Naturally, we all want the best possible accuracy from our glucose monitors. But everything comes with trade-offs -- which has been a point of discussion in the diabetes patient community since at least 2010, when the Roche Diabetes Social Media Summit asked a bunch of advocates to rate the compromises they'd be willing to make for better accuracy.
As it stands now, the FDA has proposed tighter standards for home and clinical-use meters, that are even more aggressive than international accuracy standards adopted in 2013; the FDA is calling for a +/-15% of the true blood sugar value in home meters, and an even tighter +/-10% for clinical units, whereas the ISO standards call only for a bump from from +-20% to +-15% across the board.
The patient community -- especially the grassroots initiative StripSafely -- has praised the FDA for going beyond the international rules. But we are now hearing pushback from industry contacts and some clinicians about possible negative intended consequences of mandating such tight standards in the U.S.
According to authorities at JnJ/Lifescan and their public relations agency, who reached out to us recently, if the FDA draft guidance is accepted, manufacturers will struggle to meet those standards and may have to change their designs for the worse; new meters might be bigger and bulkier, may use more blood than the tiny little droplets we've come to expect, and prices could jump higher than they are now. And the kicker, according to these PR contacts? The small improvement in glucose value accuracy might not be enough to make much difference at all in our overall diabetes management outcomes.
At least that's the message the meter-manufacturing industry is touting as it tries to influence the FDA's ongoing review of new guidelines that would be the first real update on device accuracy in a decade. We wondered why it took so long for JnJ to reach out to patient advocates on this issue, which has been been a hot one during the entire past year...?
As far as we can tell, their campaign is prompted by the overwhelmingly positive comments FDA received on the guidance docket; consumer pressure appears to be in favor of these tighter standards, and it seems the industry is feeling squeezed.
Analyzing Public Comment
In November, the American Association of Diabetes Educators (AADE) published an analysis of all 578 comments submitted on the draft guidance, looking at the type of feedback and where it was coming from and also reporting on how FDA plans to use that feedback as it moves forward.
Some interesting points from that AADE analysis:
- The FDA appears to be counting all consumer comments as separate submissions, even when those responses were in form-letter style, obviously using a prepared template.
- On the other hand, the agency considers a letter signed by multiple national health professional associations as one comment.
- For this reason, the sheer volume of positive consumer comments far exceeds the volume of negative positions taken by most manufacturers, trade associations, hospital and health associations and academia.
- Perhaps to balance out any impression of a bias toward consumers, the AADE believes that going forward, various associations will be able to file the same letter under separate cover, in which they'd be considered 'new' comments.
- Many commenters noted that a core problem is the poor quality and lack of consistency of existing testing centers for glucose meters; they want FDA to address this issue -- ideally before suggesting a new set of higher standards;
- Letters from industry and professional organizations make a case against tighter standards based on the following points:
- There is no evidence supporting the FDA's decision to deviate from industry-accepted ISO standards;
- There is no clinical evidence or justification put forth by the FDA to back up the need for these new requirements, many of which are claimed to be "technologically impossible" for manufacturers to achieve;
- The new requirements will directly impact care and increase costs for providers in some cases, especially in hospital settings where the new guidance may force the use of lab testing for glucose monitoring since clinics may be unable to meet the new standards with Point-Of-Care testing
Wow -- we wondered of course if substantiation was provided for those final, strong claims. And then we noted this statement in the AADE's analysis: "While the positions taken by the majority of comments are obvious, there are some where the writer's 'ask' was somewhat ambiguous, or they took the opportunity to expound on an issue that appears outside the scope of either the Point-Of-Care (POC) or Self-Monitoring Blood Glucose Test Systems (SMBG) issues we were asked to address, or offered apparently benign technical clarification suggestions."
There is still no timeline set for when the FDA could reach a decision and issue final guidelines, but the AADE analysis expects it could be "many months."
Meanwhile, it's interesting to see industry stepping up its advocacy game recently. As noted, we were surprised to hear from JnJ/Lifescan on the issue now, a full seven months after the comment period closed back in April.
One Elizabeth Funderburk of the Washington D.C.-based PR firm APCO Worldwide says JnJ hired her in the Fall to start reaching out to patient advocates, since they found many weren't aware of this issue or hadn't looked beyond the "better accuracy is good" argument. I felt that intro was a little imprudent, especially with all the FDA and DOC collaboration in the past year and how StripSafely has brought this debate front and center to many PWDs. What I read into this: the industry's perspective hasn't been communicated as well as they'd like, and they want to build empathy among the patient community now that the heat is on.
The main points both Funderburk and Lifescan Communications Director David Detmers relayed to us: They don't think the FDA needs to go beyond the ISO 2013 standard, as there may not be clinical evidence supporting the benefits, and the patient community hasn't fully considered what trade-offs might be needed if the regulators force this kind of rule. And despite the public comment period ending months ago, industry feels this is still good a time to advocate on the issue because the FDA is still considering the rule-making.
"When you start peeling back the layers of the onion, you have to ask if those trade-offs for better accuracy are worth it and if people would accept the implications of doing this," Detmers said.
According to him, some of those trade-offs could include:
- Bulkier devices that aren't as handy to hold, are less portable or don't look as slick as they often do these days
- Longer time before a result flashes on the meter screen
- Not being able to use AA or AAA batteries, but needing a wall charger
- More blood needed on the strip
- Higher costs in order to build-in the higher expenses of making more accurate meters
The two also said many in industry are wondering if the FDA has any specific science or clinical data showing what outcomes these accuracy improvements (beyond ISO requirements) might actually have. As of now, that apparently hasn't been studied and it's a question that needs to be answered before these rules take effect.
Word from the Doctors...
It's important to note that industry does not stand alone on that last point. A handful of well-respected endos actually asked penned a letter to FDA in March questioning whether there's enough justification for the FDA to go beyond the international guidelines from 2013, and calling for better post-market surveillance of meters already on the market (something the FDA is reviewing separately). The contributing doctors are: Drs. Steven Edelman at UCSD, James Gavin III at Emory University, Irl Hirsch at University of Washington, and Howard Wolpert of Joslin Diabetes Institute. Basically, that:
"If the FDA is in possession of clinical evidence to support the need for raising these requirements, then we would encourage you to make this public," the doctors wrote. "In the absence of such clinical justification, it is our opinion that raising the required glucose monitoring standards while not addressing the issue of enforcement is premature... In summary, although well-intentioned, the newly issued guidance documents if adopted could lead to unintended consequences, negatively impacting the quality of blood glucose monitoring and the care of patients with diabetes in the U.S."
When we reached out to Edelman about this, he surprisingly referred us to Abbott Diabetes Care to provide more feedback on any follow-up to that letter. Edelman tells us that all of the clinical folk who signed that letter were on an advisory board for the Abbott Freestyle Libre Flash Glucose Monitoring (FGM) system just released overseas, and at one get-together the doctors decided on their own to write this letter; Abbott did supply some specific information at the doctors' request, which they included in the letter.
We've asked Abbott for a response about any follow-up to that letter, but with the holiday season we haven't heard anything to date.
These are important questions and considerations, without a doubt.
Just as important, if not even a bit more, is the Diabetes Technology Society efforts on the post-market surveillance program that we hope to see kick off soon. Just recently in mid-December, the California group announced that its Steering Committee had met in Virginia and was close to finalizing the latest version of the post-market testing protocol. That's expected to begin soon, and we hope to hear more in the coming months from DTS founder Dr. David Klonoff on key questions like how this testing will take place, and how results will be shared with both industry and patients.
As the AADE analysis wisely noted, "insulin is a very dangerous drug" and therefore "(glucose meter) accuracy should be required at the highest level that is economically feasible." This underscores the importance of both post-market surveillance and the highest possible standards for new meters, from our insulin-dependent POV.