Space GlucoseControl system for blood glucose control in intensive care patients--a European multicentre observational study.

Jan Blaha,Barbara Barteczko-Grajek,Marcello Pasculli,Jiri Chvojka,Sirak Petros,Jonathan Holmgren,Vinodkumar Singh,Johan Petersson,Teodoro Grau,Ulrich Jaschinski,Jiri Charvat,Danilo Radrizzani,Jan Manak,Mette Moehl,Mette Moehl,Jonathan Paddle,Pawel Berezowicz,Joel Starkopf,Petr Kopecky

doi:10.1186/s12871-016-0175-4

Abstract

BackgroundGlycaemia control (GC) remains an important therapeutic goal in critically ill patients. The enhanced Model Predictive Control (eMPC) algorithm, which models the behaviour of blood glucose (BG) and insulin sensitivity in individual ICU patients with variable blood samples, is an effective, clinically proven computer based protocol successfully tested at multiple institutions on medical and surgical patients with different nutritional protocols. eMPC has been integrated into the B.Braun Space GlucoseControl system (SGC), which allows direct data communication between pumps and microprocessor. The present study was undertaken to assess the clinical performance and safety of the SGC for glycaemia control in critically ill patients under routine conditions in different ICU settings and with various nutritional protocols.MethodsThe study endpoints were the percentage of time the BG was within the target range 4.4 – 8.3 mmol.l−1, the frequency of hypoglycaemic episodes, adherence to the advice of the SGC and BG measurement intervals. BG was monitored, and insulin was given as a continuous infusion according to the advice of the SGC. Nutritional management (enteral, parenteral or both) was carried out at the discretion of each centre.Results17 centres from 9 European countries included a total of 508 patients, the median study time was 2.9 (1.9-6.1) days. The median (IQR) time–in–target was 83.0 (68.7-93.1) % of time with the mean proposed measurement interval 2.0 ± 0.5 hours. 99.6 % of the SGC advices on insulin infusion rate were accepted by the user. Only 4 episodes (0.01 % of all BG measurements) of severe hypoglycaemia <2.2 mmol.l−1 in 4 patients occurred (0.8 %; 95 % CI 0.02-1.6 %).ConclusionUnder routine conditions and under different nutritional protocols the Space GlucoseControl system with integrated eMPC algorithm has exhibited its suitability for glycaemia control in critically ill patients.Trial registrationClinicalTrials.gov NCT01523665

Highlights

Glycaemia control (GC) remains an important therapeutic goal in critically ill patients
As increasing complexity of insulin protocols reduces their clarity for the user and increases the difficulty of their use, paper-based protocols became converted into computerized forms – from simple electronic algorithms to clinical decision support systems (CDSS) with the ability to predict insulin requirements based on patient-specific response to previous doses as a function of their individual insulin resistance pattern
The fraction of time with blood glucose (BG) between 4 and 7.5 mmol/l was 78 %, but with hypoglycaemia (

Summary

Introduction

Glycaemia control (GC) remains an important therapeutic goal in critically ill patients. The enhanced Model Predictive Control (eMPC) algorithm, which models the behaviour of blood glucose (BG) and insulin sensitivity in individual ICU patients with variable blood samples, is an effective, clinically proven computer based protocol successfully tested at multiple institutions on medical and surgical patients with different nutritional protocols. The present study was undertaken to assess the clinical performance and safety of the SGC for glycaemia control in critically ill patients under routine conditions in different ICU settings and with various nutritional protocols. Glycaemia control (GC) remains an important therapeutic goal in critically ill patients, despite an ongoing debate regarding the optimum target ranges. Risk of hypoglycaemia is the most important concern in GC implementation; a protocolized approach, comprising a validated insulin administration protocol and use of accurate monitoring technologies is essential for safe GC management in intensive care patients. Comparison of existing protocols is difficult due to differences in processes and outcome measures, CDSSs generally achieve better GC with consistently lower hypoglycaemia rates than paper-based systems and appear to be superior in ICU patients [8,9,10]

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