How loss of market share affects standards

DSC00426edpTWhen the 2003 ISO standard for glucose meter performance was prepared, the regulatory affairs people of industry controlled the standard. The standard called for 95% of results above 75 mg/dL to be within a total error of ± 20%. The standard was said to be based on medical requirements – clearly it was not based on state of the art since glucose meters perform better.

A problem probably unforeseen by these regulatory people was that a bunch of new players entered the glucose meter market and of course had no trouble getting FDA approval – the FDA used the ISO standard in its approval process. The number of meter brands on the market grew from 32 in 2005 to 87 in 2014. And some of the new meters sold their strips at a much lower price than the major manufacturers. This caused the four major companies to lose some market share.

Industry still plays a dominant role in glucose meter standards, but it seems that the original regulatory affairs people are out. Now, industry is working with the Diabetes Technology Society to certify glucose meters under new performance standards. Thus, meters that have FDA approval will be tested according to the tighter 2013 ISO standard and only meters that pass will receive a seal of approval from the Diabetes Technology Society.

Klonoff DC, Lias C, Beck S Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol. J Diabetes Sci Technol, in press. available at


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