The time has come for a more standardized and transparent approach to identifying, reporting and cataloguing adverse events associated with insulin pump therapy, according to a joint statement from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).
Recently, as more patients with diabetes use insulin pumps, researchers have been looking into modern insulin pumps and errors of insulin function due to pump failure. Now, they say, is the time to make significant changes in how these devices are evaluated and adverse events are reported.
Making significant changes could help both patients and health care providers understand the risks associated with insulin pump therapy. As it stands today, endocrinologists and other clinicians may not really see the true picture.
“We need to better understand the risks and benefits. [Insulin pumps] are being used more and so we are finding out what is good and bad about them,” said Anne Peters, MD, one of the statement authors and a professor of medicine at Keck School of Medicine at the University of Southern California, Los Angeles.
More Information Necessary
Errors of insulin infusion can occur for a host of reasons, Peters said. The problem may be due to pump failure, insulin infusion set (IIS) blockage or infusion site problems. Other factors may involve insulin stability issues, user error or a combination of these problems. Currently, there is very little available evidence on the safety and efficacy of insulin pump therapy.
The EASD and the ADA joined forces and set up a committee to review the systems in place for evaluating the safety of pumps from a clinical perspective. The working group, which includes Peters, has published a joint working statement that calls for adopting a more rigorous, standardized and transparent approach to pump safety.1
The working group found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. In addition, the group found that adverse event reports on the U.S. Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database are not being used optimally because of the current configuration of the system.
“We don’t have the data,” Peters said in an interview with Endocrinology Advisor. “There is not a lot of data that a clinician has access to. The FDA has the data, and you can look at it on the website, but there is not a way to sort it out to know what we need to know.”