Dexcom G5 Approval by FDA

@Lorraine: is this screen from the new app connected to the G5 sensor?

No. It’s the Clarity App which I believe is different. You can download that now on your computer, plug in dexcom and see a whole bunch of new reporting. The app links into your account and shows you reporting that you downloaded to your computer.


Neat! I hadn’t heard about it. But it IS an app by Dexcom:

I just downloaded it @Lorraine, and got this screen when I clicked to generate a PDF:

Did you experience something similar at first? Is there a 3-hour wait period like with apps that use DexCom data via apple HealthKit?

@askmanny, @Lorraine - I called Dexcom yesterday to ask some questions about the Clarity reporting software. I was told that Clarity was not FDA approved yet and is not available. I told them I downloaded it off of their website. When I went back to their website it was gone. Perhaps it was not intended to be made available until the introduction of the G5 and somebody jumped the gun.

My Clarity software still works but it does have some rough edges that prompted my call.

That’s what I got at first, but then I hadn’t uploaded any data from my CGM yet. After I did it seemed to work fine though I admit I didn’t poke around in it too much. I checked on my phone just now and was able to log in and view my last report.

What you are showing is the phone app. That is populated only after the application on your computer is populated. The data must come from the receiver via the cord at this point.

However, given this new information, it seems that it can no longer be downloaded via computer. How interesting. I don’t seem to be having any difficulty having downloaded it before the option was taken down.

I guess that’s why DexCom hasn’t made a big deal about it.

Press release from overnight… The G5 has received the CE Mark for several European countries & will be available is the coming weeks. Which is GREAT! (The US was the only country to have the Share System)

Dexcom has the countries listed on the ‘device compatibility’ page.
"United Kingdom, Germany, Netherlands, Switzerland, Sweden"

AND! It has also been approved for treatment decisions, no finger stick (Europe only). That’s a big deal. I know that Dexcom is working toward the same here in the US with the FDA but I thought that would happen with the G6. Wonder if it will clear the FDA with the current sensors?

That is a big deal in the US. If the G5 can replace at least most of the fingersticks then it will remove the major objection that Medicare (US age 65+) has to the CGM.

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Approval for treatment decisions, plus ultimately being used in an artificial pancreas will be a nice step forward, while also being scary during the first 24-48 hours after initiating a new sensor. Also, there’s the 2-hour start-up window where an AP would be essentially blind.

I confess I haven’t followed the argumentation on this as closely as I should. What’s the logic of the objection? That CGM is a waste of $$ because it doesn’t replace finger sticks, just augments them?

The argument that I’ve seen expressed is that Medicare is already paying for meters and strips and the CGM requires fingerstick calibration and as a confirmation for treatment decisions. Medicare see the CGM as redundant.

Anyone know if readings can be set to display on the smartphone’s lock screen?

@askmanny Have you been successful downloading this on your computer? It appears to be available here.

Hey Lorraine - I just did it. Are you having problems? Pretty cool information.

@mikep No. No problems here. I’ve been using it for weeks, and love it. So, so easy. Manny seemed to have some difficulty. Someone mentioned it had been taken off the Dexcom site referencing FDA approval. Just checking in w Manny to see if he was able to make it work. :smile:

@mikep and @Lorraine, I’ve been using the new Clarity software every day. I like the way it automatically loads the program and downloads my receiver as soon as I connect to my USB port. I find the 14-day standard day report as the best view of my overall control. I concentrate on eliminating the red spots that dip below my lower threshold. Slight yellow excursions above my upper threshold don’t concern me as much.

I read one study about a year ago that stated 14 days worth of diabetes blood glucose data was sufficiently robust to provide good guidance. I agree with that sentiment. I found this report because I was tired of listening to my endo fret about my exposure to low BGs. I used this study to talk about this with her. After that discussion, she pretty much backed off of her hypo-phobic remarks.

The study said that if the 10th percentile touched or exceeded the lower BG threshold then there was a moderate risk of hypos. It went on to say that if the 25th percentile touched or exceeded the lower threshold then there was a marked risk of hypos. I wished the Clarity writers would have used the 10th percentile but I’m thinking the 15th percentile is close enough.

I’m OK living with a moderate risk of hypos in exchange for a high percentage of time in range and a lower average.

The Abbot FreeStyle Libre flash glucose monitor software uses the 14-day standard day with the 10th percentile marking. It references the same scientific study that I referred to above. I like the 14-day standard day report because it communicates so much in as short time and it’s intuitively apparent to both the patient and clinician what time of day needs work.

My doctor showed me the “spaghetti graph” from the Dexcom Studio software at my last appointment. I told her that that picture was useless for me. She then quickly switched to the 14-day standard day to talk about. I think I make her nervous.

The spaghetti graph is fairly useless for any period of time, in my opinion. I had a favorite report - hourly stats. I found the 3 month or even 1 month reports smoothed things out such that isolating current times/events of the day was not practical. It gave me a nice feel for what to expect Caleb’s a1c to be though.

I’m connecting to clarity every few days - not more frequently only bc the the receiver is not with me most of the time. I like looking at the most recent three or four day period. I find that to provide laser focus on any potential problem areas. The risk with such a small period is that it may not be a trend you are seeing, but something just off for a few days. Starting with that focus and coupling it with a 7 and 14 day period is working for us right now. In the past, when I sensed something was off, I would sit down and go through the last few days of records and write everything out manually to make sure I understood where/if there was a trend. Now it’s plug and go.

Log books, be gone!


I am downloading it shortly, to try it out. Thanks @Lorraine!

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@Lorraine, The studio hourly stats report is related to the standard day graph. I prefer the visual over the raw numbers. You do such a great job with managing your son’s diabetes. I know he’s taking on responsibility, too. Some people don’t like data and math. I guess I can count my interests in these areas as a blessing. Diabetes and numbers are endlessly intertwined!

Discourse saved this as a comment to me. I added your @ name, Lorraine!

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