Societal Burden Associated With Type 1 Diabetes in Canada (T1D)

December 22, 2025 updated by: PeriPharm

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2Y 2H4

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Parental caregivers of a child with T1D

Description

Inclusion Criteria:

  1. Parental caregiver of a child recently diagnosed (<= 2 years) with T1D before study inclusion;
  2. Age ≥18 ;
  3. Residence in the Canada;
  4. Willingess to complete a 20-minute survey
  5. Ability to read and understand French or English;
  6. Signature of informed consent form (ICF)

Exclusion Criteria:

1. Participation in a clinical trial.

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
Intervention / Treatment
Caregiver of child with T1D
Caregiver of child with T1D diagnosed within the past 2 years
Other: observational study
This is an observational study in which participants complete PRO questionnaires via a web platform. No medical intervention or medication is involved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate work productivity impairment of caregivers of a T1D child.
Time Frame: At recruitment
Using the WOrk Productivity and Activity Impairment (WPAI) questionnaire
At recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate healthcare resource utilization in caregivers of T1D child
Time Frame: At recruitment
Using the modified Resource Utilization Questionnaire for Type 1 Diabetes (mRUQ-T1DM) questionnaire.
At recruitment
To estimate health-related quality of life in caregivers of a T1D child
Time Frame: At recruitment
Using the EuroQOL-5 dimension-5 levels (EQ-5D-5L) questionnaire.
At recruitment
To estimate the caregiver burden in caregivers of a T1D child
Time Frame: At recruitment
Using the Zarit Burden Interview-22 (ZBI-22) questionnaire.
At recruitment

Collaborators and Investigators

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

Sponsor

PeriPharm

Collaborators

Sanofi

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)

January 9, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOD0250

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

product manufactured in and exported from the U.S.

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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