Diabeloop announced today that it received CE mark approval for its latest automated insulin delivery (AID) platform, DBLG2.
CE mark approval comes not long after FDA approval in December 2025. The algorithm initially received CE mark last year but now has European approval for compatibility with next-generation devices.
With clearance for DBLG2, integrated with the Dexcom G7 continuous glucose monitor (CGM), the company has kicked off the gradual European launch of the technology. It currently offers DBLG2 as a smartphone application on Android, with iOS integration coming soon.
Grenoble, France-based Diabeloop plans to launch DBLG2 progressively across select European countries along with the ViCentra Kaleido pump. ViCentra announced the immediate availability of its patch pump last month. It also said that beginning with Kaleido, DBLG1 and Dexcom G6 offers the fastest path to Kaleido with DBLG2 and Dexcom G7, when the next-generation pump with the newer algorithm and CGM are available. CEO Tom Arnold explained the company’s plans for a big commercial push with a next-generation pump on the way in an interview with Drug Delivery Business News last year.
Diabeloop also says it plans to make additional configuration for DBLG2 with alternative pumps “available soon.”
Running on a user’s smartphone, DBLG2 works as a self-learning algorithm. It continuously analyzes glucose data, calculates insulin needs in real time and automatically adjusts delivery. This significantly reduces the daily mental burden of diabetes management, the company says. It requires no mandatory meal announcements as well.
“We are thrilled to bring this highly anticipated integration to the European market,” said François Miceli, Diabeloop CEO. “By pairing our DBLG2 mobile algorithm with the advanced accuracy of Dexcom G7, and offering compatibility with ViCentra’s Kaleido and soon other pumps, we are empowering patients with unprecedented choice, discretion, and optimal glycemic control.”
