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FDA OKs Glucose-Monitoring Device for Children

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

Please note: This article was published more than one year ago. The facts and conclusions presented may have since changed and may no longer be accurate. And "More information" links may no longer work. Questions about personal health should always be referred to a physician or other health care professional.

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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