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  • I Can Do This! Managing My Diabetes

    Diabetes poses a significant public health challenge in the U.S., affecting approximately 37 million people, or 11% of the population. The prevalence is rising, particularly among youth, with a forecasted 700% increase in type 2 diabetes cases by 2060. Diabetes leads to severe health complications, including increased risks of heart attacks, strokes, and kidney failure, and affects nearly 1 million people worldwide with vision loss. Many individuals struggle to manage their diabetes effectively; only about 50% achieve proper glycemic control. Diabetes self-management education is crucial for improving self-efficacy and adherence to treatment, yet only 5-7% of eligible patients receive this education. The American Diabetes Association advocates for individualized nutrition therapy, but access remains limited, especially for uninsured populations, exacerbating health disparities. To address this gap, a novel word game-based workbook is proposed to enhance diabetes self-efficacy. This workbook can be used in waiting rooms or at home, offering an engaging way to learn about diabetes management through word games and puzzles. It aims to provide accessible education for underserved communities, improve glycemic control, and ultimately reduce diabetes-related disparities.

    Phase

    N/A

    Span

    35 weeks

    Sponsor

    Emory University

    Recruiting

  • Sleep Coach for Adolescents With Type 1 Diabetes

    This randomized controlled trial will assess whether a behavioral coaching intervention to improve sleep duration and quality in adolescents with type 1 diabetes will improve glucose control and executive function. We will recruit a sample of 150 adolescents with type 1 diabetes (T1D) and their caregivers at a single medical center. We plan to recruit equal numbers of boys and girls and over-enroll youth from minoritized racial and ethnic groups. After obtaining informed consent/assent and baseline data, we will randomize adolescents to the Sleep Coach condition (n=75) or the Enhanced Usual Care condition (n=75). Randomization will be computerized, and adolescents will be stratified by diabetes device use (insulin pumps, continuous glucose monitors) and age (11-14 years vs. 15-17 years). Adolescents and caregivers will complete survey measures again at 3 months, 6 months, and 12 months during regularly scheduled clinic visits. Adolescents will complete the NIH Toolbox measures of executive function at each study visit. Adolescents will be asked to wear a FitBit watch to assess sleep and complete sleep diaries at baseline and 3 months. Participants randomized to the Sleep Coach group will be sent a binder with intervention materials for the 4 sessions. They will schedule individual phone calls with a trained member of the research team at a convenient time. The first call is expected to last 20-30 minutes, and the other calls are expected to last 10-15 minutes. Caregivers will receive an overview of the sleep intervention content, and they will be asked to support adolescents' attempts to change sleep habits. Adolescents randomized to Enhanced Usual Care will receive diabetes education materials developed by our team for adolescents with T1D (based on publicly available materials on diabetes.org). Printed materials will be sent via mail and content will be shared via smart phone messages on the same schedule as participants randomized to the Sleep Coach intervention. A representative group of 50 of the 150 adolescents in the study will be invited to participate in an additional study visit prior to the intervention to obtain magnetic resonance imaging (MRI) of the brain. Adolescents who agree to complete MRI of the brain will be asked to complete a follow-up visit approximately 6 months after the baseline visit, following the same protocol, and they will complete the daily sleep diary questions and share sleep data for another week.

    Phase

    N/A

    Span

    211 weeks

    Sponsor

    Vanderbilt University Medical Center

    Recruiting

  • A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults

    Eligible participants and their family members will be randomly assigned to either the intervention and control group. Patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. All participants will be assessed at baseline, post-intervention and six months after intervention.

    Phase

    N/A

    Span

    140 weeks

    Sponsor

    Ohio State University

    Recruiting

    Healthy Volunteers

  • DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support with Technology for Latinx Patients

    Phase

    N/A

    Span

    22 weeks

    Sponsor

    Daniel Amante

    Recruiting

    Healthy Volunteers

  • Diabetes Medical Nutrition Therapy in Southeastern African American Women

    Phase

    N/A

    Span

    209 weeks

    Sponsor

    Meharry Medical College

    Recruiting

  • Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

    The investigators will conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Diabetes Education (MBDE) versus standard Diabetes Self-Management Education (DSME) in adults with type 2 diabetes and moderate-severe diabetes distress who receive their care from safety-net healthcare systems. The goal of this pilot RCT will be to assess the acceptability and feasibility of MBDE; acceptability will be assessed through qualitative follow-up interviews with participants and feasibility will be assessed through process measures. The investigators will recruit up to approximately 96 participants, 48 from each site to account for potential loss to follow up of up to 20%, for the study with total study duration of 6 months. Participants will be randomized 1:1 to each study arm. This study will also serve as a pilot test for the procedures of the RCT and of measures to be used in participant assessments. The study will be conducted at two safety-net clinics that provide care for residents of Jefferson County using a sliding scale program based on income level - Cooper Green Mercy Health Services Authority (CGMHSA) and Alabama Regional Medicine Services (ARMS). CGMHSA, an affiliate of University of Alabama at Birmingham (UAB) Health System, is Jefferson County's public safety-net health care facility. CGMHSA provides care primarily to the indigent county residents, geographically spanning most of the Birmingham metropolitan area. Ambulatory care services are provided to patients who have type 2 diabetes through Cooper Green's Primary Care Clinic and multi-disciplinary Diabetes Clinic. ARMS is a Community Health Center serving the greater Birmingham area since 1983. ARMS provides ambulatory care for adults, including primary care, diabetes self-management education classes, and behavioral health services. ARMS offers services to patients, with or without insurance, on a sliding scale fee program based on income. Trained study staff overseen by the study PI will recruit participants from CGMHSA and ARMS through three methods. Opt-out letters will be mailed to patients seen at CGMHSA or ARMS in the preceding three years with a diagnosis of type 2 diabetes; study staff will then call potential participants to provide more information about the study and to gauge their interest in participating. The investigators will obtain a HIPAA waiver to access potential participant information from the medical record in order to generate a recruitment list. The investigators will also conduct in-person recruitment of participants at CGMHSA and ARMS, as well as direct referral of potential participants by providers or patients. Trained study personnel will obtain screening consent from potential participants prior to screening for eligibility based on inclusion and exclusion criteria, which will include assessment of diabetes distress and hemoglobin A1c (A1C) through point-of-care (POC) finger-stick sample. Study staff will then obtain informed consent from eligible participants at the time of enrollment. Both MDBE and standard DSME study arms will be delivered in-person, in a group setting with 10-14 participants per group. MBDE will be delivered in 8 weekly group sessions followed by 2 bimonthly individual, booster sessions conducted by phone for a total duration of 6 months. MBDE will be delivered by an interventionist with a background in nursing and training as an MBSR instructor, who will receive additional training in MBDE with an emphasis on content drawn from DSME. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving. Total study duration will be six months; a trained study staff will complete assessments of participants in both study arms at baseline, 2 months, and 6 months. Participants in both study arms will complete assessments that will be conducted by trained study personnel, including interviewer-administered questionnaire, biometric assessment (height, weight, blood pressure), and POC A1C testing from a finger-stick sample at 3 time points - baseline, 2 months, and 6 months. Participants in the MBDE arm will be asked to participate in a focus group (estimated length 1 hour) at the 2 month time point. Participants will receive an incentive for their participation for each study assessment and for participation in a focus group.

    Phase

    N/A

    Span

    135 weeks

    Sponsor

    University of Alabama at Birmingham

    Recruiting

  • The Comparison of Biopsychosocial Characteristics with and Without Diabetes Mellitus

    Phase

    N/A

    Span

    105 weeks

    Sponsor

    Hacettepe University

    Recruiting

  • Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes

    Phase

    N/A

    Span

    261 weeks

    Sponsor

    Tianjin Medical University General Hospital

    Recruiting

  • Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

    Phase

    N/A

    Span

    85 weeks

    Sponsor

    The Reading Hospital and Medical Center

    Recruiting

  • Diabetes Learning in Virtual Environments Just in Time for Community Reentry

    Among incarcerated persons, the rate of diabetes is almost 50% higher (9%) than the general population (6.5%) when matched for sex, age, race, and Hispanic origin. The burden of diabetes is carried forward post-incarceration, with 95% of incarcerated persons reentering the community with minimal health-related skills stemming from high-security environments with constrained self-care. These individuals lack critical knowledge and skills for diabetes self-management (DSM) regarding what foods to eat, how to control the formerly incarcerated person's blood sugar, and how and when to take insulin. Furthermore, the Principal Investigator's research in correctional institutions has demonstrated significant diabetes knowledge deficits related to treating potentially life-threatening hypo/hyperglycemia. A1C, a measure of metabolic control and predictive for diabetes complications, was suboptimal for the majority of participants. Furthermore, these returning citizens have cognitive impairment and lower literacy than those living in community households across age, sex, and educational attainment. The formerly incarcerated have higher hospitalization rates for short-term diabetes complications seven days' post-prison release compared to matched controls. Prevention is possible with Diabetes Self-Management Education and Support (DSMES) and diabetes survival skills (DSS). DSS refers to hypoglycemia and sick day management, insulin administration, and consistent nutrition habits, among other behaviors to prevent acute diabetes issues (hypo/hyperglycemia), and hospitalizations. At a minimum, incarcerated persons transitioning to the community have a critical need for DSS and support. There have been efforts to examine the effect of engaging incarcerated persons in blood glucose monitoring on glycemic control. Still, those released from incarceration have not benefitted from the decades of research that have resulted in improved outcomes. As a first step to filling this gap, the research team developed a literacy-tailored 6-week theory-based DSS intervention. The research team tested the feasibility and acceptability of the DSS intervention in incarcerated men between 6 to 9 months of transitioning from state prisons to supervised community housing or parole. The Principal Investigator found improvements in diabetes knowledge and diabetes-related distress in both groups and outcome expectancy with the treatment group. Analysis of focus group data revealed acceptance of the literacy-tailored DSS education, a need for skill-based videos, and ongoing support upon release. After an analysis of the research team's retention rate and feasibility data, the research team identified the haphazard process of releasing individuals to supervised community housing as a significant contributor to retention for the research team's in-person pre-release DSS intervention. Consequently, the primary investigator recognized a critical need to make the literacy-tailored DSS and ongoing DSMES widely accessible to returning citizens with diabetes after release to supervised housing via synchronous and asynchronous remote options. Based on the evidence that virtual environments (VE) may lead to superior learning and experience for the participants and can promote social and educational interaction via repetition, practice, feedback, and application,24,25 the research team aims to leverage the research team's collective experience with diabetes Learning in Virtual Environments (LIVE) a diabetes educator-led, DSMES in a VE26-28 to develop the Diabetes LIVE JustICE (Just In time for Community reentry) intervention using an iterative participant engaged process. Because persons living in supervised community housing do not have access to reliable private computers but do have access to mobile devices, the research team will develop Diabetes LIVE JustICE as a mobile application. The Principal Investigator's goal is to recruit a sample of vulnerable incarcerated persons with multimorbidity, including diabetes on the transition to supervised community living to develop and test the feasibility and acceptability of a multi-user virtual diabetes community (Diabetes LIVE JustICE). This platform allows users to talk to each other in real-time and participate in instructor-led education sessions and facilitated support sessions accessed through IOS/Android mobile devices. The specific aims of this study are to: 1. Examine feasibility and acceptability of the Diabetes LIVE JustICE application by tracking the following outcomes: recruitment rate, participation rates (number of log-ins, time spent in mobile application, retention) engagement (materials accessed), and the user experience (usability, usefulness, satisfaction, and attitudes toward use of Diabetes LIVE JustICE). 2. Examine the preliminary short-term effects of Diabetes LIVE JustICE compared to usual pre-release diabetes care supplemented with low literacy diabetes education materials on the following outcomes: A1C, diabetes knowledge, diabetes self-care, diabetes-related emotional distress, social support, and perceived competence.

    Phase

    N/A

    Span

    81 weeks

    Sponsor

    Louise Reagan

    Recruiting

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