CompletedNCT07440108

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

Sponsor: Adhera Health, Inc.

Trial Details

ConditionT1D, Type 1 Diabetes (T1D), Type 1 Diabetes
InterventionUse of Biopsychosocial Sensing System
StatusCompleted
Participants30
Est. Completion26 Jan 2026
Last Updated22 May 2026

Primary Outcome

Feasibility of the Biopsychosocial Sensing System; Feasibility of the Biopsychosocial Sensing System

Eligibility Criteria

Inclusion Criteria

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.

Trial Sites

Countries

Spain
View Registry Entry

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