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Diabetes Technology Society Outlines Potential Post-clearance Surveillance Program To Address Inaccuracy Of Blood Glucose Monitors
Date:9/13/2013

isco. "As a community, we need to seize this opportunity to work together to establish and implement a mandatory post-market surveillance program that will help ensure the safety of diabetes patients."

This meeting was convened following a May forum where diabetes experts reviewed post-market studies and found that some SMBG systems did not meet accuracy standards post-FDA clearance. Meter inaccuracy poses a significant health threat to patients that use these meters to guide treatment decisions including the proper dose of insulin.

About the May 2013 DTS Meeting
On May 21, 2013, the Diabetes Technology Society convened a public meeting "Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?" in Arlington, Va. This meeting publicly established monitor inaccuracy as a critical issue for the first time. The Diabetes Technology Society published a full meeting summary in the July edition of Journal of Diabetes Science and Technology.

About Blood Glucose Monitoring
The Centers for Disease Control and Prevention estimate 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 Tec
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SOURCE Diabetes Technology Society
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