The body of published research and positions on blood glucose monitoring quality continues to grow. Together, these articles paint a picture that is cause for concern. Below are some of the most recent articles and studies focused on this issue.
• Larry Ellingson and Christopher Parkin. On the Bus or Under the Bus? Is the Current Healthcare System is Endangering Elderly Diabetes Patients. Journal of Diabetes, Metabolic Disorders & Control. Volume 2 Issue 1 – 2015.
This editorial presents an overview of the failings of the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS to ensure access to accurate glucose monitoring systems and discusses how medical associations and patient advocacy groups are working to address this troubling situation.
• David C. Klonoff, M.D., Courtney Lias, Ph.D., Robert Vigersky, M.D., William Clarke, M.D., Joan Lee Parkes, Ph.D., David B. Sacks, M.D., M. Sue Kirkman, M.D., and Boris Kovatchev, Ph.D. The Surveillance Error Grid. Journal of Diabetes Science and Technology. Volume8, Issue 4, July 2014
This article details the work of many industry, government and academic experts to develop a new error grid, called the surveillance error grid (SEG) as a tool to assess the degree of clinical risk from inaccurate blood glucose (BG) monitors. This is an important issue because the error grids currently used for assessing clinical accuracy of blood glucose monitors are based on out-of-date medical practices. Error grids have not been widely embraced by regulatory agencies for clearance of monitors, but this type of tool could be useful for surveillance of the performance of cleared products.
This article summarizes the outcomes of a public meeting in May 2021 that discussed the accuracy of blood glucose monitors. The meeting determined there are accuracy concerns with some blood glucose monitors.
This article compares seven systems against current and proposed accuracy criteria. Only three of the seven systems tested met accuracy criteria, and only one met the proposed ISO criteria.
This editorial piece demonstrates the need for a shift toward testing the accuracy of blood glucose meters in the hands of patients, and calls for a roundtable to discuss how this testing could be moved forward.
This original article provides analysis of the Brazg article, and concludes that changes including mandatory post-marketing testing requirements and mandatory testing of three strip lots when performing the system accuracy evaluation may be required to better ensure meter accuracy.
This study used computer simulation to uncover information about the relationships among SMBG errors, risk for hypoglycemia, glucose variability, and long-term glycemic control. Results showed that number of parameters of glycemic control deteriorated substantially with the increase of permitted SMBG errors.
This article evaluated 27 blood glucose monitoring systems and found that only sixteen fulfilled the minimum accuracy requirements of the standard.
This article completely assessed 34 systems (for 9 systems complete accuracy assessment was not performed due to an oxygen sensitivity) and found that 7 systems did not fulfill the minimal accuracy requirements of the ISO standard.
There is a significant association between diabetes and cardiovascular disease and stroke. Two out of three people with diabetes die from heart disease or stroke.3