Bennet Dunlap
Strip Safely: Patient Advocate Bennet Dunlap Pushes for Greater Meter Accuracy
Bennet Dunlap is a parent of two children with type 1 diabetes and one of the creators of the Strip Safely – an initiative to ensure that regulations require the highest feasible level of test strip accuracy.
We recently interviewed Bennet about his effort to make the latest proposed FDA guidelines on meter accuracy in the United States responsive to patient needs.
Early this year, the FDA proposed new guidance on meter accuracy How does this impact people with diabetes?
Bennet Dunlap: Yes, there were two guidelines in fact. One proposal for individual and personal use. The other draft was for meters to be used by health care professionals in the hospital or clinic.
But let’s take a step back, because there are two big issues with meters. First there are some that fail to preform to the accuracy standards for which they were approved. Diabetes Daily has an excellent piece that outlines the problem. Second to that the accuracy standards required in the USA can and should be tighter.
First: There are meter systems in the US that are approved by FDA that are not keeping up to the level of accuracy they were approved to deliver. That issue is what we started StripSafely about. I want to be very clear, StripSafely is not about any brand or strip or meter. It is about all delivering the accuracy so people with diabetes don’t have to think twice about it.
There is a “click bait quiz” about accuracy, see what you know here in this Strip Safely Quiz. Go have a look, we’re not gonna tell ya what star you are but we are not gonna farm your interest either–well, unless you join the StripSafely mailing list–but at least we are fair about making that a clear sign up.
I also want to be clear. I am not a doctor. I am not a PhD, engineer or a scientist. But, folks – I am making this up. I am happy to share the issue with copious footnotes here.
Secondly, the accuracy standard for meters was last set in 2003. In general it called for meters to be +/- 20% – 95% of the time. Technology can and should advance. Hence the need for new guidance proposals.
What was proposed? What are the key issues at stake here?
A lot is proposed. The proposals are 30 to 40 pages each.
Key issues in the guidance are accuracy, labeling, lot release criteria, and a partridge in a pear tree. Within each, there is a fair amount nuance. For example, the drafts call for different accuracy level for personal and professional use. Labeling the box so patients can choose accurate strips, but often our insurer makes that choice for us.
A very key issue is that, even with these new standards, the old stuff based on old standards will still be approved and able to be sold. It will be cheaper since no R&D investment in upgrading will be needed. Forgive my cynicism but what do you think you insurer wants to pay, less or more?
How can people living with diabetes impact the outcome?
When the FDA proposes new guidance there is a comment period, 90 days. Anyone interested, and people with diabetes should be interested, can comment to the dockets. At Strip Safely we have draft comments and links to the FDA dockets. It is not much harder than commenting on a Facebook status except there isn’t a “like” button.
The more people with diabetes who comment the bigger influence we have in comparison with the interest of strip marketers who may be able to profit from less accurate less regulated strips.
So if nothing else, those who dose insulin to live and breathe may want to suggest to FDA that the new rules be specifically labeled to dose insulin. That may help create a situation where prior devices that lack that label can’t be seen as meeting the dosed insulin requirement. Is that a stretch? Yes it is maybe more than what the FDA is asking for.
The FDA doesn’t have a lot of official opportunities for PWDs to share our views on meter accuracy. The last rule change was in 2003. So if the FDA is listening, let answer the questions they ask and one they didn’t ask. Commenting is very easy, take two minutes and is part of the StripSafely site. Here are several “Cut and Paste” ready sample comments here.
We need to drive people to the dockets.
If FDA sees a huge turn out from people with diabetes, and I think they are seeing that now, the diabetes online community’s influence will shoot up. That is good; we need to balance economic interests.
If you could look at the future of smart meter technology, what features or services would you like to see beyond just great accuracy?
You don’t need a crystal ball to see the future of diabetes. You probably have what you need and that is a smart device and the Cloud. The future is making information more effectively serve the needs of people with diabetes. That currently means their smart phone and maybe their smart watch, and who knows, maybe even the Google Glucose-Sensing Contact Lenses.
It isn’t just blood glucose measured by a finger stick. It is all that crazy information that come up in a day with diabetes, you know, all the silly little inadequate measure of what we call life; finger stick, CGM info, insulin on board, working out, stress, Mondays, etc. It all meshes together and in diabetes care it is all separated and walled off into little clumps that not talk with each other. We need a common Diabetes User interface, a D.U.I…wait that may not be the best name for it. I wrote a piece about this future in a post on my blog here.
Bennet’s other projects Drinking with Diabetes project, a resource for families sending type 1 students to college. Living with type 2 diabetes himself, Bennet is also an integral member of the Spare a Rose/Save a Life campaign supporting the IDF’s Life for a Child Program. Read more from Bennet at his blog, Your Diabetes May Vary.