title: Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197: 2013 Accuracy Criteria, Consensus and Surveillance Error Grid Analyses, and Insulin Dosing Error Modeling in a Hospital Setting.
abstract: BACKGROUND
  Blood glucose monitoring is an essential component of diabetes management. Inaccurate blood glucose measurements can severely impact patients' health. This study evaluated the performance of 3 blood glucose monitoring systems (BGMS), Contour® Next USB, FreeStyle InsuLinx®, and OneTouch® Verio™ IQ, under routine hospital conditions.
  
  
  METHODS
  Venous blood samples (N = 236) obtained for routine laboratory procedures were collected at a Spanish hospital, and blood glucose (BG) concentrations were measured with each BGMS and with the available reference (hexokinase) method. Accuracy of the 3 BGMS was compared according to ISO 15197:2013 accuracy limit criteria, by mean absolute relative difference (MARD), consensus error grid (CEG) and surveillance error grid (SEG) analyses, and an insulin dosing error model.
  
  
  RESULTS
  All BGMS met the accuracy limit criteria defined by ISO 15197:2013. While all measurements of the 3 BGMS were within low-risk zones in both error grid analyses, the Contour Next USB showed significantly smaller MARDs between reference values compared to the other 2 BGMS. Insulin dosing errors were lowest for the Contour Next USB than compared to the other systems.
  
  
  CONCLUSIONS
  All BGMS fulfilled ISO 15197:2013 accuracy limit criteria and CEG criterion. However, taking together all analyses, differences in performance of potential clinical relevance may be observed. Results showed that Contour Next USB had lowest MARD values across the tested glucose range, as compared with the 2 other BGMS. CEG and SEG analyses as well as calculation of the hypothetical bolus insulin dosing error suggest a high accuracy of the Contour Next USB.
authors.affiliation: Core Lab, Hospital Clinic, Barcelona, Spain jlbedini@clinic.ub.es.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Bedini
authors.affiliation: Bayer HealthCare LLC, Medical Care, Mishawaka, IN, USA.
authors.forename: Jane F
authors.initials: JF
authors.lastname: Wallace
authors.affiliation: Bayer HealthCare LLC, Medical Care, Whippany, NJ, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Pardo
authors.affiliation: Bayer HealthCare Germany, Leverkusen, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Petruschke
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards*; D006801:Humans
chemical_list: D001786:Blood Glucose
keywords: Contour Next; accuracy; blood glucose monitoring system; consensus error grid; diabetes; glucose meter; insulin dosing error; surveillance error grid