Evaluation of a Biopsychosocial System

May 20, 2026 updated by: Adhera Health, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of study at month 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
From enrollment to the end of study at month 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At the end of the study (Month 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)
From enrollment to the end of the study at month 2
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)
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)
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.
From enrollment to the end of the study at month 2
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®.
From enrollment to the end of study at month 2
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
From enrollment to the end of the study at month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adhera Health, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario Miguel Servet, Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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