NCT07322380Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 5 Apr 2026
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Diseases
- Type 1 diabetes
- NCT number
- NCT07322380
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 5 Apr 2026 to the primary completion date, 1 Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned or recent (\< 6 weeks) monoclonal antibodies treatment, immunoglobulin perfusions or plasmapheresis.
Other illness
- 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
- Other serious medical illness likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator
Other
- Having a diagnosis of T1D
- Pregnancy (ongoing or current attempt to become pregnant)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.