Medtronic, Inc. (NYSE:MDT) has 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® REAL-Time System and Guardian® REAL-Time System.

"This indication reinforces Medtronic's commitment to developing and marketing novel therapies for the millions of Americans with diabetes," says Chris O'Connell, President of Medtronic's diabetes business. "We are particularly excited that children and their families will sleep better at night knowing that REAL-Time CGM is providing a new level of protection against dangerous glucose levels."

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 two percentage points. This is significant because as much as 60 percent of hypoglycemic events go undetected by current glucose monitoring standards, and for every one percentage point drop in HbA1c, there is a 35 percent reduction in diabetes-related complications like blindness, amputation and organ failure.
"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 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 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.

More Voices