Efficacy and safety of two protocols of intravenous insulin therapy in the management of diabetic ketoacidosis.

INTRODUCTION: The correction of insulin deficiency in ketoacidosis DKA is recommended by intravenous (IV) route. Despite abundant literature, the place of the initial bolus of insulin has remained controversial. AIMS: This study was designed to compare the safety and the efficacy of two protocols of intravenous (IV) insulin therapy in the management of DKA admitted in the emergency department. Protocol (A): IV bolus of regular insulin 0.10 UI/Kg followed by a continuous IV infusion of insulin 0.10 UI/kg/H. Protocol (B): No bolus, a continuous IV infusion of regular insulin 0.14 UI/kg/H. METHODS: This was a prospective, not blinded, randomized study including patients aged more than 16 years with moderate to severe DKA. Fluid therapy and potassium replacement were standardized. Patients were randomized into two groups: Bolus-maintenance 0.10 group received protocol (A) and Maintenance 0.14 group received protocol (B). The Primary outcome data was the time to recovery defined by the time to acidosis resolution. The safety was tested by the occurrence of complications: hypoglycemia and hypokalemia. RESULTS: We enrolled 129 consecutive DKA patients. There were no differences between the two groups in clinical and biochemical data on admission, Bolus-maintenance 0.10 group versus Maintenance 0.14 group: mean age (37±18 vs. 38±17 years; p=0.810), Type 1 diabetes n (%): 34(55.7) vs. 34(50); p=0.911, pH (7.14±0.13 vs. 7.15±0.12; p=0.43). There were no differences between the two groups in the outcomes data: Bolus-maintenance 0.10 group versus Maintenance 0.14 group: Time to recovery (17 vs. 16 hours; p=0.76), complication n (%): Hypoglycemia (7(11.5) vs. 10(15.9); p=0.57) and hypokalemia (32(56.1) vs. 30(46.9); p=0.30). CONCLUSION: In the treatment of diabetic ketoacidosis, the two protocols of IV insulin were safe and had a comparable efficiency.