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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07032844
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

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.
  • Continuous Glucose Monitoring Teleconsults + Digital Health Coaching — BEHAVIORAL
    In this arm, participants receive an integrated approach to diabetes management combining both digital health coaching and CGM-teleconsults, added in response to stakeholder and reviewer feedback expressing interest in benefiting from both interventions. Health coaches and CGM-trained team members work collaboratively to help participants set realistic goals and reinforce lifestyle strategies: the health coach evaluates the participant's food choices in relation to blood sugar patterns, while the CGM team reinforces the nutrition and physical activity recommendations set by the health coach during CGM teleconsults. Information flows bidirectionally - the CGM team informs the health coach of areas needing more emphasis, and the health coach flags participants who may need closer monitoring - so that each participant's care remains cohesive and adaptive to their glucose data and behavioral progress together.

Study Details

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.

Key Dates

First listed
Jun 24, 2025
Start date
Sep 15, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital Health Coaching
    Participants receive individual digital health coaching by phone: weekly calls for the first 12 weeks addressing goal setting, supportive environments for behavior change, physical activity, and nutrition, followed by biweekly calls for an additional 12 weeks (weeks 13-24) to reinforce habits and advance goals.
  • Experimental: Continuous Glucose Monitoring Teleconsults
    Participants receive continuous glucose monitoring (CGM) with periodic clinician teleconsults over 6 months. Study staff ship a CGM kit (sensor and reader, for participants without a compatible smartphone) to the participant's home; sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and safety counseling on recognizing and managing hypoglycemia (\<70 mg/dL; severe \<54 mg/dL) and hyperglycemia (\>300 mg/dL). During each teleconsult, the primary care team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and adjusts goals or medications as needed.
  • Experimental: Combination of Digital Health Coaching and CGM-Teleconsults
    Participants receive both digital health coaching and CGM-teleconsults in an integrated approach.

Primary Outcome Measure

Change in Hemoglobin A1c [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UAB Highlands Hospital/Department of Family and Community MedicineBirminghamAlabama35223
Aseel El Zein Research Scientist, PhD, RDN
[email protected]
205-201-1507

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By condition
Type 2 diabetes
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EndocrinologyMetabolic healthWeight loss
By research site
UAB Highlands Hospital/Department of Family and Community Medicine· Birmingham, AL

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