Evaluation of an Implantable Insulin Pump for Adults with Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical evaluation focuses on the Medtronic Implantable Insulin Pump System (MIIPS 2020) for adult patients suffering from Type 1 diabetes that is difficult to manage with traditional insulin therapies. The study includes a run-in period to gather baseline data, followed by a 6-month period where participants will receive intraperitoneal insulin infusion via the implanted device. After the study, participants will have continued access to the device until it receives commercial approval. The goal is to assess the effectiveness and safety of this innovative insulin delivery method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is aged ≥ 18 years old.
2. 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.
3. 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.
4. 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).
5. 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.
6. Subject is willing and able to sign and date informed consent, comply with all study procedures 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 device before enrollment into this study, that could impact the outcomes of this study; as per investigator and sponsor judgment.
2. 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.
3. Subject has any known or suspected allergy to insulin or implantable materials of the MIIPS (pump and catheter) as determined by a physician.
4. 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.
5. Subject is vulnerable, legally incompetent or illiterate.
6. Residence or planned non-pressurized travel at elevations above 10000 feet/3048 meters (commercial airline travel is acceptable).
7. Planning to engage in activities requiring a descent greater than or equal to 10 feet/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 pump bulk 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 personal continuous glucose monitor.
16. Subject who is unwilling or unable to make programming modifications to the pump based on glucose level readings.

Where it's running

• Isala Zwolle
  Zwolle, Netherlands, Netherlands Recruiting
• Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
  Bordeaux, France, France Not yet recruiting
• Centre Hospitalier Sud Francilien
  Corbeil-Essonnes, France, France Not yet recruiting
• CHU Lille - Hôpital Huriez
  Lille, France, France Active not recruiting
• Centre Hospitalier Universitaire De Montpellier
  Montpellier, France, France Active not recruiting
• CHU de Nancy - Hôpital d'Adultes de Brabois
  Nancy, France, France Not yet recruiting

Study contacts

• Study coordinator: Laura Fusco
• Email: laura.fusco@medtronic.com
• Phone: + 39 02 241371

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.