Status:
ACTIVE_NOT_RECRUITING
Continuous Glucose Monitoring System Feasibility in Youth With T2D
Lead Sponsor:
University of California, San Francisco
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
8-20 years
Phase:
NA
Brief Summary
The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior...
Detailed Description
At the beginning of the study, participants will be asked to complete surveys where demographic, clinical and behavioral data will be collected. We will ask participants to wear a glucose sensor that ...
Eligibility Criteria
Inclusion
- Age 8- 20 years at the time of consent.
- Clinical diagnosis of type 2 diabetes.
- Duration of type 2 diabetes at least 4 weeks.
- HbA1C ≥ 6.5% .
- Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
- No use of CGM 90 days before screening visit.
- English or Spanish speakers.
- Willing to abide by recommendations and study procedures.
- Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
- Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion
- Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
- Plan for undergoing bariatric surgery during the study period.
- Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
- Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
- Pregnancy or lactation.
- Currently undergoing cancer treatment or systemic treatment with steroids.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06089070
Start Date
January 3 2024
End Date
December 1 2027
Last Update
September 8 2025
Active Locations (1)
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1
University of California San Francisco (UCSF)
San Francisco, California, United States, 94158