Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. Issue 1 (17th February 2017)

• Record Type: Journal Article
• Authors: Fokkert, M J; van Dijk, P R; Edens, M A; Abbes, S; de Jong, D; Slingerland, R J; Bilo, H J G
• Is Part Of: BMJ open diabetes research and care. Volume 5:Issue 1(2017)
• Publication Date: 2017-02-17
• Subjects: Blood Glucose Self-Monitoring -- Continuous Glucose Monitoring -- Endocrinology Diabetes -- Glucose Control; Diabetes -- Periodicals; 616.462005
• DOI: 10.1136/bmjdrc-2016-000320
• Languages: English
• ISSNs: 2052-4897

Abstract

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.