Blood glucose meters and their test
strips are again coming under scrutiny. This time it is the American
Association of Clinical Endocrinologists advising other
endocrinologists and doctors about the accuracy.
They say that the accuracy of your
patient's blood glucose meter (actually it is the test strips)
matters – more than you might think. This is very true and it is a
shame that the FDA does not do any checks on accuracy and as of yet
has not set new standards for test strips. Mainly this is for
insulin users, but must also include people with type 2 diabetes on
medications that can also cause hypoglycemia.
Some important words and their acronyms
for you to remember.
- Blood glucose monitoring system (BGMS). This includes #3 below.
- Self-monitoring of blood glucose (SMBG)
- Continuous Glucose Monitor (CGM)
We need accuracy in our test strips to
be able to detect actual hypoglycemic events. This will allow us to
treat these events accurately and in a timely manner. Helping to
prevent hypoglycemia by delivering accurate blood glucose readings
that provide the basis for patients to calculate and administer the
appropriate insulin dose, blood glucose monitoring systems (BGMS)
play a key role in reducing the impact of hypoglycemia.
In patients with Type 1 diabetes, a
study shows when the margin of error of BGMS increases 2-fold, there
is more than a 10-fold increase in the risk of missing hypoglycemic
events.
Despite accuracy standards for
strip-based BGMS, important performance differences exist among
commercially available BGMS currently and previously approved by the
FDA.
Self-monitoring of blood glucose (SMBG)
by persons with diabetes, especially those who are on insulin
therapy, is an important tool for helping patients to manage their
disease and maintain optimal management of blood glucose levels. For
example, the results obtained from a blood glucose monitoring system
(BGMS) help guide patients’ insulin dosing. Measuring preprandial
glycemic influences the prandial insulin dose, which in turn affects
postprandial glycemic excursions. Therefore, the accuracy and
precision of patients’ BGMS can minimize errors in insulin dosing.
Accurate dosing not only affects clinical outcomes but also
potentially impacts economic outcomes, such as direct and indirect
health care costs.
Hypoglycemia, one of the most common
and most severe complications of insulin therapy, contributes to
considerable morbidity and mortality in persons with diabetes.
Hypoglycemia limits successful metabolic control of the disease and
may prevent both patients and their health care providers from
initiating appropriate insulin therapy and achieving optimal glycemic
control as early as possible in the battle with diabetes.
The average person with Type 1 diabetes
experiences approximately 2 episodes of symptomatic hypoglycemia each
week, a figure that has remained essentially unchanged for 20 years.
More than three quarters of people with Type 2 diabetes have
experienced self-treated hypoglycemia, with 36% experiencing an
episode within the last month.
Hypoglycemia is also associated with
substantial economic burdens. One study simulating the additional
annual risk of hypoglycemia due to BGMS errors showed that use of
more accurate BGMS can help prevent nearly 300,000 additional severe
hypoglycemic episodes in Type 1 diabetes patients. This can also
save more than 100,000 severe hypoglycemic episodes in Type 2
diabetes patients, with potential savings for the US health care
system of more than $500 million per year.
An analysis of the economic impact of
hypoglycemia in a cohort of patients with Type 2 diabetes mellitus
from 2003 through 2008 estimated the mean costs for outpatient
treatment of a hypoglycemic event at $285 and mean costs for a
patient with a hypoglycemia event treated initially in the emergency
room and then admitted as an inpatient at more than $10,000.
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