Stefan Pleus, Manuel Eichenlaub, Elisabet Eriksson Boija, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C Klonoff, Konstantinos Makris, James H Nichols, John Pemberton, Elizabeth Selvin, Robbert J Slingerland, Andreas Thomas, Nam K Tran, Lilian Witthauer, Guido Freckmann
{"title":"连续血糖监测性能评估标准化的必要性:国际临床化学和实验室医学联合会连续血糖监测工作组的意见。","authors":"Stefan Pleus, Manuel Eichenlaub, Elisabet Eriksson Boija, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C Klonoff, Konstantinos Makris, James H Nichols, John Pemberton, Elizabeth Selvin, Robbert J Slingerland, Andreas Thomas, Nam K Tran, Lilian Witthauer, Guido Freckmann","doi":"10.1177/19322968241296097","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241296097"},"PeriodicalIF":4.1000,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571573/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Stefan Pleus, Manuel Eichenlaub, Elisabet Eriksson Boija, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C Klonoff, Konstantinos Makris, James H Nichols, John Pemberton, Elizabeth Selvin, Robbert J Slingerland, Andreas Thomas, Nam K Tran, Lilian Witthauer, Guido Freckmann\",\"doi\":\"10.1177/19322968241296097\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":15475,\"journal\":{\"name\":\"Journal of Diabetes Science and Technology\",\"volume\":\" \",\"pages\":\"19322968241296097\"},\"PeriodicalIF\":4.1000,\"publicationDate\":\"2024-11-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571573/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Diabetes Science and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/19322968241296097\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Diabetes Science and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/19322968241296097","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
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.
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.
期刊介绍:
The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.