title: Accuracy and user performance evaluation of the Contour(®) Next Link 2.4 blood glucose monitoring system.
abstract: BACKGROUND
  The Contour(®) Next Link 2.4 blood glucose monitoring system (BGMS), which communicates wirelessly exclusively with a Medtronic insulin pump, was assessed in 2 separate studies.
  
  
  METHODS
  In the laboratory study (N=100), subject capillary fingertip samples were tested in duplicate using 3 test strip lots; accuracy was assessed based on ISO 15197:2013 section 6.3 accuracy criteria (95% within ±15mg/dl or ±15% of reference for glucose <100 and ≥100mg/dl, respectively). In the clinical trial (N=219), untrained subjects with diabetes tested capillary fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared based on ISO 15197:2013 section 8 accuracy criteria.
  
  
  RESULTS
  In the laboratory study, 100% of results met ISO 15197:2013 section 6.3 accuracy criteria. In the clinical trial, 98.6% of capillary fingertip and 97.2% of palm results from subjects met ISO 15197:2013 section 8 accuracy criteria. By Parkes-Consensus Error Grid analysis, 100% of subject capillary fingertip results were within Zone A. Based on questionnaire results, the majority of subjects found the BGMS easy to use.
  
  
  CONCLUSIONS
  The BGMS exceeds ISO 15197:2013 section 6.3 and section 8 accuracy criteria in the laboratory and in the hands of untrained users with diabetes.
authors.affiliation: AMCR Institute Inc., 625 West Citracado Parkway, Suite 112, Escondido, CA 92025, United States. Electronic address: tbailey@amcrinstitute.com.
authors.forename: Timothy
authors.initials: T
authors.lastname: Bailey
authors.affiliation: Bayer HealthCare LLC, Diabetes Care, 100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981, United States.
authors.forename: Jane F
authors.initials: JF
authors.lastname: Wallace
authors.affiliation: Bayer HealthCare LLC, Diabetes Care, 100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981, United States.
authors.forename: Carmine
authors.initials: C
authors.lastname: Greene
authors.affiliation: Bayer HealthCare LLC, Diabetes Care, 100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981, United States.
authors.forename: Scott
authors.initials: S
authors.lastname: Pardo
authors.affiliation: Bayer HealthCare LLC, Diabetes Care, 100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981, United States.
authors.forename: Daniel
authors.initials: D
authors.lastname: Brown
authors.affiliation: Bayer HealthCare LLC, Diabetes Care, 100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981, United States.
authors.forename: Brian
authors.initials: B
authors.lastname: Pflug
authors.affiliation: Rainier Clinical Research Center, 723 SW 10th St, Renton, WA 98057, United States.
authors.forename: Leslie J
authors.initials: LJ
authors.lastname: Klaff
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001774:Blood Chemical Analysis / Q000295:instrumentation*; D001786:Blood Glucose / Q000032:analysis*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D001786:Blood Glucose
keywords: Self-monitoring of blood glucose; Type 1 diabetes; Type 2 diabetes