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New app could help kids with diabetes dose insulin safely

NCT ID NCT07427134

Disease control Sponsor: Sultan Qaboos University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a digital tool that helps children under 12 with type 1 diabetes calculate their insulin doses. The tool considers factors like carbs, blood sugar levels, and trends. Researchers will compare blood sugar control (HbA1c) over 6 months between kids using the tool plus standard care and those receiving standard care alone. The goal is to see if the tool improves safety and glucose management.

What this could mean

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

Active substance
flexible digital insulin dose calculator (behavioural intervention)
What this could lead to
If it works, this tool could help children with type 1 diabetes achieve better blood sugar control and reduce dangerous highs and lows.
What could go wrong
This is a relatively small, early-stage trial. The tool may not improve outcomes significantly, and it requires consistent use and caregiver training.

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

About 440 people

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

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

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

1 year to 12 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: * Children and adolescents \< 12 years * Diagnosed with Type 1 Diabetes Mellitus (T1DM) * Duration of diagnosis \> 1 year * Using a multiple daily injection (MDI) regimen * Practising carbohydrate counting for at least 1 month before enrolment Exclusion Criteria: * Use of an existing insulin dose calculator (e.g., mobile application or bolus advisor) within the last 3 months * Diagnosis of other types of diabetes (e.g., Type 2 diabetes mellitus, monogenic diabetes) * Use of insulin regimens other than multiple daily injections (MDI) (e.g., insulin pump therapy)

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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.

T1DM T1DM - type 1 diabetes mellitus Type 1 diabetes mellitus Type 1 diabetes mellitus (T1DM)

How to take part

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

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • University Child Hospital

    RECRUITING

    Lahore, Pakistan

  • University of Mosul

    RECRUITING

    Mosul, Iraq

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