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.
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.
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