|Connected insulin patch pump--Courtesy of Cellnovo|
Paris-based Cellnovo Group ($CLNV) has partnered with TypeZero Technologies to be part of a previously announced clinical trial of an artificial pancreas that's being backed by a $12.8 million grant from the U.S. National Institutes of Health. Cellnovo's connected insulin patch pump will be used in conjunction with TypeZero's inControl AP software and a Dexcom ($DXCM) continuous glucose monitor to form the whole of the artificial pancreas system being tested.
The timeline of the trial has been kicked back a bit. It had been slated to start early this year, but now the partners have said it won't begin until the second half of 2016. An artificial pancreas would offer diabetics the means to both continuously track their blood glucose levels and then receive insulin automatically based upon that data. Previous studies have found that this sort of approach enhances the ability of Type 1 diabetics to maintain proper blood glucose levels.
"This is an important milestone as it will be the first time our diabetes management system will be used by American patients taking part in this leading research programme," said Cellnovo CEO Sophie Baratte in a statement. "The Cellnovo Diabetes Management System is the ideal platform for artificial pancreas system development because of its real-time connected data, as well as its wearability and discreetness."
The trial is dubbed the International Diabetes Closed Loop Trial (IDCL), given that it will be conducted at 10 sites in the U.S. and Europe including the University of Virginia School of Medicine, where TypeZero's inControl AP platform was developed initially at the Center for Diabetes Technology, in addition to the Barbara Davis Center for Diabetes at The University of Colorado, Harvard University, the Mayo Clinic, Mount Sinai School of Medicine, Stanford University, the William Sansum Diabetes Research Center, University of Montpellier in France, University of Padova in Italy and the Academic Medical Center at the University of Amsterdam in the Netherlands.
The trial is slated to enroll 240 adult Type 1 diabetics. In will run for 6 months and then continue for an additional 6 months in a subset of 180 patients, TypeZero has said previously. The first trial will compare the artificial pancreas to a control of a standard insulin pump to comparatively assess how well blood-sugar levels are controlled and whether the risk of hypoglycemia was reduced. The second one will be to test the adaptive control algorithm.
On the addition of Cellnovo to the artificial pancreas clinical testing, TypeZero founder and CEO Chad Rogers said, "The integration of Cellnovo's insulin patch pump with our inControl AP platform is a tremendous step forward for this artificial pancreas product. We believe that patients should have the choice of using the insulin delivery device that best suits their needs and lifestyle."
He continued, "We look forward to bringing this solution to patients in the upcoming IDCL trial as well as other studies throughout 2016-2017."
- here is the announcement