RecruitingNot ApplicableNCT07011147

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Sponsor

University of Colorado, Denver

Enrollment

240 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Type 2 Diabetes Type 1 Diabetes (T1D)Diabetes, Autoimmune

Summary

The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether automated insulin delivery systems (also called closed-loop or "artificial pancreas" technology) can be effectively managed through regular primary care visits — rather than only through specialist diabetes clinics. **You may be eligible if...** - You are 18–89 years old - You have type 1 diabetes and have been using insulin for at least 1 year, OR you have type 2 diabetes on an injected or infused insulin regimen for at least 3 months - Your diabetes medication doses have been stable for the past 4 weeks **You may NOT be eligible if...** - You have had a severe hypoglycemic (very low blood sugar) episode requiring outside help in the past 3 months - You have a condition that affects glucose sensing in the skin (such as severe kidney disease) - You are pregnant or planning to become pregnant during the study - You are already using an automated insulin delivery system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBionic Pancreas

The intervention group will use the iLet Bionic Pancreas (BP) for 13-weeks. They will be trained on the iLet BP system and its components by a Certified iLet Trainer. They will also be trained on how to use the study continuous glucose monitor (CGM) system, blood glucose meter, and ketone meter. Participants will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events and device issues. At the end of 13-weeks, they will complete final visit tasks and will be transitioned back to their pre-study insulin delivery method with guidance provided by a study investigator.

OTHERRoutine Care

Participants will continue with their current diabetes treatment. Participants will be trained on the use of the study blood glucose meter. They will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events. At the end of 13-weeks, they will complete final visit tasks and will be asked if they would like to participate in the observational extension phase where they will use the iLet Bionic Pancreas for 13 weeks.