Diabeloop has secured CE mark for the DBLG1, its technological solution designed to enhance quality of life for T1D patients via 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.
Diabeloop co-CEO and founder Erik Huneker said: “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.”
In Europe, CE marking is an essential stage in the DBLG1 system marketing process.
Diabeloop co-CEO and CFO Marc Julien said: “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.”
Source: Company Press Release