If you’re a Person With Diabetes, you know the importance of seeing accurate readings on your glucose meter. In a public meeting last May, officials from the U.S. Food and Drug Administration admitted that there are some glucose meters and test strips out in the marketplace that no longer meet the standards that they were approved for in the first place.
What were they approved for in the first place? In testing with the FDA, test strips are required to meet an accuracy of +/- 20%. That means if my meter says 180 mg/dL, it could actually be as high as 216 and still pass the test. Or it could be as low as 144… and still pass the test. That’s a 72 point difference! That’s a window big enough to drive a truck through. And that’s what is required to pass the test and win approval.
To their credit, the FDA is working to lower the threshold and make test strips even more accurate. So what’s the problem?
Well, once the test strips are approved for use in the USA, they aren’t subject to further scrutiny. In other words, there is no program in place to ensure the continued accuracy of test strips once they’re approved. So the test strips I’m using, that met a 20% standard of accuracy when approved, might now have an accuracy of +/- 40%, according to some experts. At that measure of accuracy, my 180 mg/dL reading might actually be 252. Or 108. A difference of 144 mg/dL.
Since dosing insulin is dependent on my blood glucose reading and how many grams of carbohydrates I’m eating, if there are 45 grams of carbs in my meal:
– That 20 percent standard means a dose as low as 3.3 units. Or a dose as high as 5.1 units.
– That 40 percent deviation could mean a dose of 3.0 units. Or a dose of as much as 6.0 units of insulin.
Imagine if my dinner bolus is 6.0 units, but it should have been 3.0 units. Since my target is to get back to 100 mg/dL, and one unit of insulin should drop me about 40 mg/dL, an over-bolus of 3 units means I could drop 120 points lower than expected, resulting in severe hypoglycemia or even death. Are you with me so far? Do you understand how critical test strip accuracy really is? Good.
This is why the Strip Safely (http://www.stripsafely.com) campaign is in full force, helping to spread the word about the importance of test strip accuracy. You can do your part too, by sending a letter, either by snail mail or by e-mail, to your elected officials in Washington. Need a little help getting started?
– A sample letter you can use is available here.
– You can find your elected officials HERE.
Hint: Our elected officials have Twitter and Facebook accounts too. So does the FDA. In fact, they have many Twitter handles, including @US_FDA, @FDADeviceInfo, and @FDAMedWatch. If you decide to send something via Twitter, be sure to include the hashtag #StripSafely.
You might be saying, “Hey Steevo, you wrote about this before… why bring it up again?”. Because it’s that important. Let’s keep the momentum going. Let’s help improve the safety of people living with diabetes, and improve the peace of mind of our loved ones affected by diabetes. It’s that important. And your help is needed and appreciated and keeps the momentum going.
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