JACKSONVILLE, FL – “The American Association of Clinical Endocrinologists applauds the FDA’s efforts to protect the safety of children and adolescents who are using insulin pumps,” said Dr. Richard Hellman, the Association’s President.
In the May edition of Pediatrics, Dr. Judith Cope, a physician at the FDA, provided new data that shows there is a serious problem regarding patient safety in insulin pump use. She reported data on 1594 injuries and 13 deaths in children and adolescents collected over 10 years. 82% of the cases resulted in hospitalization. The most common single issue was lack of education and, neither the patient nor the responsible adult knew enough about how the pump worked to avoid the injury or death that resulted. Although there were some cases due to mechanical malfunction of the pump, most problems were the result of human factors involved in the use of the pumps.
Unfortunately, the FDA has not yet provided similar data regarding the numbers of serious injuries in the larger group of pump users, adults who are using insulin pumps. This data, which is critically important, is very difficult to obtain and only the FDA is likely to have the ability to have access to the data of injuries and deaths from all of the manufacturers of insulin pumps.
There is every reason to be concerned that the data from insulin pump use in adults will also indicate a significant number of injuries and deaths similar to those found in the pediatric study. “The factors noted in the pediatric study that contributed to poor outcomes in children and adolescents can be expected to be present in a significant proportion of the adult population on insulin pumps,” said Dr. Hellman.
Limited access to education at the time of initiation of pump therapy was a common problem in children and adolescents. It may be even more of a problem in adults. So is the lack of availability of support for pump use in emergencies. Many physicians and their staff who care for patients on insulin pumps are not sufficiently knowledgeable about the pump’s performance to be able to troubleshoot when the patient makes a mistake or the pump malfunctions. Although telephone support is usually available from the manufacturer: the support personnel are neither the prescribers of the insulin doses nor directly involved in the patient’s care.
In addition, as inadequate insurance coverage for adults becomes more common, new barriers to continuing care develop. Moreover, many new pumps are very sophisticated and complex, and their complexity can overwhelm even experienced users, and greatly increase the risk of error in patients who are inexperienced with pumps, or distracted, anxious, depressed, or having any transient cognitive problems as often occurs with either severely low or high blood glucose levels.
Dr. Hellman said that the American Association of Clinical Endocrinologists has an annual program, now in its third year, to teach and provide hands-on experience to all physicians completing specialized training in endocrinology. They are taught how to care for patients on insulin pumps, how to protect them from harm due to pump malfunction, and how to improve their patient’s skills in using an insulin pump safely and well. The physicians find the program most valuable, but more such programs are needed. “This past year we appointed a task force of pump experts to develop guidelines and standards for initiating pump use and what we consider essential to provide for the safe and effective medical care of those on insulin pumps.”
The American Association of Clinical Endocrinologists is very supportive of insulin pump technology and believes more patients can benefit from these pumps. But it is also clear that there are a significant number of patients who should not have been placed on these pumps. Dr. Hellman said, “These include patients with severe emotional problems that distract them from their safe self-care, as well as patients who cannot deal with the complexity of the pumps, suffer cognitive overload as a result, and do poorly. Most patients need more education and informed medical support, and nearly all do better in an integrated program that coordinates their diabetic care. But a continuing problem is that the education, both initial and continuing, and the medical support to deal with the specific problems and needs of pump users, is neither being provided nor paid for. As a result, we have a patient safety problem that may not be the pump itself, but a systems problem, that is, a failure of the system of care for pump support. The FDA needs to obtain the safety data on insulin pumps and share it with the scientific community as soon as possible. We need to move forward to make insulin pump use safer, and allow for the elimination of the deaths and injuries in pump use as those reported by Dr. Cope and the FDA team.”