RecruitingNCT07039942

French Prospective Multicentric Study in Real World

Omnipod 5 - A French Prospective Multicentric Study in Real World

Sponsor

Insulet Corporation

Enrollment

304 participants

Start Date

Jul 23, 2025

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus Diabetes Type 1 Diabetes

Summary

The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.

Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This French study tracks how well the Omnipod 5 automated insulin delivery system works in real-world conditions for people with Type 1 diabetes, including children and adults who are new to this device. **You may be eligible if...** - You have Type 1 diabetes and are 2 years old or older - You have been newly prescribed the Omnipod 5 system with a Dexcom G6 or G7 glucose sensor - You have never used the Omnipod 5 system before - You (or your guardian) have an email address and smartphone, and have not objected to data use **You may NOT be eligible if...** - You have previously used the Omnipod 5 system - You do not have access to a smartphone or email - You have Type 2 diabetes or another form of diabetes 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

DEVICEOmnipod 5

The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin. The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.

Locations(24)

CHU Angers

Angers, France

CHU Besançon - Hôpital de Jean Minjoz

Besançon, France

APHP Hopital Avicenne

Bobigny, France

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France

CHU Bordeaux - Hôpital St-André

Bordeaux, France

CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche

Brest, France

Hôpital Femme Mère Enfant

Bron, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand

Dijon, France

GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

La Rochelle, France

APHP Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Diab-eCare

Lyon, France

Institut de Diabétologie et de Nutrition du Centre

Mainvilliers, France

Fondation Ambroise Paré - Hôpital Européen de Marseille

Marseille, France

CHU Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France

CHU Montpellier - Hôpital Lapeyronie

Montpellier, France

CHU Orléans

Orléans, France

APHP Hôpital Lariboisière

Paris, France

APHP La Pitié Salpêtrière

Paris, France

Hôpital NECKER

Paris, France

APHP Hopital Robert Debré

Paris, France

CH Périgueux

Périgueux, France

Cabinet Médical Saint-Cyr sur Loire

Saint-Cyr-sur-Loire, France

CHRU Strasbourg

Strasbourg, France

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NCT07039942

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French Prospective Multicentric Study in Real World

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(24)

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