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

Inclusion Criteria:

1. Subject is aged ≥ 18 years old.

2. Subject has a clinical diagnosis of type 1 diabetes for ≥ 6 months prior toscreening as determined via medical record or source documentation by an individualqualified to make a medical diagnosis.

3. Subject with type 1 diabetes mellitus that cannot be controlled with subcutaneousinsulin therapy (including external pump), presenting with frequent, otherwiseunexplained severe hyper-and/or hypoglycaemia.

4. Subject has access to a reliable support person, defined as an individual who hasdaily contact with the subject and knows who to contact in the event of an emergency (i.e., caregiver).

5. Subject has the physical and intellectual ability (in the opinion of the studyinvestigator) to operate the MIIP system and to comply with the data reportingrequirements of the study.

6. Subject is willing and able to sign and date informed consent, comply with all studyprocedures as required during the study.

Exclusion Criteria:

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

2. Subject has any other disease or condition that may increase risks during theimplant procedure or may preclude the subject from participating in the study, asdetermined by a physician who is not the principal investigator.

3. Subject has any known or suspected allergy to insulin or implantable materials ofthe MIIPS (pump and catheter) as determined by a physician.

4. Subject is a woman who is pregnant, of childbearing potential or lactating, and whois neither surgically sterile nor using contraceptives (devices, oral, implanted orother physician-approved contraceptive) at the time of enrollment.

5. Subject is vulnerable, legally incompetent or illiterate.

6. Residence or planned non-pressurized travel at elevations above 10000 feet/3048meters (commercial airline travel is acceptable).

7. Planning to engage in activities requiring a descent greater than or equal to 10feet/3 meters below sea level.

8. Subject has an active infection requiring antibiotic treatment.

9. Subject is a person whose body size is not sufficient to accept implantable pumpbulk and weight.

10. Subject has a life expectancy of less than 9 months.

11. Subject has diagnosis of illicit drugs abuse disorder.

12. Subject has diagnosis of marijuana abuse disorder.

13. Subject has diagnosis of prescription drugs abuse disorder.

14. Subject has diagnosis of alcohol abuse disorder.

15. Subject who is unwilling or unable to monitor their glucose level or wear a personalcontinuous glucose monitor.

16. Subject who is unwilling or unable to make programming modifications to the pumpbased on glucose level readings.