{"id":45067,"date":"2016-10-19T00:00:00","date_gmt":"2016-10-19T04:00:00","guid":{"rendered":"https:\/\/asweetlife.org\/tandems-tslim-x2-insulin-pump-qa\/"},"modified":"2016-10-31T10:27:31","modified_gmt":"2016-10-31T14:27:31","slug":"tandems-tslim-x2-insulin-pump-qa","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=45067","title":{"rendered":"Tandem’s t:slim X2 Insulin Pump: Q&A"},"content":{"rendered":"

I am notorious for holding out on purchasing a new cell phone because I\u2019m convinced that, the moment I hand over my money for Newest Phone it will immediately become obsolete at the announcement of NEWER PHONE.<\/span><\/p>\n

Which is why I\u2019m so excited about Tandem\u2019s announcement<\/span><\/a> regarding the t:slim X2 insulin pump<\/span><\/a> because the pump software can be updated remotely. \u00a0Which 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\u2019ve cobbled together some Q&A hopefully A\u2019s some of your Q\u2019s.<\/span><\/p>\n

Does the X2 currently work with the Dexcom G4 system?<\/b><\/span><\/p>\n

The X2 currently has the same features as the current t:slim Pump, so it doesn\u2019t 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.)<\/span><\/p>\n

When can users expect the X2 to sync up with the Dexcom G5 system?<\/b><\/span><\/p>\n

The first feature rollout currently planned for the t:slim X2 Pump is expected to be integration with the Dexcom G5\u00ae Mobile CGM system, pending FDA approval. FDA submission for this feature is planned for late 2016, and Tandem anticipates availability in mid-2017.<\/span><\/p>\n

Has the pump body changed at all with the X2?<\/b><\/span><\/p>\n

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<\/a> cases for their t:slim, YAY!)<\/span><\/p>\n

Is there a time frame in place for the PLGS (\u00a0predictive low glucose suspend) update?<\/b><\/span><\/p>\n

As Tandem continues to build on the t:slim X2 platform after Dexcom G5 CGM integration is offered, the next feature they\u2019re 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.<\/span><\/p>\n

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.<\/span><\/p>\n

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<\/span><\/a> from TypeZero<\/span><\/a>, as well as Dexcom CGM technology. To date, TypeZero\u2019s 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.<\/span><\/p>\n

Users will be able to update their pump software remotely with the X2 \u2013 what does that process be like for PWD?<\/b><\/span><\/p>\n

Here\u2019s a little testimonial:<\/span><\/p>\n