American and European associations want more standardization of new technologies
WebMD News from HealthDay
By Randy Dotinga
HealthDay Reporter
TUESDAY, March 17, 2015 (HealthDay News) -- The American Diabetes Association and the European Association for the Study of Diabetes are calling for more research into the safety and effectiveness of insulin pumps.
The diabetes' groups recommended "the adoption of a more rigorous, standardized and transparent approach to safety."
Among other things, they want European and American officials to bring their insulin pump standards into harmony. They also called for a single, worldwide database devoted to information about harmful events involving insulin pumps. They also recommended the database include the number of patients using the products, and the results of studies into new features.
The associations also want more funding for studies of "safety, efficacy, outcomes and adherence under real-world conditions."
"Technology is evolving rapidly for treating diabetes," Dr. Anne Peters, director of the University of Southern California Clinical Diabetes Program and a co-author of the statement, said in an American Diabetes Association news release.
"While that's certainly a good thing, we don't have very good post-marketing surveillance for devices such as insulin pumps, particularly in Europe where manufacturers often introduce products prior to releasing them in the United States. We need to make sure we have sufficient data about how the devices are working once they hit the market, so that we can support patients by helping them understand how to prevent errors in using them," she said.
An estimated 1 million people use insulin pumps worldwide, according to the American Diabetes Association (ADA).
The ADA describes insulin pumps as small computerized devices that deliver insulin to a person with diabetes in two ways: a steady measured and continuous dose (the "basal" insulin), and as a surge ("bolus") dose around mealtime.
Insulin pumps -- like any machine -- can fail sometimes, and it can take days to replace them, according to Peters. For that reason, people using insulin pumps should have what she called a "pump failure plan." She recommended that people using pumps keep track of their insulin pump settings and have an emergency supply of long-acting insulin on hand.
The joint statement was published online March 16, and will appear in the April issue of Diabetes Care.
source : Diabetes Groups Call for Greater Scrutiny of Insulin Pumps
