Fda approval: dexcom g6

Based on the CEO’s comments, it would have to be a real calibration. As any typical person would understand the term to mean.

Dexcom is having a conference call this morning so mostly like additional details will be presented. Particularly if they allow questions which often times is where the best information gets revealed.

You mean just as a standalone CGM? You can certainly do that–I have been doing it for years. But no way Mt is going to open up to any kind of integration with a non-Mt CGM.

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I hope that the sensor can be re-started after the 10 day wear time. I remember hearing that this may not be the case with the G6.

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Agreed. The CEO left this is a standing question as of a month ago. I do hope he provides a definitive answer to that question on this morning conference call.

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I think the things I’d need to see are the ability to re-start sensors, the ability to calibrate, and direct send to smart watch before I pay more a month to use this over my Libre.

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Confirmed: G6 sensor has a forced 10-day shutoff. This is due specifically to FDA special controls around approval. Dexcom will be looking to extend this to 14 days but that will not happen until 2019.

Confirmed: G6 has optional calibrations.

The Dexcom Receiver continues to be a required component of the system (in terms of initial order) for US although it has and continues to be optional in Europe. The current Receiver can be upgraded from G5 to G6 (although unclear if that is both the old and new receiver or only one or the other). Launch of G6 is not spelled out but most probable launch in the 2 to 3 month timeframe.

The FDA special controls document is not yet publicly available. No timeframe on this. These special controls may provide a competitive advantage for Dexcom if other cgm manufacturers are unable to meet the specifications contained therein. This was strongly implied.

(No mention at all regards to direct connection to watch. Reasonable assumption is no change in that area. Meaning, still waiting on the Dexcom software to allow such. Just a guess.)

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Thanks for sharing. With the cost of sensors from Dexcom I think that kills it for me. :worried:

Thanks for reporting your experience. This would have to be fixed if the Dana pump is to become a viable component in automated insulin dosing systems.

So,

Pluses:

  • calibrations allowed but not required
  • lower profile
  • you can take Tylenol
  • official sensor life is longer

Minuses:

  • official sensor life is longer, but enforced

That’s as far as I got.

Plus: Improved accuracy particular on Day #1.
Minus: Not able to “pop” the transmitter on and off during a session. (Not confirmed but 98% suspected based on early Dexcom documentation.)
Plus: Increased sensor life in the pipeline
Minus: Pipeline for sensor life not until 2019
Plus: Receiver able to be upgraded - ie - no need to rebuy transmitter
Minus: Receiver still required part of initial order for new customers (US based)
Plus: Will be Medicare approved
Minus: Medicare contracts need to be negotiated so will take some time - unknown timeframe
Plus: Much better insertion device (single button push and fast)

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Since G4/G5 Dexcom sensors could be restarted, I didn’t feel the need to report every time I hit an uncomfortable spot on day one or started getting some noise in my trace. With a fixed G6 sensor life, it would force me to be very aggressive about requesting sensor replacements whenever these things occurred.

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@Tim35, was there any info on the MARD number for the G6?

No - I don’t think that came up on the conference call but I had previously put a slide up with those numbers. I can find that post.

@Terry4

Here it is:

https://forum.tudiabetes.org/t/what-to-expect-for-cgm-in-2018/65080/37

If the MARD is comparable to the G4/G5, given this fixed life feature, it may not entice me to move to the G6.

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We may be stuck with the G5 for quite some time due to the Tandem integration.

The Tandem Basal-IQ (formerly PLGS) update planned for approval and launch this summer (2018) has been stated to work with the G5.

The Tandem Control-IQ (formerly HCL) update planned for approval and launch first half 2019 has been stated to work with the G6.

As we want to take advantage of the Tandem Basal-IQ update, does this mean we need to stick with the G5 and can not use the G6 until Tandem releases the Control-IQ update in 2019? I suspect the answer to that is YES unless Tandem comes out with a follow-up release for the Basal-IQ which would allow the G6 to integrate. But I am not sure if that would be realistic from a practical and business point of view.

Of course I wasn’t claiming my list was, y’know, exhaustive. :slight_smile:

I can see where some of those pluses might be more crucial to others than they are to me, and outweigh the sensor life drawback, but mostly I don’t see anything that would have me running out to upgrade from my G5.

In any case all owe you a huge thanks for keeping such close track of this and sharing it with us!

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Here’s a slide from Dexcom with a date of February 2018.

They don’t make a distinction of the G4 with the 505 firmware update. I believe it also has a MARD of 9%.

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The G4 with the 505 is exactly the same as the G5 due to being the same sensor and same algorithm so no difference.

Also if you note the other slide from my link above, it has more detailed MARD data as relates to the G6.

Aside from the MARD, take a look at the increase in percent of readings within plus or minus 20 points for BG less than 80 and percent of readings within plus or minus 20 percent for reading above 80 BG. That is a nice improvement.

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