Phoenix: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes
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.
• Subject is aged ≥ 18 years old.
• Subject has a clinical diagnosis of type 1 diabetes for ≥ 6 months prior to screening as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• Subject with type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), presenting with frequent, otherwise unexplained severe hyper-and/or hypoglycaemia.
• Subject has access to a reliable support person, defined as an individual who has daily contact with the subject and knows who to contact in the event of an emergency (i.e., caregiver).
• Subject has the physical and intellectual ability (in the opinion of the study investigator) to operate the MIIP system and to comply with the data reporting requirements of the study.
• Subject is willing and able to sign and date informed consent, comply with all study procedures as required during the study.