Continuous glucose monitoring with Diabetes Prevention Program coaching to prevent type 2 diabetes
A Novel Continuous Glucose Monitoring Enhanced DPP Intervention to Prevent Type 2 Diabetes in Adults With Prediabetes
This project will try adding continuous glucose monitors to DPP coaching to help adults with prediabetes stick to healthy habits and lower their risk of developing type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT07140848 on ClinicalTrials.gov |
What this trial studies
This interventional program pairs real-time continuous glucose monitoring (CGM) with trained Diabetes Prevention Program (DPP) coaches to provide personalized feedback on diet, activity, and daily habits. A total of 214 adults with prediabetes will participate in a 12-month program with regular check-ins and monitoring. Outcomes include changes in blood sugar measures, weight, physical activity, quality of life, and economic costs. Results will compare the CGM-plus-coaching group to a control group to see if the combination yields better, cost-effective prevention of diabetes.
Who should consider this trial
Good fit: Adults aged 18 or older with laboratory-defined prediabetes (HbA1c 5.7–6.4% or qualifying glucose values), a BMI ≥24 kg/m² (or ≥22 kg/m² for Asian Americans), and willingness to attend coaching and use CGM devices are ideal candidates.
Not a fit: People with diagnosed type 1 or type 2 diabetes, current CGM users, those with medical contraindications to CGM, or with significant cognitive impairment or active substance dependence are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help people with prediabetes maintain lifestyle changes more effectively and reduce progression to type 2 diabetes.
How similar studies have performed: The original DPP has strong evidence for preventing diabetes, and early small studies suggest CGMs can improve glucose awareness and behavior, but combining CGM with DPP coaching is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. adults aged 18 years or older, 2. diagnosis of prediabetes, as defined by current clinical guidelines (HbA1c 5.7% to 6.4%, fasting plasma glucose 100-125 mg/dL, or 2-hour plasma glucose 140-199 mg/dL following a 75g oral glucose tolerance test), 3. body mass index (BMI) of at least 24 kg/m² (or 22 kg/m² for Asian Americans), 4. willingness to comply with all aspects of the study protocol, including attending coaching sessions and using CGM devices. Exclusion Criteria: Individuals will be excluded from the study if they 1. have a diagnosis of type 1 or type 2 diabetes, 2. are currently using CGMs or have medical contraindications to CGM use, such as severe skin allergies or implantable defibrillators, or 3. are currently enrolled in another clinical trial for prediabetes. Additionally, using validated assessments, we will exclude participants with significant dementia, alcohol or drug abuse/dependency, active psychosis, or life expectancy less than 12 months as these conditions are likely to interfere with adherence to the intervention.
Where this trial is running
Buffalo, New York
- Division of Population Health, Department of Medicine — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Raphael A Fraser, PhD, MS
- Email: rfraser@buffalo.edu
- Phone: 7168295733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.