Societal Burden Associated With Type 1 Diabetes in Canada

Recruiting

• Conditions: Type 1 Diabetes Mellitus; Quality of Life (QOL); Work Productivity; Caregiver Subjective Burden

• Registration Number: NCT06786130
• Lead Sponsor: PeriPharm

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-16
• Study Start: 2025-01-09
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate work productivity impairment of caregivers of a T1D child.	At recruitment	Using the WOrk Productivity and Activity Impairment (WPAI) questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PROxy Network, an initiative of PeriPharm Inc.; 🇨🇦 Montreal, Quebec, Canada