INNODIA Family & Friends Early-Stage T1D Detection Protocol
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Type 1 Diabetes (T1D), Pre Diabetes. Базовые параметры: 1 год — 45 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия, Бельгия, Чехия, Франция, Германия +3
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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).
Первичные конечные точки
- Presence of one or more T1D IAb [Срок оценки: End of 2027]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Previous diagnosis of stage 3 T1D or other forms of diabetes
- Unable/unwilling to consent to participation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 8 центров
- 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
Австрия · 1 центр
- Medical University of Vienna — Vienna
Бельгия · 1 центр
- Katholieke Universiteit Leuven — Leuven
Чехия · 1 центр
- Motol University Hospital — Prague
Германия · 1 центр
- Kompetenzzentrum Diabetes Karlsburg — Greifswald
Италия · 1 центр
- San Raffaele Hospital — Milan
Польша · 1 центр
- Medical University of Silesia — Katowice
Словения · 1 центр
- University Medical Center Ljubljana — Ljubljana
Идентификаторы
NCT: NCT07118098 · INNODIA DETECT 01