Type 2 Diabetes (T2D) Clinical Trials

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Comparing the Effectiveness of Primary Care Delivered Telehealth Interventions to Manage Type 2 Diabetes in People With Physical Disabilities and Multiple Chronic Conditions

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• Physical Disability

• Diagnosed with Type 2 Diabetes

• Hemoglobin A1c ≥7% within 3 months of screening

• 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

Locations
United States
Alabama
UAB Highlands Hospital/Department of Family and Community Medicine
RECRUITING
Birmingham
Contact Information
Primary
Aseel El Zein, PhD
assilelzein@uabmc.edu
205-201-1507
Backup
Rebecca Rogers, MS
rrrogers@uab.edu
(205) 975-5221
Time Frame
Start Date: 2026-09-15
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 5000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov