French Prospective Multicentric Study in Real World
OPTIMAL-A
Omnipod 5 - A French Prospective Multicentric Study in Real World
1 other identifier
observational
304
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
June 26, 2025
CompletedStudy Start
First participant enrolled
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 4, 2026
December 1, 2025
1.8 years
June 18, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the percentage of time in the 70 - 180 mg/dL range (TIR)
Assess the effectiveness of the Omnipod 5 system in terms of glycemic control
12 months following first initiation of automated mode
Secondary Outcomes (37)
Percentage of time in the 70 - 180 mg/dL range (TIR)
Up to 12-months following first initiation of automated mode
Percentage of time in the 70 - 140 mg/dL range (TIR Tight)
Up to 12-months following first initiation of automated mode
Percentage of time below 54 mg/dL (TBR Very Low)
Up to 12-months following first initiation of automated mode
Percentage of time below 70 mg/dL (TBR Low)
Up to 12-months following first initiation of automated mode
Percentage of time above 180 mg/dL (TAR High)
Up to 12-months following first initiation of automated mode
- +32 more secondary outcomes
Study Arms (1)
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
Interventions
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
The study population contains patients (age ≥ 2 years) with T1DM initiating a commercially available configuration of the Omnipod 5 System using a Dexcom sensor (Dexcom G6 or Dexcom G7) in France.
You may qualify if:
- 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 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
CHU Angers
Angers, 49100, France
CHU Besançon - Hôpital de Jean Minjoz
Besançon, France
APHP Hopital Avicenne
Bobigny, 93000, France
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, 33000, France
CHU Bordeaux - Hôpital St-André
Bordeaux, 33000, France
CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche
Brest, 29200, France
Hôpital Femme Mère Enfant
Bron, 39500, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100, France
CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand
Dijon, France
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
La Rochelle, 17019, France
APHP Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Diab-eCare
Lyon, 69008, France
Institut de Diabétologie et de Nutrition du Centre
Mainvilliers, 28300, France
Fondation Ambroise Paré - Hôpital Européen de Marseille
Marseille, France
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34090, France
CHU Montpellier - Hôpital Lapeyronie
Montpellier, 34090, France
CHU Orléans
Orléans, 45100, France
APHP Hôpital Lariboisière
Paris, 75010, France
APHP La Pitié Salpêtrière
Paris, 75013, France
Hôpital NECKER
Paris, 75015, France
APHP Hopital Robert Debré
Paris, 75019, France
CH Périgueux
Périgueux, 24000, France
Cabinet Médical Saint-Cyr sur Loire
Saint-Cyr-sur-Loire, 37540, France
CHRU Strasbourg
Strasbourg, 67200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Pierre RIVELINE, MD, PhD
Centre Universitaire du Diabète et ses complications Hôpital Lariboisière
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2025
First Posted
June 26, 2025
Study Start
July 23, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 4, 2026
Record last verified: 2025-12