The U.S. Food and Drug Administration (FDA) recently issued new guidelines toward trying to speed up the development of an effective artificial pancreas device. This is welcome news to people with type 1 diabetes who have been hearing about technological advances toward an artificial pancreas for years but are still waiting for a significant breakthrough.
The new guidelines allow for more flexibility in how clinical trials are conducted along with opening channels of communication between those in academia and those in research to streamline the testing process with fewer regulations to inhibit the pathway to clinical studies. This would include allowing data from clinical studies outside the U.S. to be used in the approval process. Currently, there are 20 FDA approved clinical studies specifically on the artificial pancreas. These new guidelines would hopefully allow many more over a shorter period of time.
The artificial pancreas combines current technologies for continuous blood glucose monitoring and insulin pumps to deliver insulin as needed. The goal is for the device to accurately read the blood sugar and automatically dispense the precise amount of insulin needed to keep the blood sugar in a normal range.
There is still no projected time frame for when an artificial pancreas might become available. There are still several key problems that haven't been solved, which include creating consistently reliable algorithms to deliver insulin in a variety of situations.
Do you think an FDA approved artificial pancreas will become available in the next five years? Why or why not? Post your comments below.
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