title: Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting.
abstract: BACKGROUND
  This study evaluated the accuracy of Contour(®) Next (CN; Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) compared with five blood glucose monitoring systems (BGMSs) across a wide range of clinically occurring blood glucose levels.
  
  
  METHODS
  Subjects (n=146) were ≥ 18 years and had type 1 or type 2 diabetes. Subjects' glucose levels were safely lowered or raised to provide a wide range of glucose values. Capillary blood samples were tested on six BGMSs and a YSI glucose analyzer (YSI Life Sciences, Inc., Yellow Springs, OH) as the reference. Extreme glucose values were achieved by glucose modification of the blood sample. System accuracy was assessed by mean absolute difference (MAD) and mean absolute relative difference (MARD) across several glucose ranges, with <70 mg/dL evaluated by MAD as the primary end point.
  
  
  RESULTS
  In the low glucose range (<70 mg/dL), MAD values were as follows: Accu-Chek(®) Aviva Nano (Roche Diagnostics, Indianapolis, IN), 3.34 mg/dL; CN, 2.03 mg/dL; FreeStyle Lite(®) (FSL; Abbott Diabetes Care, Inc., Alameda, CA), 2.77 mg/dL; OneTouch(®) Ultra(®) 2 (LifeScan, Inc., Milpitas, CA), 10.20 mg/dL; OneTouch(®) Verio(®) Pro (LifeScan, Inc.), 4.53 mg/dL; and Truetrack(®) (Nipro Diagnostics, Inc., Fort Lauderdale, FL), 11.08 mg/dL. The lowest MAD in the low glucose range, from CN, was statistically significantly lower than those of the other BGMSs with the exception of the FSL. CN also had a statistically significantly lower MARD than all other BGMSs in the low glucose range. In the overall glucose range (21-496 mg/dL), CN yielded the lowest MAD and MARD values, which were statistically significantly lower in comparison with the other BGMSs.
  
  
  CONCLUSIONS
  When compared with other BGMSs, CN demonstrated the lowest mean deviation from the reference value (by MAD and MARD) across multiple glucose ranges.
authors.affiliation: 1 Rainier Clinical Research Center , Renton, Washington.
authors.forename: Leslie J
authors.initials: LJ
authors.lastname: Klaff
authors.forename: Ronald
authors.initials: R
authors.lastname: Brazg
authors.forename: Kristen
authors.initials: K
authors.lastname: Hughes
authors.forename: Ann M
authors.initials: AM
authors.lastname: Tideman
authors.forename: Holly C
authors.initials: HC
authors.lastname: Schachner
authors.forename: Patricia
authors.initials: P
authors.lastname: Stenger
authors.forename: Scott
authors.initials: S
authors.lastname: Pardo
authors.forename: Nancy
authors.initials: N
authors.lastname: Dunne
authors.forename: Joan Lee
authors.initials: JL
authors.lastname: Parkes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D001786:Blood Glucose