Tuesday, July 2, 2013

Strip Safely

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.

Jeffrey Shuren, MD JD jeff.shuren@fda.hhs.gov
Director, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO66-5442, Silver Spring, MD 20993

July 2, 2013

Dear Dr. Shuren,

I want to talk to you about a phrase that has been ringing in my ears for the last 3 years: "statistically significant."

I have had type 1 diabetes since 1990, diagnosed in a coma at the age of 10. I'm now 33 years old and a mother. A mother. Having two successful pregnancies with pre-existing diabetes was a massive accomplishment for me. It required checking my blood glucose levels 12-15 times per day for years - the months leading up to conceiving, the long haul of pregnancy, and the early days of caring for each child.

Ever the advocate for people with diabetes, I was speaking to an engineer from a meter company in 2010 and trying to explain why meter accuracy is so important to me.

"I take a different dosage of insulin if my blood sugar is 148 than I do if my blood sugar is 136," I told him.

"But that difference is not statistically significant," he said, staring blankly at me.

This engineer was brilliant. He was responsible for the discreet chemical workings of the test strips I use on a daily basis, but it was painfully clear that he had no idea what my daily life with diabetes must be like. He had no idea what it feels like to plummet into hypoglycemia because you overdosed by just a smidgen. He didn't know the body-rocking sick feeling or frustration of trying to bring down a high blood sugar value for hours because your meter told you to take enough insulin for a 260 when you were actually at 300.

So I can't expect you to empathize either, but I can ask you for specific help.

I need post-market regulation on meters and strips. I need my meter and strip producers to conform to the ISO +/-15% recommendations - or even FDA's current +/-20% standards.

At a recent meeting with the Diabetes Technology Society, the FDA acknowledged that there is a problem with some blood test strips manufacturers not delivering the level of accuracy for which they were approved. The FDA does not currently have a plan to do anything about the problem.

We need you to have one.

Please implement a post-market program of ongoing random sampling of strips to insure that all brands consistently deliver the accuracy in the real world that they were approved to do.

We would also love to see the accuracy standard required tightened too, but, first things first, we cannot let a lack of quality control by manufacturers or the FDA degrade the existing standards to irrelevance.

You can help. Please help.

I know firsthand that there is a scared young woman out there somewhere staring at a high number on a meter screen and rubbing her belly worriedly, scared for her child, blaming herself. I blame her meter. I blame her strips. Give her her best chance. Give her numbers she can work with. Numbers she can trust.

Thank you,
Melissa Baland Lee


  1. Wow! I want to go out and buy more meters now to see how different they all are...maybe this would explain my higher than expected A1C today. Great post and I also plan on emailing Dr. Shuren

  2. Huge love. Thanks for helping keep PWDs safe.

  3. Thanks again finding time to update StripSafely and quote you here: http://www.stripsafely.com/?page_id=78

  4. Finally getting around to updating the social Media page with quotes an links back. Linked you back (possibly more than once) http://www.stripsafely.com/?page_id=78