CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

NCT05387551 | Recruiting FDA Device

• 1 other identifier: lfox051622
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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

Impaired Glucose Tolerance; Prediabetes

Keywords

impaired glucose tolerance; obesity; adolescents

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity Score (ISS)

  Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance.

  Baseline to 6 months

Secondary Outcomes (10)

• QUICKI insulin sensitivity

  Baseline to 3 months

• QUICKI insulin sensitivity

  Baseline to 6 months

• Insulin Sensitivity Score

  Baseline to 3 months

• Glycemic levels

  Baseline to 3 and 6 months

• Mean, standard deviation of sensor glucose levels

  Baseline to 3 and 6 months

Study Arms (1)

CGM intervention

EXPERIMENTAL

Continuous glucose monitoring with real-time glucose data using Dexcom G6.

Device: CGM

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.

Also known as: Dexcom G7

CGM intervention

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Larry A Fox, MD

  Nemours Children's Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Fox, MD

CONTACT

9046973674; larry.fox@nemours.org

Liezel Riego

CONTACT

9046973431; Liezel.Riego@nemours.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 24, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)