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CGM and Lifestyle Changes for Prediabetes

N/A

Recruiting

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL

Overweight or obese (BMI ≥85th percentile for age/sex)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 6 months

Awards & highlights

Study Summary

This trial studies how a continuous glucose monitor (CGM) can help obese children lower their risk of type 2 diabetes (T2D) & other complications like hypertension & dyslipidemias. It's hypothesized that real-time glucose data will help improve adherence to lifestyle modifications, leading to better BMI & insulin sensitivity.

Who is the study for?

This trial is for overweight or obese children aged 10 to less than 17 with impaired glucose tolerance but not diagnosed with diabetes. They must be in puberty and willing to wear a continuous glucose monitor (CGM). Those on medications affecting insulin sensitivity or unwilling to comply are excluded.Check my eligibility

What is being tested?

The study tests if using a CGM device helps these young patients stick better to lifestyle changes, potentially leading to weight loss and improved insulin sensitivity, reducing the risk of developing type 2 diabetes and other obesity-related complications.See study design

What are the potential side effects?

While the use of CGM itself isn't associated with significant side effects, there may be minor skin irritation where the device attaches. The lifestyle changes could include increased physical activity and dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have started puberty.

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My BMI is in the top 15% for my age and sex.

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I am between 10 and 16 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insulin Sensitivity Score (ISS)

Secondary outcome measures

Dietary compliance questionnaires

Glycemic levels

Insulin Sensitivity Score

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CGM interventionExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CGM

2013

N/A

~1010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

18,116 Total Patients Enrolled

Media Library

Lifestyle Changes Clinical Trial Eligibility Overview. Trial Name: NCT05387551 — N/A

Prediabetes Research Study Groups: CGM intervention

Prediabetes Clinical Trial 2023: Lifestyle Changes Highlights & Side Effects. Trial Name: NCT05387551 — N/A

Lifestyle Changes 2023 Treatment Timeline for Medical Study. Trial Name: NCT05387551 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial allow seniors to participate?

"As outlined in the eligibility criteria, potential participants must be between 10 and 16 years of age."

Answered by AI

Are there any openings in this experiment for prospective participants?

"Per the information on clinicaltrials.gov, this experiment is currently recruiting research participants. The trial was published on December 1st 2022 and last modified on April 13th 2023."

Answered by AI

How might I become eligible for participation in this investigation?

"This medical trial seeks fifteen participants aged 10 to 16 who have prediabetes. Furthermore, they should also conform to American Diabetes Association standards for impaired glucose tolerance based on a standardized OGTT and be overweight or obese (BMI ≥85th percentile for age/sex) with evidence of pubertal development in female patients (breast Tanner stage II or above), or male patients (testicular volume ≥4 mL)."

Answered by AI

How many individuals are partaking in this investigation?

"Affirmative. According to clinicaltrials.gov, the medical trial which was posted on December 1st 2022 is actively recruiting participants at this time. 15 patients are required across a single location for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

Larry A. Fox, MD 2022. "CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05387551.

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