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NOT YET RECRUITING
NCT07317102

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

Sponsor: Insulet Corporation

View on ClinicalTrials.gov

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

Interventions

DEVICE

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