Fact CheckerSign in

NCT07039942Active, not recruiting

French Prospective Multicentric Study in Real World

Omnipod 5 - A French Prospective Multicentric Study in Real World

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)
Active, not recruiting
Study type
Observational
Enrollment
304 (estimated)
First submitted
18 Jun 2025
Start date
23 Jul 2025
Primary completion date
30 Jul 2027
Lead sponsor
Insulet Corporation
NCT number
NCT07039942

What you commit to

  • Study type: Observational
  • Planned participants: 304
  • From 23 Jul 2025 to the primary completion date, 30 Jul 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.
  • 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.

Who the study is looking for

  • 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.

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
AngersFranceUnknown status
CHU Besançon - Hôpital de Jean Minjoz
Coordinator of this site? Confirm its status
BesançonFranceUnknown status
APHP - Hôpital Avicenne
Coordinator of this site? Confirm its status
BobignyFranceUnknown status
CHU Bordeaux Hôpital St. André
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
CHU Bordeaux - Hopital Pellegrin
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche
Coordinator of this site? Confirm its status
BrestFranceUnknown status
Hôpital Femme Mère Enfant
Coordinator of this site? Confirm its status
BronFranceUnknown status
Centre Hospitalier Sud Francilien
Coordinator of this site? Confirm its status
Corbeil-EssonnesFranceUnknown status
CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand
Coordinator of this site? Confirm its status
DijonFranceUnknown status
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
Coordinator of this site? Confirm its status
La RochelleFranceUnknown status
APHP Hôpital Bicêtre
Coordinator of this site? Confirm its status
Le Kremlin-BicêtreFranceUnknown status
Diab-eCare
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Institut de Diabétologie et de Nutrition du Centre
Coordinator of this site? Confirm its status
MainvilliersFranceUnknown status
Fondation Ambroise Paré - Hôpital Européen de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
CHU Montpellier - Hôpital Lapeyronie
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Chu Montpellier Hopital Arnaud de Villeneuve
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
CHU Orléans
Coordinator of this site? Confirm its status
OrléansFranceUnknown status
APHP Hôpital Robert Debré
Coordinator of this site? Confirm its status
ParisFranceUnknown status
APHP La Pitié Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Aphp-Hopital Lariboisiere
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital Necker
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CH Périgueux
Coordinator of this site? Confirm its status
PérigueuxFranceUnknown status
Cabinet Médical Saint-Cyr sur Loire
Coordinator of this site? Confirm its status
Saint-Cyr-sur-LoireFranceUnknown status
CHRU Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status

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