Diabetes Technology Society Meeting Addresses Blood Glucose Meter Quality
On September 9, the Diabetes Technology Society (DTS) held a meeting on how best to actively monitor blood glucose meter quality after FDA approval. The meeting included leading scientists, health care providers, FDA representatives, industry leaders, and diabetes patients and advocates to address this crucial issue. DTS has proposed a new Blood Glucose Monitor Surveillance Program (BGMSP) that would independently test the accuracy of strips and meters on an ongoing basis. Those in attendance appeared to be receptive to the idea – there have been lower-quality meters on the market that many feel have not kept up with industry standards. A clear next step was established - DTS will move forward with creating the surveillance program, beginning with an expert committee to decide on the specifics, such as how often meters will be tested for accuracy, whether real patients or stored samples should be used for testing, and to what standards the results should be compared. We also wonder about other aspects of the program, such as whether it will be voluntary or required, who will be on the expert committee, how quickly the program can be implemented, and whether the system will be pass/fail or graded.
An earlier DTS meeting in May found that about a third of currently available strips and meters do not meet approved standards for accuracy. Part of the issue is that some meters are cleared by the FDA, but then accuracy declines over time. Also, in the current system, manufacturers supply self-reported data to the FDA and it is likely that not all of these are up to the same standards. While some manufacturers have quality systems in place to catch meters and strips that do not meet requirements, others don’t make the same investments - the BGMSP program would bring all manufacturers to a minimum threshold. This issue is particularly important now that CMS is cutting reimbursements for glucose strips.
The cornerstone of the new DTS program will likely be a lab network that will regularly buy meters and strips and independently test their accuracy. This will allow the program to identify less accurate meters and alert the FDA to take appropriate action. While it may be complicated for FDA to take action on meters and strips already approved, we are hopeful there will be a plan to address strips that are not meeting minimum accuracy levels; we also would look to CMS to reduce reimbursement for strips that do not meet an established accuracy threshold. As we understand it, DTS will also make the accuracy results publically available, so doctors, nurses, and patients will have product quality information. This would be a meaningful improvement over the current state of affairs, where there is no independent quality testing of meters and strips following FDA approval, so patients sometimes use sub-par strips believing they are accurate because they have been FDA approved.
Looking at the big picture, some very key questions remain - most importantly who will fund the program, especially in light of competitive bidding. diaTribe will continue to cover the details of the surveillance program as they come out. To read our live tweet of the meeting (and others), please see our Twitter page at @diaTribeNews or search #stripsafely. We see the meeting as a real win for the diabetes advocacy effort put forward by Strip Safely and the diabetes online community.
To read more about this issue and background on the September 9 meeting, please read our new now next from diaTribe #57. –NL/AB/KC