FDA OKs Glucose-Monitoring Device for Children
The product offers 'real time' readout on blood-sugar levels
MONDAY, March 12, 2007 (HealthDay News) -- The U.S. Food and Drug Administration approved on Monday 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.
"Diabetes management is especially difficult for pediatric patients, and Medtronic REAL-Time CGM therapy could benefit thousands of children and their families who struggle to maintain control of their disease," Dr. Bruce Buckingham, director of pediatric endocrinology at Lucille Packard Children's Hospital at Stanford University, said in a prepared statement.
More than a million people in the United States have type 1 diabetes, including more than 175,000 younger than age 20.
The American Diabetes Association has more about children and diabetes.