Prospective randomized trial of insulin glargine in acute management of diabetic ketoacidosis in the emergency department: a pilot study

Objectives: The objective was to determine the efficacy of coadministration of subcutaneous (SQ) insulin glargine in combination with intravenous (IV) insulin for treating diabetic ketoacidosis (DKA).

Methods: This was a prospective, randomized, controlled trial comparing coadministration of insulin glargine and IV insulin (experimental) with IV insulin (standard care control). The setting was emergency departments (EDs) in two hospitals in Houston, Texas. Patients presenting with blood sugar ≥ 200 mg/dL, pH ≤ 7.3, bicarbonate (HCO3 ) ≤ 18 mg/dL, ketonemia or ketonuria, and anion gap ≥ 16 between November 2012 and April 2013 were enrolled. All patients received IV insulin. Additionally, the experimental group was given SQ insulin glargine within 2 hours of diagnosis. Upon closure of anion gap, patients in the control group were subsequently transitioned to long-acting insulin. In the study group, IV insulin was discontinued and long-acting SQ insulin was reinstituted 24 hours after initial introduction. The primary outcome of time to closure of anion gap (TCAG) was compared between groups using a general linear model (GLM), adjusting for initial anion gap, etiology, and presence of comorbidities. Similarly, the secondary outcome hospital length of stay (LOS) was adjusted for age, etiology, and hospital site in the GLM. Rate of hypoglycemia and intensive care unit (ICU) admission was compared using Fisher's exact test while ICU LOS was compared using Wilcoxon's two-sample test.

Results: A total of 40 patients were enrolled in this pilot trial. The estimated mean TCAG was 10.2 hours (SE ± 6.8 hours) in the experimental group and 11.6 hours (SE ± 6.4 hours) in the control group (p = 0.63). The estimated mean hospital LOS was 3.9 days (SE ± 3.4 days) in the experimental group and 4.8 days (SE ± 3.6 days) in the control group (p = 0.66). Incidents of hypoglycemia, rates of ICU admission, and ICU LOS were similar between the groups.

Conclusions: Coadministration of glargine in combination with an insulin infusion in the acute management of DKA is feasible. Further study is needed to determine the true efficacy in terms of TCAG and hospital LOS.