Insulin pumps need greater safety review

March 16, 2015

Not enough is known about the safety and efficacy of insulin pumps, and a comprehensive safety overhaul - including greater access to data from pump manufacturers and public funding of research on the use of insulin pumps - is needed to allow health care teams to educate and support those using the devices, according to a joint statement by the American Diabetes Association and the European Association for the Study of Diabetes, being published concurrently online on March 16 and it will appear in the April issue of Diabetes Care.

The statement includes a list of recommendations intended to stimulate "the adoption of a more rigorous, standardized and transparent approach to safety." Currently, the U.S. Food and Drug Administration (FDA) conducts more rigorous reviews of devices such as pumps than the European Union. The statement therefore calls upon the FDA and EU to harmonize standards for pump manufacturing companies. It also recommends providing a single, publicly accessible, international database for reporting adverse events, including both technical and human errors; requiring pump manufacturers to provide access to information, such as how many people use their products and the results of studies testing new features of pump design; and providing greater funding for independent clinical trials of "safety, efficacy, outcomes and adherence under real world conditions," among other suggestions. A full list of recommendations can be seen http://dx.doi.org/10.2337/dc15-0168.

"Technology is evolving rapidly for treating diabetes," said Anne Peters, MD, Director, University of Southern California Clinical Diabetes Program and one of the lead authors on the statement. "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."

Roughly one million people use insulin pumps (continuous subcutaneous insulin infusion) worldwide, and more than 200 million people worldwide have been diagnosed with diabetes. Most people who use insulin pumps have type 1 diabetes, though some people with type 2 diabetes also use them.

Peters said the biggest problem her patients who use pumps run into is that the devices can break, and when they do it can take a few days to get a replacement. She advised that anyone using a pump should have a "pump failure plan" that includes maintaining a current printout of pump settings and having some long-acting insulin on hand.
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To obtain a copy of the joint statement, http://dx.doi.org/10.2337/dc15-0168. To speak with someone at the Association, contact Madison Trimble at mtrimble@diabetes.org. The American Diabetes Association is leading the fight to Stop Diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit http://www.diabetes.org. Information from both these sources is available in English and Spanish.

American Diabetes Association

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