Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies

NCT07503366 | Not Yet Recruiting

• 1 other identifier: 0010903
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 24

Brief 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). 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.

Conditions

Autoantibodies; Type 1 Diabetes (T1D); 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 10 years from baseline for each participant.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Società Italiana di Endocrinologia e Diabetologia Pediatrica: lead
• Associazione Medici Diabetologi (AMD): collaborator
• Società Italiana di Diabetologia (SID): collaborator

Study Sites (24)

SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche

Ancona, Italy

Location

Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo

Bari, Italy

Location

Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical University

Bolzano, Italy

Location

UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano

Caserta, Italy

Location

UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco"

Catanzaro, Italy

Location

Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio"

Crotone, Italy

Location

SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCS

Florence, Italy

Location

Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San Salvatore

L’Aquila, Italy

Location

Ospedale S. Raffaele

Milan, Italy

Location

Centro Regionale di Diabetologia Pediatrica, UOC Pediatria Specialistica, Dipartimento ad Attività Integrata Materno Infantile, AOU Federico II

Naples, Italy

Location

Ospedale Maggiore della Carità di Novara

Novara, Italy

Location

Azienda Ospedale-Università Padova

Padova, Italy

Location

Ospedale G.Di Cristina - ARNAS Civico di Cristina Benfratelli

Palermo, Italy

Location

UOC Endocrinologia e Malattie del Metabolismo AOU di Parma

Parma, Italy

Location

IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia Pediatrica

Pavia, Italy

Location

Centro di Diabetologia Pediatrica Grande Ospedale Metropolitano

Reggio Calabria, Italy

Location

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Location

UOC Pediatria, Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

S.C. Pediatria, P.O.C SS. Annunziata

Taranto, Italy

Location

Ospedale di Santa Chiara Azienda USL

Trento, Italy

Location

Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca Trevigiana

Treviso, Italy

Location

IRCCS "Ospedale Infantile" Burlo Garofolo

Trieste, Italy

Location

Azienda Ospedaliero Integrata di Verona

Verona, Italy

Location

Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL Viterbo

Viterbo, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Glucose Intolerance; Prediabetic State; Autoimmune Diseases; Stress, Psychological; Disease; Disease Progression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Valentino Cherubini

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

  STUDY CHAIR

Central Study Contacts

Valentino Cherubini, MD

CONTACT

+39.338.3637317; valentino.cherubini@staff.univpm.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2036
• Study Completion (Estimated): April 1, 2036
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

IT (24)