What to expect for CGM in 2018

I would presume they want people to buy more sensors or Insurance to buy more sensors. LOL

@tiaE
It may be a balance of priorities coupled with the realities of running a competitive business.

Dexcom has a number of things they want to push. They have previously stated they fully intend to allow sensors to be restarted. So this is a significant (potential) reversal of course for them. I do not think they would take this lightly. Getting the G6 with no-calibrations (although apparently including optional calibrations) out the door is likely at the top of their list right now probably second only to continued running of the current business (ie - servicing current customers). The impact to Dexcom’s business should they fail to get the no-calibration G6 out the door would be huge and can not be understated. While customers may not like to hear about the business side of things, it is the reality on which all this operates. We need a strong and healthy Dexcom to stay in business if we want to continue using Dexcom products. That is simply a reality.

If the FDA has drawn a line in the sand, then Dexcom may simply need to give up on the ability to restart a (G6 10-day) sensor in order to get the no-calibration G6 (with optional calibration) out the door.

You can’t always get everything. Often times compromises are the best way forward.

EDIT: Also note that Dexcom said once they get the FDA approval on the G6 no-calibration w/10-day sensor, they are immediately going to follow up with a request for a 14-day sensor (label change). However the wording of the CEO when he said that was such that I could not tell if he was referring to a PMA label change for the G6 (going from 10-day sensor wear to 14-day sensor wear) OR if he was referring to the Verily for 14-day sensor (which will use G6 technology).

But maybe the confusion had a basis in fact. If the G6 and the Verily use the same sensor then perhaps a label change from 10-day to 14-day would apply to BOTH the G6 AND the Verily? That would be awesome!!! But I am still a bit confused on that aspect.

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BTW, If you are interested in how the sensor is removed on the G6, you can take a look at the doc as published above at:

https://forum.tudiabetes.org/t/what-to-expect-for-cgm-in-2018/65080/11

And in the PDF, scroll down to section:
13.3 Remove Sensor

How the sensor is removed is physically different then what we have become accustomed to in the long-running world of the G4/G5.

Part of the reason the sensor removal has changed is that the sensor being applied has changed.
Refer to section:
6.4 Insert Sensor Overview
6.5 Attach Transmitter Overview

Note that this PDF was a very early iteration which (at this point) will have some obvious (and likely not so obvious) changes when the G6 is actually released. Among other things, this PDF was designed for the “once per day calibration G6” which is apparently no longer on the table for release. However there are many aspects which will almost certainly remain as published in this early version.

The applicators look enormous. The pdf said that you’d need to use a new one each time. Too bad you can’t use the same applicator for each sensor. They look like they’ll take up a lot of luggage space.

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A change of applicator has been a priority for years. The applicator was intended to be released in 2017 as part of the G5x launch. That entire release (and the G5x itself) was scuttled when the Medicare business ended up being picked up by Dexcom as opposed to distributors.

It has been a long time since I have heard any good word coming from Dexcom or the CEO regarding the current G4/G5 applicator. They are well aware of its numerous short comings of which there is no point in listing. Anybody who uses this is all too familiar with the issues.

Oh, I guess I’ve never really had a problem with the current applicator. Except perhaps that it was a little big. I’ll search through the forum to see what people’s complaints have been.

Thanks for posting all the info. It’s nice to prepare for new things entering the market.

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What is a G5x, tim?

A couple days ago was the first time I’ve included sensors (G5) in my luggage. Each one is pretty freaking large, compared to all the other paraphernalia I’m carrying, of which there is a bunch.

It was a product between the G5 and the G6. Developed and submitted for approval. Dexcom pulled the submission back when they decided not to launch. This product really was the first iteration of the G6 line even though it carried the G5 designation.

I pay out of pocket for Dex, so that’s my reality. Right now, my G4 transmitter is on month 14 (a record!) and I can usually get 2-3 weeks out of a sensor. It’s expensive, I wouldn’t go without it, and I pay full price for it. After all these years it doesn’t seem quite right that I should now pay MORE for the same thing. Sort of like insulin, you know?

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I had been looking for a PDF that I just ran across again. It is showing the MARD of the Dexcom system. I thought it was interesting and decided to post it before I lost it again.
(These are slides from Dexcom public presentations focused on the G6.)

This first one shows the historical change in MARD for Dexcom over a period of years for the various systems they have released.
Dexcom-MARD-Historical.pdf (16.2 KB)

This second one (which I find more interesting) shows the details of the G6 MARD as per clinical trial results.
Dexcom-MARD-G6.pdf (148.6 KB)

A question which I think is often asked as relates to the G6 is in regards to how accurate it will/can be with no calibrations? This second slide (I think) helps to answer that question.

As is now public information per the Dexcom CEO, Dexcom is looking to gain approval from the FDA for a G6 release which will require no calibrations. (ie - factory calibrated). HOWEVER, this same system will offer OPTIONAL calibrations. One might draw from those remarks by the Dex CEO that the G6 as released will function according to the second slide as either the “G6 w/ 1 calibration per day” or as the “G6 w/ no calibrations”. (Depending on whether the user decided to perform optional calibrations or not?)

Also note on the second slide, the second and third column of data are initially confusing as to why they are two distinct columns. Notice the “ALL DATA” vs “ADULTS” which clearly indicates the “ALL DATA” contains Pediatric data as well.

As well, if anybody is unsure why the difference between the “Day 1” vs “Overall” data distinction. Dexcom has historically provided better accuracy starting on day #2 or day #3 for many people. Often times, the data on Day #1 is not as good. Although this is individual. Personally we find the data on day 1 to be quite good but I know that is not universal. As you can see in the PDF, there is a pretty big difference with the G5 between Day #1 and “Overall”. One of the goals of the G6 was to improve Day #1 performance. Although it does not look (from the data on the chart of the second PDF linked here) like this was achieved for Pediatrics (ie - All Data), when looking at the Adult data, it does appear that a very significant improvement in Day #1 performance has been achieved. It is a small slide but there really is quite a bit of data when you look into it.

Disclaimer. I like numbers.
:smiling_imp:

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And in my experience, day 1 is usually WAY worse than the 2% difference in the G6 summary (thank you for those docs).

For me, a well-functioning Dex sensor will always beat my PBM’s preferred test strips which seem designed to forever test the envelope of the FDA’s 20% “acceptability” range for their performance.

I don’t understand why Dex’s 2/d calibration test would provide worse MARD than zero or 1/d. Sample sizes are large. Is this a byproduct of trial uncertainty, trial method like calibrating on a schedule regardless of trend, or … ?
(Presumably the trials are done with precise bg readings and they aren’t calibrating using one, and only one, of my crappy strips!)

What is MARD?

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If the trials are going to provide useful/generalizable data, they should be using strips similar to what they expect regular people to be using.

MARD Description

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@truenorth
It is kinda the reverse.
More that the G6 with 1/d (or no calibration) performs BETTER than the (older) G5 with 2/d calibration.

The 2/day is the older (current) G5 system. The G6 (new system not yet FDA approved) is an entirely different system. The sensor, membrane (on the sensor), the transmitter, the algorithm. It is all different.

The G6 is a whole new product.

That is a main point of the Dexcom produced slide. To show the improvements they have made with the G6 system in number of areas.

Misread it. Thanks

I disagree, but I’m no expert on trials. If you want to know how accurate your new sensor is, you have to compare it with independent, accurate data. If the comparison standard is subject to high potential error you have no idea whether your new device is any good.
Maybe that’s a separate bench test before you get to trials. Like I say, I’m not familiar with the setup of a trial.

But if the research question is how do various calibration methods work, the calibration needs to use the same methods real people would.

@truenorth
@cardamom
I agree with both of you. Both studies would have valid and very useful results. However, it would be more meaningful to view this data with the knowledge of which type of study was done.
I tried to search for the actual clinical study which would have had the details but am not having luck finding it.
Maybe somebody else will be able to locate it and post so we can see the details behind the numbers.