BACKGROUND: 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. 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. METHODS: The 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. RESULTS: 17 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%). CONCLUSION: Under 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 REGISTRATION: ClinicalTrials.gov NCT01523665.

Critical Care Services Department of Anaesthetics West Suffollk Hospital NHS Trust Bury St Edmunds UK

Department of Anaesthesiology and Intensive Care Medicine Capio Hospital Sur Madrid Spain

Department of Anaesthesiology and Intensive Care Medicine County Hospital Ryhov Jönköping Sweden

Department of Anaesthesiology and Intensive Care Medicine Vejle Hospital Vejle Denmark

Department of Anaesthesiology and Intensive Care Tartu University Hospital Tartu Estonia

Department of Anaesthesiology and Intensive Medicine 1st Faculty of Medicine Charles University and General University Hospital Prague U Nemocnice 2 128 08 Prague 2 Czech Republic

Department of Anaesthesiology and Intensive Therapy Wroclaw Medical University Wroclaw Poland

Department of Anaesthesiology and Surgical Intensive Care Medicine Klinikum Augsburg Augsburg Germany

Department of Anesthesiology and Intensive Care Karolinska University Hospital Solna Stockholm Sweden

Department of Anesthesiology and Intensive Care Legnano Hospital Legnano Italy

Department of Cardiothoracic Anaesthesia and Intensive Care Unit University Hospital University of Copenhagen Copenhagen Denmark

Department of Internal Medicine 3 Metabolism and Gerontology University Hospital Hradec Kralove Hradec Kralove Czech Republic

Department of Surgical and Intensive Medicine Siena University Hospital Siena Italy

Intensive Care Department Royal Cornwall Hospital Truro UK

Internal Medicine Clinic University Hospital in Motol Prague Czech Republic

Medical Department 1 Faculty of Medicine in Pilsen Charles University Prague and University Hospital in Pilsen Pilsen Czech Republic

Medical ICU University Hospital Leipzig Leipzig Germany

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NCT01523665