An Open Letter to the FDA

I know it's rare for me to talk about my diabetes on this blog, but this time around I thought it was necessary. For background on what spurred this, see Kerri Sparling and Scott Strumello's blogposts.

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I have Type 1, insulin-dependent Diabetes, and rely heavily on my test machine to be 100% accurate 100% of the time. I give myself insulin, eat a snack, exercise, drive my car, and live my daily life based on those results. My husband and I have been married for almost 3 years and we're talking about starting a family within the next few years, but I rely on my test machine to tell me what my blood sugar is doing so I can tweak my insulin pump and alter how much insulin I'm giving myself in order to get my A1C results down to the holy grail of diabetics -- 6.5% -- so I can get the "ok" from my doctor to get pregnant. I'm having an incredibly hard time believing that it's "ok" for my test machine to be +/- 20% on a regular basis, not to mention that on several occasions it's been off more than 20%, which leads me to believe that companies aren't following the policies laid down in the first place. How can I be expected to live my life as a functioning Type 1 Diabetic and be a reliable worker, driver, citizen, and, hopefully one day, a reliable mom, when the machines I rely on to be 100% accurate, aren't even close? Please, consider ALL diabetics in your decision to change the accuracy of these machines -- not just those who have Type 2 Diabetes and can rely on a range on numbers instead of an exact figure. Make the decision to raise the accuracy of our test machines, thereby allowing us to raise the quality of our lives.

-Mary Rotman

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p.s. Want to make a difference? Visit www.regulations.gov and search for Docket No. FDA-2009-N-0604 to leave your comments. Tell the FDA that 20% isn't good enough, and we deserve every chance to take the best care of ourselves.