An observational study in Type 1 Diabetes (T1D), Autoantibodies and Hyperglycemia, sponsored by Società Italiana di Endocrinologia e Diabetologia Pediatrica. Not yet recruiting at 24 sites in Italy. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Società Italiana di Endocrinologia e Diabetologia Pediatrica · Observational
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 300 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →This is the only study on the registry with Società Italiana di Endocrinologia e Diabetologia Pediatrica as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Up to 10 years from baseline for each participant.
Start is estimated for May 2026; primary completion for Apr 2036, 119 months later.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 119 months is above that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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