title: Prospective randomized trial of insulin glargine in acute management of diabetic ketoacidosis in the emergency department: a pilot study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.
authors.forename: Pratik
authors.initials: P
authors.lastname: Doshi
authors.affiliation: Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Potter
authors.affiliation: Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.
authors.forename: Daniel
authors.initials: D
authors.lastname: De Los Santos
authors.affiliation: Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.
authors.forename: Rosa
authors.initials: R
authors.lastname: Banuelos
authors.affiliation: University of Texas Medical School at Houston, Houston, TX.
authors.forename: Bryan F
authors.initials: BF
authors.lastname: Darger
authors.affiliation: Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.
authors.forename: Yashwant
authors.initials: Y
authors.lastname: Chathampally
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D001786:Blood Glucose; D016883:Diabetic Ketoacidosis / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D004636:Emergency Service, Hospital; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000627:therapeutic use; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000627:therapeutic use*; D007662:Ketosis / Q000188:drug therapy; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D016037:Single-Blind Method; D013781:Texas
chemical_list: D001786:Blood Glucose; D007328:Insulin; D000069036:Insulin Glargine