Last week on July 21, an FDA panel held a day-long meeting to consider whether the latest Dexcom continuous glucose monitor generation is safe and effective enough to be used for insulin dosing and related diabetes treatment decisions — without the need for patients to first take a fingerstick glucose test to validate the results. We were thrilled to see the panel vote 8-2 in support of this “non-adjunctive claim,” agreeing that the benefits of using a Dexcom G5 for treatment decisions outweigh the risks. This is a first step toward securing full FDA agency approval allowing Dexcom to change its product label to state that CGM data is as good as fingerstick blood glucose results for making therapy decisions.

This has some very big implications for PWDs (people with diabetes), especially when it comes to expanding access to CGM technology!

Longtime type 1 and ‘Mine correspondent Dan Fleshler attended this important hearing on our behalf, and reports today on the proceedings and consequences. Our team also weighs in with takeaways from this panel meeting, and what happens next.

I suspect it’s rare to find complete strangers hugging each other after watching the proceedings of a panel whose very name makes me want to snooze: the FDA’s “Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee.”

But that’s what happened in a packed hotel ballroom in Gaithersburg, MD, after the 10-person panel of clinicians and scientists voted to support Dexcom’s application for a new label for its G5 CGM.

(All right, just one stranger hugged me, but more than a few PWDs, researchers, clinicians, advocates and Dexcom staffers were bumping fists and shaking hands.)

If the FDA staff accepts the panel’s advice, Dexcom and healthcare providers will finally be authorized to tell PWDs that it’s OK to do what many of us are doing anyway: using data from the CGM to make treatment decisions – like insulin dosing — without first doing fingerstick tests. Dexcom’s CGM will be classified as a “replacement” for blood glucose meters, rather than an “adjunctive” or complementary device.

Why It Matters

A label change will set Dexcom free to educate PWDs about when — and when not to — use CGM data to make treatment decisions. Right now, the company is forbidden to do so by the FDA. Too many of us rely on trial-and-error to figure out when and how much insulin to dose, and how to make decisions about diet and exercise.

If the FDA’s staff approves Dexcom’s application, it will also be an important weapon in the D-community’s battle to convince the Centers for Medicaid and Medicare Services (CMS) that Medicare should cover CGMs. That’s because the current FDA label has been the primary reason – or excuse why CMS doesn’t consider these devices to be medical necessities that warrant coverage as durable medical equipment.

More generally, the FDA’s approval will ensure that an increasing number of PWDs -– including Type 2s — who need CGMs can likely start acquiring and using them. For one thing, as the diaTribe Foundation noted in a powerful letter to the FDA (signed by nearly 10,000 people!), “for many considering the technology, the need for confirmatory fingersticks presents a barrier to trying.”

The “Horse is Out of the Barn”

The meeting was no walk in the park for Dexcom. In a hotel hallway during a morning break, I overheard some worries expressed by knowledgeable people who were rooting for the company.

After Dexcom’s team presented extensive research demonstrating their CGM’s accuracy, safety and effectiveness, some panelists remained skeptical. They were hung up on the significance of “simulation studies” conducted by the company. These were done after the FDA agreed with Dexcom that extensive human clinical trials weren’t necessary.

Instead, with the FDA’s approval, Dexcom paid for studies that used computer models to create many thousands of simulated scenarios, in which virtual patients made decisions about insulin dosing. They also did a study of real people to test the effectiveness of their proposed new instructions on CGM usage. The results showed that the CGMs compared favorably with BG meters, but a few panelists still complained about the lack of “real-life data” and wanted more clinical trials to conclusively demonstrate the safety of using CGMs for insulin dosing in a broad population.

Panelist David Cooke, who’s at Johns Hopkins and has experience in pediatric endocrinology and voted against this Decom dosing claim, asked “How large would a clinical trial have to be? Can’t you test the rate of hypoglycemia?” His colleague on the panel, Marc Rendell, a diabetes specialist at Creighton University (who ultimately voted “yes”), said, “Serious failure rates can be elicited in small clinical studies” and explained why they were feasible and advisable.

Most panelists said they understood those concerns, but in the final analysis, they believed the benefits of a non-adjunctive label outweighed the risks. Dr. George Grunberger, a Michigan endo and immediate past president of the American Association of Clinical Endocrinologists (AACE), urged the regulatory agency to catch up with the realities of how PWDs are using CGM systems already in the real world.

“I can sit here and discuss and propose many different ways to do more studies… but as a practicing endocrinologist, the horse has been out of the barn for years,” he said. “So do we discuss the optimal trial designs, which would satisfy the scientists, or do we go with the flow?”

Fellow type 1 Anna McCollister-Slipp, a non-voting patient representative on the panel, described the life-changing impact of the CGM on her diabetes management. While she also yearned for more data, she pointed out that if a clinical study with randomized controls were launched, “no one would volunteer” if they had to give up their CGMs. Great point!

A Tidal Wave of Support

In the end, even with two dissenting votes on the panel, more than 35 speakers at the “open public hearing” made a convincing argument for the panelists to support this labeling change. What happened in Gaithersburg was noteworthy not only because of the vote, but also because, as D-advocate Kelly Close noted, “It was absolutely unprecedented that so many advocates and doctors and researchers came together” for an FDA Advisory Committee meeting of this sort.

Among those were passionate advocates and heavy-hitters in the diabetes world — from the JDRF’s chief mission officer Aaron Kowalski to chief medical officer of the ADA Dr. Robert Ratner to renowned researchers and clinicians including Dr. Lori Laffel at Joslin and Yale’s Dr. Bill Tamborlane. Others included Christina Roth, founder of the College Diabetes Network, and Dr. Sarah Kimball and 10-year-old T1D Sam Mazlish, the wife and son of Bryan Mazlish who works for Bigfoot Biomedical, which is developing an Artificial Pancreas system; plus young-in-spirit Joslin 50-year medalists Lynn Wickwire and Yours Truly (yes, me!), and too many others to spell out here.

More than a few PWDs shared their personal experiences, saying they trusted the accuracy of the G4 and G5 when compared with BG meters. There were many moving presentations by people of all ages conveying that CGMs had saved their lives, greatly improved their blood sugar control and reduced the stressful, painful burden of constant fingersticks.

Among other things, I told the panel that I made about 80% of my treatment decisions based solely on my Dexcom, and that “my CGM isn’t adjunctive; it’s a medical necessity.” That’s because I have hypoglycemic unawareness and rely on my CGM’s alarms to let me know when I’m dangerously low. Yet, according to the current FDA guidance, if I’m walking or driving and the low BG alarm sounds, I’m supposed to find a place to wash my hands and do a fingerstick test before I pop a glucose tablet in my mouth. That “verges on the irrational.”

Pretty good, huh?

You can watch videos of the presentations here (Part 1) and here (Part 2).

The FDA was also flooded with hundreds of letters supporting Dexcom, including the petition from diaTribe and another from the Diabetes Patient Advocacy Coalition (DPAC). Of course, it’s hard to know whether the panel would have voted the same way without all of these efforts, but our community took no chances and we should be proud of ourselves.

Still, our D-Community’s work is not done.

What’s Next?

Now, this issue will go to the full FDA for consideration, although there’s no timeline on when that might happen. While the regulatory agency isn’t obligated to follow the advisory panel’s guidance, it often does.

The morning after the panel vote, Dexcom held an investor conference call to talk about what happens next.

Note that the California CGM company actually began discussing this non-adjunctive claim with FDA back in 2014, and late last year submitted a regulatory supplement to its G5 tech specifically requesting this non-adjunctive designation. It’s still TBD whether ongoing clinical trials — including the independent Replace BG Study being conducted by the T1D Exchange — will have any impact on the timing of the FDA’s final decision.

Interestingly, Dexcom CEO Kevin Sayer took a page from the #WeAreNotWaiting initiative in our diabetes tech community, emphasizing that the company plans to immediately start meeting with CMS officials to discuss expanded coverage — even before a full agency decision. They’ll also be pushing ahead to finalize proposed label language and work out instructions for CGM users on making treatment decisions, as well as any post-market studies that may be required.

“We remain committed to expanding CGM access to the Medicare population,” Sayer said.

Even if the FDA makes a final decision by the end of this year, it could take some time to get CMS officials on board with changing the CGM coverage policy nationwide. Dexcom acknowledges it could be 2018 before we see that happening across the country, and while it’s longer than we’d ideally like to see, it’s understandable that these shifts do take time.

Short of an official CMS policy change, the best we can all do to affect change is to support advocacy efforts — from the legislation calling for Medicare CGM coverage to the personal appeals and legal system that is slowly pushing more coverage in our D-Community’s favor.

Meanwhile, Dexcom is also looking beyond just Medicare coverage to a bigger picture.

“Medicare is just the tip of the iceberg,” VP of strategy Steve Pacelli said on the investor call. “CGM is becoming the standard of care, and we’ve moved away from fingersticks already. As we move toward the G6 with one calibration per day, that grows even more. This is huge to opening up the market.”

Of course, we also have to think about unintended consequences that *could* result from this non-adjunctive label for CGM. It is possible that government and private insurers might see this “replacement” label as a sign that they can start cutting back on covering test strips, meaning we could lose coverage for traditional BG meter use if we happen to have a CGM. That’s a very scary scenario, and something that didn’t get much mention at the FDA panel meeting. But it’s a real fear that we share with others in the DOC, including fellow type 1s Ally and Tom who have written about this.

We urge the FDA to keep this in mind, even if reimbursement isn’t a particular focus of their decision-making. Not everyone feels comfortable dosing from CGM, because accuracy may not be the same for everyone. So we wouldn’t want FDA’s approval to appear as a message that fingerstick meters are no longer necessary across the board.

Meanwhile, this is a big step forward and a positive move for many, many patients — and of course a win for accelerating approval of new Artificial Pancreas systems going forward. We’re excited to keep watching these developments closely.