title: Accuracy and user performance evaluation of a blood glucose monitoring system.
abstract: BACKGROUND
  The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies.
  
  
  METHODS
  In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15 mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75 mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15 mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100 mg/dL, respectively) accuracy criteria. In the clinical trial, 220 subjects with diabetes, naive to the BGMS, tested capillary glucose from fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared.
  
  
  RESULTS
  In the laboratory study, 100% of results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria. In the clinical trial, 100% and 99.1% of subject fingerstick results and 98.1% and 96.7% of subject palm results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria, respectively. By Parkes Consensus Error Grid analysis, 100% of subject fingerstick results and 98.1% of subject palm results were within Zone A (remainder within Zone B). Questionnaire results showed most subjects found the BGMS easy to use.
  
  
  CONCLUSIONS
  The Contour Plus BGMS meets ISO 15197:2003 and ISO 15197:2013 accuracy criteria in the laboratory and when used by untrained individuals.
authors.affiliation: 1 Consumer Product Testing Company, Inc. , Fairfield, New Jersey.
authors.forename: Michael
authors.initials: M
authors.lastname: Caswell
authors.forename: Joy
authors.initials: J
authors.lastname: Frank
authors.forename: Maria T
authors.initials: MT
authors.lastname: Viggiani
authors.forename: Scott
authors.initials: S
authors.lastname: Pardo
authors.forename: Nancy
authors.initials: N
authors.lastname: Dunne
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: Warchal-Windham
authors.forename: Robert
authors.initials: R
authors.lastname: Morin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000523:psychology / Q000592:standards; D003922:Diabetes Mellitus, Type 1 / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood; D005069:Evaluation Studies as Topic; D005260:Female; D006225:Hand / Q000098:blood supply; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011677:Punctures; D011933:Reagent Kits, Diagnostic; D011934:Reagent Strips; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
chemical_list: D011933:Reagent Kits, Diagnostic; D011934:Reagent Strips