Use of Continuous Glucose Monitors in Children and Adolescents With Obesity

Not Applicable

Recruiting

• Conditions: Pediatric Obesity
• Interventions: Device: Continuous glucose monitor

• Registration Number: NCT06254768
• Lead Sponsor: University of California, Los Angeles

Brief Summary

To study if continuous glucose monitors are feasible for use in children and adolescents with obesity.

Detailed Description

Various CGMs are approved by the U.S. Food and Drug Administration (FDA) for use in children and adults with diabetes. However, to date, little is known about how CGM technology can be integrated into weight management strategies for adolescents with obesity. No study to date has explored the effects of unblinded vs. blinded CGM use alone, without any other lifestyle modification recommendations. Thus, to address this question, this is a cross-over feasibility trial of blinded vs. unblinded CGM use in youth with obesity. This study hypothesizes that CGM will be a feasible and acceptable technology for youth with obesity, without diabetes, to utilize, and that access to daily glucose trends will facilitate positive changes in eating behavior and daily activity level compared to blinded CGM use. Thirty adolescents with obesity will be recruited into a six-week cross-over trial. All participants will be randomly assigned to either the blinded or unblinded group for three weeks. And then cross over to the other group for another three weeks. The primary endpoints are recruitment, retention, and adherence. While the secondary endpoints are glycemic variability, as captured on CGM, change in weight as an excess percentage of 95th percentile, sleep, dietary intake, physical activity, and eating behaviors.

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-02-27
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-03
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 10-21 years BMI >95th percentile

Exclusion Criteria

• Previous diagnosis of Prader Willi Syndrome or hypothalamic obesity
• Intellectual disability
• Previous or planned bariatric surgery
• Hemoglobin A1c >6.5 %
• Current use of medication that impacts weight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Unblinded	Continuous glucose monitor	They will wear the device and have access to their data- UNBLINDED ARM
Blinded	Continuous glucose monitor	They will wear the device but will not have access to their data- BLINDED ARM

Primary Outcome Measures

Name	Time	Method
Feasibility of continuous glucose monitor(CGM) use in children and adolescents with obesity	6 weeks	Investigator will measure this outcome using recruitment rate achieved each month for the duration of the study period as the number of participants screened per month over the number of participants consented.

Secondary Outcome Measures

Name	Time	Method
To access the change in glycemic variability measured by CGMS in unblinded versus blinded periods through standard deviation of the mean.	6 weeks	Investigator will measure the effect of un-blinded CGM versus blinded use on glycemic variability measured by the Standard Deviation of the mean glycemia (SD) measured by CGMS.

Trial Locations

Locations (1)

Pediatric Endocrinology Division, University of California; 🇺🇸 Los Angeles, California, United States