Blood Glucose Monitor Accuracy

The Issue

In January of 2014, the FDA released a draft of their guidelines related self-monitoring of blood glucose (SMBG) systems and point-of-care blood glucose monitoring systems (BGMS). The FDA admits that it faces issues with overseas manufacturers of generic pharmaceutics. Recent studies show up to 45% of SMBG systems being marketed globally to people with diabetes do not meet the minimum accuracy requirements defined in the ISO 15197 standard. The FDA may approve an SMBG system without lot-to-lot testing and/or reporting that data if they have it. Also, the FDA doesn’t require manufacturers of SMBG systems to provide medical device reporting (MDR) of adverse events associated with the use of their monitors.

The DLC’s Stance

We support and encourage the FDA to take four important actions to ensure the accuracy of blood glucose monitors.

  1. Critically review its current criteria for approval of SMBG systems
  2. Require more comprehensive testing of the accuracy and precision of these systems by independent laboratories and institutions
  3. Continuously monitor the accuracy and precision of these systems once they are in the market
  4. Retroactively apply new FDA criteria to all SMBG systems currently marketed in the U.S. in order to better ensure patient safety, facilitate improved long-term glycemic control, and help reduce the financial burden of diabetes

Our Activism

Improving blood glucose monitor accuracy has measurable, positive effects on the lives of people with diabetes, and the healthcare system that supports them. Read our full Resolution on Blood Glucose Monitor Accuracy, our letter to the FDA, and DLC Chairman, Larry Ellingson’s piece in the Journal of Diabetes, Metabolic Disorders, and Control, “On the Bus or Under the Bus? Is the Current Healthcare System Endangering Elderly Diabetes Patients?”