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

Sensors (Basel). 2023 Aug 25;23(17):7417. doi: 10.3390/s23177417.

Abstract

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.

Keywords: agreement; blood glucose; continuous glucose monitoring; glycaemic dynamics.

MeSH terms

  • Blood Glucose
  • Blood Glucose Self-Monitoring
  • Female
  • Glucose*
  • Hematologic Tests
  • Humans
  • Hypoglycemia*

Substances

  • Glucose
  • Blood Glucose

Grants and funding

This research was supported by the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Zhuoxiu Jin is funded by the China Scholarship Council.