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New app tracks stress and sugar levels to help families of kids with diabetes

NCT ID NCT07440108

Knowledge-focused Sponsor: Adhera Health, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a digital program that monitors both the emotional well-being of caregivers and the glucose levels of children with type 1 diabetes. Thirty families used the system for two months to see if it was practical and easy to use. The goal was to learn how stress and blood sugar events are connected, which could help design better support tools in the future.

What this could mean

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

What this could lead to
If successful, this could lead to better personalized support systems for families managing a child's type 1 diabetes, potentially reducing caregiver distress and improving glucose control.
What could go wrong
This is a small, early feasibility study with only 30 participants. It does not test any treatment, so results may not lead to immediate changes in care.

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

30 people

The number who actually took part.

Started

Nov 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population consists of caregivers of children with type 1 diabetes recruited from Hospital Miguel Servet in Spain. Eligible caregivers are adults who serve as the primary caregiver for a child under 18 years old with a confirmed diagnosis of T1D and who uses the FreeStyle Libre 2 continuous glucose monitoring system. Families must be willing to share the child's CGM data and have experienced at least two severe glucose events in the previous month. Caregivers must own a compatible smartphone and be able to use a mobile sensing system. Exclusion criteria include significant cognitive or physical impairments, inability to read or understand Spanish, or participation in other clinical trials involving psychological or diabetes-related interventions.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Caregivers aged ≥18 years who are the primary caregivers of a child with T1D. * The child should be younger than 18 years with a confirmed diagnosis of T1D and currently using CGM, specifically Free-Style Libre 2. * The family should be willing to share their child's CGM data with the Adhera Caring Digital Program®, as well as retrospective CGM data from the previous 2 months prior to joining the study. * The child should have had at least 2 severe glycemic events in the previous month, either hyperglycemic (\>250 mg/dL for more than 2 hours) or hypoglycemic (\<70 mg/dL for more than 15 min). This will be assessed by their pediatric endocrinologist during recruitment. * Caregivers must own a smartphone compatible with the study app. * Willingness and ability to use a smartphone-based sensing system. Exclusion criteria: * Caregivers with significant cognitive or physical impairments preventing study participation. * Inability to read or understand the Spanish language. * Participation in other clinical trials involving psychological or diabetes management interventions.

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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.

T1D Type 1 diabetes Type 1 diabetes (T1D)

Contacts and locations

Locations

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009, Spain

More trials for these conditions

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