On Nov. 5 in a hotel just outside Washington, DC, about 75 people gathered to discuss the future of the Diabetes Technology Society's (DTS) proposed post-market quality surveillance program for glucose meters.
You may remember that DTS Director Dr. David Klonoff and his team have been working on this program for many months, assembling a Steering Committee of experts and laying out details in September. FDA appears to be supportive, and of course the patient community has lobbied hard via the grassroots StripSafely movement for this important program to assure the accuracy of the blood glucose meters and test strips our lives depend on.
The next challenge in making this a reality is to "gain consensus" amongst the healthcare establishment. And Klonoff is convinced that the buy-in of payers (health insurers) is key, because if they don't see the value in this after-market testing for quality assurance of diabetes tools, they'll just keep pushing patients to accept the cheapest (and least reliable!) products, and the manufacturers will have no incentive to cooperate with the quality testing program.
So we had this Payer's Meeting, in which glucose monitoring and quality assurance experts, clinicians, lawyers and engaged patients spoke. (I was proud to be on a panel alongside D-advocates Manny Hernandez, Christel Aprigliano and three other adult type 1s.)
The only problem was: there were hardly any payers present. By "hardly any" I mean one gentleman from Humana on a panel, who was very engaging and informative, and a lady from CMS in the audience who many recognized but did not raise her hand when the speakers repeatedly asked, "who is here from a payer organization?"
Ugh... But Klonoff emphasized that this gathering -- mainly of consultants, regulatory experts, pharma folks, and us patient reps -- was in many ways meant to brainstorm how to proceed in convincing payers of the merits of the program.
"The upshot is that we should be seeing better accuracy in this country; that poor meter performance leads to risk; and there are real potential dangers to patients."
— Dr. David Klonoff, Director of the Diabetes Technology Society
"Payers do listen, if we're telling them meters are not just good because they're initially FDA cleared. It's up to us as a community to get the evidence around risks (observational studies, etc.) to show if that if a product doesn't have the proper seal of approval, it shouldn't be in use," Klonoff said.
As one expert put it: "It's not acceptable that these meters should only have to perform once in their lifetime, at initial FDA clearance, when they have such a long shelf life and perform such a critical function."
About Testing Meters
Experts emphasized that all glucose meters are not created equal, but most people have no way of knowing what lies beneath the hood.
"There are cost differences in brands right now — what are the technological differences? And what about the quality of branded versus non-branded meters?" asked Dr. Mitchell Scott of Washington University School of Medicine rhetorically.
He pointed out that some patients are using meters up to 20 years old, "because they know and like them," whereas newer meters have three major advantages:
- They correct for hematocrit interference (amount of red blood cells), anemia, and other factors that can skew results
- They're very accurate
- They show no differences in results based on volume of the sample
Branded meters are more expensive because quality assurance measures come with them, including in the packaging and distribution. "It all goes back to traceability," said Dr. Robert Vigersky, an endo at Walter Reed National Military Medical Center and member of the new Steering Committee.
There are lots of good criteria available to measure whether a meter is accurate, according to Andreas Pfützner of the Science & Health Institute under his name in Mainz, Germany. There was lots of scientific talk about through these various methods (I shall spare you the details). Note that the very Joan Parkes, inventor of the Parkes Error Grid was present at this meeting, along with renowned glucose monitoring scholar Barry Ginsberg.
Somewhat surprisingly, several experts were emphatic that quality testing needs to be conducted by non-lab personnel in real-world settings.
"A lot of material published is made in the lab, under perfect instructions for use, but we have to see use with patients out in the world," one said.
There was mention of something called NOKLUS out of Norway, that can serve as an example of a program in which diabetes patients themselves test devices for quality.
What's sorely needed is hard evidence that poor meters create poor outcomes, the experts agreed.
It is of course hard to do clinical trials on patients using good vs. bad meters (can you say, "unethical"?) "It would be like insisting that we do an empirical study of whether parachutes help people when they're falling from a plane," quipped Vigersky.
One way around this is by "modeling patients" in a computer program that runs scenarios based on various "treatment inputs." We PWDs in the room got a kick out of Dr. Boris Kovatchev's University of Virginia study on 100 "simulated adults with type 1 diabetes" (documented here). In the study, it was clear that those using less accurate meters had more common hypoglycemia and other negative outcomes, he said, adding: "Now we just have to gain widespread acceptance of these computer-simulated studies."
Patient Realities (!)
As noted, myself, Christel Aprigliano and Manny Hernandez were paired up with three other local patient reps to discuss the impact on patients' lives: LaVonne Clark, Mark Ginevan, and Matthew Lewin, all with ties to the military. (Shout-out to Strip Safely leader Bennet Dunlap, who was in the back of the room but should have been up front!)
Despite zero help preparing for the panel from the DTS, I'm very pleased with the way the discussion went. I think we made it crystal clear that glucose meter results are the very foundation of our well-being -- the compass that leads us through life, so to speak. If they are not accurate, we are walking on some very thin ice. (Oh, the metaphors!)
Some issues discussed:
- It's not just us physically active young folks effected here; there are increasing hypos in the elderly, leading to more ER visits
- ER visits for insulin errors outnumber those for crystal meth (OMG — see YDMV)
- Risks of lows are not non-existent in type 2 either
- Competitive bidding in healthcare is restricting many people's access to anything but the cheapest, lowest quality meters
- Thousands of people whose glucose levels are bouncing around — with both types of diabetes — want and need more time in range! (which A1C does not measure effectively)
- You can look up consumer specs when you buy a car, a house or even a pair of shoes; we need a Consumer Reports-like resource for easy reference on comparative quality of glucose meters
I was a little shocked when, while explaining the misery of severe lows, a physician sitting up front asked, "Well if you can feel them so much, why do you need to test?"
Uh... because if I'm not obviously plummeting, and I feel at all funny, I might be: overtired, stressed out, developing an infection, getting the flu, starting my period, 20 other things, or even going into DKA, Dr. D-Expert. Wtf? Quality glucose meters are not only necessary for people suffering from hypoglycemia unawareness... Seriously, how much of a no-brainer is it that our meters need to be as on-point as humanly possible, when we're all making food, insulin dosing and even driving decisions based on those results?
Manny wrapped up our session beautifully with the statement: "we just want no crappy products!"
What FDA Can't Do
Huge thanks to Courtney Lias, director of the FDA's Division of Chemistry and Toxicology Devices, for being so involved in patient concerns and speaking at this event as well. The essence of her talk was that FDA is fully supportive of the program, but it can't force manufacturers to participate, and "it's virtually impossible to rescind clearance of a product once it's been approved and on the market."
Yes, it's been done for drugs like Avandia, but that was a long, difficult process in which there was evidence of catastrophic consequences, but the FDA's Device Center has never in history repealed approval of any device.
"Little Legal Recourse"
Klonoff had also gathered a trio of high-powered attorneys to lay out the possibilities of using legal means to force mandatory participation in this new glucose meter certification program. In short, the outlook for that is not good.
All three lawyers agreed that class action suits and other litigation efforts would be difficult in such a sweeping area, and thus, "legal action is probably not the best way to go." OK, gotcha.
Last not least in this payers meeting: Todd Prewitt, Chronic Condition Medical Director of Humana, was the lone payer voice, on a panel with Patricia Salber of Health Tech Hatch, who has many years of previous experience in the payer world.
Both emphasized that insurers are financial risk companies more than anything, and therefore hone in on costs and liabilities. In the case of diabetes, they're tallying up complications like kidney failure and "comorbidities" like heart disease that lead to hospitalizations. If you want them to cover something, they need evidence that it will significantly reduce these costs.
"You need to go where the payers are —- like their big annual industry meetings -- and talk in terms of gains that make sense to them," Salber noted.
Agreed! If this DTS Post-Market Surveillance program needs anything, it's a good strategic communications plan that addresses all the stakeholders, with messaging that explains why they should care. And this includes patients, too, because to many folks out there, a meter's just a meter, no matter where it's made or with how little oversight.