Diabeloop Obtains CE Marking for Its DBLG1™

Diabeloop Obtains CE Marking for Its DBLG1™

PR Newswire

PARIS, November 12, 2018

PARIS, November 12, 2018 /PRNewswire/ --

The disruptive innovation for autonomous management of T1D  

Diabeloop announced today it has received the CE marking for the DBLG1™, its innovative technological solution to radically improve quality of life for T1D patients through better blood sugar management. This news represents an important step towards the commercial release of the product.  

Developed both for and with the patients, together with a team of engineers and medical researchers, the DBLG1™​ is at the heart of an hybrid closed-loop system integrating powerful algorithms into a secured terminal. Linked to a continuous blood glucose monitoring system and a insulin patch pump, it can predict glucose levels and command the insulin pump at an optimal rate. This self-learning and highly customizable system can reproduce the insulin-dispensing functions of a pancreas and adapt to the patient's physiology and lifestyle.

The Diabeloop device will lighten the heavy mental burden associated with diabetes and prevent both low blood sugar events (hypoglycemia), that are responsible for faintness and sometimes coma in the short term, and hyperglycemia, itself responsible for major complications in the long run. This represents a major breakthrough for the patients, their relatives and health professionals regarding this disease management.

"We​ are proud to have passed the regulatory step of the CE marking. Our commercial deployment will be gradual in order to ensure quality of our product and our service towards the patients. We will also keep working for the reimbursement of our system as soon as possible," said Erik Huneker, co-CEO and founder of Diabeloop.

In Europe, CE marking is an essential stage in the DBLG1™​​System marketing process.

"With​ this certification, we're getting closer to the market launch and will move towards a new funding round to support our international scaling and our ambitious R&D roadmap. We hope to do all that by the second quarter of 2019," added Marc Julien, Diabeloop co-CEO and CFO.

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