practice advisory blood glucose meter accuracy issued september

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 15% 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







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%

Accu-Chek Nano 100% 96% 80% 99% 95% 65%

Accu-Chek Performa Nano 100% 98% 87% 100% 96% 64%

Accu-Chek Performa (maltose dependent)

100% 95% 72% 99% 94% 68%

Accu-Chek Performa (maltose independent)

98% 97% 78% 98% 92% 66%

Bayer Contour usb 90% 69% 45% 91% 68% 34%

Beurer GL32 85% 62% 40% 99% 91% 56%

Beurer GL40 98% 90% 52% 95% 78% 42%

BGStar 98% 92% 80% 97% 87% 62%

Biocheck TD-4225 76% 52% 22% 97% 80% 49%

Element 90% 79% 48% 83% 64% 30%

FreeStyle Freedom Lite 100% 100% 98% 100% 98% 90%

FreeStyle Lite 100% 100% 93% 100% 100% 86%

Futura Monometer 90% 68% 27% 79% 59% 26%

Meter







Gluco-test Plus+ TD-4230 96% 94% 76% 95% 79% 42%

GlucoCheck Classic 97% 84% 55% 85% 66% 38%

GlucoCheck Comfort 96% 86% 56% 95% 74% 41%

GlucoCheck XL 97% 92% 58% 88% 65% 40%

Glucohexal II 50% 21% 7% 80% 64% 32%

GlucoRx (TD-4230) 83% 41% 14% 65% 40% 14%

GlucoSmart Swing 84% 53% 15% 94% 67% 33%

GlucoTel 89% 70% 33% 92% 72% 41%

iBGStar 96% 90% 52% 90% 72% 35%

iDia 96% 80% 47% 90% 71% 40%

IME-DC Fidelity 72% 43% 18% 94% 85% 48%

iXell 100% 98% 68% 89% 75% 38%

iXell OLED 97% 85% 52% 97% 79% 39%

microdot+ 98% 95% 62% 94% 83% 43%

Omnitest 3 94% 86% 64% 91% 79% 48%

OneTouch Verio 97% 78% 40% 100% 95% 64%

OneTouch Verio Pro 88% 53% 21% 93% 75% 40%

Meter







OneTouch VITA 98% 93% 72% 99% 87% 50%

Pura 100% 95% 48% 100% 74% 30%

SeniorLine GM210 15% 0% 0% 79% 55% 29%

smartLAB genie 84% 52% 23% 98% 87% 57%

smartLAB global 91% 85% 57% 93% 79% 48%

WaveSense Jazz 100% 75% 38% 95% 80% 47%

Wellion CALLA Light 68% 33% 13% 89% 73% 52%

practice advisory blood glucose meter accuracy issued september

Documents