Diabeloop Obtains CE Marking for DBLG1
Diabeloop, a French medical technology company that specializes in creating accessible innovations for the type 1 diabetes community, has obtained CE marking for its DBLG1TM System. In Europe, CE marking is an essential stage in the marketing process, as it indicates a company’s conformity with health, safety and environmental protection standards for European products.
The product allows patients with type 1 diabetes (T1D) to better manage blood sugar and this news marks a big step in the direction towards the product’s release.
“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,” said Marc Julien, Diabeloop co-CEO and CFO.
DBLG1TM was developed not only for patients, but with them, and functions thanks to a hybrid closed-loop system utilizing well-built algorithms. Conceived as a result of a research project on the artificial pancreas, the DBLG1TM System is a self-learning device that loops in AI technology to better serve diabetes patients. The device, worn externally, consists of a continuous glucose monitor (CGM), a patch insulin pump and a smartphone type terminal that operates as a user interface.
Because it is linked to the continuous blood glucose monitoring system and insulin patch pump, it can predict blood glucose levels and command the insulin pump at an optimal rate. The system is uniquely customizable and seeks to reproduce the insulin-dispensing tasks of a pancreas so as to adapt to the physiology and lifestyle of every patient with T1D.
A blood glucose result is sent to the patient via Bluetooth technology every five minutes, allowing the DBLG1TM to analyze collected data in real time to ensure the proper amount of insulin is administered. This new technology puts AI at the forefront of diabetes maintenance and blood glucose monitoring.
“We are proud to have passed the regulator 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,” added Erik Huneker, co-CEO and founder of Diabeloop.
Diabeloop is convinced the device will be life-changing not only for those living with diabetes but for their loved ones as well. It will ideally prevent both low blood sugar situations (hypoglycemia) from occurring, as these are responsible for faintness and sometimes coma in the short term, as well as hyperglycemia, which is often responsible for extensive medical complications.
In addition to allowing for better glycemic control, the DBLG1TM System will alleviate the mental pressure experienced everyday by those with diabetes who are forced to make so many difficult decisions on their own. This lightening of the mental burden represents a huge breakthrough for patients, their relatives and professionals regarding the management of T1D.
Diabeloop feels it is closing in on its mission: allowing for those who live with diabetes to be more socially and professionally active than ever before, and ultimately live the lives they truly want.