[Disclosure: I have a relationship with Tandem Diabetes Care that is outlined here. Bias noted? Good. Read on, then.]
I am notorious for holding out on purchasing a new cell phone because I’m convinced that, the moment I hand over my money for Newest Phone it will immediately become obsolete at the announcement of NEWER PHONE.
Which is why I’m so excited about Tandem’s announcement regarding the t:slim X2 insulin pump because the pump software can be updated remotely. Which means that when new software comes out, I can gain access to it from my house instead of having to wait and negotiate with my insurance company, etc. I wanted to share details on the t:slim X2 and create a sort of blog post clearing house for questions that I have (and that folks in the DOC have asked about), so with the help of the Tandem team and public-facing information (press releases, FAQs on their website, etc), I’ve cobbled together some Q&A hopefully A’s some of your Q’s.
Does the X2 currently work with the Dexcom G4 system?
The X2 currently has the same features as the current t:slim Pump, so it doesn’t work with the Dexcom G4 system. However, the demand will hopefully be high for the t:slim X2 insulin pump when Tandem rolls out the first major software update for G5 CGM integration, so they have an upgrade program in place for t:slim and t:slim G4 customers. (See more below for info on the upgrade program.)
When can users expect the X2 to sync up with the Dexcom G5 system?
The first feature rollout currently planned for the t:slim X2 Pump is expected to be integration with the Dexcom G5® Mobile CGM system, pending FDA approval. FDA submission for this feature is planned for late 2016, and Tandem anticipates availability in mid-2017.
Has the pump body changed at all with the X2?
For all practical purposes, no. The X2 is the same size and shape as the t:slim pump. It has a durable aluminum housing and will be compatible with all accessories designed for the t:slim Pump. (For those who have invested in ten thousand Myabetic cases for their t:slim, YAY!)
Is there a time frame in place for the PLGS ( predictive low glucose suspend) update?
As Tandem continues to build on the t:slim X2 platform after Dexcom G5 CGM integration is offered, the next feature they’re planning to launch on the X2 is a predictive low glucose suspend algorithm. This will be their first-generation artificial pancreas product. The IDE for a feasibility study has been approved by the FDA and the study is scheduled to be completed in August. Tandem expects to file another IDE for a pivotal study in early Q4 and, based on the typical review timing, anticipate that the study will take place in Q1 2017.
The goal to launch PLGS by the end of 2017 remains unchanged. Tandem anticipates a six-month review process for this first-generation pump algorithm because it will come on the heels of an FDA review of the t:slim X2 with G5 CGM integration. The only differing feature will be the algorithm. The X2 plus PLGS, with all the features and benefits of t:slim, will be competitive with other AP pump offerings as it predicts hypoglycemia, which poses the greatest risk for people with diabetes.
The second-generation AP pump algorithm will also be based on the t:slim X2 platform and will include the treat-to-target AP technology that Tandem recently licensed from TypeZero, as well as Dexcom CGM technology. To date, TypeZero’s technology has been used in more than 28 clinical studies with more than 475 people, with data referenced in a number of journal articles. They anticipate that this agreement will allow Tandem to remain on schedule for a pivotal trial in 2017, followed by commercial launch in 2018.
Users will be able to update their pump software remotely with the X2 – what does that process be like for PWD?
Here’s a little testimonial:
For pumpers already on the t:slim, what are their upgrade options?
Online here: www.tandemdiabetes.com/upgrade
t:slim Pump customers who received their pump on or after July 1, 2016: Any customer who received a t:slim Pump on or after July 1, 2016 qualifies for a new t:slim X2 Pump at no cost. The no-cost upgrade is set to expire at the end of 2016. If folks choose to upgrade after December 31, 2016, they will still have the option for a fee of $399. Interested customers should visit www.tandemdiabetes.com/upgrade and complete the “Get Started” form or contact Tandem directly at (877) 801-6901.
t:slim Pump customers who received their pump before July 1, 2016: Any customer who received a t:slim Pump before July 1, 2016 qualifies for a new t:slim X2 Pump for either $399 or $799 depending on their date of purchase. Interested customers should visit www.tandemdiabetes.com/upgrade and complete the “Get Started” form or contact Tandem directly at (877) 801-6901.
t:slim G4 Pump customers: t:slim G4 Pump customers do not qualify for a free upgrade, but do have upgrade options available to them ranging between $399 and $799. Interested customers should visit www.tandemdiabetes.com/upgrade and complete the “Get Started” form or contact Tandem directly at (877) 801-6901.
t:flex Pump customers: t:flex Pump customers do not qualify for an upgrade to a t:slim X2 Pump, since it is prescribed specifically for its larger insulin capacity. Any change from a t:flex Pump to one with only a 300-unit insulin capacity will required a change in prescription and likely proof of medical necessity for their insurance company.
Note: These t:flex Pump customers could also opt for the 30-day return policy if they bought within the appropriate window and choose a pump with an upgrade path, if their healthcare provider feels this is a better long-term solution for them.
Once Tandem has the Dexcom integration and AP features, will it still allow you to use the Share/Follow apps on your phone?
From what I last heard, Tandem is working on a mobile app for use with all Bluetooth-enabled Tandem pumps, with the goal of providing their customers the option to see integrated pump and CGM information on their pump, their smartphone, or both. Rumor has it that Tandem is also in discussions with Dexcom to determine the best way to integrate pump information from the Tandem App with CGM information from their next-generation CGM display app.
Is there any information on the little asterisk and note in regards to the remote update of software for a fee? Will there be a fee involved to update?
Dexcom G5 CGM integration will be provided to all t:slim X2 Pump users at no charge. It seems that Tandem anticipates that some feature rollouts will be at no cost for in-warranty customers and that they might charge for others. The determination regarding cost will be made individually for each software update.
How can new pumpers/pumpers looking to switch get more information?
Here is the information page on the Tandem website.
New Pumpers, feel free to contact Tandem at (877) 801-6901, Monday-Friday 6am-5pm Pacific Time, or visit the Tandem website at:www.tandemdiabetes.com/getstarted
Pumpers looking to switch, feel free to contact Tandem at (877) 801-6901, Monday-Friday 6am-5pm Pacific Time, or visit their website and fill out the Get Started form.