The use of a non-marketed medical device is strictly regulated and limited to clinical trials. Diabeloop last clinical trial started in May 2017 in several French University hospitals and will end by the end of summer 2018. Its aim is to assess the system’s safety and performance in order to get CE marking and then go to market in the EU.
NB: As a private company, Diabeloop is not authorised to take part in the selection of the patients. Only healthcare professionals who are responsible for the clinical trials are permitted to do so.
DBLG1 will first be available in France but we plan to launch in several European countries soon after. Subscribe to our newsletter to stay in the loop.
Our medical device will be indicated for adults with Type 1 diabetes and prescribed by a trained diabetologist. We’ll inform you as soon as possible about the procedures to obtain it.
The DBLG1 system will be exclusively indicated for adults. A pediatric version (6-12 years) is currently being developed. Our algorithms have indeed to be adapted to children physiology, along with our software functionalities and ergonomy.
Clinical trials will then confirm it can be used safely by kids and marketed in the EU.
Our system will be provided with all working devices: a CGM, a patch insulin pump and a secured smartphone-like handset. Our engineering team sets each system to make sure the devices are functioning and connected to each other. That’s why you can’t use your own pump or CGM.
However, our research focuses on the integration of other connected devices.