StripSafely is the Diabetes Online Community’s raised voice to protect ourselves from inaccurate blood glucose meters and test strips.
This month Medicare begins offering a limited variety of glucose meters to its beneficiaries. Many of the test strips offered, and manufactured overseas, fall below the FDA approved standard for accuracy. That standard is already too low but don’t get me started.
I’m asking you to join the movement. It’s easy. Write a letter (samples provided) asking the FDA to ensure strip accuracy. If you have diabetes, know someone who does or love someone who does, you know this is a life and death issue.
And while you may think this doesn’t concern you because Medicare is a lifetime away, this may drive US manufacturers of meters and strips out of business. That means: no quality control, innovation, support services, educational programs, and oh yea, accuracy.
It only took me 15 minutes to write my letter. Here are sample letters to make it easy. And here’s mine. As you can see, I took the sample “Short Letter” and just made it personal.
Jeffrey Shuren, MD JD
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’ve had type 1 diabetes for 41 years and I’m turning 60 next month. Two weeks ago my A1C was 5.5%, yes, normal. How is that possible? I adhere to a healthy diet, exercise every day, and check my blood sugar diligently using a meter and strips recognized among those with the tightest accuracy.
I am writing to you because while I might have said as a teenager, “I’d die if I don’t get that!” I actually could die if I don’t have accurate test strips.
Those of us living with diabetes truly need your help and advocacy. We are facing losing our health due to Medicare’s July 1st cost-slashing program. In only a few years I will be affected by this if nothing changes, and meanwhile US manufacturers may get squeezed out of the market due to price. That means we will lose further quality control and standards, innovation, new product development, service support and educational programs.
At a recent meeting with the Diabetes Technology Society, the FDA acknowledged that many blood test strips do not deliver the accuracy for which they were approved. Further, the FDA has no plan to fix this problem.
I need you to have one. My Aunt needs you to have one, my downstairs neighbor needs you to have one, and hundreds of my friends and acquaintances need you to have one. And my husband, who doesn’t have diabetes, desperately needs you to have one. Otherwise, one day he may not have me.
Blood sugar fluctuates all day, every day both as a consequence of what we do, and by its own nature. I don’t need the quality of test strips to also be uncertain.
Please, I am asking you to, at the least, implement a program of ongoing random sampling of strips to insure that all brands consistently deliver at least the minimal accuracy approved by the FDA.
While I have previously written that the FDA should tighten the ISO standard, how wonderful it would be if Fixing Diabetes Accuracy is one of the things for which the FDA becomes known.
Don’t wait. This is something we can do together. And lives depend on it. Feel free to copy my letter, just fill in your own specifics.