Dexcom Provides Updates on Upcoming CGM Products

As we wrote in our New Now Next column in diaTribe #25, Dexcom is developing several new continuous glucose monitoring (CGM) technologies, including a fourth-generation sensor to replace the current SEVEN PLUS, an integrated pump/CGM in collaboration with Animas, and an integrated pump/CGM with the OmniPod (Insulet). However, in the fall, the FDA requested additional data before approving all these products, causing a delay in their timelines. Now that the companies have (mostly) clarified their next steps, we offer this brief update on their setbacks, their strategies, and ongoing uncertainties.

Dexcom's fourth-generation sensor will be more accurate than the SEVEN PLUS (including 25% better accuracy in the hypoglycemic range), be 50% smaller by volume, have significantly stronger sensor wires, and have a startup time of two hours rather than one hour. Additionally, the sensor will allow for reliable readings sooner after insertion and give the system better chances of lasting a full seven days. Dexcom plans to start clinical trials in the first half of 2011, and the company is hoping to receive FDA approval before the end of the year.

The Animas/Dexcom integrated pump/CGM, which will use the fourth-generation sensor, will be following right behind in the regulatory pathway. The companies plan to start clinical trials for this combination product in mid-2011, as soon as studies for the standalone fourth-generation sensor are finished. Meanwhile, both the fourth-generation sensor and the combination product are already undergoing regulatory review in Europe, where Dexcom and Animas anticipate that they could start selling their integrated devices in the first half of 2011. We're frustrated that both the next-generation Dexcom sensor and the pump/CGM combined product have been delayed in the US.

As for Insulet/Dexcom's combined pump/CGM product, the companies initially submitted a system that pairs Insulet's OmniPod with Dexcom's SEVEN PLUS. In our New Now Next column in diaTribe #28 we reported on Insulet's announcement that due to the regulatory delays, the system would instead feature the smaller next-generation OmniPod and a CGM sensor to be determined by Dexcom. Since then the companies have reframed the situation. In the coming months, Insulet gets to decide whether the companies will resubmit their original combination product (with the first-generation OmniPod and the SEVEN PLUS) or develop a new version that incorporates the second-generation OmniPod and the fourth-generation Dexcom sensor. The next-generation version would probably not receive FDA clearance until after the middle of 2012, while the original combination product could have a shot at 2011 approval. On the other hand, a combination of the current OmniPod and the SEVEN PLUS might not have much appeal in a few years, after Insulet has released its sleeker pod and Dexcom has launched its smaller, more accurate sensor. We expect to learn more in the coming months, and we'll share updates as we learn them on these companies and