Medtronic granted FDA approval for continuous glucose monitoring system for diabetes

By Lisa Kerner

Charlotte, N.C., July 17 - The Food and Drug Administration approved Medtronic, Inc.'s Guardian REAL-Time System, a doctor-prescribed continuous glucose monitoring system for diabetes management.

The Guardian REAL-Time System glucose sensor is a tiny electrode inserted under the skin that measures glucose levels in the interstitial fluid found between the body's cells, alerting users to high and low glucose levels.

Glucose readings are transmitted every five minutes to a monitor, which displays up to 288 readings a day.

In addition, trend graphs show the effect of diet, exercise, medication and lifestyle on glucose values in three-, six-, 12-, and 24-hour increments.

Improved glucose control has been shown to reduce the likelihood of certain long-term complications, including blindness, kidney failure, amputation, impotence and heart disease, according to a company news release.

"The Guardian REAL-Time System is the culmination of more than seven years of research into continuous glucose monitoring technology," said Robert Guezuraga, president of the diabetes business at Medtronic, in the release.

Medtronic is a medical technology company based in Minneapolis.

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