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Clinical Trials in France / NCT07039942
Active, not recruiting Observational

French Prospective Multicentric Study in Real World

NCT07039942 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-07-23
Last updated
2026-08-03

Condition(s) studied

DiabetesDiabetes MellitusType 1 Diabetes

Investigational drug(s) / intervention(s)

Omnipod 5

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.

Study 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

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient with T1D aged ≥ 2 years. * Patient prescribed a commercially available configuration of the Omnipod 5 System using a Dexcom sensor (Dexcom G6 or Dexcom G7). * Patient has never used the Omnipod 5 System prior to inclusion. * Patient has not objected to the use of their personal data for this study. * Patient or legal guardian has an email address and mobile phone number. * Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form. * Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French. * Patient is covered by the local social security system. Exclusion Criteria: * Patient is currently pregnant * Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM). * Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional. * Patient is already participating in a clinical trial or in another study precluding their participation in other studies. * Patient or legal guardian (for minors) is not able to understand and complete electronic questionnaires. * Adult under guardianship, curatorship or tutorship. * Adult otherwise deprived of liberty.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
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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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07039942 on ClinicalTrials.gov ↗ ← All trials in France