NCT07440108

Evaluation of a Biopsychosocial System

New Methodologies for Personalising Support for Families of Children With Diabetes: Evaluation of a Biopsychosocial System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Adhera Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• T1D
• Type 1 Diabetes (T1D)
• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-01-26
• Completion: 2026-03-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Spain