INNODIA Family & Friends Early-Stage T1D Detection Protocol

NCT ID: NCT07118098

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2027-12-31

Brief Summary

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).

Conditions

Type 1 Diabetes (T1D); Pre Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

INNODIA iVZW

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Katholieke Universiteit Leuven

Leuven, , Belgium

Site Status: RECRUITING

Institut National de la Santé et de la Recherche Médicale

Paris, , France

Site Status: NOT_YET_RECRUITING

San Raffaele Hospital

Milan, , Italy

Site Status: NOT_YET_RECRUITING

Medical University of Silesia

Katowice, , Poland

Site Status: NOT_YET_RECRUITING

University Medical Center Ljubljana

Ljubljana, , Slovenia

Site Status: NOT_YET_RECRUITING

Countries

Belgium; France; Italy; Poland; Slovenia

Central Contacts

Laura Moreno Belmonte

Role: CONTACT

laura.moreno@innodia.org

+393889544246

INNODIA Detect

Role: CONTACT

detect@innodia.org

Facility Contacts

Principal Investigator - Prof Mathieu

Role: primary

chantal.mathieu@uzleuven.be

+32 16 34 6994

Anna Jones

Role: primary

DT1.depistage.cch@aphp.fr

+33 7 83.30.37.46

Pauline Study Nurse

Role: primary

grogan.pauline@hsr.it

+39 02 2643 5257/3176

Przemyslawa Jarosz-Chobot, Professor

Role: primary

przemka1@tlen.pl

+48 604 176 773

Department of Children's Diabetology and Lifestyle Medicine

Role: backup

+48 32 207 16 57

Damjana Nikovski

Role: primary

damjana.nikovski@kclj.si

+386 1 522 3903.

Related Links

https://www.innodia.org/innodias-clinical-trials/innodia-early-t1d-detection

INNODIA is made of professionals with various disciplinary skills and a community of expert people and families living with type 1 diabetes working together with one common focus: contribute to creating a world free of type 1 diabetes

Other Identifiers

INNODIA DETECT 01

Identifier Type: -

Identifier Source: org_study_id