Session Will Address Research about Accuracy of Blood Glucose Monitors
David Klonoff, MD, FACP, FRCP
Not all blood glucose monitors are created equal. In fact, sometimes devices that are cleared by the U.S. Food and Drug Administration according to its strict 510{k} process may operate below analytical accuracy levels mandated by ISO and by the latest FDA 2016 Point-of-Care Guidance.
David Klonoff, MD, FACP, FRCP (Edin), Fellow, AIMBE, Medical Director, Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, Calif., will present data for the first time at a scientific meeting from the results of the Surveillance Program for Cleared Blood Glucose Monitor Systems that he chaired. The program looked at the performance of the 18 leading selling blood glucose monitors in the United States to see which ones would perform according to current ISO standards. The session will begin at 3:45 pm today in Room 130-133.
“There has not been an established program in place to ensure that these products continue to meet the performance levels for which they were cleared,” said Dr. Klonoff. “There are reasons why the accuracy of cleared products can degrade over time in some cases and I will discuss some of these reasons.”
Dr. Klonoff plans to cover examples of diabetes devices that require accuracy to perform properly and examples of new metrics for measuring both analytical accuracy and clinical accuracy. Additionally, he will present benchmarks of both types of accuracy that these devices should be attaining and cover point accuracy and trend accuracy of continuous glucose monitors and accuracy of A1C assays. He will also discuss the need for accuracy of dosing from insulin pens and pumps, which must deliver assigned doses of insulin as intended so they can ensure safe therapy.
“It is important for diabetes clinicians to understand the benefits of accurate performance and the limitations of inaccurate products. Lack of accuracy will result in poor performance and poor outcomes,” he said. “Clinicians should seek out products to recommend to their patients that have documented accuracy.”
Dr. Klonoff added that his goal is to insure diabetes educators are equipped with the latest knowledge regarding continual accuracy levels of blood glucose monitoring devices.
“One might assume that any medical product that has been cleared by the FDA will continuously perform at the level for which it was cleared or at the level claimed by the manufacturer at the time of clearance. This is not necessarily the case for some products. Be a cautious informed clinician, consumer, and payer when it comes to medical devices that depend on delivering a level of accuracy,” he said.
