Dexcom management provided a quarterly update as part of their earrings call last week. It contained forward looking statements so take it with that caveat. As far as I am concerned, as the parent of two T1D teens, that is the interesting stuff.
You can play it here: Listen to webcast
- They filed a PMA for the Gen 4 sensor at the end of Q1. Terry Gregg called the product “Truly Remarkable.” They will be presenting details at ADA on June 8. Boy would I like to be there.
- The Gen 4 sensor was said to be better in all respects than the Seven +. He said it would be 20% more accurate in general and 25% more accurate better in hypo range.
- The Gen 4 is said to have better range up to 30 feet than the Seven +. This was reflected in the high number of data captures in the trials.
- The FDA has responded with a “Rapid Responce.” He said that the FDA is doing everything in their power to get the thing through their process. The agency has reached out and Dexcom was clear to give the FDA credit for their efforts in the approval process.
- The Gen 4 is believed to be able to function with reduced calibration needs. Dexcom is exploring how to submit later for lower calibration requirements possibly for Gen 4 or 5. Ultimately the goal of Dexcom is to eliminate the need for calibration but lets be clear that goal not a current expectation of the Gen 4 product.
- The stand alone Gen 4 product is expected to get a CE mark and enter the market in the summer.
- The Gen 4 membrane will be used for the Gen 5 product.
- They may explore trials for approval for a longer life of the Gen 4 sensor. There was extensive conversation around that around the 38 minute mark. I found it fascinating but I’m a little geeky.
- Gen 5 is a connectivity platform; to smart phones, remote monitors and the Tandem and Roche pumps. At about 45 minutes there was more on that, data integrity and conversations with the FDA. Again good geek stuff, actual humans may find it less exciting.
- They are spending R&D to an automated inserter.
- Terry Gregg mentioned and agreement with Qualcomm to integrate GDM into the hub for transmission to the SweetSpot Cloud. Understanding that is probably worth digging around Google from more information.