Division of Population Health, Department of Medicine
Buffalo, New York, 14203, United States
Location status: Recruiting
NCT Number: NCT07140848
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Buffalo, New York, 14203, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals will be excluded from the study if they
Participants in the DPP who receive personalized CGM coaching.
Participants in control group will be referred to DPP.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Jocelyn Stooks, MPH
CONTACT
Raphael A Fraser, PhD, MS
CONTACT
State University of New York at Buffalo
Other
A Novel Continuous Glucose Monitoring Enhanced DPP Intervention to Prevent Type 2 Diabetes in Adults With Prediabetes
Acronym: CGM-DPP
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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