News & Observer | newsobserver.com | FDA: Insulin pumps pose risks for teens

Published: May 05, 2008 12:30 AM
Modified: May 05, 2008 01:25 AM

FDA: Insulin pumps pose risks for teens

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TYPE 1 DIABETES

Type 1 diabetes, which accounts for about 5 to 10 percent of all diabetes cases and used to be called "juvenile diabetes," affects an estimated 12 million to 24 million people worldwide. It occurs when the body attacks insulin-producing cells in the pancreas. Insulin regulates blood sugar levels, which when too high can lead to heart disease, blindness and kidney damage.

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CHICAGO - Insulin pumps are used by tens of thousands of teenagers with Type 1 diabetes worldwide, 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 at 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.

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