FDA OKs Medtronic’s insulin pump

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MINNEAPOLIS—The U.S. Food and Drug Administration approved on April 13 Medtronic’s MiniMed Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System for diabetics.

“The approval of the MiniMed Paradigm REAL-Time System opens the door to the next generation of diabetes management,” said Robert Guezuraga, president, Medtronic Diabetes. “As this is the first integrated insulin pump and continuous glucose monitoring system ever approved, we feel this new therapy will revolutionize the way patients manage their diabetes and will improve their lives.”

The MiniMed Paradigm REAL-Time System is made up of two components, a REAL-Time Continuous Glucose Monitoring System, and a MiniMed Paradigm insulin pump. The REAL-Time CGM System relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays to 288 readings a day—nearly 100 times more information than three daily fingersticks, according to Medtronic.

REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick.

The MiniMed Paradigm REAL-Time System’s continuous glucose sensor is a tiny electrode that is inserted under the skin using the Sen-Serter, a small device that patients or their caregivers can use at home to make sensor insertion easier. The sensor measures glucose in the interstitial fluid found between the body’s cells, and is typically discarded and replaced after three days of use.

Glucose measurements obtained by the sensor are relayed every five minutes from a transmitter to the insulin pump, which displays the glucose value, three-hour and 24-hour trend graphs, as well as arrows to indicate how quickly glucose is moving up or down. In addition, an alarm alerts patients when glucose levels become too high or too low.

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