FDA Mulls Endpoints for Trials of Artificial Pancreas Systems

The FDA is finding few answers in its quest to develop guidance on clinical trials for artificial pancreas systems. Following a full day of discussion at a public workshop, the agency remained unclear about endpoints needed to determine the safety and effectiveness of the devices, Chuck Zimliki, chairman of the agency’s Critical Path & Interagency Artificial Pancreas Working Group, said. Consequently, the FDA will likely hold another workshop, specifically dedicated to the algorithms used to control the devices, he said. Then endpoints can be established, and the agency will be able to develop a guidance. However, Zimlicki could not say when the next steps might come.
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