Studies the Omnipod 5 insulin device in people with type 1 diabetes
Observes how an automated insulin delivery device works for people with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Key facts
- Where
- Angers, Besançon, Bobigny, Bordeaux, Brest, Bron, Corbeil-Essonnes, Dijon, La Rochelle, Le Kremlin-Bicêtre, Mainvilliers, Marseille, Montpellier, Nantes, Palavas-les-Flots, Paris, Périgueux, Saint-Jean-de-Védas, Strasbourg, and Tours, FranceSee the 24 sites
Where in France
- CHU AngersAngers, FranceTaking people
- CHU Besançon - Hôpital de Jean MinjozBesançon, FranceTaking people
- APHP - Hôpital AvicenneBobigny, FranceTaking people
- CHU Bordeaux - Hopital PellegrinBordeaux, FranceTaking people
- CHU Bordeaux Hôpital St. AndréBordeaux, FranceTaking people
- CHU Brest Hôpital de la Cavale BlancheBrest, FranceTaking people
- Hôpital Femme Mère EnfantBron, FranceTaking people
- Centre Hospitalier Sud FrancilienCorbeil-Essonnes, FranceTaking people
- CHU Dijon Hôpital François MitterrandDijon, FranceTaking people
- CIRDIADijon, FranceTaking people
- GH La Rochelle-Ré-Aunis - Hôpital Saint LouisLa Rochelle, FranceTaking people
- APHP Hôpital BicêtreLe Kremlin-Bicêtre, FranceNot yet recruiting
- Institut de Diabétologie et de Nutrition du CentreMainvilliers, FranceTaking people
- Fondation Ambroise Paré - Hôpital Européen de MarseilleMarseille, FranceTaking people
- CHU Montpellier - Hôpital LapeyronieMontpellier, FranceTaking people
- CHU NantesNantes, FranceTaking people
- Institut Saint PierrePalavas-les-Flots, FranceTaking people
- APHP - Hôpital Saint AntoineParis, FranceTaking people
- APHP Hôpital Robert DebréParis, FranceTaking people
- Aphp-Hopital LariboisiereParis, FranceTaking people
- CH PérigueuxPérigueux, FranceTaking people
- Clinique Saint Jean de VédasSaint-Jean-de-Védas, FranceTaking people
- CHRU StrasbourgStrasbourg, FranceTaking people
- CHU ToursTours, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insulet Corporation
- Trial code
- NCT07317102
- Record updated
- 3 August 2026
- Original description
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.Read full original descriptionShow less
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
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.
Inclusion: Patient with T1D aged ≥ 2 years; Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor; 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: Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM); Patient is currently pregnant; 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; Adult under guardianship, curatorship or tutorship; Adult otherwise deprived of liberty.