Type 1 Diabetes MellitusT1DNCT06786130
Societal Burden Associated With Type 1 Diabetes in Canada
An observational study of Type 1 Diabetes Mellitus and Quality of Life (QOL), run by PeriPharm at 1 site in Canada.
Trial summary
The purpose of this observational study is to estimate the burden of T1D on caregivers of patient with T1D in terms of work productivity, healthcare resource utilization and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Quality of Life (QOL), Work Productivity
- What is being tested?
- observational study
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2025to 20 Jul 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: Parental caregivers of a child with T1D
Who may be able to join
- Parental caregiver of a child recently diagnosed (<= 2 years) with T1D before study inclusion;
- Age ≥18 ;
- Residence in the Canada;
- Willingess to complete a 20-minute survey
- Ability to read and understand French or English;
- Signature of informed consent form (ICF)
Who cannot join
- 1. Participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
Canada1 site
PROxy Network, an initiative of PeriPharm Inc.
Montreal, Quebec, H2Y 2H4
About this study
Official title: Burden and (Dis)Utility of Caregivers of Children With T1D
The purpose of this observational study is to estimate the burden of T1D on caregivers of patient with T1D in terms of work productivity, healthcare resource utilization and quality of life.
- Conditions
- Type 1 Diabetes Mellitus, Quality of Life (QOL), Work Productivity, Caregiver Subjective Burden
- Being tested
- observational study
- Keywords
- observational, quality of life, caregiver, work productivity, real-world
- 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.
observational studyOther
This is an observational study in which participants complete PRO questionnaires via a web platform. No medical intervention or medication is involved.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver of child with T1D | Caregiver of child with T1D diagnosed within the past 2 years Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate work productivity impairment of caregivers of a T1D child.
Using the WOrk Productivity and Activity Impairment (WPAI) questionnaire
Measured: At recruitment
Secondary outcomes (3)
To estimate healthcare resource utilization in caregivers of T1D child
Using the modified Resource Utilization Questionnaire for Type 1 Diabetes (mRUQ-T1DM) questionnaire.
Measured: At recruitment
To estimate health-related quality of life in caregivers of a T1D child
Using the EuroQOL-5 dimension-5 levels (EQ-5D-5L) questionnaire.
Measured: At recruitment
To estimate the caregiver burden in caregivers of a T1D child
Using the Zarit Burden Interview-22 (ZBI-22) questionnaire.
Measured: At recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start9 Jan 2025
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Why it stopped: Recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeriPharm
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786130
- Sponsor's protocol ID
- BOD0250
- Acronym
- T1D
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2024
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden and (Dis)Utility of Caregivers of Children With T1D
- ClinicalTrials.gov ID
- NCT06786130
- Acronym / sponsor ID
- T1D / BOD0250
- Conditions
- Type 1 Diabetes Mellitus, Quality of Life (QOL), Work Productivity, Caregiver Subjective Burden
- Keywords
- observational, quality of life, caregiver, work productivity, real-world
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- PeriPharmUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 22 Jan 2025 (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 purpose of this observational study is to estimate the burden of T1D on caregivers of patient with T1D in terms of work productivity, healthcare resource utilization and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver of child with T1D | – | Other: observational studyCaregiver of child with T1D diagnosed within the past 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parental caregivers of a child with T1D
Key inclusion criteria (6 listed)
- Parental caregiver of a child recently diagnosed (<= 2 years) with T1D before study inclusion;
- Age ≥18 ;
- Residence in the Canada;
- Willingess to complete a 20-minute survey
- Ability to read and understand French or English;
Key exclusion criteria (1 listed)
- 1. Participation in a clinical trial.
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 |
|---|---|---|
| observational studyThis is an observational study in which participants complete PRO questionnaires via a web platform. No medical intervention or medication is involved. | Other | Caregiver of child with T1D |
Primary outcome
To estimate work productivity impairment of caregivers of a T1D child.
Time frame: At recruitment
Using the WOrk Productivity and Activity Impairment (WPAI) questionnaire
3 secondary outcomes
To estimate healthcare resource utilization in caregivers of T1D child
Time frame: At recruitment
To estimate health-related quality of life in caregivers of a T1D child
Time frame: At recruitment
To estimate the caregiver burden in caregivers of a T1D child
Time frame: At recruitment
Results and safety
The study was stopped early (reason given: Recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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 Type 1 Diabetes Mellitus and Quality of Life (QOL), run by PeriPharm at 1 site in Canada.
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 1 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: stopped early, as of the sponsor's last update on 30 Jul 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 Canada. 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 was stopped early (reason given: Recruitment.). Results are not available in the source record.
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?
To estimate work productivity impairment of caregivers of a T1D child. (time frame: At recruitment). 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 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.