Diabetes Technology Society Announces Launch of Surveillance Program for Blood Glucose Monitors
On May 20, the Diabetes Technology Society (DTS) announced the launch of a post-market blood glucose monitoring surveillance program, which will aim to assess and monitor the accuracy of meters and strips after they are approved. As we outlined last year, test strips and monitors are currently only tested for accuracy prior to FDA approval, and companies can self-report their own data. The DTS surveillance program plans to setup independent, third-party centers to routinely test the accuracy of meters and strips after they are out on the market. With initial funding from Abbott, a Steering Committee will meet next month in Washington DC to begin hammering out the program’s details. The committee consists of world-class experts in blood glucose monitoring, diabetes, and laboratory methods from academia, medical practice, government, industry, and medical organizations.
We were encouraged to hear that patient advocacy group(s) will be represented in a future Advisory Board that will be established soon. Ultimately, DTS hopes to publish the accuracy data to inform patients, payers, and regulators like the FDA about which products meet or fail accuracy standards. Hopefully, this effort will increase transparency, raise the level of conversation around test strip accuracy, and drive inaccurate products off the market. Particularly now that competitive bidding can prioritize affordability over accuracy in blood glucose monitoring (read more about its effect on test strips and meters here), it is imperative that DTS and other diabetes advocates are pushing to create a safer, more accountable system for determining the accuracy of meters and strips. –AJW