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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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and adults who tested positive for at least one islet autoantibody but do not have diabetes yet. They are followed for up to 10 years.

Age
Any age.
Sex
All sexes can join.
Disease stage
Early stage of type 1 diabetes: islet autoantibody positive, no symptoms of diabetes, and no overt high blood sugar.
Biomarker or test result
At least one positive islet autoantibody test.

Main reasons for not taking part

  • Earlier diagnosis of type 1 or type 2 diabetes
  • Fasting plasma glucose of 126 mg/dL (7 mmol/L) or more, HbA1c of 6.5% (48 mmol/mol) or more, or OGTT 2-hour glucose of 200 mg/dL (11.1 mmol/L) or more
  • Symptoms that suggest diabetes, such as polyuria, polydipsia or unexplained weight loss
  • A medical or psychological condition that the investigator thinks would interfere with taking part
  • Cannot or does not want to give informed consent

Read by machine on 13 November 2026.

Where in Italy

  • SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle MarcheAncona, ItalyContact: Valentino CherubiniNo longer taking part
  • Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San PaoloBari, ItalyContact: Francesco Gallo (principal investigator)No longer taking part
  • Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical UniversityBolzano, ItalyContact: Petra Reinstadler (principal investigator)No longer taking part
  • UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San SebastianoCaserta, ItalyContact: Filomena Pascarella (principal investigator)No longer taking part
  • UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco"Catanzaro, ItalyContact: Felice Citriniti (principal investigator)No longer taking part
  • Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio"Crotone, ItalyContact: Nicola Lazzaro (principal investigator)No longer taking part
  • SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCSFlorence, ItalyContact: Lorenzo Lenzi (principal investigator)No longer taking part
  • Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San SalvatoreL’Aquila, ItalyContact: Maurizio Del Vecchio (principal investigator)No longer taking part
  • Ospedale S. RaffaeleMilan, ItalyContact: Riccardo Bonfanti (principal investigator)No longer taking part
  • Centro Regionale di Diabetologia Pediatrica, UOC Pediatria Specialistica, Dipartimento ad Attività Integrata Materno Infantile, AOU Federico IINaples, ItalyContact: Enza Mozzillo (principal investigator)No longer taking part
  • Ospedale Maggiore della Carità di NovaraNovara, ItalyContact: Ivana Rabbone (principal investigator)No longer taking part
  • Azienda Ospedale Universita PadovaPadova, ItalyContact: Carlo Moretti (principal investigator)No longer taking part
  • Ospedale G.Di Cristina - ARNAS Civico di Cristina BenfratelliPalermo, ItalyContact: Rosalia Roppolo (principal investigator)No longer taking part
  • UOC Endocrinologia e Malattie del Metabolismo AOU di ParmaParma, ItalyContact: Alessandra Dei Cas (principal investigator)No longer taking part
  • IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia PediatricaPavia, ItalyContact: Carmelo Pistone (principal investigator)No longer taking part
  • Centro di Diabetologia Pediatrica Grande Ospedale MetropolitanoReggio Calabria, ItalyContact: Maria Carmela Lia (principal investigator)No longer taking part
  • Ospedale Pediatrico Bambino GesùRoma, ItalyContact: Riccardo Schiaffini (principal investigator)No longer taking part
  • UOC Pediatria, Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyContact: Irene Rutigliano (principal investigator)No longer taking part
  • S.C. Pediatria, P.O.C SS. AnnunziataTaranto, ItalyContact: Valentino Cherubini, MDNo longer taking part
  • Ospedale di Santa Chiara Azienda USLTrento, ItalyContact: Roberto Franceschi (principal investigator)No longer taking part
  • Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca TrevigianaTreviso, ItalyContact: Anna Corò (principal investigator)No longer taking part
  • IRCCS "Ospedale Infantile" Burlo GarofoloTrieste, ItalyContact: Gianluca Tornese (principal investigator)No longer taking part
  • Azienda Ospedaliero Integrata di VeronaVerona, ItalyContact: Claudio Maffeis (principal investigator)No longer taking part
  • Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL ViterboViterbo, ItalyContact: Claudia Arnaldi (principal investigator)No longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT07503366