Insulin Pumps for Type I Diabetes May Cause Injury or Even Death

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 pumps are popular because they allow young
people to live more normal lives, giving themselves
insulin discreetly in public and buffering the acids
from an acidic meal 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 an acidic lifestyle and diet
causing obesity and more often affects adults.

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.

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
acid 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.

"The key to balancing acidic blood sugars is by
changing acidic lifestyle and dietary choices. The
need for insulin will then be significantly reduced
or in many cases eliminated with an alkaline lifestyle
and diet. Therefore, the need or the risk of using
an insulin pump is greatly reduced or eliminated,"
states Dr.Robert O. Young, a research scientist at
the pH Miracle Living Center.

To learn more about balancing acidic blood sugars
without insulin read, The pH Miracle for Diabetes.