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
- Diseases
- Type 1 diabetes, Type 2 diabetes
- 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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical University Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano Coordinator of this site? Confirm its status | Caserta | Italy | Unknown status |
| UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco" Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio" Coordinator of this site? Confirm its status | Crotone | Italy | Unknown status |
| SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San Salvatore Coordinator of this site? Confirm its status | L’Aquila | Italy | Unknown status |
| Ospedale S. Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown 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 | Naples | Italy | Unknown status |
| Ospedale Maggiore della Carità di Novara Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Ospedale G.Di Cristina - ARNAS Civico di Cristina Benfratelli Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| UOC Endocrinologia e Malattie del Metabolismo AOU di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia Pediatrica Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Centro di Diabetologia Pediatrica Grande Ospedale Metropolitano Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| UOC Pediatria, Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| S.C. Pediatria, P.O.C SS. Annunziata Coordinator of this site? Confirm its status | Taranto | Italy | Unknown status |
| Ospedale di Santa Chiara Azienda USL Coordinator of this site? Confirm its status | Trento | Italy | Unknown status |
| Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca Trevigiana Coordinator of this site? Confirm its status | Treviso | Italy | Unknown status |
| IRCCS "Ospedale Infantile" Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
| Azienda Ospedaliero Integrata di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL Viterbo Coordinator of this site? Confirm its status | Viterbo | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.