Performance Comparison of the Medtronic Sof-Sensor and Enlite Glucose Sensors in Inpatient Studies of Individuals with Type 1 Diabetes

Abstract

Knowledge of the accuracy of continuous glucose monitoring (CGM) devices is important for its use as a management tool for individuals with diabetes and for its use to assess outcomes in clinical studies. Using data from several inpatient studies, we compared the accuracy of two sensors, the Medtronic Enlite™ using MiniMed Paradigm(®) Veo™ calibration and the Sof-Sensor(®) glucose sensor using Guardian(®) REAL-Time CGM calibration (all from Medtronic Diabetes, Northridge, CA). Nocturnal data were analyzed from eight inpatient studies in which both CGM and reference glucose measurements were available. The analyses included 1,666 CGM-reference paired glucose values for the Enlite in 54 participants over 69 nights and 3,627 paired values for the Sof-Sensor in 66 participants over 91 nights. The Enlite sensor tended to report glucose levels lower than the reference over the entire range of glucose values, whereas the Sof-Sensor values tended to be higher than reference values in the hypoglycemic range and lower than reference values in the hyperglycemic range. The overall median sensor-reference difference was -15 mg/dL for the Enlite and -1 mg/dL for the Sof-Sensor (P<0.001). The median relative absolute difference was 15% for the Enlite versus 12% for the Sof-Sensor (P=0.06); 66% of Enlite values and 73% of Sof-Sensor values met International Organization for Standardization criteria. We found that the Enlite tended to be biased low over the entire glucose range, whereas the Sof-Sensor showed the more typical sensor pattern of being biased high in the hypoglycemic range and biased low in the hyperglycemic range.