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CGM and Lifestyle Changes for Prediabetes

N/A
Recruiting
Led By Larry A Fox, MD
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)
Must not have
Taking medications that affect insulin sensitivity (e.g., metformin, chronic corticosteroids whether systemic or inhaled)
Existing diagnosis of type 1 or type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on medication that affects my body's response to insulin, like metformin.
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I have been diagnosed with type 1 or type 2 diabetes.
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I am unwilling or unable to wear a CGM device for the study period.
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I have not yet gone through puberty.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insulin Sensitivity Score (ISS)
Secondary study objectives
Dietary compliance questionnaires
Glycemic levels
Insulin Sensitivity Score
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1030

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
127 Previous Clinical Trials
18,408 Total Patients Enrolled
Larry A Fox, MDPrincipal InvestigatorNemours Children's Health
4 Previous Clinical Trials
44 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
~1 spots leftby Dec 2024
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