Health authorities, but not the FDA, in
the United States and in other countries recognize the importance of
accuracy for self-monitoring of blood glucose. The American
Association of Clinical Endocrinologists/American College of
Endocrinology Clinical Practice Guidelines for Developing a Diabetes
Mellitus Comprehensive Care Plan (2015) state that “self-monitoring
of blood glucose (SMBG) is an important tactic to help patients
document hypoglycemia, although it is essential that the glucose
meter meet accuracy standards.”
In 2013, the International Organization
for Standardization (ISO) tightened accuracy standards for BGMS to
require analytical accuracy be within ±15 mg/dl when glucose
concentrations are less than 100 mg/dl, and within ±15% for samples
with glucose concentrations greater than or equal to100 mg/dl.
According to the FDA’s 2014 draft guidance accuracy standards for
BGMS, 95% of results should be within ±15% and 99% of results within
±20% across the entire glycemic range.
Even within the boundaries of these
standards, considerable differences exist in the performance of
commercially available systems, especially in the low glucose range.
Even the Centers for Medicare and Medicaid Services is forcing BGMS
of very poor quality on Medicare beneficiaries in an effort to reduce
costs, the beneficiaries be damned.
These performance differences can
potentially have a major impact on the risk for missing detection of
hypoglycemic events and thus adequately identifying and treating
them. (See Figure 1.) For example, fewer than 1 in 100 hypoglycemic
events will be missed via self-monitoring of blood glucose at 10%
error level; at 20% error level, the risk increases more than
10-fold, to 1 in 10 hypoglycemic events missed.
Meters that have only a ±20% level of
accuracy are still on the market and in patients’ homes. Help your
patients understand that the accuracy of their blood glucose meter
matters, more than they might think.
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