Improved reporting of adverse events associated with insulin pumps and increased funding of registries and clinical studies that evaluate the safety of these devices are among the recommendations included in a statement by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).
Insulin pumps “appear to provide clinically important and increasing benefits for people with diabetes,” leading to their acceptance by the international diabetes community. However, “there are associated challenges, including potential risks to users,” according to the diabetes technology working group of the ADA and the EASD.
The two organizations reviewed the current approach to the evaluation of the clinical safety of insulin pumps, with the aim of considering “how health care professionals, pump manufacturers, regulatory authorities, and policymakers can best ensure the safety of new and long-standing users of insulin pumps, as the technology continues to develop,” according to the statement, which is in the April issue of Diabetes Care (2015;38:1-7 [doi:10.2337/dc15-0168).
While the rapidly evolving technology in diabetes treatment is “certainly a good thing, we don’t have very good postmarketing surveillance for devices such as insulin pumps, particularly in Europe where manufacturers often introduce products prior to releasing them in the United States,” Dr. Anne Peters, director of the University of Southern California Clinical Diabetes Program, Los Angeles, and one of the statement’s authors, said in a press release issued by the ADA. “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.”
The working group reviewed evidence from published studies, regulatory authorities, manufacturers of pumps, and other sources. Among the conclusions is that there is a need for a more “standardized and transparent approach to identifying, reporting, and cataloging” adverse event reports, which would help patients and health care providers understand the risks of insulin pump therapy more clearly.
The statement refers to limitations of the postmarketing adverse event reporting systems for devices in the United States and in Europe, MAUDE (Manufacturer and User Facility Device Experience) and EUDAMED (European Databank on Medical Devices). For example, EUDAMED data are not accessible to the public and the MAUDE database is difficult to search.
The statement recommends specific actions that should be undertaken by five groups: regulators, pump manufacturers, professional societies, research funding bodies, and health care teams. For their part, health care teams should “encourage and support pump users under their care to report all” adverse events, and should provide structured training and regular updates for their patients who use pumps, based on standards set by national and international guidelines,
Professional societies should “provide updated evidence-based guidelines on indications for insulin pump therapy,” and “set standards for levels of staffing and skills” for health care teams.
Patient registries have collected information on metabolic control of patients. They should expand their scope to include more data on adverse events associated with insulin pumps and other information, according to the statement. More funding should be provided for trials that evaluate clinically relevant issues, and manufacturer-funded trials should be conducted by “independent investigators to minimize bias and credibility.”
The authors estimated that there could be 750,000 to 1 million pump users worldwide and that most pump users have type 1 diabetes. But a more accurate estimate would be useful to more reliably calculate the rates of malfunctioning pumps and human errors, they added.
Members of the working group did not receive honoraria for writing the manuscript or attending related meetings; their travel costs were paid by the EASD and ADA. Most of the members work with industry, and disclosures included having served as advisers or consultants to companies that manufacture diagnostic or therapeutic products for diabetes. Dr. Peters disclosed having served as a consultant for Medtronic/MiniMed, and having served as a consultant and/or speaker for non–device-related companies.