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FDA approves glucose monitoring system approved for kids


FDA approved a continuous glucose monitoring system (Dexcom G4 Platinum, Dexcom) for use in children with diabetes mellitus.

FDA’s approval makes the CGM device the first approved for children aged as young as 2 years. The system is already approved for adults aged 18 years and older.

Continuous glucose monitoring is considered to be one of the most significant recent advances in diabetes care. Experts say it is particularly important with children because it helps them learn how to manage their condition and gives them the freedom to keep their glucose levels under control whether they are at home, at school, with friends, or participating in activities.

The system uses wireless technology to monitor glucose continuously for 24 hours a day for 7 days. Users can view their blood glucose levels any time on demand, and they can enter personalized information, such as targets and alerts. The device also has a built-in alarm feature that alerts the user if levels enter a dangerous zone.

The handheld receiver is no bigger than a cell phone and has a 20-foot range. Users can place the sensor and wireless transmitter on their abdomen or upper buttocks.

According to a Centers for Disease Control and Prevention 2011 National Diabetes Fact Sheet, about 215,000 people aged younger than 20 years in the United States had type 1 or type 2 diabetes in 2010. This represents 0.26% of all people in this age group. 

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