Taking people in SloveniaNo phase

Screens blood for early type 1 diabetes markers in relatives and friends

Checks blood for markers that signal future type 1 diabetes risk.

Key facts

Who runs it: INNODIA iVZW
Where: Ljubljana, SloveniaSee the siteAlso in 7 other countries, 20 sites
Trial code: NCT07118098
Registry title: INNODIA Family & Friends Early-Stage T1D Detection Protocol
Status: Recruiting
People taking part: 30,000 people, planned
Started: 25 Jun 2025
Expected to end: Dec 2027
Type of study: Observational
Record updated: 24 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and adults aged 1 to 45 who have a family member or close friend diagnosed with type 1 diabetes before age 45. A small blood test checks for type 1 diabetes autoantibodies.

Age: 1 to 45 years
Sex: All sexes can join.
Disease stage: Not yet diagnosed with type 1 diabetes. They must have a relative or close friend diagnosed with symptomatic type 1 diabetes before age 45.
Biomarker or test result: No test result is needed to join. The blood sample is tested for T1D autoantibodies.

Main reasons for not taking part

Previous diagnosis of stage 3 T1D or other forms of diabetes
Unable or unwilling to give consent

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

Have given written informed consent to participate
Be aged between 1 and 45 years
Have a family relative with T1D or close friend diagnosed with symptomatic T1D at age <45 years

Who cannot take part

Previous diagnosis of stage 3 T1D or other forms of diabetes
Unable/unwilling to consent to participation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 1 and 45 years old?

Where in Slovenia

Also in 7 other countries, 20 sites

University Medical Center LjubljanaLjubljana, SloveniaContact: Damjana NikovskiTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The group in the trial

Family and friends of people with Type 1 diabetes
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