Recruiting

Digital Health Coaching vs. Remote Patient Monitoring

Sponsor:

University of Alabama at Birmingham

Code:

NCT07032844

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Digital Health Coaching

Continuous Glucose Monitoring Teleconsults

Study Details

Brief 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

Study ID

NCT07032844

Start date

Sep 15, 2026

Status verified date

Jul, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Hemoglobin A1c [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

UAB Highlands Hospital/Department of Family and Community Medicine

Recruiting

Birmingham, Alabama, United States, 35223

Contacts

Aseel El Zein Research Scientist, PhD, RDN

2052011507assil.elzein352@gmail.com

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Sep 9, 2026

Last verified

Jul, 2026

Keywords

  • Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-09-09.