An observational study in Type 1 Diabetes (T1D) and Pre Diabetes, sponsored by INNODIA iVZW. Recruiting at 21 sites in 8 countries. Open to participants aged 1 Year to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by INNODIA iVZW · Observational
The purpose of INNODIA DETECT is to identify people who are at increased risk of developing T1D. Investigators are doing this by testing for markers in the blood (autoantibodies) that tell them an individuals risk of getting T1D in the future.
What is Type 1 Diabetes (T1D)? T1D is a serious disease where the blood glucose (sugar) level is too high because the body cannot make a hormone called insulin.
This happens when the body's immune system attacks the cells in the pancreas that make insulin (called beta cells), meaning that insulin production stops.
This is harmful to the body as insulin does an essential job. It allows the glucose in the blood to enter cells and fuel the body, resulting in a lowering of the blood glucose level.
What are Autoantibodies? T1D autoantibodies are markers found in the blood that indicate that the destruction of insulin producing cells has begun. The risk of developing T1D increases with the number of autoantibodies detected.
People who have 1 autoantibody detected in their blood are at increased risk of developing T1D. The presence of 2 or more autoantibodies indicates that T1D is present but the individual does not show any signs or symptoms yet.
However, these autoantibodies can be present for many years before someone develops symptoms of T1D. They often appear in the first few years of life.
The investigators are asking children and adults across Europe, aged between 1 and 45 years, who have either a family member (parent, child, full or half sibling) or close friend diagnosed with T1D before 45 years of age to provided a small blood sample so they can look at these T1D autoantibodies.
If a participant's autoantibody results are negative, this means they do not have autoantibodies and are at low risk of developing T1D. No further tests will be required, and they will exit the program.
If results indicate a participant has 1 or more positive T1D autoantibodies, a member of the clinical team will contact and invite them to the hospital for a venous blood sample to confirm the result. This confirmation test will be done as part of routine clinical care by the participants clinical team. INNODIA DETECT will end here and, if confirmed positive, the participant will be invited to attend further follow-up by entering in a separate protocol (named INNODIA MONITOR).
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →This is the only study on the registry with INNODIA iVZW as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Family and friends of people living with type 1 Diabetes. People with autoimmune disorders are of particular interest
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with a first-degree relative with T1D have a 15-fold higher relative lifetime risk of T1D compared to the general population. Prevalence of T1D amongst individuals with a first-degree relative is 5% by age 20 compared to \~0.3% amongst the general population \[10-12\]. Siblings of People with T1D have, on average, a 6-7% lifetime risk of T1D, and offspring of mothers and fathers with T1D have a 1.3-4% and 6-9% lifetime risk, respectively, compared with 0.4% in the general population. The aim of the INNODIA DETECT protocol is to develop a system for identifying people at-risk and with presymptomatic T1D through targeted testing of relatives and friends of people living with symptomatic T1D. Individual will have a blood sample taken and tested for the presence of T1D autoantibodies
Presence of one or more T1D IAb
Blood sample will be tested for anti-GAD, anti-IA-2, anti-insulin, and anti-ZnT8,
Time frame: End of 2027
Started Jun 2025 (actual). Primary completion is estimated for Dec 2027, 30 months after the start.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 30 months is close to that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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