INNODIA Family & Friends Early-Stage T1D Detection Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Pre Diabetes. Basic parameters: 1 year — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Czechia, France, Germany +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Primary outcome measures
- Presence of one or more T1D IAb [Time frame: End of 2027]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Previous diagnosis of stage 3 T1D or other forms of diabetes
- Unable/unwilling to consent to participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 8 centers
- Angers University Hospital Center (CHU Angers) — Angers
- Nice-Lenval Pediatric Hospitals — Nice
- Hôpital Pitié-Salpêtrière — Paris
- Hôpital Européen Georges-Pompidou — Paris
- Hôpital Necker-Enfants Malades — Paris
- Robert Debre University Hospital — Paris
- Institut National de la Santé et de la Recherche Médicale — Paris
- CHRU de Nancy Hôpital de Brabois Enfant — Vandœuvre-lès-Nancy
Austria · 1 center
- Medical University of Vienna — Vienna
Belgium · 1 center
- Katholieke Universiteit Leuven — Leuven
Czechia · 1 center
- Motol University Hospital — Prague
Germany · 1 center
- Kompetenzzentrum Diabetes Karlsburg — Greifswald
Italy · 1 center
- San Raffaele Hospital — Milan
Poland · 1 center
- Medical University of Silesia — Katowice
Slovenia · 1 center
- University Medical Center Ljubljana — Ljubljana
Identifiers
NCT: NCT07118098 · INNODIA DETECT 01