Mar 23, 2007

Continuous Glucose Monitoring Approved for Kids

Tara Dairman

Last week, the U.S. Food and Drug Administration (FDA) approved a new model of the MiniMed Paradigm REAL-Time Continuous Glucose Monitoring (CGM) System for use in children aged 7 to 17 who have Type 1 diabetes. While multiple CGM systems have come onto the market over the past year, they were previously only approved for adults. Now, however, Medtronic’s REAL-Time CGM devices will be available in pediatric models of the MiniMed Paradigm REAL-Time System and Guardian REAL-Time System.

A CGM device measures glucose levels within the body via a sensor inserted into the fatty tissue just under the skin. Results are displayed on a receiver every five minutes. This technology enables people to see trends in their glucose levels as they are happening and warns them when levels get too high or too low. (For more information about how continuous glucose monitors work, please see the previous blog entries ”Continuous Glucose Monitoring Improves Diabetes Control” and "New Monitoring Technology Brings Movies Instead of Snapshots.") Medtronic currently offers two CGM systems: the MiniMed Paradigm REAL-Time System, which consists of an insulin pump and continuous glucose monitor, and the Guardian REAL-Time System, a stand-alone system that was officially launched last week, although it has been available in selected cities for some time now.

Clinical trials involving both adults and children have shown that using REAL-Time CGM devices can help substantially lower HbA1c levels (a measure of blood glucose control over time), which in turn reduces the risk of developing diabetes complications. Trials also showed that CGM helped reduce the length of episodes of hypoglycemia (low blood glucose). Information about glucose levels and trends from the devices, as well as programmable alarms that sound when glucose levels go above or below preset values, can alert parents and children to check blood glucose levels and make treatment adjustments accordingly.

Both of Medtronic’s CGM systems will soon include the MiniLink REAL-Time Transmitter, which is one-third the size of previous Medtronic transmitters and is also waterproof and rechargeable. Both systems will also incorporate software that integrates data from the user’s CGM system, logbook, and blood glucose meter.

CGM devices are available only by prescription.

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