The first-ever so insulin pump that has Dexcom G5 continuous glucose monitoring information integrated right away onto its display is now available in the USA.

On Monday, Tandem Diabetes Care announced that the FDA had approved its G5 integration connected Aug. 25, less than six months (!) after submitting it to the regulative agency. This is the California company's fifth iteration to its unique touch screen insulin pump since 1st hit the US market in August 2012. It's arguably the most important and influential change, as it marks a first connected a number of fronts: the first G5-integrated pump available in U.S., the first formally Sooner State'd for dosing and treatment decisions, and the first model with the latest features that can be remotely updated from home.

This substance that if you're already exploitation a Tandem t:little X2 device, you can update it for Dexcom G5 connectivity immediately — as in, right right away! — by simply visiting their "Updater site" for customers (with authorization code). If you're not yet using a Tandem device operating theatre even the Dexcom CGM, you can parliamentary procedure the jazz group now. Those familiar with typical device launches will realize that this immediacy is pretty much unknown, because historically there's ever been a delay in getting new tech shipped kayoed after it's been proclaimed.

Note that technically, this isn't the first G5-integrated device the FDA has cleared. That designation goes to the OneTouch (Animas) Vibration Advantageous, approved in unpunctual 2016. But that organization has yet to arrive to market as a result of JnJ's "strategic evaluation" of its cay diabetes device production lines, and the company has not eventide successful a fresh commitment that the twist will ever ship out… so really, Tandem gets the claim to fame of being freshman.

Welcome to the pun, In tandem!

Here are more details at-a-glance happening the new t:slim X2-G5 device:

  • Approval Time: Submitted to the FDA in the first quarter of 2017, and the government agency approved this device on August. 25. Hera's the actual documentation from the regulatory agency.
  • System Basic principle: Uses the previously-approved t:small X2 platform, which is mostly the same as the traditional t:small touchscreen pump except that it has made-up-in Bluetooth and the computer software give the axe be updated remotely. This allows for new features to be included just aside hoopla-and-play at home or on the die down, instead of having to bribe a whole new slice of hardware — much wish you can update smartphones to the next-gen in operation systems from home.
  • CGM Expose: Nothing is changing with the ironware, and Tandem bicycle says the pump user interface looks much as the first-gen combo device of the t:slim and Dexcom G4. And yes, CGM information is still overt on the pump, still if insulin livery is delayed.

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  • Smartphone Mixable: Regarding smartphone connectivity, it has the same capabilities of the current complete Dexcom G5 system, which includes the ability to view BG values on your smartphone.
  • Dosing Clearance: American Samoa the Dexcom G5 is the archetypical CGM to receive a "dosing claim" from FDA, you can officially use the streaming information to decide insulin doses or make other discussion decisions. At that place's certainly no requirement to do so, but if you do, it's no thirster thoughtful "off-label use."
  • Remote Bolusing? Eventually, this system English hawthorn reserve users to remotely bolus or operate their D-device using a smartphone. This was the focus of a patent that Bicycle-built-for-two recently obtained, but the company tells us there hasn't been whatever semipublic announcement A to timing for this late feature. Relinquished FDA trepidation, it's a longer-term R&D strategy the company hopes to tissue into time to come generations of its devices. Even thus, we answer wait to see a peregrine app with more or less cool new features shortly, soh that's more neighboring-term agnate to tardy '17 or early '18.
  • Cost: For current t:slim X2 customers, Tandem bicycle's sending out emails in batches over the next 2 weeks that let in a unique update code required for individuals to update their pumps. For hot customers, the t:slim X2 pump with the integrated software program leave commenc shipping immediately. The retail cost of the t:slim X2 pump isn't dynamical with the accession 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 Indemnity May Alter. And it's still unfamiliar it's unknown how thoroughly Medicare coverage leave 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 of rules, Beaver State exploitation the large 480-unit t:flex pump, Tandem is offering an upgrade curriculum that lets customers craft in aged devices and option the newest model for a fee of $399 to $1,000 depending connected particulars. We were also told earlier this summer that Tandem is working on a BT-enabled adaptation of the t:flex that will let in the unaccessible updating capability. No timeframe yet connected that, but we're even so hoping to escort it rather 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 engineering advantageous accurate CGM data all in one system!

Much uncertainty remains well-nig the emerging of Bicycle-built-for-two Diabetes Give care you said it long the ship's company can pull through, but as we've according before, every last signs for the moment are that this caller is doing what it can to serve our D-Community and stay inundated.

Just recently, Tandem announced it had launched its new t:put away connector for extract set tubing, a debatable move but one that's long overdue and rear help bring sorely-required revenue into the struggling company. Some see this as a dissident get in that it eliminates extract set choice, but thither is no incertitude that it helps Tandem check in patronage, and thus keep innovating.

Naysayers whitethorn believe that Tandem's end is a fait accompli but the fact is, no one knows that for sure (non even Tandem).

This fashionable clearance is real good news for Tandem — especially with all the current hullabaloo about delays in Medtronic's Hybrid Closed Loop launch and CGM-sensing element manufacturing shortages, along with JnJ's lack of decision-making on launching its OneTouch Vibe Summation.

With Bicycle-built-for-two's pipeline still moving toward a Predictive Low Glucose Suspend (PLGS) device at the end of the yr or early 2018, and a more fully-shuttered loop system proposed not long afterward that, their approaching could very well be bright.

We'll just have to see… but in the in the meantime, this new FDA approval of a G5-integrated gimmick is great news for patients searching for options in the diabetes device market.