Clinical Trial

Evaluation of a Biopsychosocial System

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Trial completed 2026-05-23
Trial Details
NCT Number NCT07440108
Lead Sponsor Adhera Health, Inc.
Collaborators: Hospital Universitario Miguel Servet, Zaragoza
Conditions T1D, Type 1 Diabetes (T1D), Type 1 Diabetes
Enrollment 30 participants
Start Date 2025-11-24
Primary Completion 2026-01-26 (estimated)
Study Completion 2026-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-22