(Reuters Health) – - When diabetic patients report problems with their insulin pumps, the pump manufacturers collect that information – but there’s no easy way for researchers to analyze the data independently, a new paper says.
In a joint statement, experts from the American Diabetes Association and the European Association for the Study of Diabetes say regulatory agencies should work together to create standards that apply to all pump manufacturers.
People who use these devices shouldn’t be alarmed, however.
“Overall they are really pretty safe as long as people follow the instruction and do what they’re supposed to,” said Dr. Anne Peters, director of the University of Southern California Clinical Diabetes Program and coauthor of the new statement.
But anybody who wears a pump knows they do sometimes fail, she told Reuters Health by phone.
Five percent of the 29 million Americans with diabetes have type 1 diabetes and need to use either daily insulin injections or an insulin pump to survive, according to the Centers for Disease Control and Prevention.
Insulin pumps combine an external pump case, which can be attached to clothing, with a catheter placed under the skin. They deliver the hormone continuously and can be programmed to deliver extra doses during meals or snacks.
Up to one million people worldwide may use these pumps, although it is difficult to estimate since the number sold and currently operating is not reported by manufacturers, the authors write in the new statement, published in Diabetes Care.
As the devices become smaller and more sophisticated, updated versions have entered the market rapidly, they write. Analyzing patient reports of problems with the new devices could help assure quality and improve safety.
In the U.S., patients report problems to the manufacturers, who in turn report the data to the Food and Drug Administration. It’s publicly available, but each company uses its own review and categorization procedure and is responsible for determining whether a pattern of problems exists. The database is difficult to search and sort, Peters said.
“It’s really hard for a clinician like myself to access that data,” Peters said. “How often does a pump fail and need to be replaced? I don’t know.”
One review found that 1,594 insulin pump problems were reported to the FDA between 1996 and 2005, including 13 deaths. Serious and fatal pump reports increased by about 17 percent per year between 2001 and 2009, which may have been due to more widespread use, but without an easier way to study the data the true cause is uncertain, the authors write.
More than 29,000 people in 2013 called a manufacturer to say their pump broke, Peters said.
“People with diabetes should know that the professional societies in Europe and the U.S. are working together to lobby the industry and the regulators to set higher standards around the approval of pumps in the marketplace and transparency of data on adverse events,” said John Petrie of the University of Glasgow in the U.K., a coauthor of the statement.
Petrie said insulin pump users should tell manufacturers about any issues that might be attributable to their device. “This will help ensure that any problems, e.g. due to ongoing changes in design and specifications, are detected as early as possible,” Petrie told Reuters Health by email.
One in every four people using a pump for a year may experience pump failure, which is too high, he said.
It’s important that patients know how to handle a pump failure, Peters said. Patients should be taught how to troubleshoot when they receive the pump and then reminded periodically, she said, so they’ll know what to do if the device stops working.
When pumps break it can take a few days to get a replacement, she said. Anyone using a pump should maintain a current printout of pump settings and have some long-acting insulin on hand.
SOURCE: bit.ly/1DDtd9j Diabetes Care, March 16, 2015.