French Prospective Multicentric Study in Real World

Last updated: April 8, 2026
Sponsor: Insulet Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Macular Edema

Diabetic Retinopathy

Diabetes Prevention

Treatment

Omnipod 5

Clinical Study ID

NCT07039942
OPTIMAL-A
  • Ages > 2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with T1D aged ≥ 2 years.

  • Patient prescribed a commercially available configuration of the Omnipod 5 Systemusing 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 studyinformation and Non-Opposition form.

  • Patient (and legal guardians if the patient is a minor) is able to understand andcomplete questionnaires in French.

  • Patient is covered by the local social security system.

Exclusion

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 ofthe study or is unwilling or unable to maintain contact with the healthcareprofessional.

  • Patient is already participating in a clinical trial or in another study precludingtheir participation in other studies.

  • Patient or legal guardian (for minors) is not able to understand and completeelectronic questionnaires.

  • Adult under guardianship, curatorship or tutorship.

  • Adult otherwise deprived of liberty.

Study Design

Total Participants: 304
Treatment Group(s): 1
Primary Treatment: Omnipod 5
Phase:
Study Start date:
July 23, 2025
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

  • CHU Angers

    Angers, 49100
    France

    Active - Recruiting

  • CHU Angers

    Angers 3037656, 49100
    France

    Site Not Available

  • CHU Besançon - Hôpital de Jean Minjoz

    Besançon,
    France

    Active - Recruiting

  • CHU Besançon - Hôpital de Jean Minjoz

    Besançon 3033123,
    France

    Site Not Available

  • APHP Hopital Avicenne

    Bobigny, 93000
    France

    Active - Recruiting

  • APHP Hopital Avicenne

    Bobigny 3032179, 93000
    France

    Site Not Available

  • CHU Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000
    France

    Active - Recruiting

  • CHU Bordeaux - Hôpital St-André

    Bordeaux, 33000
    France

    Site Not Available

  • CHU Bordeaux - Hôpital Pellegrin

    Bordeaux 3031582, 33000
    France

    Site Not Available

  • CHU Bordeaux - Hôpital St-André

    Bordeaux 3031582, 33000
    France

    Site Not Available

  • CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche

    Brest, 29200
    France

    Active - Recruiting

  • CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche

    Brest 3030300, 29200
    France

    Site Not Available

  • Hôpital Femme Mère Enfant

    Bron, 39500
    France

    Active - Recruiting

  • Hôpital Femme Mère Enfant

    Bron 3029931, 39500
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Active - Recruiting

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes 3023763, 91100
    France

    Site Not Available

  • CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand

    Dijon,
    France

    Active - Recruiting

  • CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand

    Dijon 3021372,
    France

    Site Not Available

  • GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

    La Rochelle, 17019
    France

    Active - Recruiting

  • GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

    La Rochelle 3006787, 17019
    France

    Site Not Available

  • APHP Hôpital Bicêtre

    Le Kremlin Bicêtre, 94270
    France

    Site Not Available

  • APHP Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • APHP Hôpital Bicêtre

    Le Kremlin-Bicêtre 3003737, 94270
    France

    Site Not Available

  • Diab-eCare

    Lyon, 69008
    France

    Active - Recruiting

  • Diab-eCare

    Lyon 2996944, 69008
    France

    Site Not Available

  • Institut de Diabétologie et de Nutrition du Centre

    Mainvilliers, 28300
    France

    Active - Recruiting

  • Institut de Diabétologie et de Nutrition du Centre

    Mainvilliers 2996645, 28300
    France

    Site Not Available

  • Fondation Ambroise Paré - Hôpital Européen de Marseille

    Marseille,
    France

    Active - Recruiting

  • Fondation Ambroise Paré - Hôpital Européen de Marseille

    Marseille 2995469,
    France

    Site Not Available

  • CHU Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34090
    France

    Active - Recruiting

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34090
    France

    Active - Recruiting

  • CHU Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier 2992166, 34090
    France

    Site Not Available

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier 2992166, 34090
    France

    Active - Recruiting

  • CHU Orléans

    Orléans, 45100
    France

    Active - Recruiting

  • CHU Orléans

    Orléans 2989317, 45100
    France

    Site Not Available

  • APHP Hopital Robert Debré

    Paris, 75019
    France

    Active - Recruiting

  • APHP Hôpital Lariboisière

    Paris, 75010
    France

    Active - Recruiting

  • APHP La Pitié Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • Hôpital NECKER

    Paris, 75015
    France

    Site Not Available

  • APHP Hopital Robert Debré

    Paris 2988507, 75019
    France

    Active - Recruiting

  • APHP Hôpital Lariboisière

    Paris 2988507, 75010
    France

    Site Not Available

  • APHP La Pitié Salpêtrière

    Paris 2988507, 75013
    France

    Active - Recruiting

  • Hôpital NECKER

    Paris 2988507, 75015
    France

    Site Not Available

  • CH Périgueux

    Périgueux, 24000
    France

    Active - Recruiting

  • CH Périgueux

    Périgueux 2987967, 24000
    France

    Site Not Available

  • Cabinet Médical Saint-Cyr sur Loire

    Saint-Cyr-sur-Loire, 37540
    France

    Active - Recruiting

  • Cabinet Médical Saint-Cyr sur Loire

    Saint-Cyr-sur-Loire 2980935, 37540
    France

    Site Not Available

  • CHRU Strasbourg

    Strasbourg, 67200
    France

    Active - Recruiting

  • CHRU Strasbourg

    Strasbourg 2973783, 67200
    France

    Site Not Available

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