Continuous Glucose Monitoring System Feasibility in Youth With T2D (FREE_CGM)
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring freestyle libre, continuous glucose monitor, type 2 diabetes, T2D, pediatric
Eligibility Criteria
Inclusion Criteria: 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). Naïve to CGM use. 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 Criteria: 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.
Sites / Locations
- University of California San Francisco (UCSF)
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Intervention
Participants will not have access to view the data from the CGM sensor during the screening period, nor during the main part of the study.
Participants will wear the CGM sensor and have access to the data during the main part of the study.