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Insulin Pumps Linked to Teen Deaths

By CARLA K. JOHNSON,
AP
Posted: 2008-05-06 19:13:17
Filed Under: Health News
CHICAGO (May 5) - 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.

insulin pump
MCT

Insulin pumps allow users to control how much insulin to give before each meal.


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.

Other companies with insulin pumps either on the market or in development include Abbott Laboratories, Johnson & Johnson's Animas Corp., DexCom Inc. and Insulet Corp.

Copyright 2008 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.
2008-05-06 14:28:50
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Recent Comments

1 - 6 of 6
6 comments

nikki419b 06:36:14 PM May 07 2008

INSULIN IS NOT A CURE ,TELL BUSH TO LET STEM CELLS CURE INSULIN DEPENDENT DIABETICS GET THERAPY SO THEY WONT BE DIABETIC ANYMORE !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

cdoyle1013 04:40:51 PM May 07 2008

I, also, thought my daughter's diabetes was contracted through chicken pox. She had the pox and then a couple years later, had diabetes. I know that viruses can set off the immune system to act against the beta cells...I always suspected that bout of pox

babyblonde086 12:37:11 PM May 07 2008

I have been a juvenile diabetic since I was 4 years old; I contracted the disease through the chicken pox. I am now 22 and have been on an insulin pump for approximately a year and a half. I know the do's and do not's of the pump; it is absolutely necessary for children to be educated, as well as the parents.

I cannot stress enough how much the pump has changed my life, and in ways, saved it. PLEASE PARENTS: EDUCATE YOURSELVES AND YOUR CHILDREN TO PREVENT ACCIDENTAL OVERDOSE AND SUICIDE.

salhomero 11:11:55 AM May 07 2008

Diabetes is not a joke,it is a disease that must be taken serious, because if you do not, you will be sorry and will pay consequences.It is lethal, it is deadly.
I quote a diabetic therapeutic manual: Education is not a part of therapy: It is actually THE THERAPY.But if you do not learn well, I mean,if your understanding does not translate into your daily life, then you are going to suffer pains...

Well, it is only my opinion,based on my experiences (I am a diabetic type 2)

Homero Velazquez

Cookedbabyyummy1 10:33:35 AM May 07 2008

This story is funny, I wonder what kind of look they had on their face when they died

mcurtis596 09:20:18 PM May 06 2008

I think it is important, at this time, to explain why an insulin pump is used. My son was diagnosed at 2 years old, in 2000, with type 1 diabetes. It is also known as Juvenile Diabetes as the majority of diagnoses take place in children. Type 1 diabetes occurs when the pancreas, through an autoimmune malfunction, is attacked by the body and stops creating insulin. Insulin is used by the body to convert sugar into energy. Insulin is a hormone required to sustain life.

At the time of diagnosis he had been drinking heavily, urinating frequently, and finally sleeping non-stop. I took him to the pediatrician on a Monday afternoon to find that he had also lost a considerable amount of weight. Our doctor sent us to the lab and by 11pm that night we were rushing to Bronson Children’s Hospital as our frail 2 year old was in Diabetic Ketoacidosis (DKA), a life threatening complication of untreated diabetes mellitus. We spent a few days in the hospital as his body chemistry was corre

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