Experts Debate Surveillance Program for Glucose Monitors

Miriam E. Tucker

September 12, 2013

In This Article

An ambitious new plan for postmarket surveillance of glucose testing equipment in the US aims to ameliorate recently identified accuracy problems, but attendees at a meeting earlier this week admitted that quite a few details still need to be ironed out.

David Klonoff, MD, from the University of California, San Francisco, presented his proposal for the Diabetes Technology Society's Blood Glucose Monitor Surveillance Program on September 9 at a daylong workshop entitled "Verifying the Performance of Blood Glucose Monitors Following FDA Clearance."

Dr. Klonoff, who is also the president of the Diabetes Technology Society, said: "Our organization is very interested in this public-health issue, which is to see that safe blood glucose monitoring systems are available for patients."

He said the surveillance program's purposes would include providing "independent assessment of whether cleared blood glucose monitors perform according to [Food and Drug Administration]–accepted standards" and generating "information that can assist product selection by patients, healthcare providers, and payers."

Concern on this topic has arisen since the new competitive-bidding program of the Centers for Medicare and Medicaid Services (CMS) launched July 1. This attempts to steer more Medicare beneficiaries to lower-cost nonbranded glucose testing equipment. But several studies — most, but not all of them, industry-funded — claim that once on the market, some of these nonbranded glucose meters perform below par.

Dr. Klonoff's proposed surveillance plan was generally endorsed at the workshop by representatives from the Food and Drug Administration (FDA), industry, academia, government, professional organizations, and patient-advocacy groups. However, participants raised several issues that will need to be addressed first.

For one, to make such a surveillance plan mandatory, the FDA would likely have to endorse the rulemaking process, which can take years. Second, funding for the program must be obtained, and a decision made as to whether industry should be among the funders. Moreover, there are questions about enforcement: What would happen if a brand is found to be out of compliance with FDA standards, and should compliance be tied to Medicare coverage?

There was also some drama at the workshop, when several participants took issue with statements made by CMS representative Elizabeth A. Koller, MD. She suggested that glucose test accuracy standards might not need to be as stringent for many Medicare beneficiaries, most of whom have type 2 diabetes, because the evidence is lacking for a clear benefit from intensive glycemic control in this type of diabetes.

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