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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 16
Healthy Volunteers: f
View:

• Children 10 to \<17 years old (i.e., before their 17th birthday)

• Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,

• Overweight or obese (BMI ≥85th percentile for age/sex)

• Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL

Locations
United States
Florida
Nemours Children's Clinic
RECRUITING
Jacksonville
Contact Information
Primary
Larry Fox, MD
larry.fox@nemours.org
9046973674
Backup
Liezel Riego
Liezel.Riego@nemours.org
9046973431
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 15
Treatments
Experimental: CGM intervention
Continuous glucose monitoring with real-time glucose data using Dexcom G6.
Sponsors
Leads: Nemours Children's Clinic

This content was sourced from clinicaltrials.gov