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Efficacy and safety of glucose control with Space GlucoseControl in the medical intensive care unit--an open clinical investigation.

BACKGROUND
We aimed to investigate the performance of the Space GlucoseControl system (SGC) (B. Braun, Melsungen, Germany) in medical critically ill patients. The SGC is a nurse-driven, computer-assisted device for glycemic control combining infusion pumps with the enhanced Model Predictive Control algorithm.


SUBJECTS AND METHODS
The trial was designed as a single-center, open clinical investigation in a nine-bed medical intensive care unit in a tertiary center in Graz, Austria. 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).


RESULTS
Twenty mechanically ventilated patients (age, 63±16 years; body mass index, 31.0±10.7 kg/m(2); Acute Physiology and Chronic Health Evaluation II score, 25.4±6.3; 14 males; six with diabetes) were included for a period of 7.0±3.6 days. Time within target range was 83.4±8.9% (mean±SD), and mean arterial blood glucose was 6.8±0.4 mmol/L. No severe hypoglycemic episodes (<2.2 mmol/L) occurred, and the percentage of time within 2.2 and 3.3 mmol/L was low (0.03±0.07%). The sampling interval was 2.0±0.4 h. The mean insulin dose was 93.5±80.1 IU/day, and the adherence to the given insulin dose advice was high (98.3%). A total of 11 unintended therapy interruptions (0.08 events/treatment day) caused by software problems occurred in four patients.


CONCLUSIONS
SGC is a safe and efficient method to control blood glucose in critically ill patients in the medical intensive care unit.