Medtronic receives FDA approval for first insulin pump with continuous glucose monitoring

By E. Janene Geiss

Philadelphia, April 13 -Medtronic, Inc. said Thursday that the Food and Drug Administration approved the MiniMed Paradigm REAL-Time insulin pump and continuous glucose monitoring system, a new therapy for patients who use insulin to treat diabetes.

For the first time, the product integrates an insulin pump with continuous glucose monitoring, according to a company news release.

This new technology will help patients take immediate corrective or preventive action to maintain healthy glucose levels and delay or prevent diabetes-related complications, officials said.

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 system relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays up to 288 readings a day - nearly 100 times more information than three daily fingersticks, officials said.

The 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, officials said. 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. An alarm alerts patients when glucose levels become too high or too low, officials said.

"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," Robert Guezuraga, president of Medtronic Diabetes, said in the release.

Medtronic Diabetes is a maker of insulin pump therapy and continuous glucose monitoring. Medtronic is a Minneapolis medical technology company.

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