Bringing the diabetes community together on important, united, missions is just one of the goals Glu has had from the start. On Thursday and Friday, August 15th and 16th, we will be asking two questions on Glu and we need your support. This is your chance to have your voice heard at a public meeting of the Diabetes Technology Society (DTS) on September 9th. The title of the meeting is “Verifying the Performance of Blood Glucose Monitors following FDA Clearance.” The FDA will be in attendance and the data you provide by answering Glu’s Question of the Day, over the next two days, will be used to strengthen our voice and position on why meter accuracy is so important.
We took time to interview Bennet Dunlap who is leading the Strip Safely movement alongside many others in the Diabetes Online Community.
Bill Woods: Bennet, what brought you to care about meter accuracy?
Bennet Dunlap: We have four kids and the younger two have type 1. The first was diagnosed a decade ago. At first the meter seemed super authoritative but, in time, we learned there were margins of error and how wide those margins were. I can be a geek and have been blogging about meters and accuracy for years.
Bill Woods: Why now? How is it any different from the past few decades?
Bennet Dunlap: While we hope for better, and the FDA is working for more accurate meters, there are things happening in the market that are making things worse. In May, there was a meeting organized by the Diabetes Technology Society (DTS). Researchers there reported on studies of meters. They discovered that some are not consistently delivering the level of accuracy in the marketplace, on our fingers, that they promised. These meters were approved for sale. This matters because millions of people with diabetes decide their insulin dose based on what their meter say.
Bill Woods: How bad is it?
Bennet Dunlap: One study presented there reported that more 40% of blood glucose monitoring (BGM) systems did not make the minimum accuracy requirements.
Bill Woods: Is it just a matter of meter accuracy?
Bennet Dunlap: Nope. There are reporting processes in place that are designed to protect the public, and when I say public I mean our kids and us. On July 23 the FDA issued a press release about efforts to stop “illegal sale of treatments for diabetes.” In that release they shared a warning letter to a meter and strip company for not properly filing these reports know as Medical Device Reports or MDRs.
Bill Woods: So can’t we just skip these products?
Bennet Dunlap: Yes and no. To skip them we need to know what products are accurate and comply with MDR rules and which ones don’t. We don’t know what products are accurate in the marketplace because there is no testing after approval. We need that. We need to know that MDRs are filed. We don’t. We need inspection by an independent third party of test systems found in the market through pharmacy distribution systems.
Bill Woods: What is next?
Bennet Dunlap: The Diabetes Technology Society is having a follow up to the May 21 meeting on September 9. The FDA will be there.
Bill Woods: What can we do?
Bennet Dunlap: FDA and Congress work for us. We need to be sure that our policy makers represent the diabetes community. To do that we need statistics, so be sure to answer the Glu questions of the day. Beyond that I, and many others, feel it would be useful for our Congress member to send their health policy staffer to the September 9 DTS meeting. Then the aide can help the member clearly understand the issue. To get that to happen we need to ask.
For more information and to find on additional ways to get involved visit the Strip Safely website. Be sure to spread the word to the greater d-community via Facebook, Twitter, and beyond using the hashtags #stripsafely and #bgnow.