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

Summary

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.

Conditions

• Type 2 Diabetes

Interventions

BEHAVIORAL

Digital Health Coaching

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.

BEHAVIORAL

Continuous Glucose Monitoring Teleconsults

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.

BEHAVIORAL

Continuous Glucose Monitoring Teleconsults + Digital Health Coaching

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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Tapan Mehta, PhD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2027-12-01

Completion

2028-01-31

Countries

• United States

Study Locations