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Teens with diabetes test smart insulin pumps against surprise breakfasts

NCT ID NCT07455643

Knowledge-focused Sponsor: University of Catania 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested two automated insulin delivery systems (Medtronic 780G and Tandem t:slim X2) in 20 adolescents with type 1 diabetes. Participants ate breakfasts without telling the device how many carbs they were eating. The goal was to see how well each system controlled blood sugar after these unannounced meals. Results will help improve future closed-loop algorithms to reduce the need for manual insulin dosing.

What this could mean

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

Active substance
Automated insulin delivery systems (Medtronic 780G and Tandem t:slim X2 with Control-IQ)
What this could lead to
If successful, this study could help refine closed-loop algorithms to better manage unannounced meals, reducing the burden on teens with type 1 diabetes.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply to everyone. The findings are preliminary and need confirmation in larger trials.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Apr 2025

Finished

May 2025

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.

Ages

11 to 18 years

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: * Age between 11 and 18 years; * Type 1 diabetes diagnosed for at least 12 months; * Use of an A-HCL device for at least 3 months; * Proficiency in carbohydrate counting. Exclusion Criteria: * Presence of malabsorption disorders; * Presence of chronic diabetes complications.

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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

  • Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania

    Catania, Sicily, 95123, Italy

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