INNODIA Family & Friends Early-Stage Type 1 Diabetes Detection
INNODIA Family & Friends Early-Stage T1D Detection Protocol
This program tests blood autoantibody screening to find people aged 1 to 45 who, because they have a relative or close friend with Type 1 diabetes, may be at higher risk of developing T1D.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30000 (estimated) |
| Ages | 1 Year to 45 Years |
| Sex | All |
| Sponsor | INNODIA iVZW Academic / other |
| Locations | 5 sites (Leuven and 4 other locations) |
| Trial ID | NCT07118098 on ClinicalTrials.gov |
What this trial studies
This observational project invites family members and close friends of people diagnosed with symptomatic Type 1 diabetes before age 45 to give consent and a blood sample. Researchers test the blood for diabetes-related autoantibodies that indicate early, preclinical stages of T1D. Participants are recruited at clinical sites in Leuven, Paris, and Milan and may be followed over time if antibodies are detected. The resulting registry of at-risk individuals is intended to support monitoring and future prevention efforts.
Who should consider this trial
Good fit: Ideal candidates are people aged 1–45 who have given informed consent and have a family member or close friend diagnosed with symptomatic Type 1 diabetes before age 45.
Not a fit: People with an existing diagnosis of stage 3 T1D or other forms of diabetes are unlikely to benefit from this screening protocol.
Why it matters
Potential benefit: If successful, this could identify people earlier so they can receive closer monitoring and be eligible for prevention trials or early interventions.
How similar studies have performed: Previous research has shown that autoantibody screening can predict increased risk of developing T1D, and INNODIA builds on that established approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Have given written informed consent to participate 2. Be aged between 1 and 45 years 3. Have a family relative with T1D or close friend diagnosed with symptomatic T1D at age \<45 years Exclusion Criteria: 1. Previous diagnosis of stage 3 T1D or other forms of diabetes 2. Unable/unwilling to consent to participation
Where this trial is running
Leuven and 4 other locations
- Katholieke Universiteit Leuven — Leuven, Belgium (Recruiting)
- Institut National de la Santé et de la Recherche Médicale — Paris, France (Not_yet_recruiting)
- San Raffaele Hospital — Milan, Italy (Not_yet_recruiting)
- Medical University of Silesia — Katowice, Poland (Not_yet_recruiting)
- University Medical Center Ljubljana — Ljubljana, Slovenia (Not_yet_recruiting)
Study contacts
- Study coordinator: Laura Moreno Belmonte
- Email: laura.moreno@innodia.org
- Phone: +393889544246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.