RecruitingNCT07317102

Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)


Sponsor

Insulet Corporation

Enrollment

152 participants

Start Date

Mar 16, 2026

Study Type

OBSERVATIONAL

Conditions

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 clinical trial is studying a medical device called Omnipod 5 for people with diabetes, diabetes mellitus, and other related conditions. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 2 Years and older.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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(22)

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 Brest - Hôpital de la Cavale Blanche

Brest, France

Hôpital Femme Mère Enfant

Bron, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

CIRDIA

Dijon, France

CHU Dijon - Hôpital François Mitterrand

Dijon, France

GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

La Rochelle, France

APHP Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Institut de Diabétologie et de Nutrition du Centre

Mainvilliers, France

Fondation Ambroise Paré - Hôpital Européen de Marseille

Marseille, France

CHU Montpellier - Hôpital Lapeyronie

Montpellier, France

Institut Saint Pierre

Palavas-les-Flots, France

APHP Hôpital Lariboisière

Paris, France

APHP Hopital Robert Debré

Paris, France

CH Périgueux

Périgueux, France

Clinique Saint Jean de Védas

Saint-Jean-de-Védas, France

CHRU Strasbourg

Strasbourg, France

CHU Tours

Tours, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07317102


Related Trials