NCT07317102Recruiting
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 152 (estimated)
- First submitted
- 18 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Insulet Corporation
- Diseases
- Type 1 diabetes
- NCT number
- NCT07317102
What you commit to
- Study type: Observational
- Planned participants: 152
- From Mar 2026 to the primary completion date, Nov 2027
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| CHU Besançon - Hôpital de Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| APHP - Hôpital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Recruiting |
| CHU Bordeaux Hôpital St. André Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Bordeaux - Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Brest Hôpital de la Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Hôpital Femme Mère Enfant Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre Hospitalier Sud Francilien Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Recruiting |
| CIRDIA Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| CHU Dijon Hôpital François Mitterrand Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| GH La Rochelle-Ré-Aunis - Hôpital Saint Louis Coordinator of this site? Confirm its status | La Rochelle | France | Recruiting |
| APHP Hôpital Bicêtre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Not yet recruiting |
| Institut de Diabétologie et de Nutrition du Centre Coordinator of this site? Confirm its status | Mainvilliers | France | Recruiting |
| Fondation Ambroise Paré - Hôpital Européen de Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU Montpellier - Hôpital Lapeyronie Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut Saint Pierre Coordinator of this site? Confirm its status | Palavas-les-Flots | France | Recruiting |
| APHP Hôpital Robert Debré Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| APHP - Hôpital Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Aphp-Hopital Lariboisiere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CH Périgueux Coordinator of this site? Confirm its status | Périgueux | France | Recruiting |
| Clinique Saint Jean de Védas Coordinator of this site? Confirm its status | Saint-Jean-de-Védas | France | Recruiting |
| CHRU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| CHU Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.