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RECRUITING Not applicable ClinicalTrials.gov

Advancing Diabetes Management for People With Physical Disabilities Optimally Through Primary Care-Based Telehealth (ADDOPT)

Sponsor: University of Alabama at Birmingham • ClinicalTrials.gov ID: NCT07032844

Registry updated: 2026-10-06
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Description

The purpose of the study is to compare 2 primary care based telehealth interventions- 1) digital health coaching and 2) remote patient monitoring for improving glycemic (blood sugar levels) control and overall health outcomes in individuals with physical disabilities, type 2 diabetes (T2DM) and at least one chronic condition. The project aims to determine which intervention is more effective in reducing blood sugar levels, improving patient-reported outcomes such as diabetes-related distress, and facilitating the implementation of these approaches in real-world primary care settings serving vulnerable populations. The findings intend to inform about optimal telehealth strategies for managing multiple chronic conditions in underserved groups, there by supporting improved health equity and quality of care.

Interventions

  • Digital Health Coaching (Behavioral)
    This program will be developed using existing, evidence-based curricula for chronic disease self-management. Prior to initiating health coaching with participants, coaches will review data collected related to SDoH to further tailor the intervention as appropriate for housing stability, access to food and transportation, and interpersonal safety. All coaches will have access to participants' EMRs such that they can view medical information throughout the intervention. Coaches will be trained using a curriculum developed by Family and Community Medicine's inter-professional care team and our partners at NCHPAD, making the coaching inclusive of people with physical disabilities, such that the coaches are proficient in motivating behavior change related to resilience, physical activity, nutrition, mindfulness, and relationship-building, among others.
  • Continuous Glucose Monitoring Teleconsults (Behavioral)
    This comparator arm consists of continuous glucose monitoring (CGM) with periodic teleconsult visits over 6 months, delivered by trained pharmacists, RDs, or nurses, with devices shipped centrally to participants' homes. Sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and standardized safety counseling on recognizing and managing hypoglycemia (\<70 mg/dL; severe \<54 mg/dL) and hyperglycemia (\>300 mg/dL), including when to seek urgent or emergency care. During each teleconsult, the CGM team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and supports goal setting and medication adjustments as needed. Participants with repeated missed readings are contacted by the study team to troubleshoot adherence barriers.

Eligibility criteria

Inclusion Criteria: 1. Physical Disability 2. Diagnosed with Type 2 Diabetes 3. Hemoglobin A1c ≥7% within 3 months of screening 4. Must have at least 1 additional chronic conditions from the list below Hypertension Congestive Heart Failure Coronary Artery Disease Hyperlipidemia Stroke Arthritis Asthma Cancer Chronic Kidney Disease (Stages 1-4) COPD Osteoporosis Multiple Sclerosis Parkinsons Exclusion Criteria: 1. Intellectual, Learning, Developmental Disabilities 2. Non-english speakers 3. Currently pregnant 4. Significant vision loss preventing use of phone/tablet for interventions 5. Received Remote Patient Monitoring or Digital Health Coaching for T2DM management within 30 days of enrollment 6. End-stage kidney disease (on dialysis) 7. Does not report having a physical disability 8. Perceived unwillingness or inability to participate

Conditions

Type 2 Diabetes

Locations

  • UAB Highlands Hospital/Department of Family and Community Medicine — Birmingham, Alabama, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record