Clinical trial NCT06254768: Use of Continuous Glucose Monitors in Children and Adolescents With Obesity
Official title: Use of Continuous Glucose Monitors in Children and Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of continuous glucose monitor(CGM) use in children and adolescents with obesity
timeFrame: 6 weeks
Secondary outcomes:
measure: To access the change in glycemic variability measured by CGMS in unblinded versus blinded periods through standard deviation of the mean.
timeFrame: 6 weeks
Other outcomes:
measure: Effect of on sleep in youth with obesity using CGMs
timeFrame: 6 weeks
measure: Effect of CGM use on physical activity in youth with obesity when using CGMs
timeFrame: 6 weeks
measure: Effect of CGM use on dietary intake in youth with obesity when using CGMs
timeFrame: 6 weeks
measure: Effect of CGM use on eating behaviors in youth with obesity when using CGMs
timeFrame: 6 weeks
measure: Effect of CGM use on change in the BMI as a percentage of the 95th percentile (%BMIp95) in youth with obesity when using CGMs
timeFrame: 6 weeks.
Locations:
city: Los Angeles
country: United States
facility: Pediatric Endocrinology Division, University of California
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Steven D Mittelman, MD, PhD
role: STUDY_DIRECTOR
References: