Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
304 participants
OBSERVATIONAL
2025-07-23
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Omnipod 5 User
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
Omnipod 5
The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin.
The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.
Interventions
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Omnipod 5
The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin.
The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
2 Years
ALL
No
Sponsors
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Insulet Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Pierre RIVELINE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Universitaire du Diabète et ses complications Hôpital Lariboisière
Locations
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CHU Angers
Angers, , France
CHU Besançon - Hôpital de Jean Minjoz
Besançon, , France
APHP Hopital Avicenne
Bobigny, , France
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, , France
CHU Bordeaux - Hôpital St-André
Bordeaux, , France
CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche
Brest, , France
Hôpital Femme Mère Enfant
Bron, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand
Dijon, , France
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
La Rochelle, , France
APHP Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Diab-eCare
Lyon, , France
Institut de Diabétologie et de Nutrition du Centre
Mainvilliers, , France
Fondation Ambroise Paré - Hôpital Européen de Marseille
Marseille, , France
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, , France
CHU Montpellier - Hôpital Lapeyronie
Montpellier, , France
CHU Orléans
Orléans, , France
APHP Hôpital Lariboisière
Paris, , France
APHP La Pitié Salpêtrière
Paris, , France
Hôpital NECKER
Paris, , France
APHP Hopital Robert Debré
Paris, , France
CH Périgueux
Périgueux, , France
Cabinet Médical Saint-Cyr sur Loire
Saint-Cyr-sur-Loire, , France
CHRU Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Lucie DUFOUR
Role: primary
Julie GUCCIARDI
Role: primary
Sarah YAHIAOUI
Role: primary
Caroline BOUYSSOU
Role: primary
Bogdan CATARGI
Role: primary
Pascale Quiniou
Role: primary
Karima RENDJA
Role: primary
Catherine PETIT
Role: primary
Isabelle SIMONEAU
Role: primary
Harivola ANDRIANTAOLO
Role: primary
Marie Agathe TROUVIN0
Role: primary
Sofia SEBAOUI
Role: primary
Eva BRIAND
Role: primary
Audrey OLIVETTI
Role: primary
Mérédith MERCIER
Role: primary
Manal AL MASRI-SHBAT
Role: primary
Sophie MIRAN
Role: primary
Charline POTIER
Role: primary
Marine Halbron
Role: primary
Jacques BELTRAND
Role: primary
Caroline ARNAUD-SARTHOU
Role: primary
Aude ANGELESCU
Role: primary
Magali LECOUTRE
Role: primary
Samir CHENAF
Role: primary
Other Identifiers
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OPTIMAL-A
Identifier Type: -
Identifier Source: org_study_id
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