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Analytical Performance of the Factory-Calibrated Flash Glucose Monitoring System FreeStyle Libre2TM in Healthy Women

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posted on 2023-10-02, 11:42 authored by Zhuoxiu Jin, Alice E Thackray, James A King, Kevin Deighton, Melanie J Davies, David J Stensel
Continuous glucose monitoring (CGM) is used clinically and for research purposes to capture glycaemic profiles. The accuracy of CGM among healthy populations has not been widely assessed. This study assessed agreement between glucose concentrations obtained from venous plasma and from CGM (FreeStyle Libre2TM, Abbott Diabetes Care, Witney, UK) in healthy women. Glucose concentrations were assessed after fasting and every 15 min after a standardized breakfast over a 4-h lab period. Accuracy of CGM was determined by Bland–Altman plot, 15/15% sensor agreement analysis, Clarke error grid analysis (EGA) and mean absolute relative difference (MARD). In all, 429 valid CGM readings with paired venous plasma glucose (VPG) values were obtained from 29 healthy women. Mean CGM readings were 1.14 mmol/L (95% CI: 0.97 to 1.30 mmol/L, p < 0.001) higher than VPG concentrations. Ratio 95% limits of agreement were from 0.68 to 2.20, and a proportional bias (slope: 0.22) was reported. Additionally, 45% of the CGM readings were within ±0.83 mmol/L (±15 mg/dL) or ±15% of VPG, while 85.3% were within EGA Zones A + B (clinically acceptable). MARD was 27.5% (95% CI: 20.8, 34.2%), with higher MARD values in the hypoglycaemia range and when VPG concentrations were falling. The FreeStyle Libre2TM CGM system tends to overestimate glucose concentrations compared to venous plasma samples in healthy women, especially during hypoglycaemia and during glycaemic swings.

Funding

National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre

History

Author affiliation

National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre, University of Leicester

Version

  • VoR (Version of Record)

Published in

Sensors

Volume

23

Issue

17

Pagination

7417

Publisher

MDPI AG

eissn

1424-8220

Copyright date

2023

Available date

2023-10-02

Language

en

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