Following people with islet autoantibodies to see who develops type 1 diabetes
Follows children and adults with islet autoantibodies for up to 10 years.
Plain-language title generated from the registry record
Registry title: Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies
Key facts
- Where
- Ancona, Bari, Bolzano, Caserta, Catanzaro, Crotone, Florence, L’Aquila, Milan, Naples, Novara, Padova, Palermo, Parma, Pavia, Reggio Calabria, Roma, San Giovanni Rotondo, Taranto, Trento, Treviso, Trieste, Verona, and Viterbo, ItalySee the 24 sites
Where in Italy
- SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle MarcheAncona, ItalyNo longer taking part
- Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San PaoloBari, ItalyNo longer taking part
- Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical UniversityBolzano, ItalyNo longer taking part
- UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San SebastianoCaserta, ItalyNo longer taking part
- UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco"Catanzaro, ItalyNo longer taking part
- Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio"Crotone, ItalyNo longer taking part
- SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCSFlorence, ItalyNo longer taking part
- Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San SalvatoreL’Aquila, ItalyNo longer taking part
- Ospedale S. RaffaeleMilan, ItalyNo longer taking part
- Centro Regionale di Diabetologia Pediatrica, UOC Pediatria Specialistica, Dipartimento ad Attività Integrata Materno Infantile, AOU Federico IINaples, ItalyNo longer taking part
- Ospedale Maggiore della Carità di NovaraNovara, ItalyNo longer taking part
- Azienda Ospedale Universita PadovaPadova, ItalyNo longer taking part
- Ospedale G.Di Cristina - ARNAS Civico di Cristina BenfratelliPalermo, ItalyNo longer taking part
- UOC Endocrinologia e Malattie del Metabolismo AOU di ParmaParma, ItalyNo longer taking part
- IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia PediatricaPavia, ItalyNo longer taking part
- Centro di Diabetologia Pediatrica Grande Ospedale MetropolitanoReggio Calabria, ItalyNo longer taking part
- Ospedale Pediatrico Bambino GesùRoma, ItalyNo longer taking part
- UOC Pediatria, Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyNo longer taking part
- S.C. Pediatria, P.O.C SS. AnnunziataTaranto, ItalyNo longer taking part
- Ospedale di Santa Chiara Azienda USLTrento, ItalyNo longer taking part
- Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca TrevigianaTreviso, ItalyNo longer taking part
- IRCCS "Ospedale Infantile" Burlo GarofoloTrieste, ItalyNo longer taking part
- Azienda Ospedaliero Integrata di VeronaVerona, ItalyNo longer taking part
- Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL ViterboViterbo, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Società Italiana di Endocrinologia e Diabetologia Pediatrica
- Trial code
- NCT07503366
- Record updated
- 8 April 2026
- Original description
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.Read full original descriptionShow less
Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies (SIRENA)
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.
Inclusion: 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.
Exclusion: Prior diagnosis of type 1 or type 2 diabetes; 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; Fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg/dL; Inability or unwillingness to provide informed consent.