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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.
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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:
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.
May 30, 2008
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.