Clinical characteristics and metabolic control in a large cohort of children with Type 1 diabetes (T1DM) were evaluated. Fifty-three Italian centers for childhood diabetes collected blood samples and clinical records from 3560 consecutive eligible patients aged 1.6-17.10 yr with disease duration >12 months. HbA1c determinations were centralized in a Diabetes Control and Complications Trial-controlled laboratory. HbA1c grand mean was 8.87 +/- 1.77%. Thirty-two percent of the patients had HbA1c values <8.0%. Puberty and disease duration were the main determinants of increase in HbA1c levels (<0.001). HbA1c values were inversely correlated to the frequency of blood glucose monitoring (p<0.001). Among the total population, 53.7% of the patients had 4 or more injections per day, 37.8% three injections, 7.4% < or =2 injections and only 1.1% was on pumps. Daily number of injections increased with age (p<0.001). Hypoglycemia episodes were reported in 17.6% patient-years and diabetic ketoacidosis (DKA) in 1.0% of children, more frequently in those with HbA1c >8.8% (p<0.02). Two thirds of Italian children with T1DM have HbA1c>8% despite regionalized centers, multidisciplinary team approach, free access to appropriate diabetes care, education, frequent blood glucose monitoring and multiple insulin injections.