Efficacy and Safety of Low Dose Insulin Infusion against Standard Dose Insulin Infusion in Children with Diabetic Ketoacidosis- An Open Labelled Randomized Controlled Trial

OBJECTIVE: To compare the efficacy and safety of low dose insulin infusion (0.05 U/kg/h) against the standard dose insulin infusion (0.1 U/kg/h) in children with diabetic ketoacidosis. METHOD: Children (age <12 years, n = 30) presenting with diabetic ketoacidosis were enrolled and randomised to receive insulin infusion either as 0.05 U/kg/h (low dose) or 0.1 U/kg/h (standard dose) as an open labelled randomised controlled trial. The rest of the management was identical in both groups. The time taken for resolution of acidosis (pH ≥7.3 and HCO(3) ≥15) was the primary outcome variable. The secondary outcome variables included the time taken until a decline in blood glucose to 250 mg/dl, the proportion of children developing hypoglycemia and hypokalemia, and any treatment failure. RESULTS: The two groups were similar with respect to mean age, weight and gender distribution. New-onset diabetes was diagnosed on 24/30. The mean ± SD time for resolution of acidosis was similar between the groups; 27.0 ± 6.1 hours in the low dose group vs 23.4 ± 7.3 hours in standard dose group, P = 0.16. The mean time for the decline in blood glucose to 250 mg/dl was 13.0 ± 5.9 hours in low dose vs 11.6 ± 6.0 hours in standard dose group, P = 0.52. A lesser proportion of participants developed hypoglycemia and hypokalemia in the low dose group, though not statistically significant. There was no incidence of treatment failure in either group. CONCLUSION: Low dose insulin infusion is equally effective and safe as standard dose insulin infusion in children with diabetic ketoacidosis.