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NCT07503366Not yet recruiting

Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies

Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies (SIRENA)

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
25 Mar 2026
Start date
May 2026
Primary completion date
Apr 2036
Lead sponsor
Società Italiana di Endocrinologia e Diabetologia Pediatrica
NCT number
NCT07503366

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From May 2026 to the primary completion date, Apr 2036
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior diagnosis of type 1 or type 2 diabetes.

Other illness

  • 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.

Lab values

  • Fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg/dL.

Other

  • Inability or unwillingness to provide informed consent.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche
Coordinator of this site? Confirm its status
AnconaItalyUnknown status
Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo
Coordinator of this site? Confirm its status
BariItalyUnknown status
Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical University
Coordinator of this site? Confirm its status
BolzanoItalyUnknown status
UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano
Coordinator of this site? Confirm its status
CasertaItalyUnknown status
UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco"
Coordinator of this site? Confirm its status
CatanzaroItalyUnknown status
Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio"
Coordinator of this site? Confirm its status
CrotoneItalyUnknown status
SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCS
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San Salvatore
Coordinator of this site? Confirm its status
L’AquilaItalyUnknown status
Ospedale S. Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Centro Regionale di Diabetologia Pediatrica, UOC Pediatria Specialistica, Dipartimento ad Attività Integrata Materno Infantile, AOU Federico II
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
Ospedale Maggiore della Carità di Novara
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NovaraItalyUnknown status
Azienda Ospedale Universita Padova
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PadovaItalyUnknown status
Ospedale G.Di Cristina - ARNAS Civico di Cristina Benfratelli
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PalermoItalyUnknown status
UOC Endocrinologia e Malattie del Metabolismo AOU di Parma
Coordinator of this site? Confirm its status
ParmaItalyUnknown status
IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia Pediatrica
Coordinator of this site? Confirm its status
PaviaItalyUnknown status
Centro di Diabetologia Pediatrica Grande Ospedale Metropolitano
Coordinator of this site? Confirm its status
Reggio CalabriaItalyUnknown status
Ospedale Pediatrico Bambino Gesù
Coordinator of this site? Confirm its status
RomaItalyUnknown status
UOC Pediatria, Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyUnknown status
S.C. Pediatria, P.O.C SS. Annunziata
Coordinator of this site? Confirm its status
TarantoItalyUnknown status
Ospedale di Santa Chiara Azienda USL
Coordinator of this site? Confirm its status
TrentoItalyUnknown status
Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca Trevigiana
Coordinator of this site? Confirm its status
TrevisoItalyUnknown status
IRCCS "Ospedale Infantile" Burlo Garofolo
Coordinator of this site? Confirm its status
TriesteItalyUnknown status
Azienda Ospedaliero Integrata di Verona
Coordinator of this site? Confirm its status
VeronaItalyUnknown status
Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL Viterbo
Coordinator of this site? Confirm its status
ViterboItalyUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.