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New insulin system aims to simplify diabetes management

NCT ID NCT07317102

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well the Omnipod 5 Automated Insulin Delivery System works in real-world settings for people with type 1 diabetes. About 152 participants aged 2 and older will use the system for the first time. The goal is to see if it helps keep blood sugar levels in a healthy range and improves quality of life.

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 152 people

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

Started

Mar 2026

Expected to finish

Nov 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 FreeStyle Libre 2Plus 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, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor. * 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. * 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • APHP Hopital Avicenne

    RECRUITING

    Bobigny, 93000, France

  • APHP Hopital Robert Debré

    RECRUITING

    Paris, 75019, France

  • APHP Hôpital Bicêtre

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • APHP Hôpital Lariboisière

    RECRUITING

    Paris, 75010, France

  • APHP Hôpital Saint-Antoine

    RECRUITING

    Paris, France

  • CH Périgueux

    RECRUITING

    Périgueux, 24000, France

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, 67098, France

  • CHU Angers

    RECRUITING

    Angers, 49100, France

  • CHU Besançon - Hôpital de Jean Minjoz

    RECRUITING

    Besançon, 25000, France

  • CHU Bordeaux - Hôpital Pellegrin

    RECRUITING

    Bordeaux, 33000, France

  • CHU Bordeaux - Hôpital St-André

    RECRUITING

    Bordeaux, 33000, France

  • CHU Brest - Hôpital de la Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • CHU Dijon - Hôpital François Mitterrand

    RECRUITING

    Dijon, France

  • CHU Montpellier - Hôpital Lapeyronie

    RECRUITING

    Montpellier, 34090, France

  • CHU Nantes

    RECRUITING

    Nantes, France

  • CHU Tours

    RECRUITING

    Tours, 37000, France

  • CIRDIA

    RECRUITING

    Dijon, 21000, France

  • Centre Hospitalier Sud Francilien

    RECRUITING

    Corbeil-Essonnes, 91100, France

  • Clinique Saint Jean de Védas

    RECRUITING

    Saint-Jean-de-Védas, 34430, France

  • Fondation Ambroise Paré - Hôpital Européen de Marseille

    RECRUITING

    Marseille, France

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

    RECRUITING

    La Rochelle, 17019, France

  • Hôpital Femme Mère Enfant

    RECRUITING

    Bron, 39500, France

  • Institut Saint Pierre

    RECRUITING

    Palavas-les-Flots, 34250, France

  • Institut de Diabétologie et de Nutrition du Centre

    RECRUITING

    Mainvilliers, 28300, France

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