DexCom Wins FDA Panel’s Backing for Wider Use of Glucose Monitor

Diabetes Technology Glucose Monitoring
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(Bloomberg) – FDA advisory panel voted 8-2 that benefits outweigh risks for proposed use of DexCom’s G5 continuous glucose monitoring system to inform insulin dosing in diabetics.

  • Device also wins safety vote (8-2), effectiveness vote (9-1)

  • Totals disclosed by FDA spokeswoman in e-mail

  • NOTE: FDA evaluating whether DXCM’s system should be used as replacement for traditional finger-stick blood-glucose testing; agency isn’t required to follow panel’s recommendations

  • Analysts had broadly expected FDA panel to be positive

  • Leerink said in July 19 note that DXCM’s proposed dosing claim would increase odds of Medicare coverage; cautioned this will probably take at least 6-12 months and patients may be slow to adopt new technology

  • DXCM halted; shares are up 31% since end of May

  • NOTE: FDA staff report released July 19 said DXCM’s continuous glucose monitor may help with insulin dosing

  • DXCM conf. call July 22 at 8:30am 888-771-4371, pw 43019542

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great news!

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I hope acceptance by Medicare comes sooner than later. But please just let it come.

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Great news! I hope the agency follows the panel’s recommendation ASAP.

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I am to the 3rd level of appeal trying to get Medicare to cover my Dexcom CGM. UGH! I have appealed to my Medicare Advantage Plan & was denied, then Maximus that reviews all Medicare appeals, then an Administrative Law Judge that interprets the Medicare coverage (this was a useless waste of time) & now onto the Federal Government appeal which could take up to 2 yrs. - - - well at that rate I could be dead!!! Have been transported several times with low blood sugars that wouldn’t register & didn’t have a body temperature for over 5 1/2 hours…still not a medical necessity according to Medicare! Is anyone else fighting Medicare on this??? Any advice?

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Well deserved by Dex. I hope that the continue with the development and also cooperation with pump manufacturers.

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I so hope this makes CGM access easier for those on Medicare. I also hope it doesn’t lead to tighter quantity limits on test strips. In spite of that concern, one shared by a large number of DOC members, I signed the DPAC letter.

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OMG, how awful! I am so sorry about what you are going through!

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I agree! When you get goofy readings, you can go through a lot of test strips trying to sort things out!

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Here’s the text of the press release sent out by Dexcom:

FDA Advisory Committee Votes in Favor of Non-Adjunctive Label for DexCom G5 Mobile CGM System
Conference call scheduled for 8:30AM ET

SAN DIEGO, July 22, 2016 /PRNewswire/ – DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Clinical Chemistry and Clinical Toxicology Devices Panel of the U.S. Food and Drug Administration (FDA) voted in favor of the proposed non-adjunctive indication for the DexCom G5 Mobile CGM system. This indication would designate the G5 Mobile CGM system as a replacement to fingerstick glucose testing for diabetes treatment decisions.

Specifically, the panel voted:
· 8-2 supporting that there is reasonable assurance that the DexCom G5 Mobile CGM system is safe for the proposed indications for use,
· 9-1 supporting that there is reasonable assurance that the DexCom G5 Mobile CGM system is effective for the proposed indications for use, and
· 8-2 supporting that the benefits of the DexCom G5 Mobile CGM system outweigh the risks for the proposed indications for use.

“This recommendation is a big milestone for people with diabetes,” said Kevin Sayer, DexCom President and Chief Executive Officer. “The diabetes community turned out in force to support this decision. We commend the FDA for bringing this important subject into a public forum, and thank the panel members, as well as the public speakers for their willingness to participate. We look forward to continued positive discussions with the FDA as we seek the agency’s approval of our application.”

DexCom management held a conference call and a link to the webcast will be available on the DexCom, Inc. website here.

About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked Dexcom highest in customer satisfaction and loyalty. For more information on the DexCom CGM, visit www.dexcom.com.

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I am with you but behind in the process. I am at the Maximus level right now and waiting for their decision. Am not optimistic at this point but will keep pushing on. Maybe you have some advice for me?

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I understood the Administrative Law Judge step was to ask for an exception to the Medicare guidelines…I was mistaken! The judge just interprets the guidelines and basically it was a waste of time! I already knew Medicare did NOT cover CGM & that’s exactly what he stated. My doctor & nurse were also on the conference call & were also astounded of the purpose! Also, 3 people from the Medicare Advantage Plan insurance company were on the conference call as well & most likely knew exactly what would happen in this step! I do believe it is a necessary step in the process but please be prepared as to the purpose of it & don’t expect an exception or even ask - - - that’s not what it’s about…you HAVE to go through it but it’s a total WASTE of time. The ALJ office was supposed to send me documents for the next step but failed to do so & those documents NEED to be filed within a certain amount of time. I had to contact the ALJ office & they weren’t easy or nice to work with!!! If I were you, I would be sure to let them know during your ALJ hearing that you would like to proceed & verify that they do intend to send the documents for you to proceed. I feel like they think the average Joe will not want to fight anymore… Well in my case, they figured wrong! The next step is where I am at and they are so backed up with cases that it could take 2 yrs. I could be dead by then!!! Grrrrrrrr!

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Thanks for the info. I guess I’ll have to decide if going forward is worth it. Maybe the FDA decision will change the coverage with Medicare. Maybe.

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The FDA panel decision is very important. Seniors want to use the Dexcom, but many of them cannot afford it out of pocket. If FDA does approve blousing with the Dexcom G5, then that might result in Medicare approval, and coverage. I have many friends in a Joslin Medalist group who are anxiously awaiting what lies ahead.
I have also seen many type 1 people post that they have been using their Dexcoms to bolus for meals. Apparently it works very well for them. I cannot do that because I have too many big gaps between my Meter and my Dexcom G4 numbers, but the numbers are in very close agreement about 75% of the time. I depend on my Dexcom between meals when I have that close agreement, but I always depend on my glucometer for meals and snacks.

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That is awesome news!!! CGM should be available to every diabetic. I have been Type 1 for 43 years and have always struggled to get an A1C below 9.0. I have only been using the G5 since October of 2015 and the last two A1Cs I had done were 5.6 and 5,4. Knowing what my blood sugar is every five minutes and also knowing whether I’m going up, down or sitting level has changed my life. Fortunately my wife works as a PCT at a hospital so we have insurance that pays for my CGM 100%. Thank you Lord. I pray that Medicare/Medicaid get on board and all of my diabetic brothers and sisters can enjoy good health with a CGM.

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I would like to know the basis of the two disenting votes. As a Dexcom user I have lowered my A1c from ~10 to ~6.5. Cosistiently. It also was an invaluable tool that helped me complete a 250 mile backpacking trip of the John Muir Trail averaging 13.5 miles per day with 3,000+ foot elevation gains and losses per day. I am a 62 year old T1 Diabetic. Had I had this device when diagnosed as T2 18 years ago I likely would not have been so out of control for so long and maybe still type 2.

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Congrats on such an ambitious backpacking adventure all while you managed your insulin dosing amidst high altitude hiking and climbing. When I was 19, before diabetes, I backpacked from Lake Tahoe to Yosemite. Not sure I could do that today! I am a similar age to you.

Do you mean that you were misdiagnosed as T2D initially and the Dexcom CGM helped correct your diagnosis? Or do you mean that the CGM helped you move to using insulin? Do you know that using insulin does not determine whether a person is type I or type II?

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