Efficacy and safety of reduced-dose insulin infusion in pediatric diabetic ketoacidosis: a randomized clinical trial.

Diabetic ketoacidosis (DKA) management in children traditionally employs insulin infusion rates of 0.1 units/kg/h, though emerging evidence suggests lower doses may achieve comparable outcomes with enhanced safety profiles. This study aimed to determine whether reduced-dose insulin therapy (0.05 units/kg/h) demonstrates non-inferiority compared to conventional dosing in pediatric DKA management. We conducted a prospective randomized controlled trial involving 70 children presenting with DKA at our pediatric intensive care unit between January and December 2018. Participants were randomly assigned to receive either reduced-dose insulin infusion (0.05 units/kg/h, n = 35) or standard-dose therapy (0.1 units/kg/h, n = 35). Both treatment approaches demonstrated comparable efficacy in achieving metabolic correction. Time to acidosis resolution showed no significant difference between reduced-dose and standard-dose groups (10.2 ± 5.29 vs. 11.22 ± 5.04 h, p = 0.407). However, the reduced-dose protocol exhibited superior safety characteristics, with significantly lower hypokalemia incidence (20.0% vs. 42.9%, p = 0.039) and reduced hypoglycemia rates (11.4% vs. 25.7%). Total insulin consumption was 50% lower in the reduced-dose group. In conclusion, reduced-dose insulin therapy demonstrates non-inferiority to conventional dosing while providing enhanced safety benefits, supporting consideration of lower insulin dosing strategies, particularly in resource-limited settings.