Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoantibodies Autoimmune Diseases Behavior Behavioral Symptoms Diabetes Mellitus Diabetes Mellitus, Type 1 Disease Disease Attributes Disease Progression Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Immune System Diseases Impaired Glucose Tolerance (Prediabetes) Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prediabetic State Stress, Psychological

Sex eligibility

All sexes

Study type

Observational

Primary location

SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Valentino Cherubini, MD

CONTACT

[email protected]

+39.338.3637317

Sponsors and collaborators

Lead sponsor

Società Italiana di Endocrinologia e Diabetologia Pediatrica

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SIRENA

Important dates

Study start: 2026
Primary completion: 2036
Study completion: 2036
First posted: Mar 31, 2026
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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