RecruitingNot Applicable

CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes

United States214 participantsStarted 2026-04-13

Plain-language summary

Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Although a program called the Diabetes Prevention Program (DPP) has been shown to lower the risk of diabetes through healthy lifestyle changes, many people find it difficult to stick with these changes over the long term. This study seeks to find out if combining DPP coaching with continuous glucose monitoring (CGM) technology can help people stay on track with their health goals.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. adults aged 18 years or older,
✓. 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),
✓. body mass index (BMI) of at least 24 kg/m² (or 22 kg/m² for Asian Americans),
✓. willingness to comply with all aspects of the study protocol, including attending coaching sessions and using CGM devices.

Exclusion criteria

✕. have a diagnosis of type 1 or type 2 diabetes,
✕. are currently using CGMs or have medical contraindications to CGM use, such as severe skin allergies or implantable defibrillators, or
✕. 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.

What they're measuring

Glycemic Control (HbA1c)

Timeframe: Change from baseline HbA1c at 12 months post intervention follow-ups

Trial details

NCT IDNCT07140848

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Raphael A Fraser, PhD, MS

7168295733 rfraser@buffalo.edu

View on ClinicalTrials.gov More PreDiabetes trials