NCT07322380

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

The FEDERATE-CAN Trial - FEasibility and aDoption of a scrEening pRogrAm for T1d rElatives in CANada

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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: 1. The feasibility of a IAb (islet antibody)-based screening process for first degree relatives of people living with type 1 diabetes (T1D). 2. The feasibility of two approaches for follow-up monitoring in case of positive screening: centralized (within the organization) and decentralized approach (relying on individuals' healthcare providers), in the Quebec province setting. Participants will come to the laboratory for blood sample collection, medical history and genetic risk score assessment, as well as anthropometric and cutaneous advanced glycated end (AGE) products measurements. A series of questionnaires will be completed. After screening results are obtained (i.e., presence or absence of IAbs), a virtual visit will be conducted to communicate results to participants. A positive result for IAb will warrant a second test for confirmation , using WBD within 3 months of initial screening. After IAb positivity confirmation, participants will be invited to participate in phase 2 of this project (monitoring). Participants will be given the opportunity to select either a centralized or decentralized path for study monitoring. Follow-up will be dependent of the stage of T1D: * 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)

Interventions

Type	Name	Description
BEHAVIORAL	Centralized Monitoring Approach	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.
BEHAVIORAL	Decentralized Monitoring Approach	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.

Timeline

• Start date: 2026-04-05
• Primary completion: 2028-02-01
• Completion: 2028-03-31
• First posted: 2026-01-07
• Last updated: 2026-03-04