Use of Continuous Glucose Monitors in Children and Adolescents With Obesity
CGM
1 other identifier
interventional
30
1 country
1
Brief Summary
To study if continuous glucose monitors are feasible for use in children and adolescents with obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2023
CompletedFirst Submitted
Initial submission to the registry
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 12, 2024
February 1, 2024
1.1 years
February 27, 2023
February 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To access the change in glycemic variability measured by CGMS in unblinded versus blinded periods through standard deviation of the mean.
6 weeks
Other Outcomes (5)
Effect of on sleep in youth with obesity using CGMs
6 weeks
Effect of CGM use on physical activity in youth with obesity when using CGMs
6 weeks
Effect of CGM use on dietary intake in youth with obesity when using CGMs
6 weeks
- +2 more other outcomes
Study Arms (2)
Unblinded
EXPERIMENTALThey will wear the device and have access to their data- UNBLINDED ARM
Blinded
EXPERIMENTALThey will wear the device but will not have access to their data- BLINDED ARM
Interventions
its a device used to measure glucose from interstitial fluids and provides feedback regarding the same every 5 minutes.
Eligibility Criteria
You may qualify if:
- Age 10-21 years BMI \>95th percentile
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Endocrinology Division, University of California
Los Angeles, California, 90025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven D Mittelman, MD, PhD
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 27, 2023
First Posted
February 12, 2024
Study Start
January 17, 2023
Primary Completion
March 1, 2024
Study Completion
June 1, 2024
Last Updated
February 12, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share