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NCT Number: NCT06786130

Societal Burden Associated With Type 1 Diabetes in Canada

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Caregiver Subjective Burden Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life (QOL) Work Productivity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PROxy Network, an initiative of PeriPharm Inc.

Montreal, Quebec, H2Y 2H4, Canada

Location status: Recruiting

Location contact

Catherine Beauchemin, PhD

CONTACT

[email protected]

514-731-8207 ext. 102

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Participation in a clinical trial.

Treatment and study plan

observational study

Other

This is an observational study in which participants complete PRO questionnaires via a web platform. No medical intervention or medication is involved.

Primary outcomes

  1. To estimate work productivity impairment of caregivers of a T1D child.

    Time frame: At recruitment

    Using the WOrk Productivity and Activity Impairment (WPAI) questionnaire

Secondary outcomes

  1. 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.

  2. 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.

  3. To estimate the caregiver burden in caregivers of a T1D child

    Time frame: At recruitment

    Using the Zarit Burden Interview-22 (ZBI-22) questionnaire.

Sponsors and collaborators

Lead sponsor

PeriPharm

Other

Collaborators

  • Sanofi

Registry information

Official study title

Burden and (Dis)Utility of Caregivers of Children With T1D

Acronym: T1D

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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