Using hybrid closed-loop insulin pumps to improve diabetes management in diverse adults
Starting Technology in At Risk Type 1 Diabetes (STAR-T1D) Study
NA · University of California, Los Angeles · NCT06453928
This study is testing if a new type of insulin pump can help adults with poorly controlled Type 1 Diabetes manage their condition better, especially those from different backgrounds who usually have trouble accessing diabetes technology.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles (other) |
| Locations | 3 sites (Santa Monica, California and 2 other locations) |
| Trial ID | NCT06453928 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of using hybrid closed-loop insulin pump therapy in a diverse group of adults with poorly controlled Type 1 Diabetes, specifically those with an HbA1c greater than 8.5%. The study will include 40 participants from various racial and ethnic backgrounds, focusing on those who have historically faced barriers to accessing diabetes technology. By expanding the participant pool beyond typical demographics, the researchers hope to identify facilitators and barriers to effective use of this technology. The study will take place in major health systems in the Los Angeles area, including UCLA and Harbor-UCLA Medical Center.
Who should consider this trial
Good fit: Ideal candidates are adults with Type 1 Diabetes, an HbA1c greater than 8.5%, who are not currently using an insulin pump and have medical insurance.
Not a fit: Patients with significant comorbidities affecting A1c accuracy, cognitive or physical impairments, or those with a limited life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diabetes management and health outcomes for underserved populations with Type 1 Diabetes.
How similar studies have performed: While there have been studies on diabetes technology, this approach focusing on diverse and underserved populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 Diabetes * A1c \>8.5% * Not insulin pump user * Primary language of English or Spanish * Have medical insurance coverage Exclusion Criteria: * No measured A1c in the past year * Have comorbidities that can result in inaccurate hemoglobin A1c * Have cognitive, physical or mental impairment precluding diabetes technology use * Limited life expectancy (\<1 year) * Pregnancy
Where this trial is running
Santa Monica, California and 2 other locations
- UCLA — Santa Monica, California, United States (RECRUITING)
- Olive View-UCLA Medical Center — Sylmar, California, United States (RECRUITING)
- Harbor-UCLA Medical Center — Torrance, California, United States (RECRUITING)
Study contacts
- Study coordinator: Estelle M Everett, MD, MHS
- Email: eeverett@mednet.ucla.edu
- Phone: 310-267-0625
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.
Conditions: Diabetes Mellitus, Type 1, Continuous Glucose Monitoring, Insulin Pump, Hybrid Closed Loop Systems, Diabetes Technology, Health Disparities