Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07322380 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: FEDERATE
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Jan 5, 2026 to Apr 5, 2026
    • Interventions: Monitoring (Behavioral) to Centralized Monitoring Approach (Behavioral), Decentralized Monitoring Approach (Behavioral)
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07322380
Lead Sponsor Institut de Recherches Cliniques de Montreal
Collaborators: Sanofi
Conditions
(from sponsor)
Type 1 Diabetes (T1D)
Related terms Diabetes Mellitus, Type 1
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov