In this study, glycemic control, diabetes care indices and quality of life (QoL) were assessed in 2 groups of newly diagnosed Type 1 diabetic subjects <6 yr old who were randomized to multiple daily injections with (Group A) or without (Group B) an indwelling catheter. Group A [12 males (M)/8 females (F), mean age 3.2+/-1.4 yr] and Group B (9M/11F, mean age 3.9+/-1.8 yr) were evaluated at baseline and after 6 and 12 months of treatment. No significant difference was observed in metabolic control (glycosylated hemoglobin) or in the number of hypoglycemic events between the groups. Patients in Group A had a greater number of daily insulin injections, monitored blood glucose more frequently and had a lower total daily insulin dose per kg (p<0.05). QoL was better in group A. At the end of the study 30% of group A patients progressed to continuous sc insulin infusion (CSII), while no child in Group B switched to a different insulin regimen. Based on these findings, indwelling catheter therapy may be helpful for selected CSII candidates.