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

Prior treatment

• Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device before enrollment into this study, that could impact the outcomes of this study; as per investigator and sponsor judgment.

Other illness

• Subject has any other disease or condition that may increase risks during the implant procedure or may preclude the subject from participating in the study, as determined by a physician who is not the principal investigator.
• Subject has any known or suspected allergy to insulin or implantable materials of the MIIPS (pump and catheter) as determined by a physician.
• Subject has an active infection requiring antibiotic treatment.
• Subject has diagnosis of illicit drugs abuse disorder.
• Subject has diagnosis of marijuana abuse disorder.
• Subject has diagnosis of prescription drugs abuse disorder.
• Subject has diagnosis of alcohol abuse disorder.

Lab values

• Subject who is unwilling or unable to monitor their glucose level or wear a personal continuous glucose monitor.
• Subject who is unwilling or unable to make programming modifications to the pump based on glucose level readings.

Other

• Subject is a woman who is pregnant, or of childbearing potential, or lactating, and who is neither surgically sterile, nor using contraceptives (devices, oral, implanted or other physician-approved contraceptive), or willing to use them, at the time of enrollment.
• Subject is vulnerable, legally incompetent or illiterate.
• Residence or planned non-pressurized travel at elevations above 10000 feet/3048 meters (commercial airline travel is acceptable).
• Planning to engage in activities requiring a descent greater than or equal to 10 feet/3 meters below sea level.
• Subject is a person whose body size is not sufficient to accept implantable pump bulk and weight.
• Subject has a life expectancy of less than 9 months.

• 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.