Using a continuous glucose monitor in youth with type 2 diabetes
Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)
This study is testing whether using a continuous glucose monitor can help young people with type 2 diabetes manage their condition better compared to standard blood glucose monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 8 Years to 20 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06089070 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using a continuous glucose monitoring (CGM) system in youth aged 8-20 with type 2 diabetes. Participants will be randomized into two groups: one will receive the FreeStyle Libre CGM and training on its use, while the control group will continue standard blood glucose monitoring. The study will last for six months, during which participants will wear a blinded glucose sensor for 14 days to gather baseline data before transitioning to their assigned group. The goal is to assess how the use of CGM influences behavior and management decisions in diabetes care.
Who should consider this trial
Good fit: Ideal candidates are youth aged 8-20 with a clinical diagnosis of type 2 diabetes and stable medication regimens.
Not a fit: Patients with pancreatic autoantibody positivity or those who have used a CGM in the past 90 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diabetes management and outcomes in youth by providing real-time glucose data.
How similar studies have performed: Previous studies have shown positive outcomes with continuous glucose monitoring in diabetes management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 8- 20 years at the time of consent. 2. Clinical diagnosis of type 2 diabetes. 3. Duration of type 2 diabetes at least 4 weeks. 4. HbA1C ≥ 6.5% . 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). 6. No use of CGM 90 days before screening visit. 7. English or Spanish speakers. 8. Willing to abide by recommendations and study procedures. 9. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. 10. 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: 1. Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8). 2. Plan for undergoing bariatric surgery during the study period. 3. Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently. 4. Known history of adrenal insufficiency, or ongoing renal or hepatic disease. 5. Pregnancy or lactation. 6. Currently undergoing cancer treatment or systemic treatment with steroids. 7. 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.
Where this trial is running
San Francisco, California
- University of California San Francisco (UCSF) — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Shylaja Srinivasan, MD, MAS — University of California, San Francisco
- Study coordinator: Shylaja Srinivasan, MD, MAS
- Email: shylaja.srinivasan@ucsf.edu
- Phone: 415-353-9084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.