Abstract

BackgroundThe 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.MethodsTwo 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.ResultsForty 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).ConclusionsSGC is a safe and efficient method to control blood glucose in critically ill patients as assessed in two European medical intensive care units.

Highlights

  • 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

  • Poor glycemic control - represented by hyperglycemia, hypoglycemia and high variability - is strongly and consistently associated with poor clinical outcomes [2,3,4,5], the effect seems to be attenuated in patients with diabetes [5,6]

  • In one of the largest observational databases reported to date, Badawi and colleagues demonstrated in almost 200,000 critically ill patients that mortality was lowest in a blood glucose range between 4.4-6.1 mmol/L and progressively increased with severity and duration of hyperglycemia, hypoglycemia and with higher variability [7]

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Summary

Introduction

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 The enhanced Model Predictive Control (eMPC) algorithm has been studied in several clinical trials where it was found to be efficient and safe [22,23,24,25,26,27]. It is implemented in the CE-certified Space GlucoseControl The primary objective was to investigate the efficacy of the system defined as time in target range using a broader target range of 4.4-8.3 mmol/L for glucose control in medical ICU patients

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