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Thousands to track omnipod 5 in daily life: will the smart pump deliver on its promise?

NCT ID NCT06144554

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study will follow 2,200 children and adults with type 1 diabetes who are using the Omnipod 5 system, a tubeless insulin pump that automatically adjusts insulin based on continuous glucose monitor readings. Over 12 months, researchers will track how often severe low or high blood sugar events occur and measure changes in A1C and time-in-range. The goal is to see how well the system works in real-world conditions outside of a clinic.

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 System (automated insulin delivery device)
What this could lead to
If successful, this study will confirm that the Omnipod 5 system is safe and effective in everyday life, potentially improving blood sugar control and reducing dangerous highs and lows for people with type 1 diabetes.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by participant behavior or selection bias. It does not test a new treatment, only gathers real-world data on an already-approved device.

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 2,200 people

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

Started

Sep 2023

Expected to finish

Sep 2028

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

All new users for the Omnipod 5 System will be required to register with Insulet's Podder Central. Users already in Podder Central will be required to log into their account before logging into the Omnipod 5 Controller if transitioning to the Omnipod 5 System. A minimum of 2,200 Type 1 participants will be recruited.

Ages

2 years and older

Sex

Anyone

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: 1. Self-reported type 1 diabetes 2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks 3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog 4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States 5. Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months 6. Willing and able to complete registry assessments every two weeks 7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal) 8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control 9. Access to internet via phone, tablet and/or computer to use the registry online platform 10. Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided) 11. Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable Exclusion Criteria: 1. Diagnosed with sickle cell anemia and/or hemoglobinopathy 2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5 3. Adults that are unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

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

    1 site. 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: •••••@•••••

Locations

  • Circuit Clinical

    RECRUITING

    Buffalo, New York, 14203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.