Status:
RECRUITING
CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Impaired Glucose Tolerance
Prediabetes
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief 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 ...
Detailed Description
The purpose of this research is to evaluate if having blood sugar information from a continuous glucose monitor (CGM) during activities of daily living provides additional benefit to lifestyle modific...
Eligibility Criteria
Inclusion
- Children 10 to \<18 years old (i.e., before their 18th 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
Exclusion
- Existing diagnosis of type 1 or type 2 diabetes
- Prepubertal
- Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
- Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05387551
Start Date
December 1 2022
End Date
December 1 2026
Last Update
November 26 2025
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207