Tandem Receives FDA Clearance for 480-unit t:flex Insulin Pump

Twitter summary: After lightning quick 2-month @US_FDA review, this 480-unit version of the t:slim is set to launch by June 2015 – a win for ppl w/ high insulin needs

Tandem just announced FDA clearance of the t:flex, a 480-unit of version of its t:slim insulin pump (the original holds 300 units). Tandem plans to launch the t:flex by June 2015 (the month of the big American Diabetes Association meeting), and there has been a webpage up since its approval on January 12 for those who want to be notified when it starts shipping. The t:flex uses the same touchscreen and pump body as the t:slim pump, but with a larger 480-unit cartridge, which makes a lot of sense for those who require over 100 units of insulin a day. The t:flex should help address a growing need for larger insulin pump reservoirs, especially in type 2 diabetes. At the 2014 Diabetes Technology Meeting, Dr. Bruce Bode (Atlanta Diabetes Associates, a practice that is said to have more pumpers than anywhere else in the country) estimated that there are roughly 100,000-150,000 type 2 pumpers in the US, a dramatic increase from around 35,000 only six-to-eight years ago. This number is still low overall, though, compared to the number of people with type 2 diabetes who take insulin at meals.

The results of Medtronic’s OpT2mise trial (published in The Lancet in July, 2014) suggested that insulin pump therapy was superior to taking multiple daily injections (MDI) for people with hard to control type 2 diabetes – participants saw an A1c reduction of 1.1% on an insulin pump vs. 0.4% on MDI from a starting A1c of 9.0%. With research starting to emerge on the benefits of pump therapy in type 2 diabetes (Dr. Robert Vigersky has written a lot about this and CGM in type 2) the launch of Tandem’s t:flex should provide an easier option for insulin delivery in this growing population of those who need it. -AB