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New study puts omnipod 5 to the test in Real-World diabetes management

NCT ID NCT07039942

Disease control Sponsor: Insulet Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study is testing the Omnipod 5, a tubeless insulin pump that automatically adjusts insulin delivery, in real-world settings for people with type 1 diabetes. About 304 participants aged 2 and older will use the system for the first time. Researchers will track blood sugar control, quality of life, and satisfaction over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omnipod 5 Automated Insulin Delivery System (a tubeless insulin pump)
What this could lead to
If successful, this could show that the Omnipod 5 system helps people with type 1 diabetes manage their blood sugar more easily in daily life.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. The device is already approved, so this study focuses on real-world use, not a breakthrough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes Diabetes mellitus Type 1 diabetes

Contacts and locations

Locations

  • APHP Hopital Avicenne

    Bobigny, 93000, France

  • APHP Hopital Robert Debré

    Paris, 75019, France

  • APHP Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • APHP Hôpital Lariboisière

    Paris, 75010, France

  • APHP La Pitié Salpêtrière

    Paris, 75013, France

  • CH Périgueux

    Périgueux, 24000, France

  • CHRU Strasbourg

    Strasbourg, 67200, France

  • CHU Angers

    Angers, 49100, France

  • CHU Besançon - Hôpital de Jean Minjoz

    Besançon, 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

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

    Dijon, France

  • CHU Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34090, France

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34090, France

  • CHU Orléans

    Orléans, 45100, France

  • Cabinet Médical Saint-Cyr sur Loire

    Saint-Cyr-sur-Loire, 37540, France

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100, France

  • Diab-eCare

    Lyon, 69008, France

  • Fondation Ambroise Paré - Hôpital Européen de Marseille

    Marseille, France

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

    La Rochelle, 17019, France

  • Hôpital Femme Mère Enfant

    Bron, 39500, France

  • Hôpital NECKER

    Paris, 75015, France

  • Institut de Diabétologie et de Nutrition du Centre

    Mainvilliers, 28300, France

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