Use of Continuous Glucose Monitors in Children and Adolescents With Obesity

NCT ID: NCT06254768

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2024-06-30

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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Unblinded

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

Group Type: EXPERIMENTAL

Continuous glucose monitor

Intervention Type: DEVICE

its a device used to measure glucose from interstitial fluids and provides feedback regarding the same every 5 minutes.

Blinded

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

Group Type: EXPERIMENTAL

Continuous glucose monitor

Intervention Type: DEVICE

its a device used to measure glucose from interstitial fluids and provides feedback regarding the same every 5 minutes.

Interventions

Continuous glucose monitor

its a device used to measure glucose from interstitial fluids and provides feedback regarding the same every 5 minutes.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Sri Nikhita Chimatapu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven D Mittelman, MD, PhD

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

Pediatric Endocrinology Division, University of California

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sri Nikhita Chimatapu, MD

Role: CONTACT

schimatapu@mednet.ucla.edu

9177414080

Facility Contacts

Sri Nikhita Chimatapu

Role: primary

schimatapu@mednet.ucla.edu

917-741-4080

Other Identifiers

22-000958

Identifier Type: -

Identifier Source: org_study_id