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

Official title

A Novel Continuous Glucose Monitoring Enhanced DPP Intervention to Prevent Type 2 Diabetes in Adults With Prediabetes

Overview

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.

Interventions

• Behavioral CGM-DPP
  Participants in the DPP who receive personalized CGM coaching.
• Behavioral Control
  Participants in control group will be referred to DPP.

Primary outcome measures

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

Secondary outcome measures (1)

• Quality of Life as measured by SF-12 [Time frame: Change from baseline quality of life measure at 12 months post intervention follow-ups]

Eligibility criteria

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

Individuals will be excluded from the study if they

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Division of Population Health, Department of Medicine — Buffalo

Identifiers

NCT: NCT07140848 · STUDY00009767 · ADA Grant #7-25-ICTSPC-412

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗