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Studies

Interventional Recruiting

NCT06739811 on ClinicalTrials.gov

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

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

  • Sponsor: Medtronic (Group)
  • Enrollment: 40 (Estimated)
  • Study start: 2025-03-21 (Actual)
  • Primary completion: 2027-09-01 (Estimated)
  • Study completion: 2027-09-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Device: Implantable Insulin Pump System

Primary Outcome Measures

  • Refill accuracy of MIIPS 2020 (6 months)
    Refill Accuracy= (Total Actual Volume Dispensed)/(Total Theoretical Volume Dispensed) after the last refill cycle

Countries

France, Netherlands

Locations and Investigators

  • Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France (Not yet recruiting)
    • Bogdan Catargi
  • Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France (Not yet recruiting)
    • Sylvia Franc
  • CHU Lille - Hôpital Huriez, Lille, France (Active not recruiting)
  • Centre Hospitalier Universitaire De Montpellier, Montpellier, France (Active not recruiting)
  • CHU de Nancy - Hôpital d'Adultes de Brabois, Nancy, France (Not yet recruiting)
  • CHU de Toulouse - Hôpital Rangueil, Toulouse, France (Active not recruiting)
  • CHU Dijon Bourgogne, Dijon, France (Active not recruiting)
  • Hôpital Européen Marseille, Marseille, France (Active not recruiting)
  • Hôpital Lariboisière & Fernand-Widal, Paris, France (Active not recruiting)
  • Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil, Strasbourg, France (Active not recruiting)
  • Isala Zwolle, Zwolle, Netherlands (Recruiting)
    • Peter Ruben van Dijk, Dr.
    • van Dijk, Dr. (Principal Investigator)