Consensus GuidelinePRESS RELEASE: Performance Requirements for CGMS

Overview

The DTS Performance Guideline organizes the evidence needed to judge whether the performance of a CGM system is adequate for a particular purpose, population, and practice setting. This guideline also addresses technical concepts, such as interoperability, artificial intelligence, and machine learning for CGM systems.

This 14-chapter guideline was developed through multiple rounds of review, revisions, and discussions involving 77 panelists from 20 countries across six continents. Stakeholders spanned clinical medicine, laboratory medicine, engineering, regulatory science, informatics, and patient representation.

The DTS Performance Guideline was developed with regulatory use in mind. It incorporates clear normative language, mapping to recognized standards, manufacturer checklists, and a sample protocol. Its ultimate goal is to help people with diabetes trust the accuracy and reliability of the CGM data that guide their treatment decisions, as well as to provide a clear framework for manufacturers, regulators, investigators, clinicians, and payers.

To accompany the DTS Performance Guideline, DTS has prepared an editorial that summarizes the guideline. It is being published today in Journal of Diabetes Science and Technology.

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