T1DNCT07440108
Evaluation of a Biopsychosocial System
An observational study of T1D and Type 1 Diabetes (T1D), run by Adhera Health, Inc. at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- T1D, Type 1 Diabetes (T1D), Type 1 Diabetes
- What is being tested?
- Use of Biopsychosocial Sensing System
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 24 Nov 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- T1D, Type 1 Diabetes (T1D), Type 1 Diabetes
- Being tested
- Use of Biopsychosocial Sensing System
- Keywords
- Type 1 Diabetes, T1D, mhealth, caregiver, CAT, EMA, CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Biopsychosocial Sensing SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Use of Biopsychosocial Sensing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the end of study at month 2
Secondary outcomes (6)
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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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®.
Measured: 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
Measured: From enrollment to the end of the study at month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start24 Nov 2025
- Primary completion26 Jan 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adhera Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Miguel Servet, Zaragoza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440108
- Sponsor's protocol ID
- RO02
- Status last verified
- May 2026
- First submitted
- 27 Nov 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Methodologies for Personalising Support for Families of Children With Diabetes: Evaluation of a Biopsychosocial System
- ClinicalTrials.gov ID
- NCT07440108
- Acronym / sponsor ID
- RO02
- Conditions
- T1D, Type 1 Diabetes (T1D), Type 1 Diabetes
- Keywords
- Type 1 Diabetes, T1D, mhealth, caregiver, CAT, EMA, CGM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Adhera Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Miguel Servet, Zaragoza
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary caregivers of a child with T1D | – | Other: Use of Biopsychosocial Sensing SystemThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Biopsychosocial Sensing SystemParticipants 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. | Other | Primary caregivers of a child with T1D |
Primary outcome
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
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
6 secondary outcomes
Usability and acceptability of the system
Time frame: 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 Measured by Computer Adaptive Testing (CAT)
Time frame: 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
Mobile Application Engagement
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T1D and Type 1 Diabetes (T1D), run by Adhera Health, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Biopsychosocial Sensing System (time frame: From enrollment to the end of study at month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.