FDA issues draft guidelines on artificial pancreas

The Food and Drug Administration (FDA) in the United States has issued draft guidelines on the development and manufacture of an artificial pancreas to help ensure it effectively help patients with type 1 diabetes manage their blood sugar levels.
The guidelines, aimed at researchers and manufacturers working on the device, provide advice and flexibility on how it can closely and continually glucose levels in a similar way to a real pancreas, as well as ensuring an insulin pump delivers the correct amount of hormone.
The artificial pancreas operates by connecting up its monitoring system with a computer, which calculates the best insulin dose, sending a signal to the pump to deliver the required amount.
The FDA argue that it is critical that current clinical trials move to an outpatient environment to assess how well the artificial pancreas works in real life. Jeffrey Shure, director of its Center for Devices and Radiological Health, commented that the guidance would “provide maximum flexibility to manufacturers seeking to bring this device to US patients”, in addition to making sure they are both safe and effective.
A spokesperson for the Juvenile Diabetes Research Foundation (JDRF), also said “artificial pancreas technologies have the potential to be the most revolutionary advance in treating Type 1 diabetes since the discovery of insulin.”