The Development of New Composite Metrics for the Comprehensive Analytic and Visual Assessment of Hypoglycemia Using the Hypo-Triad.

Abstract

Quantifying hypoglycemia has traditionally been limited to using the frequency of hypoglycemic events during a given time interval using data from blood glucose (BG) testing. However, continuous glucose monitoring (CGM) captures three parameters-a Hypo-Triad-unavailable with BG monitoring that can be used to better characterize hypoglycemia: area under the curve (AUC), time (duration of hypoglycemia), and frequency of daily episodes below a specified threshold. We developed two new analytic metrics to enhance the traditional Hypo-Triad of CGM-derived data to more effectively capture the intensity of hypoglycemia (IntHypo) and overall hypoglycemic environment called the "hypoglycemia risk volume" (HypoRV). We reanalyzed the CGM data from the ASPIRE In-Home study, a randomized, controlled trial of a sensor-integrated pump system with a low glucose threshold suspend feature (SIP+TS), using these new metrics and compared them to standard metrics of hypoglycemia. IntHypo and HypoRV provide additional insights into the benefit of a SIP+TS system on glycemic exposure when compared to the standard reporting methods. In addition, the visual display of these parameters provides a unique and intuitive way to understand the impact of a diabetes intervention on a cohort of subjects as well as on individual patients. The IntHypo and HypoRV are new and enhanced ways of analyzing CGM-derived data in diabetes intervention studies which could lead to new insights in diabetes management. They require validation using existing, ongoing, or planned studies to determine whether they are superior to existing metrics.