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. 2017 Feb 17;5(1):e000320.
doi: 10.1136/bmjdrc-2016-000320. eCollection 2017.

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus

M J Fokkert  1 , P R van Dijk  2 , M A Edens  3 , S Abbes  1 , D de Jong  3 , R J Slingerland  1 , H J G Bilo  4
Affiliations

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus

M J Fokkert et al. BMJ Open Diabetes Res Care. .

Abstract

Objective: To evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods.

Research design and methods: 20 subjects (8 type 1 diabetes mellitus, 12 type 2 diabetes mellitus) were analyzed. FSL-CGM sensor measurements (inserted in arm and abdomen) were compared with capillary blood glucose results analyzed with StatStrip as semigold standard. The glucose response after a standardized oral glucose load was measured by FSL-CGM and capillary samples analyzed by perchloric acid hexokinase (PCA-HK) method, StatStrip and FSL test strip (FSLC), and a commonly used CGM system (iPro2).

Results: FSL-CGM arm sensor readings showed 85.5% of paired readings falling within Clarke Error Grid (ISO 15197:2013) zone A when compared with StatStrip. For FSL-CGM abdomen and FSLC, these percentages were 64% and 98%, respectively. The overall correlation of FSL-CGM in the arm and the StatStrip indicates a performance with lower results with the FSL-CGM in the arm than expected based on the StatStrip in the lower glucose ranges, and higher results than expected in the higher ranges. Following a standardized glucose load, a slower rise in glucose level was observed for FSL-CGM arm as compared with PCA-HK, StatStrip, FSLC, and iPro2 during the first 45-60 min after glucose load ingestion.

Conclusions: Certain matters need attention while using the FSL-CGM in daily life including the observed lower values in the lower ranges, and the underestimation of the effect of a meal on glucose response. These effects of such deviations can partly be overcome by optimizing the available user instructions.

Trial registration number: TC5348; results.

Keywords: Blood Glucose Self-Monitoring; Continuous Glucose Monitoring; Endocrinology Diabetes; Glucose Control.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Clarke Error Grids (ISO15197; 2013) of StatStrip and coincident FSLTab-CGM arm (upper left panel), FSL-CGM abdomen (lower left panel) and FSLC readings (right panel) in the combined population of type 1 and 2 diabetes. Number and percentages of paired readings within error grid zones A, B, C D and E are presented. FSL-CGM, FreeStyle Libre Flash continuous glucose monitoring.
Figure 2
Figure 2
The 75 g glucose loading test. Comparison of FSL-CGM versus PCA-HK, StatStrip, FSLC test strip, and iPro2; and PCA-HK versus FSLC test strip, and iPro2. Glucose concentrations (mg/dL; median, interquartile Q1 and Q3) at time points 0, 15, 30, 45, 60, 75 and 90 min in the combined population of type 1 and 2 diabetes. *p Value ≤0.05; **p Value ≤0.01. FSL-CGM, FreeStyle Libre Flash continuous glucose monitoring; PCA-HK, perchloric acid hexokinase.
See this image and copyright information in PMC

References

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