Simple Post-Processing of Continuous Glucose Monitoring Measurements Improves Endpoints in Clinical Trials. (November 2020)

• Record Type: Journal Article
• Authors: Jensen, Morten Hasselstrøm; Dethlefsen, Claus; Hejlesen, Ole; Vestergaard, Peter
• Is Part Of: Journal of diabetes science and technology. Volume 14:Number 6(2020:Nov.)
• Page Start: 1074
• Page End: 1078
• Publication Date: 2020-11
• Subjects: diabetes -- continuous glucose monitoring -- delay -- endpoints -- hypoglycemia -- clinical trials; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296819848721
• Languages: English
• ISSNs: 1932-2968

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.