Use of Continuous Glucose Monitors in Children and Adolescents With Obesity

Pediatric Obesity Clinical Trial

— CGM  

Official title:

Use of Continuous Glucose Monitors in Children and Adolescents With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254768
• Other study ID #: 22-000958
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of California, Los Angeles
• Contact: Sri Nikhita Chimatapu, MD
• Phone: 9177414080
• Email: schimatapu[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Pediatric Endocrinology Division, University of California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of on sleep in youth with obesity using CGMs	Investigator will assess the effect on quality of sleep in youth with obesity when using CGMs with the help of Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.	6 weeks
Other	Effect of CGM use on physical activity in youth with obesity when using CGMs	Investigator will assess the effect on physical activity when using CGMS with the help of International Physical Activity Questionnaire. The items on the form are structured to provide separate scores on walking, moderate-intensity and vigorous-intensity activity. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.	6 weeks
Other	Effect of CGM use on dietary intake in youth with obesity when using CGMs	Investigator will assess the effect on dietary intake when using CGMS with the help of The Automated Self-Administered 24-hour Dietary Assessment Tool which is a tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries.	6 weeks
Other	Effect of CGM use on eating behaviors in youth with obesity when using CGMs	Investigator will assess the effect on eating behaviors in youth with obesity when using CGMs with the help of Dutch Eating Behavior Questionnaire. Items on the Dutch Eating Behavior Questionnaire range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.	6 weeks
Other	Effect of CGM use on change in the BMI as a percentage of the 95th percentile (%BMIp95) in youth with obesity when using CGMs	Investigator will measure the change in the BMI as a percentage of the 95th percentile (%BMIp95) in youth with obesity when using CGMs between baseline to week 6.	6 weeks.
Primary	Feasibility of continuous glucose monitor(CGM) use in children and adolescents with obesity	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.	6 weeks
Secondary	To access the change in glycemic variability measured by CGMS in unblinded versus blinded periods through standard deviation of the mean.	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.	6 weeks