Comparison of Two Different Doses of Insulin in Pediatric Diabetic Ketoacidosis - A Randomized Controlled Trial

Abstract

Diabetic Ketoacidosis (DKA) is a life-threatening acute metabolic complication of diabetes mellitus. Currently, the treatment of DKA relies on the administration of regular insulin by continuous intravenous infusion. However, the standard recommended dose (0.1 U/kg per hour) of insulin in diabetic ketoacidosis (DKA) guidelines is not supported by strong clinical evidence. The present investigation was carried out with the aim to compare two different doses (0.05 v/s 0.1 U/Kg/hr.) of insulin in pediatric diabetic ketoacidosis in terms of safety and efficacy. The present prospective, open-label randomized clinical trial was conducted in Pediatric intensive care unit of Guru Gobind Singh Medical College and Hospital, Faridkot (CTRI/2018/05/014040). A total of 50 children ≤14 years with diabetic ketocidosis were randomized to low-dose (n=25) and standard-dose (n=25) groups. Insulin therapy was started as a continuous I.V. infusion, 1 hour after initial fluid therapy at 0.05 U/kg/h in low-dose and at 0.1 U/kg/h in standard-dose group. Rate of fall of blood glucose and time taken to resolve acidosis were measured. Rate of fall of blood glucose till the target blood glucose (≤250 mg/dL) was reached was 45.32±16.14 mg/dL/hr. in low-dose v/s 48.99±17.36 mg/dL/hr. in standard-dose group (with p-value=0.44, Non Significant). Time taken to achieve this target was comparable in both the groups with 7.00±3.71 hours in low-dose v/s 6.96± 4.12 hours in standard-dose group, (p-value=0.971, Non Significant). Time taken to achieve resolution of acidosis was higher (18.08±5.78 hours) in low-dose and lower (17.12± 8.28 hours) in standard-dose group (p-value=0.637, Non Significant). Although statistically insignificant, incidence of hypokalemia (56% v/s 76%) and hypoglycemia (0 v/s 12%) were lower in the low-dose as compared to standard-dose group respectively. Low-dose and standard-dose insulin therapy had similar efficacy in treatment of pediatric DKA, with comparatively lesser therapy-related complications.