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

University at Buffalo (UB)

Status: Not yet enrolling

Conditions: PreDiabetes

Treatments: Behavioral: CGM-DPP; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07140848

STUDY00009767

ADA Grant #7-25-ICTSPC-412 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Control

Active Comparator group

Description:

Diabetes Prevention Program

Treatment:

Behavioral: Control

Intervention

Experimental group

Description:

Diabetes Prevention Program + Continuous Glucose Monitors/Coaching

Treatment:

Behavioral: CGM-DPP