Abstract
BACKGROUND: Continuous glucose monitoring (CGM) is a powerful tool to be considered both in clinical practice and clinical trials. However, CGM has been criticized for being inaccurate for many reasons including a physiological delay. This study sought to investigate the current delay issue and propose a simple post-processing procedure.
METHOD: More than a million hours of the Dexcom G4 CGM from 472 subjects investigated in a state-of-the-art clinical trial were analyzed by time shifting the CGM measurements and comparing them to plasma glucose (PG) measurements. The resultant CGM measurements were then assessed in relation to real-world clinical research endpoints.
RESULTS: A CGM time shift of -9 minutes was optimal and reduced mean absolute relative difference (MARD) statistically significantly with 1.0% point. The MARD reduction resulted in better clinical research endpoints of hypoglycemia and postprandial glucose increments.
CONCLUSIONS: The delay in CGM is still an issue. The delay in this study was identified to be 9 minutes compared to PG. With a simple post-processing approach of time shifting the CGM measurements with -9 minutes, it was possible to obtain a statistically significantly lower MARD and subsequently obtain clinical research endpoints of improved validity.
Original language | English |
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Journal | Journal of Diabetes Science and Technology |
Volume | 14 |
Issue number | 6 |
Pages (from-to) | 1074-1078 |
Number of pages | 5 |
ISSN | 1932-2968 |
DOIs | |
Publication status | Published - 1 Nov 2020 |
Keywords
- clinical trials
- continuous glucose monitoring
- delay
- diabetes
- endpoints
- hypoglycemia