diabetes
“The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients. We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”
- An insulin pump
- A CGM (continuous glucose monitor) – this receives data on glucose levels from a sensor that is implanted below the patient’s skin
- Whether their device provides good glycemic control alongside standard therapies
- Whether their device provides superior glycemic control compared to other therapies
Low Glucose Suspend System
“Today’s guidance was informed by the comments on the Low Glucose Suspend System guidance document. It addresses future generation artificial pancreas devices such as a treat-to-range system that would adjust insulin dosing if a person’s glucose level approaches a low or high threshold and a treat-to-target system that would set target glucose levels and try to achieve these levels at all times. This system would be fully automated and require no interaction from the user, except for calibration of the CGM system.”