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

March 2, 2026 updated by: Institut de Recherches Cliniques de Montreal

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Centralized approach
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
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.
Active Comparator: Decentralized approach
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of screening and monitoring outcomes
Time Frame: Through study completion for positive screened participants: 3 years
Percentage of conversion of eligible participants to consent to participating in the study
Through study completion for positive screened participants: 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

Sanofi

Investigators

  • Principal Investigator: Rémi Rabasa-Lhoret, M.D. Ph.D, Institut de recherches cliniques de Montreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 5, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-1340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes (T1D)

Clinical Trials on Centralized Monitoring Approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe