics", abstract="Background: Telehealth interventions where providers offer support and coaching to patients with chronic conditions such as heart failure (HF) and type 2 diabetes mellitus (T2DM) are effective in improving health outcomes. However, the understanding of the content and structure of these interactions and how they relate to health care utilization remains incomplete. Objective: This study aimed to characterize the content and structure of telecare conversations on lifestyle management for patients with HF and investigate how these conversations relate to health care utilization. Methods: We leveraged real-world data from 50 patients with HF enrolled in a postdischarge telehealth program, with the primary intervention comprising a series of telephone calls from nurse telecarers over a 12-month period. For the full cohort, we transcribed 729 English-language calls and annotated conversation topics. For a subcohort (25 patients with both HF and T2DM), we annotated lifestyle management content with fine-grained dialogue acts describing typical conversational structures. For each patient, we identified calls with unusually high ratios of utterances on lifestyle management as lifestyle-focused calls. We further extracted structured data for inpatient admissions from 6 months before to 6 months after the intervention period. First, to understand conversational structures and content of lifestyle-focused calls, we compared the number of utterances, dialogue acts, and symptom attributes in lifestyle-focused calls to those in calls containing but not focused on lifestyle management. Second, to understand the perspectives of nurse telecarers on these calls, we conducted an expert evaluation where 2 nurse telecarers judged levels of concern and follow-up actions for lifestyle-focused and other calls (not focused on lifestyle management content). Finally, we assessed how the number of lifestyle-focused calls relates to the number of admissions, and to the average length of stay per admission. Results: In comparative analyses, lifestyle-focused calls had significantly fewer utterances (P=.01) and more dialogue acts (Padj=.005) than calls containing but not focused on lifestyle management. Lifestyle-focused calls did not contain deeper discussions on clinical symptoms. These findings indicate that lifestyle-focused calls entail short, intense discussions with greater emphasis on understanding patient experience and coaching than on clinical content. In the expert evaluation, nurse telecarers identified 24.2\% (29/120) of calls assessed as concerning enough for follow-up. For these 29 calls, nurse telecarers were more attuned to concerns about symptoms and vitals (19/29, 65.5\%) than lifestyle management concerns (4/29, 13.8\%). The number of lifestyle-focused calls a patient had was modestly (but not significantly) associated with a lower average length of stay for inpatient admissions (Spearman $\rho$=-0.30; Padj=.06), but not with the number of admissions (Spearman $\rho$=-0.03; Padj=.84). Conclusions: Our approach and findings offer novel perspectives on the content, structure, and clinical associations of telehealth conversations on lifestyle management for patients with HF. Hence, our study could inform ways to enhance telehealth programs for self-care management in chronic conditions. ", doi="10.2196/46983", url="https://www.jmir.org/2024/1/e46983" } @Article{info:doi/10.2196/58137, author="Wang, Xuan and Plantinga, M. Anna and Xiong, Xin and Cromer, J. Sara and Bonzel, Clara-Lea and Panickan, Vidul and Duan, Rui and Hou, Jue and Cai, Tianxi", title="Comparing Insulin Against Glucagon-Like Peptide-1 Receptor Agonists, Dipeptidyl Peptidase-4 Inhibitors, and Sodium-Glucose Cotransporter 2 Inhibitors on 5-Year Incident Heart Failure Risk for Patients With Type 2 Diabetes Mellitus: Real-World Evidence Study Using Insurance Claims", journal="JMIR Diabetes", year="2024", month="Oct", day="22", volume="9", pages="e58137", keywords="type 2 diabetes mellitus", keywords="diabetes", keywords="diabetes complications", keywords="heart failure", keywords="antidiabetic drug", keywords="diabetes pharmacotherapy", keywords="insulin", keywords="GLP-1 RA", keywords="DPP-4I", keywords="SGLT2I", keywords="real-world data", keywords="insurance data", keywords="claims data", keywords="glucagon-like peptide-1 receptor agonist", keywords="dipeptidyl peptidase-4 inhibitor", keywords="sodium-glucose cotransporter 2 inhibitor", abstract="Background: Type 2 diabetes mellitus (T2DM) is a common health issue, with heart failure (HF) being a common and lethal long-term complication. Although insulin is widely used for the treatment of T2DM, evidence regarding the efficacy of insulin compared to noninsulin therapies on incident HF risk is missing among randomized controlled trials. Real-world evidence on insulin's effect on long-term HF risk may supplement existing guidelines on the management of T2DM. Objective: This study aimed to compare insulin therapy against other medications on HF risk among patients with T2DM using real-world data extracted from insurance claims. Methods: A retrospective, observational study was conducted based on insurance claims data from a single health care network. The study period was from January 1, 2016, to August 11, 2021. The cohort was defined as patients having a T2DM diagnosis code. The inclusion criteria were patients who had at least 1 record of a glycated hemoglobin laboratory test result; full insurance for at least 1 year (either commercial or Medicare Part D); and received glucose-lowering therapy belonging to 1 of the following groups: insulin, glucagon-like peptide 1 receptor agonists (GLP-1 RAs), dipeptidyl peptidase-4 inhibitors (DPP-4Is), or sodium-glucose cotransporter-2 inhibitors (SGLT2Is). The main outcome was the 5-year incident HF rate. Baseline covariates, including demographic characteristics, comorbidities, and laboratory test results, were adjusted to correct for confounding. Results: After adjusting for a broad list of confounders, patients receiving insulin were found to be associated with an 11.8\% (95\% CI 11.0\%?12.7\%), 12.0\% (95\% CI 11.5\%?12.4\%), and 15.1\% (95\% CI 14.3\%?16.0\%) higher 5-year HF rate compared to those using GLP-1 RAs, DPP-4Is, and SGLT2Is, respectively. Subgroup analysis showed that insulin's effect of a higher HF rate was significant in the subgroup with high HF risk but not significant in the subgroup with low HF risk. Conclusions: This study generated real-world evidence on the association of insulin therapy with a higher 5-year HF rate compared to GLP-1 RAs, DPP-4Is, and SGLT2Is based on insurance claims data. These findings also demonstrated the value of real-world data for comparative effectiveness studies to complement established guidelines. On the other hand, the study shares the common limitations of observational studies. Even though high-dimensional confounders are adjusted, remaining confounding may exist and induce bias in the analysis. ", doi="10.2196/58137", url="https://diabetes.jmir.org/2024/1/e58137" } @Article{info:doi/10.2196/59423, author="Berube, T. Lauren and Shrestha, Archana and Shrestha, Abha and Daneault, Jean-Francois and Shakya, Raj Prabin and Dhimal, Meghnath and Shrestha, Roman and Rawal, Shristi", title="Development and Testing of a Mobile App for Management of Gestational Diabetes in Nepal: Protocol for a User-Centered Design Study and Exploratory Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Oct", day="21", volume="13", pages="e59423", keywords="gestational diabetes mellitus", keywords="mobile health", keywords="mHealth", keywords="self-management", keywords="pregnancy", keywords="maternal and child health", keywords="South Asia", keywords="Nepal", keywords="low- and middle-income country", keywords="mobile phone", abstract="Background: The prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs) like Nepal. GDM self-management, including intensive dietary and lifestyle modifications and blood glucose monitoring, is critical to maintain glycemic control and prevent adverse outcomes. However, in resource-limited settings, several barriers hinder optimal self-management. Mobile health (mHealth) technology holds promise as a strategy to augment GDM treatment by promoting healthy behaviors and supporting self-management, but this approach has not yet been tested in any LMIC. Objective: This report describes the protocol to develop a culturally tailored mHealth app that supports self-management and treatment of GDM (GDM--Dhulikhel Hospital [GDM-DH] app, phase 1) and test its usability and preliminary efficacy (phase 2) among patients with GDM in a periurban hospital setting in Nepal. Methods: The study will be conducted at Dhulikhel Hospital in Dhulikhel, Nepal. In the development phase (phase 1), a prototype of the GDM-DH app will be developed based on expert reviews and a user-centered design approach. To understand facilitators and barriers to GDM self-management and to gather feedback on the prototype, focus groups and in-depth interviews will be conducted with patients with GDM (n=12), health care providers (n=5), and family members (n=3), with plans to recruit further if saturation is not achieved. Feedback will be used to build a minimum viable product, which will undergo user testing with 18 patients with GDM using a think-aloud protocol. The final GDM-DH app will be developed based on user feedback and following an iterative product design and user testing process. In the randomized controlled trial phase (phase 2), newly diagnosed patients with GDM (n=120) will be recruited and randomized to either standard care alone or standard care plus the GDM-DH app from 24-30 weeks gestation until delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be maternal glycemic control at 6 weeks post partum, birth weight, and rates of labor induction and cesarean delivery. Qualitative data obtained from phase 1 will be analyzed using thematic analysis. In phase 2, independent 2-tailed t tests or chi-square analyses will examine differences in outcomes between the 2 treatment conditions. Results: As of July 2024, we have completed phase 1. Phase 2 is underway. The first participant was enrolled in October 2021, with 99 participants enrolled as of July 2024. We anticipate completing recruitment by December 2024 and disseminating findings by December 2025. Conclusions: App-based lifestyle interventions for GDM management are not common in LMICs, where GDM prevalence is rapidly increasing. This proof-of-concept trial will provide valuable insights into the potential of leveraging mHealth app--based platforms for GDM self-management in LMICs. Trial Registration: ClinicalTrials.gov NCT04198857; https://clinicaltrials.gov/study/NCT04198857 International Registered Report Identifier (IRRID): DERR1-10.2196/59423 ", doi="10.2196/59423", url="https://www.researchprotocols.org/2024/1/e59423" } @Article{info:doi/10.2196/57720, author="Zhang, Baolu and Kalampakorn, Surintorn and Powwattana, Arpaporn and Sillabutra, Jutatip and Liu, Gang", title="Oral Diabetes Medication Videos on Douyin: Analysis of Information Quality and User Comment Attitudes", journal="JMIR Form Res", year="2024", month="Oct", day="18", volume="8", pages="e57720", keywords="diabetes", keywords="oral diabetes medication", keywords="information quality", keywords="user comment attitude", keywords="video analysis", keywords="Douyin", abstract="Background: Oral diabetes medications are important for glucose management in people with diabetes. Although there are many health-related videos on Douyin (the Chinese version of TikTok), the quality of information and the effects on user comment attitudes are unclear. Objective: The purpose of this study was to analyze the quality of information and user comment attitudes related to oral diabetes medication videos on Douyin. Methods: The key phrase ``oral diabetes medications'' was used to search Douyin on July 24, 2023, and the final samples included 138 videos. The basic information in the videos and the content of user comments were captured using Python. Each video was assigned a sentiment category based on the predominant positive, neutral, or negative attitude, as analyzed using the Weiciyun website. Two independent raters assessed the video content and information quality using the DISCERN (a tool for assessing health information quality) and PEMAT-A/V (Patient Education Materials Assessment Tool for Audiovisual Materials) instruments. Results: Doctors were the main source of the videos (136/138, 98.6\%). The overall information quality of the videos was acceptable (median 3, IQR 1). Videos on Douyin showed relatively high understandability (median 75\%, IQR 16.6\%) but poor actionability (median 66.7\%, IQR 48\%). Most content on oral diabetes medications on Douyin related to the mechanism of action (75/138, 54.3\%), precautions (70/138, 50.7\%), and advantages (68/138, 49.3\%), with limited content on indications (19/138, 13.8\%) and contraindications (14/138, 10.1\%). It was found that 10.1\% (14/138) of the videos contained misinformation, of which 50\% (7/14) were about the method of administration. Regarding user comment attitudes, the majority of videos garnered positive comments (81/138, 58.7\%), followed by neutral comments (46/138, 33.3\%) and negative comments (11/138, 8\%). Multinomial logistic regression revealed 2 factors influencing a positive attitude: user comment count (adjusted odds ratio [OR] 1.00, 95\% CI 1.00-1.00; P=.02) and information quality of treatment choices (adjusted OR 1.49, 95\% CI 1.09-2.04; P=.01). Conclusions: Despite most videos on Douyin being posted by doctors, with generally acceptable information quality and positive user comment attitudes, some content inaccuracies and poor actionability remain. Users show more positive attitudes toward videos with high-quality information about treatment choices. This study suggests that health care providers should ensure the accuracy and actionability of video content, enhance the information quality of treatment choices of oral diabetes medications to foster positive user attitudes, help users access accurate health information, and promote medication adherence. ", doi="10.2196/57720", url="https://formative.jmir.org/2024/1/e57720" } @Article{info:doi/10.2196/58658, author="Stenov, Vibeke and Cleal, Bryan and Willaing, Ingrid and Christensen, Normann Jette and Jensen, Gaden Christian and Mouritsen, Drotner Julie and Due-Christensen, Mette", title="An Evidence-Based Nurse-Led Intervention to Reduce Diabetes Distress Among Adults With Type 1 Diabetes and Diabetes Distress (REDUCE): Development of a Complex Intervention Using Qualitative Methods Informed by the Medical Research Council Framework", journal="JMIR Form Res", year="2024", month="Oct", day="18", volume="8", pages="e58658", keywords="diabetes mellitus", keywords="mental health", keywords="diabetes distress", keywords="qualitative research", keywords="co-design study", keywords="complex intervention", keywords="Medical Research Council framework", abstract="Background: Diabetes distress refers to the negative emotional reaction to living with the demands of diabetes; it occurs in >40\% of adults with type 1 diabetes (T1D). However, no interventions to reduce diabetes distress are specifically designed to be an integral part of diabetes care. Objective: This study aims to modify and adapt existing evidence-based methods into a nurse-led group intervention to reduce diabetes distress among adults with T1D and moderate to severe diabetes distress. Methods: The overall framework of this study was informed by the initial phase of the Medical Research Council's complex intervention framework that focused on undertaking intervention identification and development to guide the adaptation of the intervention. This study took place at 2 specialized diabetes centers in Denmark from November 2019 to June 2021. A total of 36 adults with T1D participated in 10 parallel workshops. A total of 12 diabetes-specialized nurses were interviewed and participated in 1 cocreation workshop; 12 multidisciplinary specialists, including psychologists, educational specialists, and researchers, participated in 4 cocreation workshops and 14 feedback meetings. Data were analyzed by applying a deductive analytic approach. Results: The intervention included 5 biweekly 2.5-hour small group sessions involving adults with T1D and diabetes distress. Guided by a detailed step-by-step manual, the intervention was delivered by 2 trained diabetes specialist nurses. The intervention material included visual conversation tools covering seven diabetes-specific sources derived from the 28-item Type 1 Diabetes Distress Scale for measuring diabetes distress: (1) powerlessness, (2) self-management, (3) fear of hypoglycemia, (4) food and eating, (5) friends and family, (6) negative social perception, and (7) physician distress. The tools are designed to kick-start awareness and sharing of diabetes-specific challenges and strengths, individual reflections, as well as plenary and peer-to-peer discussions about strategies to manage diabetes distress, providing new perspectives on diabetes worries and strategies to overcome negative emotions. Diabetes specialist nurses expressed a need for a manual with descriptions of methods and detailed guidelines for using the tools. To deliver the intervention, nurses need increased knowledge about diabetes distress, how to support diabetes distress reduction, and training and supervision to improve skills. Conclusions: This co-design study describes the adaptation of a complex intervention with a strong evidence base, including detailed reporting of the theoretical underpinnings and core mechanisms. ", doi="10.2196/58658", url="https://formative.jmir.org/2024/1/e58658", url="http://www.ncbi.nlm.nih.gov/pubmed/39239797" } @Article{info:doi/10.2196/58463, author="Tan, Kuan Joshua and Quan, Le and Salim, Mohamed Nur Nasyitah and Tan, Hong Jen and Goh, Su-Yen and Thumboo, Julian and Bee, Mong Yong", title="Machine Learning--Based Prediction for High Health Care Utilizers by Using a Multi-Institutional Diabetes Registry: Model Training and Evaluation", journal="JMIR AI", year="2024", month="Oct", day="17", volume="3", pages="e58463", keywords="diabetes mellitus", keywords="type 2 diabetes", keywords="health care utilization", keywords="population health management", keywords="population health", keywords="machine learning", keywords="artificial intelligence", keywords="predictive model", keywords="predictive system", keywords="practical model", abstract="Background: The cost of health care in many countries is increasing rapidly. There is a growing interest in using machine learning for predicting high health care utilizers for population health initiatives. Previous studies have focused on individuals who contribute to the highest financial burden. However, this group is small and represents a limited opportunity for long-term cost reduction. Objective: We developed a collection of models that predict future health care utilization at various thresholds. Methods: We utilized data from a multi-institutional diabetes database from the year 2019 to develop binary classification models. These models predict health care utilization in the subsequent year across 6 different outcomes: patients having a length of stay of ?7, ?14, and ?30 days and emergency department attendance of ?3, ?5, and ?10 visits. To address class imbalance, random and synthetic minority oversampling techniques were employed. The models were then applied to unseen data from 2020 and 2021 to predict health care utilization in the following year. A portfolio of performance metrics, with priority on area under the receiver operating characteristic curve, sensitivity, and positive predictive value, was used for comparison. Explainability analyses were conducted on the best performing models. Results: When trained with random oversampling, 4 models, that is, logistic regression, multivariate adaptive regression splines, boosted trees, and multilayer perceptron consistently achieved high area under the receiver operating characteristic curve (>0.80) and sensitivity (>0.60) across training-validation and test data sets. Correcting for class imbalance proved critical for model performance. Important predictors for all outcomes included age, number of emergency department visits in the present year, chronic kidney disease stage, inpatient bed days in the present year, and mean hemoglobin A1c levels. Explainability analyses using partial dependence plots demonstrated that for the best performing models, the learned patterns were consistent with real-world knowledge, thereby supporting the validity of the models. Conclusions: We successfully developed machine learning models capable of predicting high service level utilization with strong performance and valid explainability. These models can be integrated into wider diabetes-related population health initiatives. ", doi="10.2196/58463", url="https://ai.jmir.org/2024/1/e58463", url="http://www.ncbi.nlm.nih.gov/pubmed/39418089" } @Article{info:doi/10.2196/54223, author="Sabben, Ga{\"e}lle and Telfort, Courtney and Morales, Marissa and Zhang, Stella Wenjia and Espinoza, C. Juan and Pasquel, J. Francisco and Winskell, Kate", title="Technology and Continuous Glucose Monitoring Access, Literacy, and Use Among Patients at the Diabetes Center of an Inner-City Safety-Net Hospital: Mixed Methods Study", journal="JMIR Diabetes", year="2024", month="Oct", day="15", volume="9", pages="e54223", keywords="diabetes mellitus", keywords="type 1", keywords="type 2", keywords="digital health", keywords="continuous glucose monitoring", keywords="mobile phone", abstract="Background: Despite the existence of an increasing array of digital technologies and tools for diabetes management, there are disparities in access to and uptake and use of continuous glucose monitoring (CGM) devices, particularly for those most at risk of poor diabetes outcomes. Objective: This study aims to assess communication technology and CGM access, literacy, and use among patients receiving treatment for diabetes at an inner-city safety-net hospital. Methods: A survey on digital technology ownership and use was self-administered by 75 adults with type 1 and type 2 diabetes at the diabetes clinic of Grady Memorial Hospital in Atlanta, Georgia. In-depth interviews were conducted with 16\% (12/75) of these patient participants and 6 health care providers (HCPs) to obtain additional insights into the use of communication technology and CGM to support diabetes self-management. Results: Most participants were African American (66/75, 88\%), over half (39/75, 52\%) were unemployed or working part time, and 29\% (22/75) had no health insurance coverage, while 61\% (46/75) had federal coverage. Smartphone ownership and use were near universal; texting and email use were common (63/75, 84\% in both cases). Ownership and use of tablets and computers and use and daily use of various forms of media were more prevalent among younger participants and those with type 1 diabetes, who also rated them as easier to use. Technology use specifically for diabetes and health management was low. Participants were supportive of a potential smartphone app for diabetes management, with a high interest in such an app helping them track blood sugar levels and communicate with their care teams. Younger participants showed higher levels of interest, perceived value, and self-efficacy for using an app with these capabilities. History of CGM use was reported by 56\% (42/75) of the participants, although half (20/42, 48\%) had discontinued use, above all due to the cost of the device and issues with its adhesive. Nonuse was primarily due to not being offered CGM by their HCP. Reasons given for continued use included convenience, improved blood glucose control, and better tracking of blood glucose. The in-depth interviews (n=18) revealed high levels of satisfaction with CGM by users and supported the survey findings regarding reasons for continued use. They also highlighted the value of CGM data to enhance communication between patients and HCPs. Conclusions: Smartphone ownership was near universal among patients receiving care at an inner-city hospital. Alongside the need to address barriers to CGM access and continued use, there is an opportunity to leverage increased access to communication technology in combination with CGM to improve diabetes outcomes among underresourced populations. ", doi="10.2196/54223", url="https://diabetes.jmir.org/2024/1/e54223" } @Article{info:doi/10.2196/56741, author="Choi, Kyungseon and Park, Jun Sang and Yoon, Hyuna and Choi, Seoyoon and Mun, Yongseok and Kim, Seok and Yoo, Sooyoung and Woo, Joon Se and Park, Hyung Kyu and Na, Junghyun and Suh, Sun Hae", title="Patient-Centered Economic Burden of Diabetic Macular Edema: Retrospective Cohort Study", journal="JMIR Public Health Surveill", year="2024", month="Oct", day="8", volume="10", pages="e56741", keywords="diabetic macular edema", keywords="economic burden", keywords="cost of illness", keywords="retrospective cohort study", keywords="patient-centered care", keywords="Observational Medical Outcomes Partnership Common Data Model", abstract="Background: Diabetic macular edema (DME), a leading cause of blindness, requires treatment with costly drugs, such as anti--vascular endothelial growth factor (VEGF) agents. The prolonged use of these effective but expensive drugs results in an incremental economic burden for patients with DME compared with those with diabetes mellitus (DM) without DME. However, there are no studies on the long-term patient-centered economic burden of DME after reimbursement for anti-VEGFs. Objective: This retrospective cohort study aims to estimate the 3-year patient-centered economic burden of DME compared with DM without DME, using the Common Data Model. Methods: We used medical data from 1,903,603 patients (2003-2020), transformed and validated using the Observational Medical Outcomes Partnership Common Data Model from Seoul National University Bundang Hospital. We defined the group with DME as patients aged >18 years with nonproliferative diabetic retinopathy and intravitreal anti-VEGF or steroid prescriptions. As control, we defined the group with DM without DME as patients aged >18 years with DM or diabetic retinopathy without intravitreal anti-VEGF or steroid prescriptions. Propensity score matching, performed using a regularized logistic regression with a Laplace prior, addressed selection bias. We estimated direct medical costs over 3 years categorized into total costs, reimbursement costs, nonreimbursement costs, out-of-pocket costs, and costs covered by insurance, as well as healthcare resource utilization. An exponential conditional model and a count model estimated unbiased incremental patient-centered economic burden using generalized linear models and a zero-inflation model. Results: In a cohort of 454 patients with DME matched with 1640 patients with DM, the economic burden of DME was significantly higher than that of DM, with total costs over 3 years being 2.09 (95\% CI 1.78-2.47) times higher. Reimbursement costs were 1.89 (95\% CI 1.57-2.28) times higher in the group with DME than with the group with DM, while nonreimbursement costs were 2.54 (95\% CI 2.12-3.06) times higher. Out-of-pocket costs and costs covered by insurance were also higher by a factor of 2.11 (95\% CI 1.58-2.59) and a factor of 2.01 (95\% CI 1.85-2.42), respectively. Patients with DME had a significantly higher number of outpatient (1.87-fold) and inpatient (1.99-fold) visits compared with those with DM (P<.001 in all cases). Conclusions: Patients with DME experience a heightened economic burden compared with diabetic patients without DME. The substantial and enduring economic impact observed in real-world settings underscores the need to alleviate patients' burden through preventive measures, effective management, appropriate reimbursement policies, and the development of innovative treatments. Strategies to mitigate the economic impact of DME should include proactive approaches such as expanding anti-VEGF reimbursement criteria, approving and reimbursing cost-effective drugs such as bevacizumab, advocating for proactive eye examinations, and embracing early diagnosis by ophthalmologists facilitated by cutting-edge methodologies such as artificial intelligence for patients with DM. ", doi="10.2196/56741", url="https://publichealth.jmir.org/2024/1/e56741", url="http://www.ncbi.nlm.nih.gov/pubmed/39378098" } @Article{info:doi/10.2196/60834, author="Aguilera, Adrian and Ar{\'e}valo Avalos, Marvyn and Xu, Jing and Chakraborty, Bibhas and Figueroa, Caroline and Garcia, Faviola and Rosales, Karina and Hernandez-Ramos, Rosa and Karr, Chris and Williams, Joseph and Ochoa-Frongia, Lisa and Sarkar, Urmimala and Yom-Tov, Elad and Lyles, Courtney", title="Effectiveness of a Digital Health Intervention Leveraging Reinforcement Learning: Results From the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation (DIAMANTE) Randomized Clinical Trial", journal="J Med Internet Res", year="2024", month="Oct", day="8", volume="26", pages="e60834", keywords="digital health", keywords="physical activity", keywords="mobile phone", keywords="text messages", keywords="SMS", keywords="steps", keywords="walking", keywords="diabetes", keywords="depression", keywords="reinforcement learning", keywords="exercise", keywords="machine learning", abstract="Background: Digital and mobile health interventions using personalization via reinforcement learning algorithms have the potential to reach large number of people to support physical activity and help manage diabetes and depression in daily life. Objective: The Diabetes and Mental Health Adaptive Notification and Tracking Evaluation (DIAMANTE) study tested whether a digital physical activity intervention using personalized text messaging via reinforcement learning algorithms could increase step counts in a diverse, multilingual sample of people with diabetes and depression symptoms. Methods: From January 2020 to June 2022, participants were recruited from 4 San Francisco, California--based public primary care clinics and through web-based platforms to participate in the 24-week randomized controlled trial. Eligibility criteria included English or Spanish language preference and a documented diagnosis of diabetes and elevated depression symptoms. The trial had 3 arms: a Control group receiving a weekly mood monitoring message, a Random messaging group receiving randomly selected feedback and motivational text messages daily, and an Adaptive messaging group receiving text messages selected by a reinforcement learning algorithm daily. Randomization was performed with a 1:1:1 allocation. The primary outcome, changes in daily step counts, was passively collected via a mobile app. The primary analysis assessed changes in daily step count using a linear mixed-effects model. An a priori subanalysis compared the primary step count outcome within recruitment samples. Results: In total, 168 participants were analyzed, including those with 24\% (40/168) Spanish language preference and 37.5\% (63/168) from clinic-based recruitment. The results of the linear mixed-effects model indicated that participants in the Adaptive arm cumulatively gained an average of 3.6 steps each day (95\% CI 2.45-4.78; P<.001) over the 24-week intervention (average of 608 total steps), whereas both the Control and Random arm participants had significantly decreased rates of change. Postintervention estimates suggest that participants in the Adaptive messaging arm showed a significant step count increase of 19\% (606/3197; P<.001), in contrast to 1.6\% (59/3698) and 3.9\% (136/3480) step count increase in the Random and Control arms, respectively. Intervention effectiveness differences were observed between participants recruited from the San Francisco clinics and those recruited via web-based platforms, with the significant step count trend persisting across both samples for participants in the Adaptive group. Conclusions: Our study supports the use of reinforcement learning algorithms for personalizing text messaging interventions to increase physical activity in a diverse sample of people with diabetes and depression. It is the first to test this approach in a large, diverse, and multilingual sample. Trial Registration: ClinicalTrials.gov NCT03490253; https://clinicaltrials.gov/study/NCT03490253 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-034723 ", doi="10.2196/60834", url="https://www.jmir.org/2024/1/e60834", url="http://www.ncbi.nlm.nih.gov/pubmed/39378080" } @Article{info:doi/10.2196/56922, author="Sang, Hyunji and Lee, Hojae and Park, Jaeyu and Kim, Sunyoung and Woo, Geol Ho and Koyanagi, Ai and Smith, Lee and Lee, Sihoon and Hwang, You-Cheol and Park, Sun Tae and Lim, Hyunjung and Yon, Keon Dong and Rhee, Youl Sang", title="Machine Learning--Based Prediction of Neurodegenerative Disease in Patients With Type 2 Diabetes by Derivation and Validation in 2 Independent Korean Cohorts: Model Development and Validation Study", journal="J Med Internet Res", year="2024", month="Oct", day="3", volume="26", pages="e56922", keywords="machine learning", keywords="neurodegenerative disease", keywords="diabetes mellitus", keywords="prediction", keywords="AdaBoost", abstract="Background: Several machine learning (ML) prediction models for neurodegenerative diseases (NDs) in type 2 diabetes mellitus (T2DM) have recently been developed. However, the predictive power of these models is limited by the lack of multiple risk factors. Objective: This study aimed to assess the validity and use of an ML model for predicting the 3-year incidence of ND in patients with T2DM. Methods: We used data from 2 independent cohorts---the discovery cohort (1 hospital; n=22,311) and the validation cohort (2 hospitals; n=2915)---to predict ND. The outcome of interest was the presence or absence of ND at 3 years. We selected different ML-based models with hyperparameter tuning in the discovery cohort and conducted an area under the receiver operating characteristic curve (AUROC) analysis in the validation cohort. Results: The study dataset included 22,311 (discovery) and 2915 (validation) patients with T2DM recruited between 2008 and 2022. ND was observed in 133 (0.6\%) and 15 patients (0.5\%) in the discovery and validation cohorts, respectively. The AdaBoost model had a mean AUROC of 0.82 (95\% CI 0.79-0.85) in the discovery dataset. When this result was applied to the validation dataset, the AdaBoost model exhibited the best performance among the models, with an AUROC of 0.83 (accuracy of 78.6\%, sensitivity of 78.6\%, specificity of 78.6\%, and balanced accuracy of 78.6\%). The most influential factors in the AdaBoost model were age and cardiovascular disease. Conclusions: This study shows the use and feasibility of ML for assessing the incidence of ND in patients with T2DM and suggests its potential for use in screening patients. Further international studies are required to validate these findings. ", doi="10.2196/56922", url="https://www.jmir.org/2024/1/e56922", url="http://www.ncbi.nlm.nih.gov/pubmed/39361401" } @Article{info:doi/10.2196/56049, author="Lee, Seung-Yup and Hayes, W. Leslie and Ozaydin, Bunyamin and Howard, Steven and Garretson, M. Alison and Bradley, M. Heather and Land, M. Andrew and DeLaney, W. Erin and Pritchett, O. Amy and Furr, L. Amanda and Allgood, Ashleigh and Wyatt, C. Matthew and Hall, G. Allyson and Banaszak-Holl, C. Jane", title="Integrating Social Determinants of Health in Machine Learning--Driven Decision Support for Diabetes Case Management: Protocol for a Sequential Mixed Methods Study", journal="JMIR Res Protoc", year="2024", month="Sep", day="25", volume="13", pages="e56049", keywords="diabetes", keywords="case management", keywords="case manager", keywords="social work", keywords="case mix", keywords="social determinants of health", keywords="clinical decision support", keywords="decision support", keywords="predictive analytics", keywords="disparities", keywords="health disparities", keywords="data warehouse", keywords="tertiary care", keywords="health care system", keywords="chronic disease management", abstract="Background: The use of both clinical factors and social determinants of health (SDoH) in referral decision-making for case management may improve optimal use of resources and reduce outcome disparities among patients with diabetes. Objective: This study proposes the development of a data-driven decision-support system incorporating interactions between clinical factors and SDoH into an algorithm for prioritizing who receives case management services. The paper presents a design for prediction validation and preimplementation assessment that uses a mixed methods approach to guide the implementation of the system. Methods: Our study setting is a large, tertiary care academic medical center in the Deep South of the United States, where SDoH contribute to disparities in diabetes-specific hospitalizations and emergency department (ED) visits. This project will develop an interpretable artificial intelligence model for a population with diabetes using SDoH and clinical data to identify which posthospitalization cases have a higher likelihood of subsequent ED use. The electronic health record data collected for the study include demographics, SDoH, comorbidities, hospitalization-related factors, laboratory test results, and medication use to predict posthospitalization ED visits. Subsequently, a mixed methods approach will be used to validate prediction outcomes and develop an implementation strategy from insights into patient outcomes from case managers, clinicians, and quality and patient safety experts. Results: As of December 2023, we had abstracted data on 174,871 inpatient encounters between January 2018 and September 2023, involving 89,355 unique inpatients meeting inclusion criteria. Both clinical and SDoH data items were included for these patient encounters. In total, 85\% of the inpatient visits (N=148,640) will be used for training (learning from the data) and the remaining 26,231 inpatient visits will be used for mixed-methods validation (testing). Conclusions: By integrating a critical suite of SDoH with clinical data related to diabetes, the proposed data-driven risk stratification model can enable individualized risk estimation and inform health professionals (eg, case managers) about the risk of patients' upcoming ED use. The prediction outcome could potentially automate case management referrals, helping to better prioritize services. By taking a mixed methods approach, we aim to align the model with the hospital's specific quality and patient safety considerations for the quality of patient care and the optimization of case management resource allocation. International Registered Report Identifier (IRRID): DERR1-10.2196/56049 ", doi="10.2196/56049", url="https://www.researchprotocols.org/2024/1/e56049" } @Article{info:doi/10.2196/55546, author="Brunton, Lisa and Cotterill, Sarah and Wilson, Paul", title="Evaluating the National Rollout of a Type 2 Diabetes Self-Management Intervention: Qualitative Interview Study With Local National Health Service Leads Responsible for Implementation", journal="J Med Internet Res", year="2024", month="Sep", day="25", volume="26", pages="e55546", keywords="type 2 diabetes", keywords="structured education", keywords="self-management", keywords="digital interventions", keywords="implementation", keywords="qualitative methods", keywords="evaluation", abstract="Background: Approximately 4.5 million people live with type 2 diabetes mellitus (T2DM) in the United Kingdom. Evidence shows that structured education programs can improve glycemic control and reduce the risk of complications from T2DM, but they have low attendance rates. To widen access to T2DM structured education, National Health Service England commissioned a national rollout of Healthy Living, a digital self-management program. Objective: The objectives were to understand the barriers and enablers to adopting, implementing, and integrating Healthy Living into existing T2DM care pathways across England. Methods: We undertook a cross-sectional, qualitative telephone semistructured interview study to address the objectives. In total, 17 local National Health Service leads responsible for implementing Healthy Living across their locality were recruited. We conducted 16 one-time interviews across 16 case sites (1 of the interviews was conducted with 2 local leads from the same case site). Interview data were analyzed using thematic analysis. Results: Three overarching themes were generated: (1) implementation activities, (2) where Healthy Living fits within existing pathways, and (3) contextual factors affecting implementation. Of the 16 sites, 14 (88\%) were implementing Healthy Living; the barrier to not implementing it in 2 case sites was not wanting Healthy Living to compete with their current education provision for T2DM. We identified 6 categories of implementation activities across sites: communication strategies to raise awareness of Healthy Living, developing bespoke local resources to support general practices with referrals, providing financial reimbursement or incentives to general practices, promoting Healthy Living via public events, monitoring implementation across their footprint, and widening access across high-need groups. However, outside early engagement sites, most implementation activities were ``light touch,'' consisting mainly of one-way communications to raise awareness. Local leads were generally positive about Healthy Living as an additional part of their T2DM structured education programs, but some felt it was more suited to specific patient groups. Barriers to undertaking more prolonged, targeted implementation campaigns included implementation not being mandated, sites not receiving data on uptake across their footprint, and confusion in understanding where Healthy Living fit within existing care pathways. Conclusions: A passive process of disseminating information about Healthy Living to general practices rather than an active process of implementation occurred across most sites sampled. This study identified that there is a need for clearer communications regarding the type of patients that may benefit from the Healthy Living program, including when it should be offered and whether it should be offered instead of or in addition to other education programs. No sites other than early engagement sites received data to monitor uptake across their footprint. Understanding variability in uptake across practices may have enabled sites to plan targeted referral campaigns in practices that were not using the service. ", doi="10.2196/55546", url="https://www.jmir.org/2024/1/e55546" } @Article{info:doi/10.2196/56024, author="Ng, Ping Hui and Chong, Yun Shu and Li, Huan Yi and Goh, Hwee Tong and Pang, Yii Ka and Pereira, Jessica Michelle and Huang, Chin-Ming", title="Objective Analysis of Traditional Chinese Medicine Syndrome Differentiation of Patients With Diabetes and Prediabetes: Protocol for a Nonrandomized, Exploratory, Observational Case-Control Study Using Digitalized Traditional Chinese Medicine Diagnostic Tools", journal="JMIR Res Protoc", year="2024", month="Sep", day="12", volume="13", pages="e56024", keywords="diabetes", keywords="dyslipidemia", keywords="hypertension", keywords="prediabetes", keywords="traditional Chinese medicine syndrome differentiation", keywords="pulse diagnosis", keywords="tongue diagnosis", keywords="tongue", keywords="diabetic", keywords="protocol", keywords="diagnostic tools", keywords="diagnostic system", keywords="accuracy", keywords="diagnosis", keywords="treatment", keywords="prevention", keywords="questionnaire", keywords="sugar intake", keywords="physical activity", keywords="health evaluation", abstract="Background: Diabetes and prediabetes are diagnosed differentially by Western and Chinese medicine. While Western medicine uses objective laboratory analysis of biochemical parameters to define the severity of diabetes and prediabetes, Chinese medicine uses a comprehensive approach that integrates observation, inquiry, pulse palpation, and tongue diagnosis. The medical information collected is then categorized into different syndromes. However, traditional methods of pulse and tongue diagnoses used to determine syndrome differentiation are highly subjective and skill dependent. Objective: This study aims to identify the gap in conventional traditional Chinese medicine (TCM) diagnostic techniques for syndrome differentiation analysis using contemporary diagnostic devices. We devised a protocol for a nonrandomized, exploratory, observational case-control study with equal allocations in 5 arms to investigate the syndrome differentiation of diabetes and prediabetes. We hypothesize that the TCM syndrome differentiation of diabetes and prediabetes in the tropical climate may differ from that defined based on the Chinese demographic. We also speculate that the high-frequency spectral energy may reflect a difference in pulse wave intensity and density between the healthy and diabetes groups. Methods: A total of 250 eligible participants will be equally assigned to 1 of 5 arms (healthy or subhealthy, prediabetes, diabetes, prediabetes with hypertension and dyslipidemia, and diabetes with hypertension and dyslipidemia). Participants aged 21-75 years, of any sex or race, and have been diagnosed with diabetes (fasting plasma glucose [FPG] of 7 mmol/L, or 2-hour plasma glucose [2hPG] of 11.1 mmol/L) or prediabetes (impaired FPG of 6.1-6.9 mmol/L, or impaired glucose tolerance with an 2hPG of 7.8-11 mmol/L) will be included. The Health Evaluation Questionnaire, Physical Activity Questionnaire, sugar intake assessment, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis, and tongue diagnosis will be performed in a single visit. ANOVA for continuous data and chi-square tests of independence will be used for categorical data assessments, with a level of P<.05 considered significant. Results: The recruitment is in progress. We anticipate that the study will conclude in June 2025. As of July 15, 2024, we have enrolled 140 individuals. Conclusions: To the best of our knowledge, this is the first study to use contemporary TCM diagnostic instruments to map expert and empirical knowledge of TCM to its scientific equivalents for the purpose of evaluating the syndrome differentiation of diabetes. We designed this protocol with the exploratory goal to examine objectively the syndrome differentiation of patients with diabetes and those with prediabetes using TCM diagnostic technologies. The data collected and evaluated under standardized conditions using these contemporary diagnostic devices will exhibit a higher degree of stability, hence yielding dependable and unbiased results for syndrome differentiation. Thus, our findings may potentially increase the accuracy of identification, diagnosis, treatment, and prevention of diabetes and prediabetes through a system of targeted treatment. Trial Registration: ClinicalTrials.gov NCT05563090; https://clinicaltrials.gov/ct2/show/NCT05563090 International Registered Report Identifier (IRRID): DERR1-10.2196/56024 ", doi="10.2196/56024", url="https://www.researchprotocols.org/2024/1/e56024" } @Article{info:doi/10.2196/56993, author="Oyebola, Kolapo and Ligali, Funmilayo and Owoloye, Afolabi and Erinwusi, Blessing and Alo, Yetunde and Musa, Z. Adesola and Aina, Oluwagbemiga and Salako, Babatunde", title="Machine Learning--Based Hyperglycemia Prediction: Enhancing Risk Assessment in a Cohort of Undiagnosed Individuals", journal="JMIRx Med", year="2024", month="Sep", day="11", volume="5", pages="e56993", keywords="hyperglycemia", keywords="diabetes", keywords="machine learning", keywords="hypertension", keywords="random forest", abstract="Background: Noncommunicable diseases continue to pose a substantial health challenge globally, with hyperglycemia serving as a prominent indicator of diabetes. Objective: This study employed machine learning algorithms to predict hyperglycemia in a cohort of individuals who were asymptomatic and unraveled crucial predictors contributing to early risk identification. Methods: This dataset included an extensive array of clinical and demographic data obtained from 195 adults who were asymptomatic and residing in a suburban community in Nigeria. The study conducted a thorough comparison of multiple machine learning algorithms to ascertain the most effective model for predicting hyperglycemia. Moreover, we explored feature importance to pinpoint correlates of high blood glucose levels within the cohort. Results: Elevated blood pressure and prehypertension were recorded in 8 (4.1\%) and 18 (9.2\%) of the 195 participants, respectively. A total of 41 (21\%) participants presented with hypertension, of which 34 (83\%) were female. However, sex adjustment showed that 34 of 118 (28.8\%) female participants and 7 of 77 (9\%) male participants had hypertension. Age-based analysis revealed an inverse relationship between normotension and age (r=?0.88; P=.02). Conversely, hypertension increased with age (r=0.53; P=.27), peaking between 50?59 years. Of the 195 participants, isolated systolic hypertension and isolated diastolic hypertension were recorded in 16 (8.2\%) and 15 (7.7\%) participants, respectively, with female participants recording a higher prevalence of isolated systolic hypertension (11/16, 69\%) and male participants reporting a higher prevalence of isolated diastolic hypertension (11/15, 73\%). Following class rebalancing, the random forest classifier gave the best performance (accuracy score 0.89; receiver operating characteristic--area under the curve score 0.89; F1-score 0.89) of the 26 model classifiers. The feature selection model identified uric acid and age as important variables associated with hyperglycemia. Conclusions: The random forest classifier identified significant clinical correlates associated with hyperglycemia, offering valuable insights for the early detection of diabetes and informing the design and deployment of therapeutic interventions. However, to achieve a more comprehensive understanding of each feature's contribution to blood glucose levels, modeling additional relevant clinical features in larger datasets could be beneficial. ", doi="10.2196/56993", url="https://xmed.jmir.org/2024/1/e56993" } @Article{info:doi/10.2196/60023, author="Koo, Dae-Jeong and Moon, Sun-Joon and Moon, Suhyeon and Park, Eun Se and Rhee, Eun-Jung and Lee, Won-Young and Park, Cheol-Young", title="Long-Term Glycemic Control Improvement After the Home and Self-Care Program for Patients With Type 1 Diabetes: Real-World--Based Cohort Study", journal="J Med Internet Res", year="2024", month="Sep", day="11", volume="26", pages="e60023", keywords="type 1 diabetes", keywords="structured education", keywords="home health care", keywords="glycated hemoglobin", keywords="continuous glucose monitoring", keywords="mobile phone", abstract="Background: The prevalence of type 1 diabetes (T1D) is increasing worldwide, with a much higher proportion of adult patients. However, achieving stable glycemic control is difficult in these patients. Objective: After periodic implementation of structured education for patients with T1D through the Home and Self-Care Program, a pilot home health care project promoted by the Korean government, we evaluated the program's effects on glycemic control. Methods: This study was conducted from April 2020 to March 2023. We analyzed 119 participants with T1D aged >15 years. Nursing and nutrition education were provided separately up to 4 times per year, with physician consultation up to 6 times per year. A distinguishing feature of this study compared with previous ones was the provision of remote support using a general-purpose smartphone communication app offered up to 12 times annually on an as-needed basis to enhance the continuity of in-person education effects. Patients were followed up on at average intervals of 3 months for up to 24 months. The primary end point was the mean difference in glycated hemoglobin (HbA1c) at each follow-up visit from baseline. For continuous glucose monitoring (CGM) users, CGM metrics were also evaluated. Results: The mean HbA1c level of study participants was 8.6\% at baseline (mean duration of T1D 10.02, SD 16.10 y). The HbA1c level reduction in participants who received at least 1 structured educational session went from 1.63\% (SD 2.03\%; P<.001; adjustment model=1.69\%, 95\% CI 1.24\%-2.13\% at the first follow-up visit) to 1.23\% (SD 1.31\%; P=.01; adjustment model=1.28\%, 95\% CI 0.78\%-1.79\% at the eighth follow-up visit). In the adjustment model, the actual mean HbA1c values were maintained between a minimum of 7.33\% (95\% CI 7.20\%-7.46\% at the first follow-up visit) and a maximum of 7.62\% (95\% CI 7.41\%-7.82\% at the sixth follow-up visit). Among CGM users, after at least 1 session, the mean time in the target range was maintained between 61.59\% (adjusted model, 95\% CI 58.14\%-65.03\% at the second follow-up visit) and 54.7\% (95\% CI 50.92\%-58.48\% at the eighth follow-up visit), consistently staying above 54.7\% (corresponding to an HbA1c level of <7.6\%). The mean time below the target range (TBR) also gradually improved to the recommended range (?4\% for TBR of <70 mg/dL and ?1\% for TBR of <54 mg/dL). Conclusions: The Home and Self-Care Program protocol for glycemic control in patients with T1D is effective, producing significant improvement immediately and long-term maintenance effects, including on CGM indexes. ", doi="10.2196/60023", url="https://www.jmir.org/2024/1/e60023" } @Article{info:doi/10.2196/54429, author="Shi, Lixin and Xue, Yaoming and Yu, Xuefeng and Wang, Yangang and Hong, Tianpei and Li, Xiaoying and Ma, Jianhua and Zhu, Dalong and Mu, Yiming", title="Prevalence and Risk Factors of Chronic Kidney Disease in Patients With Type 2 Diabetes in China: Cross-Sectional Study", journal="JMIR Public Health Surveill", year="2024", month="Aug", day="30", volume="10", pages="e54429", keywords="awareness rate", keywords="chronic kidney disease", keywords="prevalence", keywords="risk factor", keywords="screening rate", keywords="type 2 diabetes", abstract="Background: Chronic kidney disease (CKD) is a significant long-term complication of diabetes and is a primary contributor to end-stage kidney disease. Objective: This study aimed to report comprehensive nationwide data on the prevalence, screening, and awareness rates of CKD in Chinese patients with type 2 diabetes, along with associated risk factors. Methods: Baseline data analysis of the ongoing prospective, observational IMPROVE study was conducted. The study cohort comprised patients who had been diagnosed with type 2 diabetes more than 12 months prior, received at least 1 hypoglycemic medication, and were aged ?18 years. The participants completed questionnaires and underwent laboratory assessments, including blood and urine samples. The data encompassed patient demographics, medical history, concurrent medications, and comorbidities. Comprehensive evaluations involved physical examinations, urinary albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR), glycated hemoglobin (HbA1c), fasting blood glucose, 2-hour postprandial blood glucose, fasting blood lipid profile, and urinalysis. Descriptive statistics were applied for data interpretation, and logistic regression analyses were used to identify the CKD-associated risk factors in patients with type 2 diabetes. Results: A national study from December 2021 to September 2022 enlisted 9672 participants with type 2 diabetes from 45 hospitals that had endocrinology departments. The enrollees were from diverse regions in China, as follows: central (n=1221), east (n=3269), south (n=1474), north (n=2219), and west (n=1489). The prevalence, screening, and awareness rates of CKD among patients with type 2 diabetes were 31\% (2997/9672), 27\% (810/2997), and 54.8\% (5295/9672), respectively. Multivariate binary regression analysis revealed that the CKD risk factors were screening, awareness, smoking, age, diabetes duration, concurrent antihypertensive and microcirculation medications, diabetic complications (foot, retinopathy, and neuropathy), hypertension, elevated low-density lipoprotein (LDL) cholesterol, and suboptimal glycemic control. Subgroup analysis highlighted an increased CKD prevalence among older individuals, those with prolonged diabetes durations, and residents of fourth-tier cities. Residents of urban areas that had robust educational and economic development exhibited relatively high awareness and screening rates. Notably, 24.2\% (1717/7107) of patients with an eGFR ?90 mL/min/1.73 m2 had proteinuria, whereas 3.4\% (234/6909) who had a UACR <30 mg/g presented with an eGFR <60 mL/min/1.73 m2. Compared with patients who were cognizant of CKD, those who were unaware of CKD had increased rates of HbA1c ?7\%, total cholesterol >5.18 $\mu$mol/L, LDL cholesterol >3.37 $\mu$mol/L, BMI ?30 kg/m2, and hypertension. Conclusions: In a Chinese population of adults with type 2 diabetes, the CKD prevalence was notable, at 31\%, coupled with low screening and awareness rates. Multiple risk factors for CKD have been identified. Trial Registration: ClinicalTrials.gov NCT05047471; https://clinicaltrials.gov/study/NCT05047471 ", doi="10.2196/54429", url="https://publichealth.jmir.org/2024/1/e54429" } @Article{info:doi/10.2196/59571, author="Jang, Wonwoo and Kim, Seokjun and Son, Yejun and Kim, Soeun and Kim, Jin Hyeon and Jo, Hyesu and Park, Jaeyu and Lee, Kyeongmin and Lee, Hayeon and Tully, A. Mark and Rahmati, Masoud and Smith, Lee and Kang, Jiseung and Woo, Selin and Kim, Sunyoung and Hwang, Jiyoung and Rhee, Youl Sang and Yon, Keon Dong", title="Prevalence, Awareness, Treatment, and Control of Type 2 Diabetes in South Korea (1998 to 2022): Nationwide Cross-Sectional Study", journal="JMIR Public Health Surveill", year="2024", month="Aug", day="27", volume="10", pages="e59571", keywords="disease management", keywords="epidemiology", keywords="prevalence", keywords="Republic of Korea", keywords="type 2 diabetes mellitus", abstract="Background: Type 2 diabetes poses an increasing disease burden in South Korea. The development and management of type 2 diabetes are closely related to lifestyle and socioeconomic factors, which have undergone substantial changes over the past few decades, including during the COVID-19 pandemic. Objective: This study aimed to investigate long-term trends in type 2 diabetes prevalence, awareness, treatment, and control. It also aimed to determine whether there were substantial alterations in the trends during the pandemic and whether these changes were more pronounced within specific demographic groups. Methods: This study examined the prevalence, awareness, treatment, and control of type 2 diabetes in a representative sample of 139,786 South Koreans aged >30 years, using data from the National Health and Nutrition Examination Survey and covering the period from 1998 to 2022. Weighted linear regression and binary logistic regression were performed to calculate weighted $\beta$ coefficients or odds ratios. Stratified analyses were performed based on sex, age, region of residence, obesity status, educational background, household income, and smoking status. $\beta$ (difference) was calculated to analyze the trend difference between the prepandemic period and the COVID-19 pandemic. To identify groups more susceptible to type 2 diabetes, we estimated interaction terms for each factor and calculated weighted odds ratios. Results: From 1998 to 2022, a consistent increase in the prevalence of type 2 diabetes was observed among South Koreans, with a notable rise to 15.61\% (95\% CI 14.83-16.38) during the pandemic. Awareness followed a U-shaped curve, bottoming out at 64.37\% (95\% CI 61.79-66.96) from 2013 to 2015 before increasing to 72.56\% (95\% CI 70.39-74.72) during the pandemic. Treatment also increased over time, peaking at 68.33\% (95\% CI 65.95-70.71) during the pandemic. Control among participants with diabetes showed no substantial change, maintaining a rate of 29.14\% (95\% CI 26.82-31.47) from 2020 to 2022, while control among treated participants improved to 30.68\% (95\% CI 27.88-33.48). During the pandemic, there was a steepening of the curves for awareness and treatment. However, while the slope of control among participants being treated increased, the slope of control among participants with diabetes showed no substantial change during the pandemic. Older populations and individuals with lower educational level exhibited less improvement in awareness and control trends than younger populations and more educated individuals. People with lower income experienced a deceleration in prevalence during the pandemic. Conclusions: Over the recent decade, there has been an increase in type 2 diabetes prevalence, awareness, treatment, and control. During the pandemic, a steeper increase in awareness, treatment, and control among participants being treated was observed. However, there were heterogeneous changes across different population groups, underscoring the need for targeted interventions to address disparities and improve diabetes management for susceptible populations. ", doi="10.2196/59571", url="https://publichealth.jmir.org/2024/1/e59571" } @Article{info:doi/10.2196/57313, author="Gudlavalleti, Gaurang Anirudh and Babu, R. Giridhara and Kamalakannan, Sureshkumar and Murthy, S. G. V. and Schaper, C. Nicolaas and van Schayck, P. Onno C.", title="Training of Community Health Workers in Diabetes Lead to Improved Outcomes for Diabetes Screening and Management in Low- and Middle-Income Countries: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2024", month="Aug", day="21", volume="13", pages="e57313", keywords="community health workers", keywords="diabetes training", keywords="community health worker training", keywords="systematic review", keywords="diabetes management", keywords="community training", keywords="low-and-middle-income countries", keywords="diabetes", keywords="type 2 diabetes mellitus", keywords="prevalence", keywords="rural", keywords="health care professionals", keywords="barriers", abstract="Background: Diabetes is a growing concern worldwide, particularly in low- and middle-income countries (LMICs). Type 2 diabetes mellitus constitutes a significant proportion of cases and is associated with debilitating microvascular complications. Type 2 diabetes mellitus is steadily increasing among the LMICs where many barriers to health care exist. Thus, task shifting to community health workers (CHWs) has been proposed as a solution to improve diabetes management in these settings. However, CHWs often lack the necessary training to manage diabetes effectively. Thus, a systematic review is required to present evidence of the highest degree for this intervention. Objective: This study aims to establish the protocols for a systemic review. Methods: Using the Participants Intervention Comparator Outcome Time Study Design (PICOTS) framework, this study outlines a systematic review aiming to evaluate the impact of training programs for CHWs in diabetes management in LMICs. Quantitative studies focusing on CHWs, diabetes training, focusing on diabetes management outcomes like hemoglobin A1c levels and fasting blood glucose levels, between January 2000 and December 2023 and found on databases such as PubMed, Ovid MEDLINE, Evidence Based Medicine Reviews, BASE, Google Scholar, and Web of Science will be included. We will include randomized controlled trials but will also include observational studies if we find less than 5 randomized controlled trials. An author committee consisting of 3 reviewers will be formed, where 2 reviewers will conduct the review independently while the third will resolve all disputes. The Cochrane Methods Risk of Bias Tool 2 will be used for assessing the risk of bias and the Grading of Recommendations, Assessment, Development and Evaluation approach for the meta-analysis and narrative synthesis analysis will be used. The results will be presented in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. Results: The review will begin in May 2024 and conclude in 3 months. Conclusions: The review will synthesize existing evidence and provide insights into the effectiveness of such programs, informing future research and practice in diabetes care in LMICs. Trial Registration: PROSPERO CRD42022341717; https://tinyurl.com/jva2hpdr International Registered Report Identifier (IRRID): PRR1-10.2196/57313 ", doi="10.2196/57313", url="https://www.researchprotocols.org/2024/1/e57313" } @Article{info:doi/10.2196/53509, author="Cheng, Yu-Shan and Lin, Cheng-Pei and Chen, Anny Lu-Yen and Hwang, Wei-Ren and Lin, Yi-Chun and Chen, Yu-Chi", title="Short-Term Effects of an eHealth Care Experiential Learning Program Among Patients With Type 2 Diabetes: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Aug", day="16", volume="26", pages="e53509", keywords="diabetes", keywords="eHealth literacy", keywords="eHealth", keywords="patient engagement", keywords="experiential learning theory", keywords="experimental learning theory", keywords="type 2 diabetes", keywords="randomized controlled trial", abstract="Background: Type 2 diabetes is a chronic disease with a significant medical burden. eHealth care integrates medicine and technology to enhance the outcomes of such patients; however, adequate eHealth literacy (eHL) is necessary for that to happen. Fostering eHL is crucial for patients with diabetes to engage with eHealth care and receive quality care and timely support. Experiential learning theory can enhance patients' eHL and skills to use eHealth care technology in their daily care. Objective: This study explored the effectiveness of an eHealth care experiential learning program in improving eHL, patient health engagement, and eHealth care use status among patients with type 2 diabetes in 3 months. Methods: In this randomized controlled trial, patients under case management services from various clinics in Taiwan were randomly assigned to either the intervention group receiving the 6-session eHealth care experiential learning program or the control group receiving the usual care. Data were collected using structured questionnaires at 3 time points: pretest, postintervention, and 3 months after the intervention. Descriptive data were presented using frequency distribution, percentage, mean, and SD. The outcomes were analyzed using a generalized estimating equation method by intention-to-treat analysis. Results: A total of 92 participants (46 in each group) were recruited in this study. Of these, 86 completed the course and follow-up evaluations with a mean age of 62.38 (SD 12.91) years. After completing the intervention, the intervention group had significantly higher posttest scores in eHL ($\beta$=19.94, SE 3.52; P<.001), patient health engagement ($\beta$=.28, SE 0.13; P=.04), and eHealth use ($\beta$=3.96, SE 0.42; P<.001) than the control group. Furthermore, the intervention group maintained these significant improvements in eHL ($\beta$=18.19, SE 3.82; P<.001) and eHealth use ($\beta$=3.87, SE 0.49; P<.001) after 3 months. Conclusions: Participating in the eHealth care experiential learning program resulted in significant improvements in eHL, patient health engagement, and eHealth use among patients with type 2 diabetes. Our interventional program can inform future clinical practice and policies to strengthen self-management skills and facilitate the use of health technology in caring for patients with chronic diseases. Trial Registration: ClinicalTrials.gov NCT05180604; https://clinicaltrials.gov/ct2/show/NCT05180604 ", doi="10.2196/53509", url="https://www.jmir.org/2024/1/e53509" } @Article{info:doi/10.2196/59266, author="Chanpitakkul, Methee and Praveen, Devarsetty and John, Renu and Ghosh, Arpita and Lekagul, Salyaveth and Kaewhiran, Malulee and Tungsanga, Kriang and Jha, Vivekanand", title="Rationale, Design, and Intervention Development of a Mobile Health--Led Primary Care Program for Management of Type 2 Diabetes in Rural Thailand: Protocol for a SMARThealth Diabetes Study", journal="JMIR Res Protoc", year="2024", month="Aug", day="16", volume="13", pages="e59266", keywords="health workforce", keywords="primary health care", keywords="diabetes", keywords="digital technology", keywords="Thailand", keywords="capacity building.", abstract="Background: Noncommunicable diseases (NCDs), particularly diabetes and chronic kidney diseases, pose a significant health burden in Thailand, especially among socioeconomically disadvantaged populations. The existing primary health care system faces challenges in providing optimal care for NCDs due to inadequate primary care workforce. The SMARThealth program offers a technology-based solution to enhance NCD management through task-sharing among nonphysician health care workers. Objective: This study aims to adapt and implement the SMARThealth Diabetes program in rural Thailand to improve diabetes management. The main objectives are to (1) adapt, validate, and integrate the SMARThealth Diabetes program for improving the management of type 2 diabetes mellitus at the primary health care level; and (2) to determine the feasibility and acceptability of the SMARThealth Diabetes program in rural communities of Thailand. Methods: A pragmatic, type 2 hybrid effectiveness or implementation, parallel-group cluster randomized controlled trial of 12 months duration and involving 51 subdistrict health offices in rural communities of Kamphaeng Phet province, Thailand, will be conducted. The intervention arm will receive the SMARThealth Diabetes program, including workforce restructuring, clinical decision support system, and continuous performance monitoring, while the control arm will continue with usual practice. Data will be collected using the SMARThealth platform and will be stored on a server in Thailand. The primary outcome measure will be the change in mean hemoglobin A1c (HbA1c) measured at randomization and 12 months from randomization between the intervention and control clusters. Secondary outcomes will include the difference in change in albuminuria status, estimated glomerular filtration rate, systolic blood pressure, and low-density lipoprotein cholesterol level. The analysis for change in HbA1c between baseline and end of study will be performed using linear mixed models. Any imbalances between the 2 arms will be addressed by sensitivity analyses. Additionally, a mixed methods process evaluation will be conducted to assess the implementation process, that will include in-depth interviews and focus group discussions, in addition to the quantitative data collected during the implementation process. The qualitative data will be thematically analyzed to explore factors that promote or inhibit the implementation and maintenance of the program. Results: The data collection commenced in November 2022, and the results will be ready for publication by the first quarter of 2025. Effectiveness of the intervention package will be assessed by change in mean HbA1c measures, and detailed feasibility, barriers, and enablers for the implementation of the intervention will be documented through a detailed process evaluation. Conclusions: The study protocol outlines a novel approach to enhancing diabetes management in rural Thailand through digital technology--based interventions that will facilitate task-sharing among health care workers. This can help inform future strategies for improving NCD care in low-resource settings globally. Trial Registration: Thai Clinical Trials Registry TCTR20200322006; https://www.thaiclinicaltrials.org/show/TCTR20200322006 International Registered Report Identifier (IRRID): DERR1-10.2196/59266 ", doi="10.2196/59266", url="https://www.researchprotocols.org/2024/1/e59266" } @Article{info:doi/10.2196/64442, author="Som, Md Ayub and Sohadi, Mohd Nur Amanina and Nor, Mohd Noor Shafina and Ali, Abdulbari Sherif and Ahmad, Aizad Mohd", title="Authors' Response to Peer Reviews of ``In-Silico Works Using an Improved Hovorka Equations Model and Clinical Works on the Control of Blood Glucose Levels in People With Type 1 Diabetes: Comparison Study''", journal="JMIRx Bio", year="2024", month="Aug", day="15", volume="2", pages="e64442", keywords="blood glucose level", keywords="closed-loop system", keywords="Hovorka model", keywords="in-silico work", keywords="meal disturbance", keywords="type 1 diabetes mellitus", doi="10.2196/64442", url="https://bio.jmirx.org/2024/1/e64442" } @Article{info:doi/10.2196/63851, author="Gore, Ross", title="Peer Review of ``In-Silico Works Using an Improved Hovorka Equations Model and Clinical Works on the Control of Blood Glucose Levels in People With Type 1 Diabetes: Comparison Study''", journal="JMIRx Bio", year="2024", month="Aug", day="15", volume="2", pages="e63851", keywords="blood glucose level", keywords="closed-loop system", keywords="Hovorka model", keywords="in-silico work", keywords="meal disturbance", keywords="type 1 diabetes mellitus", doi="10.2196/63851", url="https://bio.jmirx.org/2024/1/e63851" } @Article{info:doi/10.2196/43662, author="Som, Md Ayub and Sohadi, Mohd Nur Amanina and Nor, Mohd Noor Shafina and Ali, Abdulbari Sherif and Ahmad, Aizad Mohd", title="In-Silico Works Using an Improved Hovorka Equations Model and Clinical Works on the Control of Blood Glucose Levels in People With Type 1 Diabetes: Comparison Study", journal="JMIRx Bio", year="2024", month="Aug", day="15", volume="2", pages="e43662", keywords="blood glucose level", keywords="closed-loop system", keywords="Hovorka model", keywords="in-silico work", keywords="meal disturbance", keywords="type 1 diabetes mellitus", abstract="Background: People with type 1 diabetes (T1D) depend on external insulin to regulate their blood glucose level (BGL) within the normoglycemic range between 4.0 to 7.0 mmol/L. Patients with T1D routinely conduct self-monitoring of blood glucose through finger pricks before insulin injections. An artificial pancreas is an innovative device that mimics the function of a healthy pancreas. Despite its recent advancement, the control algorithms used in an artificial pancreas are still lagging in delivering the proper insulin dosage to patients with T1D. Previous researchers attempted to improve the interrelation between parameters and variables in the original Hovorka equations model, later known as the improved Hovorka equations model; however, the improved equations model has not been tested in terms of its usability to regulate and control the BGL in a safe range for 2 or more people with T1D. Objective: This study aimed to simulate the improved Hovorka equations model using actual patients' data via MATLAB programming coupled with enhanced model-based predicted control and determine the optimum bolus insulin. The study then compares the performance results obtained from in-silico and clinical works. Methods: Data from 3 patients were collected from clinic 1---Clinical Training Centre, Universiti Teknologi MARA Hospital, Sungai Buloh, Selangor---upon getting approval from the Universiti Teknologi MARA Ethics Committee. The inclusion criteria for participation were, namely having T1D, age 11-14 years, and highly dependent on insulin injection with four or more finger pricks or self-monitoring of blood glucose for BGL measurements per day. The patients with T1D typically received meals three times per day: breakfast, lunch, and dinner. A closed-loop algorithm (enhanced model-based predicted control) was used for the in-silico test, whereas an open-loop therapy was used for the clinical validation. As for the data analysis of patients, P values from a multiple linear regression were used to model the relationship between meal, insulin, and BGL. Results: The optimum bolus insulins for patient 1 were 83.33, 33.33, and 16.67 mU/min; for patient 2 were 66.67, 50.01, and 33.33 mU/min; and for patient 3 were 100.02, 83.33, and 66.67 mU/min for breakfast, lunch, and dinner, respectively. As for the in-silico works, the percentages of time that the BGL was on target for patients 1, 2, and 3 were 79.59\%, 87.76\%, and 71.43\%, respectively, as compared to the clinical works with <50\%. A small P value (P<.001) indicated that the variables were significant. However, when compared to the BGL profile, both profiles were not comparable in simulating the BGL for patients with T1D. Conclusions: The in-silico work was not comparable to the clinical work in simulating the BGL for patients with T1D due to the different methodologies used and the insufficient information that was reported to reproduce the calculation of the optimal bolus insulin. ", doi="10.2196/43662", url="https://bio.jmirx.org/2024/1/e43662" } @Article{info:doi/10.2196/49073, author="Nagpal, S. Meghan and Jalali, Niloofar and Sherifali, Diana and Morita, P. Plinio and Cafazzo, A. Joseph", title="Managing Type 2 Diabetes During the COVID-19 Pandemic: Scoping Review and Qualitative Study Using Systematic Literature Review and Reddit", journal="Interact J Med Res", year="2024", month="Aug", day="8", volume="13", pages="e49073", keywords="type 2 diabetes", keywords="social media", keywords="patient-generated health data", keywords="big data", keywords="machine learning", keywords="natural language processing", keywords="COVID-19, COVID-19 stress syndrome, health behaviors", keywords="Reddit", keywords="qualitative", keywords="analysis", keywords="diabetes", keywords="scoping review", abstract="Background: The COVID-19 pandemic impacted how people accessed health services and likely how they managed chronic conditions such as type 2 diabetes (T2D). Social media forums present a source of qualitative data to understand how adaptation might have occurred from the perspective of the patient. Objective: Our objective is to understand how the care-seeking behaviors and attitudes of people living with T2D were impacted during the early part of the pandemic by conducting a scoping literature review. A secondary objective is to compare the findings of the scoping review to those presented on a popular social media platform Reddit. Methods: A scoping review was conducted in 2021. Inclusion criteria were population with T2D, studies are patient-centered, and study objectives are centered around health behaviors, disease management, or mental health outcomes during the COVID-19 pandemic. Exclusion criteria were populations with other noncommunicable diseases, examining COVID-19 as a comorbidity to T2D, clinical treatments for COVID-19 among people living with T2D, genetic expressions of COVID-19 among people living with T2D, gray literature, or studies not published in English. Bias was mitigated by reviewing uncertainties with other authors. Data extracted from the studies were classified into thematic categories. These categories reflect the findings of this study as per our objective. Data from the Reddit forums related to T2D from March 2020 to early March 2021 were downloaded, and support vector machines were used to classify if a post was published in the context of the pandemic. Latent Dirichlet allocation topic modeling was performed to gather topics of discussion specific to the COVID-19 pandemic. Results: A total of 26 studies conducted between February and September 2020, consisting of 13,673 participants, were included in this scoping literature review. The studies were qualitative and relied mostly on qualitative data from surveys or questionnaires. Themes found from the literature review were ``poorer glycemic control,'' ``increased consumption of unhealthy foods,'' ``decreased physical activity,'' ``inability to access medical appointments,'' and ``increased stress and anxiety.'' Findings from latent Dirichlet allocation topic modeling of Reddit forums were ``Coping With Poor Mental Health,'' ``Accessing Doctor \& Medications and Controlling Blood Glucose,'' ``Changing Food Habits During Pandemic,'' ``Impact of Stress on Blood Glucose Levels,'' ``Changing Status of Employment \& Insurance,'' and ``Risk of COVID Complications.'' Conclusions: Topics of discussion gauged from the Reddit forums provide a holistic perspective of the impact of the pandemic on people living with T2D, which were found to be comparable to the findings of the literature review. The study was limited by only having 1 reviewer for the literature review, but biases were mitigated by consulting authors when there were uncertainties. Qualitative analysis of Reddit forms can supplement traditional qualitative studies of the behaviors of people living with T2D. ", doi="10.2196/49073", url="https://www.i-jmr.org/2024/1/e49073" } @Article{info:doi/10.2196/53338, author="Subramanian, Devika and Sonabend, Rona and Singh, Ila", title="A Machine Learning Model for Risk Stratification of Postdiagnosis Diabetic Ketoacidosis Hospitalization in Pediatric Type 1 Diabetes: Retrospective Study", journal="JMIR Diabetes", year="2024", month="Aug", day="7", volume="9", pages="e53338", keywords="pediatric type 1 diabetes", keywords="postdiagnosis diabetic ketoacidosis", keywords="risk prediction and stratification", keywords="XGBoost", keywords="Shapley values", keywords="ketoacidosis", keywords="risks", keywords="predict", keywords="prediction", keywords="predictive", keywords="gradient-boosted ensemble model", keywords="diabetes", keywords="pediatrics", keywords="children", keywords="machine learning", abstract="Background: Diabetic ketoacidosis (DKA) is the leading cause of morbidity and mortality in pediatric type 1 diabetes (T1D), occurring in approximately 20\% of patients, with an economic cost of \$5.1 billion/year in the United States. Despite multiple risk factors for postdiagnosis DKA, there is still a need for explainable, clinic-ready models that accurately predict DKA hospitalization in established patients with pediatric T1D. Objective: We aimed to develop an interpretable machine learning model to predict the risk of postdiagnosis DKA hospitalization in children with T1D using routinely collected time-series of electronic health record (EHR) data. Methods: We conducted a retrospective case-control study using EHR data from 1787 patients from among 3794 patients with T1D treated at a large tertiary care US pediatric health system from January 2010 to June 2018. We trained a state-of-the-art; explainable, gradient-boosted ensemble (XGBoost) of decision trees with 44 regularly collected EHR features to predict postdiagnosis DKA. We measured the model's predictive performance using the area under the receiver operating characteristic curve--weighted F1-score, weighted precision, and recall, in a 5-fold cross-validation setting. We analyzed Shapley values to interpret the learned model and gain insight into its predictions. Results: Our model distinguished the cohort that develops DKA postdiagnosis from the one that does not (P<.001). It predicted postdiagnosis DKA risk with an area under the receiver operating characteristic curve of 0.80 (SD 0.04), a weighted F1-score of 0.78 (SD 0.04), and a weighted precision and recall of 0.83 (SD 0.03) and 0.76 (SD 0.05) respectively, using a relatively short history of data from routine clinic follow-ups post diagnosis. On analyzing Shapley values of the model output, we identified key risk factors predicting postdiagnosis DKA both at the cohort and individual levels. We observed sharp changes in postdiagnosis DKA risk with respect to 2 key features (diabetes age and glycated hemoglobin at 12 months), yielding time intervals and glycated hemoglobin cutoffs for potential intervention. By clustering model-generated Shapley values, we automatically stratified the cohort into 3 groups with 5\%, 20\%, and 48\% risk of postdiagnosis DKA. Conclusions: We have built an explainable, predictive, machine learning model with potential for integration into clinical workflow. The model risk-stratifies patients with pediatric T1D and identifies patients with the highest postdiagnosis DKA risk using limited follow-up data starting from the time of diagnosis. The model identifies key time points and risk factors to direct clinical interventions at both the individual and cohort levels. Further research with data from multiple hospital systems can help us assess how well our model generalizes to other populations. The clinical importance of our work is that the model can predict patients most at risk for postdiagnosis DKA and identify preventive interventions based on mitigation of individualized risk factors. ", doi="10.2196/53338", url="https://diabetes.jmir.org/2024/1/e53338", url="http://www.ncbi.nlm.nih.gov/pubmed/39110490" } @Article{info:doi/10.2196/55650, author="Idalski Carcone, April and Holtz, E. Bree and Reardon, Madeleine and Vesey, Dariane and Ellis, A. Deborah and Parks, Michael", title="Meeting the Needs of Emerging Adults With Type 1 Diabetes Living in a Rural Area With Mobile Health Interventions: Focus Group Study", journal="JMIR Form Res", year="2024", month="Aug", day="7", volume="8", pages="e55650", keywords="emerging adults", keywords="type 1 diabetes", keywords="intervention", keywords="qualitative", keywords="mHealth", keywords="mobile phone", keywords="smartphone", abstract="Background: Emerging adults (EAs; age 18-30 years) with type 1 diabetes (T1D) have more challenges with diabetes management and glycemic control than other age groups. Living in a rural community introduces additional unique diabetes care challenges due to limited access to specialty care and ancillary support services. Yet, few interventions have been developed to improve diabetes management in rural-dwelling EAs with T1D. Objective: This study aimed to understand the diabetes management experiences of older adolescents and EAs (age 16-25 years) with T1D living in a rural area and to assess their perceptions of the acceptability of 4 fully automated mobile health (mHealth) interventions to support diabetes management. Methods: EAs were identified by clinical staff through convenience sampling. In total, 8 EAs participated in 1 focus group and 1 EA completed an individual interview; all data were collected over Zoom. Facilitators explored EAs' experiences living in a rural community with T1D and discussed EAs' impressions of, feedback on, and recommendations for improving 4 mHealth interventions to meet the specific needs of EAs with T1D living in rural communities. Discussions were transcribed and analyzed using conventional content analysis. Results: In total, 9 EAs (aged 18.8, SD 2.7 years; 5, 56\% men; 8, 89\% White) with a duration of diabetes of 8.6 (SD 4.3) years participated. They described experiences with diabetes stigma (attributing diabetes to poor lifestyle choices) and feelings of self-consciousness (hyperawareness) in their rural communities. They attributed these experiences to the small size of their communities (``everyone knows'') and community members' lack of knowledge about diabetes (unable to differentiate between type 1 and type 2 diabetes). In contrast, EAs reported high levels of social support for diabetes and diabetes care from family, friends, and other community members, but low support for medical needs. The location of their diabetes care providers and the limited accessibility of diabetes-specific and general medical care services in their local community created a challenging medical care context. Overall, EAs found mHealth interventions appealing due to their digital delivery and highlighted features that increased accessibility (voiceovers and simple, jargon-free language), individualization (ability to tailor intervention content and delivery), and applicability to their own lives and other EAs with T1D (relatability of vignettes and other content). EAs suggestions for improving the interventions included more opportunities to tailor the interventions to their preferences (greater frequency and duration, ability to adapt content to emerging needs), increasing opportunities for peer support within the interventions (friend and significant other as identified support person, connecting with peers beyond their local community), and making the tone of intervention components more casual and engaging. Conclusions: mHealth interventions aligned with EAs' needs and preferences are a promising strategy to support EAs in communities where social support and resources might be limited. Trial Registration: N/A, not a clinical trial ", doi="10.2196/55650", url="https://formative.jmir.org/2024/1/e55650", url="http://www.ncbi.nlm.nih.gov/pubmed/39110496" } @Article{info:doi/10.2196/50849, author="den Braber, Niala and Braem, R. Carlijn I. and Vollenbroek-Hutten, R. Miriam M. and Hermens, J. Hermie and Urgert, Thomas and Yavuz, S. Utku and Veltink, H. Peter and Laverman, D. Gozewijn", title="Consequences of Data Loss on Clinical Decision-Making in Continuous Glucose Monitoring: Retrospective Cohort Study", journal="Interact J Med Res", year="2024", month="Jul", day="31", volume="13", pages="e50849", keywords="continuous glucose monitoring", keywords="missing data", keywords="clinical decision-making", keywords="clinical targets", keywords="time below range", keywords="TBR", keywords="diabetes mellitus", keywords="data interpretation", keywords="clinical practice", keywords="data analysis", keywords="continuous glucose monitoring metrics", keywords="glucose", keywords="diabetes", keywords="diabetic", keywords="metrics", keywords="data loss", keywords="decision-making", keywords="decision support", keywords="missing values", keywords="data science", abstract="Background: The impact of missing data on individual continuous glucose monitoring (CGM) data is unknown but can influence clinical decision-making for patients. Objective: We aimed to investigate the consequences of data loss on glucose metrics in individual patient recordings from continuous glucose monitors and assess its implications on clinical decision-making. Methods: The CGM data were collected from patients with type 1 and 2 diabetes using the FreeStyle Libre sensor (Abbott Diabetes Care). We selected 7-28 days of 24 hours of continuous data without any missing values from each individual patient. To mimic real-world data loss, missing data ranging from 5\% to 50\% were introduced into the data set. From this modified data set, clinical metrics including time below range (TBR), TBR level 2 (TBR2), and other common glucose metrics were calculated in the data sets with and that without data loss. Recordings in which glucose metrics deviated relevantly due to data loss, as determined by clinical experts, were defined as expert panel boundary error ($\epsilon$EPB). These errors were expressed as a percentage of the total number of recordings. The errors for the recordings with glucose management indicator <53 mmol/mol were investigated. Results: A total of 84 patients contributed to 798 recordings over 28 days. With 5\%-50\% data loss for 7-28 days recordings, the $\epsilon$EPB varied from 0 out of 798 (0.0\%) to 147 out of 736 (20.0\%) for TBR and 0 out of 612 (0.0\%) to 22 out of 408 (5.4\%) recordings for TBR2. In the case of 14-day recordings, TBR and TBR2 episodes completely disappeared due to 30\% data loss in 2 out of 786 (0.3\%) and 32 out of 522 (6.1\%) of the cases, respectively. However, the initial values of the disappeared TBR and TBR2 were relatively small (<0.1\%). In the recordings with glucose management indicator <53 mmol/mol the $\epsilon$EPB was 9.6\% for 14 days with 30\% data loss. Conclusions: With a maximum of 30\% data loss in 14-day CGM recordings, there is minimal impact of missing data on the clinical interpretation of various glucose metrics. Trial Registration: ClinicalTrials.gov NCT05584293; https://clinicaltrials.gov/study/NCT05584293 ", doi="10.2196/50849", url="https://www.i-jmr.org/2024/1/e50849" } @Article{info:doi/10.2196/55757, author="Kerr, David and Ahn, David and Waki, Kayo and Wang, Jing and Breznen, Boris and Klonoff, C. David", title="Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis", journal="J Med Internet Res", year="2024", month="Jul", day="22", volume="26", pages="e55757", keywords="coaching", keywords="digital health", keywords="eHealth", keywords="meta-analysis", keywords="patient empowerment", keywords="patient engagement", keywords="self-care", keywords="systematic review", keywords="telemedicine", keywords="type 2 diabetes", keywords="digital interventions", keywords="self-management", keywords="systematic literature review", keywords="effectiveness", keywords="efficacy", keywords="safety", keywords="meta-regression", abstract="Background: The proliferation of digital technology has the potential to transform diabetes management. One of the critical aspects of modern diabetes management remains the achievement of glycemic targets to avoid acute and long-term complications. Objective: This study aims to describe the landscape of evidence pertaining to the relative effectiveness or efficacy and safety of various digital interventions for the self-management of type 2 diabetes mellitus (T2DM), with a primary focus on reducing glycated hemoglobin A1c (HbA1c) levels. Methods: A systematic literature review (SLR) was conducted by searching Embase, MEDLINE, and CENTRAL on April 5, 2022. Study selection, data extraction, and quality assessment were performed by 2 independent reviewers. Eligibility criteria for the SLR included randomized controlled trials (RCTs) and comparative observational studies evaluating interventions containing both human (eg, coaching) and digital components (eg, glucose meter) in adult patients with T2DM. The primary meta-analysis was restricted to studies that reported laboratory-measured HbA1c. In secondary analyses, meta-regression was performed with the intensity of coaching in the digital intervention as a categorical covariate. Results: In total, 28 studies were included in this analysis. Most studies (23/28, 82\%) used the reduction of HbA1c levels as the primary end point, either directly or as a part of a multicomponent outcome. In total, 21 studies reported statistically significant results with this primary end point. When stratified into 3 intervention categories by the intensity of the intervention supporting the digital health technology (analyzing all 28 studies), the success rate appeared to be proportional to the coaching intensity (ie, higher-intensity studies reported higher success rates). When the analysis was restricted to RCTs using the comparative improvement of HbA1c levels, the effectiveness of the interventions was less clear. Only half (12/23, 52\%) of the included RCTs reported statistically significant results. The meta-analyses were broadly aligned with the results of the SLR. The primary analysis estimated a greater reduction in HbA1c associated with digital interventions compared with usual care (--0.31\%, 95\% CI --0.45\% to --0.16\%; P<.001). Meta-regression estimated reductions of --0.45\% (95\% CI --0.81\% to --0.09\%; P=.02), --0.29\% (95\% CI --0.48\% to --0.11\%; P=.003), and --0.28\% (95\% CI --0.65\% to 0.09\%; P=.20) associated with high-, medium-, and low-intensity interventions, respectively. Conclusions: These findings suggest that reducing HbA1c levels in individuals with T2DM with the help of digital interventions is feasible, effective, and acceptable. One common feature of effective digital health interventions was the availability of timely and responsive personalized coaching by a dedicated health care professional. ", doi="10.2196/55757", url="https://www.jmir.org/2024/1/e55757", url="http://www.ncbi.nlm.nih.gov/pubmed/39037772" } @Article{info:doi/10.2196/58832, author="Allaire, C. Jason and Dennis, Consuela and Masturzo, Arti and Wittlin, Steven", title="Exploring the Impact of Device Sourcing on Real-World Adherence and Cost Implications of Continuous Glucose Monitoring in Patients With Diabetes: Retrospective Claims Analysis", journal="JMIR Diabetes", year="2024", month="Jul", day="22", volume="9", pages="e58832", keywords="diabetes", keywords="diabetic", keywords="adherence", keywords="medical costs", keywords="continuous glucose monitor", keywords="propensity score matching", keywords="CGM", keywords="glucose", keywords="cost", keywords="costs", keywords="claim", keywords="claims", keywords="insurance", keywords="economic", keywords="economics", keywords="finance", keywords="financial", abstract="Background: Insurance benefit design influences whether individuals with diabetes who require a continuous glucose monitor (CGM) to provide real-time feedback on their blood glucose levels can obtain the CGM device from either a pharmacy or a durable medical equipment supplier. The impact of the acquisition channel on device adherence and health care costs has not been systematically evaluated. Objective: This study aims to compare the adherence rates for patients new to CGM therapy and the costs of care for individuals who obtained CGM devices from a pharmacy versus acquisition through a durable medical equipment supplier using retrospective claims analysis. Methods: Using the Mariner commercial claims database, individuals aged >18 years with documented diabetes and an initial CGM claim during the first quarter of 2021 (2021 Q1, index date) were identified. Patients had to maintain uninterrupted enrollment for a duration of 15 months but file no CGM claim during the 6 months preceding the index date. We used direct matching to establish comparable pharmacy and durable medical equipment cohorts. Outcomes included quarterly adherence, reinitiation, and costs for the period from 2021 Q1 to the third quarter of 2022 (2022 Q3). Between-cohort differences in adherence rates and reinitiation rates were analyzed using z tests, and cost differences were analyzed using 2-tailed t tests. Results: Direct matching was used to establish comparable pharmacy and durable medical equipment cohorts. A total of 2356 patients were identified, with 1178 in the pharmacy cohort and 1178 in the durable medical equipment cohorts. Although adherence declined over time in both cohorts, the durable medical equipment cohort exhibited significantly superior adherence compared to the pharmacy cohort at 6 months (pharmacy n=615, 52\% and durable medical equipment n=761, 65\%; P<.001), 9 months (pharmacy n=579, 49\% and durable medical equipment cohorts n=714, 61\%; P<.001), and 12 months (pharmacy 48\% and durable medical equipment n=714, 59\%; P<.001). Mean annual total medical costs for adherent patients in the pharmacy cohort were 53\% higher than the durable medical equipment cohort (pharmacy US \$10,635 and durable medical equipment US \$6967; P<.001). In nonadherent patients, the durable medical equipment cohort exhibited a significantly higher rate of therapy reinitiation during the period compared to the pharmacy cohort (pharmacy 61/613, 10\% and durable medical equipment 108/485, 22\%; P<.001). Conclusions: The results from this real-world claims analysis demonstrate that, in a matched set, individuals who received their CGM through a durable medical equipment supplier were more adherent to their device. For individuals who experienced a lapse in therapy, those whose supplies were provided through the durable medical equipment channel were more likely to resume use after an interruption than those who received their supplies from a pharmacy. In the matched cohort analysis, those who received their CGM equipment through a durable medical equipment supplier demonstrated a lower total cost of care. ", doi="10.2196/58832", url="https://diabetes.jmir.org/2024/1/e58832", url="http://www.ncbi.nlm.nih.gov/pubmed/38804821" } @Article{info:doi/10.2196/54703, author="Tan, Wen Jun and Tan, Gabriel and Lian, Xia and Chong, Siang Darren Kai and Rajalingam, Preman and Dalan, Rinkoo and Mogali, Reddy Sreenivasulu", title="Impact of Facilitation on Cognitive Flow in a Novel Diabetes Management Rehearsal Game for Health Professions Education: Mixed Methods, Open-Label, Superiority Randomized Controlled Trial", journal="JMIR Serious Games", year="2024", month="Jul", day="17", volume="12", pages="e54703", keywords="serious game", keywords="randomized control trial", keywords="facilitation", keywords="diabetes", keywords="diabetes management", keywords="flow", keywords="education", abstract="Background: Though the prevalence of diabetes is set to increase, most serious game solutions typically target patient self-management and education. Few games target health care professions education, and even fewer consider the factors that may increase their efficacies. The impact of facilitation, a prominent feature of health professions education, is examined in the context of a rehearsal-based diabetes management serious game. Objective: In this mixed methods, open-label, superiority randomized controlled trial, we compare student performance, attitudes, and perceptions of a rehearsal-based diabetes management game for health care professionals. Methods: Student participants were randomized into 2 groups to play a diabetes management game. The control group played the game alone, and the intervention group played the same game alongside a facilitator tasked to moderate overall challenge levels and address queries. Both groups were administered the Flow Short Scale, a 13-item measure rated on a 7-point Likert scale ranging from 1 (``not at all'') to 7 (``very much'') immediately after the game. Students were then invited to voluntary focus group discussions to elicit their attitudes and perceptions of the game. Findings were subject to between-group comparisons and inductive thematic analysis respectively. Results: A total of 48 (26 control, 22 intervention) clinical-year undergraduates from the Lee Kong Chian School of Medicine in Singapore participated in this study, with 18 continuing to the focus group discussions. Flow Short Scale results indicated the superiority of the intervention group for overall flow (t46=--2.17, P=.04) and the absorption subdomain (t46=--2.6, P=.01). Qualitative results indicated students viewed facilitation as helpful and appropriate, and were able to identify improvable elements of the game's theoretical foundations and overall design. Conclusions: While serious games are efficacious means of rehearsing previously learned knowledge, facilitation allows for their efficiency to be greatly increased. Such increases are likely crucial in the coming years with the increased digitization of health care professions education and the prevalence of diabetes. Trial Registration: ClinicalTrials.gov NCT05637749; https://www.clinicaltrials.gov/study/NCT05637749 ", doi="10.2196/54703", url="https://games.jmir.org/2024/1/e54703", url="http://www.ncbi.nlm.nih.gov/pubmed/38900700" } @Article{info:doi/10.2196/51538, author="Zhang, Kun and Huang, Qiyuan and Wang, Qiaosong and Li, Chengyang and Zheng, Qirong and Li, Zhuoyue and Xu, Dan and Xie, Cuiling and Zhang, Mingqi and Lin, Rongjin", title="Telemedicine in Improving Glycemic Control Among Children and Adolescents With Type 1 Diabetes Mellitus: Systematic Review and Meta-Analysis", journal="J Med Internet Res", year="2024", month="Jul", day="9", volume="26", pages="e51538", keywords="telemedicine", keywords="digital health", keywords="web-based", keywords="type 1 diabetes mellitus", keywords="children", keywords="adolescents", keywords="glycemic control", keywords="chronic disease management", keywords="randomized controlled trials", keywords="meta-analysis", keywords="mobile phone", abstract="Background: Type 1 diabetes mellitus (T1DM) is the most common chronic autoimmune disease among children and adolescents. Telemedicine has been widely used in the field of chronic disease management and can benefit patients with T1DM. However, existing studies lack high-level evidence related to the effectiveness of telemedicine for glycemic control in children and adolescents with T1DM. Objective: This study aims to systematically review the evidence on the effectiveness of telemedicine interventions compared with usual care on glycemic control among children and adolescents with T1DM. Methods: In this systematic review and meta-analysis, we searched PubMed, Cochrane Library, Embase, Web of Science (all databases), and CINAHL Complete from database inception to May 2023. We included randomized controlled trials (RCTs) that evaluated the effectiveness of a telemedicine intervention on glycemic control in children and adolescents with T1DM. In total, 2 independent reviewers performed the study selection and data extraction. Study quality was assessed using the Cochrane Risk of Bias 2 tool. Our primary outcome was glycated hemoglobin (HbA1c) levels. Secondary outcomes were quality of life, self-monitoring of blood glucose, the incidence of hypoglycemia, and cost-effectiveness. A random-effects model was used for this meta-analysis. Results: Overall, 20 RCTs (1704 participants from 12 countries) were included in the meta-analysis. Only 5\% (1/20) of the studies were at high risk of bias. Compared to usual care, telemedicine was found to reduce HbA1c levels by 0.22 (95\% CI --0.33 to --0.10; P<.001; I2=35\%). There was an improvement in self-monitoring of blood glucose (mean difference [MD] 0.54, 95\% CI --0.72 to 1.80; P=.40; I2=67.8\%) and the incidence of hypoglycemia (MD --0.15, 95\% CI --0.57 to 0.27; P=.49; I2=70.7\%), although this was not statistically significant. Moreover, telemedicine had no convincing effect on the Diabetes Quality of Life for Youth score (impact of diabetes: P=.59; worries about diabetes: P=.71; satisfaction with diabetes: P=.68), but there was a statistically significant improvement in non--youth-specific quality of life (MD --0.24, 95\% CI --0.45 to --0.02; P=.04; I2=0\%). Subgroup analyses revealed that the effect of telemedicine on HbA1c levels appeared to be greater in studies involving children (MD --0.41, 95\% CI --0.62 to --0.20; P<.001), studies that lasted <6 months (MD --0.32, 95\% CI --0.48 to --0.17; P<.001), studies where providers used smartphone apps to communicate with patients (MD --0.37, 95\% CI --0.53 to --0.21; P<.001), and studies with medication dose adjustment (MD --0.25, 95\% CI --0.37 to --0.12; P<.001). Conclusions: Telemedicine can reduce HbA1c levels and improve quality of life in children and adolescents with T1DM. Telemedicine should be regarded as a useful supplement to usual care to control HbA1c levels and a potentially cost-effective mode. Meanwhile, researchers should develop higher-quality RCTs using large samples that focus on hard clinical outcomes, cost-effectiveness, and quality of life. ", doi="10.2196/51538", url="https://www.jmir.org/2024/1/e51538" } @Article{info:doi/10.2196/56123, author="Hackstadt, J. Amber and Elasy, A. Tom and Gangaputra, Sapna and Harper, J. Kryseana and Mayberry, S. Lindsay and Nelson, A. Lyndsay and Peterson, B. Neeraja and Rosenbloom, Trent S. and Yu, Zhihong and Martinez, William", title="Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Jun", day="28", volume="13", pages="e56123", keywords="patient portals", keywords="self-management", keywords="self-efficacy", keywords="diabetes mellitus", keywords="health literacy", keywords="attitudes", abstract="Background: Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months). Objective: This study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes. Methods: We are conducting a pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if they have type 1 or 2 DM, can read in English, are aged 18-75 years, have a current patient portal account, and have reliable access to a mobile device with internet access. We exclude patients with medical conditions that prevent them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among 4 DM preventive care services (diabetes eye examination, pneumococcal vaccination, hemoglobin A1c, and urine microalbumin) at 12 months after randomization. Secondary outcomes will include diabetes self-efficacy, confidence managing diabetes in general, understanding of diabetes preventive care, diabetes distress, patient portal satisfaction, and patient-initiated orders at baseline, 3 months, 6 months, and 12 months after randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at the 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used. Results: This study is ongoing. Recruitment was closed in February 2022; a total of 433 patients were randomized. Of those randomized, most (n=288, 66.5\%) were non-Hispanic White, 33.5\% (n=145) were racial or ethnic minorities, 33.9\% (n=147) were aged 65 years or older, and 30.7\% (n=133) indicated limited health literacy. Conclusions: The study directly tests the hypothesis that a patient portal intervention---alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care---will reduce diabetes care gaps compared with usual care. The insights gained from this study may have broad implications for developing future interventions to address various care gaps, such as gaps in cancer screening, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention. Trial Registration: ClinicalTrials.gov NCT04894903; https://classic.clinicaltrials.gov/ct2/show/NCT04894903 International Registered Report Identifier (IRRID): DERR1-10.2196/56123 ", doi="10.2196/56123", url="https://www.researchprotocols.org/2024/1/e56123", url="http://www.ncbi.nlm.nih.gov/pubmed/38941148" } @Article{info:doi/10.2196/53517, author="Demissie, Debalkie Getu and Birungi, Josephine and Haregu, Tilahun and Thirunavukkarasu, Sathish and Oldenburg, Brian", title="Effects of Lifestyle Interventions on Cardiovascular Disease Risk and Risk Factors Among Individuals at High Risk for Type 2 Diabetes: Protocol for a Systematic Review and Meta-Analysis of Randomized Controlled Trials", journal="JMIR Res Protoc", year="2024", month="Jun", day="27", volume="13", pages="e53517", keywords="diabetes", keywords="prediabetes", keywords="cardiovascular disease", keywords="CVD", keywords="CVD risk", keywords="CVD risk factors", keywords="lifestyle interventions", keywords="systematic review", keywords="meta-analysis", abstract="Background: Individuals at high risk for type 2 diabetes are also at an increased risk for developing cardiovascular disease (CVD). Although there are separate trials examining the effects of lifestyle interventions on absolute CVD risk among people at high risk for type 2 diabetes, a comprehensive evidence synthesis of these trials is lacking. Objective: We will systematically synthesize the evidence on the effects of lifestyle interventions in reducing absolute CVD risk and CVD risk factors among people at high risk for type 2 diabetes. Methods: We adhered to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) statement in reporting the details of this protocol. Randomized controlled trials of diabetes prevention that examined the effects of lifestyle interventions for at least 6 months on absolute CVD risk and CVD risk factors among individuals at high risk for type 2 diabetes will be eligible. We will systematically search the MEDLINE, Embase, PsycINFO, CENTRAL, and Scopus databases and ClinicalTrials.gov using a mix of Medical Subject Headings and text words. Two authors will independently screen the abstract and title of the articles retrieved from the search, followed by full-text reviews using the inclusion and exclusion criteria and data extraction from the eligible studies. Article screening and data extraction will be performed in the Covidence software. The primary outcome will be the changes in absolute 10-year CVD risk, as estimated by risk prediction models. The secondary outcomes are the changes in CVD risk factors, including behavioral, clinical, biochemical, and psychosocial risk factors, and incidence of type 2 diabetes. Results: An initial database search was conducted in July 2023. After screening 1935 articles identified through the database search, 42 articles were considered eligible for inclusion. It is anticipated that the study findings will be submitted for publication in a peer-reviewed journal by the end of 2024. Conclusions: This study will provide up-to-date, systematically synthesized evidence on the effects of lifestyle interventions on absolute CVD risk and CVD risk factors among individuals at high risk for type 2 diabetes. Trial Registration: PROSPERO CRD42023429869; https://tinyurl.com/59ajy7rw International Registered Report Identifier (IRRID): DERR1-10.2196/53517 ", doi="10.2196/53517", url="https://www.researchprotocols.org/2024/1/e53517", url="http://www.ncbi.nlm.nih.gov/pubmed/38935416" } @Article{info:doi/10.2196/50939, author="Yoon, Sungwon and Goh, Hendra and Lee, Ching Phong and Tan, Chang Hong and Teh, Ming Ming and Lim, Ting Dawn Shao and Kwee, Ann and Suresh, Chandran and Carmody, David and Swee, Soon Du and Tan, Tse Sarah Ying and Wong, Jun-Wei Andy and Choo, Hui-Min Charlotte and Wee, Zongwen and Bee, Mong Yong", title="Assessing the Utility, Impact, and Adoption Challenges of an Artificial Intelligence--Enabled Prescription Advisory Tool for Type 2 Diabetes Management: Qualitative Study", journal="JMIR Hum Factors", year="2024", month="Jun", day="13", volume="11", pages="e50939", keywords="clinical decision support system", keywords="artificial intelligence", keywords="endocrinology", keywords="diabetes management", keywords="human factors", abstract="Background: The clinical management of type 2 diabetes mellitus (T2DM) presents a significant challenge due to the constantly evolving clinical practice guidelines and growing array of drug classes available. Evidence suggests that artificial intelligence (AI)--enabled clinical decision support systems (CDSSs) have proven to be effective in assisting clinicians with informed decision-making. Despite the merits of AI-driven CDSSs, a significant research gap exists concerning the early-stage implementation and adoption of AI-enabled CDSSs in T2DM management. Objective: This study aimed to explore the perspectives of clinicians on the use and impact of the AI-enabled Prescription Advisory (APA) tool, developed using a multi-institution diabetes registry and implemented in specialist endocrinology clinics, and the challenges to its adoption and application. Methods: We conducted focus group discussions using a semistructured interview guide with purposively selected endocrinologists from a tertiary hospital. The focus group discussions were audio-recorded and transcribed verbatim. Data were thematically analyzed. Results: A total of 13 clinicians participated in 4 focus group discussions. Our findings suggest that the APA tool offered several useful features to assist clinicians in effectively managing T2DM. Specifically, clinicians viewed the AI-generated medication alterations as a good knowledge resource in supporting the clinician's decision-making on drug modifications at the point of care, particularly for patients with comorbidities. The complication risk prediction was seen as positively impacting patient care by facilitating early doctor-patient communication and initiating prompt clinical responses. However, the interpretability of the risk scores, concerns about overreliance and automation bias, and issues surrounding accountability and liability hindered the adoption of the APA tool in clinical practice. Conclusions: Although the APA tool holds great potential as a valuable resource for improving patient care, further efforts are required to address clinicians' concerns and improve the tool's acceptance and applicability in relevant contexts. ", doi="10.2196/50939", url="https://humanfactors.jmir.org/2024/1/e50939", url="http://www.ncbi.nlm.nih.gov/pubmed/38869934" } @Article{info:doi/10.2196/54853, author="Talanki, Sri Ananya and Bajaj, Neha and Trehan, Twinkle and Thirunavukkarasu, Sathish", title="Incidence, Risk, and Clinical Course of New-Onset Diabetes in Long COVID: Protocol for a Systematic Review and Meta-Analysis of Cohort Studies", journal="JMIR Res Protoc", year="2024", month="Jun", day="4", volume="13", pages="e54853", keywords="COVID-19", keywords="SARS-CoV-2", keywords="type 1 diabetes", keywords="type 2 diabetes", keywords="new-onset diabetes", keywords="long COVID", keywords="incidence", keywords="cohort studies", keywords="postacute sequela", keywords="systematic review", keywords="meta-analysis", abstract="Background: COVID-19, an infectious disease pandemic, affected millions of people globally, resulting in high morbidity and mortality. Causing further concern, significant proportions of COVID-19 survivors endure the lingering health effects of SARS-CoV-2, the pathogen that causes COVID-19. One of the diseases manifesting as a postacute sequela of COVID-19 (also known as ``long COVID'') is new-onset diabetes. Objective: The aim of this study is to examine the incidence of new-onset diabetes in patients with long COVID and assess the excess risk compared with individuals who tested negative for COVID-19. The study also aims to estimate the population-attributable fraction for COVID-19 as a risk factor for new-onset diabetes in long COVID and investigate the clinical course of new-onset diabetes cases. Methods: This is a protocol for a systematic review and meta-analysis. PubMed, MEDLINE, Embase, Scopus, and Web of Science databases will be systematically searched to identify articles published between December 2019 and July 2024. A comprehensive search strategy for each database will be developed using a combination of Medical Subject Headings terms, subject headings, and text words to identify eligible studies. Cohort studies and randomized controlled trials (only control arms) involving patients with COVID-19 of any age, with follow-up data on new-onset diabetes in long COVID, will be considered for inclusion. Controls will comprise individuals who tested negative for COVID-19, with or without other respiratory tract infections. Three independent reviewers (AST, NB, and TT) will perform article selection, data extraction, and quality assessment of the studies. A fourth reviewer (ST) will review the identified studies for final inclusion in the analysis. The random-effects DerSimonian-Laird models will be used to estimate the pooled incidence proportion (\%), incidence rate of diabetes (per 1000 person-years), and risk ratio (with 95\% CIs) for diabetes incidence. Results: A total of 1972 articles were identified through the initial search conducted in August 2023. After excluding duplicates, conducting title and abstract screening, and completing full-text reviews, 41 articles were found to be eligible for inclusion. The search will be updated in July 2024. Currently, data extraction is underway, and the meta-analysis is expected to be completed in August 2024. Publication of the study findings is anticipated by the end of 2024. Conclusions: The study findings should provide valuable insights to inform both clinical practice and public health policies regarding the effective management of new-onset diabetes in patients with long COVID. International Registered Report Identifier (IRRID): DERR1-10.2196/54853 ", doi="10.2196/54853", url="https://www.researchprotocols.org/2024/1/e54853", url="http://www.ncbi.nlm.nih.gov/pubmed/38833277" } @Article{info:doi/10.2196/49617, author="Cheng, Hui and Jia, Zhihui and Li, Ting Yu and Yu, Xiao and Wang, Ji Jia and Xie, Jie Yao and Hernandez, Jose and Wang, X. Harry H.", title="Metabolic Score for Insulin Resistance and New-Onset Type 2 Diabetes in a Middle-Aged and Older Adult Population: Nationwide Prospective Cohort Study and Implications for Primary Care", journal="JMIR Public Health Surveill", year="2024", month="Jun", day="3", volume="10", pages="e49617", keywords="metabolic score for insulin resistance", keywords="type 2 diabetes mellitus", keywords="blood pressure", keywords="longitudinal study", keywords="primary care", abstract="Background: The metabolic score for insulin resistance (METS-IR) has emerged as a noninsulin-based index for the approximation of insulin resistance (IR), yet longitudinal evidence supporting the utility of METS-IR in the primary prevention of type 2 diabetes mellitus (T2DM) remains limited. Objective: We aimed to investigate the longitudinal association between METS-IR, which combines fasting plasma glucose (FPG), lipid profiles, and anthropometrics that can be routinely obtained in resource-limited primary care settings, and the incidence of new-onset T2DM. Methods: We conducted a closed-cohort analysis of a nationwide, prospective cohort of 7583 Chinese middle-aged and older adults who were free of T2DM at baseline, sampled from 28 out of 31 provinces in China. We examined the characteristics of participants stratified by elevated blood pressure (BP) at baseline and new-onset T2DM at follow-up. We performed Cox proportional hazard regression analysis to explore associations of baseline METS-IR with incident T2DM in participants overall and in participants stratified by baseline BP. We also applied net reclassification improvement and integrated discrimination improvement to examine the incremental value of METS-IR. Results: During a mean follow-up period of 6.3 years, T2DM occurred in 527 participants, among which two-thirds (332/527, 62.9\%; 95\% CI 58.7\%-67.1\%) had baseline FPG<110 mg/dL. A SD unit increase in baseline METS-IR was associated with the first incidence of T2DM (adjusted hazard ratio [aHR] 1.33, 95\% CI 1.22-1.45; P<.001) in all participants. We obtained similar results in participants with normal baseline BP (aHR 1.41, 95\% CI 1.22-1.62; P<.001) and elevated baseline BP (aHR 1.29, 95\% CI 1.16-1.44; P<.001). The predictive capability for incident T2DM was improved by adding METS-IR to FPG. In study participants with new-onset T2DM whose baseline FPG was <126 mg/dL and <110 mg/dL, 62.9\% (332/527; 95\% CI 60\%-65.9\%) and 58.1\% (193/332; 95\% CI 54.3\%-61.9\%) of participants had baseline METS-IR above the cutoff values, respectively. Conclusions: METS-IR was significantly associated with new-onset T2DM, regardless of baseline BP level. Regular monitoring of METS-IR on top of routine blood glucose in clinical practice may add to the ability to enhance the early identification of primary care populations at risk for T2DM. ", doi="10.2196/49617", url="https://publichealth.jmir.org/2024/1/e49617", url="http://www.ncbi.nlm.nih.gov/pubmed/38569189" } @Article{info:doi/10.2196/56067, author="Nielsen, Flindt Steffen and Duus, Lundgreen Camilla and Buus, Henrik Niels and Bech, N{\o}rgaard Jesper and Mose, Holden Frank", title="Effects of Empagliflozin in Type 2 Diabetes With and Without Chronic Kidney Disease and Nondiabetic Chronic Kidney Disease: Protocol for 3 Crossover Randomized Controlled Trials (SiRENA Project)", journal="JMIR Res Protoc", year="2024", month="May", day="29", volume="13", pages="e56067", keywords="SGLT2i", keywords="empagliflozin", keywords="renal function", keywords="blood flow", keywords="DM2", keywords="diabetes mellitus type 2", keywords="CKD", keywords="chronic kidney disease", keywords="vascular function", keywords="sodium-glucose cotransporter 2 inhibitors", keywords="T2DM", keywords="type 2 diabetes mellitus", keywords="randomized controlled trial", keywords="RCT", keywords="CVD", keywords="placebo", keywords="renal", keywords="recruitment", keywords="Denmark", keywords="cardiovascular disease", abstract="Background: Sodium-glucose-cotransporter 2 inhibitors (SGLT2is) have revolutionized the treatment of type 2 diabetes mellitus (DM2) and chronic kidney disease (CKD), reducing the risk of cardiovascular and renal end points by up to 40\%. The underlying mechanisms are not fully understood. Objective: The study aims to examine the effects of empagliflozin versus placebo on renal hemodynamics, sodium balance, vascular function, and markers of the innate immune system in patients with DM2, DM2 and CKD, and nondiabetic CKD. Methods: We conducted 3 double-blind, crossover, randomized controlled trials, each with identical study protocols but different study populations. We included patients with DM2 and preserved kidney function (estimated glomerular filtration rate >60 mL/min/1.73 m2), DM2 and CKD, and nondiabetic CKD (both with estimated glomerular filtration rate 20-60 mL/min/1.73 m2). Each participant was randomly assigned to 4 weeks of treatment with either 10 mg of empagliflozin once daily or a matching placebo. After a wash-out period of at least 2 weeks, participants were crossed over to the opposite treatment. End points were measured at the end of each treatment period. The primary end point was renal blood flow measured with 82Rubidium positron emission tomography--computed tomography (82Rb-PET/CT). Secondary end points include glomerular filtration rate measured with 99mTechnetium-diethylene-triamine-pentaacetate (99mTc-DTPA) clearance, vascular function assessed by forearm venous occlusion strain gauge plethysmography, measurements of the nitric oxide (NO) system, water and sodium excretion, body composition measurements, and markers of the complement immune system. Results: Recruitment began in April 2021 and was completed in September 2022. Examinations were completed by December 2022. In total, 49 participants completed the project: 16 participants in the DM2 and preserved kidney function study, 17 participants in the DM2 and CKD study, and 16 participants in the nondiabetic CKD study. Data analysis is ongoing. Results are yet to be published. Conclusions: This paper describes the rationale, design, and methods used in a project consisting of 3 double-blind, crossover, randomized controlled trials examining the effects of empagliflozin versus placebo in patients with DM2 with and without CKD and patients with nondiabetic CKD, respectively. Trial Registration: EU Clinical Trials Register 2019-004303-12; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004303-12, EU Clinical Trials Register 2019-004447-80; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004447-80, EU Clinical Trials Register 2019-004467-50; https://www.clinicaltrialsregister.eu/ctr-search/search?query=and+2019-004467-50 International Registered Report Identifier (IRRID): DERR1-10.2196/56067 ", doi="10.2196/56067", url="https://www.researchprotocols.org/2024/1/e56067", url="http://www.ncbi.nlm.nih.gov/pubmed/38680116" } @Article{info:doi/10.2196/57292, author="Sesgundo III, Angeles Jaime and Maeng, Collin David and Tukay, Aubrey Jumelle and Ascano, Patricia Maria and Suba-Cohen, Justine and Sampang, Virginia", title="Evaluation of Artificial Intelligence Algorithms for Diabetic Retinopathy Detection: Protocol for a Systematic Review and Meta-Analysis", journal="JMIR Res Protoc", year="2024", month="May", day="27", volume="13", pages="e57292", keywords="artificial intelligence", keywords="diabetic retinopathy", keywords="deep learning", keywords="ophthalmology", keywords="accuracy", keywords="imaging", keywords="AI", keywords="DR", keywords="complication", keywords="retinopathy", keywords="Optha", keywords="AI algorithms", keywords="detection", keywords="management", keywords="ophthalmologists", keywords="early detection", keywords="screening", keywords="meta-analysis", keywords="diabetes mellitus", keywords="DM", keywords="diabetes", keywords="systematic review", abstract="Background: Diabetic retinopathy (DR) is one of the most common complications of diabetes mellitus. The global burden is immense with a worldwide prevalence of 8.5\%. Recent advancements in artificial intelligence (AI) have demonstrated the potential to transform the landscape of ophthalmology with earlier detection and management of DR. Objective: This study seeks to provide an update and evaluate the accuracy and current diagnostic ability of AI in detecting DR versus ophthalmologists. Additionally, this review will highlight the potential of AI integration to enhance DR screening, management, and disease progression. Methods: A systematic review of the current landscape of AI's role in DR will be undertaken, guided by the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) model. Relevant peer-reviewed papers published in English will be identified by searching 4 international databases: PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomized controlled trials, observational studies, and cohort studies published on or after 2022 that evaluate AI's performance in retinal imaging detection of DR in diverse adult populations. Studies that focus on specific comorbid conditions, nonimage-based applications of AI, or those lacking a direct comparison group or clear methodology will be excluded. Selected papers will be independently assessed for bias by 2 review authors (JS and DM) using the Quality Assessment of Diagnostic Accuracy Studies tool for systematic reviews. Upon systematic review completion, if it is determined that there are sufficient data, a meta-analysis will be performed. Data synthesis will use a quantitative model. Statistical software such as RevMan and STATA will be used to produce a random-effects meta-regression model to pool data from selected studies. Results: Using selected search queries across multiple databases, we accumulated 3494 studies regarding our topic of interest, of which 1588 were duplicates, leaving 1906 unique research papers to review and analyze. Conclusions: This systematic review and meta-analysis protocol outlines a comprehensive evaluation of AI for DR detection. This active study is anticipated to assess the current accuracy of AI methods in detecting DR. International Registered Report Identifier (IRRID): DERR1-10.2196/57292 ", doi="10.2196/57292", url="https://www.researchprotocols.org/2024/1/e57292", url="http://www.ncbi.nlm.nih.gov/pubmed/38801771" } @Article{info:doi/10.2196/55483, author="Varela-Moreno, Esperanza and Anarte-Ortiz, Teresa Maria and Jodar-Sanchez, Francisco and Garcia-Palacios, Azucena and Monreal-Bartolom{\'e}, Alicia and Gili, Margalida and Garc{\'i}a-Campayo, Javier and Mayoral-Cleries, Fermin", title="Economic Evaluation of a Web Application Implemented in Primary Care for the Treatment of Depression in Patients With Type 2 Diabetes Mellitus: Multicenter Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2024", month="May", day="16", volume="12", pages="e55483", keywords="depression", keywords="depressive", keywords="type 2", keywords="diabetes", keywords="diabetic", keywords="type 2 diabetes mellitus", keywords="eHealth", keywords="web-based intervention", keywords="efficacy", keywords="economic evaluation", keywords="cost-effectiveness", keywords="cost-utility", keywords="randomized controlled trial", keywords="RCT", keywords="randomized", keywords="controlled trial", keywords="controlled trials", keywords="cost", keywords="costs", keywords="economic", keywords="economics", keywords="web based", keywords="internet based", keywords="CBT", keywords="psychotherapy", keywords="cognitive behavioral therapy", keywords="mental health", abstract="Background: Depressive disorder and type 2 diabetes mellitus (T2DM) are prevalent in primary care (PC). Pharmacological treatment, despite controversy, is commonly chosen due to resource limitations and difficulties in accessing face-to-face interventions. Depression significantly impacts various aspects of a person's life, affecting adherence to medical prescriptions and glycemic control and leading to future complications and increased health care costs. To address these challenges, information and communication technologies (eg, eHealth) have been introduced, showing promise in improving treatment continuity and accessibility. However, while eHealth programs have demonstrated effectiveness in alleviating depressive symptoms, evidence regarding glycemic control remains inconclusive. This randomized controlled trial aimed to test the efficacy of a low-intensity psychological intervention via a web app for mild-moderate depressive symptoms in individuals with T2DM compared with treatment as usual (TAU) in PC. Objective: This study aimed to analyze the cost-effectiveness and cost-utility of a web-based psychological intervention to treat depressive symptomatology in people with T2DM compared with TAU in a PC setting. Methods: A multicenter randomized controlled trial was conducted with 49 patients with T2DM, depressive symptoms of moderate severity, and glycosylated hemoglobin (HbA1c) of 7.47\% in PC settings. Patients were randomized to TAU (n=27) or a web-based psychological treatment group (n=22). This web-based treatment consisted of cognitive behavioral therapy, improvement of diabetes self-care behaviors, and mindfulness. Cost-effectiveness analysis for the improvement of depressive symptomatology was conducted based on reductions in 3, 5, or 50 points on the Patient Health Questionnaire--9 (PHQ-9). The efficacy of diabetes control was estimated based on a 0.5\% reduction in HbA1c levels. Follow-up was performed at 3 and 6 months. The cost-utility analysis was performed based on quality-adjusted life years. Results: Efficacy analysis showed that the web-based treatment program was more effective in improving depressive symptoms than TAU but showed only a slight improvement in HbA1c. Incremental cost-effectiveness ratios of 186.76 for a 3-point reduction in PHQ-9 and 206.31 for reductions of 5 and 50 percentage points were obtained. In contrast, the incremental cost-effectiveness ratio for improving HbA1c levels amounted to {\texteuro}1510.90 ({\texteuro}1=US \$1.18 in 2018) per participant. The incremental cost-utility ratio resulted in {\texteuro}4119.33 per quality-adjusted life year gained. Conclusions: The intervention, using web-based modules incorporating cognitive behavioral therapy tools, diabetes self-care promotion, and mindfulness, effectively reduced depressive symptoms and enhanced glycemic control in patients with T2DM. Notably, it demonstrated clinical efficacy and economic efficiency. This supports the idea that eHealth interventions not only benefit patients clinically but also offer cost-effectiveness for health care systems. The study emphasizes the importance of including specific modules to enhance diabetes self-care behaviors in future web-based psychological interventions, emphasizing personalization and adaptation for this population. Trial Registration: ClinicalTrials.gov NCT03426709; https://clinicaltrials.gov/study/NCT03426709 International Registered Report Identifier (IRRID): RR2-10.1186/S12888-019-2037-3 ", doi="10.2196/55483", url="https://mhealth.jmir.org/2024/1/e55483", url="http://www.ncbi.nlm.nih.gov/pubmed/38754101" } @Article{info:doi/10.2196/49478, author="Novak, Daniel", title="A Serious Game (MyDiabetic) to Support Children's Education in Type 1 Diabetes Mellitus: Iterative Participatory Co-Design and Feasibility Study", journal="JMIR Serious Games", year="2024", month="May", day="7", volume="12", pages="e49478", keywords="diabetes mellitus", keywords="serious games", keywords="mobile app", keywords="co-design", keywords="user-centered design", keywords="serious game", keywords="gaming", keywords="diabetes", keywords="child with diabetes", keywords="child", keywords="children", keywords="insulin", keywords="glucometer", keywords="glucose", keywords="patient education", keywords="mobile phone", abstract="Background: Serious games, which are gaming applications used for purposes beyond entertainment to educate users on, and address, specific issues, may present a timely approach to promote healthy diabetes management behaviors among children with type 1 diabetes mellitus (T1DM). The lasting benefits associated with these serious games encompass improved patient education; enhanced glycemic control; the reinforcement of bonds within the community of people with diabetes; the facilitation of meaningful dialogues with caregivers, especially within the familial setting; and a significant reduction in the economic burdens associated with subsequent complications. Objective: This paper primarily aims to provide a detailed overview of the iterative design process and the associated evaluation methods used in the development of the educational game. Furthermore, this study aims to enhance motivation for sustained and extended engagement with the game over time. The MyDiabetic game design aims to educate children on various aspects, including the connections among food, insulin, and physical activity. Furthermore, it seeks to impart knowledge related to the operation of a glucometer and an insulin pen, as well as more advanced technologies such as administering glucagon, measuring ketoacidosis, and continuous glucose monitoring. Methods: The co-design methodology was applied, involving interviews, design workshops, and prototype feedback sessions. A combination of several approaches, such as tailoring, observational learning, social and family support, decision-making practice, and reward systems, was used to support children's compliance. Moreover, incorporating the literature, guidelines, and current practices into the design ensured that the game was aligned with established health care pathways and included relevant information and best practices for diabetes management. Results: The game was tested on 32 children in 3 iterations. Positive responses were received from children who tested the game as well as their parents. The game was also presented to 5 schoolmates of children with T1DM who appreciated a better understanding of the disease and the opportunity to support their friends more efficiently in T1DM compensation. The involvement of children and clinicians in participatory co-design contributed to to the game's high acceptance. With regard to the game's impact on education, 1 week of testing revealed an enhancement in educational outcomes. Conclusions: The game is especially suitable for children newly diagnosed with T1DM because it acquaints them in a fun way with new terminology; for example, they can try to measure glycemia levels in an interactive way. The game also caters to children who still need to develop reading skills by including an audio guide. The guide ensures that children of all literacy levels can benefit from the game's educational content and interactive experiences. The game is available for download on Google Play and the Apple App Store. ", doi="10.2196/49478", url="https://games.jmir.org/2024/1/e49478", url="http://www.ncbi.nlm.nih.gov/pubmed/38713496" } @Article{info:doi/10.2196/55976, author="Makunts, Tigran and Joulfayan, Haroutyun and Abagyan, Ruben", title="Thyroid Hyperplasia and Neoplasm Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists in the Food and Drug Administration Adverse Event Reporting System: Retrospective Analysis", journal="JMIRx Med", year="2024", month="May", day="1", volume="5", pages="e55976", keywords="GLP-1", keywords="FDA", keywords="averse event reporting", keywords="cancer", keywords="oncology", keywords="neoplasm", keywords="drugs", keywords="pharmacy", keywords="pharmacology", keywords="pharmaceutics", keywords="medication", keywords="medications", keywords="glucagon-like peptide-1", keywords="Food and Drug Administration", keywords="weight loss", keywords="diabetes", keywords="obesity", keywords="thyroid hyperplasia", keywords="FAERS", keywords="FDA Adverse Event Reporting System", abstract="Background: Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are one of the most commonly used drugs for type 2 diabetes mellitus. Clinical guidelines recommend GLP-1 RAs as an adjunct to diabetes therapy in patients with chronic kidney disease, presence or risk of atherosclerotic cardiovascular disease, and obesity. The weight loss observed in clinical trials has been explored further in healthy individuals, putting GLP-1 RAs on track to be the next weight loss treatment. Objective: Although the adverse event profile is relatively safe, most GLP-1 RAs come with a labeled boxed warning for the risk of thyroid cancers, based on animal models and some postmarketing case reports in humans. Considering the increasing popularity of this drug class and its expansion into a new popular indication, a further review of the most recent postmarketing safety data was warranted to quantify thyroid hyperplasia and neoplasm instances. Methods: GLP-1 RA patient reports from the US Food and Drug Administration (FDA) Adverse Event Reporting System database were analyzed using reporting odds ratios and 95\% CIs. Results: In this study, we analyzed over 18 million reports from the US FDA Adverse Event Reporting System and provided evidence of significantly increased propensity for thyroid hyperplasias and neoplasms in patients taking GLP-1 RA monotherapy when compared to patients taking sodium-glucose cotransporter-2 (SGLT-2) inhibitor monotherapy. Conclusions: GLP-1 RAs, regardless of indication, are associated with an over 10-fold increase in thyroid neoplasm and hyperplasia adverse event reporting when compared to SGLT-2 inhibitors. ", doi="10.2196/55976", url="https://xmed.jmir.org/2024/1/e55976" } @Article{info:doi/10.2196/51092, author="Pinho, Xavier and Meijer, Willemijn and de Graaf, Albert", title="Deriving Treatment Decision Support From Dutch Electronic Health Records by Exploring the Applicability of a Precision Cohort--Based Procedure for Patients With Type 2 Diabetes Mellitus: Precision Cohort Study", journal="Online J Public Health Inform", year="2024", month="May", day="1", volume="16", pages="e51092", keywords="personalized care", keywords="electronic health records", keywords="EHRs", keywords="machine learning", keywords="type 2 diabetes mellitus", keywords="T2DM", keywords="decision-making", abstract="Background: The rapidly increasing availability of medical data in electronic health records (EHRs) may contribute to the concept of learning health systems, allowing for better personalized care. Type 2 diabetes mellitus was chosen as the use case in this study. Objective: This study aims to explore the applicability of a recently developed patient similarity--based analytics approach based on EHRs as a candidate data analytical decision support tool. Methods: A previously published precision cohort analytics workflow was adapted for the Dutch primary care setting using EHR data from the Nivel Primary Care Database. The workflow consisted of extracting patient data from the Nivel Primary Care Database to retrospectively generate decision points for treatment change, training a similarity model, generating a precision cohort of the most similar patients, and analyzing treatment options. This analysis showed the treatment options that led to a better outcome for the precision cohort in terms of clinical readouts for glycemic control. Results: Data from 11,490 registered patients diagnosed with type 2 diabetes mellitus were extracted from the database. Treatment-specific filter cohorts of patient groups were generated, and the effect of past treatment choices in these cohorts was assessed separately for glycated hemoglobin and fasting glucose as clinical outcome variables. Precision cohorts were generated for several individual patients from the filter cohorts. Treatment options and outcome analyses were technically well feasible but in general had a lack of statistical power to demonstrate statistical significance for treatment options with better outcomes. Conclusions: The precision cohort analytics workflow was successfully adapted for the Dutch primary care setting, proving its potential for use as a learning health system component. Although the approach proved technically well feasible, data size limitations need to be overcome before application for clinical decision support becomes realistically possible. ", doi="10.2196/51092", url="https://ojphi.jmir.org/2024/1/e51092", url="http://www.ncbi.nlm.nih.gov/pubmed/38691393" } @Article{info:doi/10.2196/54852, author="Andrikopoulou, Elisavet and Chatzistergos, Panagiotis and Chockalingam, Nachiappan", title="Exploring the Pathways of Diabetes Foot Complications Treatment and Investigating Experiences From Frontline Health Care Professionals: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="24", volume="13", pages="e54852", keywords="diabetic foot", keywords="first-ever diabetic foot ulcer", keywords="qualitative research", keywords="quantitative evaluation", keywords="surveys and questionnaires", keywords="telephone interviews", keywords="primary care", keywords="community care", keywords="acute care", keywords="education of patients", keywords="foot ulcer", keywords="exploration", keywords="diabetes", keywords="foot ulceration", keywords="United Kingdom", keywords="diabetic foot ulceration", keywords="DFU", keywords="amputation", keywords="complication", keywords="perspectives", keywords="experiences", keywords="health care professionals", keywords="barrier", keywords="barriers", keywords="effective care", keywords="foot care", keywords="primary ulcers", keywords="quality of life", abstract="Background: Diabetes affects more than 4.3 million individuals in the United Kingdom, with 19\% to 34\% developing diabetes-related foot ulceration (DFU) during their lifespan, which can lead to an amputation. In the United Kingdom, every week, approximately 169 people have an amputation due to diabetes. Preventing first-ever ulcers is the most effective strategy to reduce the occurrence of diabetes-related amputations, but research in this space is lacking. Objective: This protocol seeks to document the experiences and perspectives of frontline health care professionals who work with people who have diabetes and diabetes-related foot problems. Special attention is given to their perceptions of barriers to effective care, their views about barriers to effective and inclusive engagement with people with diabetes, and their experience with the first-ever DFU. Another aspect of the study is the focus on whether clinical management is affected by data sharing, data availability, and interoperability issues. Methods: This is a mixed methods explanatory protocol, which is sequential, and its purpose is to use the qualitative data to explain the initial quantitative data collected through a survey of frontline health care professionals. Data analysis of quantitative data will be completed first and then synthesized with the qualitative data analysis. Qualitative data will be analyzed using the framework method. This study will use joint displays to integrate the data. Ethical approval has been granted by the ethics committee of Staffordshire University. Results: The quantitative data collection started in March 2023 and will close in May 2024. The qualitative interviews commenced in November 2023 with volunteer participants who initially completed the survey. Conclusions: This study's survey focuses on data interoperability and the interviews focus more on the perspectives and experiences of clinicians and their perceived barriers for the effective management of diabetes foot ulcers. Including a geographically relevant and diverse cohort of health care professionals that spans a wide range of roles and care settings involved in diabetes-related foot care is very important for the successful application of this protocol. Special care is given to advertise and promote participation as widely as possible. The qualitative part of this protocol is also limited to 30-40 interview participants, as it is not realistic to interview higher numbers, due to time and resource constraints. International Registered Report Identifier (IRRID): DERR1-10.2196/54852 ", doi="10.2196/54852", url="https://www.researchprotocols.org/2024/1/e54852", url="http://www.ncbi.nlm.nih.gov/pubmed/38656782" } @Article{info:doi/10.2196/54940, author="Fundoiano-Hershcovitz, ?Yifat and Ritholz, D. Marilyn and Horwitz, L. David and Behar, Ephraim and Manejwala, Omar and Goldstein, Pavel", title="The Impact of Digital Self-Monitoring of Weight on Improving Diabetes Clinical Outcomes: Quasi-Randomized Study", journal="J Med Internet Res", year="2024", month="Apr", day="2", volume="26", pages="e54940", keywords="obesity", keywords="diabetes management", keywords="weight monitoring", keywords="digital health platform", keywords="self-monitoring", keywords="clinical outcome", keywords="type 2 diabetes", keywords="weight changes", keywords="blood glucose", keywords="patient empowerment", abstract="Background: The management of type 2 diabetes (T2D) and obesity, particularly in the context of self-monitoring, remains a critical challenge in health care. As nearly 80\% to 90\% of patients with T2D have overweight or obesity, there is a compelling need for interventions that can effectively manage both conditions simultaneously. One of the goals in managing chronic conditions is to increase awareness and generate behavioral change to improve outcomes in diabetes and related comorbidities, such as overweight or obesity. There is a lack of real-life evidence to test the impact of self-monitoring of weight on glycemic outcomes and its underlying mechanisms. Objective: This study aims to assess the efficacy of digital self-monitoring of weight on blood glucose (BG) levels during diabetes management, investigating whether the weight changes may drive glucose fluctuations. Methods: In this retrospective, real-world quasi-randomized study, 50\% of the individuals who regularly used the weight monitoring (WM) feature were propensity score matched with 50\% of the users who did not use the weight monitoring feature (NWM) based on demographic and clinical characteristics. All the patients were diagnosed with T2D and tracked their BG levels. We analyzed monthly aggregated data 6 months before and after starting their weight monitoring. A piecewise mixed model was used for analyzing the time trajectories of BG and weight as well as exploring the disaggregation effect of between- and within-patient lagged effects of weight on BG. Results: The WM group exhibited a significant reduction in BG levels post intervention (P<.001), whereas the nonmonitoring group showed no significant changes (P=.59), and both groups showed no differences in BG pattern before the intervention (P=.59). Furthermore, the WM group achieved a meaningful decrease in BMI (P<.001). Finally, both within-patient (P<.001) and between-patient (P=.008) weight variability was positively associated with BG levels. However, 1-month lagged back BMI was not associated with BG levels (P=.36). Conclusions: This study highlights the substantial benefits of self-monitoring of weight in managing BG levels in patients with diabetes, facilitated by a digital health platform, and advocates for the integration of digital self-monitoring tools in chronic disease management. We also provide initial evidence of testing the underlying mechanisms associated with BG management, underscoring the potential role of patient empowerment. ", doi="10.2196/54940", url="https://www.jmir.org/2024/1/e54940", url="http://www.ncbi.nlm.nih.gov/pubmed/38564266" } @Article{info:doi/10.2196/41065, author="He, Feng and Ng Yin Ling, Clarissa and Nusinovici, Simon and Cheng, Ching-Yu and Wong, Yin Tien and Li, Jialiang and Sabanayagam, Charumathi", title="Development and External Validation of Machine Learning Models for Diabetic Microvascular Complications: Cross-Sectional Study With Metabolites", journal="J Med Internet Res", year="2024", month="Mar", day="28", volume="26", pages="e41065", keywords="machine learning", keywords="diabetic microvascular complication", keywords="diabetic kidney disease", keywords="diabetic retinopathy", keywords="biomarkers", keywords="metabolomics", keywords="complication", keywords="adult", keywords="cardiovascular disease", keywords="metabolites", keywords="biomedical big data", keywords="kidney disease", abstract="Background: Diabetic kidney disease (DKD) and diabetic retinopathy (DR) are major diabetic microvascular complications, contributing significantly to morbidity, disability, and mortality worldwide. The kidney and the eye, having similar microvascular structures and physiological and pathogenic features, may experience similar metabolic changes in diabetes. Objective: This study aimed to use machine learning (ML) methods integrated with metabolic data to identify biomarkers associated with DKD and DR in a multiethnic Asian population with diabetes, as well as to improve the performance of DKD and DR detection models beyond traditional risk factors. Methods: We used ML algorithms (logistic regression [LR] with Least Absolute Shrinkage and Selection Operator and gradient-boosting decision tree) to analyze 2772 adults with diabetes from the Singapore Epidemiology of Eye Diseases study, a population-based cross-sectional study conducted in Singapore (2004-2011). From 220 circulating metabolites and 19 risk factors, we selected the most important variables associated with DKD (defined as an estimated glomerular filtration rate <60 mL/min/1.73 m2) and DR (defined as an Early Treatment Diabetic Retinopathy Study severity level ?20). DKD and DR detection models were developed based on the variable selection results and externally validated on a sample of 5843 participants with diabetes from the UK biobank (2007-2010). Machine-learned model performance (area under the receiver operating characteristic curve [AUC] with 95\% CI, sensitivity, and specificity) was compared to that of traditional LR adjusted for age, sex, diabetes duration, hemoglobin A1c, systolic blood pressure, and BMI. Results: Singapore Epidemiology of Eye Diseases participants had a median age of 61.7 (IQR 53.5-69.4) years, with 49.1\% (1361/2772) being women, 20.2\% (555/2753) having DKD, and 25.4\% (685/2693) having DR. UK biobank participants had a median age of 61.0 (IQR 55.0-65.0) years, with 35.8\% (2090/5843) being women, 6.7\% (374/5570) having DKD, and 6.1\% (355/5843) having DR. The ML algorithms identified diabetes duration, insulin usage, age, and tyrosine as the most important factors of both DKD and DR. DKD was additionally associated with cardiovascular disease history, antihypertensive medication use, and 3 metabolites (lactate, citrate, and cholesterol esters to total lipids ratio in intermediate-density lipoprotein), while DR was additionally associated with hemoglobin A1c, blood glucose, pulse pressure, and alanine. Machine-learned models for DKD and DR detection outperformed traditional LR models in both internal (AUC 0.838 vs 0.743 for DKD and 0.790 vs 0.764 for DR) and external validation (AUC 0.791 vs 0.691 for DKD and 0.778 vs 0.760 for DR). Conclusions: This study highlighted diabetes duration, insulin usage, age, and circulating tyrosine as important factors in detecting DKD and DR. The integration of ML with biomedical big data enables biomarker discovery and improves disease detection beyond traditional risk factors. ", doi="10.2196/41065", url="https://www.jmir.org/2024/1/e41065", url="http://www.ncbi.nlm.nih.gov/pubmed/38546730" } @Article{info:doi/10.2196/55351, author="Basch, H. Corey and Hillyer, C. Grace and Basch, E. Charles", title="Wait Times for Scheduling Appointments for Prevention of Macrovascular and Microvascular Complications of Diabetes: Cross-Sectional Descriptive Study", journal="J Med Internet Res", year="2024", month="Mar", day="26", volume="26", pages="e55351", keywords="appointment scheduling", keywords="cardiologists", keywords="chronic disease", keywords="cross-sectional study", keywords="diabetes", keywords="endocrinologists", keywords="healthcare utilization", keywords="lifestyle modification", keywords="management plan", keywords="metabolic control", keywords="online booking", keywords="ophthalmologists", keywords="prevention", keywords="quality of life", keywords="scheduling appointments", keywords="scheduling", keywords="specialist", keywords="timeliness", keywords="United States", keywords="wait time", keywords="well-being", abstract="Background: Diabetes is a chronic disease that requires lifelong management and care, affecting around 422 million people worldwide and roughly 37 million in the United States. Patients newly diagnosed with diabetes must work with health care providers to formulate a management plan, including lifestyle modifications and regular office visits, to improve metabolic control, prevent or delay complications, optimize quality of life, and promote well-being. Objective: Our aim is to investigate one component of system-wide access to timely health care for people with diabetes in New York City (NYC), namely the length of time for someone with newly diagnosed diabetes to obtain an appointment with 3 diabetes care specialists: a cardiologist, an endocrinologist, and an ophthalmologist, respectively. Methods: We contacted the offices of 3 different kinds of specialists: cardiologists, endocrinologists, and ophthalmologists, by telephone, for this descriptive cross-sectional study, to determine the number of days required to schedule an appointment for a new patient with diabetes. The sampling frame included all specialists affiliated with any private or public hospital in NYC. The number of days to obtain an appointment with each specialist was documented, along with ``time on hold'' when attempting to schedule an appointment and the presence of online booking capabilities. Results: Of the 1639 unique physicians affiliated with (private and public) hospitals in the 3 subspecialties, 1032 (cardiologists, endocrinologists, and ophthalmologists) were in active practice and did not require a referral. The mean wait time for scheduling an appointment was 36 (SD 36.4; IQR 12-51.5) days for cardiologists; 82 (SD 47; IQR 56-101) days for endocrinologists; and 50.4 (SD 56; IQR 10-72) days for ophthalmologists. The median wait time was 27 days for cardiologists, 72 days for endocrinologists, and 30 days for ophthalmologists. The mean time on hold while attempting to schedule an appointment with these specialists was 2.6 (SD 5.5) minutes for cardiologists, 5.4 (SD 4.3) minutes for endocrinologists, and 3.2 (SD 4.8) minutes for ophthalmologists, respectively. Over 46\% (158/341) of cardiologists enabled patients to schedule an appointment on the web, and over 55\% (128/228) of endocrinologists enabled patients to schedule an appointment on the web. In contrast, only approximately 25\% (117/463) of ophthalmologists offered web-based appointment scheduling options. Conclusions: The results indicate considerable variation in wait times between and within the 3 specialties examined for a new patient in NYC. Given the paucity of research on wait times for newly diagnosed people with diabetes to obtain an appointment with different specialists, this study provides preliminary estimates that can serve as an initial reference. Additional research is needed to document the extent to which wait times are associated with complications and the demographic and socio-economic characteristics of people served by different providers. ", doi="10.2196/55351", url="https://www.jmir.org/2024/1/e55351", url="http://www.ncbi.nlm.nih.gov/pubmed/38530352" } @Article{info:doi/10.2196/53054, author="Bonn, E. Stephanie and Hummel, Madeleine and Peveri, Giulia and Eke, Hel{\'e}n and Alexandrou, Christina and Bellocco, Rino and L{\"o}f, Marie and Trolle Lagerros, Ylva", title="Effectiveness of a Smartphone App to Promote Physical Activity Among Persons With Type 2 Diabetes: Randomized Controlled Trial", journal="Interact J Med Res", year="2024", month="Mar", day="21", volume="13", pages="e53054", keywords="behavior change", keywords="exercise", keywords="intervention", keywords="mHealth", keywords="smartphone app", keywords="self-monitoring", abstract="Background: Physical activity is well known to have beneficial effects on glycemic control and to reduce risk factors for cardiovascular disease in persons with type 2 diabetes. Yet, successful implementation of lifestyle interventions targeting physical activity in primary care has shown to be difficult. Smartphone apps may provide useful tools to support physical activity. The DiaCert app was specifically designed for integration into primary care and is an automated mobile health (mHealth) solution promoting daily walking. Objective: This study aimed to investigate the effect of a 3-month-long intervention promoting physical activity through the use of the DiaCert app among persons with type 2 diabetes in Sweden. Our primary objective was to assess the effect on moderate to vigorous physical activity (MVPA) at 3 months of follow-up. Our secondary objective was to assess the effect on MVPA at 6 months of follow-up and on BMI, waist circumference, hemoglobin A1c, blood lipids, and blood pressure at 3 and 6 months of follow-up. Methods: We recruited men and women with type 2 diabetes from 5 primary health care centers and 1 specialized center. Participants were randomized 1:1 to the intervention or control group. The intervention group was administered standard care and access to the DiaCert app at baseline and 3 months onward. The control group received standard care only. Outcomes of objectively measured physical activity using accelerometers, BMI, waist circumference, biomarkers, and blood pressure were assessed at baseline and follow-ups. Linear mixed models were used to assess differences in outcomes between the groups. Results: A total of 181 study participants, 65.7\% (119/181) men and 34.3\% (62/181) women, were recruited into the study and randomized to the intervention (n=93) or control group (n=88). The participants' mean age and BMI were 60.0 (SD 11.4) years and 30.4 (SD 5.3) kg/m2, respectively. We found no significant effect of the intervention (group by time interaction) on MVPA at either the 3-month ($\beta$=1.51, 95\% CI --5.53 to 8.55) or the 6-month ($\beta$=--3.53, 95\% CI --10.97 to 3.92) follow-up. We found no effect on any of the secondary outcomes at follow-ups, except for a significant effect on BMI at 6 months ($\beta$=0.52, 95\% CI 0.20 to 0.84). However, mean BMI did not differ between the groups at the 6-month follow-up. Conclusions: We found no evidence that persons with type 2 diabetes being randomized to use an app promoting daily walking increased their levels of MVPA at 3 or 6 months' follow-up compared with controls receiving standard care. The effect of the app on BMI was unclear, and we found nothing to support an effect on secondary outcomes. Further research is needed to determine what type of mHealth intervention could be effective to increase physical activity among persons with type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT03053336; https://clinicaltrials.gov/study/NCT03053336 ", doi="10.2196/53054", url="https://www.i-jmr.org/2024/1/e53054", url="http://www.ncbi.nlm.nih.gov/pubmed/38512333" } @Article{info:doi/10.2196/54807, author="H{\"o}lgyesi, {\'A}ron and Luczay, Andrea and T{\'o}th-Heyn, P{\'e}ter and Muzslay, Eszter and Vil{\'a}gos, Eszter and Szab{\'o}, J. Attila and Baji, Petra and Kov{\'a}cs, Levente and Gul{\'a}csi, L{\'a}szl{\'o} and Zrubka, Zsombor and P{\'e}ntek, M{\'a}rta", title="The Impact of Parental Electronic Health Literacy on Disease Management and Outcomes in Pediatric Type 1 Diabetes Mellitus: Cross-Sectional Clinical Study", journal="JMIR Pediatr Parent", year="2024", month="Mar", day="20", volume="7", pages="e54807", keywords="electronic health literacy", keywords="parents", keywords="caregivers", keywords="diabetes mellitus", keywords="child", abstract="Background: Despite the growing uptake of smart technologies in pediatric type 1 diabetes mellitus (T1DM) care, little is known about caregiving parents' skills to deal with electronic health information sources. Objective: We aimed to assess the electronic health literacy of parents caring for children with T1DM and investigate its associations with disease management and children's outcomes. Methods: A cross-sectional survey was performed involving 150 parent-child (8-14 years old with T1DM) dyads in a university pediatric diabetology center. Parents' electronic health literacy (eHealth Literacy Scale [eHEALS]), general health literacy (Chew questionnaire and Newest Vital Sign [NVS]), and attitudes toward T1DM care (Parental Self-Efficacy Scale for Diabetes Management [PSESDM] and Hypoglycemia Fear Survey [HFS]) were investigated. Children's treatment, HbA1c level, and quality of life (Pediatric Quality of Life Inventory Diabetes Module [PedsQL Diab] and EQ-5D-Y-3L) were assessed. Multiple linear regression analysis was performed to investigate the determining factors of 6-month average HbA1c. Results: Of the 150 children, 38 (25.3\%) used a pen, 55 (36.7\%) used a pen plus a sensor, 6 (4.0\%) used an insulin pump, and 51 (34.0\%) used an insulin pump plus a sensor. Parents' average eHEALS score (mean 31.2, SD 4.9) differed significantly by educational level (P=.04) and the children's treatment (P=.005), being the highest in the pump + sensor subgroup. The eHEALS score showed significant Pearson correlations with the Chew score (r=?0.45; P<.001), NVS score (r=0.25; P=.002), and PSESDM score (r=0.35; P<.001) but not with the children's HbA1c (r=?0.143; P=.08), PedsQL Diab (r=?0.0002; P>.99), and EQ-5D-Y-3L outcomes (r=?0.13; P=.12). Regression analysis revealed significant associations of the child's HbA1c level with sex ($\beta$=0.58; P=.008), treatment modality (pen + sensor: $\beta$=?0.66; P=.03; pump + sensor: $\beta$=?0.93; P=.007), and parents' self-efficacy (PSESDM; $\beta$=?0.08; P=.001). Conclusions: Significantly higher parental electronic health literacy was found in T1DM children using a glucose sensor. The electronic health literacy level was associated with parents' diabetes management attitude but not with the child's glycemic control. Studies further investigating the role of parental electronic health literacy in T1DM children managed at different levels of care and the local context are encouraged. ", doi="10.2196/54807", url="https://pediatrics.jmir.org/2024/1/e54807", url="http://www.ncbi.nlm.nih.gov/pubmed/38506893" } @Article{info:doi/10.2196/49105, author="Toledo, Marques Marileila and da Silva, Edson and Esteves, Adriana Elizabethe", title="Analysis of Self-Care Activities in Type 2 Diabetes in Brazil: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2024", month="Mar", day="20", volume="13", pages="e49105", keywords="type 2 diabetes mellitus", keywords="self-care", keywords="self-care activities", keywords="Brazil", keywords="diabetes mellitus", keywords="T2D", keywords="chronic disease", keywords="self-care activity", keywords="aging", keywords="ageing", keywords="methodological guidelines", keywords="knowledge", keywords="gaps", keywords="diabetes education", keywords="hyperglycemia", keywords="insulin resistance", keywords="health education", abstract="Background: Diabetes mellitus is a chronic disease that is growing worldwide. It is estimated that 15.7 million people aged between 20 and 79 years live with diabetes in Brazil, and the majority of cases are type 2 diabetes (T2D). To successfully manage diabetes, the patient needs to develop self-care activities. However, there is limited understanding of what self-care activities are performed by people with T2D in Brazil. Objective: This study aims to identify and map studies that evaluate self-care activities in T2D in Brazil. Methods: This is a scoping review protocol structured according to the methodological guidelines of the Joanna Briggs Institute. Six databases and gray literature were used. The process of searching, identifying, and evaluating the papers was carried out by 2 independent reviewers, guided by the assumptions established by the Joanna Briggs Institute. We sought to answer the following guiding question: How are self-care activities for people with T2D evaluated in Brazil? We included papers and publications in any language, from public and private domains, and with different methodological approaches. Results: Initial database searches produced a total of 681 results. These papers will be critically analyzed, and relevant information will be extracted. Quantitative and qualitative results of the papers reviewed will be presented to respond to the study's objective. We intend to publish the scoping review in the first half of 2024. Conclusions: The protocol for this scoping review will evaluate the main self-care activities carried out by adults and older people with T2D in Brazil. The results may help identify knowledge gaps and contribute to future research and diabetes education interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/49105 ", doi="10.2196/49105", url="https://www.researchprotocols.org/2024/1/e49105", url="http://www.ncbi.nlm.nih.gov/pubmed/38506891" } @Article{info:doi/10.2196/52688, author="Killian, A. Jackson and Jain, Manish and Jia, Yugang and Amar, Jonathan and Huang, Erich and Tambe, Milind", title="New Approach to Equitable Intervention Planning to Improve Engagement and Outcomes in a Digital Health Program: Simulation Study", journal="JMIR Diabetes", year="2024", month="Mar", day="15", volume="9", pages="e52688", keywords="chronic disease", keywords="type-2 diabetes", keywords="T2D", keywords="restless multiarmed bandits", keywords="multi-armed bandit", keywords="multi-armed bandits", keywords="machine learning", keywords="resource allocation", keywords="digital health", keywords="equity", abstract="Background: Digital health programs provide individualized support to patients with chronic diseases and their effectiveness is measured by the extent to which patients achieve target individual clinical outcomes and the program's ability to sustain patient engagement. However, patient dropout and inequitable intervention delivery strategies, which may unintentionally penalize certain patient subgroups, represent challenges to maximizing effectiveness. Therefore, methodologies that optimize the balance between success factors (achievement of target clinical outcomes and sustained engagement) equitably would be desirable, particularly when there are resource constraints. Objective: Our objectives were to propose a model for digital health program resource management that accounts jointly for the interaction between individual clinical outcomes and patient engagement, ensures equitable allocation as well as allows for capacity planning, and conducts extensive simulations using publicly available data on type 2 diabetes, a chronic disease. Methods: We propose a restless multiarmed bandit (RMAB) model to plan interventions that jointly optimize long-term engagement and individual clinical outcomes (in this case measured as the achievement of target healthy glucose levels). To mitigate the tendency of RMAB to achieve good aggregate performance by exacerbating disparities between groups, we propose new equitable objectives for RMAB and apply bilevel optimization algorithms to solve them. We formulated a model for the joint evolution of patient engagement and individual clinical outcome trajectory to capture the key dynamics of interest in digital chronic disease management programs. Results: In simulation exercises, our optimized intervention policies lead to up to 10\% more patients reaching healthy glucose levels after 12 months, with a 10\% reduction in dropout compared to standard-of-care baselines. Further, our new equitable policies reduce the mean absolute difference of engagement and health outcomes across 6 demographic groups by up to 85\% compared to the state-of-the-art. Conclusions: Planning digital health interventions with individual clinical outcome objectives and long-term engagement dynamics as considerations can be both feasible and effective. We propose using an RMAB sequential decision-making framework, which may offer additional capabilities in capacity planning as well. The integration of an equitable RMAB algorithm further enhances the potential for reaching equitable solutions. This approach provides program designers with the flexibility to switch between different priorities and balance trade-offs across various objectives according to their preferences. ", doi="10.2196/52688", url="https://diabetes.jmir.org/2024/1/e52688", url="http://www.ncbi.nlm.nih.gov/pubmed/38488828" } @Article{info:doi/10.2196/46699, author="Mannoubi, Choumous and Kairy, Dahlia and Menezes, Vanessa Karla and Desroches, Sophie and Layani, Geraldine and Vachon, Brigitte", title="The Key Digital Tool Features of Complex Telehealth Interventions Used for Type 2 Diabetes Self-Management and Monitoring With Health Professional Involvement: Scoping Review", journal="JMIR Med Inform", year="2024", month="Mar", day="13", volume="12", pages="e46699", keywords="telehealth", keywords="telemedicine", keywords="telenutrition", keywords="telemonitoring", keywords="electronic coaching", keywords="e-coaching", keywords="scoping review", keywords="type 2 diabetes", keywords="prediabetes", keywords="diabetes management", keywords="diabetes self-management", keywords="mobile phone", abstract="Background: Therapeutic education and patient self-management are crucial in diabetes prevention and treatment. Improving diabetes self-management requires multidisciplinary team intervention, nutrition education that facilitates self-management, informed decision-making, and the organization and delivery of appropriate health care services. The emergence of telehealth services has provided the public with various tools for educating themselves and for evaluating, monitoring, and improving their health and nutrition-related behaviors. Combining health technologies with clinical expertise, social support, and health professional involvement could help persons living with diabetes improve their disease self-management skills and prevent its long-term consequences. Objective: This scoping review's primary objective was to identify the key digital tool features of complex telehealth interventions used for type 2 diabetes or prediabetes self-management and monitoring with health professional involvement that help improve health outcomes. A secondary objective was to identify how these key features are developed and combined. Methods: A 5-step scoping review methodology was used to map relevant literature published between January 1, 2010 and March 31, 2022. Electronic searches were performed in the MEDLINE, CINAHL, and Embase databases. The searches were limited to scientific publications in English and French that either described the conceptual development of a complex telehealth intervention that combined self-management and monitoring with health professional involvement or evaluated its effects on the therapeutic management of patients with type 2 diabetes or prediabetes. Three reviewers independently identified the articles and extracted the data. Results: The results of 42 studies on complex telehealth interventions combining diabetes self-management and monitoring with the involvement of at least 1 health professional were synthesized. The health professionals participating in these studies were physicians, dietitians, nurses, and psychologists. The digital tools involved were smartphone apps or web-based interfaces that could be used with medical devices. We classified the features of these technologies into eight categories, depending on the intervention objective: (1) monitoring of glycemia levels, (2) physical activity monitoring, (3) medication monitoring, (4) diet monitoring, (5) therapeutic education, (6) health professional support, (7) other health data monitoring, and (8) health care management. The patient-logged data revealed behavior patterns that should be modified to improve health outcomes. These technologies, used with health professional involvement, patient self-management, and therapeutic education, translate into better control of glycemia levels and the adoption of healthier lifestyles. Likewise, they seem to improve monitoring by health professionals and foster multidisciplinary collaboration through data sharing and the development of more concise automatically generated reports. Conclusions: This scoping review synthesizes multiple studies that describe the development and evaluation of complex telehealth interventions used in combination with health professional support. It suggests that combining different digital tools that incorporate diabetes self-management and monitoring features with a health professional's advice and interaction results in more effective interventions and outcomes. ", doi="10.2196/46699", url="https://medinform.jmir.org/2024/1/e46699", url="http://www.ncbi.nlm.nih.gov/pubmed/38477979" } @Article{info:doi/10.2196/48310, author="Yoon, Sungwon and Tang, Haoming and Tan, Min Chao and Phang, Kie Jie and Kwan, Heng Yu and Low, Leng Lian", title="Acceptability of Mobile App--Based Motivational Interviewing and Preferences for App Features to Support Self-Management in Patients With Type 2 Diabetes: Qualitative Study", journal="JMIR Diabetes", year="2024", month="Mar", day="6", volume="9", pages="e48310", keywords="mobile health", keywords="motivational interviewing", keywords="diabetes", keywords="self-management", keywords="health coaching", keywords="acceptability", keywords="application", keywords="management", keywords="type 2 diabetes", keywords="communication", keywords="patient barrier", keywords="healthy behavior", keywords="feedback", keywords="visualization", keywords="hybrid model", abstract="Background: Patients with type 2 diabetes mellitus (T2DM) experience multiple barriers to improving self-management. Evidence suggests that motivational interviewing (MI), a patient-centered communication method, can address patient barriers and promote healthy behavior. Despite the value of MI, existing MI studies predominantly used face-to-face or phone-based interventions. With the growing adoption of smartphones, automated MI techniques powered by artificial intelligence on mobile devices may offer effective motivational support to patients with T2DM. Objective: This study aimed to explore the perspectives of patients with T2DM on the acceptability of app-based MI in routine health care and collect their feedback on specific MI module features to inform our future intervention. Methods: We conducted semistructured interviews with patients with T2DM, recruited from public primary care clinics. All interviews were audio recorded and transcribed verbatim. Thematic analysis was conducted using NVivo. Results: In total, 33 patients with T2DM participated in the study. Participants saw MI as a mental reminder to increase motivation and a complementary care model conducive to self-reflection and behavior change. Yet, there was a sense of reluctance, mainly stemming from potential compromise of autonomy in self-care by the introduction of MI. Some participants felt confident in their ability to manage conditions independently, while others reported already making changes and preferred self-management at their own pace. Compared with in-person MI, app-based MI was viewed as offering a more relaxed atmosphere for open sharing without being judged by health care providers. However, participants questioned the lack of human touch, which could potentially undermine a patient-provider therapeutic relationship. To sustain motivation, participants suggested more features of an ongoing supportive nature such as the visualization of milestones, gamified challenges and incremental rewards according to achievements, tailored multimedia resources based on goals, and conversational tools that are interactive and empathic. Conclusions: Our findings suggest the need for a hybrid model of intervention involving both app-based automated MI and human coaching. Patient feedback on specific app features will be incorporated into the module development and tested in a randomized controlled trial. ", doi="10.2196/48310", url="https://diabetes.jmir.org/2024/1/e48310", url="http://www.ncbi.nlm.nih.gov/pubmed/38446526" } @Article{info:doi/10.2196/49940, author="Setyawati, Andina and Saleh, Ariyanti and Tahir, Takdir and Yusuf, Saldy and Syahrul, Syahrul and Aminuddin, Aminuddin and Raihan, Muhammad and Jafar, Nuurhidayat and Hamzah, Hasyrul and Arfian, Nur", title="Matrix Metalloproteinase-9 Testing of Golden Rice Cookies With Piper Crocatum Active Extract for Preventing Foot Ulcers in Patients With Diabetes: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Feb", day="29", volume="13", pages="e49940", keywords="diabetic foot ulcer", keywords="prevention", keywords="diabetic neuropathy", keywords="cookies", keywords="food supplement", keywords="study protocol", abstract="Background: Diabetic foot ulcers (DFUs) present a formidable challenge to both patients and health care systems. DFUs significantly reduce the quality of life for patients, prolong hospital stays, and are the cause of approximately 70,000 lower limb amputations across the globe annually. Prevention of DFUs primarily involves the optimization of blood sugar levels and the effective management of complications, particularly peripheral neuropathy. Golden Rice has been proven to lower blood sugar levels due to its beta-carotene content, and Piper crocatum (P. crocatum) has been found to be effective in reducing the risk factors of DFUs through biomolecular regulation because of its polyphenol content. Objective: The principal objective of this study is to identify the efficacy of P. crocatum--enriched cookies, with Golden Rice as their primary ingredient, in preventing DFUs. The evaluation will center on their impact on the expression of matrix metalloproteinase-9 (MMP-9), a pivotal factor in the development of DFUs. Methods: This study is an experimental clinical research that follows the randomized controlled trial method and uses a single-blind design. The participants in the study are outpatients from primary health centers in Makassar, Indonesia, who have been diagnosed with diabetes mellitus. The sample for the study will be randomly selected and subsequently categorized into 2 groups: the intervention group and the control group. The intervention group consumes P. crocatum--enriched Golden Rice cookies, while the control group receives cookies without these additives. The participants from both groups will consume their respective cookies (packaged identically) twice a day for 14 days. The cookies will be prepared according to a modified recipe with an emphasis on low glucose content, resulting in 51 calories per cookie, comprising 1\% carbohydrates, 6\% fat, 4\% cholesterol, and 4\% fiber, excluding gluten, sugar, and salt. They will be baked at 158{\textdegree}C for 20 minutes. The process involves the addition of 20\% Golden Rice and 10\% P. crocatum ethanol extract, both prepared via maceration with 96\% ethanol. The dependent variable in this study is the expression of gelatinases matrix metalloproteinase, to be assessed at 2 distinct time points---preintervention (pretest) and postintervention (posttest)---with the evaluation conducted through the western blotting method. Results: The recruitment and testing phase started in January 2024. The study is scheduled to be completed by the end of March 2024. Data analysis will commence in April 2024, and the publication of the results is anticipated in the same year (2024). The study will report on the changes in primary data, encompassing gelatinases matrix metalloproteinase, as well as secondary data, including the ankle-brachial index, neuropathy score, and random blood glucose level. Conclusions: The findings of this trial are expected to significantly impact the selection of strategies by health care practitioners to enhance diabetes self-management, particularly in the domain of therapeutic snacking, for patients diagnosed with diabetes mellitus. Trial Registration: Thai Clinical Trials Registry TCTR20230502001; https://www.thaiclinicaltrials.org/show/TCTR20230502001 International Registered Report Identifier (IRRID): PRR1-10.2196/49940 ", doi="10.2196/49940", url="https://www.researchprotocols.org/2024/1/e49940", url="http://www.ncbi.nlm.nih.gov/pubmed/38422498" } @Article{info:doi/10.2196/45536, author="Dreyer, A. Nancy and Knuth, B. Kendall and Xie, Yiqiong and Reynolds, W. Matthew and Mack, D. Christina", title="COVID-19 Vaccination Reactions and Risk of Breakthrough Infections Among People With Diabetes: Cohort Study Derived From Community Reporters", journal="JMIR Diabetes", year="2024", month="Feb", day="27", volume="9", pages="e45536", keywords="COVID-19", keywords="diabetes", keywords="vaccine", keywords="vaccine hesitancy", keywords="registry", keywords="person-generated health data", keywords="patient-reported outcomes", keywords="side effects", keywords="vaccination", keywords="infection", keywords="nondiabetic adult", keywords="clinical data", keywords="fatigue", keywords="headache", keywords="risk", keywords="patient data", keywords="medication", keywords="community health", abstract="Background: This exploratory study compares self-reported COVID-19 vaccine side effects and breakthrough infections in people who described themselves as having diabetes with those who did not identify as having diabetes. Objective: The study uses person-reported data to evaluate differences in the perception of COVID-19 vaccine side effects between adults with diabetes and those who did not report having diabetes. Methods: This is a retrospective cohort study conducted using data provided online by adults aged 18 years and older residing in the United States. The participants who voluntarily self-enrolled between March 19, 2021, and July 16, 2022, in the IQVIA COVID-19 Active Research Experience project reported clinical and demographic information, COVID-19 vaccination, whether they had experienced any side effects, test-confirmed infections, and consented to linkage with prescription claims. No distinction was made for this study to differentiate prediabetes or type 1 and type 2 diabetes nor to verify reports of positive COVID-19 tests. Person-reported medication use was validated using pharmacy claims and a subset of the linked data was used for a sensitivity analysis of medication effects. Multivariate logistic regression was used to estimate the adjusted odds ratios of vaccine side effects or breakthrough infections by diabetic status, adjusting for age, gender, education, race, ethnicity (Hispanic or Latino), BMI, smoker, receipt of an influenza vaccine, vaccine manufacturer, and all medical conditions. Evaluations of diabetes medication-specific vaccine side effects are illustrated graphically to support the examination of the magnitude of side effect differences for various medications and combinations of medications used to manage diabetes. Results: People with diabetes (n=724) reported experiencing fewer side effects within 2 weeks of vaccination for COVID-19 than those without diabetes (n=6417; mean 2.7, SD 2.0 vs mean 3.1, SD 2.0). The adjusted risk of having a specific side effect or any side effect was lower among those with diabetes, with significant reductions in fatigue and headache but no differences in breakthrough infections over participants' maximum follow-up time. Diabetes medication use did not consistently affect the risk of specific side effects, either using self-reported medication use or using only diabetes medications that were confirmed by pharmacy health insurance claims for people who also reported having diabetes. Conclusions: People with diabetes reported fewer vaccine side effects than participants not reporting having diabetes, with a similar risk of breakthrough infection. Trial Registration: ClinicalTrials.gov NCT04368065; https://clinicaltrials.gov/study/NCT04368065 ", doi="10.2196/45536", url="https://diabetes.jmir.org/2024/1/e45536", url="http://www.ncbi.nlm.nih.gov/pubmed/38412008" } @Article{info:doi/10.2196/50340, author="Holm, Fredensborg Tanja and Udsen, Witt Flemming and F{\ae}rch, Kristine and Jensen, Hasselstr{\o}m Morten and von Scholten, Johan Bernt and Hejlesen, Kristian Ole and Hangaard, Stine", title="The Effectiveness of Digital Health Lifestyle Interventions on People With Prediabetes: Protocol for a Systematic Review, Meta-Analysis, and Meta-Regression", journal="JMIR Res Protoc", year="2024", month="Feb", day="9", volume="13", pages="e50340", keywords="digital health", keywords="effectiveness", keywords="lifestyle intervention", keywords="meta-analysis", keywords="meta-regression", keywords="prediabetic state", keywords="systematic review", keywords="type 2 diabetes prevention", keywords="weight loss", abstract="Background: There has been an increasing interest in the use of digital health lifestyle interventions for people with prediabetes, as these interventions may offer a scalable approach to preventing type 2 diabetes. Previous systematic reviews on digital health lifestyle interventions for people with prediabetes had limitations, such as a narrow focus on certain types of interventions, a lack of statistical pooling, and no broader subgroup analysis of intervention characteristics. The identified limitations observed in previous systematic reviews substantiate the necessity of conducting a comprehensive review to address these gaps within the field. This will enable a comprehensive understanding of the effectiveness of digital health lifestyle interventions for people with prediabetes. Objective: The objective of this systematic review, meta-analysis, and meta-regression is to systematically investigate the effectiveness of digital health lifestyle interventions on prediabetes-related outcomes in comparison with any comparator without a digital component among adults with prediabetes. Methods: This systematic review will include randomized controlled trials that investigate the effectiveness of digital health lifestyle interventions on adults (aged 18 years or older) with prediabetes and compare the digital interventions with nondigital interventions. The primary outcome will be change in body weight (kg). Secondary outcomes include, among others, change in glycemic status, markers of cardiometabolic health, feasibility outcomes, and incidence of type 2 diabetes. Embase, PubMed, CINAHL, and CENTRAL (Cochrane Central Register of Controlled Trials) will be systematically searched. The data items to be extracted include study characteristics, participant characteristics, intervention characteristics, and relevant outcomes. To estimate the overall effect size, a meta-analysis will be conducted using the mean difference. Additionally, if feasible, meta-regression on study, intervention, and participant characteristics will be performed. The Cochrane risk of bias tool will be applied to assess study quality, and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach will be used to assess the certainty of evidence. Results: The results are projected to yield an overall estimate of the effectiveness of digital health lifestyle interventions on adults with prediabetes and elucidate the characteristics that contribute to their effectiveness. Conclusions: The insights gained from this study may help clarify the potential of digital health lifestyle interventions for people with prediabetes and guide the decision-making regarding future intervention components. Trial Registration: PROSPERO CRD42023426919; http://tinyurl.com/d3enrw9j International Registered Report Identifier (IRRID): PRR1-10.2196/50340 ", doi="10.2196/50340", url="https://www.researchprotocols.org/2024/1/e50340", url="http://www.ncbi.nlm.nih.gov/pubmed/38335018" } @Article{info:doi/10.2196/48120, author="Chen, Jiaheng and Li, Ting Yu and Niu, Zimin and He, Zhanpeng and Xie, Jie Yao and Hernandez, Jose and Huang, Wenyong and Wang, X. Harry H. and ", title="Association of Visceral Obesity Indices With Incident Diabetic Retinopathy in Patients With Diabetes: Prospective Cohort Study", journal="JMIR Public Health Surveill", year="2024", month="Feb", day="6", volume="10", pages="e48120", keywords="Chinese visceral adiposity index", keywords="community-based cohort", keywords="diabetic retinopathy", keywords="lipid accumulation product", keywords="visceral adiposity index", keywords="visceral obesity indices", abstract="Background: Visceral adipose tissue plays an active role in the pathogenesis of type 2 diabetes and vascular dysfunction. The lipid accumulation product (LAP), visceral adiposity index (VAI), and Chinese VAI (CVAI) have been proposed as simple and validated surrogate indices for measuring visceral adipose tissue. However, the evidence from prospective studies on the associations between these novel indices of visceral obesity and diabetic retinopathy (DR) remains scant. Objective: This study aimed to investigate the longitudinal associations of LAP, VAI, and CVAI with incident DR in Chinese patients with diabetes. Methods: This was a prospective cohort study conducted in Guangzhou in southern China. We collected baseline data between November 2017 and July 2020, while on-site follow-up visits were conducted annually until January 2022. The study participants consisted of 1403 patients with a clinical diagnosis of diabetes, referred from primary care, who were free of DR at baseline. The LAP, VAI, and CVAI levels were calculated by sex-specific equations based on anthropometric and biochemical parameters. DR was assessed using 7-field color stereoscopic fundus photographs and graded according to the modified Airlie House Classification scheme. Time-dependent Cox proportional hazard models were constructed to estimate the hazard ratios with 95\% CIs. Restricted cubic spline curves were fitted to examine the dose-response relationship between the 3 indices of visceral obesity and new-onset DR. Subgroup analyses were performed to investigate the potential effect modifiers. Results: The mean age of study participants was 64.5 (SD 7.6) years, and over half (816/1403, 58.2\%) were female. During a median follow-up of 2.13 years, 406 DR events were observed. A 1-SD increment in LAP, VAI, or CVAI was consistently associated with increased risk for new-onset DR, with a multivariable?adjusted hazard ratio of 1.24 (95\% CI 1.09-1.41; P=.001), 1.22 (95\% CI 1.09-1.36; P<.001), and 1.48 (95\% CI 1.19-1.85; P=.001), respectively. Similar patterns were observed across tertiles in LAP (P for trend=.001), VAI (P for trend<.001), and CVAI (P for trend=.009). Patients in the highest tertile of LAP, VAI, and CVAI had an 84\%, 86\%, and 82\% higher hazard of DR, respectively, compared to those in the lowest tertile. A nonlinear dose-response relationship with incident DR was noted for LAP and VAI (both P for nonlinearity<.05), but not for CVAI (P for nonlinearity=.51). We did not detect the presence of effect modification by age, sex, duration of diabetes, BMI, or comorbidity (all P for interaction>.10). Conclusions: Visceral obesity, as measured by LAP, VAI, or CVAI, is independently associated with increased risk for new-onset DR in Chinese patients with diabetes. Our findings may suggest the necessity of incorporating regular monitoring of visceral obesity indices into routine clinical practice to enhance population-based prevention for DR. ", doi="10.2196/48120", url="https://publichealth.jmir.org/2024/1/e48120", url="http://www.ncbi.nlm.nih.gov/pubmed/38319705" } @Article{info:doi/10.2196/50735, author="Denny, Alanna and Curtin, Brian and Taylor-Robinson, Simon and Chirambo, Baxter Griphin and Cilliers, Liezel and Wu, Joseph Tsung-Shu and O'Meara, Ciara and Booth, Richard and O'Donoghue, John", title="Evaluating the Appropriateness of Podcasts to Improve the Knowledge and Awareness of Selected Health Topics Among Undergraduate General Nursing Students: Protocol for an International Feasibility Study", journal="JMIR Res Protoc", year="2024", month="Feb", day="6", volume="13", pages="e50735", keywords="podcasting", keywords="podcast", keywords="nursing student", keywords="gestational diabetes", keywords="mental health", keywords="health", keywords="knowledge", abstract="Background: Podcasts have proven to be a successful alternative source of educational material for students. Given the ability to listen to podcasts 24/7 and while on the go, this technology has the potential to provide informative and educational material to a large number of people at any given time. Podcasts are usually freely available on commonly used mobile devices, such as smartphones, laptops, and tablets. Objective: This paper describes the impact of health-related podcasts as an intervention tool to support the knowledge and awareness of nursing students on a given topic. Methods: Pre- and postpodcast questionnaires will gather data regarding the participants' knowledge and awareness of two topics---gestational diabetes and mental health. This intervention will be tested on general nursing undergraduate students. The total number of students (N=2395) from the participating universities are broken down as follows: (1) University College Cork (n=850) and the University of Galway (n=450) in Ireland, (2) Mzuzu University in Malawi (n=719), and (3) University of Fort Hare in South Africa (n=376). Results: The study received ethical approval from the University College Cork Ethics Committee (2022-027A1). The approval obtained from University College Cork sufficed as ethics coverage for the University of Galway in Ireland. Ethics approval was also received from the Mzuzu University Research Ethics Committee (ID MZUNIREC/DOR/23/28) and the Inter-Faculty Research Ethics Committee of the University of Fort Hare (ID CIL002-21). Data collection is currently underway and will continue until the end of February 2024. The quantitative and qualitative data are expected to be analyzed in March 2024. Conclusions: Results from this study will allow for an investigation into the impact of podcasts in different settings: a high-income country (Ireland), an upper-middle--income country (South Africa), and a low-to-middle--income country (Malawi). The data gathered from this feasibility study will provide more clarity on the potential utility of podcasts as an intervention tool. We will gather data regarding listener demographics (eg, country of residence, age, gender, and year of study). International Registered Report Identifier (IRRID): DERR1-10.2196/50735 ", doi="10.2196/50735", url="https://www.researchprotocols.org/2024/1/e50735", url="http://www.ncbi.nlm.nih.gov/pubmed/38319702" } @Article{info:doi/10.2196/42595, author="Karimi, Nazgol and Opie, Rachelle and Crawford, David and O'Connell, Stella and Ball, Kylie", title="Digitally Delivered Interventions to Improve Nutrition Behaviors Among Resource-Poor and Ethnic Minority Groups With Type 2 Diabetes: Systematic Review", journal="J Med Internet Res", year="2024", month="Feb", day="1", volume="26", pages="e42595", keywords="digitally delivered", keywords="eHealth", keywords="type 2 diabetes", keywords="nutrition", keywords="socioeconomically disadvantaged", keywords="mobile phone", abstract="Background: Resource-poor individuals, such as those with a low income, are disproportionately affected by diabetes and unhealthy eating patterns that contribute to poor disease self-management and prognosis. Digitally delivered interventions have the potential to address some of the barriers to healthy eating experienced by this group. However, little is known about their effectiveness in disadvantaged populations. Objective: This systematic review is conducted to assess the effectiveness of digitally delivered interventions in improving nutritional behaviors and nutrition?related health outcomes among disadvantaged people with type 2 diabetes (T2D). Methods: MEDLINE complete, Global Health, Embase, CINAHL complete, Informit Health, IEEE Xplore, and Applied Science and Technology Source databases were searched for studies published between 1990 and 2022 on digitally delivered nutrition interventions for disadvantaged people with T2D. Two reviewers independently assessed the studies for eligibility and determined the study quality using the Cochrane Risk-of-Bias Assessment Tool. The Behavioral Change Technique Taxonomy V1 was used to identify behavior change techniques used in the design of interventions. Results: Of the 2434 identified records, 10 (0.4\%), comprising 947 participants, met the eligibility criteria and were included in the review. A total of 2 digital platforms, web and messaging services (eg, SMS text messaging interventions or multimedia messaging service), were used to deliver interventions. Substantial improvements in dietary behaviors were reported in 5 (50\%) of the 10 studies, representing improvements in healthier food choices or increases in dietary knowledge and skills or self-efficacy. Of the 10 studies, 7 (70\%) examined changes in blood glucose levels, of which 4 (57\%) out of 7 achieved significant decreases in hemoglobin A1C levels ranging from 0.3\% to 1.8\%. The most frequently identified behavior change techniques across all studies were instruction on how to perform the behavior, information about health consequences, and social support. Conclusions: This review provided some support for the efficacy of digitally delivered interventions in improving healthy eating behaviors in disadvantaged people with T2D, an essential dietary prerequisite for changes in clinical metabolic parameters. Further research is needed into how disadvantaged people with T2D may benefit more from digital approaches and to identify the specific features of effective digital interventions for supporting healthy behaviors among disadvantaged populations. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020149844; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=149844 ", doi="10.2196/42595", url="https://www.jmir.org/2024/1/e42595", url="http://www.ncbi.nlm.nih.gov/pubmed/38300694" } @Article{info:doi/10.2196/47701, author="Aldaghi, Tahmineh and Muzik, Jan", title="Multicriteria Decision-Making in Diabetes Management and Decision Support: Systematic Review", journal="JMIR Med Inform", year="2024", month="Feb", day="1", volume="12", pages="e47701", keywords="analytical hierarchy process", keywords="diabetes management", keywords="diabetes recognition", keywords="glucose management", keywords="multi-criteria decision making", keywords="technique for order of preference by similarity to ideal solution", keywords="decision support", keywords="diabetes", keywords="diabetic", keywords="glucose", keywords="blood sugar", keywords="review methodology", keywords="systematic review", keywords="decision making", keywords="self-management", keywords="digital health tool", abstract="Background: Diabetes mellitus prevalence is increasing among adults and children around the world. Diabetes care is complex; examining the diet, type of medication, diabetes recognition, and willingness to use self-management tools are just a few of the challenges faced by diabetes clinicians who should make decisions about them. Making the appropriate decisions will reduce the cost of treatment, decrease the mortality rate of diabetes, and improve the life quality of patients with diabetes. Effective decision-making is within the realm of multicriteria decision-making (MCDM) techniques. Objective: The central objective of this study is to evaluate the effectiveness and applicability of MCDM methods and then introduce a novel categorization framework for their use in this field. Methods: The literature search was focused on publications from 2003 to 2023. Finally, by applying the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) method, 63 articles were selected and examined. Results: The findings reveal that the use of MCDM methods in diabetes research can be categorized into 6 distinct groups: the selection of diabetes medications (19 publications), diabetes diagnosis (12 publications), meal recommendations (8 publications), diabetes management (14 publications), diabetes complication (7 publications), and estimation of diabetes prevalence (3 publications). Conclusions: Our review showed a significant portion of the MCDM literature on diabetes. The research highlights the benefits of using MCDM techniques, which are practical and effective for a variety of diabetes challenges. ", doi="10.2196/47701", url="https://medinform.jmir.org/2024/1/e47701", url="http://www.ncbi.nlm.nih.gov/pubmed/38300703" } @Article{info:doi/10.2196/45659, author="Humiston, Tori and Cummings, Caroline and Suss, Stephen and Cohen, B. Laura and Hazlett-Stevens, Holly and Hughes Lansing, Amy", title="Acceptability of a Self-Led Mindfulness-Based Intervention for Teens with Type 1 Diabetes: Pilot Randomized Controlled Trial", journal="JMIR Form Res", year="2024", month="Jan", day="30", volume="8", pages="e45659", keywords="adolescents", keywords="diabetes distress", keywords="diabetes", keywords="health group intervention", keywords="intervention", keywords="mindfulness", keywords="psychosocial intervention", keywords="self-led mindfulness", keywords="type 1 diabetes", abstract="Background: Diabetes distress among adolescents with type 1 diabetes has been associated with suboptimal diabetes outcomes, including lower quality of life, increased diabetes self-management challenges, and suboptimal glycemic outcomes. Objective: This study examined the feasibility and acceptability of a scalable self-led mindfulness-based intervention to reduce diabetes distress in adolescents with type 1 diabetes. Methods: Adolescents (N=25) aged between 14 and 18 years diagnosed with type 1 diabetes completed a baseline assessment. Participants were randomized to receive a 10-week self-guided mindfulness-based stress reduction workbook program (e-book or paper option) immediately (n=15) or after a 10-week wait (n=10). During the intervention period, participants completed weekly assignments and feedback surveys. At 10 weeks and 20 weeks, follow-up assessments were completed. Results: Findings indicated that participants did not find the original intervention feasible or acceptable. Adolescents reported barriers to completing the weekly material, such as that they forgot or that the material was not sufficiently related to their diabetes management. Adolescents also reported that a digital format rather than a workbook or e-book may be more acceptable. Results from weekly surveys provided the foundation for recommendations for future iterations of the mindfulness-based intervention for adolescents with type 1 diabetes. Conclusions: Participant feedback informed recommendations for self-led mindfulness programs for youth with type 1 diabetes. Adolescents indicated that a shorter, digital mindfulness-based intervention focused on diabetes-specific behaviors may be more helpful. Trial Registration: ClinicalTrials.gov NCT05115175; https://clinicaltrials.gov/study/NCT05115175 ", doi="10.2196/45659", url="https://formative.jmir.org/2024/1/e45659", url="http://www.ncbi.nlm.nih.gov/pubmed/38289663" } @Article{info:doi/10.2196/50732, author="Skaria, Geena and Reshmi, Bhageerathy and K M, Sabu and Shetty, Sahana and Lakshmi R, Vani", title="Development and Testing of an Electronic Diabetes Diary Integrated With a Hospital Information System for Individuals With Type 2 Diabetes Mellitus: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2024", month="Jan", day="23", volume="13", pages="e50732", keywords="self-management of blood glucose", keywords="SMBG", keywords="diabetes self-management", keywords="DSM", keywords="personal health records", keywords="electronic diabetes diary", keywords="glycemic control", keywords="patient adherence", keywords="digital health", abstract="Background: Type 2 diabetes mellitus (T2DM) is one of the leading noncommunicable diseases that require diabetes self-management (DSM) practices. This study proposes to develop a customized mobile health (mHealth) app integrated with a hospital information system (HIS) to enable real-time, two-way transfer of information between the patient and physician. The captured information in the electronic health record will facilitate physicians to have a chronological account of the patient's diabetes history and enable tweaking of the treatment. Objective: The objectives of the study are (1) to develop the HIS-integrated Electronic Diabetes Diary (EDDy) per the end-user expectations at a tertiary care hospital in a south Indian state with a high prevalence of T2DM and (2) to evaluate and test adherence to EDDy in the management of T2DM. Methods: The study will be carried out in 3 phases. Phase 1 involved in-depth interviews with primary end users to gather information regarding their expectations from the hospital-based EDDy. Phase 2 will use this information to develop a customized mHealth app using an iterative model of software development. Phase 3 will involve a pre- and posttest design; the developed app will be tested among consenting patients, where physicians will receive the patients' data through the HIS-integrated mHealth app. The pre- and posttest values will be analyzed for adherence leading to improvement in patients' self-management of blood glucose, user experience, glycemic control, and clinical utility. Results: Phase 1 was completed on November 28, 2023. Phase 2 commenced in December 2023 and will end in May 2025. Phase 3 will follow afterward. Conclusions: The proposed app will include a convenient and simple alert system that enables the patient to test glucose values at self-selected intervals, provide grading options to enter diabetic-related complications, enhance patients' knowledge of tracking and managing the complications of diabetes, and help in maintaining the visual representation of glucose values and complications. The simplicity and usability of the modules are its novelty, which may motivate the patients to keep track of their glucose values and help them attain better health outcomes. Trial Registration: Clinical Trial Registry India CTRI/2023/03/051077; http://tinyurl.com/4tau4ndb International Registered Report Identifier (IRRID): PRR1-10.2196/50732 ", doi="10.2196/50732", url="https://www.researchprotocols.org/2024/1/e50732", url="http://www.ncbi.nlm.nih.gov/pubmed/38261369" } @Article{info:doi/10.2196/46450, author="Yoo, Eun Jung and Jeong, Su-Min and Lee, Na Kyu and Lee, Heesun and Yoon, Won Ji and Han, Kyungdo and Shin, Wook Dong", title="Smoking Behavior Change and the Risk of Heart Failure in Patients With Type 2 Diabetes: Nationwide Retrospective Cohort Study", journal="JMIR Public Health Surveill", year="2024", month="Jan", day="10", volume="10", pages="e46450", keywords="smoking", keywords="change in smoking behavior", keywords="cessation", keywords="heart failure", keywords="type 2 diabetes", keywords="diabetes", keywords="cardiovascular disease", keywords="smoking cessation", keywords="smoker", keywords="risk factor", abstract="Background: Heart failure (HF) is one of the most common initial manifestations of cardiovascular disease in patients with type 2 diabetes. Although smoking is an independent risk factor for HF, there is a lack of data for the incidence of HF according to changes in smoking behaviors in patients with type 2 diabetes. Objective: We aimed to examine the association between interval changes in smoking behavior and the risk of HF among patients with type 2 diabetes. Methods: We conducted a retrospective cohort study using the National Health Insurance Service database. We identified 365,352 current smokers with type 2 diabetes who had 2 consecutive health screenings (2009-2012) and followed them until December 31, 2018, for the incident HF. Based on smoking behavior changes between 2 consecutive health screenings, participants were categorized into quitter, reducer I (?50\% reduction) and II (<50\% reduction), sustainer (reference group), and increaser groups. Results: During a median follow-up of 5.1 (IQR 4.0-6.1) years, there were 13,879 HF cases (7.8 per 1000 person-years). Compared to sustainers, smoking cessation was associated with lower risks of HF (adjusted hazard ratio [aHR] 0.90, 95\% CI0.86-0.95), whereas increasers showed higher risks of HF than sustainers; heavy smokers who increased their level of smoking had a higher risk of HF (aHR 1.13, 95\% CI 1.04-1.24). In the case of reducers, the risk of HF was not reduced but rather increased slightly (reducer I: aHR 1.14, 95\% CI 1.08-1.21; reducer II: aHR 1.03, 95\% CI 0.98-1.09). Consistent results were noted for subgroup analyses including type 2 diabetes severity, age, and sex. Conclusions: Smoking cessation was associated with a lower risk of HF among patients with type 2 diabetes, while increasing smoking amount was associated with a higher risk for HF than in those sustaining their smoking amount. There was no benefit from reduction in smoking amount. ", doi="10.2196/46450", url="https://publichealth.jmir.org/2024/1/e46450", url="http://www.ncbi.nlm.nih.gov/pubmed/38198206" } @Article{info:doi/10.2196/42823, author="B{\'e}rub{\'e}, Caterina and Lehmann, Franziska Vera and Maritsch, Martin and Kraus, Mathias and Feuerriegel, Stefan and Wortmann, Felix and Z{\"u}ger, Thomas and Stettler, Christoph and Fleisch, Elgar and Kocaballi, Baki A. and Kowatsch, Tobias", title="Effectiveness and User Perception of an In-Vehicle Voice Warning for Hypoglycemia: Development and Feasibility Trial", journal="JMIR Hum Factors", year="2024", month="Jan", day="9", volume="11", pages="e42823", keywords="hypoglycemia", keywords="type-1 diabetes mellitus", keywords="in-vehicle voice assistant", keywords="voice interface", keywords="voice warning", keywords="digital health intervention", keywords="mobile phone", abstract="Background: Hypoglycemia is a frequent and acute complication in type 1 diabetes mellitus (T1DM) and is associated with a higher risk of car mishaps. Currently, hypoglycemia can be detected and signaled through flash glucose monitoring or continuous glucose monitoring devices, which require manual and visual interaction, thereby removing the focus of attention from the driving task. Hypoglycemia causes a decrease in attention, thereby challenging the safety of using such devices behind the wheel. Here, we present an investigation of a hands-free technology---a voice warning that can potentially be delivered via an in-vehicle voice assistant. Objective: This study aims to investigate the feasibility of an in-vehicle voice warning for hypoglycemia, evaluating both its effectiveness and user perception. Methods: We designed a voice warning and evaluated it in 3 studies. In all studies, participants received a voice warning while driving. Study 0 (n=10) assessed the feasibility of using a voice warning with healthy participants driving in a simulator. Study 1 (n=18) assessed the voice warning in participants with T1DM. Study 2 (n=20) assessed the voice warning in participants with T1DM undergoing hypoglycemia while driving in a real car. We measured participants' self-reported perception of the voice warning (with a user experience scale in study 0 and with acceptance, alliance, and trust scales in studies 1 and 2) and compliance behavior (whether they stopped the car and reaction time). In addition, we assessed technology affinity and collected the participants' verbal feedback. Results: Technology affinity was similar across studies and approximately 70\% of the maximal value. Perception measure of the voice warning was approximately 62\% to 78\% in the simulated driving and 34\% to 56\% in real-world driving. Perception correlated with technology affinity on specific constructs (eg, Affinity for Technology Interaction score and intention to use, optimism and performance expectancy, behavioral intention, Session Alliance Inventory score, innovativeness and hedonic motivation, and negative correlations between discomfort and behavioral intention and discomfort and competence trust; all P<.05). Compliance was 100\% in all studies, whereas reaction time was higher in study 1 (mean 23, SD 5.2 seconds) than in study 0 (mean 12.6, SD 5.7 seconds) and study 2 (mean 14.6, SD 4.3 seconds). Finally, verbal feedback showed that the participants preferred the voice warning to be less verbose and interactive. Conclusions: This is the first study to investigate the feasibility of an in-vehicle voice warning for hypoglycemia. Drivers find such an implementation useful and effective in a simulated environment, but improvements are needed in the real-world driving context. This study is a kickoff for the use of in-vehicle voice assistants for digital health interventions. ", doi="10.2196/42823", url="https://humanfactors.jmir.org/2024/1/e42823", url="http://www.ncbi.nlm.nih.gov/pubmed/38194257" } @Article{info:doi/10.2196/43583, author="Bazzano, N. Alessandra and Patel, Tejal and Nauman, Elizabeth and Cernigliaro, Dana and Shi, Lizheng", title="Optimizing Telehealth for Diabetes Management in the Deep South of the United States: Qualitative Study of Barriers and Facilitators on the Patient and Clinician Journey", journal="J Med Internet Res", year="2024", month="Jan", day="1", volume="26", pages="e43583", keywords="telemedicine", keywords="diabetes mellitus", keywords="chronic disease", keywords="patient participation", keywords="delivery of health care", keywords="COVID-19", keywords="mobile phone", abstract="Background: The Deep South of the United States, and Louisiana in particular, bears a greater burden of obesity, diabetes, and heart disease compared with other regions in the United States. Throughout the COVID-19 pandemic, there has been a substantial increase in telehealth visits for diabetes management to protect the safety of patients. Although there have been significant advancements in telehealth and chronic disease management, little is known about patient and provider perspectives on the challenges and benefits of telehealth visits among people living with diabetes and providers who care for patients with diabetes in Louisiana. Objective: This study aimed to explore barriers, facilitators, challenges, and benefits to telehealth for patients with diabetes and health care providers as they transitioned from in-person to remote care during the early COVID-19 pandemic to understand potential optimization. Methods: A total of 24 semistructured qualitative interviews were conducted with 18 patients living with diabetes and 6 clinicians who served patients with diabetes to explore their experiences and perceptions of telehealth services for diabetes care. Approximately half of the participants identified as Black or African American, half as White, and 75\% as female. Interviews were recorded, transcribed, and coded by experienced qualitative researchers using inductive and deductive techniques. A narrative, descriptive approach to the patient and clinician journey framed the study, including the development of internal journey maps, and reflexive thematic analysis was applied to the transcripts, with special attention to barriers and facilitators. Results: In total, 5 themes illustrated barriers and facilitators for participants: convenience, safety, and comfort are the benefits of telehealth for patients and clinicians; yet telehealth and in-person visits are valued differently; the convenience of telehealth may have a downside; technology acts as a double-edged sword; and managing expectations and efficiency of the visit experience was an important factor. Individual experiences varied in relation to several factors, including comfort level and access to technology, health system protocols for providing telemedicine, and level of diabetes control among patients. Conclusions: Recommendations for optimization include providing support to help guide and inform patients about what to expect and how to prepare for telehealth visits as well as allowing clinicians to schedule telehealth and in-person visits during discrete blocks of time to improve efficiency. Further research should address how hybrid models of telehealth and in-person care may differentially impact health outcomes for patients with diabetes, particularly for people with multiple chronic conditions in settings where access to technology and connectivity is not optimal. ", doi="10.2196/43583", url="https://www.jmir.org/2024/1/e43583", url="http://www.ncbi.nlm.nih.gov/pubmed/37976468" } @Article{info:doi/10.2196/48267, author="Wu, Nancy and Wang, Joanne Susan and Brazeau, Anne-Sophie and Chan, Deborah and Mussa, Joseph and Nakhla, Meranda and Elkeraby, Mariam and Ell, Maryna and Prevost, Melinda and Lepine, Laurie and Panagiotopoulos, Constadina and Mukerji, Geetha and Butalia, Sonia and Henderson, M{\'e}lanie and Da Costa, Deborah and Rahme, Elham and Dasgupta, Kaberi", title="Supporting and Incentivizing Peer Leaders for an Internet-Based Private Peer Community for Youths With Type 1 Diabetes: Social Network and Directed Content Analysis", journal="J Med Internet Res", year="2023", month="Dec", day="12", volume="25", pages="e48267", keywords="Facebook", keywords="chronic disease communities", keywords="internet-based communities", keywords="type 1 diabetes", keywords="adolescents", keywords="young adults", keywords="peer support", abstract="Background: Youths with type 1 diabetes (T1D) frequently experience stigma. Internet-based peer communities can mitigate this through social support but require leaders to catalyze exchange. Whether nurturing potential leaders translates into a central role has not been well studied. Another issue understudied in such communities is lurking, the viewing of exchanges without commenting or posting. Objective: We aimed to assess the centrality of the peer leaders we selected, trained, and incentivized within the Canadian Virtual Peer Network (VPN)-T1D. This is a private Facebook (Meta Platforms, Inc) group that we created for persons aged 14 to 24 years with T1D. We specifically sought to (1) compare a quantitative estimate of network centrality between peer leaders and regular members, (2) assess the proportions of network exchanges that were social support oriented, and (3) assess proportions of high engagement (posts, comments, reactions, and votes) and low engagement (lurking) exchanges. Methods: We recruited peer leaders and members with T1D from prior study cohorts and clinics. We trained 10 leaders, provided them with a monthly stipend, and encouraged them to post on the private Facebook group we launched on June 21, 2017. We extracted all communications (posts, messages, reactions, polls, votes, and views) that occurred until March 20, 2020. We calculated each member's centrality (80\% of higher engagement communications comprising posts, comments, and reactions plus 20\% of members with whom they connected). We divided each member's centrality by the highest centrality to compute the relative centrality, and compared the mean values between leaders and members (linear regression). We calculated the proportions of communications that were posts, comments, reactions, and views without reaction. We performed content analysis with a social support framework (informational, emotional, esteem-related, network, and tangible support), applying a maximum of 3 codes per communication. Results: VPN-T1D gained 212 regular members and 10 peer leaders over 33 months; of these 222 members, 26 (11.7\%) exited. Peer leaders had 10-fold higher relative centrality than regular members (mean 0.53, SD 0.26 vs mean 0.04, SD 0.05; 0.49 difference; 95\% CI 0.44-0.53). Overall, 91.4\% (203/222) of the members connected at least once through posts, comments, or reactions. Among the 75,051 communications, there were 5109 (6.81\%) posts, comments, and polls, 6233 (8.31\%) reactions, and 63,709 (84.9\%) views (lurking). Moreover, 54.9\% (3430/6253) of codes applied were social support related, 66.4\% (2277/3430) of which were informational (eg, insurance and travel preparation), and 20.4\% (699/3430) of which were esteem related (eg, relieving blame). Conclusions: Designating, training, and incentivizing peer leaders may stimulate content exchange and creation. Social support was a key VPN-T1D deliverable. Although lurking accounted for a high proportion of the overall activity, even those demonstrating this type of passive participation likely derived benefits, given that the network exit rate was low. International Registered Report Identifier (IRRID): RR2-10.2196/18714 ", doi="10.2196/48267", url="https://www.jmir.org/2023/1/e48267", url="http://www.ncbi.nlm.nih.gov/pubmed/38085568" } @Article{info:doi/10.2196/51024, author="Huang, Shan and Liang, Yuzhen and Li, Jiarui and Li, Xuejun", title="Applications of Clinical Decision Support Systems in Diabetes Care: Scoping Review", journal="J Med Internet Res", year="2023", month="Dec", day="8", volume="25", pages="e51024", keywords="scoping review", keywords="clinical decision support system", keywords="CDSS", keywords="diabetes care", keywords="health information technology", keywords="clinical decision support", keywords="decision", keywords="decision support", keywords="diabetes", keywords="clinical application", keywords="decision-making", keywords="medical resources", abstract="Background: Providing comprehensive and individualized diabetes care remains a significant challenge in the face of the increasing complexity of diabetes management and a lack of specialized endocrinologists to support diabetes care. Clinical decision support systems (CDSSs) are progressively being used to improve diabetes care, while many health care providers lack awareness and knowledge about CDSSs in diabetes care. A comprehensive analysis of the applications of CDSSs in diabetes care is still lacking. Objective: This review aimed to summarize the research landscape, clinical applications, and impact on both patients and physicians of CDSSs in diabetes care. Methods: We conducted a scoping review following the Arksey and O'Malley framework. A search was conducted in 7 electronic databases to identify the clinical applications of CDSSs in diabetes care up to June 30, 2022. Additional searches were conducted for conference abstracts from the period of 2021-2022. Two researchers independently performed the screening and data charting processes. Results: Of 11,569 retrieved studies, 85 (0.7\%) were included for analysis. Research interest is growing in this field, with 45 (53\%) of the 85 studies published in the past 5 years. Among the 58 (68\%) out of 85 studies disclosing the underlying decision-making mechanism, most CDSSs (44/58, 76\%) were knowledge based, while the number of non-knowledge-based systems has been increasing in recent years. Among the 81 (95\%) out of 85 studies disclosing application scenarios, the majority of CDSSs were used for treatment recommendation (63/81, 78\%). Among the 39 (46\%) out of 85 studies disclosing physician user types, primary care physicians (20/39, 51\%) were the most common, followed by endocrinologists (15/39, 39\%) and nonendocrinology specialists (8/39, 21\%). CDSSs significantly improved patients' blood glucose, blood pressure, and lipid profiles in 71\% (45/63), 67\% (12/18), and 38\% (8/21) of the studies, respectively, with no increase in the risk of hypoglycemia. Conclusions: CDSSs are both effective and safe in improving diabetes care, implying that they could be a potentially reliable assistant in diabetes care, especially for physicians with limited experience and patients with limited access to medical resources. International Registered Report Identifier (IRRID): RR2-10.37766/inplasy2022.9.0061 ", doi="10.2196/51024", url="https://www.jmir.org/2023/1/e51024", url="http://www.ncbi.nlm.nih.gov/pubmed/38064249" } @Article{info:doi/10.2196/42497, author="Guo, Huey-Ming Sophie and Lin, Jiun-Lu and Hsing, Hung-Chun and Lee, Chun-Chuan and Chuang, Shih-Ming", title="The Effect of Mobile eHealth Education to Improve Knowledge, Skills, Self-Care, and Mobile eHealth Literacies Among Patients With Diabetes: Development and Evaluation Study", journal="J Med Internet Res", year="2023", month="Dec", day="6", volume="25", pages="e42497", keywords="mobile eHealth technology", keywords="mHealth literacy", keywords="eHealth literacy", keywords="diabetes", keywords="HbA1c", keywords="self-care behavior", abstract="Background: The promotion of mobile health (mHealth) and eHealth technologies as tools for managing chronic diseases, particularly diabetes mellitus, is on the rise. Nevertheless, individuals with diabetes frequently face a literacy gap that hinders their ability to fully leverage the benefits offered by these resources. Enhancing technology literacy to facilitate the adoption of mobile eHealth services poses a significant challenge in numerous countries. Objective: This study aims to develop an educational mobile eHealth literacy (eHL) program for patients with diabetes and to evaluate its effect on patients' outcomes. Methods: This study designed a mobile eHL education program comprising 2 modules specifically tailored for individuals with type 2 diabetes (T2D). These modules focused on guiding participants through the process of effectively navigating reliable health websites and utilizing diabetes-related apps. Using a pre- and posttest experimental design, the study featured an intervention group and a control group. Participants were recruited from 3 outpatient departments in hospitals, and assessments were conducted both before and after the intervention, along with a follow-up measure at the 3-month mark. The evaluation encompassed sociodemographic characteristics, computer and internet proficiency, mobile app usage, mobile eHL, and patient outcomes such as self-care behaviors and glycated hemoglobin (HbA1c) levels. Results: The analysis included a total of 132 eligible participants. Significant differences were observed in the mean scores of knowledge (P<.001) and skills (P<.001) related to computers, the web, and mobile devices at the initiation of the study and after the intervention. During the 3-month follow-up, the findings indicated a significant improvement in mobile eHL (t114=3.391, P=.001) and mHealth literacy (mHL, a subconcept of mobile eHL; t114=3.801, P<.001) within the intervention group, whereas no such improvement was observed in the control group. The chi-square values from the McNemar test underscored that individuals with uncontrolled diabetes (HbA1c?7\%) in the intervention group exhibited more improvement compared with the control group. The generalized estimating equations model unveiled a significant difference in the change of general mHL in the intervention group ($\beta$=1.91, P=.047) and self-care behavior in the control group from T0 to T2 ($\beta$=--8.21, P=.015). Despite being small, the effect sizes for mobile eHL (d=0.49) and HbA1c (d=0.33) in the intervention group were greater than those in the control group (d=0.14 and d=0.16, respectively). Conclusions: The implementation of a mobile eHL education intervention demonstrates a positive influence on the familiarity of patients with T2D regarding health technology, leading to favorable glycemic outcomes. While additional studies are warranted for a more comprehensive understanding, this program emerges as a promising solution for enhancing patients' uptake of digital health technology. ", doi="10.2196/42497", url="https://www.jmir.org/2023/1/e42497", url="http://www.ncbi.nlm.nih.gov/pubmed/38055321" } @Article{info:doi/10.2196/48746, author="Li, Wen-Wen and Tong, Jacqueline", title="Family-Based, Culturally Responsive Intervention for Chinese Americans With Diabetes: Lessons Learned From a Literature Review to Inform Study Design and Implementation", journal="Asian Pac Isl Nurs J", year="2023", month="Nov", day="20", volume="7", pages="e48746", keywords="family-based intervention", keywords="diabetes", keywords="HbA1c", keywords="Chinese", keywords="implementation", keywords="prevalence", keywords="systematic review", keywords="patient", keywords="intervention", keywords="diabetes care", keywords="effectiveness", keywords="diabetes management", keywords="cultural intervention", keywords="patient education", keywords="Chinese Americans", abstract="Background: The prevalence of diabetes in the United States is very high, and Chinese peoples with diabetes are estimated to comprise 50\% of the total cases. Rates of diabetes continue to rise among Chinese and Chinese American people; however, research regarding effective diabetes interventions for this minority group is sparse. Objective: A literature review was conducted to determine a study design and interventions for future studies investigating the efficacy of a family-based intervention to improve diabetes care for Chinese Americans. Methods: The review was conducted from January 2023 to April 2023. The PubMed, CINAHL, ScienceDirect, ProQuest, Google Scholar, Scopus, and Cochrane Central Register of Controlled Trials databases were searched. The key search terms were ``diabetes type 2,'' ``Chinese patients,'' ``minority patients,'' ``interventions for diabetes,'' ``diabetes and family,'' ``culturally responsive interventions for diabetic patients,'' ``family education for diabetes,'' and ``diabetes in China.'' Results: The initial search retrieved 2335 articles, and 10 articles met the selection criteria to examine the efficacy of family-based interventions for Chinese American people. The review showed that providing multiple sessions of education and counseling for both patients and family members is promising for improving diabetes care. Recruitment of 20 to 60 dyads consisting of a patient and a family member can help assess family dynamics in the process of diabetes care, such as food shopping and preparation, and of diabetes management to further evaluate the efficacy of an intervention. Glycated hemoglobin (HbA1c) was the most often used primary outcome. Other secondary outcomes included knowledge and efficacy in diabetes management and self-care activities related to diabetes care. Conclusions: A family-based intervention is essential for optimizing diabetes care for Chinese Americans. Thus, recruitment of a dyad consisting of a patient and a family member is important to investigate the efficacy of a family-based intervention for improving diabetes care in this population. Strategies for improving recruitment and retention of dyads were identified. In addition, technology can be used to promote the delivery of interventions to patients, which in turn increases efficacy. This review can help researchers investigate the efficacy of family-based interventions for promoting diabetes management by designing culturally appropriate study protocols and interventions. ", doi="10.2196/48746", url="https://apinj.jmir.org/2023/1/e48746/" } @Article{info:doi/10.2196/49817, author="Sousa, Fabianne and de Araujo, Nascimento Lucianne and de Oliveira, Onuma Tain{\'a} Sayuri and Gomes, Cunha Mateus and Ferreira, Glenda and Aben-Athar, Cintia and da Silva, Dias Silvio Eder and Cruz Ramos, MP Aline and Rodrigues, Pereira Diego", title="Demographic, Clinical, and Quality of Life Profiles of Older People With Diabetes During the COVID-19 Pandemic: Cross-Sectional Study", journal="JMIR Form Res", year="2023", month="Nov", day="16", volume="7", pages="e49817", keywords="aged", keywords="diabetes mellitus", keywords="COVID-19", keywords="cross-sectional study", keywords="quality of life", keywords="long COVID-19", keywords="diabetic", keywords="older people", abstract="Background: Diabetes mellitus, one of the main diseases that affects the Brazilian population older than 60 years, is defined as a divergent group of metabolic disorders that present a high level of glycemia (hyperglycemia), causing damage to various organs and systems of the body, including the heart, kidneys, eyes, and nervous system. It is believed that in 2025, in Brazil alone, there will be more than 18.5 million individuals diagnosed with diabetes mellitus. Therefore, it is important to know the individuals' quality of life in the context of life and culture. Objective: This study aimed to assess the demographic, clinical, and quality of life profiles of older adults with diabetes during the COVID-19 pandemic in a university hospital complex in the northern Amazon region. Methods: We conducted a cross-sectional, exploratory, noninterventional, descriptive, and analytical study using a nonrandom sample of 54 older people diagnosed with diabetes mellitus at the geriatrics outpatient clinic of the medium and high complexity university hospital in the western Brazilian Amazon between 2020 and 2022. We used 3 instruments, namely, a sociodemographic questionnaire, a clinical conditions questionnaire, and Diabetes-39. Qualitative data were described using absolute and relative frequencies. The Kolmogorov-Smirnov normality test was applied, and the z test was used for inferential analysis. SPSS software (version 27) was used for data analysis, and the significance level was 5\%. Results: Of the 54 interviewees, the majority were women, married, retired, and had a good quality of life. Of these, 48.1\% (n=26) were infected by COVID-19, 61.5\% (n=16) of whom progressed to long COVID, presenting with fatigue or muscle weakness. As for the quality of life, the ``social overload'' (P<.001) and ``sexual functioning'' (P<.001) dimensions had with low scores compared to the ``energy and mobility'' (P=.005), ``diabetes control'' (P<.001), and ``anxiety and worry'' (P<.001) dimensions. Quality of life was negatively impacted in the ``anxiety and worry'' dimension. Among those affected by COVID-19, most progressed to long COVID; however, there was a lack of data on this theme in the population of older people with diabetes. Conclusions: The majority of interviewees progressed to long COVID, with their quality of life negatively impacted in the ``anxiety and worry'' dimension, reflecting that health actions prioritizing mental health should be implemented by health professionals. ", doi="10.2196/49817", url="https://formative.jmir.org/2023/1/e49817", url="http://www.ncbi.nlm.nih.gov/pubmed/37971795" } @Article{info:doi/10.2196/46381, author="Kalmus, Olivier and Smits, Kirsten and Seitz, Max and Haux, Christian and Robra, Bernt-Peter and Listl, Stefan", title="Evaluation of a Digital Decision Support System to Integrate Type 2 Diabetes Mellitus and Periodontitis Care: Case-Vignette Study in Simulated Environments", journal="J Med Internet Res", year="2023", month="Oct", day="2", volume="25", pages="e46381", keywords="digital health", keywords="integrated care", keywords="decision support", keywords="oral health", keywords="diabetes", keywords="periodontitis", keywords="oral care", keywords="type 2 diabetes", keywords="evaluation", keywords="survey", keywords="hemoglobin", keywords="diagnostic device", keywords="telemedicine", abstract="Background: As highlighted by the recent World Health Organization Oral Health Resolution, there is an urgent need to better integrate primary and oral health care. Despite evidence and guidelines substantiating the relevance of integrating type 2 diabetes mellitus (T2DM) and periodontitis care, the fragmentation of primary and oral health care persists. Objective: This paper reports on the evaluation of a prototype digital decision support system (DSS) that was developed to enhance the integration of T2DM and periodontitis care. Methods: The effects of the prototype DSS were assessed in web-based simulated environments, using 2 different sets of case vignettes in combination with evaluation surveys among 202 general dental practitioners (GDPs) and 206 general practitioners (GPs). Each participant evaluated 3 vignettes, one of which, chosen at random, was assisted by the DSS. Logistic regression analyses were conducted at the participant and case levels. Results: Under DSS assistance, GPs had 8.3 (95\% CI 4.32-16.03) times higher odds of recommending a GDP visit. There was no significant impact of DSS assistance on GP advice about common risk factors for T2DM and periodontal disease. GDPs had 4.3 (95\% CI 2.08-9.04) times higher odds of recommending a GP visit, 1.6 (95\% CI 1.03-2.33) times higher odds of giving advice on disease correlations, and 3.2 (95\% CI 1.63-6.35) times higher odds of asking patients about their glycated hemoglobin value. Conclusions: The findings of this study provide a proof of concept for a digital DSS to integrate T2DM and periodontal care. Future updating and testing is warranted to continuously enhance the functionalities of the DSS in terms of interoperability with various types of data sources and diagnostic devices; incorporation of other (oral) health dimensions; application in various settings, including via telemedicine; and further customization of end-user interfaces. ", doi="10.2196/46381", url="https://www.jmir.org/2023/1/e46381", url="http://www.ncbi.nlm.nih.gov/pubmed/37782539" } @Article{info:doi/10.2196/46988, author="Seng, Benjamin Jun Jie and Gwee, Ryan Meng Ferng and Yong, Amanda Mei Hui and Kwan, Heng Yu and Thumboo, Julian and Low, Leng Lian", title="Role of Caregivers in Remote Management of Patients With Type 2 Diabetes Mellitus: Systematic Review of Literature", journal="J Med Internet Res", year="2023", month="Sep", day="11", volume="25", pages="e46988", keywords="care", keywords="caregiver", keywords="diabetes", keywords="glucose monitoring", keywords="glucose", keywords="medication", keywords="mHealth", keywords="monitoring", keywords="patient care", keywords="quality of life", keywords="remote management", keywords="remote monitoring", keywords="systematic review", keywords="telehealth", keywords="telemedicine", keywords="type 2 diabetes mellitus", keywords="utilization", abstract="Background: With the growing use of remote monitoring technologies in the management of patients with type 2 diabetes mellitus (T2DM), caregivers are becoming important resources that can be tapped into to improve patient care. Objective: This review aims to summarize the role of caregivers in the remote monitoring of patients with T2DM. Methods: We performed a systematic review in MEDLINE, Embase, Scopus, PsycINFO, and Web of Science up to 2022. Studies that evaluated the role of caregivers in remote management of adult patients with T2DM were included. Outcomes such as diabetes control, adherence to medication, quality of life, frequency of home glucose monitoring, and health care use were evaluated. Results: Of the 1198 identified citations, 11 articles were included. The majority of studies were conducted in North America (7/11, 64\%) and South America (2/11, 18\%). The main types of caregivers studied were family or friends (10/11, 91\%), while the most common remote monitoring modalities evaluated were interactive voice response (5/11, 45\%) and phone consultations (4/11, 36\%). With regard to diabetes control, 3 of 6 studies showed improvement in diabetes-related laboratory parameters. A total of 2 studies showed improvements in patients' medication adherence rates and frequency of home glucose monitoring. Studies that evaluated patients' quality of life showed mixed evidence. In 1 study, increased hospitalization rates were noted in the intervention group. Conclusions: Caregivers may play a role in improving clinical outcomes among patients with T2DM under remote monitoring. Studies on mobile health technologies are lacking to understand their impact on Asian populations and long-term patient outcomes. ", doi="10.2196/46988", url="https://www.jmir.org/2023/1/e46988", url="http://www.ncbi.nlm.nih.gov/pubmed/37695663" } @Article{info:doi/10.2196/40560, author="Riihimies, Riikka and Kosunen, Elise and Koskela, H. Tuomas", title="Segmenting Patients With Diabetes With the Navigator Service in Primary Care and a Description of the Self-Acting Patient Group: Cross-Sectional Study", journal="J Med Internet Res", year="2023", month="Sep", day="8", volume="25", pages="e40560", keywords="patient segmentation", keywords="Navigator", keywords="self-acting patient", keywords="diabetes", keywords="primary care", keywords="self-management", keywords="skills", keywords="care", keywords="nurse", keywords="medication", keywords="quality of life", keywords="well-being", keywords="digital", keywords="patient", abstract="Background: The aim of patient segmentation is to recognize patients with similar health care needs. The Finnish patient segmentation service Navigator segregates patients into 4 groups, including a self-acting group, who presumably manages their everyday life and coordinates their health care. Digital services could support their self-care. Knowledge on self-acting patients' characteristics is lacking. Objective: The study aims are to describe how Navigator assigns patients with diabetes to the 4 groups at nurses' appointments at a health center, the self-acting patient group's characteristics compared with other patient groups, and the concordance between the nurse's evaluation of the patient's group and the actual group assigned by Navigator (criterion validity). Methods: Patients with diabetes ?18 years old visiting primary care were invited to participate in this cross-sectional study. Patients with disability preventing informed consent for participation were excluded. Nurses estimated the patients' upcoming group results before the appointment. We describe the concordance (\%) between the evaluation and actual groups. Nurses used Navigator patients with diabetes (n=304) at their annual follow-up visits. The self-acting patients' diabetes care values (glycated hemoglobin [HbA1c], urine albumin to creatinine ratio, low-density lipoprotein cholesterol, blood pressure, BMI), chronic conditions, medication, smoking status, self-rated health, disability (World Health Organization Disability Assessment Schedule [WHODAS] 2.0), health-related quality of life (EQ-5D-5L), and well-being (Well-being Questionnaire [WBQ-12]) and the patients' responses to Navigator's question concerning their digital skills as outcome variables were compared with those of the other patients. We used descriptive statistics for the patients' distribution into the 4 groups and demographic data. We used the Mann-Whitney U test with nonnormally distributed variables, independent samples t test with normally distributed variables, and Pearson chi-square tests with categorized variables to compare the groups. Results: Most patients (259/304, 85.2\%) were in the self-acting group. Hypertension, hyperlipidemia, and joint ailments were the most prevalent comorbidities among all patients. Self-acting patients had less ischemic cardiac disease (P=.001), depression or anxiety (P=.03), asthma or chronic obstructive pulmonary disease (P<.001), long-term pain (P<.001), and related medication. Self-acting patients had better self-rated health (P<.001), functional ability (P<.001), health-related quality of life (P<.001), and general well-being (P<.001). All patients considered their skills at using electronic services to be good. Conclusions: The patients in the self-acting group had several comorbidities. However, their functional ability was not yet diminished compared with patients in the other groups. Therefore, to prevent diabetic complications and disabilities, support for patients' self-management should be emphasized in their integrated care services. Digital services could be involved in the care of patients willing to use them. The study was performed in 1 health center, the participants were volunteers, and most patients were assigned to self-acting patient group. These facts limit the generalizability of our results. International Registered Report Identifier (IRRID): RR2-10.2196/20570 ", doi="10.2196/40560", url="https://www.jmir.org/2023/1/e40560", url="http://www.ncbi.nlm.nih.gov/pubmed/37682585" } @Article{info:doi/10.2196/43687, author="Li, Xiaopan and Liu, Ru and Chen, Yichen and Han, Yan and Wang, Qizhe and Xu, Yaxin and Zhou, Jing and Jiang, Sunfang", title="Patterns and Trends in Mortality Associated With and Due to Diabetes Mellitus in a Transitioning Region With 3.17 Million People: Observational Study", journal="JMIR Public Health Surveill", year="2023", month="Sep", day="4", volume="9", pages="e43687", keywords="diabetes mellitus", keywords="mortality", keywords="years of life lost", keywords="multimorbidity", keywords="trend analysis", keywords="diabetes", keywords="disease", keywords="urbanization", keywords="aging", keywords="epidemiology", abstract="Background: Diabetes mellitus (DM) imposes a significant disease burden in economically transitioning regions. Most transitioning regions share similar experience in urbanization processes. Shanghai's Pudong district serves as a representative area of such regions. Objective: We aimed to assess the burden of and trends in DM mortality in Shanghai's Pudong district and analyze the impact of aging and multimorbidity. Methods: A longitudinal, population-based study was conducted to analyze DM mortality in Pudong from 2005 to 2020. We used joinpoint regression to analyze epidemiological features and long-term trends in crude mortality rate (CMR), age-standardized mortality rate worldwide (ASMRW), and years of life lost (YLL). Furthermore, the decomposition method was used to evaluate the contribution of demographic and nondemographic factors associated with mortality. Results: There were 49,414 deaths among individuals with DM, including 15,512 deaths due to DM. The CMR and ASMRW were 109.55/105 and 38.01/105 person-years, respectively. Among the mortality associated with and due to DM, the total annual ASMRW increased by 3.65\% (95\% CI 3.25\%-4.06\%) and 1.38\% (95\% CI 0.74\%-2.02\%), respectively. Additionally, the total annual YLL rate increased by 4.98\% (95\% CI 3.92\%-6.05\%) and 2.68\% (95\% CI 1.34\%-4.04\%). The rates of YLL increase in persons aged 30 to 44 years (3.98\%, 95\% CI 0.32\%-7.78\%) and 45 to 59 years (4.31\%, 95\% CI 2.95\%-5.69\%) were followed by the increase in persons aged 80 years and older (10.53\%, 95\% CI 9.45\%-11.62\%) for deaths associated with DM. The annual CMR attributable to demographic factors increased by 41.9\% (95\% CI 17.73\%-71.04\%) and 36.72\% (95\% CI 16.69\%-60.2\%) for deaths associated with and due to DM, respectively. Hypertension, cerebrovascular disease, and ischemic heart disease were the top 3 comorbidities. Conclusions: Aging and multimorbidity played essential roles in changing the burden of DM in an urbanizing and transitioning region. There is an increasing disease burden among young and middle-aged people, emphasizing the need for greater attention to these groups. Health management is an emerging method that holds important implications for alleviating the future burden of DM. ", doi="10.2196/43687", url="https://publichealth.jmir.org/2023/1/e43687", url="http://www.ncbi.nlm.nih.gov/pubmed/37665630" } @Article{info:doi/10.2196/47822, author="Zhong, Xuefeng and Li, Shaohua and Luo, Meng and Ma, Xinyu and Fisher, B. Edwin", title="Peer Support Self-Management Intervention for Individuals With Type 2 Diabetes in Rural Primary Care Settings: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2023", month="Sep", day="4", volume="12", pages="e47822", keywords="type 2 diabetes", keywords="peer support", keywords="self-management", keywords="rural primary care setting", keywords="mixed study", keywords="rural", keywords="primary care", keywords="diabetes", keywords="diabetic", abstract="Background: The increasing prevalence of diabetes is placing important demands on the Chinese health care system. Providing self-management programs to the fast-growing number of people with diabetes presents an urgent need in rural primary care settings in China. Peer support has demonstrated effectiveness in improving self-management for individuals with diabetes in urban communities in China. A priority then becomes developing and evaluating a peer support program in primary care settings in rural communities of China and determining whether it is feasible and acceptable. Objective: The aims of this study are (1) to evaluate the feasibility and acceptability of a peer support approach to type 2 diabetes self-management in rural primary care settings; (2) to identify enabler and facilitator factors likely to influence the peer support implementation; (3) to provide primary data and evidence for developing a version of the program suitable for a randomized controlled trial in rural primary care settings. Methods: Three townships will be sampled from 3 different counties of Anhui province as the study setting. Participants will be recruited based on these counties' local primary care health record system. The peer supporters will be recruited from among the participants. The peer support program will be led by peer supporters who have completed 12 hours of training. It will be guided by primary care providers. The program will include biweekly meetings over 3 months with varied peer support contacts between meetings to encourage the implementation of diabetes self-management. Mixed methods will be used for evaluation. Qualitative methods will be used to collect information from health care system professionals, individuals with diabetes, and peer supporters. Quantitative methods will be used to collect baseline data and data at the end of the 3-month intervention regarding psychosocial factors and self-management practices. Results: The results will include (1) quantitative baseline data that will characterize type 2 diabetes self-management practices of individuals with diabetes; (2) qualitative data that will identify enablers of and barriers to self-management practices for individuals with type 2 diabetes in rural communities; (3) both qualitative and quantitative evaluation data, after the 3-month intervention, to demonstrate the feasibility and acceptability of the peer support approach for individuals with type 2 diabetes. Conclusions: Our findings will inform the design of a tailored intervention program to improve self-management among individuals with type 2 diabetes in rural primary care settings. If we find that the peer support approach is feasible and acceptable, we will develop a larger randomized controlled trial to evaluate effectiveness in multiple rural settings in the province. International Registered Report Identifier (IRRID): PRR1-10.2196/47822 ", doi="10.2196/47822", url="https://www.researchprotocols.org/2023/1/e47822", url="http://www.ncbi.nlm.nih.gov/pubmed/37665619" } @Article{info:doi/10.2196/38447, author="Scheckel, Benjamin and Schmidt, Katharina and Stock, Stephanie and Reda{\`e}lli, Marcus", title="Patient Portals as Facilitators of Engagement in Patients With Diabetes and Chronic Heart Disease: Scoping Review of Usage and Usability", journal="J Med Internet Res", year="2023", month="Aug", day="25", volume="25", pages="e38447", keywords="patient portal", keywords="eHealth", keywords="online platform", keywords="usability", keywords="feasibility", keywords="diabetes", keywords="heart disease", abstract="Background: Patient portals have the potential to improve care for chronically ill patients by engaging them in their treatment. These platforms can work, for example, as a standalone self-management intervention or a tethered link to treatment providers in routine care. Many different types of portals are available for different patient groups, providing various features. Objective: This scoping review aims to summarize the current literature on patient portals for patients with diabetes mellitus and chronic heart disease regarding usage behavior and usability. Methods: We conducted this review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement for scoping reviews. We performed database searches using PubMed, PsycInfo, and CINAHL, as well as additional searches in reviews and reference lists. We restricted our search to 2010. Qualitative and quantitative studies, and studies using both approaches that analyzed usage behavior or usability of patient portals were eligible. We mapped portal features according to broad thematic categories and summarized the results of the included studies separately according to outcome and research design. Results: After screening, we finally included 85 studies. Most studies were about patients with diabetes, included patients younger than 65 years, and were conducted in the United States. Portal features were categorized into educational/general information, reminder, monitoring, interactivity, personal health information, electronic/personal health record, and communication. Portals mostly provided educational, monitoring, and communication-related features. Studies reported on usage behavior including associated variables, usability dimensions, and suggestions for improvement. Various ways of reporting usage frequency were identified. A noticeable decline in portal usage over time was reported frequently. Age was most frequently studied in association with portal use, followed by gender, education, and eHealth literacy. Younger age and higher education were often associated with higher portal use. In two-thirds of studies reporting on portal usability, the portals were rated as user friendly and comprehensible, although measurement and reporting were heterogeneous. Portals were considered helpful for self-management through positive influences on motivation, health awareness, and behavioral changes. Helpful features for self-management were educational/general information and monitoring. Barriers to portal use were general (eg, aspects of design or general usability), related to specific situations during portal use (eg, login procedure), or not portal specific (eg, user skills and preferences). Frequent themes were aspects of design, usability, and technology. Suggestions for improvement were mainly related to technical issues and need for support. Conclusions: The current state of research emphasizes the importance of involving patients in the development and evaluation of patient portals. The consideration of various research designs in a scoping review is helpful for a deeper understanding of usage behavior and usability. Future research should focus on the role of disease burden, and usage behavior and usability among older patients. ", doi="10.2196/38447", url="https://www.jmir.org/2023/1/e38447", url="http://www.ncbi.nlm.nih.gov/pubmed/37624629" } @Article{info:doi/10.2196/46880, author="O'Meara, Miguel and Mateus Acu{\~n}a, Camilo Juan and Uribe, Andrea", title="Long-Term Benefits of an Integrated Continuous Glucose Monitoring and Insulin Pump System for Emergency Admissions, Hospitalization, and Metabolic Control in a Cohort of People With Diabetes: Retrospective Cohort Study", journal="JMIR Diabetes", year="2023", month="Aug", day="23", volume="8", pages="e46880", keywords="automated insulin delivery", keywords="continuous glucose monitoring", keywords="CGM", keywords="glycemic control", keywords="hypoglycemia", keywords="sensor-augmented insulin pump", keywords="type 1 diabetes", abstract="Background: There is evidence in the literature that the use of sensor-augmented insulin pumps in patients with high-complexity diabetes improves metabolic control. However, there is no long-term information on clinical outcomes such as hospitalization or admission to the emergency room. This study describes outcomes for metabolic control, incidence of hospitalizations, and emergency room visits in a specific population using this technology. Objective: We aimed to assess long-term glycemic and clinical outcomes after the use of continuous subcutaneous insulin infusion and continuous glucose monitoring in people with diabetes. Methods: A retrospective cohort study was carried out in patients with diabetes previously treated with an intensive insulin regimen at a specialized diabetes treatment center who required a sensor-augmented insulin pump due to nonoptimal glycemic control. Glycated hemoglobin, severe hypoglycemic episodes, nonsevere hypoglycemic episodes, perception of hypoglycemia, and the incidence of emergency room visits and hospitalizations before and after treatment were evaluated. Results: Between January 2013 and August 2020, 74 patients with a median age of 36 (IQR 27-46) years were included in the study with a median 4 (IQR 2-7) years of follow-up. We found a statistically significant reduction in glycated hemoglobin (8.35\% vs 7\%; P<.001), nonsevere hypoglycemic episodes (71/74, 96\% vs 62/74, 84\%; P=.01), emergency room visits (42/73, 58\% vs 4/62, 6\%; P<.001), and hospitalizations (36/72, 50\% vs 10/72, 14\%; P<.001) after use of continuous subcutaneous insulin infusion. Conclusions: The use of a sensor-augmented insulin pump associated with a strict follow-up program for patients with high-complexity diabetes led to a significant and sustained reduction in glycated hemoglobin and hypoglycemic episodes, as well as in the rate of emergency room visits and hospitalizations. These results encourage the adoption of this technology in patients who do not achieve metabolic control with optimal management of diabetes. ", doi="10.2196/46880", url="https://diabetes.jmir.org/2023/1/e46880", url="http://www.ncbi.nlm.nih.gov/pubmed/37610810" } @Article{info:doi/10.2196/46415, author="Griggs, Stephanie and Ash, I. Garrett and Pignatiello, Grant and Papik, AnnMarie and Huynh, Johnathan and Leuchtag, Mary and Hickman Jr, L. Ronald", title="Internet-Based Recruitment and Retention of Young Adults With Type 1 Diabetes: Cross-Sectional Study", journal="JMIR Form Res", year="2023", month="Aug", day="22", volume="7", pages="e46415", keywords="type 1 diabetes", keywords="internet-based recruitment", keywords="young adult", keywords="diabetes", keywords="diabetic", keywords="type 1", keywords="recruit", keywords="research platform", keywords="T1D", keywords="social media", keywords="research subject", keywords="research participant", keywords="study participant", abstract="Background: Multiple research strategies are required to recruit and engage a representative cohort of young adults in diabetes research. In this report, we describe an approach for internet-based recruitment for a repeated-measures descriptive study. Objective: The objective of this cross-sectional study was to determine whether internet-based recruitment through multiple social media platforms, a clinical research platform, and cooperation with community partnerships---College Diabetes Network and Beyond Type 1---would serve as an effective way to recruit a representative sample of young adults aged 18-25 years with type 1 diabetes (T1D). Methods: We conducted a repeated-measures descriptive study. We captured enrollment rates and participant characteristics acquired from each social media platform through survey data and Facebook analytics. This study was advertised via paid postings across a combination of different social media platforms (eg, Facebook, Instagram, Twitter, and Reddit). We used quarterly application postings, quarterly newsletters, and participation in the ResearchMatch registry to identify potentially eligible participants from February 3, 2021, to June 6, 2022. Results: ResearchMatch proved to be the most cost-effective strategy overall, yielding the highest gender and racial diversity compared to other internet platforms (eg, Facebook, Instagram, Twitter, and Reddit), application postings (eg, Beyond Type 1), and newsletters (eg, College Diabetes Network and a local area college). However, we propose that the combination of these approaches yielded a larger, more diverse sample compared to any individual strategy. Our recruitment cost was US \$16.69 per eligible participant, with a 1.27\% conversion rate and a 30\% eligibility rate. Conclusions: Recruiting young adults with T1D across multiple internet-based platforms was an effective strategy to yield a moderately diverse sample. Leveraging various recruitment strategies is necessary to produce a representative sample of young adults with T1D. As the internet becomes a larger forum for study recruitment, participants from underrepresented backgrounds may continue engaging in research through advertisements on the internet and other internet-based recruitment platforms. ", doi="10.2196/46415", url="https://formative.jmir.org/2023/1/e46415", url="http://www.ncbi.nlm.nih.gov/pubmed/37606985" } @Article{info:doi/10.2196/43593, author="Lin, Kuei Yu and Newman, Sean and Piette, John", title="Response Consistency of Crowdsourced Web-Based Surveys on Type 1 Diabetes", journal="J Med Internet Res", year="2023", month="Aug", day="18", volume="25", pages="e43593", keywords="diabetes", keywords="Amazon Mechanical Turk", keywords="MTurk", keywords="crowdsourcing", keywords="survey", keywords="type 1 diabetes", keywords="T1D", keywords="cross-sectional survey", keywords="website", keywords="online platform", keywords="web-based platform", keywords="reliability", doi="10.2196/43593", url="https://www.jmir.org/2023/1/e43593", url="http://www.ncbi.nlm.nih.gov/pubmed/37594797" } @Article{info:doi/10.2196/47436, author="Ross, Jamie and Hawkes, E. Rhiannon and Miles, M. Lisa and Cotterill, Sarah and Bower, Peter and Murray, Elizabeth", title="Design and Early Use of the Nationally Implemented Healthier You National Health Service Digital Diabetes Prevention Programme: Mixed Methods Study", journal="J Med Internet Res", year="2023", month="Aug", day="17", volume="25", pages="e47436", keywords="digital health", keywords="engagement", keywords="diabetes prevention", keywords="mobile phone", abstract="Background: The Healthier You National Health Service Digital Diabetes Prevention Programme (NHS-digital-DPP) is a 9-month digital behavior change intervention delivered by 4 independent providers that is implemented nationally across England. No studies have explored the design features included by service providers of digital diabetes prevention programs to promote engagement, and little is known about how participants of nationally implemented digital diabetes prevention programs such as this one make use of them. Objective: This study aimed to understand engagement with the NHS-digital-DPP. The specific objectives were to describe how engagement with the NHS-digital-DPP is promoted via design features and strategies and describe participants' early engagement with the NHS-digital-DPP apps. Methods: Mixed methods were used. The qualitative study was a secondary analysis of documents detailing the NHS-digital-DPP intervention design and interviews with program developers (n=6). Data were deductively coded according to an established framework of engagement with digital health interventions. For the quantitative study, anonymous use data collected over 9 months for each provider representing participants' first 30 days of use of the apps were obtained for participants enrolled in the NHS-digital-DPP. Use data fields were categorized into 4 intervention features (Track, Learn, Coach Interactions, and Peer Support). The amount of engagement with the intervention features was calculated for the entire cohort, and the differences between providers were explored statistically. Results: Data were available for 12,857 participants who enrolled in the NHS-digital-DPP during the data collection phase. Overall, 94.37\% (12,133/12,857) of those enrolled engaged with the apps in the first 30 days. The median (IQR) number of days of use was 11 (2-25). Track features were engaged with the most (number of tracking events: median 46, IQR 3-22), and Peer Support features were the least engaged with, a median value of 0 (IQR 0-0). Differences in engagement with features were observed across providers. Qualitative findings offer explanations for the variations, including suggesting the importance of health coaches, reminders, and regular content updates to facilitate early engagement. Conclusions: Almost all participants in the NHS-digital-DPP started using the apps. Differences across providers identified by the mixed methods analysis provide the opportunity to identify features that are important for engagement with digital health interventions and could inform the design of other digital behavior change interventions. ", doi="10.2196/47436", url="https://www.jmir.org/2023/1/e47436", url="http://www.ncbi.nlm.nih.gov/pubmed/37590056" } @Article{info:doi/10.2196/47887, author="Martorina, Wagner and Tavares, Almir", title="Effects of Melatonin on Glycemic Variability in Type 2 Diabetes Mellitus: Protocol for a Crossover, Double-Blind, Placebo-Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Aug", day="16", volume="12", pages="e47887", keywords="type 2 diabetes mellitus", keywords="glycemic control", keywords="melatonin", keywords="randomized controlled trial", keywords="cross-over studies", keywords="T2DM", keywords="glucose", keywords="glycemic variability", keywords="circadian rhythm", abstract="Background: Glycemic variability is recognized as a significant factor contributing to the development of micro- and macrovascular complications in individuals with type 2 diabetes mellitus (T2DM). Numerous studies have shown that melatonin, a hormone involved in regulating various biological rhythms, including those related to glucose regulation, such as hunger, satiety, sleep, and circadian hormone secretion (ie, cortisol, growth hormone, catecholamines, and insulin), is deficient in individuals with T2DM. This raises an important question: Could melatonin replacement potentially reduce glycemic variability in these patients? This warrants investigation as a novel approach to improving glycemic control and reducing the risk of complications associated with T2DM. Objective: We aimed to investigate whether melatonin replacement in individuals with T2DM who supposedly have melatonin deficiency can positively impact the regulation of insulin secretion rhythms and improve insulin sensitivity, ultimately resulting in a reduction in glycemic variability. Methods: This study will use a crossover, randomized, double-blind, placebo-controlled trial design. Patients with T2DM in group 1 will receive 3 mg of melatonin at 9:00 PM in the first week, undergo a washout period in the second week, and receive a placebo in the third week (melatonin-washout-placebo). Group 2 will be randomized to receive a placebo-washout-melatonin sequence (3 mg). Capillary blood glucose levels will be measured at 6 different times before and after meals during the last 3 days of the first and third weeks. The study aims to compare the mean differences in blood glucose levels and the coefficient of glycemic variability in patients receiving melatonin and placebo during the first and third weeks. After analyzing the initial results, the number of needed patients will be recalculated. If the recalculated number is higher than 30, new participants will be recruited. Thirty patients with T2DM will be randomized into the 2 groups: melatonin-washout-placebo or placebo-washout-melatonin. Results: Participant recruitment took place between March 2023 to April 2023. In all, 30 participants were eligible and completed the study. We expect that patients will show different glycemic variability on the days they receive placebo or melatonin. Studies on melatonin and glycemic control have shown both positive and negative results. We hope that there will be a positive outcome regarding glycemic variability (ie, a reduction in glycemic variability), as melatonin has a well-described chronobiotic effect in the literature. Conclusions: This study aims to determine whether melatonin supplementation can effectively reduce glycemic variability in patients with T2DM. The crossover design is necessary due to the multiple variables involved in the circadian variations of glucose, including diet, physical activity, sleep parameters, and pharmacological treatments. The relatively low cost of melatonin and its potential role in reducing the severe complications associated with T2DM have motivated this research effort. Furthermore, the indiscriminate use of melatonin in current times makes conducting this study essential to evaluate the effect of this substance in patients with T2DM. Trial Registration: Brazilian Registry of Clinical Trials RBR-6wg54rb; https://ensaiosclinicos.gov.br/rg/RBR-6wg54rb International Registered Report Identifier (IRRID): DERR1-10.2196/47887 ", doi="10.2196/47887", url="https://www.researchprotocols.org/2023/1/e47887", url="http://www.ncbi.nlm.nih.gov/pubmed/37410852" } @Article{info:doi/10.2196/46050, author="Figg, Lauren and Addala, Ananta and Jain, Ishaan and Anez, Claudia and Midney, Paul and DeChirico, Corin and Symanski, Colleen and Fitzgerald, C. Brian and Colbert, Kristi and Raymer, Terry and Stockton-Joreteg, Candy and Murphy, Elizabeth and Collins, Leah and Bernstein, Cyd and Hechavarria, Melanie and Sheehan, P. Eleni and Bernier, Angelina and Westen, C. Sarah and Hood, K. Korey and Zaharieva, P. Dessi and Basina, Marina and Cuttriss, Nicolas and Filipp, L. Stephanie and Gurka, J. Matthew and Walker, F. Ashby and Maahs, M. David and Haller, J. Michael and Lal, A. Rayhan", title="The Promising Success of Project Extension for Community Healthcare Outcomes (ECHO) Diabetes: Case Series", journal="JMIR Diabetes", year="2023", month="Aug", day="3", volume="8", pages="e46050", keywords="type 1 diabetes", keywords="care delivery", keywords="primary care", keywords="community health care", abstract="Background: In the United States, there are over 37 million people with diabetes but only 8000 endocrinologists. Therefore, many people with diabetes receive care exclusively from primary care providers (PCPs). To democratize knowledge regarding insulin-requiring diabetes through tele-education, Stanford University and the University of Florida developed Project Extension for Community Healthcare Outcomes (ECHO) Diabetes. Objective: ECHO Diabetes uses a Hub and Spoke model connecting specialists (the ``Hub'') with PCPs (the ``Spokes''). One-hour, weekly sessions include Hub diabetes didactic presentations and Spoke deidentified case presentations. Lessons learned during these sessions target provider knowledge and confidence surrounding diabetes management and patient care. Methods: Spokes were asked to provide short descriptions of people with diabetes whose diabetes management improved directly or indirectly from their providers' participation or their involvement with a Diabetes Support Coach (DSC). We provide a case series to describe individuals and outcomes. Because this study was not a randomized controlled trial and was a prospective observation of patients with the intervention delivered to providers, the trial is not registered in a public trials registry. Results: A case series of 11 people with diabetes was compiled from 10 PCPs and 1 DSC from California and Florida between 2021 and 2022. The principal impact of ECHO Diabetes is the education amplified from PCPs and DSCs to people with diabetes. In all cases, people with diabetes reported increased engagement and improved diabetes management. Several cases reflected increased access to diabetes technology, improvement in glycemic outcomes, and positive trends in mental health measures. Conclusions: This case series elucidates the potential value of the ECHO Diabetes program to people with diabetes who receive their diabetes care from PCPs. Those matched with a DSC saw clinically significant improvements in hemoglobin A1c and mental health outcomes. ", doi="10.2196/46050", url="https://diabetes.jmir.org/2023/1/e46050", url="http://www.ncbi.nlm.nih.gov/pubmed/37535407" } @Article{info:doi/10.2196/44943, author="Barker, M. Mary and Chauhan, Radhika and Davies, J. Melanie and Brough, Christopher and Northern, Alison and Stribling, Bernie and Schreder, Sally and Khunti, Kamlesh and Hadjiconstantinou, Michelle", title="User Retention and Engagement in the Digital-Based Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (myDESMOND) Program: Descriptive Longitudinal Study", journal="JMIR Diabetes", year="2023", month="Jul", day="21", volume="8", pages="e44943", keywords="retention", keywords="engagement", keywords="digital self-management", keywords="type 2 diabetes", keywords="mobile phone", abstract="Background: Digital health interventions have the potential to improve the physical and psychosocial health of people living with type 2 diabetes. However, research investigating the long-term (?1 year) retention and engagement of users within these programs is limited. Objective: The aim of this study was to evaluate long-term user retention and engagement in the digital-based Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (myDESMOND) program, using real-world data. Methods: Anonymized data from all myDESMOND users who registered with the program on or before November 16, 2020, were included in the analyses. User retention was defined as the period between the day a user registered with the myDESMOND program and their last day of access. The primary engagement outcome was defined as the total number of log-ins to the program per user. The associations between retention, engagement, and sociodemographic factors (age, sex, and ethnicity) were tested using Cox regression models and Wilcoxon rank sum tests. Results: A total of 9522 myDESMOND users were included in this analysis. Of the 9522 users, 5360 (56.29\%) remained on the program for at least a month, whereas 1676 (17.6\%) remained on the program for at least 1 year. Retention was significantly higher among older users; the adjusted hazard ratio (representing the risk of users leaving the program within the first year) among users aged ?50 years, compared with those aged <50 years, was 0.79 (95\% CI 0.75-0.84; P<.001). The median number of myDESMOND log-ins per user was 8 (IQR 4-8); however, this was significantly lower among users aged <50 years (P<.001). Engagement metrics also differed according to sociodemographic characteristics; the estimated time spent per log-in was 5.35 (IQR 2.22-11.80) minutes among all users; however, this was significantly higher among female users (P<.001), users aged ?50 years (P<.001), and users of White ethnicity (P=.02). Conclusions: Although retention and engagement of users within myDESMOND were found to be high, these findings highlight the need for age- and culture-specific implementation strategies and content adaptations to improve retention and engagement among all users of self-management programs. ", doi="10.2196/44943", url="https://diabetes.jmir.org/2023/1/e44943", url="http://www.ncbi.nlm.nih.gov/pubmed/37477963" } @Article{info:doi/10.2196/46513, author="Cyranka, Katarzyna and Juza, Anna and Kwiendacz, Hanna and Nabrdalik, Katarzyna and Gumprecht, Janusz and Ma?ecki, Maciej and Klupa, Tomasz and Matejko, Bart?omiej", title="Evaluation of Psychological Resources of Young Adults With Type 1 Diabetes Mellitus During the Transition From Pediatric to Adult Diabetes Clinics: Multicenter Cross-sectional Study", journal="JMIR Form Res", year="2023", month="May", day="29", volume="7", pages="e46513", keywords="young adults", keywords="type 1 diabetes", keywords="transitioning care", keywords="psychological", keywords="diabetes", keywords="cross-sectional study", keywords="anxiety", keywords="socioeconomic", keywords="validation", keywords="anger", keywords="depression", keywords="outpatient", keywords="chronic disease", keywords="pediatric", keywords="adulthood", keywords="coping mechanism", abstract="Background: The transition period of patients with type 1 diabetes from pediatric to adult-oriented health care is associated with poorer glycemic control and less frequent clinic attendance. Fears and anxiety about the unknown, care approach differences in adult settings, and sadness about leaving the pediatric provider all contribute to a patient's reluctance to transition. Objective: This study aimed to evaluate the psychological parameters of young patients with type 1 diabetes transitioning to an adult outpatient clinic during the first visit. Methods: We examined 50 consecutive patients (n=28, 56\% female) transitioning from March 2, 2021, to November 21, 2022, into adult care (3 diabetes centers from 3 regions in southern Poland: A, n=16; B, n=21; and C, n=13) and their basic demographic information. They completed the following psychological questionnaires: State-Trait Anxiety Inventory (STAI), Generalized Self-Efficacy Scale, Perceived Stress Scale, Satisfaction with Life Scale, Acceptance of Illness Scale, Multidimensional Health Locus of Control Scale Form C, Courtauld Emotional Control Scale, and Quality of Life Questionnaire Diabetes. We compared their data with those for the general healthy population and patients with diabetes from Polish Test Laboratory validation studies. Results: During the first adult outpatient visit, patients' mean age was 19.2 (SD 1.4) years, with a diabetes duration of 9.8 (SD 4.3) years and BMI of 23.5 (SD 3.1) kg/m2. Patients came from diverse socioeconomic backgrounds: 36\% (n=18) live in villages, 26\% (n=13) live in towns with ?100,000 inhabitants, and 38\% (n=19) live in bigger cities. Regarding therapy type, 68\% (n=34) were treated with insulin pump therapy, whereas 32\% (n=16) were treated with multiple daily injections. Patients from center A had a mean glycated hemoglobin level of 7.5\% (SD 1.2\%). There was no difference regarding the level of life satisfaction, perceived level of stress, and state anxiety between the patients and reference populations. Patients had similar health locus of control and negative emotions control to the general population of patients with diabetes. Most patients (n=31, 62\%) believe that control over their health depends on themselves, whereas 52\% (n=26) believe that it depends mostly on others. Patients had higher levels of suppression of negative emotions---anger, depression, and anxiety---than the age-matched general population. Additionally, the patients were characterized by a higher acceptance of illness and higher level of self-efficacy compared to the reference populations: 64\% (n=32) had a high level of self-efficacy and 26\% (n=13) had a high level of life satisfaction. Conclusions: This study indicated that young patients transitioning to adult outpatient clinics have good psychological resources and coping mechanisms, which might result in adequate adaptation and adult life satisfaction including future metabolic control. These result also disprove the stereotypes that young people with chronic disease have worse life perspectives when entering adulthood. ", doi="10.2196/46513", url="https://formative.jmir.org/2023/1/e46513", url="http://www.ncbi.nlm.nih.gov/pubmed/37247225" } @Article{info:doi/10.2196/43597, author="Carswell, Claire and Coventry, A. Peter and Brown, E. Jennifer V. and Alderson, L. Sarah and Double, Keith and Gilbody, Simon and Holt, G. Richard I. and Jacobs, Rowena and Lister, Jennie and Osborn, David and Shiers, David and Siddiqi, Najma and Taylor, Johanna and Kellar, Ian and ", title="Development of a Supported Self-management Intervention for People With Severe Mental Illness and Type 2 Diabetes: Theory and Evidence-Based Co-design Approach", journal="J Med Internet Res", year="2023", month="May", day="12", volume="25", pages="e43597", keywords="severe mental illness", keywords="diabetes", keywords="intervention development", keywords="co-design", keywords="mental health", keywords="comorbidity", keywords="mobile phone", abstract="Background: Type 2 diabetes is 2 to 3 times more common among people with severe mental illness (SMI). Self-management is crucial, with additional challenges faced by people with SMI. Therefore, it is essential that any diabetes self-management program for people with SMI addresses the unique needs of people living with both conditions and the inequalities they experience within health care services. Objective: We combined theory, empirical evidence, and co-design approaches to develop a type 2 diabetes self-management intervention for people with SMI. Methods: The development process encompassed 4 steps: step 1 involved prioritizing the mechanisms of action (MoAs) and behavior change techniques (BCTs) for the intervention. Using findings from primary qualitative research and systematic reviews, we selected candidate MoAs to target in the intervention and candidate BCTs to use. Expert stakeholders then ranked these MoAs and BCTs using a 2-phase survey. The average scores were used to generate a prioritized list of MoAs and BCTs. During step 2, we presented the survey results to an expert consensus workshop to seek expert agreement with the definitive list of MoAs and BCTs for the intervention and identify potential modes of delivery. Step 3 involved the development of trigger films using the evidence from steps 1 and 2. We used animations to present the experiences of people with SMI managing diabetes. These films were used in step 4, where we used a stakeholder co-design approach. This involved a series of structured workshops, where the co-design activities were informed by theory and evidence. Results: Upon the completion of the 4-step process, we developed the DIAMONDS (diabetes and mental illness, improving outcomes and self-management) intervention. It is a tailored self-management intervention based on the synthesis of the outputs from the co-design process. The intervention incorporates a digital app, a paper-based workbook, and one-to-one coaching designed to meet the needs of people with SMI and coexisting type 2 diabetes. Conclusions: The intervention development work was underpinned by the MoA theoretical framework and incorporated systematic reviews, primary qualitative research, expert stakeholder surveys, and evidence generated during co-design workshops. The intervention will now be tested for feasibility before undergoing a definitive evaluation in a pragmatic randomized controlled trial. ", doi="10.2196/43597", url="https://www.jmir.org/2023/1/e43597", url="http://www.ncbi.nlm.nih.gov/pubmed/37171868" } @Article{info:doi/10.2196/42193, author="MacGirlley, Rizqah and Mokgalaboni, Kabelo", title="The Effect of Vitamin D on Inflammation and Dyslipidemia in Type 2 Diabetes Mellitus: Protocol for a Systematic Review and Meta-analysis of Randomized Controlled Trials", journal="JMIR Res Protoc", year="2023", month="Mar", day="14", volume="12", pages="e42193", keywords="vitamin D", keywords="dyslipidemia", keywords="inflammation", keywords="hyperglycemia", keywords="type 2 diabetes mellitus", keywords="systematic review", keywords="chronic disease", keywords="mortality", abstract="Background: Type 2 diabetes mellitus is a chronic disease that contributes to an increasing global burden on the health system. It has a high chance of leading to macrovascular complications and cardiovascular disease. As an inflammatory condition, it would be essential to target inflammatory pathways when developing therapeutic drugs for type 2 diabetes mellitus. Objective: We aimed to evaluate the effect of vitamin D on markers of inflammation and lipid profile among adult patients with diabetes. Methods: A systematic review will seek studies published on Embase, Google Scholar, PubMed, Web of Science, and Science Direct. This planned systematic review and meta-analysis will be limited to randomized controlled trials; moreover, the search will include published studies regarding the effects of vitamin D on pro-inflammatory cytokines and lipid profiles. The review will include studies published from inception until December 30, 2022. The study identification and selection will be based on the eligibility criteria by 2 independent reviewers. Additionally, a meta-analysis will only be performed if more than 2 studies are available and explore the same outcomes, and this will be analyzed using RevMan (version 5.4.1). The quality and risk of bias will be assessed following the Cochrane risk of bias tool and Jadad checklist. Results: The process for searching literature review has already started, and this is conducted independently by 2 reviewers using a predefined eligibility and ``participants, intervention, comparator, and outcome'' criteria. This systematic review and meta-analysis will not require any direct involvement of patients and the public; thus, no ethical approval was required. Conclusions: The findings obtained from the proposed study will be presented in scientific seminars, journal clubs, and conferences and published in peer-reviewed journals. Trial Registration: International Platform of Registered Systematic Review and Meta-analysis Protocols INPLASY202260022; https://inplasy.com/?s=INPLASY202260022 International Registered Report Identifier (IRRID): PRR1-10.2196/42193 ", doi="10.2196/42193", url="https://www.researchprotocols.org/2023/1/e42193", url="http://www.ncbi.nlm.nih.gov/pubmed/36917169" } @Article{info:doi/10.2196/41880, author="Venkatesan, Aarathi and Zimmermann, Gretchen and Rawlings, Kelly and Ryan, Claudia and Voelker, Louise and Edwards, Caitlyn", title="Improvements in Glycemic Control and Depressive Symptoms Among Adults With Type 2 Diabetes: Retrospective Study", journal="JMIR Form Res", year="2023", month="Jan", day="13", volume="0", pages="e0", keywords="type 2 diabetes", keywords="digital health", keywords="diabetes intervention", keywords="diabetes", keywords="diabetic", keywords="health app", keywords="coaching", keywords="patient education", keywords="mobile health", keywords="mHealth", keywords="app-based", keywords="health coaching", keywords="hemoglobin A1c", keywords="HbA1c", keywords="depression", keywords="depressive", keywords="anxiety", keywords="mental health", keywords="glycemic control", keywords="diabetes management", keywords="health management", keywords="digital health intervention", abstract="Background: The prevalence of diabetes remains high, with traditional lifestyle interventions demonstrating limited success in improving diabetes-related outcomes, particularly among individuals with diabetes-related mental health comorbidities. Digital health interventions provide the ability to ease the sustained and rigorous self-management needs associated with diabetes care and treatment. Current interventions though, are plagued by small sample sizes, underpowered pilot studies, and immense heterogeneity in program intervention, duration, and measured outcomes. Objective: Therefore, this work aimed to evaluate the effectiveness of a mobile health diabetes management program on measures of glycemic control in a high-risk population with type 2 diabetes (hemoglobin A1c [HbA1c] ?8.0\%), utilizing a sample of 1128 participants who provided baseline and follow-up data. The sustainability of this change in glycemic control was examined in a subset of participants (n=455) at 6 months and 1 year following program enrollment. A secondary analysis examined changes in glycemic control among a subset of participants with self-reported mild-to-moderate depression at baseline. Methods: This study utilized a single-arm, retrospective design. Participants were enrolled in the Vida Health Diabetes Management Program. This app-based intervention utilized one-on-one remote sessions with a health coach, registered dietitian nutritionist, and/or a certified diabetes care and education specialist and structured lessons and tools related to diabetes management and self-care. Participants provided baseline (--365 to 21 days of program enrollment) as well as follow-up (at least 90 days following program enrollment) HbA1c values. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up time points. The 8-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder Scale were utilized to assess self-reported depressive and anxiety symptoms, respectively. Paired t tests and linear regression modeling accounting for pertinent covariates were used to evaluate changes in mental health symptom acuity and their relationship with changes in glycemic control. Results: We observed a significant decrease in HbA1c of --1.35 points between baseline (mean 9.84, SD 1.64) and follow-up (mean 8.48, SD 1.77; t=22.56, P<.001) among this large, high-risk sample. This decrease was sustained up to 1 year following program enrollment. Additionally, a significant relationship between improvements in depressive symptom acuity and improvements in HbA1c was observed ($\beta$=--0.74, P=.03). Conclusions: This study demonstrates clinically meaningful improvements in glycemic control among participants enrolled in the Vida Health Diabetes Management Program. Additionally, this work presents one of the largest studied samples of participants enrolled in a digital health diabetes management program to date. ", doi="10.2196/41880", url="https://formative.jmir.org/2023/0/e0/" } @Article{info:doi/10.2196/43377, author="Brew-Sam, Nicola and Parkinson, Anne and Chhabra, Madhur and Henschke, Adam and Brown, Ellen and Pedley, Lachlan and Pedley, Elizabeth and Hannan, Kristal and Brown, Karen and Wright, Kristine and Phillips, Christine and Tricoli, Antonio and Nolan, J. Christopher and Suominen, Hanna and Desborough, Jane", title="Toward Diabetes Device Development That Is Mindful to the Needs of Young People Living With Type 1 Diabetes: A Data- and Theory-Driven Qualitative Study", journal="JMIR Diabetes", year="2023", month="Jan", day="25", volume="8", pages="e43377", keywords="type 1 diabetes mellitus", keywords="unified theory of acceptance and use of technology", keywords="UTAUT", keywords="value-sensitive design", keywords="young people", keywords="data- and theory-driven analysis", keywords="improved device design", abstract="Background: An important strategy to understand young people's needs regarding technologies for type 1 diabetes mellitus (T1DM) management is to examine their day-to-day experiences with these technologies. Objective: This study aimed to examine young people's and their caregivers' experiences with diabetes technologies in an exploratory way and relate the findings to the existing technology acceptance and technology design theories. On the basis of this procedure, we aimed to develop device characteristics that meet young people's needs. Methods: Overall, 16 in-person and web-based face-to-face interviews were conducted with 7 female and 9 male young people with T1DM (aged between 12 and 17 years) and their parents between December 2019 and July 2020. The participants were recruited through a pediatric diabetes clinic based at Canberra Hospital. Data-driven thematic analysis was performed before theory-driven analysis to incorporate empirical data results into the unified theory of acceptance and use of technology (UTAUT) and value-sensitive design (VSD). We used the COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist for reporting our research procedure and findings. In this paper, we summarize the key device characteristics that meet young people's needs. Results: Summarized interview themes from the data-driven analysis included aspects of self-management, device use, technological characteristics, and feelings associated with device types. In the subsequent theory-driven analysis, the interview themes aligned with all UTAUT and VSD factors except for one (privacy). Privacy concerns or related aspects were not reported throughout the interviews, and none of the participants made any mention of data privacy. Discussions around ideal device characteristics focused on reliability, flexibility, and automated closed loop systems that enable young people with T1DM to lead an independent life and alleviate parental anxiety. However, in line with a previous systematic review by Brew-Sam et al, the analysis showed that reality deviated from these expectations, with inaccuracy problems reported in continuous glucose monitoring devices and technical failures occurring in both continuous glucose monitoring devices and insulin pumps. Conclusions: Our research highlights the benefits of the transdisciplinary use of exploratory and theory-informed methods for designing improved technologies. Technologies for diabetes self-management require continual advancement to meet the needs and expectations of young people with T1DM and their caregivers. The UTAUT and VSD approaches were found useful as a combined foundation for structuring the findings of our study. ", doi="10.2196/43377", url="https://diabetes.jmir.org/2023/1/e43377", url="http://www.ncbi.nlm.nih.gov/pubmed/36696176" } @Article{info:doi/10.2196/41320, author="Da Moura Semedo, Cidila and Bath, A. Peter and Zhang, Ziqi", title="Social Support in a Diabetes Online Community: Mixed Methods Content Analysis", journal="JMIR Diabetes", year="2023", month="Jan", day="6", volume="8", pages="e41320", keywords="diabetes online community", keywords="social support", keywords="health communication", keywords="mixed methods", keywords="content analysis", keywords="prediabetes", keywords="type 2 diabetes", keywords="type 2 diabetes insulin", keywords="type 2 diabetes remission", abstract="Background: Patients with diabetes may experience different needs according to their diabetes stage. These needs may be met via online health communities in which individuals seek health-related information and exchange different types of social support. Understanding the social support categories that may be more important for different diabetes stages may help diabetes online communities (DOCs) provide more tailored support to web-based users. Objective: This study aimed to explore and quantify the categorical patterns of social support observed in a DOC, taking into consideration users' different diabetes stages, including prediabetes, type 2 diabetes (T2D), T2D with insulin treatment, and T2D remission. Methods: Data were collected from one of the largest DOCs in Europe: Diabetes.co.uk. Drawing on a mixed methods content analysis, a qualitative content analysis was conducted to explore what social support categories could be identified in users' posts. A total of 1841 posts were coded by 5 human annotators according to a modified version of the Social Support Behavior Code, including 7 different social support categories: achievement, congratulations, network support, seeking emotional support, seeking informational support, providing emotional support, and providing informational support. Subsequently, quantitative content analysis was conducted using chi-square post hoc analysis to compare the most prominent social support categories across different stages of diabetes. Results: Seeking informational support (605/1841, 32.86\%) and providing informational support (597/1841, 32.42\%) were the most frequent categories exchanged among users. The overall distribution of social support categories was significantly different across the diabetes stages ($\chi$218=287.2; P<.001). Users with prediabetes sought more informational support than those in other stages (P<.001), whereas there were no significant differences in categories posted by users with T2D (P>.001). Users with T2D under insulin treatment provided more informational and emotional support (P<.001), and users with T2D in remission exchanged more achievement (P<.001) and network support (P<.001) than those in other stages. Conclusions: This is the first study to highlight what, how, and when different types of social support may be beneficial at different stages of diabetes. Multiple stakeholders may benefit from these findings that may provide novel insights into how these categories can be strategically used and leveraged to support diabetes management. ", doi="10.2196/41320", url="https://diabetes.jmir.org/2023/1/e41320", url="http://www.ncbi.nlm.nih.gov/pubmed/36607714" } @Article{info:doi/10.2196/38678, author="Holmen, Heidi and Singstad, Tone and Ribu, Lis and Jensen, Lunde Annesofie and Weldingh, Mickelson Nina and Torbj{\o}rnsen, Astrid", title="Adapting a Patient-Reported Outcome Measure to Digital Outpatient Specialist Health Care Services for Type 1 Diabetes: User Involvement Study", journal="JMIR Hum Factors", year="2022", month="Nov", day="15", volume="9", number="4", pages="e38678", keywords="patient-reported outcome measures", keywords="user involvement", keywords="type 1 diabetes", keywords="digital interventions", abstract="Background: Diabetes self-management is crucial for patients with type 1 diabetes, and digital services can support their self-management and facilitate flexible follow-up. The potential of using digital patient-reported outcome (PRO) measures in routine outpatient care is not fully used owing to a lack of adapted PRO measures. Objective: This study presents the process of identifying and adapting a digital PRO measure for use in clinical diabetes practice and describes the preferred item topics of the adapted PRO measure, as reported by patients and diabetes specialist nurses. Methods: With the involvement of patients, diabetes specialist nurses, management, and researchers, we hosted a series of workshops and 2 dialogue conferences. Scoping searches to identify relevant PRO measures formed the foundation for the process. An in-person dialogue conference was conducted with diabetes specialist nurses as participants, and a digital dialogue conference was conducted with patients with type 1 diabetes as participants. A diabetes-specific PRO measure was translated and adapted to our digital platform. Notes and summaries from the dialogue conferences were imported into NVivo (QSR International) and thematically analyzed as a single combined data set. Results: The thematic analysis of the 2 dialogue conferences aimed to explore the views of patients with type 1 diabetes and diabetes specialist nurses on the outcomes necessary to measure. An overarching theme, Ensuring that the PRO measure captures the patients' needs precisely and accurately, in a way that facilitates care and communication with health care personnel, was identified and supported with data from both the patients and diabetes specialist nurses. This theme contained four categories: The need for explanatory text after questions to ensure understanding and accurate response, Capturing individual needs in standardized questions, getting to the heart of the patient's problem, and The questions increase patient reflection. Conclusions: We successfully conducted an iterative process that identified a PRO measure aligned with the topics raised by the diabetes specialist nurses. Similarly, the patients found the PRO measure to be relevant and one that was addressing their needs. Only minor adjustments were necessary when programming the PRO measure in the digital platform. Our management, patients, and diabetes specialist nurses had a valuable impact on the results. User involvement facilitated a specific focus on the clinical requests to be met by PRO measures and how they must be adapted to local and digital platforms. Overall, this has facilitated the current implementation of the adapted digital PRO measure. ", doi="10.2196/38678", url="https://humanfactors.jmir.org/2022/4/e38678", url="http://www.ncbi.nlm.nih.gov/pubmed/36378513" } @Article{info:doi/10.2196/31619, author="Mzimela, Christina Nomusa and Sosibo, Mbulelo Aubrey and Ngubane, Siphosethu Phikelelani and Khathi, Andile", title="The Changes That Occur in the Immune System During Immune Activation in Patients With Prediabetes From All Ethnicities, Aged 25-45 Years: Protocol for a Systematic Review and Meta-analysis", journal="JMIR Res Protoc", year="2022", month="Nov", day="14", volume="11", number="11", pages="e31619", keywords="systematic review", keywords="meta-analysis", keywords="prediabetes", keywords="immune cells", keywords="inflammatory markers", keywords="diabetes", keywords="inflammatory response", keywords="immunology", keywords="demographics", keywords="risk factors", abstract="Background: Prediabetes is an asymptomatic, intermediate state between normoglycemia and the onset of type 2 diabetes mellitus. Recent reports indicate that during prediabetes, there are subclinical changes to immune cells and inflammatory markers. Therefore, this systematic review will provide a synthesis of the available data on the changes in the concentration of immune cells and selective inflammatory markers. It will also give evidence of a demographic impact on changes or complications in the prediabetes state. Objective: The objectives of this study are to create a protocol that will be used to analyze the collected data of previously published research based on immune cells such as neutrophils, lymphocytes, monocytes, eosinophils, and basophils, as well as inflammatory markers such as C-reactive protein, tumor necrosis factor-alpha, interleukin-6, P-selectin, cluster of differentiation 40 ligand, and fibrinogen. Additionally, an impact of demographics will be determined using the previously published data collected. Methods: This protocol was prepared through adhering to the PRISMA (Preferred Reporting Items for Systemic Reviews and Meta-Analysis) 2015 guidelines for reporting protocols. Published clinical studies that involve observational (cross-sectional, comparative cross-sectional, case-control, or cohort) study designs that include normal or nondiabetic and prediabetes reports will be used in this systematic review and meta-analysis. This will be accomplished by using clinical Medical Subject Headings to search on MEDLINE, Cochrane library, and African Journal Online. Reviewers (NCM, AMS, and AK) will screen all the results and select the studies that meet the eligibility criteria. Downs and Black Checklist will be used to check the risk of bias, and then a Review Manager v5.4 forest plot will be used for meta-analysis. Additionally, the forest plot will also be used for sensitivity analysis. The strength of evidence will then be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: Since July 5, 2020, there are no participants recruited. Publicly available data will be used in the review and will be collected after this protocol publication. No ethics approval is required as no subjects will be used, and analysis will be based on reported data. Authors will be contacted if there was a misunderstanding related to reading their reported data. Conclusions: The findings will clarify changes that might be observed in a study of interest based in the eThekwini district in South Africa. Trial Registration: International Prospective Registry of Systematic Reviews (PROSPERO) CRD42020184828; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=184828 International Registered Report Identifier (IRRID): PRR1-10.2196/31619 ", doi="10.2196/31619", url="https://www.researchprotocols.org/2022/11/e31619", url="http://www.ncbi.nlm.nih.gov/pubmed/36374548" } @Article{info:doi/10.2196/41933, author="Nikpour, Soghra and Mehrdad, Neda and Sanjari, Mahnaz and Aalaa, Maryam and Heshmat, Ramin and Khabaz Mafinejad, Mahboobeh and Larijani, Bagher and Nomali, Mahin and Najafi Ghezeljeh, Tahereh", title="Challenges of Type 2 Diabetes Mellitus Management From the Perspective of Patients: Conventional Content Analysis", journal="Interact J Med Res", year="2022", month="Oct", day="27", volume="11", number="2", pages="e41933", keywords="diabetes mellitus", keywords="challenges", keywords="conventional content analysis", keywords="disease management", keywords="Iran", abstract="Background: Patients with type 2 diabetes mellitus (T2DM) face significant challenges in the treatment process, which can have a negative impact on disease management. Proper management of the disease can reduce symptoms and complications, improve glycemic indices, and reduce mortality and readmission. Objective: Given the influential role of patients in prevention and self-care, this study was conducted to explore the challenges of diabetes management from the perspective of patients. Methods: Two rounds of focus group discussions with T2DM patients were conducted. The principal investigator of the study and a research assistant compiled a list of volunteer patients with names and contact information and selected participants based on their medical information. Participants were chosen via a purposive sampling technique. The questions were designed to encourage patients to share their views on how the treatment team communicates and participates in treatment, how they are trained, and the health care system. The discussion continued until data saturation. During 2 rounds of focus group discussions, the voices of the participants were recorded by 2 voice recorders, and one of the team members was a transcriber. After discussion, participant views were transcribed, and common issues were identified, sorted, and reported as categories and subcategories. Results: According to the conventional content analysis, 88 primary codes were extracted from the detailed and in-depth description of the participants. The codes were summarized after repeated readings and classified based on their similarities and semantic relevance. Through analysis and comparison, 4 categories and 7 subcategories were identified: communication challenges (poor medical staff communication, lack of psychological support), challenges to participation in treatment (lack of patient participation), educational challenges (training program bugs, inadequate training), and challenges of the health care system (inefficiency of the care system, caregiver inefficiency). Conclusions: This study showed that the treatment team members should pay more attention to the challenges of care and treatment from the perspective of patients with T2DM. Therefore, recommendations for future policies to overcome these obstacles include establishing a multidisciplinary health care team; using trained health care workers to provide organized treatment and care services; holding individual counseling sessions with patients in need of counseling; and providing counseling services, involving patients in the treatment and self-care process, and designing a comprehensive diabetes education program with an emphasis on education. Necessary information should be provided to the patients, and effective communicate should address patient concerns. ", doi="10.2196/41933", url="https://www.i-jmr.org/2022/2/e41933", url="http://www.ncbi.nlm.nih.gov/pubmed/36301605" } @Article{info:doi/10.2196/38267, author="Southgate, Genevieve and Yassaee, A. Arrash and Harmer, J. Matthew and Livesey, Helen and Pryde, Kate and Roland, Damian", title="Use of Telemedicine in Pediatric Services for 4 Representative Clinical Conditions: Scoping Review", journal="J Med Internet Res", year="2022", month="Oct", day="26", volume="24", number="10", pages="e38267", keywords="telemedicine", keywords="telehealth", keywords="eHealth", keywords="digital health", keywords="video consultation", keywords="remote consultation", keywords="paediatric", keywords="child", keywords="safeguarding", keywords="diabetes", keywords="diabetic", keywords="asthma", keywords="epilepsy", keywords="epileptic", keywords="renal", keywords="kidney", keywords="evidence-based medicine", keywords="review", abstract="Background: Telemedicine is becoming routine in health care. Postpandemic, a universal return to face-to-face consultations may risk a loss of some of the advantages of telemedicine. However, rapid implementation and adoption without robust evaluation of usability, efficacy, and effectiveness could potentially lead to suboptimal health outcomes and downstream challenges to providers. Objective: This review assesses telemedicine interventions against international guidance and sufficiency of evidence to support postpandemic utilization in pediatric settings. Methods: This scoping review was performed following searches on PubMed, Embase, and CINAHL databases on April 15, 2021, and May 31, 2022, and examined studies focused on telemedicine, remote consultation, video call, or remote patient monitoring in children (0-18 years) receiving outpatient care for diabetes, asthma, epilepsy, or renal disease. Exclusion criteria included studies published before 2011 as the technologies used have likely been improved or replaced, studies in adult populations or where it was not possible to disaggregate data for participants younger than 18 years as the focus of the review was on pediatric care, and studies not published in English. Data were extracted by 4 authors, and the data were corroborated by a second reviewer. Studies were examined for feasibility and usability, clinical and process outcomes, and cost-effectiveness. Results: Of the 3158 studies identified, 56 were suitable for final inclusion and analysis. Data on feasibility or usability of interventions (48 studies) were overwhelmingly positive in support of telemedicine interventions, with common themes including convenience, perceived cost savings, and ease of use. However, use in preference to usual care was rarely explored. Clinical and process outcome data (31 studies) were mostly positive. Across all studies, there was limited measurement of standardized clinical outcomes, although these were more commonly reported in asthma (peak flow) and diabetes (glycated hemoglobin [HbA1c]). Implementation science data generally supported cost-effectiveness of telemedicine with a reduction of health care costs. Conclusions: There is promising evidence supporting telemedicine in pediatric settings. However, there is a lack of evaluation of telemedicine in comparison with usual outpatient care for noninferiority of clinical outcomes, and this review highlights the need for a more standardized approach to evaluation of digital interventions. ", doi="10.2196/38267", url="https://www.jmir.org/2022/10/e38267", url="http://www.ncbi.nlm.nih.gov/pubmed/36287609" } @Article{info:doi/10.2196/37572, author="de Leon, Brosina Elisa and Campos, Morais H{\'e}rcules L{\'a}zaro and Brito, Almeida Fabiana and Almeida, Araujo Fabio", title="Study of Health in Primary Care of the Amazonas Population: Protocol for an Observational Study on Diabetes Management in Brazil", journal="JMIR Res Protoc", year="2022", month="Sep", day="15", volume="11", number="9", pages="e37572", keywords="health management", keywords="diabetes", keywords="patient activation", keywords="health care", keywords="T2DM", keywords="Amazon", keywords="patient profile", keywords="behavioral change", keywords="health policy", keywords="epidemiological profile", keywords="epidemiology", keywords="management", abstract="Background: Changes in the profiles of patients have significant impacts on the health care system. Diabetes mellitus type 2 (T2DM) prevention and management should be studied in different contexts. Objective: The Study of Health in Primary Care for the Amazonas Population (SAPPA) primarily aims to describe T2DM prevention and management actions offered by primary health care settings in Brazil and whether the care delivered is consistent with the chronic care model (CCM). Second, the study aims to examine the impact of T2DM management actions on health and lifestyle, and third, to understand how sociodemographic characteristics, health, and subjective outcomes impact diabetes management. Methods: As part of this observational study, managers and health professionals complete a questionnaire containing information about T2DM prevention and management actions and CCM dimensions. During in-home visits, patients are asked about their health, lifestyle, sociodemographics, diabetes care, and subjective variables. Results: A total of 34 managers, 1560 professional health workers, and 955 patients will be recruited. The data collection will be completed in October 2022. Conclusions: The SAPPA is an observational study that intends to understand the T2DM management process in primary health care, including planning, execution, reach, and impact on patient motivation and adherence. International Registered Report Identifier (IRRID): DERR1-10.2196/37572 ", doi="10.2196/37572", url="https://www.researchprotocols.org/2022/9/e37572", url="http://www.ncbi.nlm.nih.gov/pubmed/36107477" } @Article{info:doi/10.2196/34433, author="Moldovan, A. Ioana and Bragg, Alexa and Nidhiry, S. Anna and De La Cruz, A. Barbara and Mitchell, E. Suzanne", title="The Physical Activity Assessment of Adults With Type 2 Diabetes Using Accelerometer-Based Cut Points: Scoping Review", journal="Interact J Med Res", year="2022", month="Sep", day="6", volume="11", number="2", pages="e34433", keywords="accelerometer", keywords="cut points", keywords="type 2 diabetes", keywords="physical activity", abstract="Background: Incorporating physical activity into lifestyle routines is recommended for individuals with type 2 diabetes. Accelerometers offer a promising method for objectively measuring physical activity and for assessing interventions. However, the existing literature for accelerometer-measured physical activity among middle-aged and older adults with type 2 diabetes is lacking. Objective: This study aims to identify research studies in which accelerometer-based cut points were used to classify the physical activity intensity of middle-aged to older adults with type 2 diabetes as sedentary, light, moderate, vigorous, and very vigorous, and to determine if validated accelerometer cut points specifically for this population exist. Methods: We followed the Joanna Briggs Institute methodology for scoping reviews. Between June 23 and July 12, 2020, two reviewers independently screened records from four databases (PubMed, Web of Science, Embase, Engineering Village) and the ActiGraph Corp web site for eligible studies that included patients with type 2 diabetes with a sample mean age ?50 years, used research-grade accelerometers, applied cut points to categorize objectively measured physical activity, and were available in English. We excluded studies reporting exclusively steps or step counts measured by accelerometers or pedometers and conference abstracts or other sources that did not have a full text available. Data extraction was completed using Microsoft Excel. Data for the following variables were tabulated based on frequency distributions: study design, accelerometer type, device placement, epoch length, total wear time, and cut points used. Study aims and participant demographic data were summarized. Results: A total of 748 records were screened at the abstract level, and 88 full-text articles were assessed for eligibility. Ultimately, 46 articles were retained and analyzed. Participants' mean ages ranged from 50 to 79.9 years. The ActiGraph accelerometer and the Freedson et al and Troiano et al counts-per-minute cut points were the most frequently used across the literature. Freedson et al and Troiano et al counts-per-minute cut points for light, moderate, and vigorous activity correspond to <1952, 1952-5724, and ?5725, and 100-2019, 2020-5998, and ?5999, respectively. The Lopes et al cut points were developed by calibrating the ActiGraph in middle-aged and older adults with overweight/obesity and type 2 diabetes. These counts-per-minute thresholds are ?200 (light), ?1240 (moderate), and ?2400 (vigorous), and were applied in 1 interventional study. Conclusions: An assortment of accelerometer cut points have been used by researchers to categorize physical activity intensity for middle-aged and older adults with diabetes. Only one set of cut points was validated and calibrated in our population of interest. Additional research is warranted to address the need for diabetes-specific cut points to inform public health recommendations. This includes confirmation that the Lopes et al cut points reflect clinically meaningful changes in physical activity for adults with diabetes who have comorbidities other than overweight/obesity and the development of relative intensity cut points that may be more suitable for those with suboptimal physical functioning. ", doi="10.2196/34433", url="https://www.i-jmr.org/2022/2/e34433", url="http://www.ncbi.nlm.nih.gov/pubmed/36066937" } @Article{info:doi/10.2196/37223, author="Torp, C{\ae}sar Daniel and Sandb{\ae}k, Annelli and Pr{\ae}torius, Thim", title="The Technology Acceptance of Video Consultations for Type 2 Diabetes Care in General Practice: Cross-sectional Survey of Danish General Practitioners", journal="J Med Internet Res", year="2022", month="Aug", day="30", volume="24", number="8", pages="e37223", keywords="video consultations", keywords="telemedicine", keywords="diabetes", keywords="chronic diseases", keywords="general practice", keywords="technology acceptance", keywords="technology acceptance model", abstract="Background: During the COVID-19 pandemic, video consultations became a common method of delivering care in general practice. To date, research has mostly studied acute or subacute care, thereby leaving a knowledge gap regarding the potential of using video consultations to manage chronic diseases. Objective: This study aimed to examine general practitioners' technology acceptance of video consultations for the purpose of managing type 2 diabetes in general practice. Methods: A web-based survey based on the technology acceptance model measuring 4 dimensions---perceived usefulness, perceived ease of use, attitude, and behavioral intention to use---was sent to all general practices (N=1678) in Denmark to elicit user perspectives. The data were analyzed using structural equation modeling. Results: The survey sample comprised 425 general practitioners who were representative of the population. Structural equation modeling showed that 4 of the 5 hypotheses in the final research model were statistically significant (P<.001). Perceived ease of use had a positive influence on perceived usefulness and attitude. Attitude was positively influenced by perceived usefulness. Attitude had a positive influence on behavioral intention to use, although perceived usefulness did not. Goodness-of-fit indices showed acceptable fits for the structural equation modeling estimation. Conclusions: Perceived usefulness was the primary driver of general practitioners' positive attitude toward video consultations for type 2 diabetes care. The study suggests that to improve attitude and technology use, decision-makers should focus on improving usefulness, that is, how it can improve treatment and make it more effective and easier. ", doi="10.2196/37223", url="https://www.jmir.org/2022/8/e37223", url="http://www.ncbi.nlm.nih.gov/pubmed/36040765" } @Article{info:doi/10.2196/38477, author="Zara, Sandra and Kruse, Johannes and Leveling, Maria Anna and Schmitz, Jana and Hempler, Isabelle and Kampling, Hanna", title="Capturing Diabetes-Related Distress and Burden From the Perspective of Patients With Type 1 or Type 2 Diabetes: Protocol for an Explorative Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Aug", day="1", volume="11", number="8", pages="e38477", keywords="diabetes", keywords="diabetes-related distress", keywords="glycemic control", keywords="depression and anxiety", keywords="mixed methods design", keywords="mixed methods", keywords="protocol", keywords="stress", keywords="anxiety", keywords="depression", keywords="patient perspective", keywords="psychosocial", keywords="management", keywords="treatment", keywords="self-management", abstract="Background: Diabetes is one of the most common diseases worldwide and is associated with increased morbidity, mortality, and reduced quality of life. Many patients experience high diabetes-related distress as well as depression and anxiety symptoms, which are associated with poor diabetes self-management. As disease management is a central component in diabetes treatment, poor management enhances the occurrence of micro- and macrovascular complications. This emphasizes the relevance of reducing diabetes-related distress and providing adequate treatment options addressing the individual psychosocial burden of patients with diabetes. Since patients' perspectives diverge significantly from those of practitioners in terms of relevant treatment aspects, the patient perspective on, for example, barriers to and facilitators of diabetes treatment is crucial for adequate and effective treatment as well as improvements to self-management and therefore, needs to be further explored. Objective: This study aims to examine diabetes-related distress, the course of distress throughout diabetes management, as well as barriers and facilitating factors in dealing with diabetes from the individual perspective of patients with type 1 and type 2 diabetes. Methods: The study employs a mixed methods design combining qualitative and quantitative data. Semistructured interviews (N=40) will be conducted with patients with type 1 diabetes (n=20) and patients with type 2 diabetes (n=20). The primary outcomes comprise (1) diabetes-related distress, (2) the severity of distress, (3) the course of distress throughout diabetes management, (4) barriers, and (5) facilitating factors. Questionnaires will provide data on the following secondary outcomes: diabetes-related emotional distress (the Problem Areas in Diabetes scale), symptoms of depression and anxiety (Patient Health Questionnaire, German version), personality functioning (Operationalized Psychodynamic Diagnosis-Structure Questionnaire), mentalizing capacities (Mentalization Questionnaire), epistemic trust (Epistemic Trust, Mistrust and Credulity Questionnaire) and experiences of child maltreatment (Childhood Trauma Questionnaire), and the overall health status of the patient (routine medical data). Results: As of April 2022, the conceptualization phase of the study was finalized. Ethics approval was received in January 2022 from the local ethics committee of the Justus Liebig University Giessen -- Faculty of Medicine (AZ 161/21). Conclusions: This study will provide insights into the individual perspective of patients with type 1 and type 2 diabetes regarding their experiences with diabetes management and what they perceive to be relevant, obstructive, or beneficial. The insights gained could help further tailor diabetes treatment to the individual needs of patients with diabetes and therefore optimize diabetes self-management. Trial Registration: German Clinical Trial Register DRKS00024999; https://tinyurl.com/2wb4xdh8 International Registered Report Identifier (IRRID): PRR1-10.2196/38477 ", doi="10.2196/38477", url="https://www.researchprotocols.org/2022/8/e38477", url="http://www.ncbi.nlm.nih.gov/pubmed/35916703" } @Article{info:doi/10.2196/34206, author="Feher, Michael and Hinton, William and Forbes, Anna and Munro, Neil and Joy, Mark and Wheeler, David and de Lusignan, Simon", title="Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study)", journal="JMIR Res Protoc", year="2022", month="Jul", day="19", volume="11", number="7", pages="e34206", keywords="type 2 diabetes", keywords="sodium-glucose cotransporter-2 inhibitor", keywords="glucagon-like peptide-1 receptor agonist", keywords="renal", keywords="kidney", keywords="electronic health records", abstract="Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are both considered to be part of standard care in the management of glycemia in type 2 diabetes. Recent trial evidence has indicated benefits on primary kidney end points for individual drugs within each medication class. Despite the potential benefits of combining SGLT2is and GLP-1RAs for glycemia management, according to national and international guideline recommendations, there is currently limited data on kidney end points for this drug combination. Objective: The aims of the study are to assess the real-world effects of combination SGLT2i and GLP-1RA therapies for diabetes management on kidney end points, glycemic control, and weight in people with type 2 diabetes who are being treated with renin-angiotensin system blockade medication. Methods: This retrospective cohort study will use the electronic health records of people with type 2 diabetes that are registered with general practices covering over 15 million people in England and Wales and are included in the Oxford-Royal College of General Practitioners Research and Surveillance Centre network. A propensity score--matched cohort of prevalent new users of SGLT2is and GLP-1RAs and those who have been prescribed SGLT2is and GLP-1RAs in combination will be identified. They will be matched based on drug histories, comorbidities, and demographics. A repeated-measures, multilevel, linear regression analysis will be performed to compare the mean change (from baseline) in estimated glomerular filtration rate at 12 and 24 months between those who switched to combined therapy and those continuing monotherapy with an SGLT2i or GLP-1RA. The secondary end points will be albuminuria, serum creatinine level, glycated hemoglobin level, and BMI. These will also be assessed for change at the 12- and 24-month follow-ups. Results: The study is due to commence in March 2022 and is expected to be complete by September 2022. Conclusions: Our study will be the first to assess the impact of combination SGLT2i and GLP-1RA therapy in type 2 diabetes on primary kidney end points from a real-world perspective. International Registered Report Identifier (IRRID): PRR1-10.2196/34206 ", doi="10.2196/34206", url="https://www.researchprotocols.org/2022/7/e34206", url="http://www.ncbi.nlm.nih.gov/pubmed/35852840" } @Article{info:doi/10.2196/35655, author="Vrebalov Cindro, Pavle and Krni{\'c}, Mladen and Modun, Darko and Vukovi{\'c}, Jonatan and Ti{\v c}inovi{\'c} Kurir, Tina and Kardum, Goran and Ru{\vs}i{\'c}, Doris and {\vS}e{\vs}elja Peri{\vs}in, Ana and Buki{\'c}, Josipa", title="Comparison of the Impact of Insulin Degludec U100 and Insulin Glargine U300 on Glycemic Variability and Oxidative Stress in Insulin-Naive Patients With Type 2 Diabetes Mellitus: Pilot Study for a Randomized Trial", journal="JMIR Form Res", year="2022", month="Jul", day="8", volume="6", number="7", pages="e35655", keywords="type two diabetes mellitus", keywords="type 2 diabetes mellitus", keywords="insulin degludec", keywords="insulin glargine U300", keywords="glucose variability", keywords="oxidative stress", keywords="insulin", keywords="diabetes", keywords="diabetic", keywords="glycemic variability", keywords="glycaemic variability", keywords="RCT", keywords="pilot", keywords="control trial", keywords="clinical trial", abstract="Background: There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300). There is little data and head-to-head comparison of IDeg-100 and IGlar-300 regarding their simultaneous impact on glycemic variability and oxidative stress in patients with type 2 diabetes mellitus (T2DM). Objective: In our randomized, open-label, crossover study, we compared the impact of IDeg-100 and IGlar-300 on glycemic variability and oxidative stress in insulin-naive patients with T2DM. Methods: We recruited a total of 25 adult patients with T2DM (7 females) whose diabetes was uncontrolled (HbA1c ?7.5\%) on two or more oral glucose-lowering drugs; a total of 22 completed the study. Mean age was 57.3 (SD 6.99) years and duration of diabetes was 9.94 (SD 5.01) years. After the washout period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin. Each insulin was administered for 12 weeks and then switched. At the beginning and end of each phase, biochemical and oxidative stress parameters were analyzed. On 3 consecutive days prior to each control point, patients performed a 7-point self-monitoring of blood glucose profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides (determination of reactive oxygen metabolites test) in serum. Results: IGlar-300 reduced mean glucose by 0.02-0.13 mmol/L, and IDeg-100 reduced glucose by 0.10-0.16 mmol/L, with no significant difference. The reduction of the coefficient of glucose variation also did not show a statistically significant difference. IGlar-300 increased thiols by 0.08 {\textmu}mol/L and IDeg-100 increased thiols by 0.15 {\textmu}mol/L, with no significant difference (P=.07) between them. IGlar-300 reduced hydroperoxides by 0.040 CARR U and IDeg-100 increased hydroperoxides by 0.034 CARR U, but the difference was not significant (P=.12). Conclusions: The results of our study do not show a significant difference regarding glycemic variability between patients receiving either insulin IDeg-100 or IGlar-300, although IGlar-300 showed greater dispersion of data. No significant difference in oxidative stress was observed. In a larger study, doses of insulins should be higher to achieve significant impact on glycemic parameters and consequently on glycemic variability and oxidative stress. Trial Registration: ClinicalTrials.gov, NCT04692415; https://clinicaltrials.gov/ct2/show/NCT04692415 ", doi="10.2196/35655", url="https://formative.jmir.org/2022/7/e35655", url="http://www.ncbi.nlm.nih.gov/pubmed/35802405" } @Article{info:doi/10.2196/34255, author="Litchman, L. Michelle and Kwan, M. Bethany and Zittleman, Linda and Simonetti, Juliana and Iacob, Eli and Curcija, Kristen and Neuberger, Julie and Latendress, Gwen and Oser, K. Tamara", title="A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Jun", day="14", volume="11", number="6", pages="e34255", keywords="diabetes", keywords="rural", keywords="telehealth", keywords="implementation science", keywords="community-based participatory research", keywords="Spanish", keywords="implementation", keywords="community", keywords="participatory", keywords="protocol", keywords="randomized controlled trial", keywords="intervention", keywords="adapt", keywords="framework", abstract="Background: Diabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities. Objective: The specific aims of this paper are (1) to adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D); and (2) to conduct a patient-level randomized controlled trial to examine the effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Methods: This is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at 2 rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Patient-level effectiveness outcomes (hemoglobin A1c, diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice-level and patient-level acceptability and feasibility will be assessed using surveys and interviews. Results: This study is supported by the National Institute of Nursing. The study procedures were approved, and the adaptation processes have been completed. Recruitment and enrollment started in July 2021. Conclusions: To our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES, culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited. Trial Registration: ClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622 International Registered Report Identifier (IRRID): DERR1-10.2196/34255 ", doi="10.2196/34255", url="https://www.researchprotocols.org/2022/6/e34255", url="http://www.ncbi.nlm.nih.gov/pubmed/35700026" } @Article{info:doi/10.2196/37534, author="Li, Shiyu and Yin, Zenong and Lesser, Janna and Li, Chengdong and Choi, Yeob Byeong and Parra-Medina, Deborah and Flores, Belinda and Dennis, Brittany and Wang, Jing", title="Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial", journal="JMIR Diabetes", year="2022", month="May", day="30", volume="7", number="2", pages="e37534", keywords="health disparity", keywords="rural health", keywords="rural", keywords="community health worker", keywords="health education", keywords="digital health", keywords="diabetes", keywords="diabetes management", keywords="mHealth", keywords="community health", keywords="self management", keywords="mobile health", keywords="technology feasibility", keywords="underserved", keywords="Latino", abstract="Background: Latinos living in rural South Texas have a higher prevalence of diabetes, but their access to diabetes self-management education and support (DSMES) is limited. Objective: We aimed to test the feasibility of a community health worker-led, mobile health (mHealth)-based DSMES intervention to reduce disparities in accessing DSMES in underserved rural Latino residents in South Texas. Methods: This 12-week, single-arm, pre-post trial was delivered by trained community health workers to 15 adults with type 2 diabetes. The intervention consisted of digital diabetes education, self-monitoring, a cloud-based connected platform, and community health worker support. Feasibility was evaluated as retention, actual intervention use, program satisfaction, and barriers to implementation. We also explored the intervention's effect on weight loss and hemoglobin A1c (HbA1c). Results: All 15 participants were Latino (mean age 61.87 years, SD 10.67; 9/15 female, 60\%). The retention rate at posttest was 14 of 15 (93\%). On average, the participants completed 37 of 42 (88\%) digital diabetes education lessons with 8 participants completing all lessons. Participants spent 81/91 days (89\%) step tracking, 71/91 days (78\%) food logging, 43/91 days (47\%) blood glucose self-monitoring, and 74/91 days (81\%) weight self-monitoring. The level of program satisfaction was high. On average, participants lost 3.5 (SD 3.2) kg of body weight (P=.001), while HbA1c level remained unchanged from baseline (6.91\%, SD 1.28\%) to posttest (7.04\%, SD 1.66\%; P=.668). Conclusions: A community health worker-led mHealth-based intervention was feasible and acceptable to improve access to DSMES services for Latino adults living in rural communities. Future randomized controlled trials are needed to test intervention efficacy on weight loss and glycemic control. ", doi="10.2196/37534", url="https://diabetes.jmir.org/2022/2/e37534", url="http://www.ncbi.nlm.nih.gov/pubmed/35635752" } @Article{info:doi/10.2196/36181, author="Brakenridge, John Christian and Salim, Agus and Healy, Nissa Genevieve and Grigg, Ruth and Carver, Alison and Rickards, Kym and Owen, Neville and Dunstan, Wayne David", title="The Associations of COVID-19 Lockdown Restrictions With Longer-Term Activity Levels of Working Adults With Type 2 Diabetes: Cohort Study", journal="JMIR Diabetes", year="2022", month="May", day="18", volume="7", number="2", pages="e36181", keywords="COVID-19", keywords="Fitbit", keywords="activity", keywords="sedentary behavior", keywords="type 2 diabetes", keywords="digital health", keywords="pandemic", keywords="physical activity", keywords="wearable", keywords="health technology", abstract="Background: Lockdown restrictions reduce COVID-19 community transmission; however, they may pose challenges for noncommunicable disease management. A 112-day hard lockdown in Victoria, Australia (commencing March 23, 2020) coincided with an intervention trial of reducing and breaking up sitting time in desk workers with type 2 diabetes who were using a provided consumer-grade activity tracker (Fitbit). Objective: This study aims to compare continuously recorded activity levels preceding and during COVID-19 lockdown restrictions among working adults with type 2 diabetes participating in a sitting less and moving more intervention. Methods: A total of 11 participants (n=8 male; mean age 52.8, SD 5 years) in Melbourne, Australia had Fitbit activity tracked before (mean 122.7, SD 47.9 days) and during (mean 99.7, SD 62.5 days) citywide COVID-19 lockdown restrictions. Regression models compared device (Fitbit Inspire HR)--derived activity (steps; metabolic equivalent tasks [METs]; mean time in sedentary, lightly, fairly, and very active minutes; and usual bout durations) during restrictions to prerestrictions. Changes in activity were statistically significant when estimates ($\Delta$\%) did not intercept zero. Results: Overall, there was a decrease in mean steps (--1584 steps/day; $\Delta$\% --9\%, 95\% CI --11\% to --7\%); METs (--83 METs/day; $\Delta$\% --5\%, 95\% CI --6\% to --5\%); and lightly active ($\Delta$\% --4\%, 95\% CI --8\% to --1\%), fairly active ($\Delta$\% --8\%, 95\% CI --21\% to --15\%), and very active ($\Delta$\% --8\%, 95\% CI --11\% to --5\%) intensity minutes per day, and increases in mean sedentary minutes per day (51 mins/day; $\Delta$\% 3\%, 95\% CI 1\%-6\%). Only very active (+5.1 mins) and sedentary (+4.3 mins) bout durations changed significantly. Conclusions: In a convenience sample of adults with type 2 diabetes, COVID-19 lockdown restrictions were associated with decreases in overall activity levels and increases in very active and sedentary bout durations. A Fitbit monitor provided meaningful continuous long-term data in this context. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001159246; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001159246 ", doi="10.2196/36181", url="https://diabetes.jmir.org/2022/2/e36181", url="http://www.ncbi.nlm.nih.gov/pubmed/35486904" } @Article{info:doi/10.2196/34681, author="Zheng, Yaguang and Dickson, Vaughan Victoria and Blecker, Saul and Ng, M. Jason and Rice, Campbell Brynne and Melkus, D'Eramo Gail and Shenkar, Liat and Mortejo, R. Marie Claire and Johnson, B. Stephen", title="Identifying Patients With Hypoglycemia Using Natural Language Processing: Systematic Literature Review", journal="JMIR Diabetes", year="2022", month="May", day="16", volume="7", number="2", pages="e34681", keywords="hypoglycemia", keywords="natural language processing", keywords="electronic health records", keywords="diabetes", abstract="Background: Accurately identifying patients with hypoglycemia is key to preventing adverse events and mortality. Natural language processing (NLP), a form of artificial intelligence, uses computational algorithms to extract information from text data. NLP is a scalable, efficient, and quick method to extract hypoglycemia-related information when using electronic health record data sources from a large population. Objective: The objective of this systematic review was to synthesize the literature on the application of NLP to extract hypoglycemia from electronic health record clinical notes. Methods: Literature searches were conducted electronically in PubMed, Web of Science Core Collection, CINAHL (EBSCO), PsycINFO (Ovid), IEEE Xplore, Google Scholar, and ACL Anthology. Keywords included hypoglycemia, low blood glucose, NLP, and machine learning. Inclusion criteria included studies that applied NLP to identify hypoglycemia, reported the outcomes related to hypoglycemia, and were published in English as full papers. Results: This review (n=8 studies) revealed heterogeneity of the reported results related to hypoglycemia. Of the 8 included studies, 4 (50\%) reported that the prevalence rate of any level of hypoglycemia was 3.4\% to 46.2\%. The use of NLP to analyze clinical notes improved the capture of undocumented or missed hypoglycemic events using International Classification of Diseases, Ninth Revision (ICD-9), and International Classification of Diseases, Tenth Revision (ICD-10), and laboratory testing. The combination of NLP and ICD-9 or ICD-10 codes significantly increased the identification of hypoglycemic events compared with individual methods; for example, the prevalence rates of hypoglycemia were 12.4\% for International Classification of Diseases codes, 25.1\% for an NLP algorithm, and 32.2\% for combined algorithms. All the reviewed studies applied rule-based NLP algorithms to identify hypoglycemia. Conclusions: The findings provided evidence that the application of NLP to analyze clinical notes improved the capture of hypoglycemic events, particularly when combined with the ICD-9 or ICD-10 codes and laboratory testing. ", doi="10.2196/34681", url="https://diabetes.jmir.org/2022/2/e34681", url="http://www.ncbi.nlm.nih.gov/pubmed/35576579" } @Article{info:doi/10.2196/30058, author="Bartlett, Kiera Yvonne and Farmer, Andrew and Newhouse, Nikki and Miles, Lisa and Kenning, Cassandra and French, P. David", title="Effects of Using a Text Message Intervention on Psychological Constructs and the Association Between Changes to Psychological Constructs and Medication Adherence in People With Type 2 Diabetes: Results From a Randomized Controlled Feasibility Study", journal="JMIR Form Res", year="2022", month="Apr", day="29", volume="6", number="4", pages="e30058", keywords="medication adherence", keywords="type 2 diabetes mellitus", keywords="behavior change techniques", keywords="text messaging", keywords="feasibility studies", keywords="diabetes", keywords="medication", keywords="digital health", abstract="Background: Poor adherence to oral medications is common in people with type 2 diabetes and can lead to an increased chance of health complications. Text messages may provide an effective delivery method for an intervention; however, thus far, the majority of these interventions do not specify either a theoretical basis or propose specific mechanisms of action. This makes it hard to determine how and whether an intervention is having an effect. The text messages included in the current intervention have been developed to deliver specific behavior change techniques. These techniques are the ``active ingredients'' of the intervention and were selected to target psychological constructs identified as predictors of medication adherence. Objective: There are 2 aims of this study: (1) to assess whether a text message intervention with specified behavior change techniques can change the constructs that predict medication adherence behaviors in people with type 2 diabetes and (2) to assess whether changes to psychological constructs are associated with changes in self-reported medication adherence. Methods: We conducted a randomized controlled, 6-month feasibility trial. Adults prescribed oral medication for type 2 diabetes (N=209) were recruited from general practice and randomized to either receive a text message--based intervention or care as usual. Data were analyzed with repeated measures analysis of covariance and Spearman rho correlation coefficients. Results: For 8 of the 14 constructs that were measured, a significant time-by-condition interaction was found: necessity beliefs, intention, maintenance self-efficacy, recovery self-efficacy, action control, prompts and cues, social support, and satisfaction with experienced consequences all increased in the intervention group compared to the control group. Changes in action self-efficacy, intention, automaticity, maintenance self-efficacy, and satisfaction with experienced consequences were positively associated with changes in self-reported medication adherence. Conclusions: A relatively low-cost, scalable, text message--only intervention targeting medication adherence using behavior change techniques can influence psychological constructs that predict adherence. Not only do these constructs predict self-reported medication adherence, but changes in these constructs are correlated with changes in self-reported medication adherence. These findings support the promise of text message--based interventions for medication adherence in this population and suggest likely mechanisms of action. Trial Registration: ISRCTN Registry ISRCTN13404264; https://www.isrctn.com/ISRCTN13404264 ", doi="10.2196/30058", url="https://formative.jmir.org/2022/4/e30058", url="http://www.ncbi.nlm.nih.gov/pubmed/35486430" } @Article{info:doi/10.2196/22912, author="Ronaldson, Amy and Freestone, Mark and Zhang, Haoyuan and Marsh, William and Bhui, Kamaldeep", title="Using Structural Equation Modelling in Routine Clinical Data on Diabetes and Depression: Observational Cohort Study", journal="JMIRx Med", year="2022", month="Apr", day="27", volume="3", number="2", pages="e22912", keywords="depression", keywords="diabetes", keywords="electronic health records", keywords="acute care", keywords="PLS-SEM", keywords="path analysis", keywords="equation modelling", keywords="accident", keywords="emergency care", keywords="emergency", keywords="structural equation modelling", keywords="clinical data", abstract="Background: Large data sets comprising routine clinical data are becoming increasingly available for use in health research. These data sets contain many clinical variables that might not lend themselves to use in research. Structural equation modelling (SEM) is a statistical technique that might allow for the creation of ``research-friendly'' clinical constructs from these routine clinical variables and therefore could be an appropriate analytic method to apply more widely to routine clinical data. Objective: SEM was applied to a large data set of routine clinical data developed in East London to model well-established clinical associations. Depression is common among patients with type 2 diabetes, and is associated with poor diabetic control, increased diabetic complications, increased health service utilization, and increased health care costs. Evidence from trial data suggests that integrating psychological treatment into diabetes care can improve health status and reduce costs. Attempting to model these known associations using SEM will test the utility of this technique in routine clinical data sets. Methods: Data were cleaned extensively prior to analysis. SEM was used to investigate associations between depression, diabetic control, diabetic care, mental health treatment, and Accident \& Emergency (A\&E) use in patients with type 2 diabetes. The creation of the latent variables and the direction of association between latent variables in the model was based upon established clinical knowledge. Results: The results provided partial support for the application of SEM to routine clinical data. Overall, 19\% (3106/16,353) of patients with type 2 diabetes had received a diagnosis of depression. In line with known clinical associations, depression was associated with worse diabetic control ($\beta$=.034, P<.001) and increased A\&E use ($\beta$=.071, P<.001). However, contrary to expectation, worse diabetic control was associated with lower A\&E use ($\beta$=--.055, P<.001) and receipt of mental health treatment did not impact upon diabetic control (P=.39). Receipt of diabetes care was associated with better diabetic control ($\beta$=--.072, P<.001), having depression ($\beta$=.018, P=.007), and receiving mental health treatment ($\beta$=.046, P<.001), which might suggest that comprehensive integrated care packages are being delivered in East London. Conclusions: Some established clinical associations were successfully modelled in a sample of patients with type 2 diabetes in a way that made clinical sense, providing partial evidence for the utility of SEM in routine clinical data. Several issues relating to data quality emerged. Data improvement would have likely enhanced the utility of SEM in this data set. ", doi="10.2196/22912", url="https://med.jmirx.org/2022/2/e22912", url="http://www.ncbi.nlm.nih.gov/pubmed/37725546" } @Article{info:doi/10.2196/34466, author="Rajanala, Susruthi and Wilson, K. Jennifer and Mitchell, D. Paul and Garvey, C. Katharine and Fishman, N. Laurie", title="Contrasting Social Media Use Between Young Adults With Inflammatory Bowel Disease and Type 1 Diabetes: Cross-sectional Study", journal="JMIR Pediatr Parent", year="2022", month="Apr", day="25", volume="5", number="2", pages="e34466", keywords="social media", keywords="inflammatory bowel disease", keywords="type 1 diabetes", keywords="internet", keywords="young adult", keywords="children", keywords="Instagram", keywords="Facebook", keywords="type 1", keywords="diabetes", abstract="Background: Social media is used by young adult patients for social connection and self-identification. Objective: This study aims to compare the social media habits of young adults with inflammatory bowel disease (IBD) and type 1 diabetes (T1D). Methods: This is a cross-sectional study of subjects from Boston Children's Hospital outpatient IBD and diabetes clinics. Patients above 18 years of age were invited to complete a brief anonymous survey, which asked about the various ways they use several social media platforms. Results: Responses were received from 108 patients (92.5\% response rate), evenly split across disease type. We found that 83\% of participants spent at least 30 minutes per day on social media, most commonly on Instagram and Facebook. Although the content varied based on the platform, patients with IBD posted or shared content related to their disease significantly less than those with T1D (23\% vs 38\%, P=.02). Among Instagram users, patients with IBD were less likely to engage with support groups (22\% vs 56\%, P=.04). Among Twitter users, patients with IBD were less likely to seek disease information (77\% vs 29\%, P=.005). Among Facebook users, patients with IBD were less likely to post about research and clinical trials (31\% vs 65\%, P=.04) or for information seeking (49\% vs 87\%, P=.003). Patients with IBD were also less likely to share their diagnosis with friends or family in person. Conclusions: Young adults with IBD were less willing to share their diagnosis and post about or explore the disease on social media compared to those with T1D. This could lead to a sense of isolation and should be further explored. ", doi="10.2196/34466", url="https://pediatrics.jmir.org/2022/2/e34466", url="http://www.ncbi.nlm.nih.gov/pubmed/35139484" } @Article{info:doi/10.2196/35971, author="Mathew, Mekha and van Vlymen, Jeremy and Meza-Torres, Bernardo and Hinton, William and Delanerolle, Gayathri and Yonova, Ivelina and Feher, Michael and Fan, Xuejuan and Liyanage, Harshana and Joy, Mark and Carinci, Fabrizio and de Lusignan, Simon", title="The Effect of the COVID-19 Pandemic on Glycemic Monitoring and Other Processes of Care for Type 2 Diabetes: Protocol for a Retrospective Cohort Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="22", volume="11", number="4", pages="e35971", keywords="cohort studies", keywords="COVID-19", keywords="computerized medical record systems", keywords="primary health care", keywords="type 2 diabetes mellitus", keywords="diabetes", keywords="glycemic control", keywords="monitoring", abstract="Background: Social distancing and other nonpharmaceutical interventions to reduce the spread of COVID-19 infection in the United Kingdom have led to substantial changes in delivering ongoing care for patients with chronic conditions, including type 2 diabetes mellitus (T2DM). Clinical guidelines for the management and prevention of complications for people with T2DM delivered in primary care services advise routine annual reviews and were developed when face-to-face consultations were the norm. The shift in consultations from face-to-face to remote consultations caused a reduction in direct clinical contact and may impact the process of care for people with T2DM. Objective: The aim of this study is to explore the impact of the COVID-19 pandemic's first year on the monitoring of people with T2DM using routine annual reviews from a national primary care perspective in England. Methods: A retrospective cohort study of adults with T2DM will be performed using routinely collected primary care data from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We will describe the change in the rate of monitoring of hemoglobin A1c (HbA1c) between the first year of the COVID-19 pandemic (2020) and the preceding year (2019). We will also report any change in the eight checks that make up the components of these reviews. The change in HbA1c monitoring rates will be determined using a multilevel logistic regression model, adjusting for patient and practice characteristics, and similarly, the change in a composite measure of the completeness of all eight checks will be modeled using ordinal regression. The models will be adjusted for the following patient-level variables: age, gender, socioeconomic status, ethnicity, COVID-19 shielding status, duration of diabetes, and comorbidities. The model will also be adjusted for the following practice-level variables: urban versus rural, practice size, Quality and Outcomes Framework achievement, the National Health Service region, and the proportion of face-to-face consultations. Ethical approval was provided by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (September 2, 2021, reference R77306/RE001). Results: The analysis of the data extract will include 3.96 million patients with T2DM across 700 practices, which is 6\% of the available Oxford-RCGP RSC adult population. The preliminary results will be submitted to a conference under the domain of primary care. The resulting publication will be submitted to a peer-reviewed journal on diabetes and endocrinology. Conclusions: The COVID-19 pandemic has impacted the delivery of care, but little is known about the process of caring for people with T2DM. This study will report the impact of the COVID-19 pandemic on these processes of care. International Registered Report Identifier (IRRID): DERR1-10.2196/35971 ", doi="10.2196/35971", url="https://www.researchprotocols.org/2022/4/e35971", url="http://www.ncbi.nlm.nih.gov/pubmed/35417404" } @Article{info:doi/10.2196/26339, author="Olson, Jenny and Hadjiconstantinou, Michelle and Luff, Carly and Watts, Karen and Watson, Natasha and Miller, Venus and Schofield, Deborah and Khunti, Kamlesh and Davies, J. Melanie and Calginari, Sara", title="From the United Kingdom to Australia---Adapting a Web-Based Self-management Education Program to Support the Management of Type 2 Diabetes: Tutorial", journal="J Med Internet Res", year="2022", month="Apr", day="20", volume="24", number="4", pages="e26339", keywords="diabetes mellitus", keywords="type 2", keywords="technology", keywords="self-management", doi="10.2196/26339", url="https://www.jmir.org/2022/4/e26339", url="http://www.ncbi.nlm.nih.gov/pubmed/35442198" } @Article{info:doi/10.2196/33205, author="Blanchette, E. Julia and Tran, MJ and Grigorian, G. Ernest and Iacob, Eli and Edelman, S. Linda and Oser, K. Tamara and Litchman, L. Michelle", title="GoFundMe as a Medical Plan: Ecological Study of Crowdfunding Insulin Success", journal="JMIR Diabetes", year="2022", month="Apr", day="15", volume="7", number="2", pages="e33205", keywords="diabetes", keywords="health care cost", keywords="crowdfunding", keywords="financial stress", keywords="insulin", abstract="Background: Individuals in need of medical care turn to crowdfunding websites?to engage a ``crowd'' or group for financial support. In the?last decade, access to insulin has decreased considerably for several reasons, including the rising cost of insulin, increasing popularity of high-deductible insurance plans, and increasing insurance premiums. Many people with diabetes are forced to ration or go without insulin, and they turn to crowdfunding websites to seek financial donations to purchase insulin needed to reduce health risks and mortality, and sustain quality of life.? Objective: This study aimed to explore crowdfunding campaign requests to purchase insulin in the United States. Methods: In this retrospective, quantitative, and qualitative study, we coded the text of GoFundMe online crowdfunding campaigns and viral measures (shares, hearts, and comments) from February 25 to April 15, 2019. We described campaigns (N=205) and explored the factors associated with campaign success using correlations and qualitative thematic analysis. Results: The majority of campaigns were initiated by middle-aged adults (age 26-64 years; 77/205, 37.6\%), those with type 1 diabetes (94/205, 45.9\%), and those needing funds owing to insurance coverage issues (125/205, 61.0\%). The factors associated with campaign success included requests for ?US \$500 (P=.007) and higher viral measures (shares, P=.007; hearts, P<.001; comments, P=.002). The following 4 themes emerged from the campaign text: (1) desire for self-management and survival, (2) diabetes management untenable given insulin access, (3) aftermath of insulin unaffordability, and (4) privacy issues with crowdfunding. Campaign comments were both supportive (tangible, informational, and emotional) and unsupportive (questioned the need for the campaign and deemed crowdfunding inappropriate). Conclusions: Despite crowdfunding websites being used to support the purchase of insulin, campaigns raised only a fraction of the money requested. Therefore, GoFundMe campaigns are not a reliable solution to obtain funds for insulin in the United States. Applying quantitative and qualitative methods is adequate to analyze online crowdfunding for costs of medications such as insulin. However, it is critical for people with diabetes to use resources other than online crowdfunding to access and obtain insulin owing to low success rates. Clinicians should routinely assess difficulty accessing or affording insulin, and federal health care policies should support lowering the cost of insulin. ", doi="10.2196/33205", url="https://diabetes.jmir.org/2022/2/e33205", url="http://www.ncbi.nlm.nih.gov/pubmed/35436214" } @Article{info:doi/10.2196/33213, author="Cooper, Drew and Ubben, Tebbe and Knoll, Christine and Ballhausen, Hanne and O'Donnell, Shane and Braune, Katarina and Lewis, Dana", title="Open-source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Platform Feasibility Study", journal="JMIR Diabetes", year="2022", month="Mar", day="31", volume="7", number="1", pages="e33213", keywords="diabetes", keywords="type 1 diabetes", keywords="automated insulin delivery", keywords="diabetes technology", keywords="open-source", keywords="patient-reported outcomes", keywords="real-world data", keywords="research methods", keywords="mixed methods", keywords="insulin", keywords="digital health", keywords="web portal", abstract="Background: People with diabetes and their support networks have developed open-source automated insulin delivery systems to help manage their diabetes therapy, as well as to improve their quality of life and glycemic outcomes. Under the hashtag \#WeAreNotWaiting, a wealth of knowledge and real-world data have been generated by users of these systems but have been left largely untapped by research; opportunities for such multimodal studies remain open. Objective: We aimed to evaluate the feasibility of several aspects of open-source automated insulin delivery systems including challenges related to data management and security across multiple disparate web-based platforms and challenges related to implementing follow-up studies. Methods: We developed a mixed methods study to collect questionnaire responses and anonymized diabetes data donated by participants---which included adults and children with diabetes and their partners or caregivers recruited through multiple diabetes online communities. We managed both front-end participant interactions and back-end data management with our web portal (called the Gateway). Participant questionnaire data from electronic data capture (REDCap) and personal device data aggregation (Open Humans) platforms were pseudonymously and securely linked and stored within a custom-built database that used both open-source and commercial software. Participants were later given the option to include their health care providers in the study to validate their questionnaire responses; the database architecture was designed specifically with this kind of extensibility in mind. Results: Of 1052 visitors to the study landing page, 930 participated and completed at least one questionnaire. After the implementation of health care professional validation of self-reported clinical outcomes to the study, an additional 164 individuals visited the landing page, with 142 completing at least one questionnaire. Of the optional study elements, 7 participant--health care professional dyads participated in the survey, and 97 participants who completed the survey donated their anonymized medical device data. Conclusions: The platform was accessible to participants while maintaining compliance with data regulations. The Gateway formalized a system of automated data matching between multiple data sets, which was a major benefit to researchers. Scalability of the platform was demonstrated with the later addition of self-reported data validation. This study demonstrated the feasibility of custom software solutions in addressing complex study designs. The Gateway portal code has been made available open-source and can be leveraged by other research groups. ", doi="10.2196/33213", url="https://diabetes.jmir.org/2022/1/e33213", url="http://www.ncbi.nlm.nih.gov/pubmed/35357312" } @Article{info:doi/10.2196/32162, author="Ramchandran, S. Rajeev and Yousefi-Nooraie, Reza and Dadgostar, Porooshat and Yilmaz, Sule and Basant, Jesica and Dozier, M. Ann", title="Implementation of Teleophthalmology to Improve Diabetic Retinopathy Surveillance: Qualitative Interview Study of Clinical Staff Informed by Implementation Science Frameworks", journal="JMIR Diabetes", year="2022", month="Mar", day="30", volume="7", number="1", pages="e32162", keywords="Consolidated Framework for Implementation Research", keywords="teleophthalmology", keywords="diabetic retinopathy", keywords="implementation", keywords="qualitative study", keywords="Practical, Robust Implementation and Sustainability Model", abstract="Background: The store-and-forward camera-based evaluation of the eye, or teleophthalmology, is an effective way to identify diabetic retinopathy, the leading cause of blindness in the United States, but uptake has been slow. Understanding the barriers to and facilitators of implementing teleophthalmology programs from those actively adopting, running, and sustaining such programs is important for widespread adoption. Objective: This study aims to understand the factors that are important in introducing teleophthalmology to improve access to diagnostic eye care for patients with diabetes in primary care clinics by using implementation science. Methods: This qualitative study in 3 urban, low-income, largely racial and ethnic minority--serving safety-net primary care clinics in Rochester, New York, interviewed nurses and physicians on implementing a teleophthalmology program by using questions informed by the Practical, Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research. Results: Primary care nurses operationalizing the program in their clinics saw increased work burden and a lack of self-efficacy as barriers. Continuous training on the teleophthalmology process for nurses, physicians, and administrative staff through in-service and peer training by champions and superusers were identified by interviewees as needs. Facilitators included the perceived convenience for the patient and a perceived educational advantage to the program, as it gave an opportunity for providers to discuss the importance of eye care with patients. Concerns in making and tracking referrals to ophthalmology because of challenges related to care coordination were highlighted. The financial aspects of the program (eg, patient coverage and care provider reimbursement) were unclear to many staff members, influencing adoption and sustainability. Conclusions: Streamlining processes and workflows, training and assigning adequate staff, effectively coordinating care between primary care and eye care to improve follow-ups, and ensuring financial viability can all help streamline the adoption of teleophthalmology. ", doi="10.2196/32162", url="https://diabetes.jmir.org/2022/1/e32162", url="http://www.ncbi.nlm.nih.gov/pubmed/35353038" } @Article{info:doi/10.2196/35461, author="Lambert-Obry, Veronique and Lafrance, Jean-Philippe and Savoie, Michelle and Lachaine, Jean", title="The Impact of Hypoglycemia on Productivity Loss and Utility in Patients With Type 2 Diabetes Treated With Insulin in Real-world Canadian Practice: Protocol for a Prospective Study", journal="JMIR Res Protoc", year="2022", month="Mar", day="28", volume="11", number="3", pages="e35461", keywords="real-world evidence", keywords="work productivity", keywords="health-related quality of life", keywords="diabetes", keywords="hypoglycemia", abstract="Background: Type 2 diabetes mellitus (T2DM) imposes a substantial burden owing to its increasing prevalence and life-threatening complications. In patients who do not achieve glycemic targets with oral antidiabetic drugs, the initiation of insulin is recommended. However, a serious concern regarding insulin is drug-induced hypoglycemia. Hypoglycemia is known to affect quality of life and the use of health care resources. However, health economics and outcomes research (HEOR) data for economic modelling are limited, particularly regarding utility values and productivity losses. Objective: This real-world prospective study aims to assess the impact of hypoglycemia on productivity and utility in insulin-treated adults with T2DM from Ontario and Quebec, Canada. Methods: This noninterventional, multicenter, 3-month prospective study will recruit patients from 4 medical clinics and 2 endocrinology or diabetes clinics. Patients will be identified using appointment lists and enrolled through consecutive sampling during routinely scheduled consultations. To be eligible, patients must be aged ?18 years, diagnosed with T2DM, and treated with insulin. Utility and productivity will be measured using the EQ-5D-5L questionnaire and Institute for Medical Technology Assessment Productivity Cost Questionnaire, respectively. Questionnaires will be completed 4, 8, and 12 weeks after recruitment. Generalized estimating equation models will be used to investigate productivity losses and utility decrements associated with incident hypoglycemic events while controlling for individual patient characteristics. A total of 500 patients will be enrolled to ensure the precision of HEOR estimates. Results: This study is designed to fill a gap in the Canadian evidence on the impact of hypoglycemia on HEOR outcomes. More specifically, it will generate productivity and utility inputs for the economic modeling of T2DM. Conclusions: Insulin therapy is expensive, and hypoglycemia is a significant component of economic evaluation. Robust HEOR data may help health technology assessment agencies in future reimbursement decision-making. International Registered Report Identifier (IRRID): PRR1-10.2196/35461 ", doi="10.2196/35461", url="https://www.researchprotocols.org/2022/3/e35461", url="http://www.ncbi.nlm.nih.gov/pubmed/35343912" } @Article{info:doi/10.2196/27486, author="Ryan, Irene and Herrick, Cynthia and Ebeling, E. Mary F. and Foraker, Randi", title="Constructing an Adapted Cascade of Diabetes Care Using Inpatient Admissions Data: Cross-sectional Study", journal="JMIR Diabetes", year="2022", month="Mar", day="25", volume="7", number="1", pages="e27486", keywords="diabetes mellitus", keywords="cascade of care", keywords="EHR data", keywords="health care monitoring", keywords="inpatient care", abstract="Background: The diabetes mellitus cascade of care has been constructed to evaluate diabetes care at a population level by determining the percentage of individuals diagnosed and linked to care as well as their reported glycemic control. Objective: We sought to adapt the cascade of care to an inpatient-only setting using the electronic health record (EHR) data of 81,633 patients with type 2 diabetes. Methods: In this adaptation, linkage to care was defined as prescription of diabetes medications within 3 months of discharge, and control was defined as hemoglobin A1c (HbA1c) below individual target levels, as these are the most reliably captured items in the inpatient setting. We applied the cascade model to assess differences in demographics and percent loss at each stage of the cascade; we then conducted two-sample chi-square equality of proportions tests for each demographic. Based on findings in the previous literature, we hypothesized that women, Black patients, younger patients (<45 years old), uninsured patients, and patients living in an economically deprived area called the Promise Zone would be disproportionately unlinked and uncontrolled. We also predicted that patients who received inpatient glycemic care would be more likely to reach glycemic control. Results: We found that out of 81,633 patients, 28,716 (35.2\%) were linked to care via medication prescription. Women and younger patients were slightly less likely to be linked to care than their male and older counterparts, while Black patients (n=19,141, 23.4\% of diagnosed population vs n=6741, 23.5\% of the linked population) were as proportionately part of the linked population as White patients (n=58,291, 71.4\% of diagnosed population vs n=20,402, 71.0\% of the linked population). Those living in underserved communities (ie, the Promise Zone) and uninsured patients were slightly overrepresented (n=6789, 8.3\% of diagnosed population vs n=2773, 9.7\% of the linked population) in the linked population as compared to patients living in wealthier zip codes and those who were insured. Similar patterns were observed among those more likely to reach glycemic control via HbA1c. However, conclusions are limited by the relatively large amount of missing glycemic data. Conclusions: We conclude that inpatient EHR data do not adequately capture the care cascade as defined in the outpatient setting. In particular, missing data in this setting may preclude assessment of glycemic control. Future work should integrate inpatient and outpatient data sources to complete the picture of diabetes care. ", doi="10.2196/27486", url="https://diabetes.jmir.org/2022/1/e27486", url="http://www.ncbi.nlm.nih.gov/pubmed/35333182" } @Article{info:doi/10.2196/30829, author="Rothmann, Juel Mette and Mouritsen, Drotner Julie and Ladefoged, Skov Nanna and Jeppesen, Nedergaard Marie and Lillevang, Sofie Anna and Laustrup, Helle and Ellingsen, Torkell", title="The Use of Telehealth for Psychological Counselling of Vulnerable Adult Patients With Rheumatic Diseases or Diabetes: Explorative Study Inspired by Participatory Design", journal="JMIR Hum Factors", year="2022", month="Mar", day="21", volume="9", number="1", pages="e30829", keywords="telehealth", keywords="videoconferencing", keywords="app", keywords="co-production", keywords="co-creation", keywords="psychologist", keywords="psychology", keywords="rheumatic diseases", keywords="diabetes", keywords="mobile phone", abstract="Background: Video consultation is increasingly used in different health care settings to reach patients. However, little is known about telehealth in psychological counselling for vulnerable patients with somatic and chronic conditions such as rheumatoid arthritis and diabetes. Objective: This study aimed to develop and pilot test a telepsychology module for inclusion in the app My Hospital (Mit Sygehus) to provide remote psychological counselling to vulnerable adults with either rheumatic diseases or diabetes. Methods: With inspiration from participatory design, the content of the telepsychology module was developed through user involvement and evaluated by individual interviews with patients and psychologists as well as questionnaires. Results: We developed a module with our patient partners that targeted patients with rheumatic diseases and diabetes in relation to the psychological challenges of living with chronic diseases. The module included information, tools, exercises, and videoconferencing. In total, 16 patients and 3 psychologists participated in the pilot test. Psychological counselling was described by 4 themes: ``The good relation despite physical distance,'' ``The comfort of being at home,'' ``The pros of saving time on transport and energy,'' and ``A therapeutic alliance at a distance.'' Conclusions: Psychological counselling in relation to somatic care can be provided by videoconferencing supported by web-based or mobile delivery of tailored information, tools, and exercises without compromising on the quality of care. To ensure a good alliance between the patient and psychologist, a first face-to-face meeting is important. The home location provided patients with a safe environment and increased accessibility and reduced travel time to the hospital. ", doi="10.2196/30829", url="https://humanfactors.jmir.org/2022/1/e30829", url="http://www.ncbi.nlm.nih.gov/pubmed/35311690" } @Article{info:doi/10.2196/23535, author="Idris, Y. Muhammed and Alema-Mensah, Ernest and Olorundare, Elizabeth and Mohammad, Mohammad and Brown, Michelle and Ofili, Elizabeth and Pemu, Priscilla", title="Exploring the Discursive Emphasis on Patients and Coaches Who Participated in Technology-Assisted Diabetes Self-management Education: Clinical Implementation Study of Health360x", journal="J Med Internet Res", year="2022", month="Mar", day="18", volume="24", number="3", pages="e23535", keywords="self-management", keywords="structural topic modeling", keywords="coaching", keywords="diabetes", keywords="minority populations", keywords="mobile phone", abstract="Background: A critical unmet need for underserved patients with diabetes is regular access to sufficient support for diabetes self-management. Although advances in digital technologies have made way for eHealth applications that provide a scalable path for tailored interventions for self-management of chronic conditions, health and digital literacy has remained an obstacle to leveraging these technologies for effective diabetes self-management education. Studies have shown that the availability of coaches helps to maintain engagement in internet-based studies and improves self-efficacy for behavior change. However, little is known about the substances involved in these interactions. Objective: This study aims to compare the content of conversations between patient--coach pairs that achieved their self-management goals and those that did not. The context is a clinical implementation study of diabetes self-management behavior change using Health360x within the practices of the Morehouse Choice Accountable Care Organization in the Atlanta metro area. Health360x is a coach-assisted consumer health information technology designed to support self-management skills acquisition and behavior among underserved, high-risk patients with diabetes. Methods: We provide a novel analysis of the discursive emphasis on patients and coaches. We examined transcripts of visits using a structural topic model to estimate topic content and prevalence as a function of patient and coach characteristics. We compared topics between patient--coach pairs that achieved diabetes-related self-management goals and those who did not. We also estimated a regression in which utterances are the units, the dependent variable is the proportion of an utterance that is about a given topic, and the independent variables are speaker types and explored other themes. Results: Transcripts from 50 patients who were recruited and consented, starting in February 2015, were analyzed. A total of 44 topics were estimated for patient--coach pairs that achieved their intended health goals and 50 topics for those who did not. Analysis of the structural topic model results indicated that coaches in patient--coach pairs that were able to achieve self-management goals provided more contextual feedback and probed into patients' experience with technology and trust in consumer information technologies. We also found that discussions around problem areas and stress, support ($\beta$Coach=.015; P<.001), initial visits ($\beta$Coach=.02; P<.001), problems with technology ($\beta$Coach=.01; P<.001), health eating goals ($\beta$Coach=.01; P=.04), diabetes knowledge ($\beta$Coach=.02; P<.001), managing blood sugar ($\beta$Coach=.03; P<.001), and using Health360x ($\beta$Coach=.003; P=.03) were dominated by coaches. Conclusions: Coach-facilitated, technology-based diabetes self-management education can help underserved patients with diabetes. Our use of topic modeling in this application sheds light on the actual dynamics in conversations between patients and coaches. Knowledge of the key elements for successful coach--patient interactions based on the analysis of transcripts could be applied to understanding everyday patient--provider encounters, given the recent paradigm shift around the use of telehealth. ", doi="10.2196/23535", url="https://www.jmir.org/2022/3/e23535", url="http://www.ncbi.nlm.nih.gov/pubmed/35302506" } @Article{info:doi/10.2196/34918, author="Schretzlmaier, Patrik and Hecker, Achim and Ammenwerth, Elske", title="Suitability of the Unified Theory of Acceptance and Use of Technology 2 Model for Predicting mHealth Acceptance Using Diabetes as an Example: Qualitative Methods Triangulation Study", journal="JMIR Hum Factors", year="2022", month="Mar", day="9", volume="9", number="1", pages="e34918", keywords="mHealth", keywords="mobile health", keywords="mobile apps", keywords="diabetes mellitus", keywords="technology acceptance", keywords="UTAUT2", keywords="mobile phone", abstract="Background: In recent years, the use of mobile health (mHealth) apps to manage chronic diseases has increased significantly. Although mHealth apps have many benefits, their acceptance is still low in certain areas and groups. Most mHealth acceptance studies are based on technology acceptance models. In particular, the Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) model was developed to predict technology acceptance in a consumer context. However, to date, only a few studies have used the UTAUT2 model to predict mHealth acceptance and confirm its suitability for the health sector. Thus, it is unclear whether the UTAUT2 model is suitable for predicting mHealth acceptance and whether essential variables for a health-related context are missing. Objective: This study aims to validate the suitability of UTAUT2 for predicting mHealth acceptance. Methods: In this study, diabetes was used as an example as mHealth apps are a significant element of diabetes self-management. In addition, diabetes is one of the most common chronic diseases affecting young and older people worldwide. An explorative literature review and guided interviews with 11 mHealth or technology acceptance experts and 8 mHealth users in Austria and Germany were triangulated to identify all relevant constructs for predicting mHealth acceptance. The interview participants were recruited by purposive sampling until theoretical saturation was reached. Data were analyzed using structured content analysis based on inductive and deductive approaches. Results: This study was able to confirm the relevance of all exogenous UTAUT2 constructs. However, it revealed two additional constructs that may also need to be considered to better predict mHealth acceptance: trust and perceived disease threat. Conclusions: This study showed that the UTAUT2 model is suitable for predicting mHealth acceptance. However, the model should be extended to include 2 additional constructs for use in the mHealth context. ", doi="10.2196/34918", url="https://humanfactors.jmir.org/2022/1/e34918", url="http://www.ncbi.nlm.nih.gov/pubmed/35262493" } @Article{info:doi/10.2196/13635, author="Kumar, Dinesh and Bhardwaj, Ashok and Sharma, Shruti and Malhotra, Bhavya and Amadi-Mgbenka, Chioma and Grover, Ashoo and Joshi, Ashish", title="Designing and Evaluating a Personalized, Human-Centered Dietary Decision Support System for Use Among People With Diabetes in an Indian Setting: Protocol for a Quasi-Experimental Study", journal="JMIR Res Protoc", year="2022", month="Mar", day="8", volume="11", number="3", pages="e13635", keywords="type 2 diabetes", keywords="diabetes management", keywords="dietary decision support", keywords="diet record", keywords="India", abstract="Background: Human-centered dietary decision support systems are fundamental to diabetes management, and they address the limitations of existing diet management systems. Objective: The objective of the proposed study is to evaluate the use of an interactive, telephone-linked, personalized, human-centered decision support system for facilitating the delivery of personalized nutrition care for patients with diabetes. Methods: A quasi-experimental trial was conducted between the period of June and December 2018. Study participants were recruited from Community Health Center, Dharamshala, Kangra (urban population), and Model Rural Health Unit, Haroli Block, Una (rural population). Eligible participants included adults aged ?30 years with controlled or uncontrolled diabetes, those who agreed to participate in the study, those who were available for follow-up interviews, and those with a telephone or computer at home. Diabetic status was determined via a physician's diagnosis. Individuals with mental or physical challenges that affected their ability to use an electronic diet record, those who were not available for a telephone follow-up, and those who were involved in other protocols related to dietary assessments were excluded. The study participants were randomized into the following two groups: the intervention group (telephone-linked dietary decision support system) and the control group (paper-based diet record). Study participants in the intervention group recorded their daily dietary intake by using a telephone-linked, personalized, human-centered dietary decision support system and received personalized feedback and diet education via SMS text messaging. Study participants in the control group were provided with only a paper-based diet record for documenting their daily dietary intake. Follow-up visits were conducted at 3 and 6 months from the baseline in both groups. Differences in diabetes knowledge, attitudes, and practices will be measured across groups. Results: The collection of baseline data from 800 study participants in both the intervention (n=400) and control groups (n=400), which were stratified by urban (control group: n=200; intervention group: n=200) and rural settings (control group: n=200; intervention group: n=200), has been completed. Follow-up data collection for months 3 and 6 is ongoing and is expected to be completed by October 2019. Conclusions: We anticipate that the intervention group will show significant changes in nutrition knowledge, attitudes, and practices; satisfaction with care; and overall diabetes management. We also expect to see urban-rural differences across the groups. The uniqueness of our nutrient data capture process is demonstrated by its cultural and contextually relevant features---diet capture in both English and Hindi, diet conversion into caloric components, sustained diet data collection and participant adherence through telephone-linked care, and auto-generated reminders. International Registered Report Identifier (IRRID): DERR1-10.2196/13635 ", doi="10.2196/13635", url="https://www.researchprotocols.org/2022/3/e13635", url="http://www.ncbi.nlm.nih.gov/pubmed/35258472" } @Article{info:doi/10.2196/25855, author="Penley, Benjamin and Minshew, Lana and Chen, Hui-Han and Eckel, Stephen and Ozawa, Sachiko", title="Accessibility of Low-cost Insulin From Illegitimate Internet Pharmacies: Cross-sectional Study", journal="J Med Internet Res", year="2022", month="Feb", day="14", volume="24", number="2", pages="e25855", keywords="insulin", keywords="diabetes", keywords="internet", keywords="online", keywords="pharmacy", keywords="medication", keywords="cost", abstract="Background: There is much public debate regarding the high cost of insulin. With 1-in-4 patients in the United States with type 1 diabetes reporting difficulties affording insulin, there is concern that some of these patients might look for cost savings on the internet, unaware that 96\% of internet pharmacies are illegitimate. Patients who purchase insulin from illegitimate internet pharmacies remove themselves from traditional health care systems that ensure safe, quality-assured, and effective medication use. Objective: This study aims to determine the accessibility of Humalog and NovoLog insulin from internet pharmacies and characterize how these sites approached patient safety, and priced as well as marketed their products. Methods: From September to December 2019, we queried the phrases buy insulin online, buy Humalog online, and buy NovoLog online in common search engines. The first 100 search results from Google and Bing, and the first 50 search results from Yahoo! and DuckDuckGo were screened. Websites were included if they claimed to sell Humalog or NovoLog insulin, were active, free access, in the English language, and had a unique URL. The legitimacy of websites was classified using LegitScript. Safety and marketing characteristics were compared across the legitimacy of internet pharmacies. Internet pharmacy prices were compared with the prices offered through brick-and-mortar pharmacies using GoodRx. Results: We found that 59\% (n=29) of the 49 internet pharmacies in our analysis were illegitimate, whereas only 14\% (n=7) were legitimate and 27\% (n=13) were unclassified. Across illegitimate internet pharmacies, Humalog and NovoLog insulin were 2 to 5 times cheaper as compared with both legitimate internet pharmacies and brick-and-mortar stores. Risks associated with the use of illegitimate internet pharmacies by American consumers were evident: 57\% (8/14) did not require a prescription, 43\% (6/14) did not display medication information or warnings, and only 21\% (3/14) offered access to purported pharmacists. This included 9 rogue internet pharmacies that sold Humalog and NovoLog insulin within the United States, where 11\% (1/9) required a prescription, 11\% (1/9) placed quantity limits per purchase, and none offered pharmacist services. Rogue internet pharmacies often offered bulk discounts (11/18, 61\%), assured privacy (14/18, 78\%), and promoted other products alongside insulin (13/18, 72\%). The marketing language of illegitimate internet pharmacies appealed more to quality, safety, and customer service as compared with legitimate sites. Conclusions: The ease of access to low-cost insulin through illegitimate internet pharmacies calls for urgent attention. Illegitimate internet pharmacies place patients at risk of poor-quality medications and subpar pharmacy services, resulting in adverse events and poor diabetes control. A multifaceted approach is needed to close illegitimate internet pharmacies through legal and regulatory measures, develop better search engine filters, raise public awareness of the dangers of illegitimate internet pharmacies, and address the high costs of insulin. ", doi="10.2196/25855", url="https://www.jmir.org/2022/2/e25855", url="http://www.ncbi.nlm.nih.gov/pubmed/35156937" } @Article{info:doi/10.2196/32923, author="Fundoiano-Hershcovitz, ?Yifat and Bacher, Dror and Ritholz, D. Marilyn and Horwitz, L. David and Manejwala, Omar and Goldstein, Pavel", title="Blood Pressure Monitoring as a Digital Health Tool for Improving Diabetes Clinical Outcomes: Retrospective Real-world Study", journal="J Med Internet Res", year="2022", month="Feb", day="8", volume="24", number="2", pages="e32923", keywords="blood glucose", keywords="blood pressure", keywords="monitoring", keywords="digital therapeutic", keywords="diabetes", keywords="hypertension", keywords="app", keywords="model", keywords="chronic disease", keywords="health data", abstract="Background: Remote data capture for blood glucose (BG) or blood pressure (BP) monitoring and the use of a supportive digital app are becoming the model in diabetes and hypertension chronic care. One of the goals in chronic condition management is to increase awareness and generate behavioral change in order to improve outcomes in diabetes and related comorbidities, such as hypertension. In addition, there is a lack of understanding of the association between BG and BP levels when using digital health tools. Objective: By applying a rigorous study framework to digital health data, this study investigated the relationship between BP monitoring and BG and BP levels, as well as a lagged association between BP and BG. We hypothesized that during the first 6 months of BP monitoring, BG and BP levels would decrease. Finally, we suggested a positive association between BP levels and the following month's BG levels. Methods: In this retrospective, real-world case-control study, we extracted the data of 269 people with type 2 diabetes (T2D) who tracked their BG levels using the Dario digital platform for a chronic condition. We analyzed the digital data of the users who, in addition to BG, monitored their BP using the same app (BP-monitoring [BPM] group, n=137) 6 months before and after starting their BP monitoring. Propensity score matching established a control group, no blood pressure monitoring (NBPM, n=132), matched on demographic and baseline clinical measures to the BPM group. A piecewise mixed model was used for analyzing the time trajectories of BG, BP, and their lagged association. Results: Analysis revealed a significant difference in BG time trajectories associated with BP monitoring in BPM and NBPM groups (t=--2.12, P=.03). The BPM group demonstrated BG reduction improvement in the monthly average BG levels during the first 6 months (t=--3.57, P<.001), while BG did not change for the NBPM group (t=0.39, P=.70). Both groups showed similarly stable BG time trajectories (B=0.98, t=1.16, P=.25) before starting the use of the BP-monitoring system. In addition, the BPM group showed a significant reduction in systolic (t=--6.42, P<.001) and diastolic (t=--4.80, P<.001) BP during the first 6 months of BP monitoring. Finally, BG levels were positively associated with systolic (B=0.24, t=2.77, P=.001) and diastolic (B=0.30, t=2.41, P=.02) BP. Conclusions: The results of this study shed light on the association between BG and BP levels and on the role of BP self-monitoring in diabetes management. Our findings also underscore the need and provide a basis for a comprehensive approach to understanding the mechanism of BP regulation associated with BG. ", doi="10.2196/32923", url="https://www.jmir.org/2022/2/e32923", url="http://www.ncbi.nlm.nih.gov/pubmed/35133284" } @Article{info:doi/10.2196/31123, author="Hopper, Wade and Fox, Justin and Dimucci-Ward, JuliSu", title="Assessment of Glycemic Control at St. Luke's Free Medical Clinic: Retrospective Chart Review", journal="Interact J Med Res", year="2022", month="Jan", day="24", volume="11", number="1", pages="e31123", keywords="free clinic", keywords="glycemic control", keywords="underserved", keywords="uninsured", keywords="diabetes", keywords="health care delivery", keywords="treatment program", abstract="Background: A free clinic is a health care delivery model that provides primary care and pharmaceutical services exclusively to uninsured patients. With a multidisciplinary volunteer clinical staff, which includes physicians, social workers, dieticians, and osteopathic medical students, St. Luke's Free Medical Clinic (SLFMC) cares for over 1700 patients annually in Spartanburg, South Carolina. Objective: This study aims to measure the change, over time, in patient hemoglobin A1c measurements at the SLFMC to quantify the success of the clinic's diabetes treatment program. Methods: A prospective-retrospective chart review of patients (n=140) enrolled at the SLFMC between January 1, 2018, and January 1, 2021, was performed. Patients were stratified as having controlled (hemoglobin A1c<7.0, n=53) or uncontrolled (hemoglobin A1c?7.0, n=87) diabetes relative to a therapeutic hemoglobin A1c target of 7.0, which is recommended by the American Diabetes Association. For both controlled and uncontrolled groups, baseline hemoglobin A1c values were compared to subsequent readings using a Wilcoxon matched-pairs signed rank test. Results from the SLFMC population were compared to the published literature on hemoglobin A1c from other free clinics. Results: Patients with uncontrolled diabetes experienced significant reductions in median hemoglobin A1c at both 6 months (P=.006) and 1 year (P=.002) from baseline. Patients with controlled diabetes showed no significant changes. Black and Hispanic patients with uncontrolled diabetes experienced a 1.0\% mean improvement in hemoglobin A1c over the study window. The SLFMC's wholly uninsured patient population showed a population rate of controlled diabetes (42\%), which was similar to recent nationwide averages for adults with diabetes (51\% to 56\%), as reported by the National Health and Nutrition Examination Survey. The clinic's Hispanic population (n=47) showed the greatest average improvement in hemoglobin A1c of any ethnic group from baseline. Additionally, 61\% of the SLFMC's Black population (n=33) achieved a hemoglobin A1c of <7.0 by the end of the study window, which surpassed the nationwide averages for glycemic control. Conclusions: We present free clinic hemoglobin A1c outcomes obtained through a retrospective chart review. Uninsured patients treated for diabetes at the SLFMC show a reduction in hemoglobin A1c, which is comparable to nationwide standards, although average hemoglobin A1c levels in this study were higher than nationwide averages. Black and Hispanic patients with uncontrolled diabetes showed a mean 1\% improvement in hemoglobin A1c levels. These results represent some of the first in the literature emerging from a free clinic that is not affiliated with a major medical school. ", doi="10.2196/31123", url="https://www.i-jmr.org/2022/1/e31123", url="http://www.ncbi.nlm.nih.gov/pubmed/35072636" } @Article{info:doi/10.2196/27434, author="Ahne, Adrian and Fagherazzi, Guy and Tannier, Xavier and Czernichow, Thomas and Orchard, Francisco", title="Improving Diabetes-Related Biomedical Literature Exploration in the Clinical Decision-making Process via Interactive Classification and Topic Discovery: Methodology Development Study", journal="J Med Internet Res", year="2022", month="Jan", day="18", volume="24", number="1", pages="e27434", keywords="evidence-based medicine", keywords="clinical decision making", keywords="clinical decision support", keywords="digital health", keywords="medical informatics", keywords="transparency", keywords="hierarchical clustering", keywords="active learning", keywords="classification", keywords="memory consumption", keywords="natural language processing", abstract="Background: The amount of available textual health data such as scientific and biomedical literature is constantly growing and becoming more and more challenging for health professionals to properly summarize those data and practice evidence-based clinical decision making. Moreover, the exploration of unstructured health text data is challenging for professionals without computer science knowledge due to limited time, resources, and skills. Current tools to explore text data lack ease of use, require high computational efforts, and incorporate domain knowledge and focus on topics of interest with difficulty. Objective: We developed a methodology able to explore and target topics of interest via an interactive user interface for health professionals with limited computer science knowledge. We aim to reach near state-of-the-art performance while reducing memory consumption, increasing scalability, and minimizing user interaction effort to improve the clinical decision-making process. The performance was evaluated on diabetes-related abstracts from PubMed. Methods: The methodology consists of 4 parts: (1) a novel interpretable hierarchical clustering of documents where each node is defined by headwords (words that best represent the documents in the node), (2) an efficient classification system to target topics, (3) minimized user interaction effort through active learning, and (4) a visual user interface. We evaluated our approach on 50,911 diabetes-related abstracts providing a hierarchical Medical Subject Headings (MeSH) structure, a unique identifier for a topic. Hierarchical clustering performance was compared against the implementation in the machine learning library scikit-learn. On a subset of 2000 randomly chosen diabetes abstracts, our active learning strategy was compared against 3 other strategies: random selection of training instances, uncertainty sampling that chooses instances about which the model is most uncertain, and an expected gradient length strategy based on convolutional neural networks (CNNs). Results: For the hierarchical clustering performance, we achieved an F1 score of 0.73 compared to 0.76 achieved by scikit-learn. Concerning active learning performance, after 200 chosen training samples based on these strategies, the weighted F1 score of all MeSH codes resulted in a satisfying 0.62 F1 score using our approach, 0.61 using the uncertainty strategy, 0.63 using the CNN, and 0.45 using the random strategy. Moreover, our methodology showed a constant low memory use with increased number of documents. Conclusions: We proposed an easy-to-use tool for health professionals with limited computer science knowledge who combine their domain knowledge with topic exploration and target specific topics of interest while improving transparency. Furthermore, our approach is memory efficient and highly parallelizable, making it interesting for large Big Data sets. This approach can be used by health professionals to gain deep insights into biomedical literature to ultimately improve the evidence-based clinical decision making process. ", doi="10.2196/27434", url="https://www.jmir.org/2022/1/e27434", url="http://www.ncbi.nlm.nih.gov/pubmed/35040795" } @Article{info:doi/10.2196/31567, author="Poduval, Shoba and Ross, Jamie and Pal, Kingshuk and Newhouse, Nikki and Hamilton, Fiona and Murray, Elizabeth", title="Web-Based Structured Education for Type 2 Diabetes: Interdisciplinary User-Centered Design Approach", journal="JMIR Hum Factors", year="2022", month="Jan", day="14", volume="9", number="1", pages="e31567", keywords="type 2 diabetes", keywords="patient self-management", keywords="diabetes education", keywords="primary care", keywords="digital health", abstract="Background: Digital health research encompasses methods from human-computer interaction and health research. Objective: This paper aims to describe how these methods were combined to develop HeLP-Diabetes: Starting Out, a web-based structured education program for people newly diagnosed with type 2 diabetes. Methods: The development process consisted of three phases: initial design for effectiveness, optimization for usability, and in the wild testing in the National Health Service with people newly diagnosed with type 2 diabetes, and further revisions. We adopted an iterative user-centered approach and followed steps from the human-computer interaction design life cycle and the Medical Research Council guidelines on developing and evaluating complex interventions. Results: The initial design process resulted in an 8-session program containing information and behavior change techniques targeting weight loss, being more active, and taking medication. The usability testing was highlighted at an early stage, where changes needed to be made to the language and layout of the program. The in the wild testing provided data on uptake of and barriers to use. The study suggested low uptake and completion of the program, but those who used it seemed to benefit from it. The qualitative findings suggested that barriers to use included an expectation that the program would take too long. This informed refinements to the program. Conclusions: The use of interdisciplinary methods resulted in an iterative development process and refinements to the program that were based on user needs and data on uptake. The final intervention was more suitable for a definitive evaluation than the initial version. The description of our approach informs other digital health researchers on how to make interventions more sensitive to user needs. ", doi="10.2196/31567", url="https://humanfactors.jmir.org/2022/1/e31567", url="http://www.ncbi.nlm.nih.gov/pubmed/35029531" } @Article{info:doi/10.2196/23243, author="Batten, Ryan and Alwashmi, F. Meshari and Mugford, Gerald and Nuccio, Misa and Besner, Angele and Gao, Zhiwei", title="A 12-Month Follow-Up of the Effects of a Digital Diabetes Prevention Program (VP Transform for Prediabetes) on Weight and Physical Activity Among Adults With Prediabetes: Secondary Analysis", journal="JMIR Diabetes", year="2022", month="Jan", day="14", volume="7", number="1", pages="e23243", keywords="mHealth", keywords="mobile health", keywords="diabetes", keywords="DPP", keywords="diabetes prevention program", keywords="digital health", keywords="longitudinal study", keywords="prevention", keywords="weight loss", keywords="physical activity", abstract="Background: The prevalence of diabetes is increasing rapidly. Previous research has demonstrated the efficacy of a diabetes prevention program (DPP) in lifestyle modifications that can prevent or delay the onset of type 2 diabetes among individuals at risk. Digital DPPs have the potential to use technology, in conjunction with behavior change science, to prevent prediabetes on a national and global scale. Objective: The aim of this study is to investigate the effects of a digital DPP (Virgin Pulse [VP] Transform for Prediabetes) on weight and physical activity among participants who had completed 12 months of the program. Methods: This study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in VP Transform for Prediabetes for 12 months of the program. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. Results: The sample (N=1095) was comprised of people with prediabetes who completed at least 9 months of the VP Transform for Prediabetes program. Participants were 67.7\% (n=741) female, with a mean age of 53.6 (SD 9.75) years. After 12 months, participants decreased their weight by an average of 10.9 lbs (5.5\%; P<.001) and increased their physical activity by 91.2 (P<.001) minutes. Conclusions: These results suggest that VP Transform for Prediabetes is effective at preventing type 2 diabetes through a significant reduction in body weight and increase of physical activity. Furthermore, these results suggest that the DPP remains effective 12 months after beginning the program. A prospective randomized controlled clinical study is warranted to validate these findings. ", doi="10.2196/23243", url="https://diabetes.jmir.org/2022/1/e23243", url="http://www.ncbi.nlm.nih.gov/pubmed/35029532" } @Article{info:doi/10.2196/27220, author="Wang, Y. Seamus and Yeh, Hsin-Chieh and Stein, Apfel Arielle and Miller, R. Edgar", title="Use of Health Information Technology by Adults With Diabetes in the United States: Cross-sectional Analysis of National Health Interview Survey Data (2016-2018)", journal="JMIR Diabetes", year="2022", month="Jan", day="12", volume="7", number="1", pages="e27220", keywords="health information technology", keywords="National Health Interview Survey", keywords="diabetes", keywords="Healthy People 2020", keywords="Healthy People 2030", keywords="mobile phone", abstract="Background: The use of health information technology (HIT) has been proposed to improve disease management in patients with type 2 diabetes mellitus. Objective: This study aims to report the prevalence of HIT use in adults with diabetes in the United States and examine the factors associated with HIT use. Methods: We analyzed data from 7999 adults who self-reported a diabetes diagnosis as collected by the National Health Interview Survey (2016-2018). All analyses were weighted to account for the complex survey design. Results: Overall, 41.2\% of adults with diabetes reported looking up health information on the web, and 22.8\% used eHealth services (defined as filled a prescription on the web, scheduled an appointment with a health care provider on the web, or communicated with a health care provider via email). In multivariable models, patients who were female (vs male: prevalence ratio [PR] 1.16, 95\% CI 1.10-1.24), had higher education (above college vs less than high school: PR 3.61, 95\% CI 3.01-4.33), had higher income (high income vs poor: PR 1.40, 95\% CI 1.23-1.59), or had obesity (vs normal weight: PR 1.11, 95\% CI 1.01-1.22) were more likely to search for health information on the web. Similar associations were observed among age, race and ethnicity, education, income, and the use of eHealth services. Patients on insulin were more likely to use eHealth services (on insulin vs no medication: PR 1.21, 95\% CI 1.04-1.41). Conclusions: Among adults with diabetes, HIT use was lower in those who were older, were members of racial minority groups, had less formal education, or had lower household income. Health education interventions promoted through HIT should account for sociodemographic factors. ", doi="10.2196/27220", url="https://diabetes.jmir.org/2022/1/e27220", url="http://www.ncbi.nlm.nih.gov/pubmed/35019844" } @Article{info:doi/10.2196/33348, author="Keller, Roman and Hartmann, Sven and Teepe, Wilhelm Gisbert and Lohse, Kim-Morgaine and Alattas, Aishah and Tudor Car, Lorainne and M{\"u}ller-Riemenschneider, Falk and von Wangenheim, Florian and Mair, Louise Jacqueline and Kowatsch, Tobias", title="Digital Behavior Change Interventions for the Prevention and Management of Type 2 Diabetes: Systematic Market Analysis", journal="J Med Internet Res", year="2022", month="Jan", day="7", volume="24", number="1", pages="e33348", keywords="digital health companies", keywords="health care", keywords="type 2 diabetes", keywords="prevention", keywords="management", keywords="conversational agent", keywords="digital behavior change intervention", keywords="investment", keywords="just-in-time adaptive intervention", keywords="digital health", keywords="diabetes", keywords="agent", keywords="behavior", abstract="Background: Advancements in technology offer new opportunities for the prevention and management of type 2 diabetes. Venture capital companies have been investing in digital diabetes companies that offer digital behavior change interventions (DBCIs). However, little is known about the scientific evidence underpinning such interventions or the degree to which these interventions leverage novel technology-driven automated developments such as conversational agents (CAs) or just-in-time adaptive intervention (JITAI) approaches. Objective: Our objectives were to identify the top-funded companies offering DBCIs for type 2 diabetes management and prevention, review the level of scientific evidence underpinning the DBCIs, identify which DBCIs are recognized as evidence-based programs by quality assurance authorities, and examine the degree to which these DBCIs include novel automated approaches such as CAs and JITAI mechanisms. Methods: A systematic search was conducted using 2 venture capital databases (Crunchbase Pro and Pitchbook) to identify the top-funded companies offering interventions for type 2 diabetes prevention and management. Scientific publications relating to the identified DBCIs were identified via PubMed, Google Scholar, and the DBCIs' websites, and data regarding intervention effectiveness were extracted. The Diabetes Prevention Recognition Program (DPRP) of the Center for Disease Control and Prevention in the United States was used to identify the recognition status. The DBCIs' publications, websites, and mobile apps were reviewed with regard to the intervention characteristics. Results: The 16 top-funded companies offering DBCIs for type 2 diabetes received a total funding of US \$2.4 billion as of June 15, 2021. Only 4 out of the 50 identified publications associated with these DBCIs were fully powered randomized controlled trials (RCTs). Further, 1 of those 4 RCTs showed a significant difference in glycated hemoglobin A1c (HbA1c) outcomes between the intervention and control groups. However, all the studies reported HbA1c improvements ranging from 0.2\% to 1.9\% over the course of 12 months. In addition, 6 interventions were fully recognized by the DPRP to deliver evidence-based programs, and 2 interventions had a pending recognition status. Health professionals were included in the majority of DBCIs (13/16, 81\%,), whereas only 10\% (1/10) of accessible apps involved a CA as part of the intervention delivery. Self-reports represented most of the data sources (74/119, 62\%) that could be used to tailor JITAIs. Conclusions: Our findings suggest that the level of funding received by companies offering DBCIs for type 2 diabetes prevention and management does not coincide with the level of evidence on the intervention effectiveness. There is considerable variation in the level of evidence underpinning the different DBCIs and an overall need for more rigorous effectiveness trials and transparent reporting by quality assurance authorities. Currently, very few DBCIs use automated approaches such as CAs and JITAIs, limiting the scalability and reach of these solutions. ", doi="10.2196/33348", url="https://www.jmir.org/2022/1/e33348", url="http://www.ncbi.nlm.nih.gov/pubmed/34994693" } @Article{info:doi/10.2196/33116, author="Shrestha, Ruchi and Singh, Prerana and Dhakhwa, Parami and Tetali, Shailaja and Batchu, Tripura and Shrestha Thapa, Pragati", title="Augmenting the Referral Pathway for Retinal Services Among Patients With Diabetes Mellitus at Reiyukai Eiko Masunaga Eye Hospital, Nepal: Protocol for a Nonrandomized, Pre--Post Intervention Study", journal="JMIR Res Protoc", year="2021", month="Dec", day="17", volume="10", number="12", pages="e33116", keywords="diabetes mellitus", keywords="diabetic retinopathy", keywords="Nepal", keywords="health education", keywords="study protocol", abstract="Background: Diabetic retinopathy (DR) is an important public health issue in Nepal with a huge social and economic impact. Despite the availability of retinal services, people may not access them because of the lack of knowledge about DR and poor referral systems. Published studies on referral pathways in Nepal are scarce. Improving DR awareness among general physicians has the potential to address these challenges. Objective: The aim of this study is to evaluate the effect of a health education intervention on health personnel, establish a referral pathway, and assess the impact of the intervention on the attendance of patients with diabetes mellitus for retinal screening at Reiyukai Eiko Masunaga Eye Hospital in Nepal. Methods: This is a nonrandomized, pre- and postintervention study. Health education on DR will be provided to selected health personnel of the intervention hospital (Scheer Memorial) using information education and communication (IEC) materials in the form of PowerPoint presentations, posters, pamphlets, videos, and pre- and postevaluation questionnaires along with referral slip. Pre- and postevaluation will be undertaken during the study period. Data will be analyzed using MS Excel and Epi Info 7. Results: The ethical approval for this study has been obtained from the Ethical Review Board of the Nepal Health Research Council (ERB Protocol Registration Number \# 582/2020P). The study is expected to be completed in 18 months from the start of the project. The baseline data collection was from June to January 2020 for a period of 8 months. The postintervention data collection was from February to September 2021 for a period of 8 months. The last 2 months are planned for data analysis and report writing. Conclusions: Health education intervention could be a low-cost solution to improve the awareness, access, and utilization of retinal health care services; this is an understudied topic in Nepal. Working closely with the stakeholders, this study will evaluate the role of health education interventions (which are already validated in other low-income settings) to strengthen referral and reduce the burden of DR in Nepal. Trial Registration: ClinicalTrials.gov NCT04829084; https://clinicaltrials.gov/ct2/show/NCT04829084 International Registered Report Identifier (IRRID): DERR1-10.2196/33116 ", doi="10.2196/33116", url="https://www.researchprotocols.org/2021/12/e33116", url="http://www.ncbi.nlm.nih.gov/pubmed/34927596" } @Article{info:doi/10.2196/27873, author="Rego, Nazar{\'e} and Pereira, Silva Helena and Crispim, Jos{\'e}", title="Perceptions of Patients and Physicians on Teleconsultation at Home for Diabetes Mellitus: Survey Study", journal="JMIR Hum Factors", year="2021", month="Nov", day="23", volume="8", number="4", pages="e27873", keywords="teleconsultation", keywords="diabetes mellitus", keywords="telemedicine", keywords="eHealth", keywords="mobile phone", abstract="Background: Diabetes mellitus (DM) is one of the most challenging diseases in the 21st century and is the sixth leading cause of death. Telemedicine has increasingly been implemented in the care of patients with DM. Although teleconsultations at home have shown to be more effective for inducing HbA1c reduction than other telemedicine options, before the 2019 coronavirus disease crisis, their use had been lagging behind. Studies on physicians' or patients' perceptions about telemedicine have been performed independently of each other, and very few have focused on teleconsultations. In a time of great pressure for health systems and when an important portion of health care has to be assured at a distance, obtaining insights about teleconsultations at home from the stakeholders directly involved in the health care interaction is particularly important. Objective: The perceptions of patients and physicians about their intentions to use home synchronous teleconsultations for DM care are examined to identify drivers and barriers inherent to programs that involve home teleconsultations. Methods: Two identical questionnaires integrating the technology acceptance model and the unified theory of acceptance and use of technology and assessing the confidence in information and communication technology use of patients and physicians were developed. Responses by patients (n=75) and physicians (n=68) were analyzed using canonical correlation analysis. Results: Associations between predictor constructs (performance, effort, social influence, facilitating conditions, and attitude) and intention to use yielded significant functions, with a canonical R2 of 0.95 (for physicians) and 0.98 (patients). The main identified barriers to patient intention to use were the expected effort to explain the medical problem, and privacy and confidentiality issues. The major drivers were the facilitation of contact with the physician, which is beneficial to patient disease management and treatment, time savings, and reciprocity concerning physicians' willingness to perform teleconsultations. Responses from physicians revealed an association between intention to use and the expected performance of home teleconsultations. The major barrier to intention to use expressed in physicians' answers was doubts concerning the quality of patient examination. The major drivers were time savings, productivity increases, improvements in patient's health and patient management, National Health System costs reduction, and reciprocity relative to patients' willingness to engage in teleconsultations. Conclusions: To promote the use of home teleconsultations for DM, decision makers should improve patients' health literacy so the physician--patient communication is more effective; explore information and communication technology developments to reduce current limitations of non--face-to-face examinations; ensure patient privacy and data confidentiality; and demonstrate the capabilities of home teleconsultations to physicians. ", doi="10.2196/27873", url="https://humanfactors.jmir.org/2021/4/e27873", url="http://www.ncbi.nlm.nih.gov/pubmed/34817394" } @Article{info:doi/10.2196/32167, author="Singh, Tavleen and Olivares, Sofia and Cohen, Trevor and Cobb, Nathan and Wang, Jing and Franklin, Amy and Myneni, Sahiti", title="Pragmatics to Reveal Intent in Social Media Peer Interactions: Mixed Methods Study", journal="J Med Internet Res", year="2021", month="Nov", day="17", volume="23", number="11", pages="e32167", keywords="online health communities", keywords="diabetes self-management", keywords="tobacco cessation", keywords="speech acts", keywords="behavior change", keywords="communication themes", abstract="Background: Online health communities (OHCs) have emerged as the leading venues for behavior change and health-related information seeking. The soul and success of these digital platforms lie in their ability to foster social togetherness and a sense of community by providing personalized support. However, we have a minimal understanding of how conversational posts in these settings lead to collaborative societies and ultimately result in positive health changes through social influence. Objective: Our objective is to develop a content-specific and intent-sensitive methodological framework for analyzing peer interactions in OHCs. Methods: We developed and applied a mixed-methods approach to understand the manifestation of expressions in peer interactions in OHCs. We applied our approach to describe online social dialogue in the context of two online communities, QuitNet (QN) and the American Diabetes Association (ADA) support community. A total of 3011 randomly selected peer interactions (n=2005 from QN, n=1006 from ADA) were analyzed. Specifically, we conducted thematic analysis to characterize communication content and linguistic expressions (speech acts) embedded within the two data sets. We also developed an empirical user persona based on their engagement levels and behavior profiles. Further, we examined the association between speech acts and communication themes across observed tiers of user engagement and self-reported behavior profiles using the chi-square test or the Fisher test. Results: Although social support, the most prevalent communication theme in both communities, was expressed in several subtle manners, the prevalence of emotions was higher in the tobacco cessation community and assertions were higher in the diabetes self-management (DSM) community. Specific communication theme-speech act relationships were revealed, such as the social support theme was significantly associated (P<.05) with 9 speech acts from a total of 10 speech acts (ie, assertion, commissive, declarative, desire, directive, expressive, question, stance, and statement) within the QN community. Only four speech acts (ie, commissive, emotion, expressive, and stance) were significantly associated (P<.05) with the social support theme in the ADA community. The speech acts were also significantly associated with the users' abstinence status within the QN community and with the users' lifestyle status within the ADA community (P<.05). Conclusions: Such an overlay of communication intent implicit in online peer interactions alongside content-specific theory-linked characterizations of social media discourse can inform the development of effective digital health technologies in the field of health promotion and behavior change. Our analysis revealed a rich gradient of expressions across a standardized thematic vocabulary, with a distinct variation in emotional and informational needs, depending on the behavioral and disease management profiles within and across the communities. This signifies the need and opportunities for coupling pragmatic messaging in digital therapeutics and care management pathways for personalized support. ", doi="10.2196/32167", url="https://www.jmir.org/2021/11/e32167", url="http://www.ncbi.nlm.nih.gov/pubmed/34787578" } @Article{info:doi/10.2196/28329, author="Skovlund, E. Soren and Troelsen, Havb{\ae}k Lise and Noergaard, Mellergaard Lise and Pietraszek, Anna and Jakobsen, Erik Poul and Ejskjaer, Niels", title="Feasibility and Acceptability of a Digital Patient-Reported Outcome Tool in Routine Outpatient Diabetes Care: Mixed Methods Formative Pilot Study", journal="JMIR Form Res", year="2021", month="Nov", day="3", volume="5", number="11", pages="e28329", keywords="patient-reported outcomes", keywords="diabetes", keywords="person-centered care", keywords="person-centered communication", keywords="dialog", keywords="mental health", keywords="self-management", keywords="collaborative care", keywords="value-based health care", keywords="mixed-methods", keywords="mobile phone", keywords="mHealth", abstract="Background: Improvements in the digital capabilities of health systems provide new opportunities for the integration of patient-reported outcome (PRO) solutions in routine care, which can facilitate the delivery of person-centered diabetes care. We undertook this study as part of our development of a new digital PRO diabetes questionnaire and clinical dialog support tool for use by people with diabetes and their health care professionals (HCPs) to improve person-centered diabetes care quality and outcomes. Objective: This study evaluates the feasibility, acceptability, and perceived benefits and impacts of using a digital PRO diabetes tool, DiaProfil, in routine outpatient diabetes care. Methods: Overall, 12 people with diabetes scheduled for routine medical diabetes visits at the outpatient clinic were recruited. Purposive sampling was used to optimize heterogeneity regarding age, gender, duration, type of diabetes, treatment modality, and disease severity. Participants filled out a PRO diabetes questionnaire 2 to 5 days before their visit. During the visit, HCPs used a digital PRO tool to review PRO data with the person with diabetes for collaborative care planning. Participants completed evaluation forms before and after the visit and were interviewed for 30 to 45 minutes after the visit. HCPs completed the evaluation questionnaires after each visit. All visits were audio-recorded and transcribed for analysis. Data were analyzed using quantitative, qualitative, and mixed methods analyses. Results: People with diabetes found the PRO diabetes questionnaire to be relevant, acceptable, and feasible to complete from home. People with diabetes and HCPs found the digital PRO tool to be feasible and acceptable for use during the diabetes visit and would like to continue using it. HCPs were able to use the tool in a person-centered manner, as intended. For several people with diabetes, completion of the questionnaire facilitated positive reflection and better preparation for the visit. The use of the PRO tool primarily improved the quality of the dialog by improving the identification and focus on the issues most important to the person with diabetes. People with diabetes did not report any negative aspects of the PRO tool, whereas HCPs highlighted that it was demanding when the person with diabetes had many PRO issues that required attention within the predefined time allocated for a visit. Conclusions: The Danish PRO diabetes questionnaire and the digital tool, DiaProfil, are feasible and acceptable solutions for routine diabetes visits, and this tool may generate important benefits related to advancement of person-centered care. Further research is now required to corroborate and expand these formative insights on a larger scale and in diverse health care settings. The results of this study are therefore being used to define research hypotheses and finalize real-world PRO evaluation tools for a forthcoming large-scale multisector implementation study in Denmark. ", doi="10.2196/28329", url="https://formative.jmir.org/2021/11/e28329", url="http://www.ncbi.nlm.nih.gov/pubmed/34730545" } @Article{info:doi/10.2196/26957, author="Worth, Chris and Harper, Simon and Salomon-Estebanez, Maria and O'Shea, Elaine and Nutter, W. Paul and Dunne, J. Mark and Banerjee, Indraneel", title="Clustering of Hypoglycemia Events in Patients With Hyperinsulinism: Extension of the Digital Phenotype Through Retrospective Data Analysis", journal="J Med Internet Res", year="2021", month="Oct", day="29", volume="23", number="10", pages="e26957", keywords="hyperinsulinism", keywords="continuous glucose monitoring", keywords="digital phenotype", keywords="hypoglycemia", keywords="nocturnal hypoglycemia", abstract="Background: Hyperinsulinism (HI) due to excess and dysregulated insulin secretion is the most common cause of severe and recurrent hypoglycemia in childhood. High cerebral glucose use in the early hours results in a high risk of hypoglycemia in people with diabetes and carries a significant risk of brain injury. Prevention of hypoglycemia is the cornerstone of the management of HI, but the risk of hypoglycemia at night or the timing of hypoglycemia in children with HI has not been studied; thus, the digital phenotype remains incomplete and management suboptimal. Objective: This study aims to quantify the timing of hypoglycemia in patients with HI to describe glycemic variability and to extend the digital phenotype. This will facilitate future work using computational modeling to enable behavior change and reduce exposure of patients with HI to injurious hypoglycemic events. Methods: Patients underwent continuous glucose monitoring (CGM) with a Dexcom G4 or G6 CGM device as part of their clinical assessment for either HI (N=23) or idiopathic ketotic hypoglycemia (IKH; N=24). The CGM data were analyzed for temporal trends. Hypoglycemia was defined as glucose levels <3.5 mmol/L. Results: A total of 449 hypoglycemic events totaling 15,610 minutes were captured over 237 days from 47 patients (29 males; mean age 70 months, SD 53). The mean length of hypoglycemic events was 35 minutes. There was a clear tendency for hypoglycemia in the early hours (3-7 AM), particularly for patients with HI older than 10 months who experienced hypoglycemia 7.6\% (1480/19,370 minutes) of time in this period compared with 2.6\% (2405/92,840 minutes) of time outside this period (P<.001). This tendency was less pronounced in patients with HI who were younger than 10 months, patients with a negative genetic test result, and patients with IKH. Despite real-time CGM, there were 42 hypoglycemic events from 13 separate patients with HI lasting >30 minutes. Conclusions: This is the first study to have taken the first step in extending the digital phenotype of HI by describing the glycemic trends and identifying the timing of hypoglycemia measured by CGM. We have identified the early hours as a time of high hypoglycemia risk for patients with HI and demonstrated that simple provision of CGM data to patients is not sufficient to eliminate hypoglycemia. Future work in HI should concentrate on the early hours as a period of high risk for hypoglycemia and must target personalized hypoglycemia predictions. Focus must move to the human-computer interaction as an aspect of the digital phenotype that is susceptible to change rather than simple mathematical modeling to produce small improvements in hypoglycemia prediction accuracy. ", doi="10.2196/26957", url="https://www.jmir.org/2021/10/e26957", url="http://www.ncbi.nlm.nih.gov/pubmed/34435596" } @Article{info:doi/10.2196/29727, author="Sushko, Katelyn and Wang, Rui Qi and Tschirhart Menezes, Holly and Fitzpatrick-Lewis, Donna and Sherifali, Diana", title="Patient-Reported Benefits and Limitations of Mobile Health Technologies for Diabetes in Pregnancy: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2021", month="Oct", day="29", volume="10", number="10", pages="e29727", keywords="diabetes", keywords="pregnancy", keywords="type 1 diabetes", keywords="type 2 diabetes", keywords="gestational diabetes mellitus", keywords="mobile health", keywords="mHealth", keywords="virtual care", keywords="scoping review", abstract="Background: For women with pre-existing and gestational diabetes mellitus, pregnancy involves specialized and intensive medical care to improve maternal and infant outcomes. Medical management for patients with diabetes in pregnancy typically occurs via frequent face-to-face outpatient appointments. Barriers to face-to-face care during the COVID-19 pandemic have signaled the need for high-quality, patient-centered virtual health care modalities, such as mobile health (mHealth). Objective: The objective of the proposed scoping review is to identify the patient-reported benefits and limitations of mHealth technology among women with diabetes in pregnancy. We also aim to determine how the women's experiences align with the best practice standards for patient-centered communication. Methods: Arksey and O'Malley's framework for conducting scoping reviews with refinements by Levac et al will be used to guide the conduct of this scoping review. Relevant studies will be identified through comprehensive database searches of MEDLINE, Embase, Emcare, and PsycINFO. Following database searches, studies will be screened for eligibility at the title, abstract, and full-text level by two independent reviewers, with the inclusion of a third reviewer if required to reach consensus. Data charting of included studies will be conducted by one reviewer using a standardized data extraction form and verified independently by a second reviewer. Synthesis of results will be guided by Thomas and Harden's ``Methods for the Thematic Synthesis of Qualitative Research in Systematic Reviews.'' Results: As of August 2020, we have carried out the qualitative searches in the electronic databases MEDLINE, Embase, Emcare, and PsycINFO (Ovid interface) for a combined total of 8207 articles. Next, we plan to conduct the quantitative searches in the electronic databases MEDLINE, Embase, and Emcare (Ovid interface). We also plan to review the reference lists of relevant studies to identify additional eligible studies. Conclusions: With the results of this review, we hope to describe the patient-reported benefits and limitations of mHealth technology for women with diabetes in pregnancy. Furthermore, we aim to determine how women's experiences align with the best practice standards for patient-centered communication. Ultimately, our review can provide valuable information for guideline developers, policy makers, and clinicians related to mobile technologies to support virtual care delivery for women with diabetes in pregnancy. International Registered Report Identifier (IRRID): PRR1-10.2196/29727 ", doi="10.2196/29727", url="https://www.researchprotocols.org/2021/10/e29727", url="http://www.ncbi.nlm.nih.gov/pubmed/34714251" } @Article{info:doi/10.2196/28723, author="Belli, M. Hayley and Troxel, B. Andrea and Blecker, B. Saul and Anderman, Judd and Wong, Christina and Martinez, R. Tiffany and Mann, M. Devin", title="A Behavioral Economics--Electronic Health Record Module to Promote Appropriate Diabetes Management in Older Adults: Protocol for a Pragmatic Cluster Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Oct", day="27", volume="10", number="10", pages="e28723", keywords="diabetes", keywords="behavioral economics", keywords="electronic health records", keywords="clinical decision support", keywords="randomized controlled trial", keywords="pragmatic", abstract="Background: The integration of behavioral economics (BE) principles and electronic health records (EHRs) using clinical decision support (CDS) tools is a novel approach to improving health outcomes. Meanwhile, the American Geriatrics Society has created the Choosing Wisely (CW) initiative to promote less aggressive glycemic targets and reduction in pharmacologic therapy in older adults with type 2 diabetes mellitus. To date, few studies have shown the effectiveness of combined BE and EHR approaches for managing chronic conditions, and none have addressed guideline-driven deprescribing specifically in type 2 diabetes. We previously conducted a pilot study aimed at promoting appropriate CW guideline adherence using BE nudges and EHRs embedded within CDS tools at 5 clinics within the New York University Langone Health (NYULH) system. The BE-EHR module intervention was tested for usability, adoption, and early effectiveness. Preliminary results suggested a modest improvement of 5.1\% in CW compliance. Objective: This paper presents the protocol for a study that will investigate the effectiveness of a BE-EHR module intervention that leverages BE nudges with EHR technology and CDS tools to reduce overtreatment of type 2 diabetes in adults aged 76 years and older, per the CW guideline. Methods: A pragmatic, investigator-blind, cluster randomized controlled trial was designed to evaluate the BE-EHR module. A total of 66 NYULH clinics will be randomized 1:1 to receive for 18 months either (1) a 6-component BE-EHR module intervention + standard care within the NYULH EHR, or (2) standard care only. The intervention will be administered to clinicians during any patient encounter (eg, in person, telemedicine, medication refill, etc). The primary outcome will be patient-level CW compliance. Secondary outcomes will measure the frequency of intervention component firings within the NYULH EHR, and provider utilization and interaction with the BE-EHR module components. Results: Study recruitment commenced on December 7, 2020, with the activation of all 6 BE-EHR components in the NYULH EHR. Conclusions: This study will test the effectiveness of a previously developed, iteratively refined, user-tested, and pilot-tested BE-EHR module aimed at providing appropriate diabetes care to elderly adults, compared to usual care via a cluster randomized controlled trial. This innovative research will be the first pragmatic randomized controlled trial to use BE principles embedded within the EHR and delivered using CDS tools to specifically promote CW guideline adherence in type 2 diabetes. The study will also collect valuable information on clinician workflow and interaction with the BE-EHR module, guiding future research in optimizing the timely delivery of BE nudges within CDS tools. This work will address the effectiveness of BE-inspired interventions in diabetes and chronic disease management. Trial Registration: ClinicalTrials.gov NCT04181307; https://clinicaltrials.gov/ct2/show/NCT04181307 International Registered Report Identifier (IRRID): DERR1-10.2196/28723 ", doi="10.2196/28723", url="https://www.researchprotocols.org/2021/10/e28723", url="http://www.ncbi.nlm.nih.gov/pubmed/34704959" } @Article{info:doi/10.2196/21405, author="Malik, S. Faisal and Lind, Cara and Duncan, Sarah and Mitrovich, Connor and Pascual, Michael and Yi-Frazier, P. Joyce", title="Augmenting Traditional Support Groups for Adolescents With Type 1 Diabetes Using Instagram: Mixed Methods Feasibility Study", journal="JMIR Diabetes", year="2021", month="Oct", day="21", volume="6", number="4", pages="e21405", keywords="diabetes mellitus, type 1", keywords="self-help groups", keywords="social media", keywords="adolescent", abstract="Background: In-person support groups have been shown to benefit adolescents with type 1 diabetes (T1D) by helping to decrease perceived diabetes burden and improving knowledge related to chronic disease management. However, barriers exist to participation in traditional support groups, including the timing and location of meetings and resources needed to attend. Adolescents are increasingly utilizing online support groups, which may provide solutions to some of the challenges faced when implementing in-person support groups. Objective: The purpose of this study was to assess the feasibility and acceptability of a hybrid support group model where traditional in-person support groups were augmented with Instagram participation between monthly support group sessions for adolescents with T1D. Methods: Participants (13-18 years old with T1D for ?6 months) were asked to post photos each week for 3 months based on predetermined topics related to diabetes management. At the end of each month, participants attended an in-person support group to discuss their photos using the Photovoice method. Feasibility was assessed through enrollment and retention, number of Instagram posts, poststudy questionnaire, and a template analysis of the focus groups. Results: Of 24 eligible participants, 16 (67\%) enrolled in the study, with 3 dropping out prior to support group participation. The number of photos posted over 3 months ranged from 14 to 41. Among the 11 participants who completed a follow-up questionnaire, the majority of participants (6/11, 55\%) reported that they very much enjoyed participating in the hybrid support group, and more than three-quarters (9/11, 82\%) of participants reported that they ``related to the photos posted.'' Over half of participants (8/11, 73\%) reported ``learning something new from the photos posted,'' which arose from sharing knowledge and experiences related to navigating the common challenges of diabetes management. Additionally, the use of Instagram posts helped facilitate peer discussions during the in-person support groups. Conclusions: The novel combination of using Instagram to augment traditional in-person support groups was feasible and acceptable to adolescents with T1D. The overall satisfaction with the hybrid support group model, combined with the observed engagement with peers between support group sessions over social media, suggests that a hybrid support group model may have the potential to provide more pronounced benefits to adolescents than in-person meetings alone. Future research should investigate the use of social media as part of the support group model and examine the potential improvement of self-esteem, benefit-finding, and social support using validated tools in adolescents with diabetes. ", doi="10.2196/21405", url="https://diabetes.jmir.org/2021/4/e21405", url="http://www.ncbi.nlm.nih.gov/pubmed/34673527" } @Article{info:doi/10.2196/30756, author="Bedford-Petersen, Cianna and Weston, J. Sara", title="Mapping Individual Differences on the Internet: Case Study of the Type 1 Diabetes Community", journal="JMIR Diabetes", year="2021", month="Oct", day="15", volume="6", number="4", pages="e30756", keywords="type 1 diabetes", keywords="diabetes community", keywords="social media", keywords="Twitter", keywords="natural language processing", keywords="social network analysis", keywords="Latent Dirichlet Allocation", keywords="diabetes", keywords="data scraping", keywords="sentiment analysis", abstract="Background: Social media platforms, such as Twitter, are increasingly popular among communities of people with chronic conditions, including those with type 1 diabetes (T1D). There is some evidence that social media confers emotional and health-related benefits to people with T1D, including emotional support and practical information regarding health maintenance. Research on social media has primarily relied on self-reports of web-based behavior and qualitative assessment of web-based content, which can be expensive and time-consuming. Meanwhile, recent advances in natural language processing have allowed for large-scale assessment of social media behavior. Objective: This study attempts to document the major themes of Twitter posts using a natural language processing method to identify topics of interest in the T1D web-based community. We also seek to map social relations on Twitter as they relate to these topics of interest, to determine whether Twitter users in the T1D community post in ``echo chambers,'' which reflect their own topics back to them, or whether users typically see a mix of topics on the internet. Methods: Through Twitter scraping, we gathered a data set of 691,691 tweets from 8557 accounts, spanning a date range from 2008 to 2020, which includes people with T1D, their caregivers, health practitioners, and advocates. Tweet content was analyzed for sentiment and topic, using Latent Dirichlet Allocation. We used social network analysis to examine the degree to which identified topics are siloed within specific groups or disseminated through the broader T1D web-based community. Results: Tweets were, on average, positive in sentiment. Through topic modeling, we identified 6 broad-bandwidth topics, ranging from clinical to advocacy to daily management to emotional health, which can inform researchers and practitioners interested in the needs of people with T1D. These analyses also replicate prior work using machine learning methods to map social behavior on the internet. We extend these results through social network analysis, indicating that users are likely to see a mix of these topics discussed by the accounts they follow. Conclusions: Twitter communities are sources of information for people with T1D and members related to that community. Topics identified reveal key concerns of the T1D community and may be useful to practitioners and researchers alike. The methods used are efficient (low cost) while providing researchers with enormous amounts of data. We provide code to facilitate the use of these methods with other populations. ", doi="10.2196/30756", url="https://diabetes.jmir.org/2021/4/e30756", url="http://www.ncbi.nlm.nih.gov/pubmed/34652277" } @Article{info:doi/10.2196/26164, author="Vera Cruz dos Santos, Daniela and Coelho de So{\'a}rez, Patr{\'i}cia and Cavero, Victoria and U Rocha, I. Tha{\'i}s and Aschar, Suzana and Daley, Louise Kate and Garcia Claro, Helo{\'i}sa and Abud Scotton, George and Fernandes, Ivan and Diez-Canseco, Francisco and Brandt, Rebeca Lena and Toyama, Mauricio and Martins Castro, Carolina Hellen and Miranda, Jaime J. and Araya, Ricardo and Quayle, Julieta and Rossi Menezes, Paulo", title="A Mobile Health Intervention for Patients With Depressive Symptoms: Protocol for an Economic Evaluation Alongside Two Randomized Trials in Brazil and Peru", journal="JMIR Res Protoc", year="2021", month="Oct", day="13", volume="10", number="10", pages="e26164", keywords="cost-effectiveness", keywords="depression", keywords="diabetes", keywords="hypertension", keywords="noncommunicable diseases", keywords="randomized trials", keywords="low- and middle-income countries", keywords="mHealth", keywords="task shifting", keywords="behavioral activation", abstract="Background: Mobile health interventions provide significant strategies for improving access to health services, offering a potential solution to reduce the mental health treatment gap. Economic evaluation of this intervention is needed to help inform local mental health policy and program development. Objective: This paper presents the protocol for an economic evaluation conducted alongside 2 randomized controlled trials (RCTs) to evaluate the cost-effectiveness of a psychological intervention delivered through a technological platform (CONEMO) to treat depressive symptoms in people with diabetes, hypertension, or both. Methods: The economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO plus enhanced usual care in comparison with enhanced usual care from public health care system and societal perspectives. Participants are patients of the public health care services for hypertension, diabetes, or both conditions in S{\~a}o Paulo, Brazil (n=880) and Lima, Peru (n=432). Clinical effectiveness will be measured by reduction in depressive symptoms and gains in health-related quality of life. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost per at least 50\% reduction in 9-item Patient Health Questionnaire scores, and cost per quality-adjusted life year gained. The measurement of clinical effectiveness and resource use will take place over baseline, 3-month follow-up, and 6-month follow-up in the intervention and control groups. We will use a mixed costing methodology (ie, a combination of top--down and bottom--up approaches) considering 4 cost categories: intervention (CONEMO related) costs, health care costs, patient and family costs, and productivity costs. We will collect unit costs from the RCTs and national administrative databases. The multinational economic evaluations will be fully split analyses with a multicountry costing approach. We will calculate incremental cost-effectiveness ratios and present 95\% CIs from nonparametric bootstrapping (1000 replicates). We will perform deterministic and probabilistic sensitivity analyses. Finally, we will present cost-effectiveness acceptability curves to compare a range of possible cost-effectiveness thresholds. Results: The economic evaluation project had its project charter in June 2018 and is expected to be completed in September 2021. The final results will be available in the second half of 2021. Conclusions: We expect to assess whether CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared with enhanced usual care. This study will contribute to the evidence base for health managers and policy makers in allocating additional resources for mental health initiatives. It also will provide a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT12345678 (Brazil) and NCT03026426 (Peru); https://clinicaltrials.gov/ct2/show/NCT02846662 and https://clinicaltrials.gov/ct2/show/NCT03026426 International Registered Report Identifier (IRRID): DERR1-10.2196/26164 ", doi="10.2196/26164", url="https://www.researchprotocols.org/2021/10/e26164", url="http://www.ncbi.nlm.nih.gov/pubmed/34643538" } @Article{info:doi/10.2196/32216, author="Kvale, Gerd and Frisk, Bente and J{\"u}rgensen, Marte and B{\o}rtveit, Tore and {\O}degaard-Olsen, Theodor {\O}ystein and Wilhelmsen-Langeland, Ane and Aarli, B{\o}gvald Bernt and Sandnes, Kristina and Rykken, Sidsel and Haugstvedt, Anne and Hystad, William Sigurd and S{\o}fteland, Eirik", title="Evaluation of Novel Concentrated Interdisciplinary Group Rehabilitation for Patients With Chronic Illnesses: Protocol for a Nonrandomized Clinical Intervention Study", journal="JMIR Res Protoc", year="2021", month="Oct", day="7", volume="10", number="10", pages="e32216", keywords="COVID-19", keywords="chronic illnesses", keywords="concentrated rehabilitation", keywords="low back pain", keywords="post--COVID-19 symptoms", keywords="post--COVID-19 syndrome", keywords="long COVID", keywords="fatigue", keywords="type 2 diabetes", keywords="anxiety", keywords="depression", abstract="Background: An aging population with a growing burden of chronic complex illnesses will seriously challenge the public health care system. Consequently, novel and efficacious treatment approaches are highly warranted. Based on our experiences with concentrated treatment formats for other health challenges, we developed a highly concentrated interdisciplinary group rehabilitation approach for chronic illnesses. Objective: We aim to explore the acceptability of the intervention and describe potential changes in functional impairment at follow-up. Methods: The cornerstones of the intervention are as follows: (1) prepare the patient for change prior to treatment, (2) focus on health promoting microchoices instead of symptoms, and (3) expect the patient to integrate the changes in everyday living with limited hands-on follow-up. The intervention will be delivered to patients with highly diverse primary symptoms, namely patients with low back pain, post--COVID-19 symptoms, anxiety and depression, and type 2 diabetes. Results: Recruitment started between August 2020 and January 2021 (according to the illness category). For initial 3-month results, recruitment is expected to be completed by the end of 2021. Conclusions: If successful, this study may have a substantial impact on the treatment of low back pain, post--COVID-19 symptoms, anxiety and depression, and type 2 diabetes, which together constitute a major socioeconomic cost. Further, the study may widen the evidence base for the use of the concentrated treatment format in a diverse group of medical conditions. International Registered Report Identifier (IRRID): DERR1-10.2196/32216 ", doi="10.2196/32216", url="https://www.researchprotocols.org/2021/10/e32216", url="http://www.ncbi.nlm.nih.gov/pubmed/34505838" } @Article{info:doi/10.2196/26881, author="AshaRani, PV and Jue Hua, Lau and Roystonn, Kumarasan and Siva Kumar, Devi Fiona and Peizhi, Wang and Ying Jie, Soo and Shafie, Saleha and Chang, Sherilyn and Jeyagurunathan, Anitha and Boon Yiang, Chua and Abdin, Edimansyah and Ajit Vaingankar, Janhavi and Sum, Fang Chee and Lee, Sing Eng and Chong, Ann Siow and Subramaniam, Mythily", title="Readiness and Acceptance of eHealth Services for Diabetes Care in the General Population: Cross-sectional Study", journal="J Med Internet Res", year="2021", month="Sep", day="2", volume="23", number="9", pages="e26881", keywords="eHealth", keywords="diabetes", keywords="general population", keywords="acceptance", keywords="readiness", abstract="Background: Diabetes management is a growing health care challenge worldwide. eHealth can revolutionize diabetes care, the success of which depends on end user acceptance. Objective: This study aims to understand the readiness and acceptance of eHealth services for diabetes care among the general population, perceived advantages and disadvantages of eHealth, and factors associated with eHealth readiness and acceptance in a multiethnic Asian country. Methods: In this cross-sectional epidemiological study, participants (N=2895) were selected through disproportionate stratified random sampling from a population registry. Citizens or permanent residents of Singapore aged >18 years were recruited. The data were captured through computer-assisted personal interviews. An eHealth questionnaire was administered in one of four local languages (English, Chinese, Malay, or Tamil), as preferred by the participant. Bivariate chi-square analyses were performed to compare the sociodemographic characteristics and perception of advantages and disadvantages of eHealth services between the diabetes and nondiabetes groups. Multivariable logistic regression models were used to determine factors associated with eHealth readiness and acceptance. All analyses were weighted using survey weights to account for the complex survey design. Results: The sample comprised participants with (n=436) and without (n=2459) diabetes. eHealth readiness was low, with 47.3\% of the overall sample and 75.7\% of the diabetes group endorsing that they were not ready for eHealth (P<.001). The most acceptable eHealth service overall was booking appointments (67.4\%). There was a significantly higher preference in the diabetes group for face-to-face sessions for consultation with the clinician (nondiabetes: 83.5\% vs diabetes: 92.6\%; P<.001), receiving prescriptions (61.9\% vs 79.3\%; P<.001), referrals to other doctors (51.4\% vs 72.2\%; P<.001), and receiving health information (34\% vs 63.4\%; P<.001). The majority of both groups felt that eHealth requires users to be computer literate (90.5\% vs 94.3\%), does not build clinician-patient rapport compared with face-to-face sessions (77.5\% vs 81\%), and might not be credible (56.8\% vs 64.2\%; P=.03). Age (?35 years), ethnicity (Indian), and lower education status had lower odds of eHealth readiness. Age (?35 years), ethnicity (Indian), lower education status (primary school), BMI (being underweight), and marital status (being single) were associated with a lower likelihood of eHealth acceptance. Among only those with diabetes, a longer duration of diabetes (4-18 years), higher education (degree or above), and younger age (23-49 years) were associated with eHealth readiness, whereas younger age and income (SGD 2000-3999 [US \$1481-\$2961]) were associated with acceptance. Conclusions: Overall, an unfavorable attitude toward eHealth was observed, with a significantly higher number of participants with diabetes reporting their unwillingness to use these services for their diabetes care. Sociodemographic factors associated with acceptance and readiness identified a group of people who were unlikely to accept the technology and thus need to be targeted for eHealth literacy programs to avoid health care disparity. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2020-037125 ", doi="10.2196/26881", url="https://www.jmir.org/2021/9/e26881", url="http://www.ncbi.nlm.nih.gov/pubmed/34473062" } @Article{info:doi/10.2196/17431, author="Sneha, Sweta and Thalla, Srivarun and Rischie, Ishaan and Shahriar, Hossain", title="Health Internet Technology for Chronic Conditions: Review of Diabetes Management Apps", journal="JMIR Diabetes", year="2021", month="Aug", day="31", volume="6", number="3", pages="e17431", keywords="chronic disease", keywords="diabetes", keywords="blood glucose", keywords="diabetes management", keywords="mHealth disease apps", keywords="diabetes apps", keywords="best Apple diabetes apps", abstract="Background: Mobile health (mHealth) smartphone apps have shown promise in the self-management of chronic disease. In today's oversaturated health app market, selection criteria that consumers are employing to choose mHealth apps for disease self-management are of paramount importance. App quality is critical in monitoring disease controls but is often linked to consumer popularity rather than clinical recommendations of effectiveness in disease management. Management of key disease variances can be performed through these apps to increase patient engagement in disease self-management. This paper provides a comprehensive review of features found in mHealth apps frequently used in the self- management of diabetes. Objective: The purpose of this study was to review features of frequently used and high consumer-rated mHealth apps used in the self-management of diabetes. This study aimed to highlight key features of consumer-favored mHealth apps used in the self-management of diabetes. Methods: A 2-fold approach was adopted involving the Apple iOS store and the Google search engine. The primary search was conducted on the Apple iOS store using the term ``diabetes apps'' (device used: Apple iPad). The top 5 most frequently used mHealth apps were identified and rated by the number of consumer reviews, app ratings, and the presence of key diabetes management features, such as dietary blood glucose, A1C, insulin, physical activity, and prescription medication. A subsequent Google search was conducted using the search term ``best Apple diabetes apps.'' The top 3 search results---``Healthline,'' ``Everyday Health,'' and ``Diabetes Apps--American Diabetes Association''---were explored. Results: In total, 12 mHealth apps were reviewed due to their appearing across 4 evaluated sources. Only 1 health app---Glucose Buddy Diabetes Tracker---appeared as the most frequently used within the Apple iOS store and across the other 3 sources. The OneTouch Reveal app ranked first on the list in the iOS store with 39,000 consumer reviews and a rating of 4.7 out of 5.0 stars but only appeared in 1 of the other 3 sources. Blood glucose tracking was present across all apps, but other disease management features varied in type with at least 3 of the 5 key features being present across the 12 reviewed apps. Subscription cost and integration needs were present in the apps which could impact consumers' decision to select apps. Although mobile app preference was assessed and defined by the number of consumer reviews and star ratings, there were no scientific standards used in the selection and ranking of the health apps within this study. Conclusions: mHealth apps have shown promise in chronic disease management, but a surge in development of these nonregulated health solutions points to a need for regulation, standardization, and quality control. A governing body of health IT professionals, clinicians, policymakers, payors, and patients could be beneficial in defining health app standards for effective chronic disease management. Variabilities in features, cost, and other aspects of management could be reduced by regulatory uniformity, which would increase patient engagement and improve disease outcomes. ", doi="10.2196/17431", url="https://diabetes.jmir.org/2021/3/e17431", url="http://www.ncbi.nlm.nih.gov/pubmed/34463627" } @Article{info:doi/10.2196/28163, author="MacPherson, Megan and Cranston, Kaela and Johnston, Cara and Locke, Sean and Jung, E. Mary", title="Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study", journal="JMIR Form Res", year="2021", month="Aug", day="27", volume="5", number="8", pages="e28163", keywords="text messaging", keywords="prediabetic state", keywords="telemedicine", keywords="telecommunications", keywords="exercise", keywords="diet", keywords="preventive medicine", keywords="mHealth", keywords="intervention development", keywords="behavior change", keywords="mobile phone", abstract="Background: SMS text messaging is a low-cost and far-reaching modality that can be used to augment existing diabetes prevention programs and improve long-term diet and exercise behavior change adherence. To date, little research has been published regarding the process of SMS text message content development. Understanding how interventions are developed is necessary to evaluate their evidence base and to guide the implementation of effective and scalable mobile health interventions in public health initiatives and in future research. Objective: This study aims to describe the development and refinement of a bank of SMS text messages targeting diet and exercise behavior change to be implemented following a diabetes prevention program. Methods: A bank of 124 theory-based SMS text messages was developed using the Behaviour Change Wheel and linked to active intervention components (behavior change techniques [BCTs]). The Behaviour Change Wheel is a theory-based framework that provides structure to intervention development and can guide the use of evidence-based practices in behavior change interventions. Once the messages were written, 18 individuals who either participated in a diabetes prevention program or were a diabetes prevention coach evaluated the messages on their clarity, utility, and relevance via survey using a 5-point Likert scale. Messages were refined according to participant feedback and recoded to obtain an accurate representation of BCTs in the final bank. Results: 76/124 (61.3\%) messages were edited, 4/124 (3.2\%) were added, and 8/124 (6.5\%) were removed based on participant scores and feedback. Of the edited messages, 43/76 (57\%) received minor word choice and grammar alterations while retaining their original BCT code; the remaining 43\% (33/76, plus the 4 newly written messages) were recoded by a reviewer trained in BCT identification. Conclusions: This study outlines the process used to develop and refine a bank of SMS text messages to be implemented following a diabetes prevention program. This resulted in a bank of 120 theory-based, user-informed SMS text messages that were overall deemed clear, useful, and relevant by both individuals who will be receiving and delivering them. This formative development process can be used as a blueprint in future SMS text messaging development to ensure that message content is representative of the evidence base and is also grounded in theory and evaluated by key knowledge users. ", doi="10.2196/28163", url="https://formative.jmir.org/2021/8/e28163", url="http://www.ncbi.nlm.nih.gov/pubmed/34448713" } @Article{info:doi/10.2196/31061, author="Kawai, Yuki and Sankoda, Akiko and Waki, Kayo and Miyake, Kana and Hayashi, Aki and Mieno, Makiko and Wakui, Hiromichi and Tsurutani, Yuya and Saito, Jun and Hirawa, Nobuhito and Yamakawa, Tadashi and Komiya, Shiro and Isogawa, Akihiro and Satoh, Shinobu and Minami, Taichi and Osada, Uru and Iwamoto, Tamio and Takano, Tatsuro and Terauchi, Yasuo and Tamura, Kouichi and Yamauchi, Toshimasa and Kadowaki, Takashi and Nangaku, Masaomi and Kashihara, Naoki and Ohe, Kazuhiko", title="Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Aug", day="17", volume="10", number="8", pages="e31061", keywords="diabetic kidney disease", keywords="microalbuminuria", keywords="albuminuria", keywords="diabetes mellitus", keywords="self-management support system", keywords="mHealth", keywords="randomized controlled trial", keywords="diabetes", keywords="kidney", keywords="chronic disease", keywords="support", keywords="self-management", keywords="efficacy", keywords="protocol", keywords="therapy", keywords="intervention", keywords="self-care", keywords="behavior", abstract="Background: Diabetic kidney disease (DKD) is one of the main complications of type 2 diabetes mellitus (T2DM). DKD is a known risk factor for end-stage renal disease, cardiovascular disease, and all-cause death. Effective intervention for early-stage DKD is vital to slowing down the progression of kidney disease and improve prognoses. Mobile health (mHealth) is reportedly effective in supporting patients' self-care and improving glycemic control, but the impact of mHealth on DKD has yet to be shown. Objective: The purpose of this study is to evaluate the efficacy of standard therapy with the addition of a self-management support system, DialBetesPlus, in patients with DKD and microalbuminuria. Methods: This study is a prospective, randomized, open-label, multicenter clinical trial. The target population consists of 160 patients diagnosed with T2DM accompanied by microalbuminuria. We randomly assigned the patients to 2 groups---the intervention group using DialBetesPlus in addition to conventional therapy and the control group using conventional therapy alone. DialBetesPlus is a smartphone application that supports patients' self-management of T2DM. The study period was 12 months, with a follow-up survey at 18 months. The primary outcome was a change in albuminuria levels at 12 months. Secondary outcomes included changes in physical parameters, blood test results (glycemic control, renal function, and lipid metabolism), lifestyle habits, self-management scores, medication therapy, and quality of life. Results: The study was approved in April 2018. We began recruiting patients in July 2018 and completed recruiting in August 2019. The final 18-month follow-up was conducted in March 2021. We recruited 159 patients and randomly allocated 70 into the intervention group and 61 into the control group, with 28 exclusions due to withdrawal of consent, refusal to continue, or ineligibility. The first results are expected to be available in 2021. Conclusions: This is the first randomized controlled trial assessing the efficacy of mHealth on early-stage DKD. We expect that albuminuria levels will decrease significantly in the intervention group due to improved glycemic control with ameliorated self-care behaviors. Trial Registration: UMIN-CTR UMIN000033261; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr\_view.cgi?recptno=R000037924 International Registered Report Identifier (IRRID): DERR1-10.2196/31061 ", doi="10.2196/31061", url="https://www.researchprotocols.org/2021/8/e31061", url="http://www.ncbi.nlm.nih.gov/pubmed/34402802" } @Article{info:doi/10.2196/27471, author="Jeftha, Anthea and Roberts, Tina and Kimmie-Dhansay, Faheema", title="The Effect of Periodontal Disease on Metabolic Control in Patients With Diabetes Mellitus in South Africa: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2021", month="Jul", day="22", volume="10", number="7", pages="e27471", keywords="periodontal disease", keywords="periodontitis", keywords="bleeding on probing, type 2 diabetes mellitus", keywords="fasting glucose", keywords="HbA1C", keywords="South Africa", abstract="Background: The increase in the prevalence of type 2 diabetes mellitus (T2DM) and its associated complications is burdensome to the South African health system. Understanding the role of comorbid diseases, such as periodontal disease (PD), and their effect on metabolic control in patients with DM in South Africa will raise awareness about the importance of periodontal interventions among patients with DM in South Africa. Objective: The review will aim to determine the effect of PD on the metabolic control of T2DM in a South African population. Methods: A systematic review of the relationship between PD and metabolic control in patients with T2DM in a South African population will be conducted. Cohort, cross-sectional, and case-controlled studies will be considered in which the outcome of interest is diabetic control. A search will be done in the following sources: EBSCOhost (academic search complete; dentistry and oral sciences), PubMed, ScienceDirect, and the South African National ETD Portal for articles published in English. There will be no limit placed on the date of the publication. The reference list of articles will be reviewed for further inclusion of critical articles. Two independent reviewers (AJ and FK-D) will do study selection, data extraction, and quality analysis. All disputes will be resolved by discussion, and the entire team will verify final decisions. Results: The systematic review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO). A preliminary search was conducted using the keywords ((perio*) AND (diabet*)) AND (``South Africa''). The review process should be completed by December 2021. Conclusions: The review will determine the effect of PD on metabolic control in patients with T2DM in South Africa. The outcome would inform health policy to highlight the need to include periodontal care into treatment protocols in patients with T2DM. In this process, the feasibility for future research in this area of interest will also be defined. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020221064; https://www.crd.york.ac.uk/PROSPERO/display\_record.php?RecordID=221064 International Registered Report Identifier (IRRID): PRR1-10.2196/27471 ", doi="10.2196/27471", url="https://www.researchprotocols.org/2021/7/e27471", url="http://www.ncbi.nlm.nih.gov/pubmed/34292169" } @Article{info:doi/10.2196/27062, author="Laursen, Hjorth Ditte and Rom, Gitte and Bangh{\o}j, Margareta Anne and Tarnow, Lise and Schou, Lone", title="Improving Diabetes Self-management by Providing Continuous Positive Airway Pressure Treatment to Patients With Obstructive Sleep Apnea and Type 2 Diabetes: Qualitative Exploratory Interview Study", journal="JMIR Form Res", year="2021", month="Jul", day="20", volume="5", number="7", pages="e27062", keywords="diabetes", keywords="diabetes self-management", keywords="obstructive sleep apnea", keywords="continued positive airway pressure", keywords="sleep patterns", keywords="sleepiness in daily life", keywords="sleep apnea", keywords="elderly", keywords="sleep", abstract="Background: There is a high prevalence of unexplained and unexplored obstructive sleep apnea (OSA) among patients with type 2 diabetes. The daytime symptoms of OSA include severe fatigue, cognitive problems, a decreased quality of life, and the reduced motivation to perform self-care. These symptoms impair the management of both diabetes and daily life. OSA may therefore have negative implications for diabetes self-management. Continuous positive airway pressure (CPAP) therapy is used to treat OSA. This treatment improves sleep quality, insulin resistance, and glycemic control. Although the benefits of using CPAP as a treatment for OSA are clear, the noncompliance rate is high, and the evidence for the perceived effect that CPAP treatment has on patients with type 2 diabetes and OSA is poor. Objective: The purpose of this study was to analyze the impacts that comorbid diabetes and OSA have on the daily lives of older adults and to investigate the perceived effect that CPAP treatment for OSA has on patients' diabetes self-management. Methods: A qualitative follow-up study that involved in-depth, semistructured dyad interviews with couples before and after CPAP treatment (N=22) was conducted. Patients were recruited from the Hilleroed Hospital in Denmark and were all diagnosed with type 2 diabetes, aged >18 years, and had an apnea-hypopnea index of ?15. All interviews were coded and analyzed via thematic analysis. Results: The results showed that patients and their partners did not consider OSA to be a serious disorder, as they believed that OSA symptoms were similar to those of the process of aging. Patients experienced poor nocturnal sleep, took frequent daytime naps, exhibited reduced cognitive function, and had low levels of physical activity and a high-calorie diet. These factors negatively influenced their diabetes self-management. Despite the immediate benefit of CPAP treatment, most patients (11/12, 92\%) faced technical challenges when using the CPAP device. Only the patients with severe OSA symptoms that affected their daily lives overcame the challenges of using the CPAP device and thereby improved their diabetes self-management. Patients with less severe symptoms rated CPAP-related challenges as more burdensome than their symptoms. Conclusions: If used correctly, CPAP has the potential to significantly improve OSA, resulting in better sleep quality; improved physical activity; improved diet; and, in the end, better diabetes self-management. However, there are many barriers to undergoing CPAP treatment, and only few patients manage to overcome these barriers and comply with correct treatment. ", doi="10.2196/27062", url="https://formative.jmir.org/2021/7/e27062", url="http://www.ncbi.nlm.nih.gov/pubmed/34283032" } @Article{info:doi/10.2196/27453, author="Lesser, I. Lenard and Behal, Raj", title="Change in Glycemic Control for Patients Enrolled in a Membership-Based Primary Care Program: Longitudinal Observational Study", journal="JMIR Diabetes", year="2021", month="Jun", day="11", volume="6", number="2", pages="e27453", keywords="diabetes mellitus", keywords="primary care", keywords="chronic care model", keywords="diabetes", keywords="self-management", keywords="patient", keywords="observational", keywords="digital health", keywords="decision support", keywords="decision-making", keywords="clinical information system", abstract="Background: Both primary care practices based on the chronic care model (CCM) and digital therapeutics have been shown to improve the care of patients with diabetes. Objective: The aim of this observational study was to examine the change in diabetes control for patients enrolled in a membership-based primary care service that is based on the CCM. Methods: Using a diabetes registry, we analyzed the change in glycated hemoglobin (HbA1c) for patients with uncontrolled diabetes mellitus (initial HbA1c?9\%). All patients had access to a technology-enhanced primary care practice built on the CCM. Results: The registry included 621 patients diagnosed with uncontrolled diabetes. All patients had at least two HbA1c measurements, with the average time between the first and last measurement of 1.2 years (SD 0.4). The average starting value of HbA1c was 10.7, which decreased to 8.7, corresponding to a reduction of 2.03 (P<.001). Secondary analyses showed statistically significant reductions in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides. Conclusions: Patients with initially uncontrolled diabetes who undergo care in a technology-enhanced primary care practice based on the CCM have long-term clinically meaningful reductions in HbA1c. ", doi="10.2196/27453", url="https://diabetes.jmir.org/2021/2/e27453", url="http://www.ncbi.nlm.nih.gov/pubmed/33999830" } @Article{info:doi/10.2196/17170, author="Sharp, Kay Lisa and Biggers, Alana and Perez, Rosanne and Henkins, Julia and Tilton, Jessica and Gerber, S. Ben", title="A Pharmacist and Health Coach--Delivered Mobile Health Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Crossover Study", journal="JMIR Res Protoc", year="2021", month="Mar", day="10", volume="10", number="3", pages="e17170", keywords="mHealth", keywords="type 2 diabetes mellitus", keywords="community health workers", keywords="clinical pharmacists", abstract="Background: Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management. Objective: The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach--delivered intervention on hemoglobin A1c (HbA1c, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes. Methods: A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA1c ?8\%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year. Results: Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022. Conclusions: This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals. International Registered Report Identifier (IRRID): DERR1-10.2196/17170 ", doi="10.2196/17170", url="https://www.researchprotocols.org/2021/3/e17170", url="http://www.ncbi.nlm.nih.gov/pubmed/33688847" } @Article{info:doi/10.2196/18245, author="Pike, M. Julie and Moore, M. Courtney and Yazel, G. Lisa and Lynch, O. Dustin and Haberlin-Pittz, M. Kathryn and Wiehe, E. Sarah and Hannon, S. Tamara", title="Diabetes Prevention in Adolescents: Co-design Study Using Human-Centered Design Methodologies", journal="J Participat Med", year="2021", month="Feb", day="24", volume="13", number="1", pages="e18245", keywords="diabetes prevention", keywords="adolescents", keywords="human-centered design", abstract="Background: The rise in pediatric obesity and its accompanying condition, type 2 diabetes (T2D), is a serious public health concern. T2D in adolescents is associated with poor health outcomes and decreased life expectancy. Effective diabetes prevention strategies for high-risk adolescents and their families are urgently needed. Objective: The aim of this study was to co-design a diabetes prevention program for adolescents by using human-centered design methodologies. Methods: We partnered with at-risk adolescents, parents, and professionals with expertise in diabetes prevention or those working with adolescents to conduct a series of human-centered design research sessions to co-design a diabetes prevention intervention for youth and their families. In order to do so, we needed to (1) better understand environmental factors that inhibit/promote recommended lifestyle changes to decrease T2D risk, (2) elucidate desired program characteristics, and (3) explore improved activation in diabetes prevention programs. Results: Financial resources, limited access to healthy foods, safe places for physical activity, and competing priorities pose barriers to adopting lifestyle changes. Adolescents and their parents desire interactive, hands-on learning experiences that incorporate a sense of fun, play, and community in diabetes prevention programs. Conclusions: The findings of this study highlight important insights of 3 specific stakeholder groups regarding diabetes prevention and lifestyle changes. The findings of this study demonstrate that, with appropriate methods and facilitation, adolescents, parents, and professionals can be empowered to co-design diabetes prevention programs. ", doi="10.2196/18245", url="https://jopm.jmir.org/2021/1/e18245", url="http://www.ncbi.nlm.nih.gov/pubmed/33625364" } @Article{info:doi/10.2196/21934, author="Schnitzer, Kristina and Cather, Corrine and Zvonar, Vanya and Dechert, Alyson and Plummer, Rachel and Lowman, Kelsey and Pachas, Gladys and Potter, Kevin and Evins, Eden Anne", title="Patient Experience and Predictors of Improvement in a Group Behavioral and Educational Intervention for Individuals With Diabetes and Serious Mental Illness: Mixed Methods Case Study", journal="J Participat Med", year="2021", month="Feb", day="12", volume="13", number="1", pages="e21934", keywords="mental disorders, severe", keywords="diabetes mellitus", keywords="delivery of health care, integrated", keywords="behavior and behavior mechanisms", keywords="patient education as topic", abstract="Background: In a previous study, participation in a 16-week reverse integrated care and group behavioral and educational intervention for individuals with diabetes and serious mental illness was associated with improved glycemic control (hemoglobin A1c) and BMI. To inform future implementation efforts, more information about the effective components of the intervention is needed. Objective: The goal of this study is to identify the aspects of the intervention participants reported to be helpful and to evaluate the predictors of outcomes. Methods: This study involved qualitative evaluation and post hoc quantitative analysis of a previous intervention. Qualitative data were collected using semistructured interviews with 69\% (24/35) of the individuals who attended 1 or more group sessions and 35\% (9/26) of the individuals who consented but attended no sessions. Quantitative mixed effects modeling was performed to test whether improved diabetes knowledge, diet, and exercise or higher group attendance predicted improved hemoglobin A1c and BMI. These interview and modeling outcomes were combined using a mixed methods case study framework and integrated thematically. Results: In qualitative interviews, participants identified the application of health-related knowledge gained to real-world situations, accountability for goals, positive reinforcement and group support, and increased confidence in prioritizing health goals as factors contributing to the success of the behavioral intervention. Improved knowledge of diabetes was associated with reduced BMI ($\beta$=--1.27, SD 0.40; P=.003). No quantitative variables examined were significantly associated with improved hemoglobin A1c levels. Conclusions: In this mixed methods analysis of predictors of success in a behavioral diabetes management program, group participants highlighted the value of positive reinforcement and group support, accountability for goals set, and real-world application of health-related knowledge gained. Improved diabetes knowledge was associated with weight loss. ", doi="10.2196/21934", url="http://jopm.jmir.org/2021/1/e21934/", url="http://www.ncbi.nlm.nih.gov/pubmed/33576747" } @Article{info:doi/10.2196/21440, author="Essuman, Adobea Vera and Tagoe, Naamuah Naa and Akpalu, Josephine and Essuman, Akye and Sackey, H. Adziri and Hayfron-Benjamin, CF and Asare, George and Abaidoo, Benjamin and Amoah, AGB and Ndanu, Thomas and Ofori-Adjei, IDB and Barnes, NA and Appiah-Thompson, BL and Amoaku, M. Winfried", title="Morbidity and Complications of Diabetes Mellitus in Children and Adolescents in Ghana: Protocol for a Longitudinal Study", journal="JMIR Res Protoc", year="2021", month="Jan", day="6", volume="10", number="1", pages="e21440", keywords="diabetes mellitus", keywords="type 1 diabetes", keywords="type 2 diabetes", keywords="microvascular", keywords="macrovascular complications", keywords="quality of life", abstract="Background: Diabetes is associated with premature morbidity and mortality from its many complications. There are limited data on the chronic complications of diabetes in children and adolescents in sub-Saharan Africa. Objective: The study aims to determine the (1) burden and related factors of chronic systemic complications of diabetes, including diabetic and nondiabetic ocular conditions in children and adolescents, and (2) quality of life (QoL) of participants compared to healthy controls. This manuscript describes the study methodology. Methods: Demographic information, medical history, anthropometric measurements, and laboratory characteristics were collected, and the participants were screened for microvascular and macrovascular complications as well as nondiabetic ocular disease. QoL questionnaires were administered to participants, their caregivers, and controls. Participants were followed up annually up to 3 years to determine the natural history of and trends in these conditions. SPSS Version 25.0 will be used for data analysis. Continuous and categorical data will be presented as mean (SD) and as percentages (\%), respectively. t tests and analysis of variance will be used to compare means, and chi-square tests will be used to compare categorical data. Correlation, regression, and logistic regression analyses will be employed to establish linear associations and causal associations as appropriate. Relative risk and odds ratios will be used to estimate risk. QoL outcomes in Ghanaian children and adolescents with diabetes mellitus compared with caregivers and healthy controls will be assessed using the Pediatric Quality of Life inventory. Significance will be set at $\alpha$=.05. Results: Institutional approval from the Ethical and Protocol Review Committee of the University of Ghana Medical School was received on August 22, 2014 (Protocol Identification Number: MS-Et/M.12-P4.5/2013-2014). Funding for the project was received from the University of Ghana Research Fund (\#UGRF/9/LMG-013/2015-2016) in March 2016. Patient recruitment, clinical examination, and data collection commenced in August 2016 and was completed in September 2019. A total of 58 children and adolescents with diabetes mellitus have been recruited. Blood samples were stored at --80 {\textdegree}C for analysis, which was completed at the end of July 2020. Data analysis is ongoing and will be completed by the end of December 2020. Investigators plan to submit the results for publication by the end of February 2021. Conclusions: The prevalence, natural history, trends in diabetic complications and nondiabetic ocular disease, and QoL will be provided. Our data may inform policies and interventions to improve care given to children and adolescents with diabetes. International Registered Report Identifier (IRRID): DERR1-10.2196/21440 ", doi="10.2196/21440", url="https://www.researchprotocols.org/2021/1/e21440", url="http://www.ncbi.nlm.nih.gov/pubmed/33404517" } @Article{info:doi/10.2196/22471, author="Bhatti, Rahila and Khamis, Hassan Amar and Khatib, Samara and Shiraz, Seemin and Matfin, Glenn", title="Clinical Characteristics and Outcomes of Patients With Diabetes Admitted for COVID-19 Treatment in Dubai: Single-Centre Cross-Sectional Study", journal="JMIR Public Health Surveill", year="2020", month="Dec", day="7", volume="6", number="4", pages="e22471", keywords="Diabetes", keywords="COVID-19", keywords="characteristic", keywords="outcome", keywords="chronic condition", keywords="cross-sectional", abstract="Background: Recent studies have shown that diabetes is a major risk factor that contributes to the severity of COVID-19 and resulting mortality. Poor glycemic control is also associated with poor patient outcomes (eg, hospitalization and death). Objective: This study aimed to describe the clinical characteristics and outcomes of patients with diabetes who were admitted to our hospital for COVID-19 treatment. Methods: This cross-sectional, observational study comprised patients with diabetes admitted with COVID-19 to Mediclinic Parkview Hospital in Dubai, United Arab Emirates, from March 30 to June 7, 2020. We studied the differences among characteristics, length of hospital stay, diabetes status, comorbidities, treatments, and outcomes among these patients. Results: Of the cohort patients, 25.1\% (103/410) had coexistent diabetes or prediabetes. These patients represented 17 different ethnicities, with 59.2\% (61/103) from Asian countries and 35\% (36/103) from Arab countries. Mean patient age was 54 (SD 12.5) years, and 66.9\% (69/103) of patients were male. Moreover, 85.4\% (88/103) of patients were known to have diabetes prior to admission, and 14.6\% (15/103) were newly diagnosed with either diabetes or prediabetes at admission. Most cohort patients had type 2 diabetes or prediabetes, and only 2.9\% (3/103) of all patients had type 1 diabetes. Furthermore, 44.6\% (46/103) of patients demonstrated evidence suggesting good glycemic control during the 4-12 weeks prior to admission, as defined arbitrarily by admission hemoglobin A1c level <7.5\%, and 73.8\% (76/103) of patients had other comorbidities, including hypertension, ischemic heart disease, and dyslipidemia. Laboratory data (mean and SD values) at admission for patients who needed ward-based care versus those who needed intensive care were as follows: fibrinogen, 462.8 (SD 125.1) mg/dL vs 660.0 (SD 187.6) mg/dL; D-dimer, 0.7 (SD 0.5) {\textmu}g/mL vs 2.3 (SD 3.5) {\textmu}g/mL; ferritin, 358.0 (SD 442.0) mg/dL vs 1762.4 (SD 2586.4) mg/dL; and C-reactive protein, 33.9 (SD 38.6) mg/L vs 137.0 (SD 111.7) mg/L. Laboratory data were all significantly higher for patients in the intensive care unit subcohort (P<.05). The average length of hospital stay was 14.55 days for all patients, with 28.2\% (29/103) of patients requiring intensive care. In all, 4.9\% (5/103) died during hospitalization---all of whom were in the intensive care unit. Conclusions: Majority of patients with diabetes or prediabetes and COVID-19 had other notable comorbidities. Only 4 patients tested negative for COVID-19 RT-PCR but showed pathognomonic changes of COVID-19 radiologically. Laboratory analyses revealed distinct abnormal patterns of biomarkers that were associated with a poor prognosis: fibrinogen, D-dimer, ferritin, and C-reactive protein levels were all significantly higher at admission in patients who subsequently needed intensive care than in those who needed ward-based care. More studies with larger sample sizes are needed to compare data of COVID-19 patients admitted with and without diabetes within the UAE region. ", doi="10.2196/22471", url="http://publichealth.jmir.org/2020/4/e22471/", url="http://www.ncbi.nlm.nih.gov/pubmed/33284130" } @Article{info:doi/10.2196/17877, author="Patton, R. Susana and McConville, Andrew and Marker, M. Arwen and Monzon, D. Alexandra and Driscoll, A. Kimberly and Clements, A. Mark", title="Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP): Protocol for a Randomized Clinical Trial to Test a Video-Based Telehealth Intervention", journal="JMIR Res Protoc", year="2020", month="Aug", day="18", volume="9", number="8", pages="e17877", keywords="diabetes mellitus, type 1", keywords="telemedicine", keywords="eHealth", keywords="child", keywords="parents", keywords="hypoglycemia", keywords="fear", abstract="Background: Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60\% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children. Objective: The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention. Methods: We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children. Results: Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date. Conclusions: If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world. Trial Registration: ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547 International Registered Report Identifier (IRRID): PRR1-10.2196/17877 ", doi="10.2196/17877", url="http://www.researchprotocols.org/2020/8/e17877/", url="http://www.ncbi.nlm.nih.gov/pubmed/32808936" } @Article{info:doi/10.2196/16277, author="Lecamwasam, R. Ashani and Mohebbi, Mohammadreza and Ekinci, I. Elif and Dwyer, M. Karen and Saffery, Richard", title="Identification of Potential Biomarkers of Chronic Kidney Disease in Individuals with Diabetes: Protocol for a Cross-sectional Observational Study", journal="JMIR Res Protoc", year="2020", month="Jul", day="31", volume="9", number="7", pages="e16277", keywords="epigenetics", keywords="metabolomics", keywords="gut microbiome", keywords="diabetes", keywords="chronic kidney disease", abstract="Background: The importance of identifying people with diabetes and progressive kidney dysfunction relates to the excess morbidity and mortality of this group. Rates of cardiovascular disease are much higher in people with both diabetes and kidney dysfunction than in those with only one of these conditions. By the time these people are identified in current clinical practice, proteinuria and renal dysfunction are already established, limiting the effectiveness of therapeutic interventions. The identification of an epigenetic or blood metabolite signature or gut microbiome profile may identify those with diabetes at risk of progressive chronic kidney disease, in turn providing targeted intervention to improve patient outcomes. Objective: This study aims to identify potential biomarkers in people with diabetes and chronic kidney disease (CKD) associated with progressive renal injury and to distinguish between stages of chronic kidney disease. Three sources of biomarkers will be explored, including DNA methylation profiles in blood lymphocytes, the metabolomic profile of blood-derived plasma and urine, and the gut microbiome. Methods: The cross-sectional study recruited 121 people with diabetes and varying stages (stages 1-5) of chronic kidney disease. Single-point data collection included blood, urine, and fecal samples in addition to clinical data such as anthropometric measurements and biochemical parameters. Additional information obtained from medical records included patient demographics, medical comorbidities, and medications. Results: Data collection commenced in January 2018 and was completed in June 2018. At the time of submission, 121 patients had been recruited, and 119 samples remained after quality control. There were 83 participants in the early diabetes-associated CKD group with a mean estimated glomerular filtration rate (eGFR) of 61.2 mL/min/1.73 m2 (early CKD group consisting of stage 1, 2, and 3a CKD), and 36 participants in the late diabetic CKD group with a mean eGFR of 23.9 mL/min/1.73 m2 (late CKD group, consisting of stage 3b, 4, and 5), P<.001. We have successfully obtained DNA for methylation and microbiome analyses using the biospecimens collected via this protocol and are currently analyzing these results together with the metabolome of this cohort of individuals with diabetic CKD. Conclusions: Recent advances have improved our understanding of the epigenome, metabolomics, and the influence of the gut microbiome on the incidence of diseases such as cancers, particularly those related to environmental exposures. However, there is a paucity of literature surrounding these influencers in renal disease. This study will provide insight into the fundamental understanding of the pathophysiology of CKD in individuals with diabetes, especially in novel areas such as epigenetics, metabolomics, and the kidney-gut axis. International Registered Report Identifier (IRRID): DERR1-10.2196/16277 ", doi="10.2196/16277", url="http://www.researchprotocols.org/2020/7/e16277/", url="http://www.ncbi.nlm.nih.gov/pubmed/32734931" } @Article{info:doi/10.2196/15478, author="Ritchie, D. Natalie and Guti{\'e}rrez-Raghunath, Silvia and Durfee, Josh Michael and Fischer, Henry", title="Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial", journal="JMIR Mhealth Uhealth", year="2020", month="Jun", day="18", volume="8", number="6", pages="e15478", keywords="eHealth", keywords="prediabetes", keywords="texting", keywords="weight loss", abstract="Background: The evidence-based National Diabetes Prevention Program (NDPP) is now widely disseminated, yet strategies to increase its effectiveness are needed, especially for underserved populations. The yearlong program promotes lifestyle changes for weight loss and can be offered in-person, online, via distance learning, or a combination of modalities. Less is known about which delivery features are optimal and may help address disparities in outcomes for subgroups. We previously demonstrated the efficacy of a stand-alone text messaging intervention based on the NDPP (SMS4PreDM) in a randomized controlled trial in a safety net health care system. Upon broader dissemination, we then showed that SMS4PreDM demonstrated high retention and modest weight loss at a relatively low cost, suggesting the potential to improve in-person NDPP delivery. Objective: In this study, we aim to compare the effectiveness of in-person NDPP classes with and without supplementary SMS4PreDM on attendance and weight loss outcomes to determine whether text messaging can enhance in-person NDPP delivery for a safety net patient population. Methods: From 2015 to 2017, patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability. Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285). This analysis compares the first two groups to evaluate whether supplemental text messaging may improve in-person NDPP outcomes. Outcomes for SMS4PreDM-only participants were previously reported. NDPP classes followed standard delivery guidelines, including weekly-to-monthly classes over a year. SMS4PreDM delivery included messages promoting lifestyle change and modest weight loss, sent 6 days per week for 12 months. Differences in characteristics between intervention groups were assessed using chi-square and t tests. Differences in NDPP attendance and weight loss outcomes were analyzed with multivariable linear and logistic regressions. Results: The mean age was 50.4 years (SD 13.9). Out of a total of 488 participants, 76.2\% (n=372) were female and 59.0\% (n=288) were Hispanic. An additional 17.2\% (n=84) were non-Hispanic white and 12.9\% (n=63) were non-Hispanic black. A total of 48.4\% (n=236) of participants elected to receive supplemental text message support in addition to NDPP classes. Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone. Relatively more women and Hispanic individuals enrolled in the NDPP with supplemental text messages than in NDPP classes alone, 83.9\% (n=198) vs 69.0\% (n=174, P<.001) and 68.6\% (n=162) vs 50.0\% (n=126, P=.001), respectively. Attendance and weight loss outcomes were comparable between groups. Conclusions: Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP. Further research is needed to identify optimal strategies to improve the effectiveness of the NDPP. ", doi="10.2196/15478", url="http://mhealth.jmir.org/2020/6/e15478/", url="http://www.ncbi.nlm.nih.gov/pubmed/32554385" } @Article{info:doi/10.2196/16629, author="Kassavou, Aikaterini and Mirzaei, Venus and Brimicombe, James and Edwards, Simon and Massou, Efthalia and Prevost, Toby A. and Griffin, Simon and Sutton, Stephen", title="A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness", journal="J Med Internet Res", year="2020", month="May", day="19", volume="22", number="5", pages="e16629", keywords="medication adherence", keywords="hypertension", keywords="type 2 diabetes", keywords="text messaging", keywords="interactive voice response", abstract="Background: The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective: This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods: This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results: A total of 135 nonadherent patients (62/135, 46\% female; 122/135, 90.3\%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13\% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95\% CI ?7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95\% CI ?13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100\% fidelity, a median of 12 days of engagement, and 76\% overall satisfaction. Conclusions: Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149. ", doi="10.2196/16629", url="http://www.jmir.org/2020/5/e16629/", url="http://www.ncbi.nlm.nih.gov/pubmed/32427113" } @Article{info:doi/10.2196/13746, author="Seidling, Marita Hanna and Mahler, Cornelia and Strau{\ss}, Beate and Weis, Aline and St{\"u}tzle, Marion and Krisam, Johannes and and Szecsenyi, Joachim and Haefeli, Emil Walter", title="An Electronic Medication Module to Improve Health Literacy in Patients With Type 2 Diabetes Mellitus: Pilot Randomized Controlled Trial", journal="JMIR Form Res", year="2020", month="Apr", day="28", volume="4", number="4", pages="e13746", keywords="medication self-management", keywords="patient empowerment", keywords="health literacy", keywords="chronic diseases", keywords="type 2 diabetes mellitus", keywords="electronic health record", keywords="PEPA", keywords="electronic medication module", keywords="structured medication review", abstract="Background: In primary care, patients play a crucial role in managing care processes and handling drug treatment. A decisive factor for success is their health literacy, and several interventions have been introduced to support patients in fulfilling their responsibility. Objective: The aim of this study is to assess the influence of such an intervention (ie, a medication module) within a patient-led electronic health record on patients' health literacy. Methods: We conducted a randomized controlled study among community-dwelling patients with type 2 diabetes mellitus. Patients were recruited from primary care practices. After randomization, patients either had access to an internet-based medication module allowing them to store their medication information, look up drug information, and print a medication schedule (intervention group), or they received an information brochure on the importance of medication schedules (control group). After 4-8 weeks, all patients were invited to attend a structured medication review (ie, follow-up visit). Data were collected via questionnaires before the start of the intervention and during the follow-up visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessments of patients in the control and intervention groups. Results: Of 116 recruited patients, 107 (92.2\%) completed the follow-up assessment and were eligible for intention-to-treat analyses. Only 73 patients, of which 29 were in the intervention group, followed the study protocol and were eligible for per-protocol analysis. No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts. Reasons for a null effect might be that the cohort was not particularly enriched with participants with low health literacy, thus precluding measurable improvement (ie, ceiling effect). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (ie, randomization according to the protocol and dropout of 29 patients) and the actual interaction with the medication module was modest (ie, dropout of 9 patients). Conclusions: The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short of a duration, or insufficient efficacy of the intervention, as such, contributed to the null effect of this study. This clearly outlines the value of piloting complex interventions and the accompanying process evaluations. ", doi="10.2196/13746", url="http://formative.jmir.org/2020/4/e13746/", url="http://www.ncbi.nlm.nih.gov/pubmed/32343246" } @Article{info:doi/10.2196/18333, author="Li, Xian and Duolikun, Nadila and Cheng, Fengzhuo and Billot, Laurent and Jia, Weiping and Zhang, Puhong", title="Road to Hierarchical Diabetes Management at Primary Care (ROADMAP) Study in China: Protocol for the Statistical Analysis of a Cluster Randomized Controlled Trial", journal="JMIR Res Protoc", year="2020", month="Apr", day="28", volume="9", number="4", pages="e18333", keywords="statistical analysis plan", keywords="cluster randomized controlled trial", keywords="diabetes control", keywords="China", keywords="community-based", keywords="hemoglobin", keywords="primary care", abstract="Background: As the management of type 2 diabetes remains suboptimal in primary care, the Road to Hierarchical Diabetes Management at Primary Care (ROADMAP) study was designed and conducted in diverse primary care settings to test the effectiveness of a three-tiered diabetes management model of care in China. Objective: This paper aims to predetermine the detailed analytical methods for the ROADMAP study before the database lock to reduce potential bias and facilitate transparent analyses. Methods: The ROADMAP study adopts a community-based, cluster randomized controlled trial design that compares the effectiveness of a tiered diabetes management model on diabetes control with usual care among patients with diabetes over a 1-year study period. The primary outcome is the control rate of glycated hemoglobin (HbA1c) <7\% at 1 year. Secondary outcomes include the control rates of ABC (HbA1c, blood pressure, and low-density lipoprotein cholesterol [LDL-C], individual and combined) and fasting blood glucose, and the change in each outcome. The primary analysis will be the log-binomial regression with generalized estimating equation (GEE), which accounts for the clustering within communities, for binary outcomes and linear regression with GEE for continuous outcomes. For both, the baseline value of the analyzed outcome will be the covariate. The other covariate further adjusted models and the repetitive models after multiple imputation (when more than 10\% of observations in HbA1c after 1 year are missing) will be used for sensitivity analysis. Five prespecified subgroup analyses have also been planned to explore the heterogeneity of the intervention effects by adding the subgroup variable and its interaction with the intervention to the primary model. Results: This plan has been finalized, approved, and signed off by the principle investigator, co-principle investigator, and lead statisticians as of November 22, 2019, and made public on the institutional website without any knowledge of intervention allocation. Templates for the main figure and tables are presented. Conclusions: This statistical analysis protocol was developed for the main results of the ROADMAP study by authors blinded to group allocation and with no access to study data, which will guarantee the transparency and reduce potential bias during statistical analysis. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IOC-17011325; https://tinyurl.com/ybpr9xrq International Registered Report Identifier (IRRID): DERR1-10.2196/18333 ", doi="10.2196/18333", url="http://www.researchprotocols.org/2020/4/e18333/", url="http://www.ncbi.nlm.nih.gov/pubmed/32343257" } @Article{info:doi/10.2196/16421, author="Ramirez, Magaly and Chen, Kimberly and Follett, W. Robert and Mangione, M. Carol and Moreno, Gerardo and Bell, S. Douglas", title="Impact of a ``Chart Closure'' Hard Stop Alert on Prescribing for Elevated Blood Pressures Among Patients With Diabetes: Quasi-Experimental Study", journal="JMIR Med Inform", year="2020", month="Apr", day="17", volume="8", number="4", pages="e16421", keywords="decision support systems, clinical", keywords="diabetes mellitus", keywords="hypertension", keywords="drug prescriptions", abstract="Background: University of California at Los Angeles Health implemented a Best Practice Advisory (BPA) alert for the initiation of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) for individuals with diabetes. The BPA alert was configured with a ``chart closure'' hard stop, which demanded a response before closing the chart. Objective: The aim of the study was to evaluate whether the implementation of the BPA was associated with changes in ACEI and ARB prescribing during primary care encounters for patients with diabetes. Methods: We defined ACEI and ARB prescribing opportunities as primary care encounters in which the patient had a diabetes diagnosis, elevated blood pressure in recent encounters, no active ACEI or ARB prescription, and no contraindications. We used a multivariate logistic regression model to compare the change in the probability of an ACEI or ARB prescription during opportunity encounters before and after BPA implementation in primary care sites that did (n=30) and did not (n=31) implement the BPA. In an additional subgroup analysis, we compared ACEI and ARB prescribing in BPA implementation sites that had also implemented a pharmacist-led medication management program. Results: We identified a total of 2438 opportunity encounters across 61 primary care sites. The predicted probability of an ACEI or ARB prescription increased significantly from 11.46\% to 22.17\% during opportunity encounters in BPA implementation sites after BPA implementation. However, in the subgroup analysis, we only observed a significant improvement in ACEI and ARB prescribing in BPA implementation sites that had also implemented the pharmacist-led program. Overall, the change in the predicted probability of an ACEI or ARB prescription from before to after BPA implementation was significantly greater in BPA implementation sites compared with nonimplementation sites (difference-in-differences of 11.82; P<.001). Conclusions: A BPA with a ``chart closure'' hard stop is a promising tool for the treatment of patients with comorbid diabetes and hypertension with an ACEI or ARB, especially when implemented within the context of team-based care, wherein clinical pharmacists support the work of primary care providers. ", doi="10.2196/16421", url="http://medinform.jmir.org/2020/4/e16421/", url="http://www.ncbi.nlm.nih.gov/pubmed/32301741" } @Article{info:doi/10.2196/17455, author="Zhang, Yiyu and Liu, Chaoyuan and Luo, Shuoming and Huang, Jin and Li, Xia and Zhou, Zhiguang", title="Effectiveness of Lilly Connected Care Program (LCCP) App-Based Diabetes Education for Patients With Type 2 Diabetes Treated With Insulin: Retrospective Real-World Study", journal="JMIR Mhealth Uhealth", year="2020", month="Mar", day="6", volume="8", number="3", pages="e17455", keywords="diabetes mellitus", keywords="mobile app", keywords="diabetes self-management education", keywords="glycemic control", abstract="Background: Diabetes poses heavy economic and social burdens worldwide. Mobile apps show great potential for diabetes self-management education. However, there is limited evidence for the effectiveness of providing general diabetes education through mobile apps. Objective: The aim of this study was to clarify the effectiveness of Lilly Connected Care Program (LCCP) app-based diabetes education for glycemic control. Methods: This retrospective cohort study included patients with diabetes recruited to the LCCP platform from September 1, 2018, to May 31, 2019. Each patient was followed for 12 weeks. According to the number of diabetes education courses they had completed, the patients were divided into the following three groups: group A (0-4 courses), group B (5-29 courses), and group C (?30 courses). The main outcomes were the change in blood glucose at the 12th week compared with baseline and the differences in blood glucose at the 12th week among the three groups. The associations of the number of diabetes education courses completed with the average blood glucose and frequency of self-monitoring of blood glucose (SMBG) at the 12th week were assessed by multivariate linear regression analyses controlling for other confounding covariates. Univariate and multivariate linear regression analyses were used to assess factors influencing patients' engagement in the diabetes education courses. Results: A total of 5011 participants were enrolled. Their mean fasting blood glucose (FBG) and postprandial blood glucose (PBG) were significantly lower at the 12th week than at baseline (FBG, 7.46 [standard deviation (SD) 1.95] vs 7.79 [SD 2.18] mmol/L, P<.001; PBG, 8.94 [SD 2.74] vs 9.53 [SD 2.81] mmol/L, P<.001). The groups that completed more diabetes education courses had lower FBG (group B, $\beta$=?0.14, 95\% CI ?0.26 to ?0.03; group C, $\beta$=?0.29, 95\% CI ?0.41 to ?0.16; P for trend <.001) and PBG (group B, $\beta$=?0.29, 95\% CI ?0.46 to ?0.11; group C, $\beta$=?0.47, 95\% CI ?0.66 to ?0.28; P for trend <.001) and a higher frequency of SMBG at the 12th week (group B, $\beta$=1.17, 95\% CI 0.81-1.53; group C, $\beta$=4.21, 95\% CI 3.81-4.62; P for trend <.001) when compared with the findings in group A. Age and education were related to patients' engagement in the diabetes education courses. Middle-aged patients (35-59 years old) and elderly patients (?60 years old) completed more diabetes education courses (middle-aged group, $\beta$=2.22, P=.01; elderly group, $\beta$=2.42, P=.02) than young patients (18-34 years old). Conclusions: LCCP app-based diabetes education is effective for glycemic control and SMBG behavior improvement in patients with type 2 diabetes receiving insulin therapy. Young patients' engagement in the education courses was relatively low. We need to conduct in-depth interviews with users to further improve the curriculum. ", doi="10.2196/17455", url="https://mhealth.jmir.org/2020/3/e17455", url="http://www.ncbi.nlm.nih.gov/pubmed/32141838" } @Article{info:doi/10.2196/15007, author="Halliday, A. Jennifer and Speight, Jane and Bennet, Andrea and Beeney, J. Linda and Hendrieckx, Christel", title="The Diabetes and Emotional Health Handbook and Toolkit for Health Professionals Supporting Adults With Type 1 and Type 2 Diabetes: Formative Evaluation", journal="JMIR Form Res", year="2020", month="Feb", day="21", volume="4", number="2", pages="e15007", keywords="diabetes mellitus", keywords="mental health", keywords="medical reference books", keywords="needs assessment", keywords="evaluation studies", keywords="qualitative research", abstract="Background: Health professionals have expressed unmet needs, including lacking the skills, confidence, training, and resources needed to properly attend to the psychological needs of people with diabetes. Objective: Informed by needs assessments, this study aimed to develop practical, evidence-based resources to support health professionals to address the emotional needs of adults with type 1 or type 2 diabetes. Methods: We developed a new handbook and toolkit informed by formative evaluation, including literature reviews, stakeholder consultation and review, and a qualitative study. In the qualitative study, health professionals participated in interviews after reading sections of the handbook and toolkit. Results: The literature review uncovered that psychological problems are common among adults with diabetes, but health professionals lack resources to provide related support. We planned and drafted resources to fill this unmet need, guided by stakeholder consultation and an Expert Reference Group (ERG). Before finalizing the resources, we implemented feedback received from stakeholders (ERG, health professionals, academics, and people with diabetes). The resulting resources were the practical, evidence-based Diabetes and Emotional Health handbook and toolkit. A total of 19 health professionals took part in the qualitative study about the handbook and toolkit. They viewed the resources favorably, felt empowered to support people with diabetes experiencing psychological problems, and felt motivated to share the resources with others. Some gave examples of how they had used the handbook in clinical practice. A perceived highlight was the inclusion of a process model outlining 7 steps for identifying and supporting people with emotional problems: the 7 A's model. With funding from the National Diabetes Services Scheme (NDSS), more than 2400 copies of Diabetes and Emotional Health have been distributed. It is freely available on the Web. The NDSS is an initiative of the Australian Government administered with the assistance of Diabetes Australia. Conclusions: The new evidence-based resources are perceived by stakeholders as effective aids to assist health professionals in providing emotional support to adults with diabetes. The 7 A's model may have clinical utility for routine monitoring of other psychological and health-related problems, as part of person-centered clinical care. ", doi="10.2196/15007", url="https://formative.jmir.org/2020/2/e15007", url="http://www.ncbi.nlm.nih.gov/pubmed/32130112" } @Article{info:doi/10.2196/15364, author="Huang, Zhilian and Lum, Elaine and Car, Josip", title="Medication Management Apps for Diabetes: Systematic Assessment of the Transparency and Reliability of Health Information Dissemination", journal="JMIR Mhealth Uhealth", year="2020", month="Feb", day="19", volume="8", number="2", pages="e15364", keywords="health apps", keywords="digital health", keywords="diabetes", keywords="privacy", keywords="evidence-based guidance", abstract="Background: Smartphone apps are increasingly used for diabetes self-management because of their ubiquity and ability to help users to personalize health care management. The number of diabetes apps has proliferated in recent years, but only a small subset of apps that pose a higher risk are regulated by governmental agencies. The transparency and reliability of information sources are unclear for apps that provide health care advice and are not regulated by governmental agencies. Objective: This study aimed to assess the transparency and reliability of information disseminated via diabetes apps against 8 criteria adapted from the Health On the Net code of conduct (HONcode) principles. Methods: English-language diabetes-related terms were searched on a market explorer (42matters) on June 12, 2018. Apps with medication and blood glucose management features were downloaded and evaluated against the App-HONcode criteria adapted from the 8 HONcode principles: authoritative, complementarity, privacy, attribution, justifiability, transparency, financial disclosure, and advertising policy. Apps were profiled by operating platforms (ie, Android and iOS) and the number of downloads (ie, Android only: ?100,000 downloads and <100,000 downloads). Results: A total of 143 apps (81 Android and 62 iOS) were downloaded and assessed against the adapted App-HONcode criteria. Most of the apps on the Android and iOS platforms fulfilled between 2 and 6 criteria, but few (20/143, 14.0\%) apps mentioned the qualifications of individuals who contributed to app development. Less than half (59/143, 39.2\%) of the apps disclaimed that the information provided or app functions do not replace the advice of the health care provider. A higher proportion of iOS apps fulfilled 5 or more App-HONcode criteria compared with Android apps. However, Android apps were more likely to have the developer's email listed on the app store (Android: 75/81, 98\%; and iOS: 52/62, 84\%; P=.005) compared with iOS apps. Of the Android apps assessed, a significantly higher proportion of highly downloaded apps had a privacy and confidentiality clause (high downloads: 15/17, 88\%; and low downloads: 33/64, 52\%; P=.006) and were more likely to discuss their financial sources (high downloads: 14/17, 82\%; and low downloads: 32/64, 50\%; P=.03) compared with apps with a low number of downloads. Conclusions: Gaps in the disclosure of the developer's qualification, funding source, and the complementary role of the app in disease management were identified. App stores, developers, and medical providers should collaborate to close these gaps and provide more transparency and reliability to app users. Future work can further examine the consent-seeking process for data collection, data management policies, the appropriateness of advertising content, and clarity of privacy clause of these apps. ", doi="10.2196/15364", url="http://mhealth.jmir.org/2020/2/e15364/", url="http://www.ncbi.nlm.nih.gov/pubmed/32130163" } @Article{info:doi/10.2196/15814, author="Nordyke, J. Robert and Appelbaum, Kevin and Berman, A. Mark", title="Estimating the Impact of Novel Digital Therapeutics in Type 2 Diabetes and Hypertension: Health Economic Analysis", journal="J Med Internet Res", year="2019", month="Oct", day="9", volume="21", number="10", pages="e15814", keywords="digital therapeutics", keywords="behavioral intervention", keywords="economic evaluation", keywords="diabetes", keywords="hypertension", abstract="Background: Behavioral interventions can meaningfully improve cardiometabolic conditions. Digital therapeutics (DTxs) delivering these interventions may provide benefits comparable to pharmacologic therapies, displacing medications for some patients. Objective: Our objective was to estimate the economic impact of a digital behavioral intervention in type 2 diabetes mellitus (T2DM) and hypertension (HTN) and estimate the impact of clinical inertia on deprescribing medications. Methods: Decision analytic models estimated health resource savings and cost effectiveness from a US commercial payer perspective. A 3-year time horizon was most relevant to the intervention and payer. Effectiveness of the DTx in improving clinical outcomes was based on cohort studies and published literature. Health resource utilization (HRU), health state utilities, and costs were drawn from the literature with costs adjusted to 2018 dollars. Future costs and quality-adjusted life years (QALYs) were discounted at 3\%. Sensitivity analyses assessed uncertainty. Results: Average HRU savings ranged from \$97 to \$145 per patient per month, with higher potential benefits in T2DM. Cost-effectiveness acceptability analyses using a willingness-to-pay of \$50,000/QALY indicated that the intervention would be cost effective at total 3-year program costs of \$6468 and \$6620 for T2DM and HTN, respectively. Sensitivity analyses showed that reduced medication costs are a primary driver of potential HRU savings, and the results were robust within values tested. A resistance to deprescribe medications when a patient's clinical outcomes improve can substantially reduce the estimated economic benefits. Our models rely on estimates of clinical effectiveness drawn from limited cohort studies with DTxs and cannot account for other disease management programs that may be implemented. Performance of DTxs in real-world settings is required to further validate their economic benefits. Conclusions: The DTxs studied may provide substantial cost savings, in part by reducing the use of conventional medications. Clinical inertia may limit the full cost savings of DTxs. ", doi="10.2196/15814", url="https://www.jmir.org/2019/10/e15814", url="http://www.ncbi.nlm.nih.gov/pubmed/31599740" } @Article{info:doi/10.2196/13610, author="Jin, Haomiao and Wu, Shinyi", title="Use of Patient-Reported Data to Match Depression Screening Intervals With Depression Risk Profiles in Primary Care Patients With Diabetes: Development and Validation of Prediction Models for Major Depression", journal="JMIR Form Res", year="2019", month="Oct", day="1", volume="3", number="4", pages="e13610", keywords="patient-reported data", keywords="patient-centered decision making", keywords="depression screening", keywords="depression", keywords="diabetes", keywords="health information technology", keywords="data analytics", keywords="predictive modeling", keywords="machine learning", keywords="data mining", abstract="Background: Clinical guidelines recommend screening for depression in the general adult population but recognizes that the optimum interval for screening is unknown. Ideal screening intervals should match the patient risk profiles. Objective: This study describes a predictive analytics approach for mining clinical and patient-reported data from a large clinical study for the identification of primary care patients at high risk for depression to match depression screening intervals with patient risk profiles. Methods: This paper analyzed data from a large safety-net primary care study for diabetes and depression. A regression-based data mining technique was used to examine 53 demographics, clinical variables, and patient-reported variables to develop three prediction models for major depression at 6, 12, and 18 months from baseline. Predictors with the strongest predictive power that require low information collection efforts were selected to develop the prediction models. Predictive accuracy was measured by the area under the receiver operating curve (AUROC) and was evaluated by 10-fold cross-validation. The effectiveness of the prediction algorithms in supporting clinical decision making for six ``typical'' types of patients was demonstrated. Results: The analysis included 923 patients who were nondepressed at the study baseline. Five patient-reported variables were selected in the prediction models to predict major depression at 6, 12, and 18 months: (1) Patient Health Questionnaire 2-item score; (2) the Sheehan Disability Scale; (3) previous problems with depression; (4) the diabetes symptoms scale; and (5) emotional burden of diabetes. All three depression prediction models had an AUROC>0.80, comparable with published depression prediction studies. Among the 6 ``typical'' types of patients, the algorithms suggest that patients who reported impaired daily functioning by health status are at an elevated risk for depression in all three periods. Conclusions: This study demonstrated that leveraging patient-reported data and prediction models can help improve identification of high-risk patients and clinical decisions about the depression screening interval for diabetes patients. Implementation of this approach can be coupled with application of modern technologies such as telehealth and mobile health assessment for collecting patient-reported data to improve privacy, reducing stigma and costs, and promoting a personalized depression screening that matches screening intervals with patient risk profiles. ", doi="10.2196/13610", url="https://formative.jmir.org/2019/4/e13610", url="http://www.ncbi.nlm.nih.gov/pubmed/31573900" } @Article{info:doi/10.2196/10857, author="Litchman, L. Michelle and Edelman, S. Linda", title="Perceptions of the Diabetes Online Community's Credibility, Social Capital, and Help and Harm: Cross-Sectional Comparison Between Baby Boomers and Younger Adults", journal="JMIR Aging", year="2019", month="Sep", day="26", volume="2", number="2", pages="e10857", keywords="diabetes mellitus", keywords="online social networking", keywords="social capital", keywords="trust", keywords="social media", keywords="older adult", abstract="Background: The use of online health communities such as the diabetes online community (DOC) is growing. Individuals who engage in the DOC are able to interact with peers who have the same medical condition. It is not known if older adults are perceiving the DOC differently compared with younger adults. Objective: The purpose of this study was to explore and understand how the DOC is perceived in terms of social capital, source credibility, and help and harm. The findings from this study will shed light on how users of different age groups (baby boomers and younger adult counterparts) perceive DOC use. Methods: This study represents a subset of participants from a larger study of DOC users. Baby boomers and younger adults with diabetes were recruited from the DOC to participate in a cross-sectional survey. Demographics, electronic health use (reasons to join the DOC, DOC intensity, DOC engagement, internet social capital, and help or harm from the DOC), source credibility, health-related quality of life, and diabetes self-care data were collected. We examined the differences between baby boomer and younger adult responses. Results: The participants included baby boomers (N=76) and younger adult counterparts (N=102). Participants scored their diabetes health care team (mean 33.5 [SD 8]) significantly higher than the DOC (mean 32 [SD 6.4]) with regard to competence (P<.05) and trustworthiness (diabetes health care team mean 36.3 [SD 7.1]; DOC mean 33.6 [SD 6.2]; P<.001). High bonding and bridging social capital correlated with high DOC intensity (r=.629; P<.001 and r=.676; P<.001, respectively) and high DOC engagement (r=.474; P<.01 and r=.507; P?.01, respectively). The greater majority (69.8\%) reported the DOC as being helpful, and 1.8\% reported that the DOC had caused minor harm. Baby boomers perceived DOC credibility, social capital, help, and harm similarly to their younger adult counterparts. Conclusions: Baby boomers are using and perceiving the DOC similarly to younger adults. DOC users find the DOC to be credible; however, they scored their health care team higher with regard to competence and trustworthiness. The DOC is beneficial with low risk and may augment current diabetes care. ", doi="10.2196/10857", url="https://aging.jmir.org/2019/2/e10857/", url="http://www.ncbi.nlm.nih.gov/pubmed/31573907" } @Article{info:doi/10.2196/13407, author="Bellass, Sue and Taylor, Johanna and Han, Lu and Prady, L. Stephanie and Shiers, David and Jacobs, Rowena and Holt, Gregory Richard Ian and Radford, John and Gilbody, Simon and Hewitt, Catherine and Doran, Tim and Alderson, L. Sarah and Siddiqi, Najma", title="Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study", journal="JMIR Res Protoc", year="2019", month="Sep", day="06", volume="8", number="9", pages="e13407", keywords="schizophrenia", keywords="bipolar disorder", keywords="diabetes mellitus", keywords="diabetes complications", abstract="Background: The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15 to 20 years less than that for the population as a whole. Diabetes contributes significantly to this inequality, being 2 to 3 times more prevalent in people with SMI. Various risk factors have been implicated, including side effects of antipsychotic medication and unhealthy lifestyles, which often occur in the context of socioeconomic disadvantage and health care inequality. However, little is known about how these factors may interact to influence the risk of developing diabetes and poor diabetic outcomes, or how the organization and provision of health care may contribute. Objective: This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with SMI. Methods: This study will employ a concurrent mixed methods design combining the interrogation of electronic primary care health records from the Clinical Practice Research Datalink (CPRD GOLD) with qualitative interviews with adults with SMI and diabetes, their relatives and friends, and health care staff. The study has been funded for 2 years, from September 2017 to September 2019, and data collection has recently ended. Results: CPRD and linked health data will be used to explore the association of sociodemographics, illness, and health care--related factors with both the development and outcomes of type 2 diabetes in people with SMI. Experiences of managing the comorbidity and accessing health care will be explored through qualitative interviews using topic guides informed by evidence synthesis and expert consultation. Findings from both datasets will be merged to develop a more comprehensive understanding of diabetes risks, interventions, and outcomes for people with SMI. Findings will be translated into recommendations for interventions and services using co-design workshops. Conclusions: Improving diabetes outcomes for people with SMI is a high-priority area nationally and globally. Understanding how risk factors combine to generate high prevalence of diabetes and poor diabetic outcomes for this population is a necessary first step in developing health care interventions to improve outcomes for people with diabetes and SMI. Trial Registration: ClinicalTrials.gov NCT03534921;?https://clinicaltrials.gov/ct2/show/NCT03534921 ", doi="10.2196/13407", url="https://www.researchprotocols.org/2019/9/e13407", url="http://www.ncbi.nlm.nih.gov/pubmed/31493324" } @Article{info:doi/10.2196/13857, author="Crawford, Joanna and Wilhelm, Kay and Proudfoot, Judy", title="Web-Based Benefit-Finding Writing for Adults with Type 1 or Type 2 Diabetes: Preliminary Randomized Controlled Trial", journal="JMIR Diabetes", year="2019", month="Jun", day="27", volume="4", number="2", pages="e13857", keywords="diabetes", keywords="adult", keywords="distress", keywords="benefit-finding", keywords="depression", keywords="anxiety", keywords="emotions", keywords="internet", keywords="writing", keywords="surveys and questionnaires", keywords="treatment outcome", abstract="Background: The high prevalence of diabetes distress and subclinical depression in adults with type 1 and type 2 diabetes mellitus (T1DM and T2DM, respectively) indicates the need for low-intensity self-help interventions that can be used in a stepped care approach to address some of their psychological needs. However, people with diabetes can be reluctant to engage in mental health care. Benefit-finding writing (BFW) is a brief intervention that involves writing about any positive thoughts and feelings concerning a stressful experience such as an illness, avoiding potential mental health stigma. It has been associated with increases in positive affect and positive growth and has demonstrated promising results in trials in other clinical populations. However, BFW has not been examined in people with diabetes. Objective: This study aimed to evaluate the efficacy of a Web-based BFW intervention for reducing diabetes distress and increasing benefit finding in diabetic adults with T1DM or T2DM compared to a control writing condition. Methods: Adults with T1DM or T2DM and diabetes distress were recruited online through the open access Writing for Health program. After completing baseline questionnaires, they were randomly allocated to receive online BFW or an active control condition of online writing about the use of time (CW). Both groups completed 15-minute online writing sessions, once per day, for 3 consecutive days. Online measures were administered at baseline, 1 month, and 3 months postintervention. Participants were also asked to rate their current mood immediately prior to and following each writing session. Results: Seventy-two adults with T1DM or T2DM were recruited and randomly allocated to receive BFW (n=24) or CW (n=48). Participants adhered to the BFW regimen. Greater increases in positive affect immediately postwriting were found in the BFW group than in the CW group. However, there were no significant group-by-time interactions (indicating intervention effects) for benefit finding or diabetes distress at either the 1-month or 3-month follow-up. Both the BFW and CW groups demonstrated small, significant decreases in diabetes distress over time. Conclusions: BFW was well tolerated by adults with diabetes in this study but did not demonstrate efficacy in improving diabetes distress or benefit finding compared to an active control writing condition. However, due to recruitment difficulties, the study was underpowered and the sample was skewed to individuals with minimal diabetes distress and none to minimal depression and anxiety at baseline. Future research should continue to investigate the efficacy of variants of therapeutic writing for adults with T1DM or T2DM, using larger samples of participants with elevated diabetes distress. Trial Registration: Australiand New Zealand Clinical Trials Registry ACTRN12615000241538; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368146 ", doi="10.2196/13857", url="http://diabetes.jmir.org/2019/2/e13857/", url="http://www.ncbi.nlm.nih.gov/pubmed/31250827" } @Article{info:doi/10.2196/11701, author="Brandt, R. Lena and Hidalgo, Liliana and Diez-Canseco, Francisco and Araya, Ricardo and Mohr, C. David and Menezes, R. Paulo and Miranda, Jaime J.", title="Addressing Depression Comorbid With Diabetes or Hypertension in Resource-Poor Settings: A Qualitative Study About User Perception of a Nurse-Supported Smartphone App in Peru", journal="JMIR Ment Health", year="2019", month="Jun", day="18", volume="6", number="6", pages="e11701", keywords="mental health", keywords="depression", keywords="noncommunicable diseases", keywords="mHealth", keywords="smartphone", keywords="developing countries", abstract="Background: Smartphone apps could constitute a cost-effective strategy to overcome health care system access barriers to mental health services for people in low- and middle-income countries. Objective: The aim of this paper was to explore the patients' perspectives of CONEMO (Emotional Control, in Spanish: Control Emocional), a technology-driven, psychoeducational, and nurse-supported intervention delivered via a smartphone app aimed at reducing depressive symptoms in people with diabetes, hypertension or both who attend public health care centers, as well as the nurses' feedback about their role and its feasibility to be scaled up. Methods: This study combines data from 2 pilot studies performed in Lima, Peru, between 2015 and 2016, to test the feasibility of CONEMO. Interviews were conducted with 29 patients with diabetes, hypertension or both with comorbid depressive symptoms who used CONEMO and 6 staff nurses who accompanied the intervention. Using a content analysis approach, interview notes from patient interviews were transferred to a digital format, coded, and categorized into 6 main domains: the perceived health benefit, usability, adherence, user satisfaction with the app, nurse's support, and suggestions to improve the intervention. Interviews with nurses were analyzed by the same approach and categorized into 4 domains: general feedback, evaluation of training, evaluation of study activities, and feasibility of implementing this intervention within the existing structures of health system. Results: Patients perceived improvement in their emotional health because of CONEMO, whereas some also reported better physical health. Many encountered some difficulties with using CONEMO, but resolved them with time and practice. However, the interactive elements of the app, such as short message service, android notifications, and pop-up messages were mostly perceived as challenging. Satisfaction with CONEMO was high, as was the self-reported adherence. Overall, patients evaluated the nurse accompaniment positively, but they suggested improvements in the technological training and an increase in the amount of contact. Nurses reported some difficulties in completing their tasks and explained that the CONEMO intervention activities competed with their everyday work routine. Conclusions: Using a nurse-supported smartphone app to reduce depressive symptoms among people with chronic diseases is possible and mostly perceived beneficial by the patients, but it requires context-specific adaptations regarding the implementation of a task shifting approach within the public health care system. These results provide valuable information about user feedback for those building mobile health interventions for depression. ", doi="10.2196/11701", url="https://mental.jmir.org/2019/6/e11701/", url="http://www.ncbi.nlm.nih.gov/pubmed/31215511" } @Article{info:doi/10.2196/humanfactors.9481, author="Jalil, Sakib and Myers, Trina and Atkinson, Ian and Soden, Muriel", title="Complementing a Clinical Trial With Human-Computer Interaction: Patients' User Experience With Telehealth", journal="JMIR Hum Factors", year="2019", month="Jun", day="06", volume="6", number="2", pages="e9481", keywords="clinical user-experience evaluation", keywords="telehealth", keywords="type 2 diabetes", keywords="user experience", keywords="human-computer interaction", keywords="patient-centered", keywords="patient-technology interaction", keywords="eHealth", abstract="Background: The use of telehealth to monitor patients from home is on the rise. Telehealth technology is evaluated in a clinical trial with measures of health outcomes and cost-effectiveness. However, what happens between a technology and the patients is not investigated during a clinical trial---the telehealth technology remains as a ``black box.'' Meanwhile, three decades of research in the discipline of human-computer interaction (HCI) presents design, implementation, and evaluation of technologies with a primary emphasis on users. HCI research has exposed the importance of user experience (UX) as an essential part of technology development and evaluation. Objective: This research investigates the UX of patients with type 2 diabetes mellitus (T2D) with a telehealth in-home monitoring device to manage T2D from home. We investigate how the UX during a clinical trial can be researched and what a clinical trial can learn from HCI research. Methods: We adopted an ethnographic philosophy and conducted a contextual inquiry due to time limitations followed by semistructured interviews of 9 T2D patients. We defined the method as Clinical User-experience Evaluation (CUE). The patients were enrolled in a telehealth clinical trial of T2D; however, this research was an independent study conducted by information technologists and health researchers for a user-centered evaluation of telehealth. Results: Key analytical findings were that patients valued the benefits of in-home monitoring, but the current device did not possess all functionalities that patients wanted. The results include patients' experiences and emotions while using the device, patients' perceived benefits of the device, and how patients domesticated the device. Further analysis showed the influence of the device on patients' awareness, family involvement, and design implications for telehealth for T2D. Conclusions: HCI could complement telehealth clinical trials and uncover knowledge about T2D patients' UX and future design implications. Through HCI we can look into the ``black box'' phenomenon of clinical trials and create patient-centered telehealth solutions. ", doi="10.2196/humanfactors.9481", url="http://humanfactors.jmir.org/2019/2/e9481/", url="http://www.ncbi.nlm.nih.gov/pubmed/31172958" } @Article{info:doi/10.2196/13571, author="Su, Min and Haldane, Victoria and Upshur, Ross and Sullivan, Frank and L{\'e}gar{\'e}, France and Greiver, Michelle and Wei, Xiaolin", title="The Impact of Treatment Adherence for Patients With Diabetes and Hypertension on Cardiovascular Disease Risk: Protocol for a Retrospective Cohort Study, 2008-2018", journal="JMIR Res Protoc", year="2019", month="May", day="31", volume="8", number="5", pages="e13571", keywords="treatment adherence", keywords="cardiovascular disease", keywords="primary care", abstract="Background: Cardiovascular disease (CVD) is the leading cause of death globally and in Canada. Diabetes and hypertension are major risk factors for CVD events. Despite the increasing availability of effective treatments, the majority of diabetic and hypertensive patients do not have adequate blood pressure and glycemic control. One of the major contributors is poor treatment adherence. Objective: This study aims to evaluate the impact of treatment adherence for patients with both diabetes and hypertension on acute severe CVD events and intermediate clinical outcomes in Canadian primary care settings. Methods: We will conduct a population-based retrospective cohort study of patients living with both diabetes and hypertension in Ontario, Canada, between January 1, 2008, and March 31, 2018. The Social Cognitive Theory will be used as a conceptual framework by which to frame the reciprocal relationship between treatment adherence, personal factors, and environmental determinants and how this interplay impacts CVD events and clinical outcomes. Data will be derived from the Diabetes Action Canada National Data Repository. A time-varying Cox proportional hazards model will be used to estimate the impacts of treatment adherence on CVD morbidity and mortality. Multivariable linear regression models and hierarchical regression models will be used to estimate the associations between treatment adherence of different medication categories and intermediate clinical outcomes. Our primary outcome is the association between treatment adherence and the risk of acute severe CVD events, including CVD mortality. The secondary outcome is the association between treatment adherence and intermediate clinical outcomes including diastolic and systolic blood pressures, glycated hemoglobin, low-density lipoprotein cholesterol, and total cholesterol. Owing to data limitation, we use medication prescriptions as a proxy to estimate treatment adherence. We assume that a patient adhered to medications if she or he had any prescription record in the 4 preceding quarters and 1 quarter after each quarter of interest. Acute severe CVD events are defined based on the World Health Organization's Monitoring Trends and Determinants in Cardiovascular Disease Project, including acute coronary heart disease, stroke, and heart failure. As causes of death are not available, the number of CVD deaths will be computed using the most recent systolic blood pressure distributions and the population attributable risks related to systolic blood pressure level. Results: The project was funded by Diabetes Action Canada (reference number: 503854) and approved by the University of Toronto Research Ethics Board (reference number: 36065). The project started in June 2018 and is expected to be finished by September 2019. Conclusions: The findings will be helpful in identifying the challenges of treatment adherence for diabetic and hypertensive patients in primary care settings. This will also help to develop intervention strategies to promote treatment adherence for patients with multi-morbidities. International Registered Report Identifier (IRRID): DERR1-10.2196/13571 ", doi="10.2196/13571", url="http://www.researchprotocols.org/2019/5/e13571/", url="http://www.ncbi.nlm.nih.gov/pubmed/31152529" } @Article{info:doi/10.2196/13615, author="Hansen, Helen Anne and Bradway, Meghan and Broz, Jan and Claudi, Tor and Henriksen, {\O}ystein and Wangberg, C. Silje and {\AA}rsand, Eirik", title="Inequalities in the Use of eHealth Between Socioeconomic Groups Among Patients With Type 1 and Type 2 Diabetes: Cross-Sectional Study", journal="J Med Internet Res", year="2019", month="May", day="29", volume="21", number="5", pages="e13615", keywords="inequalities", keywords="eHealth", keywords="internet", keywords="health care utilization", keywords="cross-sectional study", keywords="diabetes mellitus, type 1", keywords="diabetes mellitus, type 2", keywords="education", keywords="income", keywords="Norway", abstract="Background: The prevalence of diabetes and the use of electronic health (eHealth) are increasing. People with diabetes need frequent monitoring and follow-up of health parameters, and eHealth services can be highly valuable. However, little is known about the use of eHealth in different socioeconomic groups among people with diabetes. Objective: The aim of this study was to investigate the use of 4 different eHealth platforms (apps, search engines, video services, and social media sites) and the association with socioeconomic status (SES) among people diagnosed with type 1 and type 2 diabetes mellitus (T1D and T2D, respectively). Methods: We used email survey data from 1250 members of the Norwegian Diabetes Association (aged 18-89 years), collected in 2018. Eligible for analyses were the 1063 respondents having T1D (n=523) and T2D (n=545). 5 respondents reported having both diabetes types and thus entered into both groups. Using descriptive statistics, we estimated the use of the different types of eHealth. By logistic regressions, we studied the associations between the use of these types of eHealth and SES (education and household income), adjusted for gender, age, and self-rated health. Results: We found that 87.0\% (447/514) of people with T1D and 77.7\% (421/542) of people with T2D had used 1 or more forms of eHealth sometimes or often during the previous year. The proportion of people using search engines was the largest in both diagnostic groups, followed by apps, social media, and video services. We found a strong association between a high level of education and the use of search engines, whereas there were no educational differences for the use of apps, social media, or video services. In both diagnostic groups, high income was associated with the use of apps. In people with T1D, lower income was associated with the use of video services. Conclusions: This paper indicates a digital divide among people with diabetes in Norway, with consequences that may contribute to sustaining and shaping inequalities in health outcomes. The strong relationship between higher education and the use of search engines, along with the finding that the use of apps, social media, and video services was not associated with education, indicates that adequate communication strategies for audiences with varying education levels should be a focus in future efforts to reduce inequalities in health outcomes. ", doi="10.2196/13615", url="http://www.jmir.org/2019/5/e13615/", url="http://www.ncbi.nlm.nih.gov/pubmed/31144669" } @Article{info:doi/10.2196/14110, author="Alvarez-Mon, Angel Miguel and Llavero-Valero, Mar{\'i}a and S{\'a}nchez-Bayona, Rodrigo and Pereira-Sanchez, Victor and Vallejo-Valdivielso, Maria and Monserrat, Jorge and Lahera, Guillermo and Asunsolo del Barco, Angel and Alvarez-Mon, Melchor", title="Areas of Interest and Stigmatic Attitudes of the General Public in Five Relevant Medical Conditions: Thematic and Quantitative Analysis Using Twitter", journal="J Med Internet Res", year="2019", month="May", day="28", volume="21", number="5", pages="e14110", keywords="social stigma", keywords="social media", keywords="psychosis", keywords="breast cancer", keywords="HIV", keywords="dementia", keywords="public opinion", keywords="diabetes", abstract="Background: Twitter is an?indicator of real-world?performance, thus, is an appropriate arena to assess the social consideration and attitudes toward psychosis. Objective: The aim of this study was to perform a mixed-methods study of the content and key metrics of tweets referring to psychosis in comparison with tweets referring to control diseases (breast cancer, diabetes, Alzheimer, and human immunodeficiency virus). Methods: Each tweet's content was rated as nonmedical (NM: testimonies, health care products, solidarity or awareness and misuse) or medical (M: included a reference to the illness's diagnosis, treatment, prognosis, or prevention). NM tweets were classified as positive or pejorative. We assessed the appropriateness of the medical content. The number of retweets generated and the potential reach and impact of the hashtags analyzed was also investigated. Results: We analyzed a total of 15,443 tweets: 8055 classified as NM and 7287 as M. Psychosis-related tweets (PRT) had a significantly higher frequency of misuse 33.3\% (212/636) vs 1.15\% (853/7419; P<.001) and pejorative content 36.2\% (231/636) vs 11.33\% (840/7419; P<.001). The medical content of the PRT showed the highest scientific appropriateness 100\% (391/391) vs 93.66\% (6030/6439; P<.001) and had a higher frequency of content about disease prevention. The potential reach and impact of the tweets related to psychosis were low, but they had a high retweet-to-tweet ratio. Conclusions: We show a reduced number and a different pattern of contents in tweets about psychosis compared with control diseases. PRT showed a predominance of nonmedical content with increased frequencies of misuse and pejorative tone. However, the medical content of PRT showed high scientific appropriateness aimed toward prevention. ", doi="10.2196/14110", url="http://www.jmir.org/2019/5/e14110/", url="http://www.ncbi.nlm.nih.gov/pubmed/31140438" } @Article{info:doi/10.2196/12793, author="Fletcher, Susan and Clarke, Janine and Sanatkar, Samineh and Baldwin, Peter and Gunn, Jane and Zwar, Nick and Campbell, Lesley and Wilhelm, Kay and Harris, Mark and Lapsley, Helen and Hadzi-Pavlovic, Dusan and Proudfoot, Judy", title="Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care", journal="J Med Internet Res", year="2019", month="May", day="24", volume="21", number="5", pages="e12793", keywords="e-mental health", keywords="primary care", keywords="patient recruitment", keywords="depression", keywords="type 2 diabetes", keywords="learning", abstract="Background: E-mental health (eMH) interventions are now widely available and they have the potential to revolutionize the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, services currently delivered face to face in the community setting. However, randomized trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants who are recruited online differ from those who attend primary care. Objective: This paper aimed to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods. Methods: Recruitment to the SpringboarD randomized controlled trial was initially focused on general practices in 2 states of Australia. Over 15 months, we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face-to-face site visits, regular contact via telephone and trial newsletters, and development of a Web-based patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size, and we therefore supplemented recruitment through national online advertising and promoted the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using the analysis of variance and chi square tests. Results: Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on the recruitment source. Of these, only 24 were recruited through general practice, whereas 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritization of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the 3 different approaches differed in age, gender, employment status, depressive symptoms, and diabetes distress, with online participants being distinguished from those recruited through general practice or other sources. However, most differences reached only a small effect size and are unlikely to be of clinical importance. Conclusions: Time, labor, and cost-intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were broadly similar to those recruited via general practice. ", doi="10.2196/12793", url="https://www.jmir.org/2019/5/e12793/", url="http://www.ncbi.nlm.nih.gov/pubmed/31127718" } @Article{info:doi/10.2196/13312, author="Han, Peijin and Nicholson, Wanda and Norton, Anna and Graffeo, Karen and Singerman, Richard and King, Steven and Sundaresan, Aditi and Bennett, Wendy", title="DiabetesSistersVoices: Virtual Patient Community to Identify Research Priorities for Women Living With Diabetes", journal="J Med Internet Res", year="2019", month="May", day="10", volume="21", number="5", pages="e13312", keywords="social media", keywords="online social networking", keywords="women's health", keywords="diabetes mellitus", abstract="Background: Women with or at high risk of diabetes have unique health concerns across their life course. Effective methods are needed to engage women living with diabetes to develop and carry out a patient-centered research agenda. Objective: This study aimed to (1) describe the creation of DiabetesSistersVoices, a virtual patient community for women living with and at risk for diabetes and (2) assess the feasibility and acceptability of DiabetesSistersVoices for engaging women in talking about their experiences, health care, and research priorities. Methods: We partnered with a national advocacy organization to create DiabetesSistersVoices and to develop recruitment strategies, which included use of social media, Web-based newsletters, and weblinks through partnering organizations. Study inclusion criteria were as follows: Being a woman aged ?18 years, residing in the United States, and self-reporting a diagnosis of diabetes or risk of diabetes. Eligible participants were given access to DiabetesSistersVoices and completed online surveys at enrollment and 6 months. We assessed trends in participants' activities, including posting questions, sharing experiences about living with diabetes, and searching for posted resources. Results: We enrolled 332 women (white: 86.5\%; type 1 diabetes: 76.2\%; median age: 51 years [interquartile range: 31 to 59 years]) over 8 months. Most (41.6\%, 138/332) were classified as being active users (ie, posting) of the virtual community, 36.1\% (120/332) as observers (ie, logged in but no posts), and 22.3\% (74/332) as never users (ie, completed baseline surveys but then never logged in). Online activities were constant during the study, although participants had the highest website usage during the first 10 weeks after their enrollment. Conclusions: We demonstrated the feasibility and acceptability of an online patient community for women living with diabetes by showing durability of recruitment and online usage over 6 months of testing. Next steps are to address barriers to joining a virtual patient community for women of color and women with type 2 diabetes to enhance inclusiveness and gain diverse perspectives to inform diabetes research. ", doi="10.2196/13312", url="https://www.jmir.org/2019/5/e13312/", url="http://www.ncbi.nlm.nih.gov/pubmed/31094360" } @Article{info:doi/10.2196/12297, author="Wu, Xinghan and Guo, Xitong and Zhang, Zhiwei", title="The Efficacy of Mobile Phone Apps for Lifestyle Modification in Diabetes: Systematic Review and Meta-Analysis", journal="JMIR Mhealth Uhealth", year="2019", month="Jan", day="15", volume="7", number="1", pages="e12297", keywords="smartphone", keywords="mobile applications", keywords="diabetes mellitus", keywords="lifestyle", keywords="physical activity", keywords="diet", keywords="behavior therapy", abstract="Background: Diabetes and related complications are estimated to cost US \$727 billion worldwide annually. Type 1 diabetes, type 2 diabetes, and gestational diabetes are three subtypes of diabetes that share the same behavioral risk factors. Efforts in lifestyle modification, such as daily physical activity and healthy diets, can reduce the risk of prediabetes, improve the health levels of people with diabetes, and prevent complications. Lifestyle modification is commonly performed in a face-to-face interaction, which can prove costly. Mobile phone apps provide a more accessible platform for lifestyle modification in diabetes. Objective: This review aimed to summarize and synthesize the clinical evidence of the efficacy of mobile phone apps for lifestyle modification in different subtypes of diabetes. Methods: In June 2018, we conducted a literature search in 5 databases (Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, and PsycINFO). We evaluated the studies that passed screening using The Cochrane Collaboration's risk of bias tool. We conducted a meta-analysis for each subtype on the mean difference (between intervention and control groups) at the posttreatment glycated hemoglobin (HbA1c) level. Where possible, we analyzed subgroups for short-term (3-6 months) and long-term (9-12 months) studies. Heterogeneity was assessed using the I2 statistic. Results: We identified total of 2669 articles through database searching. After the screening, we included 26 articles (23 studies) in the systematic review, of which 18 studies (5 type 1 diabetes, 11 type 2 diabetes, and 2 prediabetes studies) were eligible for meta-analysis. For type 1 diabetes, the overall effect on HbA1c was statistically insignificant (P=.46) with acceptable heterogeneity (I2=39\%) in the short-term subgroup (4 studies) and significant heterogeneity between the short-term and long-term subgroups (I2=64\%). Regarding type 2 diabetes, the overall effect on HbA1c was statistically significant (P<.01) in both subgroups, and when the 2 subgroups were combined, there was virtually no heterogeneity within and between the subgroups (I2 range 0\%-2\%). The effect remained statistically significant (P<.01) after adjusting for publication bias using the trim and fill method. For the prediabetes condition, the overall effect on HbA1c was statistically insignificant (P=.67) with a large heterogeneity (I2=65\%) between the 2 studies. Conclusions: There is strong evidence for the efficacy of mobile phone apps for lifestyle modification in type 2 diabetes. The evidence is inconclusive for the other diabetes subtypes. ", doi="10.2196/12297", url="http://mhealth.jmir.org/2019/1/e12297/", url="http://www.ncbi.nlm.nih.gov/pubmed/30664494" } @Article{info:doi/10.2196/11843, author="Yonel, Zehra and Sharma, Praveen and Gray, J. Laura", title="Use of Dental Practices for the Identification of Adults With Undiagnosed Type 2 Diabetes Mellitus or Nondiabetic Hyperglycemia: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2018", month="Nov", day="19", volume="7", number="11", pages="e11843", keywords="adults", keywords="case-finding", keywords="dental", keywords="diabetes", keywords="nondiabetic hyperglycemia", keywords="risk assessment", abstract="Background: Type 2 diabetes mellitus (T2DM) is a growing global health burden and is expected to affect more than 590 million people by the year 2035. Evidence exists to demonstrate that dental settings have been used for risk assessment and identification of individuals who may be at high risk for T2DM or who may already unknowingly have the condition. Objective: This protocol aims to outline the methodology that will be undertaken to synthesize the literature relating to the use of primary care (nonhospital-based) dental services for the identification of undiagnosed T2DM or prediabetes---often termed nondiabetic hyperglycemia---in adult patients. Methods: This paper outlines the protocol that will be followed to conduct a systematic review and meta-analysis of the available literature. The protocol outlines the aims, objectives, search strategy, data extraction and data management methods, as well as the statistical analysis plan. The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines were followed in developing the protocol as were elements of the Cochrane handbook. Results: We expect the systematic review to be completed within 18 months of publication of this protocol and expect to see a high degree of heterogeneity in the existing literature. Conclusions: This review is of importance as it will synthesize the existing evidence base and inform future studies in the field. Following the publication of the protocol, the review will be registered on Prospective Register of Systematic Reviews. Following the completion of the review, results will be published in a suitable peer-reviewed journal. International Registered Report Identifier (IRRID): PRR1-10.2196/11843 ", doi="10.2196/11843", url="http://www.researchprotocols.org/2018/11/e11843/", url="http://www.ncbi.nlm.nih.gov/pubmed/30455173" } @Article{info:doi/10.2196/diabetes.9694, author="Franco, Pamela and Gallardo, Mar{\'i}a Ana and Urtubey, Xavier", title="Web-Based Interventions for Depression in Individuals with Diabetes: Review and Discussion", journal="JMIR Diabetes", year="2018", month="Sep", day="14", volume="3", number="3", pages="e13", keywords="Web-based intervention", keywords="internet", keywords="depression", keywords="diabetes", keywords="cognitive behavioral therapy", abstract="Background: Depression is twice as common in people with diabetes, and this comorbidity worsens the course of both pathologies. In clinical practice guidelines, screening and treatment of depression in patients with diabetes are highly recommended. However, depression is still both underrecognized and undertreated. To find ways to enhance their reach, psychological treatments have taken advantage of benefits of internet and technological devices as delivery formats, providing interventions that require considerably less (or even no) interaction time with therapists. Web-based treatments hold promise for effective interventions at low cost with positive results. Objective: The objectives of this review were to describe Web-based interventions for depression in individuals with diabetes and to discuss these studies' procedures and findings in light of evidence from a wider range of interventions for depression and diabetes. Methods: A comprehensive literature search was conducted in PsycINFO and MEDLINE electronic databases. Studies were included when they met the following selection criteria: the study was available in a peer-reviewed journal mainly publishing studies written in either English or Spanish; the studied sample comprised individuals with diabetes; the intervention targeted depression symptomatology; the intervention was accessible via the internet; and the intervention was accessible via the internet with little or no clinician support. Results: Overall, 5 research studies were identified in the review. All studies were randomized controlled trials, and most used a wait list as a control; 4 studies reported treatment dropout, rates of which varied from 13\% to 42\%. Studies supported the notion that the Web-based format is a suitable psychology service delivery option for diabetic individuals with depression (effect size range for completers 0.7-0.89). Interventions varied in their characteristics but most were clinical-assisted, had a cognitive behavioral therapy approach, used diabetes-specific topics, had a weekly modular display, used homework assignments, and had some adherence management strategy. These characteristics are consistent with the intervention features associated with positive results in the literature. Conclusions: The analyzed studies' findings and procedures are discussed in light of evidence drawn from a wider range of reviews on Web-based interventions for depression and diabetes. Consistent with previous research on depression treatment, Web-based interventions for depression among individuals with diabetes have shown positive results. Future research should contribute new evidence as to why these interventions are effective, for whom, and which particular aspects can increase patients' adherence. ", doi="10.2196/diabetes.9694", url="http://diabetes.jmir.org/2018/3/e13/", url="http://www.ncbi.nlm.nih.gov/pubmed/30291082" } @Article{info:doi/10.2196/jmir.9432, author="Brazeau, Anne-Sophie and Nakhla, Meranda and Wright, Michael and Henderson, M{\'e}lanie and Panagiotopoulos, Constadina and Pacaud, Daniele and Kearns, Patricia and Rahme, Elham and Da Costa, Deborah and Dasgupta, Kaberi", title="Stigma and Its Association With Glycemic Control and Hypoglycemia in Adolescents and Young Adults With Type 1 Diabetes: Cross-Sectional Study", journal="J Med Internet Res", year="2018", month="Apr", day="20", volume="20", number="4", pages="e151", keywords="type 1 diabetes", keywords="youth", keywords="young adult", keywords="social stigma", keywords="perception", keywords="glycated hemoglobin A1c", abstract="Background: Qualitative studies in type 1 diabetes indicate that visibility of diabetes supplies, self-care, and hypoglycemia symptoms are associated with stigma and suboptimal management. This may be particularly salient in youth who face concurrent challenges such as establishing autonomy and making vocational choices. Objective: The aim of the study was to estimate stigma prevalence in youth (aged 14-24 years) with type 1 diabetes and its associations with glycemic control. Methods: Participants, recruited largely through social media, were asked to complete a Web-based survey and to send via mail capillary blood samples for glycated hemoglobin (HbA1c) measurement. The primary definition of stigma required endorsement of one or more of 3 stigma-specific items of the Barriers to Diabetes Adherence questionnaire. These addressed avoidance of diabetes management with friends present, difficulty telling others about diabetes diagnosis, and embarrassment in performing diabetes care with others present. Poor glycemic control was defined as HbA1c>9\% (ie, >75 mmol/mol; measured value when available, else self-report) and/or ?1 severe hypoglycemic episode in the previous year (reported requiring assistance from someone else during the episode). Stigma prevalence was computed (95\% CI), and associations with glycemic control were evaluated (multivariate logistic regression models). Results: Among the 380 respondents, stigma prevalence was 65.5\% (95\% CI 60.7-70.3). Stigma was associated with a 2-fold higher odds of poor glycemic control overall (odds ratio [OR] 2.25, 95\% CI 1.33-3.80; adjusted for age, sex, and type of treatment). There were specific associations with both HbA1c>9\% (75 mmol/mol; OR 3.05, 95\% CI 1.36-6.86) and severe hypoglycemia in the previous year (OR 1.86, 95\% CI 1.05-3.31). Conclusions: There is a high prevalence of stigma in youth with type 1 diabetes that is associated with both elevated HbA1c levels and severe hypoglycemia. Targeted strategies to address stigma are needed. Trial Registration: ClinicalTrials.gov NCT02796248; http://clinicaltrials.gov/ct2/show/NCT02796248 (Archived by WebCite at http://www.webcitation.org/6yisxeV0B) ", doi="10.2196/jmir.9432", url="http://www.jmir.org/2018/4/e151/", url="http://www.ncbi.nlm.nih.gov/pubmed/29678801" } @Article{info:doi/10.2196/ijmr.6952, author="Alkhaldi, Ghadah and Modrow, Kerstin and Hamilton, Fiona and Pal, Kingshuk and Ross, Jamie and Murray, Elizabeth", title="Promoting Engagement With a Digital Health Intervention (HeLP-Diabetes) Using Email and Text Message Prompts: Mixed-Methods Study", journal="Interact J Med Res", year="2017", month="Aug", day="22", volume="6", number="2", pages="e14", keywords="mHealth", keywords="eHealth", keywords="email", keywords="text messages", abstract="Background: Engagement with digital health interventions (DHIs) may be regarded as a prerequisite for the intervention to achieve positive health or behavior change outcomes. One method employed to promote engagement is the use of prompts such as emails and text messages. However, little is known about the characteristics of prompts that promote engagement. This study explored the association between the content and delivery mode of prompts and the users' engagement with HeLP-Diabetes (Healthy Living for People with type 2 Diabetes), a DHI that aimed to promote self-management in adults with type 2 diabetes. Objective: The objective of this study was to identify the characteristics of prompts, specifically the content and delivery mode, which were associated with increased engagement. Methods: This was a mixed-methods study. Email and text message prompts were sent to the registered users of HeLP-Diabetes. Use of the intervention was recorded and examined to identify which email and text message prompts were associated with subsequent visits to the DHI. Characteristics of prompts that were identified as particularly effective or ineffective were explored through think-aloud interviews with the participants. Results: Of a total of 39 email prompts, 49\% (19/39) prompts showed a significant association with subsequent visits to the DHI. However, none of the text message prompts were associated with subsequent visits to the DHI. Furthermore, think-aloud interviews were carried out with 6 experienced participants with type 2 diabetes. The findings suggest that these participants preferred email prompts that were clear, relatively short, and empowering; used nondirective advice; included health professional references; were visually appealing; and contained news and updates. Conclusions: The findings of this study contribute to the existing evidence supporting the role of email prompts in promoting and maintaining engagement with DHIs. This study described the content of prompts that may be engaging. However, the results should be interpreted with caution, as prompts may be context-specific interventions and the results may not be generalizable across other DHIs or other types of interventions targeting self-management of type 2 diabetes. ", doi="10.2196/ijmr.6952", url="http://www.i-jmr.org/2017/2/e14/", url="http://www.ncbi.nlm.nih.gov/pubmed/28829328" } @Article{info:doi/10.2196/ijmr.4504, author="Vaala, E. Sarah and Hood, K. Korey and Laffel, Lori and Kumah-Crystal, A. Yaa and Lybarger, K. Cindy and Mulvaney, A. Shelagh", title="Use of Commonly Available Technologies for Diabetes Information and Self-Management Among Adolescents With Type 1 Diabetes and Their Parents: A Web-Based Survey Study", journal="Interact J Med Res", year="2015", month="Dec", day="29", volume="4", number="4", pages="e24", keywords="diabetes mellitus, Type 1", keywords="adolescent", keywords="technology", keywords="adoption", keywords="self-management", keywords="self-care", abstract="Background: For individuals with Type 1 diabetes (T1D), following a complicated daily medical regimen is critical to maintaining optimal health. Adolescents in particular struggle with regimen adherence. Commonly available technologies (eg, diabetes websites, apps) can provide diabetes-related support, yet little is known about how many adolescents with T1D use them, why they are used, or relationships between use and self-management. Objective: This study examined adolescent and parent use of 5 commonly available technologies for diabetes, including proportions who use each technology, frequency of use, and number of different technologies used for diabetes. Analyses also investigated the reasons adolescents reported for using or not using technologies for diabetes, and factors correlated with adolescents' technology use. Finally, this study examined relationships between the type and number of technologies adolescents use for diabetes and their self-management and glycemic control. Methods: Adolescents (12-17 years) and their parents (N=174 pairs), recruited from a pediatric diabetes clinic (n=134) and the Children with Diabetes community website (n=40), participated in this Web-based survey study. Glycosylated hemoglobin (A1C) values were obtained from medical records for pediatric clinic patients. Adolescents reported their use of 5 commonly available technologies for diabetes (ie, social networking, diabetes websites, mobile diabetes apps, text messaging, and glucometer/insulin pump software), reasons for use, and self-management behavior (Self-Care Inventory-Revised, SCI-R). Results: Most adolescents and parents used at least one of the 5 technologies for diabetes. Among adolescents, the most commonly used technology for diabetes was text messaging (53\%), and the least commonly used was diabetes websites (25\%). Most adolescents who used diabetes apps, text messaging, or pump/glucometer software did so more frequently (?2 times per week), compared to social networking and website use (?1 time per week). The demographic, clinical, and parent-technology use factors related to adolescents' technology use varied by technology. Adolescents who used social networking, websites, or pump/glucometer software for diabetes had better self-management behavior (SCI-R scores: beta=.18, P=.02; beta=.15, P=.046; beta=.15, P=.04, respectively), as did those who used several technologies for diabetes (beta=.23, P=.003). However, use of diabetes websites was related to poorer glycemic control (A1C: beta=.18, P=.01). Conclusions: Adolescents with T1D may be drawn to different technologies for different purposes, as individual technologies likely offer differing forms of support for diabetes self-management (eg, tracking blood glucose or aiding problem solving). Findings suggest that technologies that are especially useful for adolescents' diabetes problem solving may be particularly beneficial for their self-management. Additional research should examine relationships between the nature of technology use and adolescents' T1D self-management over time. ", doi="10.2196/ijmr.4504", url="http://www.i-jmr.org/2015/4/e24/", url="http://www.ncbi.nlm.nih.gov/pubmed/26715191" } @Article{info:doi/10.2196/resprot.4036, author="Chan, Sophia Shu Wing", title="Interleukin 2 Topical Cream for Treatment of Diabetic Foot Ulcer: Experiment Protocol", journal="JMIR Res Protoc", year="2015", month="Aug", day="14", volume="4", number="3", pages="e89", keywords="type 1 diabetes", keywords="topical cream", keywords="chronic wound healing", keywords="immunotherapy", keywords="IL-2", abstract="Background: It is estimated there are 2.9 million diabetic patients in the United Kingdom, and around 5\%-7\% of patients have diabetic ulcers. This number will continue to increase globally. Diabetic ulcers are a major economic burden on the healthcare system. More than {\textsterling}650 million is spent on foot ulcers or amputations each year, and up to 100 people a week have a limb amputated due to diabetes. In T1DM, the level of IL-2 is reduced, and hence, wound healing is in a prolonged inflammatory phase. It is not known if IL-2 topical cream can shorten the healing process in T1DM patients. Objective: The objective of this study is to understand the pathophysiology in type 1 diabetes (T1DM) and investigate possible future treatment based on its clinical features. The hypothesis is that IL-2 cream can speed up wound healing in NOD mice and that this can be demonstrated in a ten-week study. An experiment protocol is designed in a mouse model for others to conduct the experiment. The discussion is purely based on diabetic conditions; lifestyle influences like smoking and drinking are not considered. Methods: Skin incisions will be created on 20 nonobese diabetic (NOD) mice, and IL-2 topical cream will be applied in a 10-week study to prove the hypothesis. Mice will be randomly and equally divide into two groups with one being the control group. Results: T1DM patients have a decreased number of T regulatory (Treg) cells and interleukin 2 (IL-2). These are the keys to the disease progression and delay in wound healing. Diabetic ulcer is a chronic wound and characterized by a prolonged inflammatory phase. Conclusions: If the experiment is successful, T1DM patients will have an alternative, noninvasive treatment of foot ulcers. In theory, patients with other autoimmune diseases could also use IL-2 topical cream for treatment. ", doi="10.2196/resprot.4036", url="http://www.researchprotocols.org/2015/3/e89/", url="http://www.ncbi.nlm.nih.gov/pubmed/26276522" } @Article{info:doi/10.2196/ijmr.3856, author="Schroeder, B. Emily and Desai, Jay and Schmittdiel, A. Julie and Paolino, R. Andrea and Schneider, L. Jennifer and Goodrich, K. Glenn and Lawrence, M. Jean and Newton, M. Katherine and Nichols, A. Gregory and O'Connor, J. Patrick and Fitz-Randolph, Marcy and Steiner, F. John", title="An Innovative Approach to Informing Research: Gathering Perspectives on Diabetes Care Challenges From an Online Patient Community", journal="Interact J Med Res", year="2015", month="Jun", day="30", volume="4", number="2", pages="e13", keywords="social networking", keywords="diabetes mellitus", keywords="quality of health care", keywords="patient centered outcome research", abstract="Background: Funding agencies and researchers increasingly recognize the importance of patient stakeholder engagement in research. Despite calls for greater patient engagement, few studies have engaged a broad-based online community of patient stakeholders in the early stages of the research development process. Objective: The objective of our study was to inform a research priority-setting agenda by using a Web-based survey to gather perceptions of important and difficult aspects of diabetes care from patient members of a social networking site-based community. Methods: Invitations to participate in a Web-based survey were sent by email to members of the PatientsLikeMe online diabetes community. The survey asked both quantitative and qualitative questions addressing individuals' level of difficulty with diabetes care, provider communication, medication management, diet and exercise, and relationships with others. Qualitative responses were analyzed using content analysis. Results: Of 6219 PatientsLikeMe members with diabetes who were sent survey invitations, 1044 (16.79\%) opened the invitation and 320 (5.15\% of 6219; 30.65\% of 1044) completed the survey within 23 days. Of the 320 respondents, 33 (10.3\%) reported having Type 1 diabetes; 107 (33.4\%), Type 2 diabetes and taking insulin; and 180 (56.3\%), Type 2 diabetes and taking oral agents or controlling their diabetes with lifestyle modifications. Compared to 2005-2010 National Health and Nutrition Examination Survey data for individuals with diabetes, our respondents were younger (mean age 55.8 years, SD 9.9 vs 59.4 years, SE 0.5); less likely to be male (111/320, 34.6\% vs 48.4\%); and less likely to be a racial or ethnic minority (40/312, 12.8\% vs 37.5\%). Of 29 potential challenges in diabetes care, 19 were categorized as difficult by 20\% or more of respondents. Both quantitative and qualitative results indicated that top patient challenges were lifestyle concerns (diet, physical activity, weight, and stress) and interpersonal concerns (trying not to be a burden to others, getting support from family/friends). In our quantitative analysis, similar concerns were expressed across patient subgroups. Conclusions: Lifestyle and interpersonal factors were particularly challenging for our online sample of adults with Type 1 or Type 2 diabetes. Our study demonstrates the innovative use of social networking sites and online communities to gather rapid, meaningful, and relevant patient perspectives that can be used to inform the development of research agendas. ", doi="10.2196/ijmr.3856", url="http://www.i-jmr.org/2015/2/e13/", url="http://www.ncbi.nlm.nih.gov/pubmed/26126421" } @Article{info:doi/10.5210/ojphi.v7i2.6011, title="Roles of Health Literacy in Relation to Social Determinants of Health and Recommendations for Informatics-Based Interventions: Systematic Review", journal="Online J Public Health Inform", year="2015", volume="7", number="2", pages="e6011", doi="10.5210/ojphi.v7i2.6011", url="", url="http://www.ncbi.nlm.nih.gov/pubmed/26284148" }