Performance of a new blood glucose monitoring system in the hands of intended users.

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  • Additional Information
    • Source:
      Publisher: Mary Ann Liebert, Inc Country of Publication: United States NLM ID: 100889084 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-8593 (Electronic) Linking ISSN: 15209156 NLM ISO Abbreviation: Diabetes Technol Ther Subsets: MEDLINE
    • Publication Information:
      Original Publication: Larchmont, NY : Mary Ann Liebert, Inc., c1999-
    • Subject Terms:
      Blood Glucose/*metabolism ; Blood Glucose Self-Monitoring/*instrumentation ; Diabetes Mellitus, Type 1/*blood ; Diabetes Mellitus, Type 2/*blood ; Hematocrit/*instrumentation; Adolescent ; Adult ; Aged ; Blood Glucose Self-Monitoring/standards ; Diabetes Mellitus, Type 1/epidemiology ; Diabetes Mellitus, Type 2/epidemiology ; Female ; Humans ; Male ; Middle Aged ; Patient Satisfaction/statistics & numerical data ; Reproducibility of Results ; Surveys and Questionnaires ; United States/epidemiology ; Young Adult
    • Abstract:
      Background: This study assessed the performance of a blood glucose monitoring system (BGMS) in development that uses a new generation of blood glucose test strips with capillary and venous blood in the hands of its intended users, people with diabetes and healthcare professionals (HCPs).
      Subjects and Methods: In total, 93 subjects ≥ 18 years old (median age, 33 years) with type 1 (78%) or type 2 (22%) diabetes participated. Untrained subjects performed self-test fingersticks using a Microlet(®)2 lancing device (Bayer HealthCare LLC, Diabetes Care, Tarrytown, NY) followed by testing of their own capillary blood on the BGMS. HCPs performed fingersticks (using a Tenderlett(®) lancing device [International Technidyne Corp., Edison, NJ]) and venipunctures on subjects and tested both capillary and venous samples from subjects on the BGMS. All BGMS results were compared with Yellow Springs Instruments (YSI) (YSI Life Sciences, Inc., Yellow Springs, OH) laboratory results. Analytical accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., within ± 15 mg/dL or ± 20% of the YSI results for samples with glucose concentrations < 75 mg/dL and ≥ 75 mg/dL, respectively) and more stringent criteria (i.e., within ± 15 mg/dL or ± 15% of the YSI results for samples with glucose concentrations < 100 mg/dL and ≥ 100 mg/dL, respectively).
      Results: Overall, 98.9% (180/182) of subject Microlet2 capillary fingerstick results, 99.5% (182/183) of HCP Tenderlett capillary fingerstick results, and 100% (186/186) of venous results met current ISO criteria and more stringent criteria. The average hematocrit was 44%, with values ranging from 32% to 52%.
      Conclusions: Test results from both capillary fingerstick and venous samples with a new BGMS in development met current accuracy guidelines as well as proposed tighter criteria.
    • Accession Number:
      0 (Blood Glucose)
    • Publication Date:
      Date Created: 20120704 Date Completed: 20121228 Latest Revision: 20191210
    • Publication Date:
      20240628
    • Accession Number:
      10.1089/dia.2012.0046
    • Accession Number:
      22746838