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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding a continuous glucose monitor (CGM), a device that tracks blood sugar, to Diabetes Prevention Program coaching helps people keep up healthy habits. It is for adults with prediabetes, which means blood sugar is higher than normal but not high enough to be diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have prediabetes based on one of these blood tests: HbA1c of 5.7%–6.4% (average blood sugar), fasting blood sugar of 100–125 mg/dL, or blood sugar of 140–199 mg/dL two hours after a 75-gram sugar drink.
  • Your body mass index (BMI), a measure based on height and weight, is at least 24, or at least 22 if you are Asian American.
  • You are willing to follow all study steps, including coaching sessions and using a blood sugar monitor.

Who can't join

  • You have type 1 or type 2 diabetes.
  • You already use a continuous glucose monitor.
  • You have a medical reason you cannot use the monitor, such as severe skin allergies or an implanted device that shocks the heart to fix dangerous rhythms.
  • You are in another clinical trial for prediabetes.
  • Study screening shows serious dementia, which causes problems with memory and thinking.
  • Study screening shows alcohol or drug abuse or dependence.
  • Study screening shows active psychosis, which means trouble knowing what is real.
  • You are expected to live less than 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY