FDA OKs Glucose-Monitoring Device for Children

The product offers 'real time' readout on blood-sugar levels

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TUESDAY, March 13, 2007 (HealthDay News) -- The U.S. Food and Drug Administration has approved a real-time glucose-monitoring device for children ages 7 to 17 with type 1 diabetes.

The device, previously approved only for adults with type 1 diabetes, is called a REAL-Time continuous glucose monitoring (CGM) system, which warns about dangerously high or low glucose levels, manufacturer Medtronic Inc. of Minneapolis said. It is a specially designed pediatric model of the MiniMed Paradigm REAL-Time System and Guardian REAL-Time System, the company said in a prepared statement.

Clinical studies showed that REAL-Time continuous glucose monitoring devices help reduce the duration of hypoglycemic events and lower HbA1c levels by as much as 2 percentage points. For every 1 percentage point drop in HbA1c, there is a 35 percent reduction in diabetes-related complications such as blindness, amputation and organ failure, the company said.

More than a million people in the United States have type 1 diabetes, including more than 175,000 younger than age 20.

More information

The American Diabetes Association has more about children and diabetes.

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