NCT06453928 Starting Technology in At Risk Type 1 Diabetes Study
| NCT ID | NCT06453928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-05 |
| Primary Completion | 2027-01-31 |
Trial Parameters
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Brief Summary
Diabetes technology has revolutionized T1D management, disparities in technology access are evident among racial-ethnic minorities, patients with lower socioeconomic status and those with poorly controlled T1D (A1c\>8.5%). In order to examine whether diabetes technology can reduce diabetes care burdens and enhance outcomes among some of highest need patients, diabetes technology clinical trials must be expanded beyond the very select populations included in studies thus far (ie., mostly White, higher SES). Therefore, the investigators propose to perform a pilot RCT of hybrid closed-loop insulin pump therapy (HCL) in 40 diverse adult patients with poorly controlled T1D (HbA1c \>8.5%) from the largest academic and safety net health systems in the Los Angeles region to determine the feasibility of a RCT in this population and identify facilitators and barriers of effective use of closed loop insulin pump therapy in patients with poorly controlled T1D.
Eligibility 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
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