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One Disease + Two Concerns = FDA’s Need To Communicate Better and Modernize Standards

Diabetes is like other chronic diseases: matters worsen over time, the ultimate downstream consequences are severe, and patients can affect the course of their disease by careful attention to their health. One difference: diabetics have a valuable, universally available tool: blood glucose monitors and test strips. Larger lessons can be learned by asking: how reliable is that tool?

For more than 11 million Americans, monitors and strips are a central part of everyday life. Frequent readings let diabetics monitor their own situation and adjust diet, behavior and medications. They have all been taught to “live by the numbers.”

A few months back, Gardiner Harris of the New York Times broke the story that blood glucose meters are allowed to have a +/- 20% margin of error. He also reported that different meters can produce dramatically different results from the same blood sample.

FDA has recognized the problem and is pushing for changes in international standards for the accuracy of diabetic meters. Failing that, they will probably go through the more lengthy process required by the Administrative Procedures Act. All this is good….and credit goes to Gardiner Harris and FDA leadership.

Meantime, diabetic patients are left to wonder whether their home meters are providing accurate and reliable information.

This concern was compounded by last week’s announcement that certain types of strips cannot distinguish between glucose and other sugars. When combined with certain medicines and therapies, these strips may give inaccurately high readings.

FDA’s public health advisory covered all the basics nicely: which meters/strips are involved, how FDA reached its conclusion, what patients should do next, etc. It was explicit in its direction to high risk diabetics taking any of the named medications: alert your doctors and decide on a different type of meter and strips.

It was much less helpful for the millions of diabetics who are committed to slowing their disease progression, but are not insulin-dependent or at risk for hypoglycemia (low blood sugar). They are just as dependent on accurate meter readings; except the immediate consequences are less drastic. They would want to know: given that sugars are in lots of products, why is the problem limited to a small number of medications? And: why doesn’t dietary intake of non-glucose sugars result in inaccurate meter readings?

Public health advisories need to reflect a broad understanding of the patient audience and their likely questions. I suspect that this advisory missed the concerns of lower risk diabetics because the real public health target was hospitals using home monitors on seriously-ill patients. But the entire public gets the announcement…and diabetics who follow the news are already unsure whether meters and strips are tools or distractions. I assume there were good answers for them, but I couldn’t find it in the public health advisory.

There is another point to make. Diabetic meters/strips are constantly being improved, but the standards for accuracy are old and don’t reflect progress in computerization, miniaturization, fluid dynamics and bio-chemistry. With this example, FDA should start systematically identifying other drug, device, diagnostic and food standards that are based on old science and need to be modernized.

Neither FDA nor industry will be able to act quickly on updated standards. An FDA list, however, would put industry on notice to get started.


Gardiner Harris’ most recent New York Times story on this issue:

Standards Might Rise On Monitors For Diabetics
July 19, 2009

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