New Methodologies for Personalising Support for Families of Children With Diabetes: Evaluation of a Biopsychosocial System
Sponsor: Adhera Health, Inc.
Trial Details
| Condition | T1D, Type 1 Diabetes (T1D), Type 1 Diabetes |
| Intervention | Use of Biopsychosocial Sensing System |
| Status | Completed |
| Participants | 30 |
| Est. Completion | 26 Jan 2026 |
| Last Updated | 22 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
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