Tuesday, May 10, 2011

Diabetes: Beware of Your Glucose Meter Control Solution

Today, I received a call from a reputable medical supply distributor's quality assurance person in response to a letter I sent complaining that their brand of control solution for a nationally distributed brand of glucose meters and test strips gave lower values than the name brand manufacturer's control solution. While this might seem like a minimal technical issue, it has practical implications for patients who work hard (and shed blood in the process) to maintain "diabetes control" - by keeping their blood sugar within specific ranges.  Too high, and kidney, visual and neurologic problems may develop; too low and the patients may suffer strokes or pass out.  When patients and their physicians cannot easily tell whether glucose meters are accurate, or how inaccurate they are, trouble follows.

The conversation led me to conclude that the company was not communicating well with its customers and lettering them know up front, clearly and unequivocally that there was a problem with its control solution. Someone in the company had made the decision to obfuscate and should take public responsibility. Meanwhile, patients, physicians, Medicare (as a payer) and the FDA should ask: what is going on here?  Diabetes is a common, potentially fatal and incapacitating disease which costs patients, insurers and the federal and state governments billions of dollars each year.  Let's get the diabetes glucose monitor control solution issue resolved.

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