Type 1 Diabetes (T1D)FEDERATENCT07322380
Feasibility and Adoption of a Screening Program for T1D Relatives in Canada
A study testing Centralized Monitoring Approach and Decentralized Monitoring Approach in people with Type 1 Diabetes (T1D), run by Institut de Recherches Cliniques de Montreal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Centralized Monitoring Approach and Decentralized Monitoring Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maha Lebbar, M.D. contact
About this study
Official title: 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:
Read more
- The feasibility of a IAb (islet antibody)-based screening process for first degree relatives of people living with type 1 diabetes (T1D).
- 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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Centralized Monitoring Approach, Decentralized Monitoring Approach
- Keywords
- screening, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized Monitoring ApproachBehavioural
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 ApproachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Centralized approach | Active comparator | 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) Receives: Behavioral: Centralized Monitoring Approach |
| Decentralized approach | Active comparator | 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. Receives: Behavioral: Decentralized Monitoring Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of screening and monitoring outcomes
Percentage of conversion of eligible participants to consent to participating in the study
Measured: Through study completion for positive screened participants: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start5 Apr 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Rémi Rabasa-Lhoret, M.D. Ph.D, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322380
- Sponsor's protocol ID
- 2026-1340
- Acronym
- FEDERATE
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FEDERATE-CAN Trial - FEasibility and aDoption of a scrEening pRogrAm for T1d rElatives in CANada
- ClinicalTrials.gov ID
- NCT07322380
- Acronym / sponsor ID
- FEDERATE / 2026-1340
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- screening, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The feasibility of a IAb (islet antibody)-based screening process for first degree relatives of people living with type 1 diabetes (T1D).
- 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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Centralized approach | Active comparator | Behavioral: Centralized Monitoring ApproachCentralized 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) |
| Decentralized approach | Active comparator | Behavioral: Decentralized Monitoring ApproachIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centralized Monitoring ApproachA 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. | Behavioural | Centralized approach |
| Decentralized Monitoring ApproachMonitored 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. | Behavioural | Decentralized approach |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maha Lebbar, M.D. contact
Rémi Rabasa-Lhoret, M.D. Ph.D principal investigator
Institut de Recherches Cliniques de Montreal
Questions about this trial
What is this clinical trial studying?
A study testing Centralized Monitoring Approach and Decentralized Monitoring Approach in people with Type 1 Diabetes (T1D), run by Institut de Recherches Cliniques de Montreal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie Boudreau, Ph.D (5149703660, valerie.boudreau@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of screening and monitoring outcomes (time frame: Through study completion for positive screened participants: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.