title: Evaluation of a new blood glucose monitoring system with auto-calibration.
abstract: BACKGROUND
  The Ascensia CONTOUR System (Bayer HealthCare LLC, Elkhart, IN) is a new blood glucose (BG) monitoring system (BGMS) that uses glucose dehydrogenase chemistry and that combines low sample volume, fast response time, an auto-control marking feature, and an auto-calibration function in a small package.
  
  
  METHODS
  The system was evaluated at four diabetes clinics with ambulatory subjects who had diabetes. The BGMS was tested by both health care professionals (HCPs) and lay users. It was also evaluated at high altitude (10,200 feet) and, in conjunction with the Ascensia MICROLET VACULANCE (Bayer), for use with samples obtained from four alternative anatomical sites.
  
  
  RESULTS
  When the system was used with blood from fingersticks, both lay users and HCPs obtained results that fulfilled the International Organization for Standardization (ISO) 15197:2003 accuracy criteria, which advocate that 95% of BG measurements should fall within +/-15 mg/dL (for BG concentrations <75 mg/dL) or +/-20% (for BG concentrations > or = 75 mg/dL) of the laboratory value. Lay users obtained 96.9% of glucose results, and HCPs obtained 96.4% of glucose results, within ISO accuracy criteria. People with diabetes who had no prior experience using the system also obtained acceptable results (97.0%), as did the HCP using fingerstick samples from subjects in the high altitude study (97.0%). Among the alternative anatomical sites tested, only the results from the palm met the ISO criteria (97.5%), although the results from all four sites (palm, thigh, abdomen, and forearm) were clinically acceptable when assessed using error grid analysis. Most subjects rated the BGMS as either excellent or very good in a questionnaire, and were able to use it properly without training.
  
  
  CONCLUSIONS
  These findings indicate that the Ascensia CONTOUR System, which does not require calibration by the user, is a convenient and accurate instrument with useful features for people who routinely monitor BG.
authors.affiliation: West County Internal Medicine, St. Louis, Missouri, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Kilo
authors.forename: Mary
authors.initials: M
authors.lastname: Pinson
authors.forename: Judy Ostrom
authors.initials: JO
authors.lastname: Joynes
authors.forename: Hal
authors.initials: H
authors.lastname: Joseph
authors.forename: Nanette
authors.initials: N
authors.lastname: Monhaut
authors.forename: Joan Lee
authors.initials: JL
authors.lastname: Parkes
authors.forename: John
authors.initials: J
authors.lastname: Baum
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000531:Altitude; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D002138:Calibration; D002648:Child; D003920:Diabetes Mellitus / Q000097:blood* / Q000188:drug therapy; D005260:Female; D006400:Hematocrit; D006801:Humans; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
chemical_list: D001786:Blood Glucose