Why the Diabetes Technology Society Surveillance Protocol for Glucose Meters Needs to Be Revised

摘要

The Diabetes Technology Society surveillance protocol provides a seal of approval for a glucose meter if a sufficient number of a candidate glucose meter’s results meet ISO 15197:2013 limits. The protocol provides clear details about how to conduct this study and analyze the data but has two flaws. There is no specification about the size of glucose meter errors that are outside of ISO limits. A meter that has a result in the E zone of a glucose meter error grid could receive the DTS seal of approval. In addition, the protocol uses the ISO standard, which could be considered a “state of the art” standard instead of an error grid, which is a clinical standard. Remedies for these problems are to replace the ISO standard with an error grid and to include requirements for errors found in C or higher zones of an error grid.