If you’re someone who needs more insulin on a daily basis than can be accommodated by a typical insulin pump, then there’s a new diabetes device that could be an option for you!
Say hello to the Tandem Diabetes t:flex insulin pump, just approved by the FDA, that will hold a whopping 480 units of insulin inside — the largest amount of any device on the market to date.
On Monday, Tandem Diabetes announced that the FDA had approved this new larger device (with actualapproval on Jan. 9) — within just 65 days including the holidays since the company filed its paperwork on Nov. 5. That’s significantly shorter than the 90 days it typically takes for this kind of 510(k) submission, in which a new device is pretty much the same as a previously-approved product, with just some minor changes or revisions.
The new t:flex is expected to launch and begin shipping to customers in mid-2015.
So what is the t:flex exactly? It’s pretty much the same as the original t:slim pump from Tandem, but with an expanded insulin cartridge that holds 480 units instead of just 300…
Or, as someone wrote in the diabetes online community post-announcement: “It’s like the Big Gulp of insulin pumps!”
Clearly this t:flex is aimed specifically at those who use a lot more insulin — type 2s, teenagers, and possibly even women who are pregnant and need a higher volume of insulin delivery. Tandem is touting how the t:flex is perfect those who use 100+ units a day, and may therefore find a traditional, smaller pump too cumbersome because they’d have to change cartridges too often.
By comparison, here’s the capacity of other existing insulin pumps on the market:
- Animas Ping/Vibe: holds 200 units
- Asante Snap: 300 units
- OmniPod: 200 units
- Medtronic: 180 units or 300 units
- Roche Accu-Chek Combo Spirit: 315 units
- Tandem t:slim: 300 units
Due to the larger insulin reservoir, the t:flex has an expanded “bump” on the back side (as seen below), which Tandem tells us doesn’t add much in size to the new device but does add a little weight to it overall. Still, it remains smaller than even the current Medtronic 5-series pump that holds 300 units. It also uses different, larger cartridges that are not interchangeable with those used with the regular t:slim.