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Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Sponsor: Insulet Corporation
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.
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
OBSERVATIONAL
Enrollment
152
Start Date
2026-02
Completion Date
2027-11
Last Updated
2026-01-05
Healthy Volunteers
No
Conditions
Interventions
Omnipod 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