Accuracy of an Off-Label Transmitter and Data Manager Paired With an Intermittent Scanned Continuous Glucose Monitor in Adults With Type 1 Diabetes

Abstract

Background: This work evaluates the accuracy and agreement between the FreeStyle Libre sensor (FSL) and an off-label converted real-time continuous glucose monitor (c-rtCGM) device consisting of the MiaoMiao transmitter and the xDrip+ application which can be coupled to the FSL. Methods: Four weeks of glucose data were collected from 21 participants with type 1 diabetes using the c-rtCGM and FSL: two weeks with a single initial calibration (uncalibrated) and two weeks with a daily calibration (calibrated). Accuracy and agreement evaluation included mean absolute relative difference (MARD), the %20/20 rule, Bland-Altman plots, and the Consensus Error Grid analysis. Results: Values reported by the c-rtCGM system compared with the FSL resulted in an overall MARD of 12.06% and 84.71% of the results falling within Consensus Error Grid Zone A when the device is calibrated. For uncalibrated devices, an overall MARD of 17.49% was obtained. Decreased accuracy was shown in the hypoglycemic range and for rates of change greater than 2 mg/dL/min. The between-device bias also incremented with increasing glucose values. Conclusion: Measurements recorded by the c-rtCGM were found to be accurate when compared with FSL data only when performing daily c-rtCGM device calibrations. High drops in accuracy and agreement between devices occurred when the c-rtCGM was not calibrated.