Biomedical device makers are currently designing artificial pancreases for the treatment of diabetes type 1 while the FDA has drafted guidance to provide phase guidelines.
Although not a cure for diabetes type 1, an artificial pancreas could lead to a significant improvement in the quality of life and outcome for these patients. An artificial pancreas consists of an insulin pump and a continuous glucose monitor.
The FDA guidance documentation provides information for clinical studies, and the FDA is recommending a 3 phase human trial progression. The current draft guidance incorporates information gleaned from the original first generation artificial pancreas system and addresses future generation devices.
While the development of medical devices and drugs are important to advance the quality of patient options and outlooks, the FDA guidance is vital to ensure efficacy and safety of those protocols and designs.
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