Turning to our product pipeline, we submitted our G6 PMA to the FDA at the end of the third quarter. Based on our review of the data, the G6 platform takes real-time CGM sensor performance to the next level, especially in terms of its improvements in stability and consistency over an extended period of time. It also carries important ease of use enhancements including a new applicator and smaller form factor. We know patients will be excited by the reliability and convenience of this system. As I mentioned in my opening remarks, since our filing, we have been in regular communication with the FDA. And while it is early, we believe we have a path to bring the first real-time no calibration sensor to market before the end of 2018. We will continue discussions with the FDA to bring this important advancement to the diabetes community.
On the app and wearables front, the number of DexCom customers using their mobile phones is rising steadily with the availability of both iOS and Android systems. Patients want to share their data with loved ones and DexCom’s connectivity provides that very important capability.
We are also leveraging our connectivity to provide patient CGM data on alternative displays like the Apple Watch and Android Wear devices. We also recently announced our efforts with Fitbit to provide a display on their new smartwatch. Our open API platform went live during Q3 and received a great response.
Within our insulin delivery partners, development of DexCom integrated systems are making progress. Insulet has shown tremendous dedication to our partnership and our teams are working hard to bring our connected systems to market. Once launched, we see a number of differentiating features in our combined systems including an attractive form factor and opportunities for a smartphone connectivity. In the meantime, we have embarked on a few commercial activities together and will continue to work with Insulet to deliver attractive options for our shared patients.
Tandem recently launched its G5 sensor augmented pump, representing the first insulin pump system that carries a non-adjunctive sensor claim. And because Tandem’s pump offering is field upgradeable, patients won’t be locked into a legacy technology and will be able to use enhancements as soon as they are available.
Very nice nuggets, @Anthony! And welcome (a little late on my part) to the forums, I am really glad to see you here!
If you have a chance, you might want to fill your profile a bit as well as your “card” (About me", if you make it really short, it will show when people click on your name in-page). You can also introduce yourself on the welcome thread.
Nice go on the Apple watch update, btw I look forward to your future posts!
A G6 slide from a Dexcom presentation on the upcoming G6 system. This presentation was made prior to the FDA submission as referenced by @Anthony at the start of this thread. Date of the presentation was May 5 of this year, 2017.
In the Diatribe review of the Advanced Technologies & Treatments conference,
there is the (supposedly final) feature list for the G6. No calibration required but optional calibrations used, 2 hour warmup, same accuracy as G5 but better on day 1, predicted low alert, much nicer inserter, 10-day sensor life, no interference from acetaminophen/Tylenol/Paracetamol. Expected availability in the second half of '18 in the USA. The conference call is on February 27; perhaps they’ll mention whether the sensor will be restartable or if it will have a suicide timer.
With respect to the G6, they stated that their goal is to release it mid-year. They are still discussing with the FDA whether or not they must implement a timer to prevent sensor use beyond the 10th day. That issue is still undecided. Although they didn’t state it plainly, my impression is that they understand that the ability to restart the sensor lowers the user’s cost which helps Dexcom’s competitive position relative to the Libre,
They said that the initial G6 transmitter will be followed by a higher performing revision “not long after.” After the G6 comes out, they plan to reapply for approval for 14-day sensor life: the (Google) Verily CGM will use the G6 sensor and will be approved for 14-days.
Medicare approval of the G6 will take some time after the FDA approval. And they are still trying to get Medicare to allow patients to use the Dexcom phone app, which currently is forbidden.
They told the story of an email from the parent of a child in the G6 study. Evidently the child is refusing to go back to the G5…
Is there a benefit for the user in a time limit, or is a limit purely profit-driven? My current sensor is now at 35 days. With the G6 and a 10-day lifespan, I’d be into my fourth sensor by now. Clearly hanging on to my G4 benefits me as a user/consumer, but I can see why Dexcom would prefer I didn’t do this.
Not really, other than they must not have data showing that their sensor works beyond this time period that is adequate for the FDA.
I think similarly to @bkh, that for Dexcom the restart is a competitive advantage which brings the total cost of ownership down for many patients. But if they can’t convince the FDA that their sensors last that long, they may have to include the kill switch.
This is probably the result of the Libre submission. My guess is they touted the automatic “killing” of the sensor as a safety improvement, and if the FDA reviewer buys that, they may hold Dexcom to the same standard.
As I understand it, the issue is that the sensors become less responsive and less accurate as they age. In order to get FDA approval for insulin dosing from CGM readings and no calibrations required, the FDA may require a hard time limit on the sensor to “guarantee” it won’t become unsafe for the broad spectrum of users.
My sensors often perform best in week 2, and I don’t think I’m the only one who experiences that.
Did anyone notice whether they confirmed that the transmitter will not be able to be removed and reinserted into an active sensor? That’s the main potential dealbreaker on the G6 to me, as someone who is in the process of getting an MRI research study up and running…
It is approved in a new category of CGM device, considered less dangerous than the Class III category of the G5. It is approved for use in integrated systems (i.e., pumps can use it for their BG data without the combination of Pump+G6 having to go through the FDA approval process, provided each one alone was approved in this category.)
No calibrations required. 10 day sensor life (I don’t know whether or not there is a suicide timer that kills the sensor after 10 days.) Compatible with Tylenol/Paracetamol. FDA approved for people age 2 and above.
Just spoke with our local Dexcom rep. He said should be about 3-4 months. I am out of warranty on my G5 so I’m up for 2 new transmitters. He said to order them and then anyone on G5 will get Auto upgrade to G6.
That sounds to me like you get the 6-months worth of G5, then your next transmitter/sensor order after that, in October, will be for G6. Or do you think the rep was suggesting there could be some kind of trade-in program for you to return unused G5 equipment in exchange for G6 (I kind of doubt they could afford that.)
Dexcom was pretty clear. When your G5 transmitter expires then you can reorder the G6.
No hint of any sort of a trade-in.
Almost certainly you would have to request it however. There is no force to the G6. It was specifically mentioned about people using the G4 and G5 with existing pump technologies and how long those will be supported for. At this point there does not appear to be a timeframe for stopping production and sales of the G4 and G5. Obviously those will not be around forever but as of this point, there is no date to force people onto the G6.
I look forward to your future posts!