Tests an implanted insulin pump in adults with type 1 diabetes
Tests an implanted insulin pump in adults whose diabetes is hard to control.
Plain-language title generated from the registry record
Registry title: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)
Key facts
- Where
- Bordeaux, Corbeil-Essonnes, Dijon, Lille, Marseille, Montpellier, Nancy, Paris, Strasbourg, and Toulouse, FranceSee the 10 sites
Where in France
- Hôpital Saint André -Centre Hospitalier Universitaire de BordeauxBordeaux, FranceNot yet recruiting
- Centre Hospitalier Sud FrancilienCorbeil-Essonnes, FranceNot yet recruiting
- Chu Dijon BourgogneDijon, FranceNo longer taking part
- CHU Lille - Hôpital HuriezLille, FranceNo longer taking part
- Hopital Europeen MarseilleMarseille, FranceNo longer taking part
- Centre Hospitalier Universitaire de MontpellierMontpellier, FranceNo longer taking part
- CHU de Nancy - Hôpital d'Adultes de BraboisNancy, FranceNot yet recruiting
- Hopital Lariboisiere-Fernand WidalParis, FranceNo longer taking part
- Hopitaux Universitaires de Strasbourg - Nouvel Hopital CivilStrasbourg, FranceNo longer taking part
- CHU de Toulouse - Hopital RangueilToulouse, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic MiniMed, Inc.
- Trial code
- NCT06739811
- Record updated
- 22 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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; 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.