Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies
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), Autoantibodies, Hyperglycemia, Impaired Glucose Tolerance (Prediabetes). Базовые параметры: Без ограничений · 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies (SIRENA)
Обзор
This project characterizes the longitudinal progression of children and adults who have tested positive for one or more islet cell autoantibodies across the early stages of type 1 diabetes (T1D). Despite advances in screening, limited evidence exists on how clinical, metabolic, and immunological markers evolve over time and predict progression to symptomatic disease. Using a screened cohort, participants are followed for up to 10 years with repeated standardized assessments. The study evaluates whether population-based screening can reduce diabetic ketoacidosis (DKA) at diagnosis and identify early predictors of progression to clinical T1D. Results are expected to improve risk stratification, inform surveillance strategies, and guide the timing of preventive interventions, with implications for clinical practice and health policy.
Подробное описание
This is a multicenter, prospective, observational study of individuals who have tested positive for one or more islet cell autoantibodies and do not have clinical diabetes at enrolment. Participants undergo longitudinal follow-up for up to 10 years in accordance with standard clinical practice. Follow-up assessments include measures of glucose metabolism (fasting plasma glucose, HbA1c, oral glucose tolerance test \[OGTT\], and C-peptide), repeated islet cell autoantibody testing, and documentation of autoimmune comorbidities. Where available, continuous glucose monitoring (CGM) may be used to detect early dysglycemia. Psychological well-being is assessed at predefined intervals using validated instruments.
Data are collected and managed through a secure REDCap platform with pseudonymization and built-in quality control procedures.
No experimental interventions are planned; all evaluations are performed as part of routine care.
The study is approved by the National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions (CEN), and written informed consent is obtained from all participants or, where applicable, from a parent or legal guardian.
Первичные конечные точки
- Progression to Stage 3 Type 1 Diabetes [Срок оценки: Up to 10 years from baseline for each participant.]
Критерии участия
Критерии включения
- Individuals of any age who test positive for at least one islet autoantibody.
- Absence of clinical symptoms of diabetes.
- Do not meet ADA diagnostic criteria for diabetes (no overt hyperglycemia).
- Ability to comply with follow-up procedures according to clinical practice.
- Written informed consent obtained from the participant or, for minors, from a parent or legal guardian.
Критерии исключения
- Prior diagnosis of type 1 or type 2 diabetes.
- Fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg/dL.
- Presence of symptoms suggestive of diabetes (e.g., polyuria, polydipsia, unexplained weight loss, fatigue, visual disturbances, acetone breath, Kussmaul respiration).
- Any medical or psychological condition judged by the investigator to interfere with study participation or data reliability.
- Inability or unwillingness to provide informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 24 центра
- SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche — Ancona
- Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo — Bari
- Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsu — Bolzano
- UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano — Caserta
- UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco" — Catanzaro
- Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni d — Crotone
- SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCS — Florence
- Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San Salvatore — L’Aquila
- … и ещё 16 центров
Идентификаторы
NCT: NCT07503366 · 0010903