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Published: Monday, May 5, 2008

FDA raises concerns over children's use of insulin pumps

CHICAGO -- Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths, a review by federal regulators finds.

Parents should be vigilant in watching their children's use of the pumps, researchers from the Food and Drug Administration wrote. They didn't advise against using the devices. But they called for more study to address safety concerns in teens and even younger children who use the popular pumps.

The federal review of use by young people over a decade found 13 deaths and more than 1,500 injuries connected with the pumps. At times, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote.

Some teens didn't know how to use the pumps correctly, dropped them or didn't take good care of them. There were two possible suicide attempts by teens who gave themselves too much insulin, according to the analysis.

"The FDA takes pediatric deaths seriously," said the agency's Dr. Judith Cope, lead author of the analysis. "Parental oversight and involvement are important. Certainly teenagers don't always consider the consequences."

The pumps are popular because they allow young people to live more normal lives, giving themselves insulin discreetly in public. And they're a growing segment of diabetes care, with $1.3 billion in annual sales worldwide, said Kelly Close, a San Francisco-based editor of a patient newsletter. She said 100,000 teenagers may be using them.

The pumps are used for those with Type 1 diabetes, which accounts for about 5 percent to 10 percent of all diabetes cases and used to be called "juvenile diabetes." The more common form is Type 2, which is often linked to obesity and more often affects adults.

Insulin pumps are the size of a cell phone and are worn on a belt or pocket. They send insulin into the body through a plastic tube with a small tip that inserts under the skin and is taped in place.

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