Starting Technology in At Risk Type 1 Diabetes Study
This study is looking at how a Hybrid Closed Loop Insulin Pump System (an automated insulin delivery system) might help adults with Type 1 Diabetes who have difficulty managing their blood sugar (A1c over 8.5%). The goal is to see if this technology can make managing diabetes easier and improve health outcomes for people who haven't used an insulin pump before. The study aims to include a diverse group of 40 participants. Researchers will measure how many people are eligible and how many join the study within six months to understand how to better include more people in future diabetes technology trials.
- Study design
- This is an interventional study planning to enroll 40 participants. It is a pilot randomized controlled trial (RCT).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures eligibility and enrollment over 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Starting Technology in At Risk Type 1 Diabetes Study
At a glance
Conditions
Where it's being run
3 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Proportion of screened participants that are eligible6 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 randomized6 months
Randomized among enrolled, and receiving allocated intervention among randomized.
- Proportion of average time delay to enrollment6 months
Average time delay from screening to enrollment.
- Proportion of retention among participants randomized to the Intervention Group6 months
Retention among participants receiving allocated intervention after being randomized and discontinued intervention among randomized.
- Proportion of retention among participants randomized6 months
Participants lost to follow-up among those initially randomized.
- Proportion of retention among participants randomized6 months
Retention rates by participants completing all research assessments among randomized.
- Number of participants who adhere to assigned treatment6 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.