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Improving real-time and remote monitoring system for diabetic subjects using flash continuous glucose measurement: accuracy and reliability

Jhon Edison Goez Mora, Natalia Arbeláez Córdoba, Norman Balcázar-Morales,Pablo S. Rivadeneira

Research Square (Research Square)(2023)

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摘要
Abstract Background: Flash glucose monitoring systems like the FreeStyle Libre (FSL) sensor have gained popularity for monitoring glucose levels in people with diabetes mellitus. This sensor can be paired with an off-label converted real-time continuous glucose monitor (c-rtCGM) plus an ad hoc computer/smartphone interface for remote real-time monitoring of diabetic subjects, allowing for trend analysis and alarm generation. Objectives: This work evaluates the accuracy and agreement between the FSL sensor and the developed c-rtCGM system. As real-time monitoring is the main feature, the system's connectivity was assessed at five-minute intervals during the trials. Methods: One week of glucose data was collected from 16 type 1 diabetic rats using the FSL sensor and the c-rtCGM. Baseline blood samples were taken the first day before inducing type 1 diabetes with streptozotocin. Once confirmed diabetic rats, FSL and c-rtCGM, were implanted, and to improve data matching between the two monitoring devices, the c-rtCGM was calibrated to the FSL glucometer readings. Accuracy, agreement, and connectivity were assessed by mean absolute relative difference (MARD), range averaging times, Parkes consensus error grid analysis (EGA), and Bland-Altman analysis. Results: Compared to the FSL sensor, the c-rtCGM had an overall MARD of 9.07%, with 93.06% of results in zone A when calibration was carried out. When calibration frequency changed from every 50 hours to 1 hour, the overall MARD improved from 8.58% to 4.69%, respectively. The connectivity evaluation showed that 95% of data was successfully received every 5 minutes by the computer interface. Conclusions and clinical importance: The results demonstrate the feasibility and reliability of real-time and remote subjects with diabetes monitoring using the developed c-rtCGM system. Performing calibrations relative to the FSL readings increases the accuracy of the data displayed at the interface.
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关键词
continuous glucose measurement,remote monitoring system,diabetic subjects,real-time
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