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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; T1D; Type 1 Diabetes (T1D)
• Intervention / Treatment: Other: Use of Biopsychosocial Sensing System

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Universitario Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of caregivers of children with type 1 diabetes recruited from Hospital Miguel Servet in Spain. Eligible caregivers are adults who serve as the primary caregiver for a child under 18 years old with a confirmed diagnosis of T1D and who uses the FreeStyle Libre 2 continuous glucose monitoring system. Families must be willing to share the child's CGM data and have experienced at least two severe glucose events in the previous month. Caregivers must own a compatible smartphone and be able to use a mobile sensing system. Exclusion criteria include significant cognitive or physical impairments, inability to read or understand Spanish, or participation in other clinical trials involving psychological or diabetes-related interventions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Primary caregivers of a child with T1D; This cohort includes caregivers of children with type 1 diabetes who will use the biopsychosocial sensing system integrated into the Adhera Caring Digital Program® for 2 months. No interventions are administered; caregivers use the system as part of this observational feasibility study.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Biopsychosocial Sensing System	Feasibility will be assessed using metrics from the Adhera Caring Digital Program®, including: - Response rate to Ecological Momentary Assessment (EMA) prompts	From enrollment to the end of study at month 2
Feasibility of the Biopsychosocial Sensing System	Feasibility will be assessed using metrics from the Adhera Caring Digital Program®, including: - Completion rates of scheduled CAT assessments	From enrollment to the end of study at month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability and acceptability of the system	Outcome Measure: System Usability Scale (SUS) score. Unit of Measure: SUS score (0-100, higher scores indicate better usability). Description: The System Usability Scale is a 10-item scale based on a 5-point Likert scale assessing perceived usability.	At the end of the study (Month 2)
Caregiver Distress Measured by Ecological Momentary Assessment (EMA)	Caregiver distress will be measured using Ecological Momentary Assessment (EMA) delivered via smartphone. Distress will be quantified using EMA distress scores reported in response to daily prompts. Unit of Measure: EMA distress score (continuous scale)	From enrollment to the end of the study at month 2
Caregiver Distress Measured by Computer Adaptive Testing (CAT)	Caregiver distress will be assessed using Computer Adaptive Testing (CAT) administered electronically. Distress will be quantified using CAT-generated distress scores. Unit of Measure: CAT distress score (continuous scale)	From enrollment to the end of the study at month 2
Psychosocial Patterns and Caregiver Responses to Glucose Events - Caregiver Distress (Parent Diabetes Distress Scale)	Caregiver distress will be measured using the Parent Diabetes Distress Scale (Parent-DDS), a 20-item questionnaire assessing four subscales: Personal distress; Teen management distress; Parent/teen relationship distress; Healthcare team distress Scoring: For each scale and the total score, responses are summed and divided by the number of items in that scale, yielding a mean item score ranging from 0 to 5. Interpretation of scores: -1.9: Little or no distress; 2.0-2.9: Moderate distress; ≥3.0: High distress Higher scores indicate greater caregiver distress. Associations between Parent-DDS scores (total and subscale scores) and children's severe glucose events (hyperglycemia >250 mg/dL for >2 hours or hypoglycemia <70 mg/dL for >15 minutes) will be analyzed. Clinicians may consider moderate or high distress worthy of clinical attention depending on context.	From enrollment to the end of the study at month 2
Mobile Application Engagement	Engagement will be quantified using app logs and user profiling, including frequency and duration of interactions with the Adhera Caring Digital Program®.	From enrollment to the end of study at month 2
Frequency of Severe Glucose Events in Children	Outcome Measure Description Severe glucose events will be defined as hyperglycemia >250 mg/dL for more than 2 hours or hypoglycemia <70 mg/dL for more than 15 minutes, as measured by continuous glucose monitoring. Unit of Measure Number of severe glucose events. Higher number, worse outcome	From enrollment to the end of the study at month 2

Collaborators and Investigators

• Sponsor: Adhera Health, Inc.
• Collaborators: Hospital Universitario Miguel Servet, Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; T1D; CGM; mhealth; caregiver; CAT; EMA
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RO02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No