French Prospective Multicentric Study in Real World (OPTIMAL-A)

Insulet

Status: Begins enrollment this month

Conditions: Diabetes; Type 1 Diabetes; Diabetes Mellitus

Treatments: Device: Omnipod 5

Study type: Observational

Funder types: Industry

Identifiers

NCT07039942

OPTIMAL-A

Details and patient eligibility

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.

Full description

Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed one of the Dexcom (Dexcom G6 or G7) configurations commercially available of the Omnipod 5 Automated Insulin Delivery System in France.

OPTIMAL-A 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.

Enrollment: 304 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.
• 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.

Trial design

304 participants in 1 patient group

Omnipod 5 User

Description:

Participation of each patient begins at inclusion and continues until the end-of-study visit, 12 months (± 1 month) following first initiation of automated mode of the Omnipod 5 System

Treatment:

Device: Omnipod 5