Analysis of “Seven Year Surveillance of the Clinical Performance of a Blood Glucose Test-Strip Product”

Abstract

The article titled “Seven Year Surveillance of the Clinical Performance of a Blood Glucose Test-Strip Product” by Setford and coworkers in this issue of Journal of Diabetes Science and Technology is an impressive study showing that over 7 years in three clinics, using multiple reagent lots, a total of 73 600 samples met the ISO 15197 2015 standard with no results in the D or E zones of a Parkes glucose meter error grid. Three requirements are suggested for a clinically acceptable glucose meter. The authors provide strong evidence for meeting two requirements but fail to provide summarized data about the number of nonnumeric results. Finally, the authors overstate some results, called “spin” by some which is not necessary. The superb results should stand on their own.