Actively Recruiting

Phase Not Applicable
Age: 10Years - 18Years
All Genders
NCT05387551

CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

Led by Nemours Children's Clinic · Updated on 2025-11-26

15

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

Who Can Participate

Age: 10Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children 10 to under 18 years old
  • 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 patients defined as females with breast Tanner stage II or above, or males with testicular volume 4 mL or more
Not Eligible

You will not qualify if you...

  • Existing diagnosis of type 1 or type 2 diabetes
  • Prepubertal patients
  • Taking medications affecting insulin sensitivity (e.g., chronic corticosteroids), except stable dose of metformin
  • Patients or families unwilling or unable to wear the CGM device consistently during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nemours Children's Clinic

Jacksonville, Florida, United States, 32207

Actively Recruiting

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Research Team

L

Larry Fox, MD

CONTACT

L

Liezel Riego

CONTACT

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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