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CGM and Lifestyle Changes in Patients with Impaired Glucose Tolerance

NCT ID: NCT05387551

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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 modifications in reducing the risk of developing diabetes and achieving a healthier weight. A CGM is a small device often worn on the back of the arm that uses a very small needle to insert a small sensor just under the skin in the fatty tissue. The CGM device transmits the blood sugar level to either a smartphone or a special receiver.

The investigators expect patients will have an overall improvement in health by decreasing weight and therefore improving the way the child's insulin works in their body. This could result in decreased risk of obesity-related complications such as diabetes mellitus, cardiovascular disease, kidney disease, and loss of vision and/or limbs, among others.

Conditions

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Impaired Glucose Tolerance

Keywords

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impaired glucose tolerance obesity adolescents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CGM intervention

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

Group Type EXPERIMENTAL

CGM

Intervention Type DEVICE

Dexcom G6 sensor, transmitter and supplies will be provided to family for use. Participants will wear G6 and have real-time glucose data throughout the study.

Interventions

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CGM

Dexcom G6 sensor, transmitter and supplies will be provided to family for use. Participants will wear G6 and have real-time glucose data throughout the study.

Intervention Type DEVICE

Other Intervention Names

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Dexcom G6

Eligibility Criteria

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Inclusion Criteria

1. Children 10 to \<17 years old (i.e., before their 17th birthday)
2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
3. Overweight or obese (BMI ≥85th percentile for age/sex)
4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL

Exclusion Criteria

1. Existing diagnosis of type 1 or type 2 diabetes
2. Prepubertal
3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Larry A. Fox, MD

Division Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larry A Fox, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Health

Locations

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Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Larry Fox, MD

Role: CONTACT

Phone: 9046973674

Email: [email protected]

Liezel Riego

Role: CONTACT

Phone: 9046973431

Email: [email protected]

Facility Contacts

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Liezel Riego

Role: primary

Larry A Fox, MD

Role: backup

Other Identifiers

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lfox051622

Identifier Type: -

Identifier Source: org_study_id