Deciding performance standards for glucose meters has been controversial and challenging. In spite of effort in the late 1970s and 1980s by both FDA and CDC, no universally accepted standards or testing methods have been developed for the measurement of glucose. CDC (Centers for Disease Control and Prevention) recently held a standards conference and is exploring the possibility of developing a standard reference material for whole blood.
The ADA has recommended accuracy goals twice over the past twenty years, once in 1986 (target accuracy of +/- 15%) and once in 1993 (target accuracy of +/- 5%) No company that manufacturers glucose meters has developed a cost-effective system to meet these goals. A number of alternative standards have been suggested by national standards organizations in the U.S., Canada, and Europe. An international standard ISO DIS 15197 is currently under development that recommends accuracy of +/- 20 mg/dl for glucose values under 100 mg/dl and +/- 20% for higher glucose values.
Although data on glucose meters continue to show variable performance, the newest generations of meters are simpler to use and more accurate than older models. Improvements in the chemical, mechanical and software components of glucose meters are continuing to help with the management of diabetes.
