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NCT Number: NCT07322380

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Lebbar, M.D.

CONTACT

[email protected]

Valérie Boudreau, Ph.D

CONTACT

[email protected]

5149703660

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Collaborators

Sanofi

Registry information

Official study title

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

Acronym: FEDERATE

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jan 7, 2026
Registry last updated: Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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