Hello, Dexcom G6!
Our diabetes community is pretty excited about the FDA's recent approval of the latest generation of the Dexcom continuous glucose monitor, for good reason! The new Dexcom G6 CGM is the first of its kind offering direct-to-phone smartphone connectivity, with no need for a separate receiver and no fingerstick calibrations required.
Plus, this marks an unprecedented regulatory move that paves the way for faster regulatory approval of future CGMs and other diabetes devices that will be equally interoperable and easy to use.
On March 27, the FDA approved the Dexcom G6 -- only six months after it had been submitted to the agency! Both Dexcom and the FDA issued news releases on the announcement. Coincidentally, this regulatory clearance came on the California CGM company's 12th anniversary of its first product approval in 2006.
For the past decade, Dexcom's offered systems that can be worn on the skin for an FDA-approved time of seven days. Though many of us have been able to extend the wear time well past a week, that's officially been "off-label" -- until now. With the G6, we have the first CGM sensor approved for 10-day wear that continuously beams data directly to a smartphone.
Those are the biggest changes for customers here. But there's a whole lot to digest on this next-gen Dexcom, so here's the scoop, point-by-point on this new CGM system.
Dexcom G6: Features of the Next-Gen CGM
Transmitter & Range: The G6 transmitter (brain of the system) is now about a third smaller, thinner and lower-profile than the previous model and has a new glucose-analyzing algorithm inside. It still has a three-month battery life that also includes a brief grace period on the tail-end. But now there's built-in Bluetooth connectivity allowing it to communicate results every five minutes directly to a smartphone app and compatible devices (more on that below), and we hear the transmission range remains at 20 feet as it has been with the prior CGM generation.
No ‘Required’ Fingerstick: The G6 no longer requires once or twice-a-day fingerstick calibrations -- which was the biggest open question on what FDA would allow. Like the G5, this next-gen product is approved for use in making insulin dosing and treatment decisions without a backup fingerstick test (if you are comfortable doing so). What's awesome is that even though the G6 is factory-calibrated, Dexcom has built in the capability for users to still enter calibrations, should we want to. Now, Dexcom joins Abbott's FreeStyle Libre Flash system in being the two on the market not requiring calibrations; the Medtronic Guardian 3 sensor and newly-approved Guardian Connect stand-alone CGM still require daily calibrations, and are not FDA-approved for dosing decisions as the two competitors are.
10-day Wear Sensor: Here's the part that may be the most bittersweet of all -- the water-resistant G6 sensor is said to be more accurate and reliable, and can be worn for 10 days compared to the current seven days.Yay for that! But the caveat: There's a hard-shutoff at the 10-day mark, meaning you won't be able to extend the sensor for prolonged wear, as many of us have gotten out of previous sensors. Boo on that! say many users. FDA actually laid this out in a letter to Dexcom desribing requirements for the G6, with a specific clause that the disposable sensor must shut off and be incapable of use beyond the approved 10 days of wear.
Shutoff Workaround Rumors: Some were hoping to find a workound for the automatic shutoff after noticing mention of a new "sensor code" that must be plugged in for each new sensor, described in the G6 simulator app (that Dexcom is offering to introduce the product). If that special code is not scanned or entered, the sensor will require the daily calibrations as they exist with the G5 now (every 12 hours). Some wondered if you might be able to manipulate the code to work beyond the initial 10 days with calibrations, but Dexcom's customer reps and leadership says that’s not the case. Each sensor apparently has a built-in shutdown separate from the calibration-related code, and it will stop functioning at that 10-day mark. Boo!
New, Disposable Auto Inserter: We've got a whole new Dexcom design here, Friends. Now you’ll be using a plastic, spring-loaded self-contained auto applicator that requires you to do nothing but press an orange button to inject a new sensor. Even one-handed! Btw: Each box of sensors will now contain three sensors rather than four, and each sensor is already assembled into the auto inserter so no needles are exposed. For the G6, the adhesive is the same as before and Dexcom says they'll send over-tape to help it last the 10 days. You pull off a sticky tab to reveal the sensor and the scannable code, and then after pushing the button you dispose of the applicator once the sensor's on your body. (Note: it's a pretty chunky thing for a disposable piece, and Dexcom tells us they're considering setting up a recycling program for this applicator disposal.)
Young Kids: The G6 is approved for ages 2 and older. That's another advantage it has over Medtronic's new stand-alone Guardian Connect CGM, which is only approved for ages 14 and up.
Goodbye, Tylenol Effect: No more interference from medications containing acetaminophen (Tylenol), which has been an ongoing issue in the CGM world. The G6 has a special membrane on each sensor that eliminates the body chemistry interference from these medications, which previously could give false high glucose results.
Receiver in the Box: No, you won't have to use the relatively-new touchscreen receiver Dexcom unveiled last year. But interestingly, Dexcom says the FDA’s still requiring that a receiver be shipped out with every G6 system for now, even if customers choose not to use it and instead rely on the transmitter-to-smartphone functionality. If you're a G5 user now, your touchscreen receiver will need a free software update to function with the new G6 and once you download that, you can't go back.
Mobile App: Nothing's really different from the look and feel of the current Dexcom app. After a 2-hour warmup period without any data, the new G6 mobile app will start showing glucose results on the mobile app. It displays a circle with the current real-time glucose level and appropriate Gray/Red/Yellow color code depending on whether you're In Range, Low or High. The little arrow points in the direction you're trending and the graph with glucose value dots and other inputted data like insulin/carbs/exercise is displayed below that. Want to view more than the past 3 hours of CGM data? Turn your smartphone horizontally to see up to 24 hours of data and scroll back accordingly. Of course, data can be shared via the separate Dexcom Follow app with as many as five people and with a doctor's office through the Dexcom Clarity platform.
Both iOS and Android (!): Yep, it does appear that both Apple and Android will support the new G6 at the time of launch. There's a list of specific compatible devices on the Dexcom site, thought it's not entirely clear yet which phones or wearables may work from the get-go. Also, Dexcom says the G6 won't yet send data directly to an Apple or Android watch without the phone, but that is in the works. See the nifty G6 simulator app available on both iTunes and Google Play for a sneak-peek of the G6.
Predictive Alerts: You'll get an 'Urgent Low Soon' alert whenever the sensor picks up that glucose levels are falling fast and predicts you'll drop to 55 mg/dL within 20 minutes.
Customizable Alerts: These carry over from the past CGM generation, allowing you to set different alert preferences for times of day or night. There's a 'Do Not Disturb' feature for audible or vibration alerts, though the 'Snooze' feature is disabled on important alerts like 'Urgent Low' and 'Sensor/Transmitter Failure.'
Pump Partners: Both Tandem Diabetes and Insulet are teamed up with Dexcom, weaving the t:slim X2 pump and Omnipod patch pump with the latest CGM offerings from Dexcom. Both work with the G5 now in some capacity, and both expect to seek regulatory approval soon for weaving this new G6 tech into their pumps and eventual closed loop systems in development. The OmniPod DASH platform with Bluetooth is before the FDA and expected by the end of the year, with G5 and probably the G6 not long afterward. Recent reports say Tandem's G5-connected predictive low glucose suspend system, Basal.IQ, is pending before the FDA and expected this summer, while the next-gen Control.IQ using G6 is planned for the first half of 2019.
Future Pipeline: Dexcom says they're shooting for a 14-day-wear sensor by late 2019, along with a first-generation Verily product within a year and then a second-generation Verily product sometime after that. As a reminder, Dexcom and Google Verily are working on a miniaturized, disposable CGM sensor that is flatter than the current transmitter, with 14-day wear and no calibrations. They have stated that a second-generation joint product will be a disposable device that's even smaller, possibly the size of an M&M candy, available at lower cost -- the two companies' projected home-run product expected in roughly 2020/21.
Dexcom G6 Availability and Cost
Launch Timing: Dexcom's targeted launch date is June 4. There is a G6 upgrade program for both new and existing customers, with specifics varying based on each group.
- New customers starting on the G5 Mobile system after March 27 are also enrolled in the G6 upgrade program, to receive those new G6 supplies automatically after 90 days (in the order they signed up for this upgrade program).
- Current customers ordering supplies after March 27 will be enrolled in the G6 upgrade program, and will get the new G6 supplies after 90 days automatically.
- For current customers who remain in-warranty past early June, they'll get G6 supplies as those components each their out-of-warranty status (reminder: the G5 transmitters have a three-month warranty while the G5 receiver has a one-year warranty; G4 trasmitters have a six-month warranty while the receiver is also warrantied for one year).
- Keep ordering from wherever you've been doing that already (ie Dexcom or third-party distributor such as Edgepark, Byrum, etc).
Dexcom's also planning for an international launch in the second half of the year, once the G6 obtains CE Mark regulatory approval.
Cost: In the first day after the FDA approval announcement, Dexcom hadn’t disclosed the pricing details for the G6. That’s a key question of course, especially given the automatic 10-day shutoff that means sensor wear can't be extended to save units and money. Still, Dexcom says the G6 will be more economical – that a box of three sensors lasting 10 days each equates to 30 days overall, compared to the box of four sensors lasting 7 days each, translating to just 28 days total.
Still, that ignores the off-label wear time many Dexcom CGMers have come to rely on. For example: If you get an average of 14 days of wear now, that means a box of four G4/G5 sensors can last a full 56 days. But for the new G6, you are locked into the 30 days for three sensors – a full 26 fewer days on this latest generation!
Many users are looking at the existing $349 retail cost of a box of four sensors now, and clearly wondering how their overall costs for Dexcom use may change.
Medicare Coverage: This remains a pending issue, too. Dexcom obtained Medicare coverage for the G5 Mobile system in 2017, although the Centers for Medicare and Medicaid Services (CMS) refused to allow beneficiaries to use the smartphone app and data-sharing function of the CGM. Dexcom’s been working with the agency and meeting regularly to fix that issue, but it remains unresolved. How this latest “integrated CGM” designation from the FDA on the G6 impacts the discussion is TBD. For now, Medicare folk on Dexcom will stay on the G5 and eventually be transitioned to G6 once that smartphone-capability issue is resolved.
Interoperability and CGM, Redefined
This FDA approval is momentous in how the FDA has re-classified CGM.
For the first time, the FDA has created a new category of device that it refers to as "iCGM," or Integrated CGM – a system designed to connect directly to a compatible smartphone app or wearable device and allow for other devices to work with it.
Regulators have now classified this type of diabetes device as lower-risk, one that can go through a quicker, less-intensive review process. So instead of going through the lengthy evaluation required for higher-risk Class III devices, these newer iCGMs can be classified as "moderate risk" Class II devices as long as they meet special criteria. In doing this, FDA is paving the way for other CGMs and connected D-devices to follow this rapid pathway toward commercialization. In approving the Dexcom G6, the FDA mapped out these special rules in a document that's now available publicly.
“The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “In addition, the FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”
That's huge, Folks! It means that we could see quicker turnaround time for future sensors and closed loop systems in the coming years, as well as data-sharing platforms and updates.
We’re thrilled to see this G6 approval happen so quickly, and are very impressed with how the FDA has once again showed its vision and willingness to get products into the hands of the Diabetes Community as quickly as possible.
As of now, we have three CGMs on the market for diabetes care – this one from Dexcom; the Medtronic products including their pump-integrated Enlite and Guardian 3 and Guardian Connect stand-alone device; and the Abbott Libre Flash. We also are closely watching the 90-day implantable Eversense by Senseonics that is being reviewed by an FDA Advisory panel today, and many others who hope to enter the CGM market.
No doubt, we’ll see a contentious CGM price war materialize soon. And the improved connectivity and data sharing capabilites will also take center stage in people's purchasing decisions.
In the meantime, cheers to Dexcom, the FDA and our D-Community here!
Other G6-related posts from the Diabetes Online Community (DOC):
diaTribe -> FDA Clears Dexcom G6 With No Fingersticks!
Beyond T1 -> Dexcom CEO Explains G6
Diabetes Connections --> Dexcom G6 Approved - Bonus Episode
Juicebox Podcast --> Episode #158
SixUntilMe -> Dexcom G6 Approved by FDA
DiabetesTech blog -> How Might G6 Work for #WeAreNotWaiting Users?
Glu --> FDA Approves Fully Integrated Dexcom G6 CGM
Insulin Nation --> FDA Authorizes Marketing of New Dexcom G6
A Sweet Life --> FDA Approves G6, No Fingersticks Necessary
College Diabetes Network --> Interview with Kevin Sayer on G6
Diabetes Daily --> Dexcom CEO Answers Your Questions About the New G6