Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)
NCT ID: NCT06739811
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2025-03-26
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Run-in Period: The purpose of the run-in period is to collect CGM baseline data while subjects are on their current therapy.
Study Period: During the 6-month study period, subjects will be implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
Continued Access Period: Subjects who have completed the entire study period will continue using investigational study devices until those devices are approved for commercial use. Once CE mark is received, the subjects will continue wearing the implanted device.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MIIPS 2020
Subjects implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
Implantable Insulin Pump System
Medtronic Implantable Insulin Pump System (MIIPS 2020)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Implantable Insulin Pump System
Medtronic Implantable Insulin Pump System (MIIPS 2020)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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, of childbearing potential or lactating, and who is neither surgically sterile nor using contraceptives (devices, oral, implanted or other 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/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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Diabetes
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Universitaire De Montpellier
Montpellier, France, France
Hôpital Européen Marseille
Marseille, , France
Isala Zwolle
Zwolle, Netherlands, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Eric Prof. Renard
Role: primary
Pauline Schaepelynck
Role: primary
Peter Ruben van Dijk, Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIP347
Identifier Type: -
Identifier Source: org_study_id