Digital Health Coaching + Continuous Glucose Monitoring for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Tapan Mehta, PhD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults with a physical disability, diagnosed with type 2 diabetes, whose recent average blood sugar (A1c) is 8% or higher. Participants must also have at least one other chronic health condition like high blood pressure, heart disease, arthritis, asthma, cancer, kidney disease (not on dialysis), COPD, osteoporosis, multiple sclerosis or Parkinson's.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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 to reinforce habits and advance goals.
Continuous Glucose Monitoring Teleconsults
Participants receive continuous glucose monitoring with periodic clinician teleconsults over 6 months. Study staff ship a CGM kit to the participant's home; sensors are replaced per manufacturer guidelines. During each teleconsult, the primary care team reviews glucose data and adjusts goals or medications as needed.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on long-term outcomes such as changes in Hemoglobin A1c and diabetes distress.
What Are the Treatments Tested in This Trial?
Interventions
- Continuous Glucose Monitoring Teleconsults
- Digital Health Coaching
Trial Overview
The study compares two telehealth approaches: digital health coaching and remote glucose monitoring via online consultations. Some participants may receive both interventions together. The goal is to see which method better helps people manage their diabetes and overall health.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
Participants receive both digital health coaching and CGM-teleconsults in an integrated approach.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
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