The first-ever insulin pump that has Dexcom G5 continuous glucose monitoring data integrated directly onto its display is now available in the USA.
On Monday, Tandem Diabetes Care announced that the FDA had approved its G5 integration on Aug. 25, less than six months (!) after submitting it to the regulatory agency. This is the California company's fifth iteration to its unique touchscreen insulin pump since first hitting the US market in August 2012. It's arguably the most important and influential change, as it marks a first on a number of fronts: the first G5-integrated pump available in the States, the first officially OK'd for dosing and treatment decisions, and the first model with the latest features that can be remotely updated from home.
This means that if you're already using a Tandem t:slim X2 device, you can update it for Dexcom G5 connectivity immediately -- as in, right now! -- by simply visiting their "Updater site" for customers (with authorization code). If you're not yet using a Tandem device or even the Dexcom CGM, you can order the combo now. Those familiar with typical device launches will recognize that this immediacy is pretty much unheard-of, because historically there's always been a delay in getting new tech shipped out after it's been announced.
Note that technically, this isn't the first G5-integrated device the FDA has cleared. That designation goes to the OneTouch (Animas) Vibe Plus, approved in late 2016. But that system has yet to make it to market as a result of JnJ's "strategic evaluation" of its key diabetes device product lines, and the company has not even made a firm commitment that the device will ever ship out... so really, Tandem gets the claim to fame of being first.
Welcome to the game, Tandem!
Here are more details at-a-glance on the new t:slim X2-G5 device:
- Approval Time: Submitted to the FDA in the first quarter of 2017, and the agency approved this device on Aug. 25. Here's the actual documentation from the regulatory agency.
- System Basics: Uses the previously-approved t:slim X2 platform, which is mostly the same as the traditional t:slim touchscreen pump except that it has built-in Bluetooth and the software can be updated remotely. This allows for new features to be included just by plug-and-play at home or on the go, instead of having to buy a whole new piece of hardware -- much like you can update smartphones to the next-gen operating systems from home.
- CGM Display: Nothing is changing with the hardware, and Tandem says the pump interface looks very much like the first-gen combo device of the t:slim and Dexcom G4. And yes, CGM data is still visible on the pump, even if insulin delivery is suspended.
- Smartphone Compatible: Regarding smartphone connectivity, it has the same capabilities of the current stand-alone Dexcom G5 system, which includes the ability to view BG values on your smartphone.
- Dosing Clearance: As the Dexcom G5 is the first CGM to receive a "dosing claim" from FDA, you can officially use the streaming data to determine insulin doses or make other treatment decisions. There's certainly no requirement to do so, but if you do, it's no longer considered "off-label use."
- Remote Bolusing? Eventually, this system may allow users to remotely bolus or operate their D-device using a smartphone. This was the focus of a patent that Tandem recently obtained, but the company tells us there hasn't been any public announcement as to timing for this new feature. Given FDA trepidation, it's a longer-term R&D strategy the company hopes to weave into future generations of its devices. Even so, we do expect to see a mobile app with some cool new features before long, so that's more near-term related to late '17 or early '18.
- Cost: For current t:slim X2 customers, Tandem's sending out emails in batches over the next 2 weeks that include a unique update code required for individuals to update their pumps. For new customers, the t:slim X2 pump with the integrated software will begin shipping immediately. The retail cost of the t:slim X2 pump isn’t changing with the addition of the integrated software. The only incremental cost would be for the additional Dexcom G5 CGM supplies if the customer doesn't already use it. As with everything in diabetes, Your Insurance May Vary. And it's still unknown it's unknown how good Medicare coverage will be for this system, with lots of open questions on government-funded plans at the moment.
- Upgrading Older Models: For those on the earlier-gen t:slim-G4 system, or using the larger 480-unit t:flex pump, Tandem is offering an upgrade program that lets customers trade in older devices and option the newest model for a fee of $399 to $1,000 depending on particulars. We were also told earlier this summer that Tandem is working on a BT-enabled version of the t:flex that will include the remote updating capability. No timeframe yet on that, but we're still hoping to see it sooner rather than later in 2018.
This is huge news, and it's been a long time coming for those in the Diabetes Community hoping to get their hands on the latest insulin pump technology plus accurate CGM data all in one system!
Much uncertainty remains about the future of Tandem Diabetes Care and how long the company can survive, but as we've reported before, all signs for the moment are that this company is doing what it can to serve our D-Community and stay afloat.
Just recently, Tandem announced it had launched its new t:lock connector for infusion set tubing, a controversial move but one that's long overdue and can help bring sorely-needed revenue into the struggling company. Some see this as a negative move in that it eliminates infusion set choice, but there is no doubt that it helps Tandem stay in business, and thus keep innovating.
Naysayers may believe that Tandem's end is a fait accompli but the fact is, no one knows that for sure (not even Tandem).
This latest clearance is very good news for Tandem -- especially with all the current hullabaloo about delays in Medtronic's Hybrid Closed Loop launch and CGM-sensor manufacturing shortages, along with JnJ's lack of decision-making on launching its OneTouch Vibe Plus.
With Tandem's pipeline still moving toward a Predictive Low Glucose Suspend (PLGS) device at the end of the year or early 2018, and a more fully-closed loop system planned not long after that, their future could very well be bright.
We'll just have to see... but in the meantime, this new FDA approval of a G5-integrated device is great news for patients searching for options in the diabetes device market.