July 6, 2016

Test Strip Accuracy Matters – Part 1

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.
  1. Blood glucose monitoring system (BGMS). This includes #3 below.
  2. Self-monitoring of blood glucose (SMBG)
  3. 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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