Status:

RECRUITING

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

Lead Sponsor:

Insulet Corporation

Conditions:

Diabetes

Type 1 Diabetes

Eligibility:

All Genders

2+ years

Brief Summary

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 complicati...

Detailed Description

Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed the commercially available FreeStyle Libre 2 Plus configurati...

Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient is currently pregnant.
  • Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
  • 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.

Key Trial Info

Start Date :

March 16 2026

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2027

Estimated Enrollment :

152 Patients enrolled

Trial Details

Trial ID

NCT07317102

Start Date

March 16 2026

End Date

November 1 2027

Last Update

April 13 2026

Active Locations (22)

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Page 1 of 6 (22 locations)

1

CHU Angers

Angers, France, 49100

2

CHU Besançon - Hôpital de Jean Minjoz

Besançon, France, 25000

3

APHP Hopital Avicenne

Bobigny, France, 93000

4

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France, 33000