Actively Recruiting

Age: 2Years +
All Genders
NCT07317102

Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)

Led by Insulet Corporation · Updated on 2026-05-06

152

Participants Needed

22

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with type 1 diabetes aged 2 years or older
  • Prescribed the Omnipod 5 System with FreeStyle Libre 2 Plus sensor less than a year ago
  • Never used the Omnipod 5 System before joining the study
  • Has not objected to use of personal data for this study
  • Has an email address and mobile phone number
  • Able to understand study information and consent forms
  • Able to understand and complete questionnaires in French
  • Covered by local social security system
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Allergy to materials of the Omnipod 5 System (patch, cannula, CGM)
  • Unable or unwilling to be followed by the same study site for the entire study duration
  • Already participating in another clinical trial that prevents joining this study
  • Adult under guardianship, curatorship, or tutorship
  • Adult deprived of liberty

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

CHU Angers

Angers, France, 49100

Actively Recruiting

2

CHU Besançon - Hôpital de Jean Minjoz

Besançon, France, 25000

Actively Recruiting

3

APHP Hopital Avicenne

Bobigny, France, 93000

Not Yet Recruiting

4

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France, 33000

Actively Recruiting

5

CHU Bordeaux - Hôpital St-André

Bordeaux, France, 33000

Actively Recruiting

6

CHU Brest - Hôpital de la Cavale Blanche

Brest, France, 29200

Actively Recruiting

7

Hôpital Femme Mère Enfant

Bron, France, 39500

Actively Recruiting

8

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100

Actively Recruiting

9

CIRDIA

Dijon, France, 21000

Actively Recruiting

10

CHU Dijon - Hôpital François Mitterrand

Dijon, France

Actively Recruiting

11

GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

La Rochelle, France, 17019

Actively Recruiting

12

APHP Hôpital Bicêtre

Le Kremlin-Bicêtre, France, 94270

Not Yet Recruiting

13

Institut de Diabétologie et de Nutrition du Centre

Mainvilliers, France, 28300

Actively Recruiting

14

Fondation Ambroise Paré - Hôpital Européen de Marseille

Marseille, France

Not Yet Recruiting

15

CHU Montpellier - Hôpital Lapeyronie

Montpellier, France, 34090

Actively Recruiting

16

Institut Saint Pierre

Palavas-les-Flots, France, 34250

Actively Recruiting

17

APHP Hôpital Lariboisière

Paris, France, 75010

Not Yet Recruiting

18

APHP Hopital Robert Debré

Paris, France, 75019

Not Yet Recruiting

19

CH Périgueux

Périgueux, France, 24000

Not Yet Recruiting

20

Clinique Saint Jean de Védas

Saint-Jean-de-Védas, France, 34430

Actively Recruiting

21

CHRU Strasbourg

Strasbourg, France, 67098

Not Yet Recruiting

22

CHU Tours

Tours, France, 37000

Actively Recruiting

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Research Team

T

Trang Ly, MBBS, PhD

CONTACT

B

Bonnie Dumais

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B) | DecenTrialz