Tandem announced today that the NIH-funded International Diabetes Closed Loop (IDCL) Trial will start later this year and serve as a pivotal study of its second-gen automated insulin delivery system: a Dexcom G6 sensor-integrated t:slim X2 pump that incorporates TypeZero’s inControl algorithms directly into the touchscreen pump (basal modulation, and notably, automatic correction boluses). An FDA filing is expected in late 2017, and following an expected ~12 month PMA review process, the integrated device is still expected to launch by the end of 2018. We reported in January that this study was designed with a PMA filing in mind, though today is the first time Tandem confirmed it will indeed support an FDA submission of the fully integrated commercial device. And since it’s an NIH-funded study ($12.7 million), Tandem will benefit big time from not having to fund the cost of the 240-patient, ten-site study – what a coup! The initial phase of the study is called a “Research Site Training Protocol” (n=20) on ClinicalTrials.gov and will use a smartphone running the TypeZero inControl algorithm, a Tandem pump, and Dexcom’s G5; the hardware will be updated in 2017 with the fully integrated system. We’re glad to see NIH set it up in these two phases, allowing the team to begin gathering early data before the integrated product is ready. Dexcom’s EVP Steve Pacelli was quoted in today’s press release (a nice vote of confidence as it has shifted some focus to MDI), as was TypeZero CEO Chad Rogers and IDCL PI Dr. Boris Kovatchev. Overall, this is outstanding news for Tandem, given the tough 3Q16 it reported last week in the face of competitive headwinds from Medtronic and other forces. We’re glad to see many players in the automated insulin delivery race, since the field must have a thriving commercial market to give patients many device options.
- As an aside, we confirmed the trial will not use Cellnovo’s pump in the US as had previously been expected. The TypeZero/Cellnovo partnership was announced in February at ATTD 2016, but we assume FDA wanted to see one study pump tested for PMA filing purposes. Plus, Cellnovo is not cleared in the US.
- Nearer term, Tandem expects to run a pivotal of its t:slim X2 with predictive low glucose suspend in 1Q17, enabling an expected US launch by the end of 2017. Tandem anticipates a rapid six-month review for this first-gen algorithm because it will come on the heels of an FDA review of the t:slim X2 with G5 CGM integration – the only addition is the PLGS algorithm. Plus, it follows a three-month review for the MiniMed 670G hybrid closed loop. More details in our 3Q16 report.
- Tandem expects t:slim X2 users will be able to software update their pumps to add the PLGS and TypeZero algorithms in the future. We are major fan of this approach and salute Tandem for making it possible – it will de-risk the difficult task of deciding what pump to get at what time. Plus, patients will get new updates delivered within the four-year warranty without paying expensive upgrade fees for new hardware.
-- by Adam Brown and Kelly Close