Fda approval: dexcom g6

There is quite a bit of coverage and information out in the DOC, and it can be quite a bit to get the mind around. In particular, Dexcom CEO has been making the rounds to answer questions and talk about G6. Some of the posts/articles I’ve seen that may be worth checking out, IMHO, include: Beyond Type 1 (as linked to above); Diabetes Connections podcast by Stacey Simms; Juicebox Pocast by Scott Benner at Arden’s Day; Kerri Sparling at SixUntilMe, diaTribe coverage, and DiabetesMine news coverage (full disclosure that I wrote that!). Others that have a bit of coverage so far include College Diabetes Network, Glu, Insulin Nation, A Sweet Life, and Diabetes Daily. There are also many Facebook discussions, particularly in the CGM in the Cloud groups. As well as a great #WeAreNotWaiting focused post by Tim Street at DiabetesTech. Didn’t want to post actual links, if that’s not cool. Happy reading and listening, all!

EDIT: OK, adding in those links as Tim noted it’d probably be helpful…

DiabetesMineNEWSFLASH: FDA OKs New Dexcom G6 CGM!
diaTribeFDA Clears Dexcom G6 With No Fingersticks!
Beyond T1Dexcom CEO Explains G6
Diabetes ConnectionsDexcom G6 Approved - Bonus Episode
Juicebox PodcastEpisode #158
SixUntilMeDexcom G6 Approved by FDA
DiabetesTech blogHow Might G6 Work for #WeAreNotWaiting Users?
GluFDA Approves Fully Integrated Dexcom G6 CGM
Insulin NationFDA Authorizes Marketing of New Dexcom G6
A Sweet LifeFDA Approves G6, No Fingersticks Necessary
College Diabetes NetworkInterview with Kevin Sayer on G6
Diabetes DailyDexcom CEO Answers Your Questions About the New G6

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@Michael_Hoskins
AFAIK there is no prohibition on posting links.
I assume people would appreciate the information.

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Yes, doing a calibration on the G6 would influence it and work the same way generally as the G5 does now.

“a forced 10-day shutoff”. Seems to me that the sensors would need to each have a timer physically built in OR a unique ID which would be transmitted to the receiver.

@JJM1
Exactly. Which I do not believe they do.

Very helpful! Thank you!

The actual official Dexcom G6 cgm User Guide is now available online. This is what is linked to from Dexcom if you start at their manual page:

https://s3-us-west-2.amazonaws.com/dexcompdf/G6-CGM-Users-Guide.pdf

https://www.dexcom.com/guides

EDIT: I am just reading through it. I am quite interested to see what changes were made as compared to the pre-release versions of the user guide. I am a documentation junkie!!!

Oh - Excellent. Dexcom kept the “Jake and Kelly” examples in the user guide. I am sooo glad.

(strong sarcasm - lol)

Meet Jake and Kelly! They each manage their diabetes with a G6 and are happy to share their insights with you. When you see their pictures in this User Guide, check in with them and find out how they use their G6s in day-to-day life.

This has not changed from the pre-release versions and what is likely to be (IMHO) one of the biggest complaints.



image

Why has it been one of the biggest complaints? Hola Tim :slight_smile:

Hola !!!
Not “… has been …” (past tense) but rather “… what is likely …” (future tense).
:slight_smile:

In the past with G4 and G5, people are used to being able to remove the transmitter for various purposes without causing an interruption in the sensor session. The transmitter can then simply be reattached to the existing sensor and the session picks right back up. It just obviously has a gap in the readings during the period of disconnection.

Now, that is now longer possible according to the published documentation.
(Not surprised if a work-around develops under the radar and not approved by Dexcom nor the FDA)

Maybe this won’t be a big deal.
Maybe it really was never a common thing to remove a transmitter and then put it back in place.
Maybe the situations where the transmitter removal was applicable for the G4/G5 are now different under the G6 such that those situations simply no longer happen.

All just guess work on my part.

ahhh I see. Would be a big deal for some definitely. For us, users in other distant locations G4 is still the best option (cost related, of course). Gracias for your super clear answer :slight_smile:

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@Mariana11
Yeah, the cost and the 10-day sensor hard stop are almost certainly going to be the biggest issues.

There is no way the G6 can compete with a G4 transmitter that might run for 10 months and if it happens to be a person that is able to wear a G4/G5 sensor for 30+ days. That is just the reality.

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So if water gets into the contacts from taking a shower for example we will no longer be able to pull the transmitter off wipe it off and continue

@Dave44
Sure - that is certainly a situation which for us was common. Maybe the new design prevents the soapy water from getting in even a little bit. Hopefully. Not gonna take too many showers to prove the point one way or the other.

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Just use more cologne. LOL

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I do that precisely till next trip. No dexcom here so I have to make sure it is super glued. LOL.

i had to remove the transmitter for a CT scan once (more than once, actually!) – they let me keep the sensor on, though, so not being able to do that can be a serious issue…
10 days hard stop (or any stop, for that matter!) is another big issue for me – I need a working CGM more on the weekends than any other time – so I always change my sensors midweek – that won’t be possible with the 10-day cycle…

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For CT scan, I know the directions say to just remove it. And bottom line, you have to follow whatever directions the med tech doing the procedure states or they can refuse to do the procedure. But with CT scan and X-Ray, it is my IHMO (although perhaps different from the Dex Manual) that the sensor and transmitter are fine to be left in place if the imaging is not being directed towards where you actually have the sensor and transmitter.

I could be totally wrong on that of course.

On the other hand with MRI - I would be willing to leave the sensor in place but would not be comfortable (at all) with having the transmitter left on. So for the G4/G5 it would be quite easy to just pop the transmitter out for the MRI procedure than the pop it right back in when completed. With the G6 in the same situation, you would (according to the Dexcom G6 Manual) stop the session, completely remove the physical sensor and transmitter and then use a new sensor and start a new session to get the cgm data flowing again after the MRI procedure is completed.

In which case, I expect that Dexcom will send out a replacement sensor. Of course, that doesn’t help fix the 2+ (the “plus” being the time it takes from removing the sensor prior to the exam, to the time it takes to install a new sensor, after the exam is completed) -hour delay in getting CGM data.

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