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NCT Number: NCT07140848

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Population Health, Department of Medicine

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Jennifer A Campbell, PhD, MPH

CONTACT

[email protected]

716-829-5767

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CGM-DPP

Behavioral

Participants in the DPP who receive personalized CGM coaching.

Control

Behavioral

Participants in control group will be referred to DPP.

Primary outcomes

  1. Glycemic Control (HbA1c)

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

    Blood specimens (10 cc of blood) will be obtain by trained phlebotomists or nurse for HbA1c.

Secondary outcomes

  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

    The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.

Other outcomes

  1. Self-Care

    Time frame: Change from baseline self-care at 12 months post intervention follow-ups

    Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care.

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyn Stooks, MPH

CONTACT

[email protected]

7168292364

Raphael A Fraser, PhD, MS

CONTACT

[email protected]

7168295733

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Acronym: CGM-DPP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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