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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
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

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Angers
Coordinator of this site? Confirm its status
AngersFranceRecruiting
CHU Besançon - Hôpital de Jean Minjoz
Coordinator of this site? Confirm its status
BesançonFranceRecruiting
APHP - Hôpital Avicenne
Coordinator of this site? Confirm its status
BobignyFranceRecruiting
CHU Bordeaux Hôpital St. André
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
CHU Bordeaux - Hopital Pellegrin
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
CHU Brest Hôpital de la Cavale Blanche
Coordinator of this site? Confirm its status
BrestFranceRecruiting
Hôpital Femme Mère Enfant
Coordinator of this site? Confirm its status
BronFranceRecruiting
Centre Hospitalier Sud Francilien
Coordinator of this site? Confirm its status
Corbeil-EssonnesFranceRecruiting
CIRDIA
Coordinator of this site? Confirm its status
DijonFranceRecruiting
CHU Dijon Hôpital François Mitterrand
Coordinator of this site? Confirm its status
DijonFranceRecruiting
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
Coordinator of this site? Confirm its status
La RochelleFranceRecruiting
APHP Hôpital Bicêtre
Coordinator of this site? Confirm its status
Le Kremlin-BicêtreFranceNot yet recruiting
Institut de Diabétologie et de Nutrition du Centre
Coordinator of this site? Confirm its status
MainvilliersFranceRecruiting
Fondation Ambroise Paré - Hôpital Européen de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
CHU Montpellier - Hôpital Lapeyronie
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
CHU Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Institut Saint Pierre
Coordinator of this site? Confirm its status
Palavas-les-FlotsFranceRecruiting
APHP Hôpital Robert Debré
Coordinator of this site? Confirm its status
ParisFranceRecruiting
APHP - Hôpital Saint Antoine
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Aphp-Hopital Lariboisiere
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CH Périgueux
Coordinator of this site? Confirm its status
PérigueuxFranceRecruiting
Clinique Saint Jean de Védas
Coordinator of this site? Confirm its status
Saint-Jean-de-VédasFranceRecruiting
CHRU Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
CHU Tours
Coordinator of this site? Confirm its status
ToursFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.