As we recently posted, members of the JDRF Clinical Panel along with fellow diabetes experts met at the FDA Artificial Pancreas Workshop last week to discuss clinical recommendations for artificial pancreas testing outside of the hospital and in the real world.

The meeting marked an impactful step toward the development of an artificial pancreas, which may improve the lives of the millions of people living with type 1 diabetes. To date, artificial pancreas systems have not been tested outside of a hospital setting. To help speed the process for outpatient testing to begin, the panel proposed several clinical recommendations for safely testing and delivering these systems to patients. They included recommendations for the following:

• how artificial pancreas systems studies should move safely from inpatient (hospital) settings to outpatient (real-world) testing.

• which patients should be considered when testing artificial pancreas systems.

• how to ensure the safety of patients participating in the studies and eventually for everyday use. 

• what outcomes should be measured in studies to demonstrate the safety and effectiveness of the device.

JDRF has posted a summary of the panel’s recommendations and the FDA has posted a recording of the workshop webcast for anyone seeking more details.  Furthermore, a detailed overview about the Artificial Pancreas Project, including latest news and updates, is available on the JDRF website.