March 12, 2007 — Medtronic Inc. has announced that its new REAL-Time Continuous Glucose Monitoring (CGM) devices have received FDA approval for children and teenagers ages 7 to17. Previously approved for only adult patients, Medtronic's REAL-Time CGM will soon be available in specifically designed pediatric models of the MiniMed Paradigm REAL-Time System and Guardian REAL-Time System.
"Diabetes management is especially difficult for pediatric patients, and Medtronic REAL-Time CGM therapy could benefit thousands of children and their families who struggle to maintain control of their disease," says Dr. Bruce Buckingham, director of Pediatric Endocrinology at Lucille Packard Children's Hospital, Stanford University. "By providing real-time glucose values and alarms, patients can now recognize previously undetected glucose fluctuations."
Medtronic’s 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 valuable insights and intervene earlier to reduce the frequency and severity of high and low glucose levels.
The company says that 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.
Medtronic currently markets the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System - the world's first insulin pump with REAL-Time continuous glucose monitoring. The MiniMed Paradigm REAL-Time System has all of the benefits of CGM plus the added value of precise insulin delivery through the use of insulin pump therapy. The Guardian REAL-Time System, a stand-alone CGM device, will be available later this year.