ADA, EASD Call for Better Insulin-Pump Safety Standards

Miriam E Tucker

March 17, 2015

The safety of insulin-pump technology can be improved by adopting a "more rigorous, standardized, and transparent approach," the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) say in a joint statement issued this week.

The statement, published online in Diabetes Care and Diabetologia by Lutz Heinemann, PhD, of Science & Co, Dusseldorf, Germany, and colleagues, outlines the current limitations of regulatory measures to ensure diabetes device safety in both the United States and Europe and issues a set of recommendations aimed at achieving "meknovigilance," a word derived from the Greek mekhanikos, meaning "pertaining to machines."

The need for such a document for lobbying efforts was discussed last September at the EASD's annual meeting in Vienna, where participants noted that even with the most modern insulin pumps, adverse events such as occlusions, infusion-site problems, and insulin instability occur on a regular basis, but data on the incidence of such events and subsequent harms are difficult to obtain publicly in the United States and impossible in Europe.

Moreover, regulatory requirements for initial clearance and postmarketing study of the technology also need improvement to ensure safety and efficacy, the authors say.

Coauthor John R Petrie, professor of diabetic medicine at the University of Glasgow, Scotland, told Medscape Medical News that the new statement was prompted by "a concern that rates of diabetic ketoacidosis should be better in pump users than in those on multiple daily injections, but they are the same. And there is a risk of a poor-quality product receiving approval."

The paper issues separate specific recommendations for regulators, pump manufacturers, professional societies, funding bodies, and healthcare teams, all with the same goal: "We are great supporters of pump therapy and believe that our recommendations will ultimately contribute to better outcomes for people living with type 1 diabetes," Dr Petrie said.

Asked to comment, American Association of Clinical Endocrinologists (AACE) president elect George Grunberger, MD, chair of the Grunberger Diabetes Institute, Bloomfield Hills, Michigan, told Medscape Medical News, "I agree wholeheartedly with its premise and emphasis on safety and ongoing vigilance in that area. We really need an organized and systematic way to see all the data from the manufacturers so we can evaluate that form of therapy for appropriate patients objectively."

Dr Grunberger added, "There is really nothing new in that statement, but it's well presented and hopefully will lead to the desired action on the part of manufacturers and regulators."

He also pointed out that the issue of safety was addressed in a 2014 AACE/American College of Endocrinology statement — cited in the ADA/EASD paper — calling for better insulin-pump training for both patients and providers.

Recommendations for All Stakeholders

For healthcare providers, the authors' advice is to "encourage and support pump users under their care to report all adverse events" and to "provide structured training/regular updates for pump users under their care according to standards set by national and international guidelines."

Recommendations for the other stakeholders include the following:

  • For both US and EU regulators, harmonize both pre- and postmarketing standards to be met by pump manufacturers, develop and maintain a publicly searchable database for adverse-event reporting, and publish an annual summary of regulatory activities.

  • For pump manufacturers, provide the regulators with information about the number of users of their devices, the results of clinical research into human factors associated with newly introduced design features, updates on the compatibility of their pumps with various insulins and infusion sets (including those made by other companies), long-term efficacy, results of testing on pumps that are recalled/returned, and open listings of changes in function or features.

  • For international and national professional societies, provide updated evidence-based guidelines on indications for insulin-pump therapy, recommend appropriate structured education for new and established pump users, and set training and staffing standards for healthcare professionals who provide initial and ongoing pump user support (along with supporting reimbursement for such activities).

  • For international and national research funders, provide support for well-designed independent clinical trials of safety, efficacy, and outcomes under real-world conditions and for long-term data collection via registries.

Same Rules Should Apply to CGM and "Artificial-Pancreas" Systems

Dr Petrie told Medscape Medical News that the same principles of transparency should apply to the emerging component technologies, including pumps integrated with glucose meters and continuous glucose monitoring devices as well as the algorithms being developed to create closed-loop "artificial-pancreas" systems.

While the standards being applied to such integrated technologies are already stricter than those applied to stand-alone pumps in the past, "the principles of transparency that we call for will still be necessary — and these devices are still far from being suitable for everyday use. We will look at them when the time comes," he said.

In response to a question from Medscape Medical News as to whether the authors had modeled the potential costs to the various stakeholders of carrying out the recommendations, Dr Petrie said that while they had not done that, "several of the high-quality manufacturers have seen our recommendations and believe them to be reasonable."

No honoraria were received by members of the ADA–EASD Diabetes Technology Committee for writing the manuscript or for the associated meetings, although travel costs were covered by the EASD and ADA. Most of the members of the committee work with industry, but the industry is considered to have had no impact on the manuscript or its content by reviewers from the ADA and EASD. Prof Petrie has served on an advisory board for one company manufacturing medical diagnostic devices (Alere) and for a number of companies manufacturing pharmaceuticals used in the treatment of diabetes.

Diabetes Care. Published online March 16, 2015. Article

Diabetologia. Published online March 16, 2015. Article

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