Practice Advisory Blood Glucose Meter Accuracy Issued September 16, 2013 For the person with diabetes, blood glucose monitoring provides immediate feedback on the effects of daily activities such as taking medication, exercise, or eating on blood glucose levels. Blood glucose monitoring helps to evaluate glycemic control and is especially useful in identifying hypoglycemia and hyperglycemia which may be associated with higher morbidity and mortality rates. Blood glucose meters are regulated by the Food and Drug Administration (FDA) using guidelines issued by the International Organization for Standardization (ISO) 15197:2003, “Requirements for blood- glucose monitoring systems for self-testing in managing diabetes mellitus”. The ISO standard requires that 95% of results within range or slightly elevated be within +/- 20% of the true value. At a recent meeting of the Diabetes Technology Society, researchers presented several studies done in the United States and Germany that show many blood glucose meter devices fall short of the 95% accuracy standard required by the FDA (see Table 1). Although, ISO recently published a revised 15197:2013 standard, which has stricter accuracy guidelines for blood glucose meters, the FDA has yet to adopt it. The new ISO 15197:2013 differs from the previous 2003 version on the following points: Increased accuracy for glucose meter systems, in particular for glucose values greater than 75 mg/dl. Manufacturers of glucose meter systems must ensure their technology enables accuracy to improve from +-20% to +-15%.
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Practice Advisory
Blood Glucose Meter Accuracy Issued September 16, 2013
For the person with diabetes, blood glucose monitoring provides immediate feedback on the effects of
daily activities such as taking medication, exercise, or eating on blood glucose levels. Blood glucose
monitoring helps to evaluate glycemic control and is especially useful in identifying hypoglycemia and
hyperglycemia which may be associated with higher morbidity and mortality rates.
Blood glucose meters are regulated by the Food and Drug Administration (FDA) using guidelines issued
by the International Organization for Standardization (ISO) 15197:2003, “Requirements for blood-
glucose monitoring systems for self-testing in managing diabetes mellitus”. The ISO standard requires
that 95% of results within range or slightly elevated be within +/- 20% of the true value.
At a recent meeting of the Diabetes Technology Society, researchers presented several studies done in
the United States and Germany that show many blood glucose meter devices fall short of the 95%
accuracy standard required by the FDA (see Table 1). Although, ISO recently published a revised
15197:2013 standard, which has stricter accuracy guidelines for blood glucose meters, the FDA has yet
to adopt it.
The new ISO 15197:2013 differs from the previous 2003 version on the following points:
Increased accuracy for glucose meter systems, in particular for glucose values greater than 75
mg/dl.
Manufacturers of glucose meter systems must ensure their technology enables accuracy to
improve from +-20% to +-15%.
The new version would apply to 99% of results, as opposed to the 95% criteria required in the
previous version.
For the first time, the standard provides formal acceptance criteria for accuracy of testing by
patients and assessment of interferents that may decrease meter accuracy (including
hematocrit).
In confirming meter accuracy, diabetes educators should work with their patients to ensure other
factors, interferents, do not affect blood glucose reading accuracy.
Known glucometer interferents include:
Poor quality of test strips.
Unwashed hands before testing.
Testing site damp from pretest topical alcohol.
Hematocrit levels due to dehydration or anemia.
Interfering substances (Vitamin C, acetaminophen, and uric acid).
Altitude, temperature, and humidity.
Storage and handling.
Test site location: side of fingertip may be used at all times; alternate sites may be used when
blood glucose is stable, but not when it is changing rapidly (e.g. after eating or exercise, when
hypoglycemic or ill).
Meter not calibrated properly. Calibration of meter with quality control solutions should be
performed according to manufacturer’s instructions to ensure accuracy.
Not enough blood applied to test strip.
Until the FDA adopts the new ISO accuracy standards, current FDA standards should be maintained.
Diabetes educators should address barriers (physical abilities, mental status, insurance coverage, etc.) to
help patients choose blood glucose monitors to facilitate decision-making with the goal of improving
health outcomes.
For those persons with diabetes most at risk of severe hypoglycemia (elderly, injecting insulin or taking
oral agents associated with hypoglycemia, etc.), diabetes educators should review cost and glucometer
specifications as well as patient -specific preference and needs to identify the most appropriate
brand/model of blood glucose meter. In addition diabetes educators should confirm prescriptions are
filled as prescribed.
[Note: The data in Table 1 are from Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. [Educators should refer to the information available from device manufactures for more current data on updated models.]
Table 1.
Meter
Within 15% Under 100 mg
Within 10% Under 100 mg
Within 5% Under 100 mg
Within 15% Over 100 mg
Within 10% Over 100 mg
Within 5% Over 100 mg
Accu-Chek Active 100% 100% 72% 100% 100% 79%
Accu-Chek Aviva 100% 97% 80% 99% 91% 64%
Accu-Chek Compact Plus 100% 86% 27% 100% 94% 69%
Meter
Within 15% Under 100 mg
Within 10% Under 100 mg
Within 5% Under 100 mg
Within 15% Over 100 mg
Within 10% Over 100 mg
Within 5% Over 100 mg
Accu-Chek Go 100% 100% 94% 100% 96% 79%
Accu-Chek Mobile (maltose dependent) 98% 98% 73% 100% 96% 66%
Accu-Chek Mobile (maltose independent) 100% 98% 71% 100% 94% 66%