Tandem gains FDA approval for CGM-integrated insulin pump

The t:slim G4 Insulin Pump--Courtesy of Tandem

Johnson & Johnson ($JNJ) made a big splash in November when it garnered FDA approval for its integrated insulin pump-continuous glucose monitor device, the Animas Vibe. Now small-cap Tandem Diabetes Care ($TNDM) has nabbed the next nod from the agency for an insulin pump with an integrated CGM, the t:slim G4 Insulin Pump.

Both the Animas and the Tandem CGM-pumps rely upon Dexcom's ($DXCM) continuous glucose monitoring technology. But unlike the Vibe, the Tandem device has a touch screen on its handheld monitor.

Neither the Vibe nor the t:slim G4 enable automatic adjustment of insulin levels based on CGM data--the holy grail for all-in-one diabetic devices--they offer only user alarms and alerts. And neither replaces a dedicated hand-held control with a smartphone, like Dexcom's latest CGM device.

Enabling automatic insulin adjustment and replacing the controller with a smartphone app are goals for future device iterations. In July, Tandem extended its partnership with Dexcom to enable future iterations of the t:slim device, G5 and G6, with a CGM component.

Tandem President and CEO Kim Blickenstaff commented on an August earnings call about Animas Vibe sales so far, "Well, within our range of expectations as to how we thought it would do, I don't know that I've heard that they've quantified how well it's doing."

"But it is serving a niche, and it is serving a patient population that does want that feature, which is why we're in that race to be the second to market with an integrated product with Dexcom. So I think the Vibe is doing, from what we can tell and what we hear from them, it's doing well. But it hasn't hurt our numbers," he added.

The t:slim G4 Insulin Pump will start to ship in October; it's approved for use by diabetics 12 years or older who rely on insulin. The device can operate as a standalone insulin pump, if the patient prefers. But when used with the CGM it tracks glucose continuously and notifies the user when glucose levels rise or fall to preset levels. It's the slimmest and smallest insulin pump on the market, according to Tandem, and holds up to 300 units of insulin.

Tandem was up 5% in early trading on the approval news, but remains down by 2% for the year with a market cap of almost $375 million.

- here is the approval announcement
- see the August Tandem earnings transcript