title: Computerization of the Yale insulin infusion protocol and potential insights into causes of hypoglycemia with intravenous insulin.
abstract: BACKGROUND
  The management of critically ill hyperglycemic patients in the intensive care unit (ICU) has been fraught with recent controversy. Only one randomized trial has demonstrated a mortality benefit to intensive glycemic control, with all subsequent studies failing to confirm this benefit and revealing a markedly increased risk of severe hypoglycemia (SH) in intensively treated patients. In most of these trials, adherence to the protocols were neither tracked nor reported.
  
  
  METHODS
  A retrospective analysis of all patients admitted to an ICU who were treated with an insulin infusion directed by the GlucoCare™ IGC System, an FDA-cleared insulin-dosing calculator (Yale 100-140 mg/dL protocol). Mean blood glucose (BG) levels, time to target range and incidence of SH (<40 mg/dL) and moderate hypoglycemia (MH) (40-69 mg/dL) were determined, and potential causes of hypoglycemic episodes were assessed.
  
  
  RESULTS
  Mean post-target BG was approximately 123 mg/dL. Of >55,000 readings in 1,657 patients, overall incidence of SH was 0.01% of readings and 0.3% of patients. MH occurred in 1.1% of readings and 17.6% of patients. The top potential causes of MH were: (1) Protocol-directed recommendations including continuation of insulin with BG <100 mg/dL and decreases in the frequency of BG checks (63.7%), and (2) Staff non-adherence to protocol directives (15.3%).
  
  
  CONCLUSIONS
  The results of the GlucoCare-directed Yale 100-140 mg/dL protocol experience revealed an extremely low incidence of SH and an incidence of MH of 1.1%. The incidence of SH in this study was lower than the control group of the NICE-SUGAR study and are supportive of the new Society of Critical Care guidelines to target BG levels of 100-150 mg/dL in critically ill patients. Further refinements to the original protocol and emphasis on staff adherence to protocol directives could potentially further reduce these very low hypoglycemia rates.
authors.affiliation: Hiram C. Polk Department of Surgery, University of Louisville, Louisville, KY 40202, USA. Michael.marvin@louisville.edu
authors.forename: Michael R
authors.initials: MR
authors.lastname: Marvin
authors.forename: Silvio E
authors.initials: SE
authors.lastname: Inzucchi
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Besterman
mesh_terms: D000465:Algorithms; D001786:Blood Glucose / Q000378:metabolism*; D003422:Critical Care / Q000458:organization & administration / Q000592:standards; D016638:Critical Illness; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy / Q000453:epidemiology; D004360:Drug Therapy, Computer-Assisted / Q000379:methods; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015994:Incidence; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems; D008297:Male; D010348:Patient Care Team / Q000458:organization & administration*; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human