Talking About the Reality of Life off the Label

Contributor
Christina Roth, CEO & Founder

 

(Written late last night while Christina Roth, CDN’S CEO and Founder was at the airport after the FDA Panel on updating the current Dexcom G5 Continuous Glucose Monitor System designation)

I have never been so happy and content to be hanging out at the airport for the next few hours, waiting for a flight to get home just before midnight. Why you might ask?

No, it is not because we just found out we received millions of dollars in funding to take care of all our programs forever, I wish….

BUT it was still unbelievably exciting. I am hanging out at Reagan National Airport in D.C. after spending my day sitting in a very long FDA panel since 8 A.M this morning. Today, an FDA panel was convened to discuss the proposed update to the label of the Dexcom G5 Continuous Glucose Monitor System (CGM) to indicate that it replaces blood glucose monitoring (finger sticks), rather than simply supplementing it (which is what is currently approved).

Most of us who use Dexcom just go ahead and dose off our readings unless we think they are off, so why do 10 people in Washington, D.C. need to give us the OK to do this? Well- that’s the rub: everyone is already doing it! As George Grunberger, M.D., F.A.C.P., F.A.C.E, the 2016 - 2017 Past President of the American Association of Clinical Endocrinologists (AACE), said on the panel “the horse is already out of the barn…”.

So why does this matter? I’m paraphrasing (so be sure to check out much more detailed information from our partners at Diatribe & DPAC but the spark notes version of it is if this new treatment designation/labeling is supported it will change the classification of the Dexcom CGM. This will enable more people insurance coverage and access. More specifically, it will help to open the door for discussions with Medicare/Medicaid to start covering CGM.

There were over 30 patient advocates, passionate clinical providers, and caregivers who were accepted to speak- and you could feel the impact of these personal stories and testimonials on the panel. For comparison- there are maybe 3 public speakers in attendance at these panel meetings usually.

So after hours of testimony, data, questions, anecdotes, more questions that had nothing to do with the topic, more data, amazing patient advocates sharing their stories, and then a whole lot of discussion- the panel voted strongly (80-90%) that using the Dexcom G5 CGM to make treatment decisions is both sufficiently accurate and effective; and that the overall benefits outweigh the risks of approving this designation. Check out Dexcom's offical recap here!

So what does this actually mean? Did we win? Well kind of, there are still a few more hurdles to jump through to make it final and official- but we did have a big win today. Over the coming weeks, stay tuned to our amazing partners, like Diatribe and DPAC. They have been working to raise awareness and secure thousands of signatures over the past few weeks, and will continue to keep us posted on next steps.

And for your reading pleasure, below is my 3 minute testimony to the panel.

Hello, thank you for having me here. My name is Christina Roth and I am the Chief Executive Officer of the College Diabetes Network, or CDN, as well as the original founder of the organization in 2009.

CDN is a national nonprofit organization and the leader in providing programs and support to college students and young professionals living with diabetes.

As a disclosure, my travel here was provided by Dexcom.

Ironically, given my career now, I first started using CGM as I entered college in 2007. And it was life changing for me.

As a young adult with diabetes, and like the vast majority of people living with diabetes in general, my reality of diabetes care was vastly different from the recommendations of standard care, and its assumptions.

I often didn’t check my blood sugar, it was a success if I remembered to take insulin, and overall I felt so sick from drastic blood sugar fluctuations and extremes that I didn’t really care what I did- as I still felt horrible either way.

Going on CGM as I left for college was the first time I had a tool that let me be effective in my diabetes management. In part because it gave me continuous readings, but more than that- it gave me PROACTIVE information that enabled me to AVOID issues, not just react to them.

But I didn’t become a model patient overnight, I was still barely checking blood sugars (never mind confirming my CGM readings with BGM checks before making treatment decisions). And I still struggled to remember to take insulin.

But unlike my usual standard of care prior, which again- is the norm for a vast majority of people with diabetes. For the first time, I had context for those interstitial fluid and blood sugar readings. I had arrows telling me where I was trending, and how fast. I was able to change my behavior and treatment accordingly to avoid a high or low blood sugar. And I was able to see and monitor the effect of those decisions- creating an automatic feedback loop, informing and empowering my decisions.

Not having a designation to make treatment decisions based on CGM, and to provide the education on how to do this successfully, is akin to withholding and blatantly ignoring an invaluable piece of the data puzzle.

Despite the way I used my CGM, it kept me healthier and safer; and beyond that, it was discrete- it was a tool that actually fit into my life- enabling me to be “clinically adherent”. Before this I was likely considered the definition of a “Non-Adherant” patient.

I am here today to ask you to provide the same access to information, and the ability and knowledge to apply this valuable information, by recognizing the importance of basing treatment decisions off CGM.

If it weren’t for this tool, and the information it provides, I would not have been able to become the person that I am today. And I honestly don’t want to think of where I would be if I hadn’t had it.

So, thank you for your consideration.

*As a disclosure- I was able to attend the meeting as Dexcom paid for my travel expenses. Dexcom is a CDN Corporate Member.