Dr. Ed Damiano Presents Encouraging Data on two Bionic Pancreas studies at Carb DM’s Second Anniversary
By Kelly Close
On November 1, Dr. Ed Damiano presented results from the Beacon Hill study and Summer Camp study of the bionic pancreas at Carb DM’s Second Anniversary. For more information on the bionic pancreas, please read the test drive by Editor-in-Chief Kelly Close and our learning curve of the camp study. Although results cannot be disclosed because they have been submitted for publication, the data created a lot of excitement in the room. Data like these have never been seen before in type 1 diabetes from any system or therapy – they translate to major reductions in A1c, an increase in “time in zone,” and less hypoglycemia. As we heard at the gathering – “This [data] crushes usual care!”
During the talk, Dr. Damiano was especially optimistic regarding Xeris’ work on making a stable glucagon that does not have to be mixed prior to use (read our new now next about their work here). We look forward to hearing more about commercialization and what will be needed for this system. Currently, the need for a stable glucagon that can be used in a pump is a key roadblock to the development of the bionic pancreas (in the trial, new glucagon was used daily, which would be impractical and expensive in real life). The other necessary innovation is a dual hormone insulin pump, a project that Tandem Diabetes Care is actively working on in partnership with JDRF.
The next trial of the bionic pancreas will be a multi-center Hospital Staff study starting in 2014–staff wearing the bionic pancreas for 12 days will sleep at home and go to work as usual. Another camp study for 6-12 year olds is planned for next summer. Larger pivotal trials are planned for 2015-2016, and if all goes as planned, the team would then submit the device in late 2016 for FDA approval. Dr. Damiano’s ultimate goal is to bring the bionic pancreas to market by the fall of 2017, when his son with type 1 goes to college. This is certainly an ambitious timeline and a lot of things will have to go right for success, but after seeing the data, there is no question that there is much to look forward to. –KC/NL