As we've reported, the California-based Diabetes Technology Society is working closely with FDA to roll out a new program to ensure the quality and accuracy of glucose meters already on the market -- 'cause who knows how reliable those older models really are?
With this so-called Surveillance Program, they've introduced a new Surveillance Error Grid (SEG) by which to evaluate meters, set up a new expert Steering Committee, and are talking about developing "a protocol to assess BGM System performance" and then actually testing products out in the field.
That's what we've been wondering since the DTS first announced its plans a year ago, but specifics have been hard to come by. Fortunately, an advisory teleconference was set up for the public earlier this week, and we were able to join some industry insiders and diabetes advocates on that call to learn more details.
While those new details were interesting to hear, the call was not very interactive -- participants weren't able to pose questions except to send them to a press relations person by email, and hope they were relayed. A majority of the call was spent by DTS leader Dr. David Klonoff making the case for the Surveillance Program, with a lot of introductory comments about the whole issue of inaccurate glucose monitors that's been pretty well publicized at this point. But it was still amazing to hear him quote anecdotal findings from the past few years showing that 25% of meters on the market aren't meeting the 2003 standards for accuracy clearance, and even more shocking, that about half aren't meeting the standards adopted internationally in 2013 and the draft guidelines the FDA is currently considering. Yikes!
Definitely sells the need for this Surveillance Program to start ASAP!
Quick Summary: Nothing's finalized at this point, but it looks like the DTS is planning for a "Pass-Fail" testing system that may include rating meters based on how accurate they are in independent, third-party (non-manufacturer) testing.
As explained during Tuesday's teleconference, Dr. Robert Vigersky, a member of the new Steering Committee (listed below), said the hope is for a Pass-Fail system based on analytical accuracy of tested glucose monitors. Ultimately, they want to expand that system to clinical accuracy and eventually to a "more granular grading system" in which meters might get extra stars if they perform better than they need to. Testing would be conducted on a "Null Hypothesis" basis, meaning meters would be considered inaccurate until proven otherwise in testing.
The testers would go through 100 tests for each meter model, dividing them into three "bins" -- a quarter would be tested for less than 70 mg/dL, a quarter of them at above 250, and the rest would be in range between 50-149. If the researchers can prove the "Null Hypothesis" wrong, then the meter will pass and be dubbed accurate.
So far, no one knows where the testing might be conducted or who the independent evaluators might be. Klonoff says the Steering Committee is in the process of creating the protocols for this whole process, and eventually will be putting out a call to any labs or researchers who might be interested in being a part of the program. As of now, the plan is for post-market meter surveillance to start in mid-2015.
It's also unclear at this point just how the Error Grid may be used in this whole evaluation process, and how it might eventually be communicated with those of on the glucometer-buying side to use when considering which product to purchase.
Those specifics should come in the next several months, as the Steering Committee delves into more conversation about all this, Klonoff says.
Klonoff doesn't know how much this will all cost, but DTS hopes to include as many data points as possible with its testing, so they will have to strike a balance between the economic costs and need for accuracy information. During the past year, DTS has been actively working to raise money for this Surveillance Program. Klonoff says Abbott is the only Pharma player to sign on so far, but they're hoping more funders will follow that lead and get involved. How quickly and effectively DTS can raise money will naturally determine how quickly they can move forward with testing meters and getting the results publicized.
For the first time this week, we were able to get official word on who is part of the new Steering Committee -- an 18-person group ranging from scientific experts to regulatory and medical device industry folk and even some patient advocate voices. That is, at least two that we know of are actually living with type 1, although they appear to be selected for their professional roles and expertise rather than as patient advocates per se.
The Steering Committee members are:
- Dr. Guillermo Arreaza-Rubin, program director, Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institutes of Health
- Dr. Robert Burk, a genetics researcher at Albert Einstein College of Medicine in New York
- Dr. David Klonoff, DTS founder and endo at Mills Peninsula Medical Center in California
- Dr. Boris Kovatchev, a diabetes researcher at University of Virginia Center for Diabetes Technology
- Dr. Aaron Kowalski, vice president of transitional therapies at the JDRF (and a type 1 PWD)
- Dr. Courtney Lias, director of the FDA's Division of Chemistry and Toxicology Devices within their CDRH/OIR division
- Dr. Randie Little, co-director of the Diabetes Diagnostic Laboratory at University of Missouri School of Medicine
- Dr. James H. Nichols, medical director of clinical chemistry at Vanderbilt; representing American Association of Clinical Chemistry
- Dr. Joan Lee Parkes, a biochemist and medical device consultant and author of the original Parke's Error Grid
- Matt Petersen, director of information services for the American Diabetes Association
- Kelly Rawlings, editor of the ADA's magazine, Diabetes Forecast (also a type 1 PWD)
- Dr. David Sacks, senior investigator and researcher for the NIH Clinical Center's Department of Laboratory Medicine; representing College of American Pathologists
- Dr. Eric Sampson, a medical device regulatory consultant who formerly served as Director of the CDC's Division of Laboratory Sciences in the National Center for Environmental Health
- Steve Scott, division vice president of R&D for Abbott Diabetes Care (USA)
- Dr. Jane Seley, CDE at New York-Presbyterian/Weill Cornell Medical Center in New York City; representing AADE
- Dr. Robbert Slingerland, clinical chemist at the Isala Clinics in the Netherlands
- Dr. Hubert Vesper, chief of the CDC Protein Biomarker Lab that does testosterone measurement surveillance
- Dr. Robert Vigersky, an endo at Walter Reed National Military Medical Center; representing Endocrine Society
Since the group came together earlier this year, Klonoff says they've been discussing these issues quite a bit -- exchanging hundreds of emails, navigating 40+ phone calls between Steering Committee members, and 12 teleconferences since Spring. They've also met once in person in July behind closed doors, to discuss more in-depth the process and how they'll move forward with the program.
Coming up on Nov. 6, the DTS will kick off its annual fall meeting and will hold a pre-day meeting on Nov. 5 focusing on presenting this glucose monitoring accuracy program to payers (health insurance companies). Payers' buy-in is huge topic that needs to be talked about more, Klonoff says.
The Nov. 5 meeting will place a special emphasis on liability because that's something the DTS Surveillance Program can directly tap into to make the case for payers to back the program. As in: inaccurate meters can lead to higher healthcare and hospital costs, and payers are keenly interested in saving money, so this topic of accuracy surveillance should be appealing, Klonoff adds.
"If a payer directs (a person with diabetes) to a poorly-performing meter and knows it, then they're liable," Klonoff said. "Currently, every payer believes that any FDA-approved product works and there isn't a problem. But that's not the case. And payers mostly aren't aware of that, so we are interested in hearing their reactions to this."
We plan to bring you a report on the DTS meeting in November, but before that, glucose monitoring accuracy will take center stage at another event happening in D.C. -- one held by the American Association of Clinical Endocrinologists, which is devoting a lot of discussion time to this issue of late. We're also thrilled to see patient advocates like Kelly Close and Bennet Dunlap participating in that meeting, and we look forward to providing updates soon.