If you or someone you love has diabetes, I want to shock you for a second.
If you don't have diabetes, I want to put this shock into perspective.
Blood sugar meters are all crap. See these numbers?
They're all essentially wrong. My plasma glucose was 104.
And they're mostly within FDA's acceptable variance range. The one on the far left was -22% off, but the other four performed within the +/-20% allowance.
Meter companies and the FDA worked together to set these (arguably loose) standards. And they're thankfully petitioning for tighter standards (+/-15%) in line with international recommendations. The PROBLEM is:
1) More than 25% of blood glucose meters already fail to meet current standards.
2) There is no post-market regulation of these meters or their strips. Once released into the wild, subject to weather or age or drug interactions or, I don't know, Tuesdays, there's no one checking to see if they continue to meet standards.
3) New Medicare laws will bring low-cost, low-quality meters and strips to millions of people with diabetes. Without a regulatory process in place, people will get hurt.
4) I take a different amount of insulin depending on that number. Not enough insulin can kill me. Too much insulin can kill me. I play Russian Roulette every time I take my dosage. In the above example, I was about to drive a car. On a highway. I had to make a decision about taking insulin for the 124 or eating a snack for the 82 before I got behind the wheel. It's the kind of decision I make 6-8 times per day and I'm usually basing it on that number.
So what can we do? Join me in writing to our lawmakers. Join us. Please. Below is my letter.
