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Glucose control in intensive care: usability, efficacy and safety of Space Glucose Control in two medical European intensive care units

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Karin Amrein, Norman Kachel, Heike Fries, Roman Hovorka, Prof Dr Thomas Pieber, Johannes Plank, Urs Wenger, Barbara Lienhardt and Marco Maggiorini

BMC Endocrine Disorders 2014, 14:62, 7/2014

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.

Keywords: Tight glycemic control, Critical illness, Critically ill patients, Protocol, Computer-assisted glycemic control, Insulin infusion protocol, Glucose control in intensive care