Medtronic said it has submitted its pre-market approval application to the Food and Drug Administration for an insulin pump and continuous glucose monitor that automatically suspends the delivery of insulin if blood sugars drop too low.
The device is already available in 50 countries outside the U.S., according to the Northridge-based diabetes unit of Medtronic, which developed the system, the MiniMed 530G.
If approved, it would be the only insulin delivery system of its kind, according to the company, and would represent a significant step toward the development of an artificial pancreas, or a fully automated insulin delivery system.
The device would help patients with Type 1 diabetes, for whom low blood pressure is one of the most frightening aspects of living with diabetes. It can result in confusion, unresponsiveness and in severe cases, even death.
Typically diagnosed in childhood, people with Type 1 diabetes have a pancreas that is unable to produce insulin, a hormone that regulates blood sugar, or glucose. An artificial pancreas is a system that will closely mimic the insulin delivery of a healthy pancreas using advanced technology that continuously monitors glucose levels and automatically adjusts insulin delivery without patient interaction.
Medtronic said it has numerous research studies under way to develop different components of an artificial pancreas system. “The vision is to eventually have no human interaction in the management of diabetes — a fully automated system that acts like the human pancreas,” Katie Szyman, president of the diabetes unit, recently told the San Fernando Valley Business Journal. She said the fully automatic system is probably at least five years away, but the company is devoting substantial research and development dollars to the effort.