Use of Continuous Glucose Monitors in Children and Adolescents With Obesity (CGM)

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Pediatric Obesity

Treatments: Device: Continuous glucose monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06254768

22-000958

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Unblinded

Experimental group

Description:

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

Treatment:

Device: Continuous glucose monitor

Blinded

Experimental group

Description:

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

Treatment:

Device: Continuous glucose monitor