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FDA Study Links Insulin Pumps to Teenage Injuries, Deaths

Posted on: Monday, 5 May 2008, 21:00 CDT

Researchers from the Food and Drug Administration have concluded that insulin pumps can be risky for teens, sometimes leading to injury or even death, but they still insist that parents should ensure their children’s regular use of the devices.

Many teens diagnosed with Type 1 diabetes currently use the devices worldwide, but the administration researchers said that although they carry some added risk, more study is needed to address safety concerns in teens and even younger children who use the pumps.

The review studied use of the pumps by young people over 10 years. They found that 13 deaths and more than 1,500 injuries were connected with the pumps.

Some teens misused the pumps, others didn’t care for them properly. Also, there were two possible suicide attempts by teens who gave themselves too much insulin.

"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."

Pumps have become popular because they allow flexibility to people such as teens who need to give themselves insulin throughout the day.

Sales of umps have amounted to $1.3 billion annually worldwide, said Kelly Close, a San Francisco-based editor of a patient newsletter. She said 100,000 teenagers may be using them.

Insulin pumps can be used in people with Type 1, or “juvenile” diabetes, which only accounts for about 5 to 10 percent of all diabetes cases, or an estimated 12 million to 24 million people worldwide.

The more common form is Type 2, which is often linked to obesity and more often affects adults.

The FDA study is published in the May issue of the journal Pediatrics. It found issues with insulin pumps between 1996-2005. Patients were between the ages of 12 and 21 years old.

Researchers emphasized that the reports aren't always clear about the cause of death or injury.

Doctors said device problems such as a blocked tube can lead quickly to dangerous episodes of high blood sugar.

"In a matter of a few hours, all the insulin in the body disappears. Metabolically, the child starts to spiral out of control," said Dr. John Buse, the American Diabetes Association's president for medicine and science. “Kids need to be aware of the risk, monitor their blood sugar and be ready to give themselves an insulin injection.”

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Food and Drug Administration

Source: redOrbit Staff & Wire Reports

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