Evaluation of the Medtronic Implantable Insulin Pump System MIIPS 2020 for Treatment of Adults with Type 1 Diabetes Using Intraperitoneal Insulin Infusion

What this Trial Is About

Researchers are evaluating the Medtronic Implantable Insulin Pump System MIIPS 2020 in adults with Type 1 diabetes who cannot manage their condition with subcutaneous insulin therapy, including those using external pumps. This study aims to assess the clinical performance of this implantable device in patients experiencing frequent, unexplained severe high or low blood sugar episodes. The investigation is a premarket, interventional, open-label study conducted at multiple centers. The study includes a run-in period to collect baseline continuous glucose monitoring CGM data while participants remain on their current therapy. Following this, during a 6-month study period, participants will be implanted with the MIIPS 2020 device and treated with insulin delivered directly into the peritoneal cavity intraperitoneal insulin infusion. After completing the study period, participants may continue using the investigational device under a continued access period until it receives commercial approval, after which they will keep wearing the implant. Participants will undergo assessments including insulin pump refill accuracy at 6 months and at each refill visit. Researchers will monitor device performance, including the percentage of pumps requiring a special rinse due to accuracy issues. Participants need to be able to operate the device and comply with data reporting requirements. The overall study duration includes the run-in, treatment, and continued access phases, with safety and effectiveness monitored throughout.

Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)