Dexcom G6 Launch Approved

It’s one more hoop. First you have to contact Dexcom rep. Then have pharmacy contact Dr. for pre-authorization. Then UHC denied pre-authorization because of her age. You’re correct in the end our prescription insurance covered it that’s a blessing and all worked well. But I definitely felt insurance made it difficult to dissuade use of Dexcom and if I wasn’t stubborn she wouldn’t have one.

UHC claims some bs study that CGMs are not medically beneficial for children under the age of 8. She was 5 when diagnosed. I mentioned it was fda approved for 2 yrs and older and they stated that only meant it was safe not beneficial. I was about to file an age discrimination case when Optum approved the pre-authorization I decided that’s good enough for us and saved the money a lawyer would have cost us.

I agree that angers me as well thinking of all those who got discouraged and gave up.

3 Likes

I think that’s one of UHC’s primary tactics.

I’ve had insurance with a decent number of insurance companies at this point. UHC was by far the most difficult to get anything approved. They have a reputation in my office of being snaky.

They just make you feel so miserable and frustrated that you either decide to pay the bill yourself or forego the treatment altogether.

1 Like

Well, dang!!! :roll_eyes:

In addition to the excellent figure you referenced, there is another equilibrium between the sensor and the interstitial fluid that needs to be considered. Depending on the polymer(s) used for the sensor coatings you can also have a lag there as well. It is kind of amazing that these systems work as well as they do for most individuals (but clearly not all)

If I was still in the business, I would be working hard at creating a strategy to accurately sense in you skinny individuals.

1 Like

Yes, that is the easiest place to make improvements. Their are literally hundreds of options here. What will be interesting will be to see if they went to a second generation sensor, and no longer rely on the sensing of hydrogen peroxide, or if they just made large improvements in the coatings…

If they went to a second generation sensor then you can expect better performance at high blood glucose readings, because you will no longer be limited by the oxygen in the sensor surroundings.

It seems the FDA made approval specifically contingent upon people NOT being able to restart the sensor – https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170088.pdf … So this may be tricky.

See item 5 on page 5: “(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.”

1 Like

You are correct, so the open question is using XDrip+ does it run longer, or is there a way to “trick” your sensor into restarting. That remains unknown.

That is a hot topic over at xDrip+ on Github and Gitter. As of right now though xDrip+ does not work with the G6. ( the developer is waiting for someone to give him a G6 sensor).

Actually,JamOrham, the xDrip+ developer, just posted this just a few minutes ago:

"Use the latest nightly, in the G5 debug settings enable the OB1 G5 Collector, enable G5 Native mode disable Fallback to xDrip

Anyone who tries this please let me know the results! Thanks"

So it looks like the G6 will work with xDrip+!

@docslotnick
Has anybody run the G6 past 10 days? Even if the xdrip picks it up, my guess was the transmitter would stop at 10 days. Totally a guess.
Although my follow-up guess was a physical disconnect and reconnect (like I think the Medtronic does? Pretty sure @drbbennett has written how the Medtronic sensor works in this regard) would allow extensions past the initial 10 days.
With the “no calibration” only working for the first 10 days (assume you used it for the first and probably not a wise idea to even try no calibration for the extended if you get extended to work).
And with the assumption that somebody figures out how to physically disconnect and reconnect the G6 transmitter to the same sensor.

I just got am email from Tandem. “Dexcom is requiring their Dexcom G5 Mobile CGM users to upgrade to G6 UNLESS they indicate that they are using it with an integrated device.”

They say that I have already told them that I have a t:slim X2, and if continued CGM integration with the pump is important to me, I should be sure to specify on my next sensor order that I must have G5 sensors because I’m using them integrated with a t:slim X2.

If it turns out that we can’t figure out how to restart the G6 sensors, anyone who doesn’t want to be forced to switch to the G6 could say they’re using it with an integrated device. Or maybe just threaten to switch to the Libre because the G6 can’t be restarted, and see whether that convinces them to sell you the G5.

I don’t know whether 3rd-party suppliers such as Byram, Liberty, or Edgemark will try to enforce a switch to the G6, but they may be easier to persuade.

I find it telling that Dexcom is thinking that they will have to force people to switch to the G6. I’m inclined to resist just on principle: if the new product is worse (or just more expensive) it’s kind of outrageous that they feel free to force me into the worse option.

2 Likes

Totally. It makes no sense.
Idiots.
How about do the reverse.

Oh - we might not have enough stock at the beginning. Some people might have to wait longer on the G5 before we can get you to the G6. We will get you as soon as we can.

Cabbage Patch Kids?

2 Likes

Dexcom told me directly that they are not requiring upgrade so I’m going to believe that for now. I have it in hard copy (email)

2 Likes

There’s a bit more news on the G6 in the Dexcom conference call that was held on May 2. The transcript is available at SeekingAlpha, https://seekingalpha.com/article/4168949-dexcom-dxcm-q1-2018-results-earnings-call-transcript

They are planning for full launch of the G6 before ADA 2018, which starts June 22. They’re manufacturing enough that everyone can get it, rather than having some kind of limited-availability gradual roll-out plan. There is going to be some kind of upgrade plan: it sound like if you have bought a pair of g5 transmitters recently they’ll give you a free G6 transmitter so you don’t have to wait a half-year to switch to the G6. They plan to run the clinical trial for 14-day G6 sensors during late 2018. They’re working with the FDA to figure out how to get “receiver optional” approval for the G6, so that new users wouldn’t be forced to buy a receiver if they already have a suitable phone. They don’t know when they will finish the work to get approval for that, but the FDA appears ready to go there. Evidently the G6 inserter is wonderful: basically no pain.

They kind of contradict themselves on G6 pricing. On one hand they are modeling that the annual revenue per user will stay the same. On the other hand they are thinking that the price of the G6 sensor will be about the same as the price of the G5 sensor. When an analyst pointed out that the forced restart of the G6 sensor would seem to indicate more annual revenue per user, Dexcom gave an unclear answer and mentioned something about children who take sensor vacations for cost reasons. I’m hoping someone can figure out a way to restart the G6 sensor despite it’s suicide timer, but Dexcom didn’t even hint at that possibility (which would be contrary to the FDA requirement.)

As an aside, everybody has heard about the recently-developed software to restart the G5 transmitter after 90 days, right? I haven’t seen much discussion about it, but the source code supposedly is available for iPhone via https://github.com/Kdisimone/CGMBLEKit#resettransmitter-app-installation and you build it on a Mac and install it on the iPhone pretty much like building and installing the LOOP hybrid AP software.

They say that their biggest R&D project now is the 2nd gen Verily sensor. They’re trying for a 2020 launch.

They claim they’re not seeing Dex users switch to Libre or Medtronic. They are seeing some switching in the other direction (i.e., to Dexcom CGM.)

2 Likes

I just read through that transcript and was again disappointed to hear nothing about the transmitter talking directly to an Apple Watch without a phone in the middle.

I really hope they are planning on shipping that someday…

3 Likes

Kerri Sparling has early impressions of the G6 at https://sixuntilme.com/wp/2018/05/09/actually-using-the-dexcom-g6/

1 Like

just got off the phone with Dexcom Rep. Medicare is covering me 100% for the G5. they are not set up with approval of the G6. but, i was told, that i will be receiving the G6 receiver so that once Medicare approves the G6, all i will need are the new sensors and the new transmitter, and that they can easily transition me over. hopefully it will be seamless.

i dont know how well the G5 will work for me, but hey, its free, so whats the big deal? right?

anyone else going through this with either Medicare or their insurance carriers?

1 Like

@daisymae I personally like the G5. I hope you do as well. Congrats on your new set up! :grinning:

1 Like