Type 1 Diabetes (T1D)INNODIA DETECTNCT07118098
INNODIA Family & Friends Early-Stage T1D Detection Protocol
An observational study of Type 1 Diabetes (T1D) and Pre Diabetes, run by INNODIA iVZW at 21 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes (T1D), Pre Diabetes
- How many people
- 30,000 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 25 Jun 2025to Dec 2027
- Phase
- Observational
- 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 1 year to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Family and friends of people living with type 1 Diabetes. People with autoimmune disorders are of particular interest
Who may be able to join
- 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 join
- Previous diagnosis of stage 3 T1D or other forms of diabetes
- Unable/unwilling to consent to participation
Trial locations and contacts
21 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Program Manager contact
21 sites in 8 countries
France14 sites, 14 recruiting
- Recruiting
Angers University Hospital Center (CHU Angers)
Angers, 49000
Claire Briet, Prof., +33 2 41 35 42 40, claire.briet@chu-angers.fr
Laureen Milia, +33 2 41 35 67 48, laureen.milia@chu-angers.fr
- Recruiting
Avicenne Hospital
Bobigny, 93000
Ines Barka, Dr., +33616965466, ines.barka@aphp.fr
Emmanuel Cosson, Prof.
- Recruiting
Jean Verdier Hospital
Bondy, 93140
Nadine Lucidarme, Dr., +33 1 48 02 64 70, nadine.lucidarme@aphp.fr
Nadine Lucidarme, Dr.
- Recruiting
Centre Hospitalier Sud Francilien (CHSF)
Corbeil-Essonnes, 91100
Alfred Penfornis, Prof., +33 1 61 69 30 86, alfred.penfornis@chsf.fr
Tiphaine L'Huillier, Dr., +33 1 61 69 34 89, tiphaine.l'huillier@chsf.fr
- Recruiting
DIAB-eCARE Hospices Civils de Lyon
Lyon, 69003
Kevin Perge, Dr., +3372118890, kevin.perge@chu-lyon.fr
Sihem Jouini, CRA, +3372118890, sihem.jouini@chu-lyon.fr
- Recruiting
Centre Hospitalier Universitaire (CHU) de Nice
Nice, 06200
Chokri Hathroubi, +33 4 92 03 54 95, hathroubi.c@chu-nice.fr
Nicolas Chevalier, Prof.
- Recruiting
Nice-Lenval Pediatric Hospitals
Nice, 06200
Cécile Gouillard-Darnaud, Dr., +33 4 92 03 00 10, cecile.gouillard-darnaud@hpu.lenval.com
Ghaleb Zouzou, +33 4 92 03 05 85, zouzou.g@chu-nice.fr
- Recruiting
Hospital Lariboisière APHP
Paris, 75010
Jean-Baptiste Julla, Dr., +33 1 49 95 83 82, jeanbaptiste.julla@aphp.fr
Jean-Pierre Riveline, Prof., +33 6 11 41 61 60, jeanpierre.riveline@aphp.fr
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, 75013
Chloé Amouyal, Dr., +33 1 42 17 81 18, chloe.amouyal@aphp.fr
Marc Popelier, Dr., +33 1 42 17 80 72, marc.popelier@aphp.fr
- Recruiting
Hôpital Européen Georges-Pompidou
Paris, 75015
Alina Radu, Dr., +33 1 56 09 33 15, alina.radu@aphp.fr
Alina Radu, Dr.
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Jacques Beltrand, Prof., +33 1 44 49 48 00, jacques.beltrand@aphp.fr
Alix Besançon, Dr., +33 6 84 10 27 04, alix.besancon@aphp.fr
- Recruiting
Robert Debre University Hospital
Paris, 75019
Élise Bismuth, Dr., + 33 1 40 03 20 67, elise.bismuth@aphp.fr
Alfonso Galderisi, Dr., +39 3331410142, alfonso.galderisi@aphp.fr
- Recruiting
Institut National de la Santé et de la Recherche Médicale
Paris
Anna Jones, +33 7 83303746, DT1.depistage.cch@aphp.fr
Roberto Mallone
- Recruiting
CHRU de Nancy Hôpital de Brabois Enfant
Vandœuvre-lès-Nancy, 54500
Emeline Renard, Dr., +33 3 83 15 45 00, e.renard@chru-nancy.fr
Stephanie Jellimann, Dr., +33 3 83 15 45 00, s.jellimann@chru-nancy.fr
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Martin Tauschmann, Dr., +43-1-40400-32320, martin.tauschmann@meduniwien.ac.at
Birgit Rami-Merhar, Prof., +43-1-40400-32320, birgit.rami-merhar@meduniwien.ac.at
Belgium1 site, 1 recruiting
- Recruiting
Katholieke Universiteit Leuven
Leuven
Principal Investigator - Prof Mathieu, +32 16 34 6994, chantal.mathieu@uzleuven.be
Chantal Mathieu
Czechia1 site, 1 recruiting
- Recruiting
Motol University Hospital
Prague, 150 06
Vít Neuman, Assoc. Prof., + 420 727 971 979, vit.neuman@fnmotol.cz
Barbora Berka, Dr., +420 739 387 425, barbora.berka@fnmotol.cz
Germany1 site, 1 recruiting
- Recruiting
Kompetenzzentrum Diabetes Karlsburg
Greifswald, 17489
Petra Augstein, Dr., +49 3 83 55 70 1397, augsteinp@drguth.de
Petra Augstein, Dr.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital
Milan, 20132
Pauline Study Nurse, +39 02 2643 5257/3176, grogan.pauline@hsr.it
Emanuele Bosi, Prof
Poland1 site, 1 recruiting
- Not yet recruiting
Medical University of Silesia
Katowice
Przemyslawa Jarosz-Chobot, Professor, +48 604 176 773, przemka1@tlen.pl
Department of Children's Diabetology and Lifestyle Medicine, +48 32 207 16 57
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana
Ljubljana
Damjana Nikovski, +386 1 522 3903., damjana.nikovski@kclj.si
Tadej. Battelino
About this study
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.
Read more
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
- Keywords
- Type 1 diabetes, Autoantibodies, Screening, Pre-T1D, Stage 1, Stage 2
- Medical subject headings
- Diabetes Mellitus, Type 1, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of one or more T1D IAb
Blood sample will be tested for anti-GAD, anti-IA-2, anti-insulin, and anti-ZnT8,
Measured: End of 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start25 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- INNODIA iVZW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118098
- Sponsor's protocol ID
- INNODIA DETECT 01
- Acronym
- INNODIA DETECT
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INNODIA Family & Friends Early-Stage T1D Detection Protocol
- ClinicalTrials.gov ID
- NCT07118098
- Acronym / sponsor ID
- INNODIA DETECT / INNODIA DETECT 01
- Conditions
- Type 1 Diabetes (T1D), Pre Diabetes
- Keywords
- Type 1 diabetes, Autoantibodies, Screening, Pre-T1D, Stage 1, Stage 2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- INNODIA iVZWUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Aug 2025 (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 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Family and friends of people living with type 1 Diabetes. People with autoimmune disorders are of particular interest
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Previous diagnosis of stage 3 T1D or other forms of diabetes
- Unable/unwilling to consent to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of one or more T1D IAb
Time frame: End of 2027
Blood sample will be tested for anti-GAD, anti-IA-2, anti-insulin, and anti-ZnT8,
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 24 Aug 2026.
- 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 diabetesLink provided by the sponsor.
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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.
Program Manager contact
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D) and Pre Diabetes, run by INNODIA iVZW at 21 sites in 8 countries.
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 2 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Austria, Belgium, Czechia, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Laura Moreno Belmonte (+393889544246, laura.moreno@innodia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of one or more T1D IAb (time frame: End of 2027). 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 24 Aug 2026.