Monday, July 29, 2013

Twenty Percent

Would you bet your life on something that has a ± 20% margin of error? 

You see, the FDA only requires blood glucose meters to have a ± 20% accuracy. In addition, the FDA acknowledged that there are nearly 500,000 blood glucose meters and strips on the market, that do not meet the accuracy standards for which they were approved. 

Let me explain what this means to a person with diabetes; inaccurately high meter readings could lead to a person receiving too much insulin and cause severe hypoglycemia, seizures, coma or death. Inaccurately low meter readings could cause a person to receive too little insulin resulting in hyperglycemia, and the risk of diabetic ketoacidosis.

Why is that a big deal?  

Yesterday, 2 hours after lunch my meter read 190 mg/dl, so I corrected with 1.5 units of insulin. A hour and a half later my blood sugar was 52 mg/dl and dropping; because the insulin I gave was still active in my system.  

If the meter read at the high end of the accuracy standard, 236 mg/dl I would have given 2.3 units of insulin! That amount of insulin could have caused severe hypoglycemia.

This is a potentially deadly situation and with the current meter standards it can (and will) occur again at any time. 

It is time for the FDA to take action, my life and the 25.8 million Americans with diabetes are depending on it. I am asking for ongoing testing of blood glucose strips to assure compliance with the FDA's accuracy standards and for the FDA to improve the US accuracy standards to the latest ISO standards of ± 15%.
You can help by writing to your elected officials and to the leaders at the FDA. Sample letters are available on the Strip Safety website.

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