Cellnovo (EPA:CLNV) and Diabeloop said this week they are launching a CE Mark cross-over registration study for an artificial pancreas device Diabeloop is developing which uses Cellnovo’s insulin pump.
The registration study aims to generate appropriate security & safety data as the company seeks CE Mark approval for the Diabeloop artificial pancreas combined with Cellnovo’s CGM some time in 2018, the companies said.
Results from an initial 36-patient, 3-day trial of the Diabeloop algorithm combined with the Cellnovo pump reported “positive” outcomes, according to a press release. The newly launched study will look to enroll 60 patients at 12 centers in France, with results hoped for before the end of 2017.
“We are very pleased with the progress our Artificial Pancreas system is making in collaboration with our partner Cellnovo. This Regulatory Clinical Study is designed to bring enough data from 12 centres to file for a CE Mark registration in 2018. We are proud to be developing an Artificial Pancreas technology that will considerably improve the quality of life of Type 1 diabetes patients,” Diabeloop CEO Erik Huneker said in a prepared statement.
“Alongside our French partner, Diabeloop, we have made significant progress in the development of this Artificial Pancreas solution and we remain confident in our ability to have this product available for patients in Europe in 2018. Our activities in this field should position Cellnovo as a major player in artificial pancreas,” Cellnovo CEO Sophie Baratte said in a press release.