Recruiting

Testing an Automated Insulin Delivery System in Regular Doctor's Offices

Plain-English translation of NCT07011147 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing the iLet Bionic Pancreas, an automated device that helps deliver insulin to people with diabetes who need it. Researchers want to see if using this device for 13 weeks can better control blood sugar levels compared to the standard insulin care most people currently use. The study is special because it's being done in regular primary care doctor's offices—not just specialized diabetes clinics.

Many people with diabetes struggle to keep their blood sugar in a healthy range using traditional insulin injections or pumps. This trial is testing whether an automated system can make blood sugar management easier and more effective when prescribed by the regular doctors people already see.

Do you qualify?

You likely qualify if…

you are between 18 and 89 years old
you have been diagnosed with type 1 diabetes for at least one year and have been using insulin for at least one year, OR you have type 2 diabetes and have been on insulin injections or infusions for at least 3 months
your diabetes medications have been stable (not changed) for at least 4 weeks before the study starts
your primary care doctor is willing to refer you and manage your care during the study
you are willing to wear a continuous glucose monitor and the iLet device for the duration of your participation
if you can become pregnant, you are willing to use birth control during the study and have pregnancy tests as needed

You likely don't qualify if…

you have recently changed your diabetes medication doses in the past 4 weeks
you are unable or unwilling to wear a continuous glucose monitor or the insulin pump device
you are unwilling to use specific types of rapid-acting insulin (lispro or aspart) that the study requires
your doctor believes you don't have the ability to safely operate the devices or follow the study plan
you are pregnant or planning to become pregnant during the study

What participation looks like

If you're chosen for the study, you'll either use the iLet Bionic Pancreas for 13 weeks or continue your regular insulin routine. You'll have a virtual screening visit, wear a continuous glucose monitor, complete mid-study check-in calls, and return for a final visit. You'll also complete some surveys and blood tests. If you're in the routine care group, you'll have the option to try the iLet device afterward for another 13 weeks.

AI-generated summary from trial data · Jun 28, 2026 · Not medical advice

Testing an Automated Insulin Delivery System in Regular Doctor's Offices

What is this trial?

Do you qualify?

What participation looks like

Trial locations