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Position Statements

7. Diabetes Technology: Standards of Medical Care in Diabetes—2019

  1. American Diabetes Association
Diabetes Care 2019 Jan; 42(Supplement 1): S71-S80. https://doi.org/10.2337/dc19-S007
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Tables

  • Table 7.1

    Comparison of ISO 15197 and FDA blood glucose meter accuracy standards

    SettingFDA125,126ISO 15197-2013127
    Home use95% within 15% for all BG in the usable BG range†
    • 95% within 15% for BG ≥100 mg/dL

    • 95% within 15 mg/dL for BG <100 mg/dL

    • 99% in A or B region of Consensus Error Grid‡

    99% within 20% for all BG in the usable BG range†
    Hospital use95% within 12% for BG ≥75 mg/dL
    95% within 12 mg/dL for BG <75 mg/dL
    98% within 15% for BG ≥75 mg/dL
    98% within 15 mg/dL for BG <75 mg/dL
    • BG, blood glucose. To convert mg/dL to mmol/L, see http://www.endmemo.com/medical/unitconvert/Glucose.php.

    • ↵†The range of BG values for which the meter has been proven accurate and will provide readings (other than low, high, or error).

    • ↵‡Values outside of the “clinically acceptable” A and B regions are considered “outlier” readings and may be dangerous to use for therapeutic decisions128.

  • Table 7.2

    Interfering substances

    Glucose oxidase monitors
     Uric acid
     Galactose
     Xylose
     Acetaminophen
     L-dopa
     Ascorbic acid
    Glucose dehydrogenase monitors
     Icodextrin (used in peritoneal dialysis)
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Diabetes Care: 42 (Supplement 1)

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January 2019, 42(Supplement 1)
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7. Diabetes Technology: Standards of Medical Care in Diabetes—2019
American Diabetes Association
Diabetes Care Jan 2019, 42 (Supplement 1) S71-S80; DOI: 10.2337/dc19-S007

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7. Diabetes Technology: Standards of Medical Care in Diabetes—2019
American Diabetes Association
Diabetes Care Jan 2019, 42 (Supplement 1) S71-S80; DOI: 10.2337/dc19-S007
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More in this TOC Section

  • 13. Children and Adolescents: Standards of Medical Care in Diabetes—2019
  • 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2019
  • 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2019
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