The FDA has just approved two new devices from Medtronic for children and teenagers (ages 7-17), diagnosed with diabetes. REAL-Time Continuous Glucose Monitoring (CGM) devices will soon be available in specially designed pedi models of the already approved MiniMed Paradigm® REAL-Time System and Guardian® 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 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…
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.
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.
Press release…
Product page for Guardian REAL-Time System…