NIH Commits $20 Million for Pivotal Artificial Pancreas Studies
Twitter summary: NIH commits $20 million for outpatient artificial pancreas studies for potential FDA submission – a big step that speaks volumes
On July 21, the NIH announced a major initiative to commit $20 million to fund home studies of artificial pancreas devices; the goal is to generate data for regulatory agencies like the FDA. Any organization is eligible to apply for the one to three awards available, including for-profit businesses, academic institutions, non-profits, foreign organizations, and governments. We’re not positive, but based on the NIH’s wording, the studies that are ultimately funded could provide the data for FDA approval of an artificial pancreas device. However, the criteria for proposed trials are fairly general and do not provide specific insight as to what these studies will look like – we imagine the NIH wanted to keep this open. As a reminder, the FDA’s final Artificial Pancreas Guidance is also highly flexible and does not provide a detailed template for how companies and researchers should design artificial pancreas pivotal studies. We would assume studies to support approval of an artificial pancreas will last a minimum of three or six months in at least 100 patients.
The NIH has been a major funder of artificial pancreas trials, with over $100 million committed over the past decade – we thank the US government agency for being so forward looking and for working to support and ensure patient safety while moving things on this front forward. Their funding includes resources for exciting research conducted by the Bionic Pancreas group at Boston University/MGH, the UVA closed-loop trials, Xeris’ work on a stabilized glucagon, and more. To learn more about research on the artificial pancreas, please visit our resource page at diaTribe.org/artificialpancreas. This is exciting, cutting edge work and although big safety questions exist as with all potentially transformational research, we are excited to see NIH moving this ahead and will keep close watch on who garners these funds. –NL/KC