Actively Recruiting
Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)
Led by Medtronic MiniMed, Inc. · Updated on 2026-03-23
40
Participants Needed
6
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is aged 18 years or older
- Clinical diagnosis of Type 1 diabetes for at least 6 months prior to screening
- Type 1 diabetes not controlled with subcutaneous insulin therapy, including external pump, with frequent severe unexplained high or low blood sugar
- Access to a reliable support person with daily contact who can assist in emergencies
- Physical and intellectual ability to operate the MIIPS system and comply with study data reporting
- Willingness and ability to sign informed consent and follow all study procedures
You will not qualify if you...
- Current participation in another investigational drug or device study that could affect this study's outcomes
- Any disease or condition increasing risk during implant or preventing study participation, as judged by a physician
- Known or suspected allergy to insulin or MIIPS implant materials
- Female who is pregnant, lactating, or of childbearing potential without surgical sterilization or contraceptive use
- Vulnerable, legally incompetent, or illiterate individuals
- Residence or planned non-pressurized travel above 10,000 feet altitude
- Plans for activities involving descent 10 feet or more below sea level
- Active infection requiring antibiotic treatment
- Body size insufficient to accept implantable pump
- Life expectancy under 9 months
- Diagnosed abuse disorders for illicit drugs, marijuana, prescription drugs, or alcohol
- Unwilling or unable to monitor glucose or wear continuous glucose monitor
- Unwilling or unable to adjust pump programming based on glucose readings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Centre Hospitalier Universitaire De Montpellier
Montpellier, France, France, 34295
Actively Recruiting
2
CHU Dijon Bourgogne
Dijon, France, 21100
Actively Recruiting
3
Hôpital Européen Marseille
Marseille, France, 13003
Actively Recruiting
4
Hôpital Lariboisière & Fernand-Widal
Paris, France
Active, Not Recruiting
5
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Actively Recruiting
6
Isala Zwolle
Zwolle, Netherlands, Netherlands, 8025 AB
Actively Recruiting
Research Team
L
Laura Fusco
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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