Foster City, Ca. May 20, 2014—Diabetes Technology Society (DTS) is pleased to announce the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This program is intended to protect patients from inaccurate BGM products currently on the market. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers, and payers in making the right product selection.
After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post clearance. Low-quality BGM systems can negatively impact the ability of people with diabetes to reliably monitor their blood glucose levels and can lead to adverse health effects. Efforts by the FDA to improve accuracy standards for pre-market clearance would have little impact if performance was not maintained post-market, so a post-market surveillance program is critically important to ensuring the accuracy of cleared products for people with diabetes.
A Steering Committee and an Advisory Committee will be formed consisting of experts in blood glucose monitoring from academia, medical practice, clinical chemistry, government, industry, and medical organizations. Patient advocacy group(s) will be represented. A protocol to assess BGM System performance will be developed and then product testing will begin. It is expected that the information generated by this program will inform patients, payers, and regulators as to which cleared products actually perform accurately in a real world standardized environment.
FDA supports a BGM Surveillance program to protect public health. The agency has agreed with the concept of a surveillance plan and has stated that it will act on information that it receives on low-quality BGM products, including from surveillance testing. Initial funds to get the post-market surveillance program started have been committed by Abbott, the global healthcare company. The project will begin this month.
“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and Clinical Professor of Medicine at University of California, San Francisco. “Patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program. I encourage other manufacturers to come forward to join Abbott in support of this program.”
About Diabetes Technology Society
Diabetes Technology Society is a non-profit educational organization dedicated to promote development and use of technology to help people with diabetes. DTS publishes Journal of Diabetes Science and Technology, the world’s largest scientific journal devoted to new technologies in the fight against diabetes, including glucose monitoring, insulin delivery, the artificial pancreas, software, wireless health solutions, social media, and bioengineered solutions for treating obesity. DTS presents the annual Diabetes Technology Meeting, the Hospital Diabetes Meeting, the Certified Diabetes Technology Clinician certification meeting in the US and in Europe, and the Tissue Response to Implanted Active Medical Devices Meeting. DTS has developed a Personalized Medicine Diabetes Program for the US Air Force. DTS is currently spearheading development of a new error grid for defining clinical accuracy of a blood glucose monitor in cooperation with FDA, American Diabetes Association, The Endocrine Society, and Association for Advancement of Medical Instrumentation.