CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Nemours Children's Clinic
Study ID
NCT05387551
Status
Recruiting
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Conditions

  • Impaired Glucose Tolerance
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • CGM — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2022
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: CGM intervention
    Continuous glucose monitoring with real-time glucose data using Dexcom G6.

Primary Outcome Measure

Insulin Sensitivity Score (ISS) [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's ClinicJacksonvilleFlorida32207
Liezel Riego
[email protected]
904-697-3431
Larry A Fox, MD (PRINCIPAL_INVESTIGATOR)

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