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OpenTrials
Completed

NCT Number: NCT07440108

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.

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Key information

Conditions

T1D Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes Type 1 Diabetes (T1D)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of Biopsychosocial Sensing System

Other

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.

Primary outcomes

  1. Feasibility of the Biopsychosocial Sensing System

    Time frame: From enrollment to the end of study at month 2

    Feasibility will be assessed using metrics from the Adhera Caring Digital Program®, including:

    • Response rate to Ecological Momentary Assessment (EMA) prompts

  2. Feasibility of the Biopsychosocial Sensing System

    Time frame: From enrollment to the end of study at month 2

    Feasibility will be assessed using metrics from the Adhera Caring Digital Program®, including:

    • Completion rates of scheduled CAT assessments

Secondary outcomes

  1. Usability and acceptability of the system

    Time frame: At the end of the study (Month 2)

    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.

  2. Caregiver Distress Measured by Ecological Momentary Assessment (EMA)

    Time frame: From enrollment to the end of the study at month 2

    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)

  3. Caregiver Distress Measured by Computer Adaptive Testing (CAT)

    Time frame: From enrollment to the end of the study at month 2

    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)

  4. Psychosocial Patterns and Caregiver Responses to Glucose Events - Caregiver Distress (Parent Diabetes Distress Scale)

    Time frame: From enrollment to the end of the study at month 2

    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.

  5. Mobile Application Engagement

    Time frame: From enrollment to the end of study at month 2

    Engagement will be quantified using app logs and user profiling, including frequency and duration of interactions with the Adhera Caring Digital Program®.

  6. Frequency of Severe Glucose Events in Children

    Time frame: From enrollment to the end of the study at month 2

    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

Sponsors and collaborators

Lead sponsor

Adhera Health, Inc.

Industry

Collaborators

  • Hospital Universitario Miguel Servet, Zaragoza

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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