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FDA Approves Medtronic Continuous Glucose Monitoring Devices
Mar 12, 2007
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Medtronic, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved new REAL-Time Continuous Glucose Monitoring (CGM) devices for children and teenagers ages 7-17.  Previously approved for only adult patients, Medtronic’s REAL-Time CGM will soon be available in specifically designed pediatric models of the MiniMed Paradigm(R) REAL-Time System and Guardian(R) REAL-Time System.

Medtronic REAL-Time CGM therapy is clinically proven to help patients monitor and better control their diabetes. Clinical studies have shown that Medtronic REAL-Time CGM therapy can reduce the duration of hypoglycemic events, and lower HbA1c levels by as much as 2 percentage points. As much as 60 percent of hypoglycemic events go undetected by current glucose monitoring standards, and for every 1 percentage point drop in HbA1c, there is a 35 percent reduction in diabetes-related complications like blindness, amputation and organ failure.

Medtronic REAL-Time CGM technology displays REAL-Time glucose values, trend graphs and directional arrows, allowing patients to discover how diet, exercise, medication, and lifestyle affect their glucose levels. With this information, patients can gain insights and intervene earlier to reduce the frequency and severity of high and low glucose levels. The technology alerts patients if their glucose levels fall below—or rise above—preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on Medtronic REAL-Time CGM System values.



 

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