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Real-World test of automated insulin system aims to improve blood sugar control for type 1 diabetes

NCT ID NCT07696039

Disease control Sponsor: Papa Giovanni XXIII Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tracks 300 adults with type 1 diabetes who use the Omnipod 5, an automated insulin delivery system, as part of their routine care. Researchers will compare blood sugar control—measured by time in target range and HbA1c levels—before starting the system and at 6, 12, and 18 months after. The goal is to see if the device improves glucose management in real-world conditions outside of a controlled research setting.

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
What this could lead to
If successful, this study could confirm that the Omnipod 5 system helps adults with type 1 diabetes maintain better blood sugar control in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors other than the device. The findings depend on data from a single center and may not apply to all patients.

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

300 people

The number who actually took part.

Started

Jan 2026

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Adult individuals with type 1 diabetes treated at the Diabetes Unit of ASST Papa Giovanni XXIII Hospital who initiated Omnipod® 5 as part of routine clinical care.

Ages

18 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: * Adults aged ≥18 years * Diagnosis of type 1 diabetes * Initiation of Omnipod® 5 during routine clinical care * Availability of baseline CGM data * Availability of at least six-month follow-up CGM data Exclusion Criteria * Missing baseline CGM data * Missing follow-up CGM data * Discontinuation of Omnipod® 5 before outcome assessment * Other conditions judged by investigators to preclude reliable evaluation

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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 mellitus

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, Italy, 20126, Italy

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