Sensor and Transmitter are going to be a single unit instead of a sensor that lasts for 10 days + a transmitter that lasts for 90 days…the new G7 sensor/transmitter will BOTH last for 10 days and be disposable after the 10 days (maybe hackable?)
Warm-up time will be only 30 minutes as opposed to 2 hours with the G5/G6.
Supposidly, the G7 applicator will be even easier to insert than the G6 (Sounds like the entire sensor area may be take up a smaller footprint as well as the transmitter being smaller.)
Different type of adhesive that isn’t garnering the same types of complaints from patients over the G5/G6 adhesives (rashes, skin issues)
All of those relationships will remain in place with the G7. It will also integrate with the Apple Watch. In addition to integration with the Tandem’s Control IQ and Insulet’s OmniPod system
The G7 will be compatible with both Android and iOS smartphones, and will also work with a receiver for those patients who prefer not to use a smartphone to track their blood sugar.
Speculation is that it may be released in the first half of this year, but it’s purely speculation…schedules have shifted to the right on other matters where Dexcom is concerned.
I think we manage to restart the G6 because the transmitter can be separated from the sensor. I think the prevailing thought is the G7 won’t be able to be hacked for a restart.The libre which is all one piece has proved to withstand a lot of people trying to figure out how to restart it as most people in the UK and Europe use a LIbre (and a lot in the US too).
I didn’t see it in this article, but I believe they submitted the FDA approval with alternative site placements (arm) vs G6 only has approval for the abdomen.
Love the 30 minute warm up…as long as it works…lol🙄. I had a lot of problems with the 2 hour warm up in the abdomen with G6(essentially useless for the first 8 hours). Fortunately switching to arm placement fixed that and is pretty accurate at 2 hours.
Good point on warm up, @jim26 – I need a 12 hour “pre-soak” for G6 (the first 12 hours of data are useless for me) – wondering if this will be possible with all-in-one sensor/transmitter.
If you watch Nerdabetic’s YouTube video on the G7 where he talks with Dexcom CEO Kevin Sayer, at very beginning (time ~2:30) Sayer shows the G7 he is wearing on the back of his right arm. I doubt he would have done that if placement on the upper arm was not one of the methods approved for the G7.
I did watch a podcasts where they said the G7is to be approved for back of the arm use. He also said that in Europe and UK it’s already approved for the G6 and that they know people use it here on their arms, but that they won’t be seeking approval here as they are putting all their resources/efforts into the G7.
I think they should just eliminate the “spots” for approval altogether…list spots and say, try them all and whatever works best for you, go for it. lol.
That does make me curious because I believe the FDA required a pivotal study to allow and that was the primary reason behind them not spending the resources to do that. Do the other countries agencies not require things like that??? I have no clue, but makes me wonder why it is ok there.
Most other countries don’t have quite as strict requirements for approval of drugs that the US does. We usually get new drugs/tech faster because they get paid more here. But I think most of the countries almost automatically okay what’s been already approved in the US? Then like in Dexcom’s case to get it okayed for arms it doesn’t have to meet the same standards and is easier.
Unless he was paid by the marketing department. I’ve seen way too many pictures of people with G6’s all over the place, but mostly on muscular and invariably very sexy arms. Personally I place my on my pubes; that way it doesn’t impede the flow of the beer.
I doubt that Dexcom marketing had to pay him to plug the G7. Kevin Sayer is currently the Chairman of the Board of Directors, President and Chief Executive Officer of Dexcom. Promotion is sort of part of the job, no?
Interesting question. So in most of the world you seek a different regulatory agencies approval (CE) and then after that each country has their own reasonably simplified version of approval once the CE is approved. They have typically only required safety data for approval, but in the last years they have moved more towards the FDA model but aren’t quite as strict on the efficacy proof. So in general CE is easier to get than FDA approval and most large companies get CE and FDA approval about the same time since the data from one study can usually be approved for both agencies. Of course there are always exceptions and that is why some things lag in the US and others in the EU. The rest of the world is a grab bag, for instance Japanese approval usually requires enough Japanese patients in the study, so if it is an important market you might have a 3 country study to seek approval in EU, US, and Japan around the same time.
CE indicates conformance to the EU standards which vary by product. It can be self certified (i.e. a manufacturer simply declares that the product conforms to the relevant standards) but those standards cover a whole range of things appropriate to the product. For example my Omnipod PDM is labelled “CE 2797”, the 2797 is apparently for “medical devices” and my iPhone XR also has a CE rating, somewhere, for something.
So it might be easy, or it might be very very difficult; depends on the particular standard.
Here, for example is the gov.uk list of things that require a CE mark:
You will immediately appreciate that a suppository does require a CE mark unless it is an “active implantable medical device” and that the one for “explosives for civil uses” is not applicable. In fact most of the CE stuff is about devices of an electronic or mechanical nature. Indeed, the document says explicitly:
The CE marking is not required for items, for example:
chemicals
pharmaceuticals
cosmetics and foodstuffs
No CE markings required on Zucchinis, or, for that matter, insulin, or 99% of the FoodDrugsA control.
The system is entirely different; FDA approval of a new zucchini is pretty fast, even though it is regulated by the FDA.
I started wearing my G6 sensor on the outer thigh a few months ago. It is the best place I have found as far as comfort and accuracy. Seems more accurate from the start over the abdomen. I place it with the bottom of the sensor about fingertip length with my arms at my side and rotate legs back and forth, moving the insertion site up to 3 inches so it’s not in the same exact place every time. I have some fat there so it is comfortable and has never bled. I couldn’t stand the thought of putting it in my upper arm because that area seems so tender.
There are a couple of cons. For some odd reason the adhesive sticks like glue to my leg 1,000 times more than my abdomen. I remove the transmitter to put in the new sensor and then slowly work the old sensor off using a Q-tip saturated in oil but it hurts a lot to remove the adhesive. This only happens on my leg; the sensor tape comes right off of my abdomen.
The second con is that I walked too close by an open drawer one time and it knocked the transmitter completely out while leaving the tape still intact. That hurt severely and caused a lot of bruising. I took a break from my leg for a couple of insertions but then went back because it seems much more accurate and I get a full 10 days out of each sensor with little to no sensor errors.
