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New insulin system helps kids with diabetes keep blood sugar in check

NCT ID NCT07425912

Disease control Sponsor: University of Campania Luigi Vanvitelli 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well the TouchCare Nano automated insulin delivery system works for children and teens with type 1 diabetes in everyday life. Researchers tracked 76 kids aged 6 to 18 over six months to see if the system helped them spend more time with healthy blood sugar levels and if serious side effects like low blood sugar or diabetic ketoacidosis were rare. The goal was to improve diabetes management without needing a cure.

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

76 people

The number who actually took part.

Started

Sep 2025

Finished

Mar 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

Children and adolescents with type 1 diabetes receiving routine clinical care were recruited from specialized tertiary pediatric diabetes centers in Italy.

Ages

6 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 6 to 18 years * Diagnosis of type 1 diabetes mellitus for ≥6 months * Treatment with insulin therapy (multiple daily injections or continuous subcutaneous insulin infusion) for ≥6 months prior to enrolment * Clinical indication for transition to insulin pump therapy according to routine diabetes care * Ability of participant and family to understand and comply with study procedures * Written informed consent from parent(s) or legal guardian(s), and assent from the participant when applicable Exclusion Criteria: * Diabetic ketoacidosis within the 3 months before enrollment * Use of medications known to affect blood glucose levels * Body weight less than 20 kilograms * Total daily insulin dose less than 10 international units

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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

  • Centro Regionale di Diabetologia Pediatrica- AOU Univesità degli Studi della Campania "L.Vanvitelli"

    Naples, Italy, Italy

  • Department of Diabetology and Endocrinology at the AOU Meyer IRCCS

    Florence, Italy

  • Pediatric Diabetology Unit at the AOU "G. Martino"

    Messina, Italy, Italy

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