EASD/ADA to Lobby for Better Device Regulation in EU and US

October 02, 2014

VIENNA — The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) are collaborating to produce a joint statement on insulin pumps and other devices used to manage type 1 diabetes.

Such a document is required, experts told the recent European Association for the Study of Diabetes 2014 Meeting, "in recognition of the unacceptably low level of quality control and regulation of not just insulin pumps but medical devices in general in Europe."

And the system in the United States, while better, is far from perfect, they noted.

EASD president Andrew Boulton, from the University of Manchester, United Kingdom and University of Miami, Coral Gables, Florida, told a press conference at the meeting: "The registration and postmarketing surveillance is completely different for devices and drugs in the EU."

"We've tried to raise the profile of the safety of devices in diabetes with the European Medicines Agency, asking why we don't have a centralized European Devices Agency."

And although there is better surveillance of diabetes devices in the United States, with the Food and Drug Administration (FDA) collating adverse events for medical devices via the MAUDE database, it is still difficult to access and interpret the data reported, and it is subject to ascertainment bias, Anne Peters, MD, of University of Southern California, Los Angeles, told assembled journalists.

Hence, the EASD and ADA have partnered to try to improve the situation on both sides of the Atlantic.

Insulin Pumps Increasingly Used by Children and Adults

Optimizing glucose control is essential for preventing complications in diabetes, but it is difficult to achieve for most people with type 1 diabetes despite multiple daily insulin injections.

Insulin pumps are an alternative to numerous daily injections and provide a more flexible means of therapy, with a continuous subcutaneous insulin infusion.

They are being used by an expanding proportion of children, adolescents, and adults with type 1 diabetes and also in a small number of people with type 2 diabetes — they offer a range of adjustable settings and features and are increasingly smaller and more sophisticated.

But undetected interruption or malfunction of insulin infusion can result in diabetic ketoacidosis, hypoglycemia, and even death. This can occur due to pump failure, infusion-set blockage, user error, or a combination of these.

Also, as diabetes care becomes increasingly advanced, there are even more devices to consider: continuous glucose monitoring systems are linked up to insulin pumps to represent the so-called artificial pancreas, and other systems are also incorporating glucagon pumps [bionic pancreas].

Therefore, it is imperative that these devices are properly monitored, said John R. Petrie, professor of diabetic medicine at the University of Glasgow, Scotland.

"We have been tasked by the EASD and ADA to review the systems in place in the United States and Europe for evaluating the safety and clinical benefits of insulin pumps [and other devices]," he explained.

And Lutz Heinemann, PhD, of Profil Institute for Metabolic Research, in Neuss, Germany, added that it is vital that regulatory agents and manufacturers of these devices take physicians' views into consideration.

"What is needed is communication with the manufacturers of these devices. We will hopefully be able to make a difference by highlighting the clinical view on such devices," he noted

Lobbying EU Parliament, Working With FDA

In the European Union, the EASD and ADA intend to lobby for real change, and Dr. Boulton said they will be approaching the new European Union parliament "as soon as it is formed" to try to further discussion on this issue.

"We really need to be proactive," he added.

Dr. Heinemann agreed: "It will be a major step forward if they acknowledge the safety issues and open up a route for more detailed discussion."

Meanwhile, Dr. Peters explained the issues, as she sees them, in the United States.

"So much of the device safety is in the hands of the pump manufacturers; the [FDA] relies on the manufacturers to tell them if there is a problem, and there is not even a uniform way that data are reported. As a clinician, I cannot get data; I can only get reassurance that the pumps are reliable."

There is also a particular problem with insulin-infusion sets, which frequently clog and cause complications, she noted, adding that it "is not clear who regulates these."

"I get called every weekend by patients having problems with their devices," she added noting that the vast majority of pump-related adverse events are caused by human error.

"There are real limitations in the US, although we have more guidelines than you have in Europe. We as clinicians need to know more about this burgeoning technology, how these devices are monitored, and safety," she stressed.

But on a positive note, Dr. Peters said that following discussion with the FDA, the agency has asked for her aid, and she has been appointed as a consultant to help improve the way these devices are monitored.

Robust Systems Must Be Developed

Dr. Petrie told the meeting that to improve the safety and clinical effectiveness of insulin-pump therapy, the EASD and ADA are recommending that "more robust systems should be established for evaluation both premarketing and during marketed use."

These should include:

  • An increased requirement for testing of reliability and durability of function over time.

  • Commissioning of clinical research into the interaction between pump design and human factors.

  • A more systematic and transparent approach to the collection of adverse events.

  • Attention to the pump apparatus as a whole (ie, including the infusion set).

  • Greater support for long-term data collection within registries.

  • More well-controlled clinical trials under real-world conditions.

  • Harmonization of the approach between international regulatory bodies.

Dr. Peters has served as a consultant for Amylin/Lilly; Abbott Diabetes Care; Becton, Dickinson and Co; Janssen Pharmaceuticals; Medtronic; Perrigo; Roche; Takeda Pharmaceuticals; and Sanofi; and served as a speaker or a member of a speaker's bureau for Amylin/Lilly and NovoNordisk. Boulton has reported no relevant financial relationships.

European Association for the Study of Diabetes 2014 Meeting. September 16, 2014.

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