Clinicians, Patients and Device Manufacturers Discuss Options for Verifying the Performance of Meters and Strips Post FDA-Clearance
FOSTER CITY, Calif., Sept. 13, 2013 /PRNewswire-USNewswire/ -- Diabetes experts met this week in Bethesda, Md., to identify new measures to ensure the safety of patients using potentially inaccurate self-monitoring blood glucose (SMBG) systems. This meeting comes on the heels of recent evidence demonstrating that some monitors fail to consistently meet accuracy standards post-FDA clearance. On Sept. 9, the U.S. Food and Drug Administration (FDA), clinical experts and device manufacturers, at a meeting convened by the Diabetes Technology Society (DTS), discussed the need for improving post-market surveillance and quality assurance.
During the meeting, DTS presented a plan to develop a mandatory post-market surveillance program that could provide independent assessment of FDA-cleared SMBG systems to ensure they maintain accuracy standards. The program would be led by a diverse steering committee and implemented in several labs across the U.S. and outside of the U.S. This program could deliver performance verification information to the FDA and generate information to assist patients, healthcare providers and payers with product selections. Next steps for the program include:
- Forming a steering committee of regulators, clinicians, payers, advocates, industry and patients to develop program protocols
- Consulting with the FDA to ensure regulatory compliance and validity of the program
- Seeking funding for the program
- Collaborating with the entire diabetes community to achieve the mutual goal of patient safety
"The Diabetes Technology Society thanks everyone, particularly the FDA, for their participation in this critically important meeting," said David Klonoff, M.D., President of the Diabetes Technology Society and Clinical Professor of Medicine at the University of California, San Francisco. "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 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.
SOURCE Diabetes Technology Society