NCT06453928 · University of California, Los Angeles
Starting Technology in At Risk Type 1 Diabetes Study
(STAR-T1D)
What this study is about
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%).
View original scientific description
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.
Interventions
DEVICE
Hybrid Closed Loop Insulin Pump System
Patients will be started on an automated insulin delivery system.
Primary outcome measures
Proportion of screened participants that are eligible
Time frame: 6 months
Eligible among screened, enrolled among eligible, excluded among screened (and why) based on screening, recruitment and enrollment data.
Proportion of enrolled participants that are randomized
Time frame: 6 months
Randomized among enrolled, and receiving allocated intervention among randomized.
Proportion of average time delay to enrollment
Time frame: 6 months
Average time delay from screening to enrollment.
Proportion of retention among participants randomized to the Intervention Group
Time frame: 6 months
Retention among participants receiving allocated intervention after being randomized and discontinued intervention among randomized.
Proportion of retention among participants randomized
Time frame: 6 months
Participants lost to follow-up among those initially randomized.
Proportion of retention among participants randomized
Time frame: 6 months
Retention rates by participants completing all research assessments among randomized.
Number of participants who adhere to assigned treatment
Time frame: 6 months
Treatment-specific adherence, Adherence to study protocol and Proportion of planned assessments that are completed. Fidelity, which pertains to guaranteeing that the intervention is delivered in accordance with the established protocol, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate. Adherence, which relates to the extent to which participants follow the treatment and study protocol, as well as the proportion of planned assessments completed, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Type 1 Diabetes
- 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)
Where
- Santa Monica, California
- Sylmar, California
- Torrance, California
Collaborators
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Olive View-UCLA Education & Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations