Analysis of the performance of the OneTouch SelectSimple blood glucose monitoring system: why ease of use studies need to be part of accuracy studies.

The article entitled "Precision, Accuracy, and User Acceptance of the OneTouch SelectSimple Blood Glucose Monitoring System" by Philis-Tsimikas and colleagues in this issue of Journal of Diabetes Science and Technology demonstrates that the OneTouch® SelectSimple™ glucose meter meets current regulatory expectations for glucose meter performance. These authors describe three studies: precision, accuracy, and ease of use. Accuracy study analysis includes the effects of accuracy and precision. The ease-of-use study was analyzed separately, as recommended by the International Organization for Standardization 15197 glucose standard. The ultimate goal of an evaluation is to estimate the distribution of errors (from any source) that will be experienced in routine use. To accomplish this, ease-of-use results need to be part of the accuracy dataset.