iLet Bionic Pancreas for Type 1 and Type 2 Diabetes
This study is looking at how well the iLet Bionic Pancreas (an automated insulin delivery system) works for adults with type 1 or type 2 diabetes who use insulin. Researchers want to see if this device can be used effectively in primary care settings. You would either use the iLet Bionic Pancreas for 13 weeks or continue with your usual diabetes care. The main goal is to see if using the iLet Bionic Pancreas leads to a greater reduction in your HbA1c (a measure of average blood sugar over time) compared to routine care. This study is for adults aged 18 to 89 with type 1 diabetes for at least one year, or type 2 diabetes using insulin for at least three months. The current status of this study is unclear.
- Study design
- This is an interventional study aiming to enroll 240 participants. It compares the iLet Bionic Pancreas to routine care.
- What's involved
- If you are in the intervention group, you will use the iLet Bionic Pancreas for 13 weeks and be trained on its use. If you are in the routine care group, you will continue your current treatment and have four phone calls to review your medications and health.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your HbA1c will be measured at 13 weeks. Your percentage of time with very low blood sugar will be measured during weeks 1-13 and weeks 13-26.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Sean Oser, MD, MPH, CDCES · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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What this trial measures
- HbA1c between the BP and RC groupsRCT Week 13
Superiority testing for HbA1c at 13 weeks between the BP and RC groups using linear mixed effects regression models adjusting for baseline HbA1c.
- Percentage of Time With CGM Glucose <54 mg/dlRCT Weeks 1-13 and OEP Weeks 13-26
Non-inferiority testing for ordinal TBR\<54mg/dL will be determined using a two-sided 95% confidence interval on the mean difference in % time \<54 mg/dL between BP and RC groups using a linear mixed effects regression model adjusting for baseline % time \<54 mg/dL, diabetes type, and clinical center.