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

NCT ID: NCT07140848

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2028-01-02

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.

Detailed Description

CGM devices give individuals real-time information about their blood sugar levels, which can help them understand how their diet, exercise, and daily habits impact their health. By pairing CGM technology with support from trained DPP coaches, this approach aims to make it easier for participants to maintain healthy behaviors. The study will involve 214 adults with prediabetes who will follow a 12-month program with regular check-ins to measure improvements in blood sugar control, weight loss, physical activity, and overall quality of life.

The goal is to show whether using CGM in combination with coaching can lead to better health outcomes and whether it is a cost-effective way to prevent diabetes. If successful, this approach could be used in healthcare settings across the country, helping more people prevent diabetes and lead healthier lives.

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Diabetes Prevention Program

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Participants in control group will be referred to DPP.

Intervention

Diabetes Prevention Program + Continuous Glucose Monitors/Coaching

Group Type: EXPERIMENTAL

CGM-DPP

Intervention Type: BEHAVIORAL

Participants in the DPP who receive personalized CGM coaching.

Interventions

CGM-DPP

Participants in the DPP who receive personalized CGM coaching.

Intervention Type: BEHAVIORAL

Control

Participants in control group will be referred to DPP.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Raphael Fraser, PhD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Raphael A Fraser, PhD, MS

Role: CONTACT

rfraser@buffalo.edu

7168295733

Jocelyn Stooks, MPH

Role: CONTACT

jstooks@buffalo.edu

7168292364

Other Identifiers

ADA Grant #7-25-ICTSPC-412

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00009767

Identifier Type: -

Identifier Source: org_study_id