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BURLINGAME, CA, June 14, 2018 /24-7PressRelease/ -- Diabetes Technology Society (DTS) announces the Diabetes Care publication of its article on the findings of its Blood Glucose Monitor System (BGMS) Surveillance Program, entitled "Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors". The Program was established because of evidence that cleared BGMSs do not always achieve levels of accuracy matching either: 1) their performance that resulted in becoming cleared by FDA; or 2) international standards of accuracy. Poor performance of these devices can lead to adverse clinical and economic consequences. This surveillance program assessed the accuracy of 18 blood glucose monitoring systems (BGMSs) marketed in the USA across a wide range of blood glucose levels in the hands of trained professionals. These 18 BGMSs represented approximately 90% of the commercially available systems that were used from 2013 to 2015 by diabetes patients and obtained from consumer outlets.
The Surveillance Program followed a protocol developed by a Steering Committee and an Advisory Committee consisting of experts in BGMS from academia, medical practice, clinical chemistry, medical organizations, industry, and government, including Food and Drug Administration (FDA), CDC, NIH, and US Army.
The Diabetes Care article and the program results are intended to protect patients from inaccurate BGM products currently on the market by providing an independent assessment of the performance of cleared blood glucose monitors following FDA clearance against accepted standards. This information can assist patients, healthcare providers, and payers in making the right product selection.
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. Funding for the post-market surveillance program were provided by Abbott, the global healthcare company.
"This Diabetes Care article is important because it is the largest BGMS accuracy study ever conducted and will have a significant benefit to patients," says David Klonoff, M.D., founder of Diabetes Technology Society and Medical Director of the Diabetes Research Institute at Mills-Peninsula Medical Center in San Mateo, California. "Patients will benefit by payers, including Medicare, considering the implementation of safeguards to ensure patients have access to BGMSs that meet accuracy guidelines."
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, which is 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, with cooperation by the FDA, developed the most modern error grid for defining the clinical accuracy of blood glucose monitors called the Surveillance Error Grid. DTS presents the annual Diabetes Technology Meeting and the Digital Diabetes Congress. Diabetes Technology Society developed the first consensus standard with FDA input for verifying the cybersecurity of connected medical devices (DTSec) and the first consensus guidance for mobile phone control of these devices (DTMoSt) and is now working with IEEE and UL to expand their scope from diabetes devices to all medical devices.
For additional information, contact Fraya King at Diabetes Technology Society. 650-692-7100 ([email protected]) (www.diabetestechnology.org)
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