RECRUITINGINTERVENTIONAL

CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance

About This Trial

The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Children 10 to \<18 years old (i.e., before their 18th birthday) 2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria, 3. Overweight or obese (BMI ≥85th percentile for age/sex) 4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL Who Should NOT Join This Trial: 1. Existing diagnosis of type 1 or type 2 diabetes 2. Prepubertal 3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose. 4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Children 10 to \<18 years old (i.e., before their 18th birthday) 2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria, 3. Overweight or obese (BMI ≥85th percentile for age/sex) 4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL Exclusion Criteria: 1. Existing diagnosis of type 1 or type 2 diabetes 2. Prepubertal 3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose. 4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment

Treatments Being Tested

DEVICE

CGM

Dexcom G7 sensor, transmitter and supplies will be provided to family for use. Participants will wear G7 and have real-time glucose data throughout the study.

Locations (1)

Nemours Children's Clinic

Jacksonville, Florida, United States