Fda approval: dexcom g6

:cry:

This is such bad news! I remember several years ago I said that I was worried they’d do what they did with the G5 battery to the G6 sensors. Someone posted and said that wouldn’t be possible. It still worried me.

This essentially makes the G6 and any future iterations of Dexcom out of reach for many people who pay out of pocket. I know the only way I can afford it is by stretching sensors to a month.

I hope the G4/G5 sensors stick around for a long, long, long time to come.

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The Dexcom CEO had previously stated on multiple occasions that they would NOT force a shut-off on the sensors. It was only in the most recent conference call in February that he back tracked and said in their discussions with the FDA, it may be a requirement to get to the no-calibration point with them in terms of everything being discussed.

It would be a nice user-selected option if it could enable a restart if the user inputs at least one calibration per day.

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I’m struck by how much the G6 inserter physically resembles MdT’s (annoyingly named) “Serter” device. To me the lack of all that extra paraphernalia that MdT encumbers you with is a distinct advantage of the G5. Less crap to keep track of or find space for in your luggage and worry about losing when traveling: Serter, battery recharger, the oddly-shaped tape strips, the little clip that lets you keep hold of the transmitter while you’re struggling to remove the tenacious goop left by said tape strips, etc). By comparison the G5 insertion process is very self-contained and straightforward.

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But restarts technically aren’t allowed. So that will never be a feature.

My only hope is that this is a feature implemented in the US but ignored in other countries.

Otherwise, sadly, my Dexcom experience will be ending once G4/G5 sensors are no longer available.

Which brings me back to, ok, so why is “No calibration necessary!!!” such a big hairy deal anyway? It’s a pretty trivial annoyance, if an annoyance at all when compared to the Guardian process.

But as I write that, I realize this may be a bigger point than it looks because they’re thinking of hybrid closed-loop integration. The big annoyance with Guardian is that the calibration requirement is hardwired and absolute–the sensor shuts down* until you do it, which bounces you out of auto mode, and there’s another set of steps required to get back into auto again after that happens (inevitably at 3 a.m., especially in the first 24 hrs of a new session when calibration is scheduled every 6 hours). You can see why the FDA would view that temporary shutdown as necessary, since the sensor is tied directly into insulin delivery, and it’s deemed “inaccurate” until you’ve recalibrated. So not having a calibration requirement at all would be a huge competitive advantage in the hybrid-auto space.

ETA: *To be fair, you can get around this by recalibrating before the timer runs out–there’s a graphic on the home screen to let you keep track. Not much help at 2:45 a.m. though.

Not just out of reach for those who pay out of pocket. For those of us who purchase insurance on the indidual market, it’s another hit.

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Yeah, I don’t know anything about that since I’m in Canada. Either way, it sucks.

I literally save about $5,000/year by stretching sensors and batteries (I still spend several thousand a year on CGM supplies). If I can’t do that, I can’t use Dexcom. (Nor any closed-loop pump I may have.)

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I’m watching the Dana RS closely… I’m hoping my Vibe will last me until I can get that one!! (My endo’s office agrees!)

Yeah, I had the same thought. I test frequently, so what is the big deal with a calibration.

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Dexcom made a very wise decision in advocating and getting approval for open platform integration with other medical devices. With both basal/bolus regimens or continuous infusion through a pump, more devices, and even the JDRF have come on board with open protocols. If you look at the past two years in terms of insulin delivery many players have dropped off or out and Medtronic owns 60% of the CSII market (continuous infusion). Connected pens, algorithm pumps, pumps connected to smart technology will continue to move forward (Lilly’s new disk infusion pump and connected pen with Dexcom, Beta Bionics Ilet artificial pancreas, two new insulin delivery devices in the EU partnering with Dexcom. Many of the patients I work wth choose a Dexcom even in combination with a Medtronic 630 or even 670G mostly because of their frustration with sensor alarms and a fixed target of 120 which in actuality is 150. I doubt Medtronic will ever be open source but I advocate for patient having options to choose and work with, based upon their clinical outcomes with these devices.

@Dan8 - I may have missed part of the announcement or misunderstood. Can you provide a link that covers the points you are making regarding the “open platform” and “open source” in regards to the Dexcom G6 ?
I would find that very interesting to read further on.

I think the best thing to look at would be Dexcom particularly this device as interoperable device when the De Novo pathway is followed. Algorithm pumps, bionic pancreas technology, stand alone devices such as Bluetooth pens and certainly the Verily integration for people with Type 2 will technically lead to faster approval times for these devices. One also needs to remember that not only outpatient applications exist for continuous sensing but also inpatient which opens up another pathway that Dexcom has already been actively engaged in for several years with Edwards Life Sciences. While I cannot provide any links to show pathways in research and development, the information is out there by referencing the partnerships they have. Dexcom in terms of business opportunity and growth made a very strategic move with this designation and didn’t head down the proprietary road that some device manufacturers have both in insulin delivery and also continuous glucose sensing technology did. It will also lead to further improvements in their own technology as Kevin mentioned today on the call.

@Dan8
I still see nothing regarding open source as pertains to Dexcom nor open platform.

I perhaps misunderstood your post. Was this a hypothesis of a possible direction the company could take?

Anyone know if it Will work with Tandem X2?

Extremely implausible for the current Tandem X2 pumps which are running the most recent cgm integration update.

The Tandem Control-IQ update planned for the first half of 2019 will use the G6.
I would not hold my breath waiting for a Tandem update prior to that which would allow the G6 to be used. It could happen. But I doubt it.

thanks for insights.

so , i assume we can use it but will not chime in to the pump. hence, another gadget to carry.

@lisa_c1
Maybe and maybe not.

If you want to take advantage of the Tandem Basal-IQ which is expected to be approved and launched this summer and which has been stated to work with the G5 (always subject to changes until actually approved and launched) then you may not be able to use the G6.

Certainly if you are not going to run the Dexcom and Tandem in integrated mode than you can use whichever version of the Dexcom you choose.

Always possible for Tandem to either make the Basal-IQ compatible with the G6 or to come out soon after the initial Basal-IQ launch with an upgrade for the update so as to allow the G6 to work with the Tandem running the Basal-IQ update.

Dexcom has information up on its website regarding the G6 now.

Dexcom Updated Compatibility Listing for:
Dexcom G6 App
Dexcom G5 Mobile App
Dexcom Share2 App
Dexcom Follow App
Clarity Reports App
http://www.dexcom.com/faq/what-devices-and-software-are-compatible-dexcom-cgm-apps

Dexcom G6 Simulator App
https://play.google.com/store/apps/details?id=com.dexcomg6simulator
https://itunes.apple.com/app/id1352389740?mt=8

Dexcom G6 FAQ
https://www.dexcom.com/faq/g6
(Expand both the “Apps” and “Overview” options - lots of Q&A under those)

EDIT: A change for the G6 from the G5 is the concept of sensor codes which come into play when starting a session, the impact on calibration and the 10-day session limit. Note that the transmitter code concept remains unchanged. The sensor code is entirely different from the transmitter code. The FAQ questions and answers from the link above provide some useful information regarding the sensor codes. It would be worth reading those as I am sure this will be coming up in discussions.

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You have the option to calibrate if you want to. So yes, possible but not required.

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