Recruiting

DPP & CGM

Sponsor:

State University of New York at Buffalo

Code:

NCT07140848

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CGM-DPP

Control

Study Details

Brief 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.

Conditions

PreDiabetes

Study ID

NCT07140848

Start date

Apr 13, 2026

Status verified date

Aug, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

214 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Control

Diabetes Prevention Program

experimental: Intervention

Diabetes Prevention Program + Continuous Glucose Monitors/Coaching

Interventions

CGM-DPP

Participants in the DPP who receive personalized CGM coaching.

Control

Participants in control group will be referred to DPP.

Primary outcome measure

  • Glycemic Control (HbA1c) [ Time Frame: Change from baseline HbA1c at 12 months post intervention follow-ups ]

Central Contacts and Locations

Central contacts

Raphael A Fraser, PhD, MS

7168295733rfraser@buffalo.edu

Locations

Division of Population Health, Department of Medicine

Recruiting

Buffalo, New York, United States, 14203

Contacts

Jennifer A Campbell, PhD, MPH

716-829-5767jcampbe@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Apr 24, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-04-24.