The Diabetes Technology Society (DTS) has published a protocol that will allow a glucose meter to be tested to see if the meter meets the DTS seal of approval. This was instituted because for some FDA approved glucose meters, the performance of post release for sale meters from some companies did not meet ISO standards.
Before the DTS published their protocol, they published a new glucose meter error grid – the surveillance error grid.
But what I don’t understand is that the error grid is not part of the DTS acceptance criteria to gain the DTS seal of approval. (The error grid is plotted as supplemental material). Basically, to get DTS approval, one has to show that enough samples have differences from reference that fall within the ISO 15197:2013 standard. To be fair, the ISO standard and the “A” zone of the error grid have similar limits, but why not use the error grid, since the error grid was developed by clinicians whereas the ISO standard is weighted by industry members. And the error grid deals with results in higher zones.
Moreover, the DTS does not deal with outliers other than to categorize them – their presence does not disqualify a meter from getting DTS acceptance as long as the percentage of results within ISO limits is high enough.
So if a meter has a 1% rate of values that could kill a patient, it could still gain DTS seal of approval. This doesn’t seem right.