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ClinicalTrials.gov ID

NCT07317102

Lead Sponsor

Insulet CorporationINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

152Estimated

Last Update Posted

Aug 3, 2026Actual

Start Date

Mar 16, 2026Actual

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

Official Title

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

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 complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.

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 configuration of the Omnipod 5 Automated Insulin Delivery System in France.

OPTIMAL-B study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.

• Diabetes
• Type 1 Diabetes
• Diabetes Mellitus

• Omnipod 5

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Insulet CorporationINDUSTRY

Audrey.ERNOULD@chu-nantes.fr02 53 48 27 26