A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance.

Many continuous glucose monitoring (CGM) systems provide functionality which alerts users of potentially unwanted glycemic conditions. These alerts can include glucose threshold alerts to call the user's attention to hypoglycemia or hyperglycemia, predictive alerts warning about impeding hypoglycemia or hyperglycemia, and rate-of-change alerts. A recent review identified 129 articles about CGM performance studies, of which approximately 25% contained alert evaluations. In some studies, real alerts were assessed; however, most of these studies retrospectively determined the timing of CGM alerts because not all CGM systems record alerts which necessitates manual documentation. In contrast to assessment of real alerts, retrospective determination allows assessment of a variety of alert settings for all three types of glycemic condition alerts. Based on the literature and the Clinical and Laboratory Standards Institute's POCT05 guideline, two common approaches to threshold alert evaluation were identified, one value-based and one episode-based approach. In this review, a critical discussion of the two approaches, including a post hoc analysis of clinical study data, indicates that the episode-based approach should be preferred over the value-based approach. For predictive alerts, fewer results were found in the literature, and retrospective determination of CGM alert timing is complicated by the prediction algorithms being proprietary information. Rate-of-change alert evaluations were not reported in the identified literature, and POCT05 does not contain recommendations for assessment. A possible approach is discussed including post hoc analysis of clinical study data. To conclude, CGM systems should record alerts, and the episode-based approach to alert evaluation should be preferred.