Many of you may know that the FDA held a two-day Public Hearing on the issue of Glucose Meter Accuracy late last week. Dozens of experts gathered at the Washington DC Hilton/Gaithersburg Hotel to lend testimony.
The issue at hand, according to FDA statements, is that:
“Glucose meters are increasingly being used to achieve tight glycemic control despite the fact that these devices have not been approved for this use. There is currently no consensus that blood glucose meters currently on the market are accurate enough to be used in this way. Still, other stakeholders believe the current analytical performance of glucose meters is adequate and that there is no evidence to support the need for higher standards…“
Experts are always split on these issues it seems, so I’m sure you are as curious as I am as to what came out of this great debate. I was fortunate to spend some time on the phone with Ellen Ullman, a patient advocate and research associate at Close Concerns — who was the ONE AND ONLY PATIENT REPRESENTATIVE invited to speak at these FDA hearings. (Ellen’s grown son was diagnosed with Type 1 at 15 months.)
The title of Ellen’s 20-minute talk was, “How Meters are Used at Home and How Consumers Choose Meters.” Here’s her perspective on how the whole thing went down:
DBMine) First off, what was your overall impression of the Hearing?
EU) I felt like there was much more focus was on the critical care/intensive care patients who don’t have diabetes — whose gylcemic control is out of whack — than on the everyday concerns of patients out there at work and school, on the soccer field, etc.
The whole second day was about whether point-of-care (instant-result) meters are accurate enough to use in (the hospital) setting — as opposed to sending the tests to the lab.
Meanwhile, these meters we use out in the world are only accurate +/- 20%, ninety-five percent of the time. What I tried to drive home is that the majority of (diabetes) consumers really do want increased accuracy.
Did you anything you heard shock or frustrate you?
As patient advocate, what I was hearing was them playing down the impact of outliers — you know, how you sometimes you get a 300 when your BG is really 70.
They spent a lot of time going over everything a patient does that can alter accuracy — like not washing your hands, or leaving meter in the car — so much emphasis on,”what is the patient doing wrong?’ This, to me, was consistent with the ‘blame the patient’ approach in general.
My point, was: maybe you want to develop some guidelines for dealing with the outliers, and also the things that can cause inaccuracies.
My defensive part felt like they were looking at the outliers as if patients were just dots on a Clark error grid that sometimes fall outside the grid parameters. I kept thinking, we are not just a dots on on a grid — these are people whose lives are impacted! They’re making insulin dosing decisions off of this information.
Every single outlier is a potential problem, and we have plus or minus 20% error margin. How is this permissible?
What actually prompted this FDA meeting?
I don’t know exactly. I think maybe the results of the NICE SUGAR study had something to do with it — which indicated that people could be dying as a result of tight control. The question there was, is meter inaccuracy contributing to the ‘dangers’ of tight control?
But in fact that study has been largely questioned/refuted because of the way they gathered the data.
What was your main message to the FDA?
I talked about how people choose meters — or should we say, how meters are chosen for patients. It’s usually dictated by the insurance provider, so we don’t really have a choice.
I ran a little online survey of patients and got just over 500 responses. In the comments section, accuracy came up repeatedly. But the FDA doesn’t allow competitive meters to state what their accuracy level is; they’re only allowed to state that the products are in the approved range, I believe.
So how can consumers make informed decisions choosing a meter, if they don’t know even know what the accuracy is? That’s unacceptable to me.
Also, I heard a lot of experts saying people wouldn’t sacrifice testing time or blood sample size for better accuracy. I think that’s malarkey. Think about how significant the difference would be if they brought the error margin down to +/-10%. The technology is evolving so fast. If there are meters capable of that today, then that should be the new standard!
So there are currently NO standards for indicating accuracy to patients?
If you look at the Diabetes Forecast 2010 Consumer Guide, for example, it states that accuracy is really important.
It says you should use control solution to make sure that your meter’s in range. But control only tells you if the test strips are OK; it doesn’t say whether the meter is functioning within the acceptable accuracy range. It really doesn’t tell you anything.
And there were really experts arguing that current meters are accurate enough already? Isn’t that like saying cassette players can already play music, so why do we need to advance to MP3 technology?
Yes! Some said current meters are OK, they’re accurate enough, so why change? My reaction was: What? These are people’s lives we’re talking about. And it’s even more important now with new CGM systems and interest in the artificial pancreas. People are calibrating their CGMs based on inaccurate meters, and making dosing decisions based on the CGM (even though it’s not approved as stand-alone therapy).
There was some talk that maybe we could have two types of standards: regulatory standards and clinical standards — based on the population itself (patients on insulin or not, patients in the hospital).
But people on Medicare or without insurance will end up with the cheapest, least accurate meters. That’s not right. You cannot start stratifying that way.
Will increased accuracy come at a cost to all of us?
They were saying patients won’t want to pay for new strips, or give up some features. My feeling is that usability and convenience cannot trump accuracy.
But does it have to be a trade-off? There’s still plenty of profit for the industry to make ethically on accurate meters and test strips. They can provide a higher level of accuracy; the technology is already out there. But as consumers we’re not even allowed to know the differences.
Any endo or diabetes doctor worth their salt is trying to help patients get tight gylcemic control. But they have to keep in mind that consumers are the end users. So it’s vital to have accuracy in labeling, which should be in every box.
If stuck we’re stuck with control solution as the only measure, that doesn’t really speak to accuracy.
Do you feel like you achieved something being there as the voice of the patient?
I hope that I honorably represented patients. I definitely felt like I was representing the millions of people on street who are living this. I stood for every one of them, because they’re not being represented by the other (speakers).
Currently I believe the ADA has not pressed manufacturers or the FDA about improving accuracy. I think we can get it within +/-10% now, and that’s what I would like to see. But I don’t feel that my work is done. I have much more to say. There is definitely more work to be done.
Thank you for being our voice, Ellen!
See blogger/advocate Scott Strumello’s Call to Action
Report any problems with blood glucose meters pr CGM systems here
And/or submit your sentiments to the FDA’s Comments Docket by clicking here