title: Glucose control in intensive care: usability, efficacy and safety of Space GlucoseControl in two medical European intensive care units.
abstract: BACKGROUND
  The Space GlucoseControl system (SGC) is a nurse-driven, computer-assisted device for glycemic control combining infusion pumps with the enhanced Model Predictive Control algorithm (B. Braun, Melsungen, Germany). We aimed to investigate the performance of the SGC in medical critically ill patients.
  
  
  METHODS
  Two open clinical investigations in tertiary centers in Graz, Austria and Zurich, Switzerland were performed. Efficacy was assessed by percentage of time within the target range (4.4-8.3 mmol/L; primary end point), mean blood glucose, and sampling interval. Safety was assessed by the number of hypoglycemic episodes (≤2.2 mmol/L) and the percentage of time spent below this cutoff level. Usability was analyzed with a standardized questionnaire given to involved nursing staff after the trial.
  
  
  RESULTS
  Forty medical critically ill patients (age, 62 ± 15 years; body mass index, 30.0 ± 8.9 kg/m2; APACHE II score, 24.8 ± 5.4; 27 males; 8 with diabetes) were included for a period of 6.5 ± 3.7 days (n = 20 in each center). The primary endpoint (time in target range 4.4 to 8.3 mmol/l) was reached in 88.3% ± 9.3 of the time and mean arterial blood glucose was 6.7 ± 0.4 mmol/l. The sampling interval was 2.2 ± 0.4 hours. The mean daily insulin dose was 87.2 ± 64.6 IU. The adherence to the given insulin dose advice was high (98.2%). While the percentage of time spent in a moderately hypoglycemic range (2.2 to 3.3 mmol/L) was low (0.07 ± 0.26% of the time), one severe hypoglycemic episode (<2.2 mmol/L) occurred (2.5% of patients or 0.03% of glucose readings).
  
  
  CONCLUSIONS
  SGC is a safe and efficient method to control blood glucose in critically ill patients as assessed in two European medical intensive care units.
authors: Medical University of Graz, Austria, Department of Internal Medicine, Division of Endocrinology and Metabolism, Auenbruggerplatz 15, 8036 Graz, Austria. karin.amrein@medunigraz.at.
authors: Karin
authors: K
authors: Amrein
authors: Norman
authors: N
authors: Kachel
authors: Heike
authors: H
authors: Fries
authors: Roman
authors: R
authors: Hovorka
authors: Thomas R
authors: TR
authors: Pieber
authors: Johannes
authors: J
authors: Plank
authors: Urs
authors: U
authors: Wenger
authors: Barbara
authors: B
authors: Lienhardt
authors: Marco
authors: M
authors: Maggiorini
mesh_terms: D001786:Blood Glucose / Q000032:analysis; D016638:Critical Illness; D003920:Diabetes Mellitus / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D007328:Insulin / Q000627:therapeutic use*; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011379:Prognosis
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin