DCP Takes Action

Raising Standards to Ensure Greater Accuracy

New International Organization for Standardization (ISO) regulations, the common gold standard for meter accuracy worldwide, were approved on April 16, 2021, and it has been made clear that the FDA will seek to introduce tighter standards for self-monitoring blood glucose systems (SMBG) products to be commercialized in the United States. While manufacturers must attain target accuracy measures to receive FDA clearance, research shows that meters fail to consistently meet quality standards post clearance.1, 2, 3, 4 Following initial FDA clearance, manufacturers are required to have reliable quality systems in place to ensure products continue to meet system performance claims required by FDA and ISO standards.5

In the U.S., more comprehensive independent testing of the accuracy of these systems, and continuous monitoring of the accuracy of these systems once they are on the market is necessary. Recent studies indicate the reduction of SMBG system errors would significantly reduce the incidence of undetected severe hypoglycemia, therefore improving glycemic control, which would not only improve the quality of life for patients, but lead to significant cost savings.6, 7, 8 As a critical component of patient care, it is necessary that SMBG systems be as accurate and consistent as possible in order to ensure quality and reduce the burden on our country’s health system.

The Diabetes Care Project is helping raising awareness of this issue by working with advocacy partners and meeting with industry leaders.

Read more about this issue in Kaiser Health News, The Gray Sheet (May 2021) and The Gray Sheet (Janurary 2014).

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References

  1. Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug, C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010;12(3):221-231
  2. Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2021;7(1):144-152
  3. Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012;6(5):1076-1086
  4. Blood Glucose Meters 2021. Diabetes Forecast. American Diabetes Association. 2021.
  5. US Food and Drug Administration. Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. Accessed March 20, 2021, from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094134.htm
  6. Breten MD, Kovatchev BP. Impact of blood glucose self-monitoring errors on glycemic variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study. J Diabetes Sci Tech 2010;4(3)563-570
  7. Fitch K, Iwasaki K, Pyenson B. Improved management can help reduce the economic burden of type 2 diabetes: a 20-year actuarial project. Millman Client Report, April 28, 2010
  8. Aagren, Luo W. Association between glycemic control and short-term healthcare costs among commercially insured diabetes patients in the United States. J Med Economics. 2011;4(1):108-114.

 

Did You Know?

1 out of 3 Medicare dollars is spent on diabetes, with a high percentage attributed to tertiary illness caused by unmanaged or undermanaged diabetes.5