FDA approves artificial pancreas developed by the University of Virginia
pharmafile | January 2, 2020 | News story | Business Services, Medical Communications | FDA, Pancreas, Type 1 diabetes, diabetes, insulin, type 2 diabetes
The FDA has approved an artificial pancreas system based on technology from the University of Virginia’s Center for Diabetes Technology.
The University says that the artificial pancreas system, called Control-IQ and manufactured by Tandem Diabetes Care, tracks blood glucose levels with a continuous glucose monitor (Dexcom G6 CGM) and automatically delivers the hormone insulin as needed.
Using this, means that pateints do not have to test their blood sugar levels multiple times a day by fingerstick, or deliver insulin by multiple daily injections.
The result of their large-scale clinical trial of the artificial pancreas was published in the New England Journal of Medicine.
During the University’s study, 168 participants, aged 14 or older with type 1 diabetes, were randomly assigned to use either the artificial pancreas system or sensor-augmented pump (SAP) therapy with a continuous glucose monitor and insulin pump that did not automatically adjust insulin throughout the day.
The study found that users of the artificial pancreas system significantly increased the amount of time with their blood glucose levels in the target range, while the time in range in the SAP group remained unchanged over six months.
Boris Kovatchev, Director of the UVA Center, said: ““This is a new-generation interoperable automated glucose control system, which allows seamless integration of a continuous glucose sensor, insulin pump, and a smart control algorithm.”
Type 1 diabetes is an autoimmune disease that occurs when a person’s pancreas stops producing insulin, the hormone that controls blood-sugar levels. It develops when the insulin-producing pancreatic beta cells are mistakenly destroyed by the body’s immune system. 1.25 million Americans are living with Type 1 diabetes, and 5 million people are expected to have it by 2050.
Conor Kavanagh
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