If you’ve been considering a new Tandem t:slim insulin pump, this may be your moment to move -- on ordering the next-generation device that can be remotely updated from home just like a smartphone.
The California company announced last week (on 10/4/16) that it will begin shipping its new t:slim X2 model at the end of this month. This launch comes a little more than two months after FDA approval of the new device, which is designed to be the future platform for all Tandem insulin pumps.
The X2 looks and feels mostly the same as the earlier generation of t:slim touchscreen pumps but with three key differences: it has a new anodized housing with satin finish; includes an advanced Bluetooth-enabled receiver allowing for Dexcom G5-compatibly, and most likely compatibility with future Dexcom models; and it's designed to be compatible with the new Tandem Device Updater, that lets users update the device software from home.
This remote updating feature is an industry-first for diabetes devices! It means a break with the traditional path of being locked in to the capabilities of your chosen pump model for 2-3 years at a time, dictated by warranties and insurance coverage. Instead, patients will be able to get the latest tech updates by just plugging the t:slim X2 into a computer via USB port, and accessing the upgrade portal where they can even pick and choose preferred features – from CGM integration to mobile accessibility, and eventually closed loop functionality.
Of course, Tandem also points to benefits its t:slim brand has over competing tubed insulin pumps – 38% smaller than other models on the market, a 300-unit insulin reservoir capacity, rechargeable battery (that can save users money), and a watertight IPX7 construction tested safe in three feet of water for up to 30 minutes.
Upgrade options, costs and other details are all the same as what we originally reported in summer, below:
ORIGINAL TANDEM X2 NEWS POST - PUBLISHED JULY 29, 2016
On Thursday afternoon (7/28/16), Tandem Diabetes Care announced plans to introduce by year's end its next-generation insulin pump platform that will utilize Bluetooth to let users remotely update devices from home, and will eventually enable integration with a smartphone app, Dexcom G5 and G6 CGM sensors, and even closed loop features like predictive glucose suspend.
Say hello to the t:slim X2, coming soon to our Diabetes Community. Being built on a whole new device platform (that will still look like the flagship touchscreen t:slim, of course), Tandem describes the X2 as "the pump of the future -- unlike any other pump on the market."
The announcement came during the California pump company's second-quarter earnings call on Thursday afternoon. This investor call was highly anticipated, as Tandem's had a wave of positive news recently that overlaps with the announcements of its next-gen pipeline:
- Pediatric Approval: FDA has now OK'd Tandem pumps for use among children ages 6 and older, a change from the 12-year-old labeling the t:slim and t:flex have had since launch. This was announced on July 26.
- Closed Loop Partnership: Tandem announced on July 21 that it had licensed the artificial pancreas tech being developed by TypeZero Technologies, which is based off many years of R&D at the University of Virginia. The agreement allows Tandem to help with the R&D clinical work and eventual commercialization of this AP system in the coming years (likely by 2018).
- Remote Device Updater: Tandem announced on July 14 that it received FDA clearance for its new remote updating tool, enabling t:slim and t:flex customers to update their pump software remotely from home, like we do with our smartphones. This is PC and Mac compatible, and starting this summer some original t:slim customers will be part of test groups evaluating the updater; a wider launch is planned for the Fall. The initial version of the updater will allow t:slim customers who got their pumps before April 2015 to update to the latest software that's been built into the pumps since then. **UPDATE: Tandem announced on March 2, 2017 that it was launching the remote updating software for customers who'd bought the t:slim prior to April 2015.
But with all that, no one was expecting to hear news of this brand new t:slim X2 platform, which took center stage on the earnings call and pretty much tied all of the recent Tandem news into an incredibly impressive package.
Along with that came news of an upgrade program, meaning current Tandem users now have no reason to fret about not being included for these next-gen products. Despite issues in the past, they now have a clear pathway forward allowing existing customers to upgrade their devices! We're happy to see the company responding proactively to our D-Community's call for change on that point.
Now for the details of what Tandem has on tap:
- Pronounced just how it looks: t:slim (ex) 2
- Keeps the original aspects of the t:slim color touchscreen, first launched in Summer 2012 and updated with new features in April 2015
- Retains mostly the same look, though we're told it will have a new anodized housing with more of a satin finish
- Offers new hardware advancements that include two-way Bluetooth radio for talking with more than one external device at a time. (Think of it eventually being able to talk with both your G5 and smartphone app at the same time!)
- Shipping will start in the fourth quarter of 2016, so between October and December(!)
- Cost will be equivalent to the current t:slim pump, which goes for the cash price of $4,500 before insurance coverage is factored in (on Upgrade costs, see below)
A big open question for more than a year has been: Will the FDA allow Tandem to turn on the Bluetooth chip inside the original t:slim and t:flex pumps? Or will the company have to develop a whole new device to allow for this wireless communication and eventual CGM and closed loop integration? Apparently, the latter. Tandem's been working on this in the background for that reason specifically. The new X2 will be a Class III device, and Tandem says it won't require a lengthy FDA submission and all that's needed is some internal manufacturing controls that give the company an ability to launch this as soon as it's ready.
No images or conceptual drawings are available yet, we're told, but hopefully we will see some by early Fall. As a reminder, here's what the current t:slim looks like:
X2 will be the next-generation platform that new Tandem technology will all be built on...
T:SLIM X2 + DEXCOM G5
This will be the first new X2 feature rolled out, display Dexcom G5 CGM data directly on the pump screen:
- Tandem's working on an FDA submission before the end of this year, and the company expects a six-month review process, for expected rollout in roughly mid-2017
- This would be the first G5-integrated insulin pump on the market, moving beyond the Dexcom G4 integration that both Tandem's t:slim G4 and the Animas Vibe now offer
- Once Dexcom's G6 is approved by FDA (likely by this time next year), it would only be a matter of FDA filing for Tandem to update their platform to that next-gen sensor -- instead of having to hard-wire the next version of CGM as has been traditionally the case
The mobile app will serve as a tool that bridges the gap between existing devices and next-gen tech.
- Tandem has already kicked off the development of the new smartphone app, with plans to launch in mid-2017
- Tandem says: "Ultimately we want to provide customers with a choice to see integrated pump and CGM information on their pump, their smartphone, or both."
- No word yet on Android comparability in addition to Apple, but we'll press for more details there
PREDICTIVE LOW GLUCOSE SUSPEND (PLGS)
- This would be Tandem's first foray into closed loop tech, using the Dexcom CGM data to predict blood sugars and then shut down insulin delivery if it detects a user is going too low
- This is actually what Medtronic's Minimed 670G hybrid closed loop promises with its next generation, which is currently pending before the FDA and is expected to launch sometime in mid-2017
- Tandem received approval in June to start its investigational study on this PLGS algorithm, with a study completion date set for August. A pivotal study is already planned for the first part of 2017, in hopes of a launch by end of 2017
- If the timelines hold up for both companies, then this t:slim X2 with PLGS would only be a half-year behind the MedT system
The next feature Tandem expects to launch on the t:slim X2 platform is its Treat-to-Target Artificial Pancreas tech recently licensed from TypeZero Technologies.
- This would be a closed loop system using the Dexcom CGM data, adjusting insulin doses to stay targeted on a particular number (instead of within a BG range, like some of the other AP systems in development).
- Pivotal trial work is planned for 2017 with hope for a commercial launch in 2018
UPGRADING TANDEM TECH
Once the t:slim X2 becomes available at the end of this year, the original t:slim pumps won't be sold anymore -- though existing customers will still have access to refurbished replacements if need be. The same goes for the t:slim G4 combo devices, which will be replaced by the G5-integrated version once that's available.
OK, so remember that whole debacle last year when Tandem revealed it wasn't going to allow for device upgrades for people who were already using their technology?
Well, Tandem listened to our community! They've clearly stepped away from that policy, with this announcement being all about making upgrades easy for current t:slim customers.
The new upgrade plan is dubbed the "To-X2" program, allowing both t:slim and t:slim G4 customers access to the latest tech. It runs through Sept. 30, 2017, according to the company website.
For existing t:slim customers, the purchase date will determine the cost:
- Purchased on or after July 1-Dec. 31, 2016 = No cost
- Purchased June 30, 2015 - July 1, 2016; or after Jan. 1, 2017 = $399
- Purchased prior to June 30, 2015 = $799
For t:slim G4 customers:
- A mail-in service program for $399 allows existing customers to have their t:slim G4 retrofit and returned with the same capabilities as the newest t:slim X2 device
- OR users can upgrade to a t:slim X2 for $799
Similar to what other pumps companies have offered in the past, this is essentially an exchange program, where you'd turn in your still in-warranty t:slim or t:slim G4 pumps and get a new X2 device. This also doesn't reset a particular pump's warranty period -- if you have two years left in warranty, and you get a new X2, then you will continue to have two years left on the warranty period.
Unfortunately, this offer doesn't mean anything for t:flex customers who will only have access to the updates on the G5-integrated smartphone app once that's available next year. This offer also isn't good for those on federal and state insurance plans like Medicare and Medicaid.
What's very clear -- and refreshing -- about all of this is that the company heard the concerns of our D-Community and completely reworked their upgrade policy in response.
Thank you, Tandem!
TANDEM'S TUBELESS WEARABLE PATCH PUMP
In case you forgot, Tandem is also working on its own version of a patch pump, the so-called t:sport. We first heard some chatter about this in early 2014 during earnings calls, and then it went off the radar until Summer 2015 when we heard Tandem Diabetes execs talking more about this during the Friends For Life conference. This would be Tandem's version of an OmniPod-like tubeless pump that it describes as a "hybrid" device, and last we heard these were the details so far in the early conceptual phase:
- The t:sport will utilize the same t:slim technology to create a smaller, tubeless, waterproof patch pump
- It's designed for people who want greater discretion and flexibility, no tubing, the ability to deliver insulin without touching the pump
- Tandem anticipates it will include a wireless, touchscreen controller, and a small, waterproof reservoir unit attachable to the skin (like the Pod)
- It will be half the size of the t:slim, with a shorter cannula (of course)
- The insulin reservoir will also be smaller, likely holding 200 units (compared to the 300 in original t:slims and 480 units in the t:flex); Tandem believes this will be popular, given the success Animas had with its smaller 180-unit reservoir size
Now, during the most recent earnings call, Tandem execs explained that they have pushed the t:sport back a bit in the pipeline due to the AP focus and progress, but here's what we know:
Tandem's been talking with FDA about whether a separate controller is needed for this t:sport, or whether it could be controlled by a mobile smartphone app. Based on concerns the FDA seems to have with smartphone control of medical devices, Tandem's taking a two-step approach on this –
- Launch t:sport first with a dedicated controller (similar to what OmniPod has done with its PDM controller)
- Transition that separate t:sport controller to a mobile app, something the company touts is a good option because of its touchscreen user interface
The plan for now is to submit this to the FDA in 2018, with hopefully a short approval process. So while it's not an immediate priority, it's great to know Tandem still has this in the works.
Very exciting updates from Tandem, and we look forward to seeing this product pipeline start materializing soon!