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

NCT06739811 | Recruiting DMC FDA Device

• 1 other identifier: CIP347
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Type I Diabetes

Outcome Measures

Primary Outcomes (1)

• Delivery accuracy of MIIPS 2020

  Refill Accuracy= (Total Actual Volume Dispensed)/(Total Theoretical Volume Dispensed)

  6 months (4 refill cycles)

Secondary Outcomes (2)

• Refill accuracy at each refill visit

  6 months (4 refill cycles)

• Percentage of pump with accuracy ratio ≤ 85% prompting NaOH rinse

  6 months (4 refill cycles)

Study Arms (1)

MIIPS 2020

EXPERIMENTAL

Subjects implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.

Device: Implantable Insulin Pump System

Interventions

Implantable Insulin Pump System DEVICE

Medtronic Implantable Insulin Pump System (MIIPS 2020)

MIIPS 2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.
• 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 has an active infection requiring antibiotic treatment.
• 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.
• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (6)

Centre Hospitalier Universitaire De Montpellier

Montpellier, France, 34295, France

RECRUITING

CHU Dijon Bourgogne

Dijon, 21100, France

RECRUITING

Hôpital Européen Marseille

Marseille, 13003, France

RECRUITING

Hôpital Lariboisière & Fernand-Widal

Paris, France

ACTIVE NOT RECRUITING

Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

RECRUITING

Isala Zwolle

Zwolle, Netherlands, 8025 AB, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Laura Fusco

CONTACT

+ 39 02 241371; laura.fusco@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 18, 2024
• Study Start: March 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); NL (1)