Analytical Performance of the Factory-Calibrated Flash Glucose Monitoring System FreeStyle Libre2™ in Healthy Women

被引:6
作者
Jin, Zhuoxiu [1 ]
Thackray, Alice E. [1 ,2 ,3 ]
King, James A. [1 ,2 ,3 ]
Deighton, Kevin [4 ]
Davies, Melanie J. [2 ,3 ,5 ]
Stensel, David J. [1 ,2 ,3 ,6 ,7 ]
机构
[1] Loughborough Univ, Natl Ctr Sport & Exercise Med, Sch Sport Exercise & Hlth Sci, Loughborough LE11 3TU, England
[2] Univ Hosp Leicester Natl Hlth Serv NHS Trust, Natl Inst Hlth & Care Res NIHR, Leicester Biomed Res Ctr, Natl Hlth Serv NHS Trust, Leicester LE1 5WW, England
[3] Univ Leicester, Leicester LE1 5WW, England
[4] Nuffield Hlth, Epsom KT18 5AL, Surrey, England
[5] Univ Leicester, Diabet Res Ctr, Leicester LE5 4PW, England
[6] Waseda Univ, Fac Sport Sci, Tokorozawa 3591192, Japan
[7] Chinese Univ Hong Kong, Dept Sports Sci & Phys Educ, Ma Liu Shui, Hong Kong 999077, Peoples R China
关键词
continuous glucose monitoring; blood glucose; agreement; glycaemic dynamics; ASSESSING AGREEMENT;
D O I
10.3390/s23177417
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
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 Libre2 (TM), 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 Libre2 (TM) CGM system tends to overestimate glucose concentrations compared to venous plasma samples in healthy women, especially during hypoglycaemia and during glycaemic swings.
引用
收藏
页数:14
相关论文
共 36 条
[1]   Accuracy of Continuous Glucose Monitoring Measurements in Normo-Glycemic Individuals [J].
Akintola, Abimbola A. ;
Noordam, Raymond ;
Jansen, Steffy W. ;
de Craen, Anton J. ;
Ballieux, Bart E. ;
Cobbaert, Christa M. ;
Mooijaart, Simon P. ;
Pijl, Hanno ;
Westendorp, Rudi G. ;
van Heemst, Diana .
PLOS ONE, 2015, 10 (10)
[2]   Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes [J].
Alva, Shridhara ;
Bailey, Timothy ;
Brazg, Ronald ;
Budiman, Erwin S. ;
Castorino, Kristin ;
Christiansen, Mark P. ;
Forlenza, Gregory ;
Kipnes, Mark ;
Liljenquist, David R. ;
Liu, Hanqing .
JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY, 2022, 16 (01) :70-77
[3]   Non-adjunctive continuous glucose monitoring for control of hypoglycaemia (COACH): Results of a post-approval observational study [J].
Beck, Stayce E. ;
Kelly, Colleen ;
Price, David A. .
DIABETIC MEDICINE, 2022, 39 (02)
[4]   STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT [J].
BLAND, JM ;
ALTMAN, DG .
LANCET, 1986, 1 (8476) :307-310
[5]  
Brysbaert Marc, 2018, J Cogn, V1, P9, DOI 10.5334/joc.10
[6]   Improved Glycemic Control and Variability: Application of Healthy Ingredients in Asian Staples [J].
Camps, Stefan Gerardus ;
Kaur, Bhupinder ;
Lim, Joseph ;
Loo, Yi Ting ;
Pang, Eunice ;
Ng, Terence ;
Henry, Christiani Jeyakumar .
NUTRIENTS, 2021, 13 (09)
[7]   A Tale of Two Compartments: Interstitial Versus Blood Glucose Monitoring [J].
Cengiz, Eda ;
Tamborlane, William V. .
DIABETES TECHNOLOGY & THERAPEUTICS, 2009, 11 :S11-S16
[8]  
Clarke William L, 2007, J Diabetes Sci Technol, V1, P669
[9]   Correspondence of continuous interstitial glucose measurement against arterialised and capillary glucose following an oral glucose tolerance test in healthy volunteers [J].
Dye, Louise ;
Mansfield, Michael ;
Lasikiewicz, Nicola ;
Mahawish, Lena ;
Schnell, Rainer ;
Talbot, Duncan ;
Chauhan, Hitesh ;
Croden, Fiona ;
Lawton, Clare .
BRITISH JOURNAL OF NUTRITION, 2010, 103 (01) :134-140
[10]   Effect of divergent continuous glucose monitoring technologies on glycaemic control in type 1 diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials [J].
Elbalshy, Mona ;
Haszard, Jillian ;
Smith, Hazel ;
Kuroko, Sarahmarie ;
Galland, Barbara ;
Oliver, Nick ;
Shah, Viral ;
de Bock, Martin I. ;
Wheeler, Benjamin J. .
DIABETIC MEDICINE, 2022, 39 (08)