title: Statistical approach of assessing the reliability of glucose sensors: the GLYCENSIT procedure.
abstract: BACKGROUND
  In healthcare, patients with diabetes are instructed on how to apply intensified insulin therapy in an optimal manner. Tight blood glucose control is also performed on patients treated in the intensive care unit (ICU). Different blood glucose meters and glucose monitoring systems (GMSs) are used to achieve this goal, and some may lack reliability.
  
  
  METHODS
  The GLYCENSIT procedure is a statistical assessment tool we are proposing for evaluating the significant difference of paired glucose measurements. The performance of the GlucoDay system in the ICU is analyzed with GLYCENSIT.
  
  
  RESULTS
  THE GLYCENSIT ANALYSIS COMPRISES THREE PHASES: testing possible persistent measurement behavior as a function of the glycemic range, testing the number of measurement errors with respect to a standard criterion for binary assessment of glucose sensors, and computing the tolerance intervals that indicate possible test sensor deviations for new observations. The probability of the tolerance intervals directly reflects the number of samples and additionally improves current assessment techniques. The method can be tuned according to the clinician's preferences regarding significance level, tolerance level, and glycemic range cutoff values. The measurement behavior of the GlucoDay sensor is found to be persistent but inaccurate and returns wide tolerance intervals, suggesting that the GlucoDay sensor may not be sufficiently reliable for glycemia control in the ICU.
  
  
  CONCLUSIONS
  The GLYCENSIT procedure aims to serve as statistical guide for clinicians in the assessment of glucose sensor devices.
authors.affiliation: Department of Electrical Engineering (ESAT-SCD), Katholieke Universiteit Leuven, Heverlee (Leuven), Belgium. tom.vanherpe@esat.kuleuven.be
authors.forename: Tom Van
authors.initials: TV
authors.lastname: Herpe
authors.forename: Kristiaan
authors.initials: K
authors.lastname: Pelckmans
authors.forename: Jos De
authors.initials: JD
authors.lastname: Brabanter
authors.forename: Frizo
authors.initials: F
authors.lastname: Janssens
authors.forename: Bart De
authors.initials: BD
authors.lastname: Moor
authors.forename: Greet Van
authors.initials: GV
authors.lastname: den Berghe