The closed-loop artificial pancreas, which combines an insulin pump with a glucose monitor, has been successfully tested on people in controlled hospital settings. Now, researchers believe that it is time to try this innovation in real-life environments.
Last summer, JDRF formed a panel of experts to provide advice about how to bring this technology out of the hospital and in to the homes of people with diabetes. Their conclusion: proceed carefully, but do proceed. “The panel believes, with certain safeguards, artificial pancreas systems can be safely tested in real-world settings,” says the chair of the panel, Robert Sherwin, M.D., of Yale University School of Medicine.
To move the testing forward, the panel identified which subset of patients should be considered when testing artificial pancreas systems. They also identified what outcomes should be measured in the studies to demonstrate the safety and effectiveness of the device. The panel presented its findings at a public scientific workshop in November 2010 hosted by the Food and Drug Administration (FDA) and the National Institutes of Health.
“We believe a safe and effective first-generation artificial pancreas system is possible with today’s technology, even as we continue to encourage development of improved devices. We think it’s critical that the FDA adopt the recommendations of this expert panel to provide a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients,” says Jeffrey Brewer, president and CEO of JDRF.
For more information on the panel recommendations, please see: CLINICAL RECOMMENDATIONS PANEL ON CLOSED-LOOP SYSTEMS Preliminary Summary of Recommendations