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Starting Technology in At Risk Type 1 Diabetes Study

Starting Technology in At Risk Type 1 Diabetes (STAR-T1D) Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests an insulin pump system that partly adjusts insulin on its own in adults with type 1 diabetes whose blood sugar is not well controlled. It aims to learn whether a larger study is possible and what helps or makes it hard for people to use the system.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 1 diabetes.
  • Have an A1c of 8.0% or higher. A1c measures average blood sugar over about 3 months.
  • Do not currently use an insulin pump.
  • Speak English or Spanish as your main language.
  • Have health insurance.

Who can't join

  • Have not had an A1c test in the past year.
  • Have another health condition that can make A1c results inaccurate.
  • Have a thinking, physical, or mental health problem that prevents you from using diabetes technology.
  • Are expected to live less than 1 year.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Type 1 Diabetes * A1c ≥ 8.0% * 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

Study sites (3)

CA