Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

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.

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.