As you may have heard, some Diabetes Online Community (DOC) advocates have started a social media campaign calling for better accuracy requirements on blood sugar meters and strips.
The campaign is called Strip Safely.
We touched on this issue in a recent post, but we wanted to officially take part in this initiative’s letter-writing campaign to decision-makers on this topic. That’s the FDA, Congress, and other “powers-that-be” who weigh in on this matter.
Here’s what I wrote, as part of this StripSafely campaign. You can find template form letters to use or tweak yourself at StripSafely.com, and finding your Congressional members the traditional way or on on Twitter is easy. Be sure to share your letter and use the hashtag #StripSafely.
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Dear Congress/FDA Official:
Imagine traveling to another city for work, attending a long conference all day and then going to your hotel room on that first night to get some sleep before an equally-long day ahead.
You go to bed, thinking all is OK, but you never wake up.
As it turns out, the medical device you used just before bed to determine if you were “safe to sleep” wasn’t accurate and basically gave you a false sense of security. Instead of having an A grade of a blood sugar as it tells you, you’re really going to bed with a D. That leads to your slipping into a coma overnight, and no one is there to help or stop this tragedy from happening.
That is the fear that I have often, in my life with type 1 diabetes. In the simplest terms, the reason is that the technology that I base my insulin decision-making on is, at times, a bit like throwing a dart at a dartboard in the dark with my eyes closed.
And the medical product-supervising FDA allows this to happen.
In my mid 30s now, I’ve been living with type 1 diabetes since the age of 5 back in 1984, just about the time that home glucose meters were first becoming available. While we’ve seen many technological advances since those days and diabetes devices have gotten much more advanced, the accuracy standard for meters and test strips remains unchanged. And unfortunately, there’s no guarantee that these meters and strips are actually meeting the established standard once they hit the market for people to buy.
In an age of smartphones and tablet computers, those of us living with diabetes are forced to use glucometers and strips that are the equivalent of using dial up rotary phones and Commodore 64 computers — and we have no way of knowing whether the call is going through or the computer is even saving our data.
That scares me beyond belief, but it also angers me and makes me wonder why my federal government doesn’t ensure that this safety is required for those diabetes products being approved and sold to millions of people.
At a recent Diabetes Technology Society meeting in mid-May, the FDA acknowledged that there is a problem with some blood test strip manufacturers not delivering the level of accuracy for which they were approved. Many of these come from manufacturers overseas, particularly in Asia, but in theory there’s no guarantee that this isn’t also happening within the U.S. The FDA admits this is a problem, but does not currently have a plan to address the issue.
The Diabetes Community needs your help to do something about this. Please use your good office to help keep citizens with diabetes safe.
Of course, we would welcome a tighter standard to ensure more precise accuracy in these products. We’re pleased that the FDA is poised to follow what’s happening internationally in requiring more accuracy. But first, we need to ensure that whatever standard is in place, it’s being met — at the time of FDA approval AND after these products have hit the market for people to buy and rely on. Right now, the FDA is not doing everything it can to make sure quality control is met and the accuracy standard is being complied with.
Please do what you can to help implement a Post-Market Program, which would include ongoing random sampling of strips to ensure that all brands are consistently delivering the “real world” accuracy they were approved for. Other ways to address this issue are to make sure any competitive-bidding processes consider quality, not just cost; and to make sure a regulatory requirement is that contact information must be continually updated and current for patients to file adverse outcomes reports for all blood glucose testing devices.
Bottom line: The FDA has many responsibilities, so please make Fixing Diabetes Accuracy one of the things for which the FDA is known.
M. Hoskins, DiabetesMine.com
Again, being a part of this online campaign is as easy as writing and sending a letter, so please consider penning one yourself. We can all work together in making sure the D-Community’s voice is heard on this very important issue!