Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)
brief summary
The purpose of this study is to evaluate the clinical performance of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult patients with Type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), and presenting with frequent, otherwise unexplained severe hyper- and/or hypoglycemia.
detailed description
This study is a premarket, interventional, prospective, open-label, multi-center study. It consists of a run-in period, a study period, and a continued access period.
Run-in Period: The purpose of the run-in period is to collect CGM baseline data while subjects are on their current therapy.
Study Period: During the 6-month study period, subjects will be implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
Continued Access Period: Subjects who have completed the entire study period will continue using investigational study devices until those devices are approved for commercial use. Once CE mark is received, the subjects will continue wearing the implanted device.
official title
Phoenix: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes