FDA study: Insulin pumps linked to injuries, deaths in teens

By CARLA K. JOHNSON, Associated Press Writer Mon May 5, 12:16 AM ET

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 getting pizza with
friends late at night. 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 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.

Type 1 affects an estimated 12 million to 24 million people worldwide and
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.

Insulin pumps are the size of a cell phone and 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. They cost about $6,000 and
supplies run $250 a month. Most health insurers cover much of the cost.

Users must tell the device how much insulin to give before each meal, based
on the estimated carbohydrates in the meal. The devices also deliver a
continuous low level of insulin.

In the FDA study, appearing in the May issue of the journal Pediatrics, the
reports of adverse events and deaths in adolescents using the pumps occurred
from 1996-2005.

The FDA requires manufacturers to report injuries that could be linked to
medical devices. The authors analyzed reports from patients 12 to 21 years
old. They emphasized that the reports aren't always clear about the cause of
death or injury.

The devices provide an alternative to multiple daily injections of insulin
by syringe; some come with glucose monitors that reduce the number of times
the finger must be pricked to test blood sugar.

While some teenagers want to switch from insulin injections to pump therapy
to gain more flexibility in their lives, 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.

Dr. Christina Luedke of Children's Hospital Boston said she carefully
screens teenagers and their families before prescribing a pump. She has
refused it for some young patients.

"Without appropriate glucose monitoring, the pumps can increase the risk of
getting sick more quickly compared to injections," Luedke said. However, she
said, proper use makes life more bearable and can improve glucose control.

Teenagers also have problems keeping their diabetes under control with
multiple daily insulin injections, doctors and manufacturers said.

"It is a constant struggle for a patient who is an adolescent to stay in
control of any therapy," said Steve Sabicer, a spokesman for
Minneapolis-based Medtronic Inc., which makes the top-selling insulin pump.
The company stands behind the product's safety and "the many years of
clinical evidence that support the benefits of insulin pump therapy," he
said.

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On the Net:

Pediatrics: http://www.aap.org

Report device problems: http://www.fda.gov/medwatch