Actively Recruiting
Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
Led by Nemours Children's Clinic · Updated on 2025-11-26
15
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The incidence of type 2 diabetes (T2D) is rising among children and adolescents, alongside increasing obesity rates. This research focuses on evaluating whether using a continuous glucose monitor (CGM) to provide real-time blood sugar information can help obese youth with impaired glucose tolerance better stick to lifestyle changes. The goal is to reduce body mass index (BMI) and improve insulin sensitivity, thereby lowering the risk of diabetes and other obesity-related health problems later in life. Participants will use a Dexcom G7 CGM device, which is worn on the arm and continuously measures blood sugar levels beneath the skin. The CGM sends data to a smartphone or receiver, providing immediate glucose readings during daily activities. This intervention is combined with lifestyle modifications, and the study monitors insulin sensitivity and glucose control over six months. Throughout the study, children aged 10 to under 18 years with impaired glucose tolerance will have their insulin sensitivity scores, glucose levels, and physical activity tracked. Questionnaires on diet and exercise will be collected at three and six months. Researchers will measure changes from baseline to assess the impact of CGM use on health outcomes and adherence to lifestyle changes. The study is expected to run until December 2026.
CONDITIONS
Brief Title
CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 10 to under 18 years (before their 18th birthday)
- Impaired glucose tolerance based on standardized oral glucose tolerance test or fasting glucose per American Diabetes Association criteria
- Overweight or obese with BMI at or above the 85th percentile for age and sex
- Pubertal status defined as females with breast Tanner stage II or above, or males with testicular volume 4 mL or more
You will not qualify if you...
- Existing diagnosis of type 1 or type 2 diabetes
- Prepubertal status
- Taking medications that affect insulin sensitivity (except stable dose of Metformin)
- Patients or families unwilling to wear the CGM for the study duration or showing lack of compliance after recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants wear the Dexcom G7 continuous glucose monitor to receive real-time glucose data during daily activities while making lifestyle changes to improve insulin sensitivity and reduce diabetes risk.
Continuous use of the CGM device throughout the study period
Trial Site Locations
Total: 1 location
1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Actively Recruiting
Research Team
L
Larry Fox, MD
L
Liezel Riego
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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