Type 1 Diabetes (T1D)SIRENANCT07503366
Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies
An observational study of Type 1 Diabetes (T1D) and Autoantibodies, run by Società Italiana di Endocrinologia e Diabetologia Pediatrica at 24 sites in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes (T1D), Autoantibodies, Hyperglycemia
- How many people
- 300 participants
- Where
- 24 sitesItaly
- Study dates
- May 2026to Apr 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
Italy24 sites
SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche
Ancona
Valentino Cherubini, +39 071 596 2367, Valentino.Cherubini@ospedaliriuniti.marche.it
Valentino Cherubini
Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo
Bari
Francesco Gallo
Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical University
Bolzano
Petra Reinstadler
UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano
Caserta
Filomena Pascarella
UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco"
Catanzaro
Felice Citriniti
Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio"
Crotone
Nicola Lazzaro
SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCS
Florence
Lorenzo Lenzi
Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San Salvatore
L’Aquila
Maurizio Del Vecchio
Ospedale S. Raffaele
Milan
Riccardo Bonfanti
Centro Regionale di Diabetologia Pediatrica, UOC Pediatria Specialistica, Dipartimento ad Attività Integrata Materno Infantile, AOU Federico II
Naples
Enza Mozzillo
Ospedale Maggiore della Carità di Novara
Novara
Ivana Rabbone
Azienda Ospedale-Università Padova
Padova
Carlo Moretti
Ospedale G.Di Cristina - ARNAS Civico di Cristina Benfratelli
Palermo
Rosalia Roppolo
UOC Endocrinologia e Malattie del Metabolismo AOU di Parma
Parma
Alessandra Dei Cas
IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia Pediatrica
Pavia
Carmelo Pistone
Centro di Diabetologia Pediatrica Grande Ospedale Metropolitano
Reggio Calabria
Maria Carmela Lia
Ospedale Pediatrico Bambino Gesù
Roma
Riccardo Schiaffini
UOC Pediatria, Casa Sollievo della Sofferenza
San Giovanni Rotondo
Irene Rutigliano
S.C. Pediatria, P.O.C SS. Annunziata
Taranto
Ospedale di Santa Chiara Azienda USL
Trento
Roberto Franceschi
Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca Trevigiana
Treviso
Anna Corò
IRCCS "Ospedale Infantile" Burlo Garofolo
Trieste
Gianluca Tornese
Azienda Ospedaliero Integrata di Verona
Verona
Claudio Maffeis
Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL Viterbo
Viterbo
Claudia Arnaldi
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes (T1D), Autoantibodies, Hyperglycemia, Impaired Glucose Tolerance (Prediabetes)
- Keywords
- Diabetes Mellitus, Type 1, Autoantibodies, Islets of Langerhans, Autoimmune Diseases, Hyperglycemia, Impaired Glucose Tolerance, C-Peptide, Oral Glucose Tolerance Test, Continuous Glucose Monitoring, Psychological Stress, Early Diagnosis, Disease Progression, Presymptomatic Type 1 Diabetes, Type 1 Diabetes Stage 1, Type 1 Diabetes Stage 2, Type 1 Diabetes Stage 3
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia, Glucose Intolerance, Prediabetic State, Autoimmune Diseases, Stress, Psychological, Disease, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to Stage 3 Type 1 Diabetes
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.
Measured: Up to 10 years from baseline for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2036 (estimated)
- Study completionApr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Società Italiana di Endocrinologia e Diabetologia Pediatrica
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Medici Diabetologi (AMD), Società Italiana di Diabetologia (SID)
- Responsible party
- Sponsor
- Investigators
- Valentino Cherubini, Study chair, SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503366
- Sponsor's protocol ID
- 0010903
- Acronym
- SIRENA
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cherubini V, Gesuita R, Mozzillo E, Buzzetti R, Candido R, De Cosmo S, Ghiani M, Maddaloni E, Pintaudi B, Rabbone I; Italian Society for Pediatric Endocrinology and Diabetology (ISPED), Italian Society of Diabetology (SID), and the Italian Association of Diabetologists [Associazione Medici Diabetologi (AMD)].. SIRENA protocol: an Italian, prospective, multicentre cohort study of children and adults with islet autoimmunity and early-stage type 1 diabetes. BMJ Open. 2026 Sep 21;16(9):e124606. doi: 10.1136/bmjopen-2026-124606.
PubMed 42767751
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies (SIRENA)
- ClinicalTrials.gov ID
- NCT07503366
- Acronym / sponsor ID
- SIRENA / 0010903
- Conditions
- Type 1 Diabetes (T1D), Autoantibodies, Hyperglycemia, Impaired Glucose Tolerance (Prediabetes)
- Keywords
- Diabetes Mellitus, Type 1, Autoantibodies, Islets of Langerhans, Autoimmune Diseases, Hyperglycemia, Impaired Glucose Tolerance, C-Peptide, Oral Glucose Tolerance Test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Società Italiana di Endocrinologia e Diabetologia PediatricaUniversity, hospital or other
- Collaborators
- Associazione Medici Diabetologi (AMD), Società Italiana di Diabetologia (SID)
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2036 (estimated)
- Study completion
- Apr 2036 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 42767751Cherubini V, Gesuita R, Mozzillo E, Buzzetti R, Candido R, De Cosmo S, Ghiani M, Maddaloni E, Pintaudi B, Rabbone I; Italian Society for Pediatric Endocrinology and Diabetology (ISPED), Italian Society of Diabetology (SID), and the Italian Association of Diabetologists [Associazione Medici Diabetologi (AMD)].. SIRENA protocol: an Italian, prospective, multicentre cohort study of children and adults with islet autoimmunity and early-stage type 1 diabetes. BMJ Open. 2026 Sep 21;16(9):e124606. doi: 10.1136/bmjopen-2026-124606.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentino Cherubini study chair
SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D) and Autoantibodies, run by Società Italiana di Endocrinologia e Diabetologia Pediatrica at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentino Cherubini, MD (+39.338.3637317, valentino.cherubini@staff.univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to Stage 3 Type 1 Diabetes (time frame: Up to 10 years from baseline for each participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.