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FDA Moves to Speed Development of Artificial Pancreas Systems
Date:12/1/2011

d effectiveness goals for researchers and industry in developing the Low Glucose Suspend System, a first-generation artificial pancreas system. Those results helped inform this new guidance, Zimliki said

Hurdles in developing these systems include making sure the implanted sensors remain clear, the need to periodically recalibrate blood sugar monitors, problems with the software needed to operate insulin infusion pumps, problems creating algorithms to deliver insulin that take into account how long it takes the body to absorb it, the need for a faster-acting insulin and the overall development of safer and more reliable algorithms.

Another issue is the lack of a glucagon formulation that can be used in infusion pumps. Glucagon is a hormone used to treat severe low blood sugar. "There is a need for a glucagon formulation that is stable over several days and can be delivered by an infusion pump," the FDA said.

More information

For more on type 1 diabetes, visit the Nemours Foundation.

SOURCE: Dec. 1, 2011, teleconference with: Charles L. Zimliki, Ph.D., leader, Artificial Pancreas Working Groups and Critical Path Initiative, U.S. Food and Drug Administration


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