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Device

Blinded for Childhood Obesity (CGM Trial)

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Age 10-21 years with BMI >95th percentile

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

CGM Trial Summary

This trial aims to see if continuous glucose monitors can be used effectively in children and teenagers who have obesity. "This trial aims to see if continuous glucose monitors can be used effectively in children and teenagers who

Who is the study for?

This trial is for young people aged 10-21 who are significantly overweight, with a BMI above the 95th percentile. It's not suitable for those with diabetes (Hemoglobin A1c >6.5%), intellectual disabilities, specific genetic conditions like Prader Willi Syndrome or hypothalamic obesity, anyone on weight-affecting meds, or those who've had or plan to have weight loss surgery.Check my eligibility

What is being tested?

The study is testing if using continuous glucose monitors is practical and helpful for kids and teens with obesity. These devices track blood sugar levels throughout the day without needing to prick fingers.See study design

What are the potential side effects?

Continuous glucose monitors are generally safe but can cause skin irritation where they attach, possible allergic reactions to adhesive materials used in the device, and there might be anxiety or stress from constant monitoring of glucose levels.

CGM Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 10 and 21 years old with a BMI in the top 5% for my age.

CGM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

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

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility of continuous glucose monitor(CGM) use in children and adolescents with obesity

Secondary outcome measures

To access the change in glycemic variability measured by CGMS in unblinded versus blinded periods through standard deviation of the mean.

Other outcome measures

Effect of CGM use on change in the BMI as a percentage of the 95th percentile (%BMIp95) in youth with obesity when using CGMs

Effect of CGM use on dietary intake in youth with obesity when using CGMs

Effect of CGM use on eating behaviors in youth with obesity when using CGMs

+2 more

Side effects data

From 2009 Phase 3 trial • 451 Patients • NCT00406133

11%

Severe Hypoglycemia

100%

80%

60%

40%

20%

Study treatment Arm

Secondary Cohort Control Group

Primary Cohort RT-CGM Group

Primary Cohort Control Group

Secondary Cohort RT-CGM Group

CGM Trial Design

2Treatment groups

Experimental Treatment

Group I: UnblindedExperimental Treatment1 Intervention

They will wear the device and have access to their data- UNBLINDED ARM

Group II: BlindedExperimental Treatment1 Intervention

They will wear the device but will not have access to their data- BLINDED ARM

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous glucose monitor

2006

Completed Phase 3

~640

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,535 Previous Clinical Trials

10,267,380 Total Patients Enrolled

Steven D Mittelman, MD, PhDStudy DirectorUniversity of California, Los Angeles

Frequently Asked Questions

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

What is the total number of subjects actively involved in this research investigation?

"Indeed, as per clinicaltrials.gov records, this ongoing clinical trial is actively seeking volunteers. Initially listed on January 17th, 2023 and most recently revised on February 8th, 2024, the trial aims to enlist a total of 30 participants from one designated site."

Answered by AI

Are new participants currently being accepted for enrollment in this ongoing medical study?

"Indeed, the details on clinicaltrials.gov indicate that this research endeavor is presently seeking candidates. The trial was first shared on January 17th, 2023 and has recently been revised as of February 8th, 2024. They aim to enroll a total of 30 participants at one designated site."

Answered by AI

Which individuals are eligible to partake in this clinical research study?

"Individuals aged between 10 and 21 with a history of pediatric obesity are eligible for inclusion in this clinical research. The study is open to approximately 30 participants."

Answered by AI

Are individuals who are older than 65 eligible to participate in this research study?

"Individuals aged between 10 and 21 are eligible for this study. There are a total of 232 trials focusing on participants under 18 years old and 616 studies targeting those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Continuous Glucose Monitors in Children and Adolescents With Obesity

Sri Nikhita Chimatapu 2023. "Use of Continuous Glucose Monitors in Children and Adolescents With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06254768.

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