In 2005, the U.S. Food and Drug Administration (FDA) received five reports of deaths in teenagers whose insulin pump misuse may have contributed to the fatalities. This prompted the FDA to review all adverse events—deaths, serious injuries, and malfunctions—over the past 10 years related to insulin pump use in adolescents, aged 12 to 21. Of the 1,600 reports the FDA received, 60 percent involved hyperglycemia and 10 percent hypoglycemia (from overdelivery of insulin). Some were the result of device malfunction, such as blocked tubes and alarm failures, while others came from incorrect pump use. According to lead author Judith Cope, MD, MPH, a medical officer in the Office of Pediatric Therapeutics at the FDA, adverse events are generally underreported.

The authors cited adolescent issues such as noncompliance, risk-taking, and device misuse in their analysis, suggesting that this is a special population that needs more attention. For example, 12 reports had to do with participation in sports, during which the device can get damaged. “Adolescence is a time [when people are] exerting more control and independence over their lives,” explains Cope. “Developmentally, they are not adults and may not have the same judgment to correctly use and monitor these devices.” In addition, two of the deaths reported may have been suicides.

In total, there are around 200,000 insulin pump users in the United States, and that number is growing. The researchers hope this study will raise awareness among parents and health professionals that teens, in particular, may need more education and supervision with their pumps.

This study was published in the May 2008 issue of Pediatrics.