Evaluation of a Biopsychosocial System

NCT07440108 | Completed

• 1 other identifier: RO02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

T1D; Type 1 Diabetes (T1D); Type 1 Diabetes

Keywords

Type 1 Diabetes; T1D; mhealth; caregiver; CAT; EMA; CGM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Usability and acceptability of the system

  At the end of the study (Month 2)

• Caregiver Distress Measured by Ecological Momentary Assessment (EMA)

  From enrollment to the end of the study at month 2

• Caregiver Distress Measured by Computer Adaptive Testing (CAT)

  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)

  From enrollment to the end of the study at month 2

• Mobile Application Engagement

  From enrollment to the end of study at month 2

Study Arms (1)

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

Interventions

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 caregivers of a child with T1D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Hospital Universitario Miguel Servet, Zaragoza: collaborator

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: February 27, 2026
• Study Start: November 24, 2025
• Primary Completion: January 26, 2026
• Study Completion: March 30, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)