The Relationship Between the Percent Coefficient of Variation of Sensor Glucose Levels and the Risk of Severe Hypoglycemia or Non-Severe Hypoglycemia in Patients With Type 1 Diabetes: Post Hoc Analysis of the ISCHIA Study

Background: The relationship between the percent coefficient of variation (%CV) and the risk of severe hypoglycemia (SH) or non-severe hypoglycemia (NSH) in patients with type 1 diabetes (T1D) remains to be elucidated. Materials and Methods: The Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus (ISCHIA) study was a crossover, randomized, controlled trial for hypoglycemia prevention in patients with T1D using multiple daily injections (MDIs). Blinded continuous glucose monitoring (CGM) data of 93 patients obtained during the Control period (84 days) were used for the post hoc analysis. The receiver operating characteristics (ROC) curves were analyzed to determine the discrimination thresholds of %CV corresponding to the low blood glucose index (LBGI) > 5 and LBGI >= 2.5, and the occurrence of SH. Results: The %CV corresponding to LBGI > 5 and LBGI >= 2.5 was 42.2% and 37.0%, respectively. The episodes of SH were observed in three patients, and the %CV corresponding to the occurrence of SH was 40.7%. Conclusions: The identification of the discrimination threshold of %CV associated with the risk of SH or NSH in patients with T1D is needed.