Comparison of subcutaneous insulin aspart and intravenous regular insulin for the treatment of mild and moderate diabetic ketoacidosis in pediatric patients

Purpose: To compare the safety/efficacy of intermittent subcutaneous rapid-acting insulin aspart with the standard low-dose intravenous infusion protocol of regular insulin for treatment of pediatric diabetic-ketoacidosis.

Methods: For a prospective randomized-controlled clinical trial on 50 children/adolescents with mild/moderate diabetic-ketoacidosis, the diagnostic criteria for ketoacidosis included: blood glucose level >250 mg/dl, ketonuria>++, venous pH <7.3 and/or bicarbonate <15 mEq/l.

Data collected: age, sex, clinical/laboratory parameters including blood sugar, arterial blood gases, urine ketones, severity of diabetic-ketoacidosis, amount of insulin administered to correct acidosis, time to recover from diabetic-ketoacidosis, number of days of hospitalization, and complications. Patients were randomly assigned to intervention (subcutaneous) and control (intravenous) groups. Controls received 0.05-0.1 unit/kg/hour intravenous regular insulin infusion until resolution of diabetic-ketoacidosis and stayed in the intensive care unit. Interventions received 0.15 unit/kg subcutaneous insulin aspart every two hours and stayed in regular medical ward.

Results: From 50 children (age 2-17 years), 56% (28) were females, and 48% (24) had established-type I diabetes. Intervention and control groups had similar baseline clinical/laboratory findings. Average age (years) was 8.6 ± 0.8 for intervention and 8.86 ± 0.7 for control group (p = 0.4) with 64% having moderate diabetic-ketoacidosis. The mean total-dose of insulin units needed for treatment of diabetic-ketoacidosis in intervention (subcutaneous insulin aspart) was lower than controls (intravenous regular insulin) (p < 0.001). No mortality/serious events happened. Three diabetic-ketoacidosis recurrences among interventions and one among controls occurred.

Conclusions: To manage mild/moderate diabetic-ketoacidosis in children/adolescents, subcutaneous rapid-acting insulin aspart is an alternative to intravenous infusion of regular insulin. Subcutaneous insulin treated moderate DKA with faster recovery/shorter hospital stay.