Test strip accuracy is important to me because . . . . . I like to go to bed with my blood sugar under 100 mg/dl, so I can ride out the night in a perfect blood sugar range. I have my basals set almost perfectly to give me a flatline through the night while I sleep. However, if my blood glucose reading is “off” because of my test strips being less than accurate, it might read to low even though I’m not, and then I’d carb up before bed when it wasn’t necessary. More importantly, if it reads higher than normal, like 85, but I’m really only 65, I could go to bed already hypo thinking I’m good, and then I’ll wake up an hour later unable to think, sweating, afraid, etc. Hypoglycemia is never fun, but it’s worse when we sleep.
The current ISO standard for blood glucose meter accuracy is ISO 15197 and it allows for 20% variance above 75 mg/dl. That means if it reads my blood sugar is 85, it could actually be 68. But wait, it gets worse, since there’s no enforcement of this standard, it could actually be 60, or 55, or anything! There’s been a revision to improve the standard, but what good does that do, if there’s no enforcement by the FDA?!
Now check this out. I said 20% above 75 mg/dl right? So lets say your blood sugar is running high. Lets pick the number 320. My correction bolus is set to 60, and my target is 80-120. So that means I should bolus for 3.67 units of insulin. Remember that 20%? That means my blood sugar “could be” only 256, but I just took enough insulin to correct for 320, so that means I’m going to crash . . . hard.
Recently the NY Times reported that the FDA will be regulating smartphone apps. Smartphones. Non-medical devices. How long have we had smartphones? Since 2007. 6 Years. Blood glucose meters are real medical devices. How long have we had blood glucose meters? Since 1980. 33 years. They have thousands and thousands of diabetics, begging them to regulate glucose meters, and they won’t. Yet they’ll regulate smartphone apps at the drop of a hat? WTF?!?!? Hell, there isn’t even a standard for regulating smartphone apps!!! We already have a standard, and they won’t even regulate it? **SIGH** Can you tell this gets me pissed off?
Test strip accuracy is important to me because, inaccurate glucose readings lead to highs and lows, and both cause complications for me. I already survived cardiac arrest, I don’t need to survive anything else because my freakin’ meter can’t read my blood sugar right.
Please go to the Strip Safely website to learn how you can help effect positive change in this struggle to gain FDA regulation of blood glucose meters and test strips. http://www.stripsafely.com/