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

March 20, 2026 updated by: Medtronic Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a premarket, interventional, prospective, open-label, multi-center study. It consists of a run-in period, a study period, and a continued access period.

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21100
      • Marseille, France, 13003
      • Paris, France
        • Active, not recruiting
        • Hopital Lariboisiere & Fernand-Widal
      • Strasbourg, France
    • France
      • Montpellier, France, France, 34295
        • Recruiting
        • Centre Hospitalier Universitaire de Montpellier
        • Contact:
  • Netherlands
    • Netherlands
      • Zwolle, Netherlands, Netherlands, 8025 AB
        • Recruiting
        • Isala Zwolle
        • Contact:
        • Principal Investigator:
          • van Dijk, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIIPS 2020
Subjects implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
Device: Implantable Insulin Pump System
Medtronic Implantable Insulin Pump System (MIIPS 2020)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery accuracy of MIIPS 2020
Time Frame: 6 months (4 refill cycles)
Refill Accuracy= (Total Actual Volume Dispensed)/(Total Theoretical Volume Dispensed)
6 months (4 refill cycles)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refill accuracy at each refill visit
Time Frame: 6 months (4 refill cycles)
The average of refill accuracy will be summarized at each refill visit
6 months (4 refill cycles)
Percentage of pump with accuracy ratio ≤ 85% prompting NaOH rinse
Time Frame: 6 months (4 refill cycles)
The percentage of pump with refill accuracy ≤ 85%, which prompts NaOH rinse, will be calculated
6 months (4 refill cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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