About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Centralized Monitoring Approach
- Decentralized Monitoring Approach
Treatment groups
Locations
Sponsors and collaborators
Institut de Recherches Cliniques de Montreal
Lead sponsor
Sanofi
Collaborator