Performance of Blood Glucose Meters in the Low-Glucose Range: Current Evaluations Indicate That It Is Not Sufficient From a Clinical Point of View
| العنوان: | Performance of Blood Glucose Meters in the Low-Glucose Range: Current Evaluations Indicate That It Is Not Sufficient From a Clinical Point of View |
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| المؤلفون: | Guido Freckmann, Stefan Pleus, Lutz Heinemann, Eric Zijlstra |
| المصدر: | Diabetes Care. 38:e139-e140 |
| بيانات النشر: | American Diabetes Association, 2015. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Advanced and Specialized Nursing, Food and drug administration, Low glucose, Blood glucose meters, Animal science, business.industry, Endocrinology, Diabetes and Metabolism, Internal Medicine, Medicine, Guidance documents, business, Glycemic |
| الوصف: | System accuracy requirements for blood glucose (BG) meters (BGMs) are defined in standards (1) or guidance documents (2). In 2013, International Organization for Standardization (ISO) 15197:2013 stated that BGMs are acceptably accurate if ≥95% of their measurement results are found within ±15 mg/dL (0.83 mmol/L) or ±15% (whichever is larger) of reference results (1). The 2014 U.S. Food and Drug Administration (FDA) draft guidance for over-the-counter BGMs requires ≥95% of results within ±15% and ≥99% of results within ±20% across the whole glycemic range (2). Thus, if a patient’s BG true concentration is 60 mg/dL (3.33 mmol/L), acceptably accurate results range from 45 to 75 mg/dL (2.50 to 4.16 mmol/L) according to the ISO limits and from 51 to 69 mg/dL (2.83 to 3.83 mmol/L) according to the FDA criteria. Two questions arise: 1. Do current BGMs fulfill these criteria? 2. If a BGM … |
| تدمد: | 1935-5548 0149-5992 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::1c613f8f87d51a545d089e6c2d3d67bbTest https://doi.org/10.2337/dc15-0817Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi...........1c613f8f87d51a545d089e6c2d3d67bb |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19355548 01495992 |
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