Diabetes Groups Urge Enhanced Trial, Registry Requirements

March 27, 2015

U.S. and European diabetes groups are recommending that an international registry be established to gather reports on insulin pump safety, citing lax EU device regulations that leave patients at risk.

The registry should include both technical and human errors and be searchable by keywords, components and pump, the groups say. It should also be publicly accessible.

The American Diabetes Association and the European Association for the Study of Diabetes also want pump makers to release information on how many people use their products and to be more transparent about clinical trial results. Manufacturers should publish data on their pumps’ compatibility with specific insulin formulations and infusion sets, how well pumps perform over years of clinical use, the results of tests on recalled and returned pumps, and changes to device functions or features.

Greater Scrutiny Needed

The groups also call for research organizations to fund independent clinical trials on the safety, efficacy and outcomes of insulin pumps, and to support new and existing registries.

The concerns, laid out in an article in the April issue of Diabetes Care, center on the CE mark system that Europe relies on to approve new devices, which is less rigorous than the U.S. FDA premarket process. In particular, the EU system allows manufacturers to start selling pumps in Europe before ever launching the level of clinical trials required by the FDA, says Anne Peters, director of the clinical diabetes program at the University of Southern California and a coauthor of the article.

The authors sought feedback from devicemakers but received only three responses, none of which included the detailed information around recalls and adverse events that they say are necessary to improve insulin pump safety, Peters tells IDDM.

“It’s naïve of me, not being in the industry, to tell industry what to do, but I know we don’t have data that helps me as a doctor understand safety and efficacy,” she says. Peters would like pump makers to release better data on pump durability to help her decide which devices to recommend to patients.

The FDA provided input on the report, Peters says.

Medtronic spokeswoman Pamela Reese says most of the actions called for by the ADA and EASD — such as premarket and postmarket quality procedures, rigorous clinical trials and continuous evaluation of customer feedback — are already policy at the company.

View the article at http://care.diabetesjournals.org/content/early/2015/03/13/dc15-0168.full.pdf+html. — Elizabeth Orr