Taking people in FranceNo phase
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.
Key facts
- Who runs it
- Insulet Corporation
- 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
- Trial code
- Registry title
- Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
- Status
- Recruiting
- People taking part
- 152 people, planned
- Started
- 16 Mar 2026
- Expected to end
- Nov 2027
- Type of study
- Observational
- Treatments tested
- Omnipod 5
- Record updated
- 3 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with type 1 diabetes, aged 2 years or older, who were recently prescribed the Omnipod 5 System with a FreeStyle Libre 2 Plus sensor and have never used it.
- Age
- 2 years and older
- Sex
- All sexes can join.
- Disease stage
- Type 1 diabetes (T1D).
- Earlier treatment
- Prescribed the Omnipod 5 System less than a year ago, with a FreeStyle Libre 2 Plus sensor. Has never used the Omnipod 5 System before joining.
Main reasons for not taking part
- Currently pregnant
- Allergy to the materials of the Omnipod 5 System (patch, cannula, CGM)
- Cannot be followed by the same study site for the whole study, or cannot keep contact with the healthcare professional
- Already taking part in a clinical trial or another study that rules out other studies
- Adult under guardianship, curatorship or tutorship, or otherwise deprived of liberty
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- CHU AngersAngers, FranceContact: Lucie DUFOURTaking people
- CHU Besançon - Hôpital de Jean MinjozBesançon, FranceContact: Julie GUCCIARDITaking people
- APHP - Hôpital AvicenneBobigny, FranceContact: Sarah YAHIAOUITaking people
- CHU Bordeaux - Hopital PellegrinBordeaux, FranceContact: Caroline BOUYSSOUTaking people
- CHU Bordeaux Hôpital St. AndréBordeaux, FranceContact: Bogdan CATARGITaking people
- CHU Brest Hôpital de la Cavale BlancheBrest, FranceContact: Pascale QuiniouTaking people
- Hôpital Femme Mère EnfantBron, FranceContact: Karima RENDJATaking people
- Centre Hospitalier Sud FrancilienCorbeil-Essonnes, FranceContact: Catherine PETITTaking people
- CHU Dijon Hôpital François MitterrandDijon, FranceContact: Isabelle SIMONEAUTaking people
- CIRDIADijon, FranceContact: Sylvie PICARDTaking people
- GH La Rochelle-Ré-Aunis - Hôpital Saint LouisLa Rochelle, FranceContact: Harivola ANDRIANTAOLOTaking people
- APHP Hôpital BicêtreLe Kremlin-Bicêtre, FranceContact: Christelle AudrainNot yet recruiting
- Institut de Diabétologie et de Nutrition du CentreMainvilliers, FranceContact: Eva BRIANDTaking people
- Fondation Ambroise Paré - Hôpital Européen de MarseilleMarseille, FranceContact: Audrey OLIVETTITaking people
- CHU Montpellier - Hôpital LapeyronieMontpellier, FranceContact: Manal AL MASRI-SHBATTaking people
- CHU NantesNantes, FranceContact: Audrey ERNOULDTaking people
- Institut Saint PierrePalavas-les-Flots, FranceContact: Chrystel LEPERCHOISTaking people
- APHP - Hôpital Saint AntoineParis, FranceContact: Yasmina SAIDITaking people
- APHP Hôpital Robert DebréParis, FranceContact: Caroline ARNAUD-SARTHOUTaking people
- Aphp-Hopital LariboisiereParis, FranceContact: Charline POTIERTaking people
- CH PérigueuxPérigueux, FranceContact: Aude ANGELESCUTaking people
- Clinique Saint Jean de VédasSaint-Jean-de-Védas, FranceContact: Mérédith MERCIERTaking people
- CHRU StrasbourgStrasbourg, FranceContact: Samir CHENAFTaking people
- CHU ToursTours, FranceContact: Sophie GOUNINTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Omnipod 5 User
Participation of each patient begins at inclusion and continues until the end-of-study visit, 12 months (± 1 month) following first initiation of automated mode of the Omnipod 5 System
Treatment: Omnipod 5
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
- Plain-language title
- Studies the Omnipod 5 insulin device in people with type 1 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 August 2026