EXPERTS AGREE: INACCURATE BLOOD GLUCOSE MONITORS ON THE MARKET MAY BE PUTTING PATIENTS AT RISK
Experts in Glucose Monitoring Identify a Need to Improve and Enforce Meter Quality
Foster City, CA, May 28, 2013 /PRNewswire/ — Diabetes experts met and determined that some self-monitoring blood glucose (SMBG) systems, despite meeting accuracy standards at the time of U.S. Food and Drug Administration (FDA) clearance, fail to consistently meet accuracy standards once on the market, potentially putting patient health at risk. In a public meeting convened by the Diabetes Technology Society on May 21, 2013, in Arlington, Virginia, leading academic clinicians, clinical chemists, medical device experts, patient advocates and FDA representatives reviewed a growing body of peer-reviewed research demonstrating that the performance of some blood glucose monitors on the market may not be meeting accuracy standards.
“We have a problem, particularly with some low-cost glucose meters,” said David Klonoff, M.D., President of the Diabetes Technology Society and Clinical Professor of Medicine at the University of California, San Francisco. “Meters help patients to make important decisions about how to treat their diabetes – everything from diet and exercise to determining how much insulin to take. Inaccurate meter readings can lead to inaccurate insulin doses. Too much insulin can bring blood glucose levels down to dangerously low levels, putting the patient at risk of a hypoglycemic event or hospitalization. It’s going to be critical that industry, clinicians, academicians, regulators and the diabetes community continue to work to ensure every patient has an accurate meter they can rely on.”
Panelists reviewed a body of evidence demonstrating blood glucose monitors do not consistently meet accuracy standards post-FDA clearance.
- A study presented by Dr. Guido Freckmann of the Institut für Diabetes Technologie, (Germany) and published in the September 2012 edition of Journal of Diabetes Science and Technology showed of the 34 SMBG systems fully evaluated, seven did not meet current accuracy standards.
- A second study presented by Dr. Guido Freckmann published in the same edition of Journal of Diabetes Science and Technology showed there was considerable variability between SMBG test strip lots with three of the five systems studied, and only two systems met accuracy standards with each test strip lot.
- A study presented by Dr. Ronald Brazg of the Rainier Clinical Research Center and published in January 2013 edition of Journal of Diabetes Science and Technology showed only three of seven SMBG systems tested consistently met current accuracy standards.
Until recently, the international standard for blood glucose monitoring, known as the ISO standard, required that 95 percent of normal or elevated readings by blood glucose monitors be within +/- 20 percent of the true value. New international standards for blood glucose are expected to require 95 percent of normal or elevated readings by blood glucose monitors fall within +/- 15 percent of the true value. FDA stated at the May 21 meeting that they will be issuing new formal guidance on accuracy standards to guide product development and ensure the safety of products currently on the market.
The Diabetes Technology Society convened the meeting “Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?” on May 21, 2013. The meeting focused on addressing this critical issue and was attended by 150 people from the U.S., Canada and Europe. A full meeting summary will be published in an upcoming edition of Journal of Diabetes Science and Technology.
About Blood Glucose Monitoring
Centers for Disease Control and Prevention estimates that 18.8 million people in the U.S. have diagnosed diabetes and another seven million may be undiagnosed, impacting approximately 25.8 million people. People rely on blood glucose monitors as the foundation of diabetes self-management. Under a self-monitoring of blood glucose (SMBG) regimen, a patient uses a system (meter and strip) to monitor his or her blood glucose levels throughout the day. Patients take actions based upon the readings and the treatment plan prescribed by their healthcare professional. Physicians also use the results to optimize each patient’s therapy. The goal is to maintain normal glucose levels and minimize the risk of dangerously low or high glucose levels. The need to ensure accurate readings is critical to avoid unintended consequences.
About Diabetes Technology Society
Diabetes Technology Society (DTS) is a nonprofit organization committed to promoting development and use of technology in the fight against diabetes. DTS was established in 2001 by David C. Klonoff, M.D., F.A.C.P., Fellow A.I.M.B.E., Clinical Professor of Medicine at University of California, San Francisco. The DTS mission is to spearhead collaborative efforts by experts in academia, clinical practice, industry and government to accelerate development of practical technology for treating, monitoring, diagnosing and preventing diabetes mellitus and its complications. DTS publishes Journal of Diabetes Science and Technology.
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Why We Had The Meeting
Data and Implications