The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring

被引:4
|
作者
Pleus, Stefan [1 ,2 ]
Eichenlaub, Manuel [2 ]
Eriksson Boija, Elisabet [1 ,3 ]
Fokkert, Marion [1 ,4 ]
Hinzmann, Rolf [1 ]
Jendle, Johan [1 ,5 ]
Klonoff, David C. [1 ,6 ]
Makris, Konstantinos [1 ,7 ]
Nichols, James H. [1 ,8 ]
Pemberton, John [1 ,9 ]
Selvin, Elizabeth [1 ,10 ]
Slingerland, Robbert J. [1 ,4 ]
Thomas, Andreas [1 ,11 ]
Tran, Nam K. [1 ,12 ]
Witthauer, Lilian [1 ,13 ,14 ]
Freckmann, Guido [1 ,2 ]
机构
[1] Int Federat Clin Chem & Lab Med, Sci Div, Working Grp Continuous Glucose Monitoring, Milan, Italy
[2] Univ Ulm, Inst Diabet Technol, Forsch & Entwicklungsgesellschaft mbH, Lise Meitner Str 8-2, D-89081 Ulm, Germany
[3] EQUALIS AB, Uppsala, Sweden
[4] Isala Clin, Dept Clin Chem, Zwolle, Netherlands
[5] Orebro Univ, Fac Med & Hlth, Sch Med Sci, Orebro, Sweden
[6] Mills Peninsula Med Ctr, Diabet Res Inst, San Mateo, CA USA
[7] KAT Gen Hosp, Clin Biochem Dept, Athens, Greece
[8] Vanderbilt Univ, Med Ctr, Nashville, TN USA
[9] Birmingham Womens & Childrens NHS Fdn Trust, Birmingham, England
[10] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA
[11] Independent Sci Consulting, Pirna, Germany
[12] Univ Calif Davis Hlth, Dept Pathol & Lab Med, Sacramento, CA USA
[13] Diabet Ctr Berne, Bern, Switzerland
[14] Univ Bern, Dept Diabet Endocrinol Nutr Med & Metab, Bern, Switzerland
关键词
continuous glucose monitoring; IFCC; standardization;
D O I
10.1177/19322968241296097
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems. This standardization should include the comparator device, sample origin, and study procedures. With better aligned CGM readings, CGM-derived metrics will subsequently also align better between systems.
引用
收藏
页数:6
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