title: Testing quality of a self-monitoring blood glucose sensor with an auto-coding mechanism when used by patients versus technicians.
abstract: BACKGROUND
  In response to the problem of erroneous readings due to miscoding when performing self-monitoring blood glucose (SMBG), this study introduces a user-friendly SMBG biosensor with an innovative auto-coding module on the meter and strip. Actual users characterized the performance of the SMBG systems.
  
  
  METHODS
  A total of 105 patients were incorporated in the study and Clarke error grid analysis (EGA) was administered to evaluate the clinical accuracy of the results obtained by the patients versus the technicians. All patients used the questionnaires to comment on the use of the auto-coding sensor.
  
  
  RESULTS
  In the imprecision test, the total CV of the 5 BG levels was 2.1%. In the EGA plot, the results of the auto-coding sensor were 96.2%, both lots A and B, in zone A for the patients and 99.0% and 97.1% for the technician. The paired t-test demonstrated no statistically significant difference between the patient and technician measurements. Regression analysis also demonstrated that the measurements taken by the patients agreed with those obtained using the laboratory method.
  
  
  CONCLUSIONS
  The patients achieved satisfactory performance using the auto-coding SMBG sensor and derived similar results with both laboratory reference and operation by a technician.
authors.affiliation: School of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung, Taiwan. Electronic address: a629405@ms27.hinet.net.
authors.forename: Cheng-Teng
authors.initials: CT
authors.lastname: Hsu
authors.affiliation: Department of Laboratory Medicine, Min Sheng Hospital, Taoyuan, Taiwan.
authors.forename: Ming-Hsun
authors.initials: MH
authors.lastname: Wu
authors.affiliation: Department of Clinical Laboratory, Tai An Hospital, Taichung, Taiwan; Institute of Biochemistry and Biotechnology, Chung Shan Medical University, Taichung, Taiwan.
authors.forename: Chih-Yi
authors.initials: CY
authors.lastname: Kuo
authors.affiliation: Department of Chemistry, National Chung Hsing University, Taichung, Taiwan. Electronic address: jmzen@dragon.nchu.edu.tw.
authors.forename: Jyh-Myng
authors.initials: JM
authors.lastname: Zen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood* / Q000175:diagnosis; D005260:Female; D006801:Humans; D008297:Male; D017056:Medical Laboratory Personnel / Q000592:standards*; D008875:Middle Aged; D010358:Patient Participation; D015203:Reproducibility of Results; D012648:Self Care / Q000592:standards*; D055815:Young Adult
chemical_list: D001786:Blood Glucose
keywords: Auto-coding; Miscoding; Patient-derived; Self-monitoring of blood glucose (SMBG); User error