Fda approval: dexcom g6

Dexcom G6 has been approved by the FDA. Most exciting new features setting it apart from the G5 include: no calibrations, approval for 10-day wear, and a new one-touch auto-applicator as well as a slimmer profile. The G6 is the first CGM designed to be used with other compatible medical devices, opening the door for exciting integrations in future insulin pump closed-loop systems. It is approved for patients 2 years and older. Dexcom has indicated that it will begin shipping to patients soon - contact your Dexcom representative for specifics.

Beyond Type 1 will continue with additional coverage as more information becomes available.



Does anyone know if there is a 2-hour window of no readings when you first install a sensor?

Yes, read this earlier. Sounds exciting. Wonder if one can use it with a Medtrontic 670G. Going to have to find out more.

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G6 eliminates the need for fingerstick calibration, can be worn for up to 10 days rather than just seven, and has an updated sensor probe that minimizes interference with acetaminophen. It will also be more easily compatible with many different devices based upon it’s FDA classification.

I wonder if it will covered by Medicare (US) or not. Maybe Dexcom needs to apply to have it approved. I’d be interested in any timeline addressing this issue.

Timelines to implement is my biggest question.
I use VA for health care, and I know they are not the fastest for this part.
Also, need to have it integrate with my Tandem X2 pump.

Managed care such as the VA and Medicare will usually take longer to implement coverage for newer technology as it has to go through review like any other insurer, but there are more layers to managed care such as Kaiser, the VA, Medicare. Your X2 pump is updatable through downloads from Tandem and depending upon when you received it, those updates may be free throughout 2018.

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Yes. The G6 is covered by Medicare. However before Dexcom fills any orders, they will be writing new contracts with Medicare for pricing changes.

Dexcom CEO:
February 27, 2018

We’ll have to get a new Medicare contract for G6 because it’s a different product than G5. So there will be a lot of work to do that we have lined out and laid out upon approval. We can’t do all this now until we have the product out and available in the market but, I can tell you, the response in the community is going to be superb. We’re really bullish about this.

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I found this intriguing, from the FDA press release.

This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.

I wonder what other compatible devices they have in mind. The “automated insulin dosing systems” language grabs my attention, too. If Dexcom plans to cooperate integrating the G6 into an automated insulin dosing system, does that mean they may open their minds to allowing DIY integration of the G6 into open source systems?

Seems far-fetched but the JDRF is now advocating that developmental pathway.

Long-time insulin pump manufacturer from South Korea, SOOIL, makes the Dana RS pump that uses an open wireless protocol and could be integrated with the Dexcom G6 to form an automated insulin dosing system.


The Dana RS is not yet available in the US. I think they are available in some parts of Europe and some parts of the UK.


Ha ha ha ha ha…! Oh, wait you’re serious. No, I don’t think that’s in the cards, alas. Not how MdT rolls at all.


Dexcom EVP
February 27, 2018

Our insulin partners are making significant progress with Dexcom integrated systems. Both Tandem and Insulet presented very strong pilot data at ATTD for their automated insulin delivery systems and we remain heavily invested in these collaborations. Early results demonstrated what would be market leading outcomes, including very strong improvements to time and range. We believe each of these systems will be highly differentiated once they’re commercially available.

Our recently-announced collaboration with Eli Lilly, which is intended to generate both pump and smart pen integration, is also moving forward nicely and recently saw first in-human experience. We continue to drive other pump and smart pen integrations and expect to update the market when appropriate.

[clip] … we’re extraordinarily committed to all of our pump partners, not just Tandem, we’re committed to Lilly, we’re committed to Insulet, we’re committed to others that we’re still keeping confidential.


Know it’s not one of the approved devices, but if one didn’t care about it controlling the insulin delivery part, if one used it like a CGM, where one could read the info on a phone or smart watch, kind of get the impression one could do that. Have to read up more on it. Is not like I know much of anything about it other than the few videos I’ve watched. My Endo recommended the Libre the last time I was in. Maybe this would be a better option. Currently on the 670, but I run it in MM and often without sensors. Exciting times ahead.

All the reference to no calibration needed - but what if you really need to calibrate?! Like what if it is far off. Is calibration still possible?

Is calibration possible but not required?

Or is calibration not possible and not required?

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Good news unless your insurance doesnt even cover this properly. I was so interested in the new inserter features…

I would agree that information released so far is light. I would go back to the comments previously made by the CEO. Until we hear otherwise, this is the most recent info I am aware of in regards to that.

Dexcom CEO
February 27, 2018

And we do have, you know, one of the things we haven’t been real public about but we can talk about on this call since you mentioned it. We did leave the opportunity for a patient if they wish to calibrate the system to go ahead and do it. We think this is very important for our IP partners, they’ll be able to calibrate their systems. And there are times and there are users who have come to me directly and said well we appreciate no calibration, we’re going to want to be able to stick our finger in it from time to time just as a comfort matter. So we are going to offer that feature.

Dexcom is saying you’ll be able to calibrate if desired, though it isn’t required. It’s still very early on the same day of the announcement on the FDA approval, so stay tuned. I’ll be reporting on this more in-depth in the next day or so on DiabetesMine.

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No calibration allowed would be a deal breaker for me. It’s like having an unruly child that you are not allowed to discipline.

Every once in a while I see a “Whatchutalkinbout Willis?!” type of number on my Dex.



Dana has a very poor distribution and support network, unfortunately. I have been trying to find out who their distributor for Benelux (Belgium, Netherlands, Luxembourg) is, for several months now without success. No response from their German distributor, no response from their official contacts on the website… nothing.

Lol, agreed. We will sooner see a cure for T1D than Medtronic integrate with Dex.


The question is whether doing calibration would then influence the cgm BG number, or would it just be logged and maybe interesting output on reports.