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

April 2, 2026 updated by: Società Italiana di Endocrinologia e Diabetologia Pediatrica

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy
        • SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche
        • Principal Investigator:
          • Valentino Cherubini
        • Contact:
      • Bari, Italy
        • Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo
        • Principal Investigator:
          • Francesco Gallo
      • Bolzano, Italy
        • Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical University
        • Principal Investigator:
          • Petra Reinstadler
      • Caserta, Italy
        • UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano
        • Principal Investigator:
          • Filomena Pascarella
      • Catanzaro, Italy
        • UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco"
        • Principal Investigator:
          • Felice Citriniti
      • Crotone, Italy
        • Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio"
        • Principal Investigator:
          • Nicola Lazzaro
      • Florence, Italy
        • SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCS
        • Principal Investigator:
          • Lorenzo Lenzi
      • L’Aquila, Italy
        • Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San Salvatore
        • Principal Investigator:
          • Maurizio Del Vecchio
      • Milan, Italy
        • Ospedale S. Raffaele
        • Principal Investigator:
          • Riccardo Bonfanti
      • Naples, Italy
        • Centro Regionale di Diabetologia Pediatrica, UOC Pediatria Specialistica, Dipartimento ad Attività Integrata Materno Infantile, AOU Federico II
        • Principal Investigator:
          • Enza Mozzillo
      • Novara, Italy
        • Ospedale Maggiore della Carità di Novara
        • Principal Investigator:
          • Ivana Rabbone
      • Padova, Italy
        • Azienda Ospedale-Universita Padova
        • Principal Investigator:
          • Carlo Moretti
      • Palermo, Italy
        • Ospedale G.Di Cristina - ARNAS Civico di Cristina Benfratelli
        • Principal Investigator:
          • Rosalia Roppolo
      • Parma, Italy
        • UOC Endocrinologia e Malattie del Metabolismo AOU di Parma
        • Principal Investigator:
          • Alessandra Dei Cas
      • Pavia, Italy
        • IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia Pediatrica
        • Principal Investigator:
          • Carmelo Pistone
      • Reggio Calabria, Italy
        • Centro di Diabetologia Pediatrica Grande Ospedale Metropolitano
        • Principal Investigator:
          • Maria Carmela Lia
      • Roma, Italy
        • Ospedale Pediatrico Bambino Gesu
        • Principal Investigator:
          • Riccardo Schiaffini
      • San Giovanni Rotondo, Italy
        • UOC Pediatria, Casa Sollievo della Sofferenza
        • Principal Investigator:
          • Irene Rutigliano
      • Taranto, Italy
        • S.C. Pediatria, P.O.C SS. Annunziata
      • Trento, Italy
        • Ospedale di Santa Chiara Azienda USL
        • Principal Investigator:
          • Roberto Franceschi
      • Treviso, Italy
        • Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca Trevigiana
        • Principal Investigator:
          • Anna Corò
      • Trieste, Italy
        • IRCCS "Ospedale Infantile" Burlo Garofolo
        • Principal Investigator:
          • Gianluca Tornese
      • Verona, Italy
        • Azienda Ospedaliero Integrata di Verona
        • Principal Investigator:
          • Claudio Maffeis
      • Viterbo, Italy
        • Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL Viterbo
        • Principal Investigator:
          • Claudia Arnaldi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes children, adolescents, and adults who have tested positive for at least one islet cell autoantibody through population-based screening, family screening, routine clinical evaluation, or targeted screening of individuals with autoimmune conditions or incidental dysglycemia. Eligible participants are in the pre-symptomatic stages of T1D, without clinical signs of disease and not meeting diagnostic criteria for diabetes at enrollment. Recruitment occurs at pediatric and adult diabetes centers participating in the national study network. The resulting dataset also provides a resource for future analyses of the clinical and psychological outcomes associated with pre-symptomatic T1D.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to Stage 3 Type 1 Diabetes
Time Frame: Up to 10 years from baseline for each participant.
Proportion of participants who progress from pre-symptomatic stages (pre-stage 1, stage 1, or stage 2) to clinical stage 3 type 1 diabetes, defined according to ADA diagnostic criteria based on hyperglycemia with or without symptoms. Progression is identified using routine metabolic assessments and clinical evaluation.
Up to 10 years from baseline for each participant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Società Italiana di Endocrinologia e Diabetologia Pediatrica

Collaborators

Associazione Medici Diabetologi (AMD)
Società Italiana di Diabetologia (SID)

Investigators

  • Study Chair: Valentino Cherubini, SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 1, 2036

Study Completion (Estimated)

April 1, 2036

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0010903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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