Evaluation of a Biopsychosocial System

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

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.

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.