Diabeloop wins CE Mark for hybrid closed-loop diabetes management system

Diabeloop won CE Mark clearance in the European Union this month for its hybrid closed-loop diabetes management system, DBLG1.

The Paris-based company hopes to launch its “artificial pancreas” system for adults with Type I diabetes in Europe by the second quarter in 2019.

Diabeloop’s system connects Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitor, Kaleido’s patch insulin pump and an algorithm to a user’s phone, providing glucose measurements every five minutes.

By analyzing data in real time, the system learns and can adapt to a user’s physiology, according to Diabeloop. It also considers the user’s meals and exercise activity to determine the dose of insulin to deliver.

Diabeloop’s system is the first of its kind to win clearance since Medtronic‘s (NYSE:MDT) Minimed 670G was approved in 2016.

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