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App and talk therapy aim to ease diabetes distress in kids

NCT ID NCT06450730

Symptom relief Sponsor: Maimónides Biomedical Research Institute of Córdoba 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a program that combines a smartphone app with face-to-face therapy sessions can improve psychological well-being in children and adolescents with type 1 diabetes. The goal is to reduce diabetes-related distress and help young patients better manage their emotions. The study involves 122 participants aged 6 to 18 who have a compatible smartphone and internet access.

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

122 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Sep 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

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: * Girls and Boys with a diagnosis of T1D 6 - 18 * Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet * Having the required digital skills to follow the mHealth intervention * Not currently participating in another clinical trial involving a psychological intervention Exclusion Criteria: * Girls and Boys with a diagnosis of T1D \>18 years * Not Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet * Currently participating in another clinical trial involving a psychological intervention

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Conditions

The condition(s) this trial relates to.

Psychological Well-Being type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

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

Diabetes mellitus, type 1

Contacts and locations

Locations

  • Reina Sofía University Hospital

    Córdoba, Córdoba, 14004, Spain

More trials for these conditions

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