RecruitingNot ApplicableNCT06739811

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

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


Sponsor

Medtronic MiniMed, Inc.

Enrollment

40 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a Medtronic implantable insulin pump system in adults with type 1 diabetes whose blood sugar cannot be safely controlled with standard insulin injections or an external pump. An implantable insulin pump is a small device placed under the skin that continuously delivers insulin inside the body. **You may be eligible if...** - You are 18 or older with a confirmed type 1 diabetes diagnosis for at least 6 months - Your blood sugar is poorly controlled — you experience frequent, unexplained dangerous high or low blood sugar episodes — despite using a standard external pump or multiple daily injections - You have reliable access to follow-up care **You may NOT be eligible if...** - You do not have type 1 diabetes - Your blood sugar is reasonably well controlled with standard insulin therapy - You have conditions that make implantable device surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantable Insulin Pump System

Medtronic Implantable Insulin Pump System (MIIPS 2020)


Locations(6)

Centre Hospitalier Universitaire De Montpellier

Montpellier, France, France

CHU Dijon Bourgogne

Dijon, France

Hôpital Européen Marseille

Marseille, France

Hôpital Lariboisière & Fernand-Widal

Paris, France

Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

Isala Zwolle

Zwolle, Netherlands, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06739811


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