Dexcom G7 Now FDA Approved

For me, this Swiss youtube T! guy had a lot of details and a demo of
an actual G7 he has. Applying Dexcom G7... It finally happened! - YouTube
I wonder if the U.S. version will come with an overpatch like the one in Europe does. The guy showed it. That would be great if so. Only negative I see is the 10 day no re-use part so far.

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Article refers to Tim Street’s comparison series on Diabetech which I’ve been following, and I gotta say those accuracy numbers are kinda underwhelming. Plus I like being able to do the occasional sensor restart—basically how I manage to have a cushion of emergency back-up sensors in hand in case of, well, emergencies. At this point I’m hoping it’s a good long while before they phase out the G6.

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Have I mentioned recently that when I was dx’d in 1983 the Dr told me not to be too worried, for “a cure is probably about five years ahead.”

BTW, did everyone read the exciting news about nuclear fusion recently? /snark

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I finally had a chance to read through the FDA decision summary on the Dexcom G7 and the supporting clinical trials. As a user of the G6 I have some opinions I wanted to share.

The G7 doesn’t appear to be any worse than the G6 when comparing the stats in the FDA Decision docs.
The Dexcom Reader gets a 4 way navigation button instead of the touchscreen based on the image in the adult study so that is nice. First I’d seen it although its been out in Europe.

Shelf life is 6 or 9 months. I can’t find any info on the “bonded” vs “molded” needle hub designs referenced in the FDA doc.

Since Dexcom submitted the G7 as a “Substantially Equivalent” device to the G6 and didn’t call out any changes to the senor chemistry it looks like only the algorithm has been tweaked to give better results in the 80-120 mg/dL range. The latest study also has fewer missed <60 mg/DL events at the expense of more alerts that you are low when your BG is greater than or equal to 60. The other item that isn’t called out is the adhesive. Since the FDA approved Dexcom changing the G6 adhesive at the end of July 2022 the G7 should be using the same new adhesive. I just got my first box of sensors made after the approval so I haven’t tried it yet. My last gripe is Dexcom left out placing the sensor on the abdomen in their FDA submission.

I am not at all impressed with Dexcom’s clinical trial study design. Only 308 adults and 122 kids. 90% of the adults were white people. 1/3 were obese, 1/3 were overweight and there was one possible skinny person.

The one thing I haven’t found an answer to is do the filament still get inserted at an angle as opposed to straight in like the Abbott Freestyle. After using both I think the angled insertion is part of Dexcom’s advantage although I have no data to back that up.

In the end I didn’t find anything to be excited about. For me, since I do MDI the G6 and G7 appear equal. For pump and pod users, you’ll have to go back and read the FDA approvals of your devices to see if they left enough wiggle room in their wording to allow for new or different CGMs or if using anything other than the G6 requires FDA approval.

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The new G7 won’t be available in Canada for another 12 - 18 months

I received a notice last week from Dexcom that the G7 will launch in the US soon. I did not initially post this information as my idea of soon and Dexcon’s most likely diverge considerably. The FDA approval is in place, and now it is just a matter of getting the product into the hands of the dealers/distributors, which will most likely vary from state to state,

There is expected to be an ad during the super bowl that may include the release date. This is what I have so far.

https://view.na.dexcom.com/?qs=c6dab42caebedbadfccdf983c30f96a84e86e11ddfe50079be29331f50d991ceeec9930eda8e758aa77c43e8b8da36cf9cc929c30c2736a2b9f9a6194338d340329fe72224b0dadc449a6209d2f51c09

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Health Canada (Canada’s version of the FDA) always lags FDA decisions, sometimes taking years to approve meds and devices that are available worldwide.

So they have posted on the read more of @CJ114 's link that the release date is Feb 17th.

I just got a shipment of G6’s for 3 months plus I have extra G6 sensors anyways. I wonder how long we will be able to get G6’s. Eventually I’m sure we’ll be forced to get the G7. But at some point I’ll switch to the G7 and use up my G6’s while building a good stockpile of the G7’s before I actually start using them. Even if they only have a shelf life of 9 months, I should be able to build another good back up stockpile.

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I asked my DME supplier today (Edwards) if they have any scheduled date to start supplying the G7. They have no start date at this point and said it will depend on when the various insurers including Medicare start covering the G7. I was also told that interest in the G7 is through the roof, they are fielding constant requests for it.

Based on that I went ahead and re-ordered 90 days worth of G6 supplies, guessing it will be at least a few months before the G7 is widely available.

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