Feasibility and Adoption of a Screening Program for T1D Relatives in Canada

NCT07322380 | Not Yet Recruiting

• 1 other identifier: 2026-1340
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study will be to evaluate the feasibility of an autoantibody-based type 1 diabetes screening program for first degree relatives of people living with type 1 diabetes within the province of Quebec. Feasibility of follow-up strategies of "at-risk" individuals will also be assessed. This project will be divided into two phases, with the aim to evaluate:

• Participants in pre-stage 1 or stage 1 (2 or more positive IAbs without dysglycemia) T1D will receive a follow-up phone call six months after the initial screening.
• Participants in stage 2 (2 or more positive IAbs with dysglycemia) will be contacted one month after screening.

Conditions

Type 1 Diabetes (T1D)

Keywords

screening; type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Feasibility of screening and monitoring outcomes

  Percentage of conversion of eligible participants to consent to participating in the study

  Through study completion for positive screened participants: 3 years

Study Arms (2)

Centralized approach

ACTIVE COMPARATOR

Centralized approach managed and coordinated within the BETTER group based at IRCM (Montreal, Quebec), with standardized processes and integrated care pathways. In this approach, scheduling processes and data collection (clinical visits, laboratory analysis, questionnaires) will be handled by the research team. Participants' healthcare professional will be notified (by postal service and/or email if available)

Behavioral: Centralized Monitoring Approach

Decentralized approach

ACTIVE COMPARATOR

In this approach, participants will be monitored by their preferred HCP according to consensus-based guidelines for monitoring pre-clinical T1D which will be communicated to both participants and HCPs. Therefore, follow-up and monitoring will be at the discretion of the HCP. However, regular contacts by the research team according to T1D stages will ensure the actual follow-up received.

Behavioral: Decentralized Monitoring Approach

Interventions

Centralized Monitoring Approach BEHAVIORAL

A semi-annual clinical visit (either by medical or trained staff) will be conducted to collect various data: IAb assessment, HbA1c measure, fasting blood glucose, glucose monitoring and information about eating habits, mental health, menstrual cycle, physical activity.

Centralized approach

Decentralized Monitoring Approach BEHAVIORAL

Monitored by the participant's preferred local Healthcare Provider (HCP) according to consensus-based guidelines for pre-clinical T1D. The research team does not conduct direct clinical visits; instead, the research team conducts semi-annual phone calls (and initial 1-month or 6-month check-ins depending on T1D stage) to confirm that appropriate HCP follow-up is ongoing, document any clinical assessments conducted by the HCP, and collect the results of those investigations.

Decentralized approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years old living in the Québec province
• Having a FDR living with T1D (parents, siblings or offspring)
• Willing to adhere to follow-up care if screened positive

You may not qualify if:

• Having a diagnosis of T1D
• Pregnancy (ongoing or current attempt to become pregnant)
• Current or future expected use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®) or any systemic immunosuppressive agents
• Planned or recent (\< 6 weeks) monoclonal antibodies treatment, immunoglobulin perfusions or plasmapheresis.
• Other serious medical illness likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator

Sponsors & Collaborators

• Sanofi: collaborator
• Institut de Recherches Cliniques de Montreal: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rémi Rabasa-Lhoret, M.D. Ph.D

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Boudreau, Ph.D

CONTACT

5149703660; valerie.boudreau@ircm.qc.ca

Maha Lebbar, M.D.

CONTACT

maha.lebbar@ircm.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 7, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share