Teens on Insulin Pumps - Are They Safe? We Go Into Depth on the Recent News Reports Scaring Teen Pump Users

Earlier this month, we published an article about the AACE's call for new standards to protect the safety of children and adolescents using insulin pumps. At that time, FDA physicians provided new data showing a serious problem regarding young patient safety in insulin pump use. The most common single issue was a lack of education: neither the patient nor the responsible adult knew enough about how the pump worked to avoid the injuries and deaths reported by the FDA. Although some cases were due to mechanical malfunction of the pump, most problems were the result of human factors involved in the use of the pumps.

Here's a follow-up...

Let your child know that if he makes a mistake, has a question, or feels that he needs more advice or education on using his pump, you will listen and will get him the professional help he needs.

| May 30, 2008

With annual worldwide sales topping 1.3 billion dollars, insulin pumps are one of the most popular devices in the treatment of diabetes. Not only do they allow people with type 1 diabetes to more easily manage their blood glucose levels, but they also help users regain their freedom and enjoy a more normal life.

Insulin pumps are used by over 100,000 teenagers to manage their diabetes.  Transitioning from traditional insulin injections to the pump often brings type 1 adolescents a renewed sense of hope and excitement about being less conspicuous to their peers while managing their diabetes.  However, the insulin pump is not without its problems. According to an FDA study released in the May 2008 issue of the journal Pediatrics, insulin pump usage in youth and teenagers has special risks that need to be considered and acknowledged to keep patients safe.

The study, based on data from pump manufacturers, who are required to report injuries that could be linked to their devices, cited 1,594 injuries and 13 deaths in youth ages 12 to 21 between 1996 and 2005.  Although the study’s authors stressed that the reviewed reports did not always specify how the death or injury was related to pump usage, they did emphasize the importance of parental oversight and proper medical training prior to implementing the pump.

Following the release of the pump study, the American Association of Clinical Endocrinologists (AACE) seconded the Food and Drug Administration’s call for more pre-pump education for all type 1 pump users. Although there has not yet been a parallel study documenting injuries and fatalities among adults using the pump, the AACE believes the results would be similar.

Issues Reported by Adolescent Pump Users

The researchers categorized the FDA reports to determine the nine most common causes of adverse incidents among the teenagers in the study. These were:

  • Lack of education or knowledge on proper pump usage and procedures, either prior to implementation or when troubleshooting
  • Noncompliance, or instances where the child did not keep the parent or guardian informed, did not follow proper diabetic protocol, or did not take care of the pump
  • Problems associated with sports and other activities (such as taking off the pump to participate and forgetting to reattach following the activity)
  • Device misuse
  • Risk-taking behaviors (including alcohol abuse and possible suicide attempts)
  • Irresponsibility and/or negligence in care of device
  • Pubertal growth
  • Problems occurring away from home
  • Lack of parental supervision

Results of the Issues Reported by Adolescent Pump Users

Overall, the most common problem documented by pump users was hyperglycemia (61.9%). As a result of the patient not getting enough insulin to maintain blood glucose levels, nearly half (46.6%) of these cases resulted in diabetic ketoacidosis, or DKA. Some of the problems attributed directly to the pump itself were error messages, alarm problems, loosening and/or blockages of the catheters, bent cannulas (the tube inserted into the body at the site of the infusion), screen display problems, need for repair, replacement or removal, and pump failure.

Too much insulin being delivered from the pump to the patient was the second most common problem shared in the study. Hypoglycemia was reported in 10.5% of the cases. Specific to the pump were difficulties with over-bolusing, error messages and alarm problems.

What You Can Do To Be Safe on the Pump

Despite the fact that pump malfunction does occur and can result in serious injury and death, the critical message for parents of adolescents using pump therapy is that education and parental involvement are the two best ways to keep your child safe on the pump.

Before making the decision to move your child from injections to the pump, take the time to investigate the many models and types of pumps available. Insurance coverage varies and may allow you several or few options. Work with your child and your endocrinologist to evaluate each possible pump with regard to features, ease of use and available service and training. Often, physicians and their staffs lack sufficient training to help you or your child in an emergency situation, should the pump malfunction or in the event that you or your child make a mistake in using the pump. Most manufacturers have telephone support for times when you need help, but they do not know the medical history of your child. Some hospitals may hire infusion or pump specialists to work with patients and parents. Ask your endocrinologist or local diabetes support group if one is available in your area.

As technology in general expands, insulin pump technology becomes more complex. Even if you and your child have experience using the pump, become knowledgeable of the specifications and usage of new models before changing.

Some of the issues in the study were specific to the teenage years and the myriad challenges teenagers face. If you suspect your child may be anxious, depressed, stressed or have anger management issues, don’t be afraid to take a more active yet supportive role in his diabetes self-management. During the teenage years, your child may be dealing with tough issues, including severe emotional problems, inability to comprehend the seriousness of diabetes, lack of confidence in self-treatment, or other factors that may affect his ability to be successful with the pump. Bring this concern up with your endocrinologist as soon as you can to avoid further problems, and discuss alternative insulin therapies and other medical interventions that might benefit your child.

Keep the lines of communication open and positive with your child regarding his diabetes care. Several of the reports described adolescents who accidentally dropped and broke their pumps and others who after disconnecting their pumps for exercise, thought they had adequately reattached it only to discover that they had not. Let your child know that if he makes a mistake, has a question, or feels that he needs more advice or education on using his pump, you will listen and will get him the professional help he needs.

Finally, establish a routine or set time when you and your child check in about his diabetes. One way to start is to use the pump as a conversational piece. Encourage your child to make sure the tubing and mechanics are working properly on a regular basis. Inquire about any problems he might have had and how he solved them. One good way to be sure your child understands the use of his pump is to ask if he can teach you how it works, show you how he knows there’s a problem and how he changes insulin, adjusts dosages and boluses. Especially with younger pump users, putting them in the position of being knowledgeable will help foster their interest in learning and give you an idea of what areas they might need more help in understanding.

Insulin pumps have the potential to positively change the lives of children and teenagers living with type 1 diabetes. As with any new technology, there are problems to work out and uncertainties to master. But with proper education, insight and a collaborative mindset between you, your child and your endocrinologist and other medical professionals, you will help your child toward a future full of imagination, not limitation.

Beth Morrow is a freelance author and active volunteer for the Central Ohio Diabetes Association. She currently serves on the Youth Committee and is a member of the Camp Leadership Team. She has worked with the association’s summer residential camp for youths ages 7 to 17, Camp Hamwi, for 15 years.

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Categories: Blood Glucose, Diabetes, Diabetes, Food, Insulin, Insulin Pumps, Kids & Teens, Low Blood Sugar, Type 1 Issues

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Posted by Anonymous on 30 May 2008

Good article. Like the advice about having my teen explain to me how it works. Then I will know that he knows how to work it!

Posted by Anonymous on 31 May 2008

Thirteen deaths of youths with diabetes age 12-21 years using insulin pumps over the years between 1995-2006 may or may not be a lot. I wonder how many deaths there were of youths with diabetes age 12-21 years who were using syringes or pens? Some of the problems sound like some of the the teens lacked basic knowledge of management of type 1 diabetes. they might have had problems no matter what their management method was.

The top problem identified by the FDA is lack of education about proper pump use. Yet we know that lately many insurance companies have been decreasing payments for diabetes education. How sad! It's an example of how our national priorities are not in keeping people healthy.

Posted by Anonymous on 31 May 2008

As my husband has said he would never place anyone under 25 on a pump. And, never if they are decently controlled by injection.
Injection is safe with ordinary precautions. The pump is not safe with extraordinary precautions.
They can become erratic in delivery of insulin with no warning. They can stop for no reason.
I have two diabetic children and they will stay on injections and my husband is and Endocrinologist.

Posted by Anonymous on 1 June 2008

Very interesting article for a young person thinking of going to a pump. Making sure all concerned has the proper education is the best advice.Maybe we won't be in such a rush to change.

Posted by Anonymous on 1 June 2008

I like how the article focuses on the importance of proper education.

Posted by Anonymous on 1 June 2008

Very nice summary of the available literture with concrete excellent suggestions.

Posted by oakhaven on 2 June 2008

I am surprised that the author failed to indicate that periodic glucose tests are complementary to anyone using a pump. These glucose tests are critical to detect both hyper- as well as hypoglycemia. The pump cannot be treated as the only critical tool in Type 1 management. I would also recommend a continuous glucose monitor as an additional component.

Posted by mumafi on 3 June 2008

Moving from 5 daily injections to the pump has changed not only my sons life but our whole families. He has more freedom with food as a growing boy of 11 who always wants to eat the pump makes it so much easier for him to enjoy his food without worry of more injections. With regular testing as a safety net there should be reason to worry of dangers using insulin pump therapy. He now has stable blood sugars and an excellent HBA1c. The future looks more positive now.

Posted by Anonymous on 3 June 2008

Good article. I am left with a few questions, though.
1. What were the number of deaths of type 1 teens who were NOT on the pump during the same period of time? This would only be fair to compare.
2. The statement in paragrph 2 about the pump being "less conspicuous" than injections seems wrong to me. I have spoken with young people who have decided to go on the pump, and they perceive the pump as being more, rather than less conspicuous.
3. Could the pump manufacturers change the way the pump connects and disconnects (for sports activities) so that the user doesn't mistakenly think that he's hooked up when he isn't? Just a thought.

Posted by Anonymous on 3 June 2008

Great article with insight we can all benefit from, as a CDE and pumper I can appreciate all the issues brought forth. The insulin pump without proper education is like giving someone a care to drive without any training and setting up that person for failure. Physicians and educators need to be comfortable asking patients to demonstrate their understanding and use of insulin pumps. Insulin pumps are life changing for many people with diabetes and provide opportunity to get the best control possible while living a normal life.

Posted by tgrimm on 3 June 2008

The kids using the pump and their parents should both know how the pump works and how to change settings and infusion sites. Its not just the kid going out there on their own, to me, it has to be a team effort from both sides. I understand that sometimes we all forget to put our pumps back on from being disconnected, but isn't it the parents job also to know what their child is doing and if they will disconnected and to remind and make sure that the pumper has reconnected to their pump.

To me, it just seemed like the hospitalizations and the deaths talked about in this article were due to laziness and no self discipline. I say laziness because the pumper has to be aware of what they are doing when disconnecting or bolusing or making adjustments. As it is the parents job to oversee that pumper is doing it correctly and checking their pump and asking them about it to confirm it. And i say no self discipline because these kids who aren't knowledgeable about their pumps is their own fault. Each one of us gets pump training before we are put on it, or at least i thought we did, and it is up to the pumper and their parents to be familiar with the pump itself.

To me, i guess its just frustrating to hear bout people my age and younger dieing or being in the hospital all the time because they refuse to take care of themselves and not be active in their diabetes management. This disease we all share is a tough one to battle, but it is not unbeatable! we have the resources and the knowledge to fight back against diabetes. Not letting it control us and our lives but manipulating it and us controlling the diabetes. It is a challenge but not impossible. Self confidence, determination, knowledge can go a long way for a lot of us.

Posted by Anonymous on 6 June 2008

I am a Registered Nurse that works with children with diabetes and found the points in the article to be on target from my experience. It gives parents and educators ways to work with children/adolescents utilizing pumps. Education is so important and often gets looked over or not done as it should in a way for insurance companies to save money. Insurance companies need to realize if children and their parents were educated better than it would help to alleviate some additional expences.

Posted by Anonymous on 10 June 2008

A key element I noticed in this article is open communication and dialoue between parents and teens. As a Social Worker, I cannot agree more that having regular check-ins and talks are vital.

Posted by Anonymous on 29 November 2008

My 16 year old son has been on a pump for two years -- he was put on it after 1 month of shots. He has incredible control. He's been to Europe on a 4 week trip. He's been white water rafting. He golfs. He drives. His doctor calls him a "poster child for managing diabetes" -- and I think a lot of it has to do with the pump. He loves gadgets, and that helps, too. To be successful with a pump, I think, a teen has to understand how it works, enjoy tinkering with computer-like gadgets, test his/her sugars regularly, and understand the long-term value of tight blood sugar control. I'm a HUGE advocate of the pump.

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