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Evaluation of a Biopsychosocial System

NCT07440108 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

Summary

The goal of this observational study is to evaluate the feasibility of a biopsychosocial sensing system integrated into the Adhera Caring Digital Program® for caregivers of children with type 1 diabetes (T1D). The main questions it aims to answer are:

* Is the integrated biopsychosocial sensing system feasible to use in real-world conditions over a 2-month period?
* Is the system usable and acceptable for caregivers?
* How do biopsychosocial factors interact with severe glucose events, and what do these dynamics reveal about caregiver distress during T1D management?

Findings from this study will help determine whether the system can support future development of data-driven interventions for families managing pediatric T1D.

Conditions

Interventions

OTHER

Use of Biopsychosocial Sensing System

Participants use a biopsychosocial sensing system integrated into the Adhera Caring Digital Program® for a 2-month period. The system collects caregiver emotional well-being data through computer adaptive testing (CAT) and ecological momentary assessment (EMA), along with children's CGM data. This is an observational study and no treatment or behavioral intervention is administered.

Sponsors & Collaborators

  • Hospital Universitario Miguel Servet, Zaragoza

    collaborator UNKNOWN

  • Adhera Health, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2026-01-26
Completion
2026-03-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440108 on ClinicalTrials.gov