Autoantibodies, Hyperglycemia, Impaired Glucose Tolerance (Prediabetes), Type 1 Diabetes (T1D)
Conditions
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
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.
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.
Interventions
None listed
Sponsors
Società Italiana di Endocrinologia e Diabetologia Pediatrica
Associazione Medici Diabetologi (AMD)
Società Italiana di Diabetologia (SID)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression to Stage 3 Type 1 Diabetes | 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. |
Countries
Italy
Contacts
CONTACTValentino Cherubini, MD
STUDY_CHAIRValentino Cherubini
SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy
Outcome results
None listed