A four-year-old Australian boy
was fitted with a type of insulin pump that tracks glucose levels and can help
prevent hypoglycemia, making him the first patient outside clinical trials to
receive the technology, researchers said.
The pump mimics the biology of the pancreas to predict low glucose
levels and shut off insulin 30 minutes before a predicted hypoglycemic event,
according to a statement from the Juvenile Diabetes Research Foundation.
The device was researched and tested through clinical trials run by
specialists at Australia's Princess Margaret Hospital for Children in a network
of hospitals across the country, and can help patients manage Type 1 diabetes.
The boy was diagnosed with diabetes at 22 months.
The U.S. Food and Drug Administration released guidelines for
getting approval for artificial pancreas device systems in November 2012,
including guidance for testing of the device's software, user interface and
requirements for clinical studies.