title: Space GlucoseControl system for blood glucose control in intensive care patients--a European multicentre observational study.
abstract: 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%).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01523665.
authors.affiliation: 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. jan.blaha@lf1.cuni.cz.
authors.forename: Jan
authors.initials: J
authors.lastname: Blaha
authors.affiliation: Department of Anaesthesiology and Intensive Therapy, Wroclaw Medical University, Wroclaw, Poland. bbgrajek@wp.pl.
authors.forename: Barbara
authors.initials: B
authors.lastname: Barteczko-Grajek
authors.affiliation: Department of Anaesthesiology and Intensive Care Medicine, Vejle Hospital, Vejle, Denmark. pawel.stefan.berezowicz@slb.regionsyddanmark.dk.
authors.forename: Pawel
authors.initials: P
authors.lastname: Berezowicz
authors.affiliation: Internal Medicine Clinic, University Hospital in Motol, Prague, Czech Republic. jiri.charvat@lfmotol.cuni.cz.
authors.forename: Jiri
authors.initials: J
authors.lastname: Charvat
authors.affiliation: Medical Department I, Faculty of Medicine in Pilsen, Charles University in Prague and University Hospital in Pilsen, Pilsen, Czech Republic. chvojkaj@fnplzen.cz.
authors.forename: Jiri
authors.initials: J
authors.lastname: Chvojka
authors.affiliation: Department of Anaesthesiology and Intensive Care Medicine, Capio Hospital Sur, Madrid, Spain. teograu@terra.com.
authors.forename: Teodoro
authors.initials: T
authors.lastname: Grau
authors.affiliation: Department of Anaesthesiology and Intensive Care Medicine, County Hospital Ryhov, Jönköping, Sweden. jonathan.holmgren@lj.se.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Holmgren
authors.affiliation: Department of Anaesthesiology and Surgical Intensive Care Medicine, Klinikum Augsburg, Augsburg, Germany. ulrich.jaschinski@klinikum-augsburg.de.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jaschinski
authors.affiliation: 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. petr.kopecky@vfn.cz.
authors.forename: Petr
authors.initials: P
authors.lastname: Kopecky
authors.affiliation: Department of Internal Medicine III - Metabolism and Gerontology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic. manak@lfhk.cuni.cz.
authors.forename: Jan
authors.initials: J
authors.lastname: Manak
authors.affiliation: Department of Cardiothoracic Anaesthesia and Intensive Care Unit, University Hospital, University of Copenhagen, Copenhagen, Denmark. mmoehl@gmail.com.
authors.forename: Mette
authors.initials: M
authors.lastname: Moehl
authors.affiliation: Intensive Care Department, Royal Cornwall Hospital, Truro, UK. jonathan.paddle@rcht.cornwall.nhs.uk.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Paddle
authors.affiliation: Department of Surgical and Intensive Medicine, Siena University Hospital, Siena, Italy. marcello.pasculli@hotmail.com.
authors.forename: Marcello
authors.initials: M
authors.lastname: Pasculli
authors.affiliation: Department of Anesthesiology and Intensive Care, Karolinska University Hospital Solna, Stockholm, Sweden. johan.petersson@karolinska.se.
authors.forename: Johan
authors.initials: J
authors.lastname: Petersson
authors.affiliation: Medical ICU, University Hospital Leipzig, Leipzig, Germany. sirak.petros@medizin.uni-leipzig.de.
authors.forename: Sirak
authors.initials: S
authors.lastname: Petros
authors.affiliation: Department of Anesthesiology and Intensive Care, Legnano Hospital, Legnano, Italy. danilo.radrizzani@gmail.com.
authors.forename: Danilo
authors.initials: D
authors.lastname: Radrizzani
authors.affiliation: Critical Care Services, Department of Anaesthetics, West Suffollk Hospital NHS Trust, Bury St Edmunds, UK. vinod@uab.edu.
authors.forename: Vinodkumar
authors.initials: V
authors.lastname: Singh
authors.affiliation: Department of Anaesthesiology and Intensive Care, Tartu University Hospital, Tartu, Estonia. joel.starkopf@kliinikum.ee.
authors.forename: Joel
authors.initials: J
authors.lastname: Starkopf
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003422:Critical Care / Q000379:methods; D016638:Critical Illness / Q000628:therapy; D020000:Decision Support Systems, Clinical / Q000295:instrumentation; D005060:Europe / Q000453:epidemiology; D007328:Insulin / Q000008:administration & dosage; D007362:Intensive Care Units
chemical_list: D001786:Blood Glucose; D007328:Insulin