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A New Era in Continuous Glucose Monitoring: Food and Drug Administration Creates a New Category of Factory-Calibrated Nonadjunctive, Interoperable Class II Medical Devices

2018; Mary Ann Liebert, Inc.; Volume: 20; Issue: 6 Linguagem: Inglês

10.1089/dia.2018.0142

1557-8593

Satish K. Garg, Halis Kaan Aktürk,

Hyperglycemia and glycemic control in critically ill and hospitalized patients

Diabetes Technology & TherapeuticsVol. 20, No. 6 EditorialA New Era in Continuous Glucose Monitoring: Food and Drug Administration Creates a New Category of Factory-Calibrated Nonadjunctive, Interoperable Class II Medical DevicesSatish K. Garg and H. Kaan AkturkSatish K. Garg and H. Kaan AkturkPublished Online:1 Jun 2018https://doi.org/10.1089/dia.2018.0142AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited byContinuous glucose monitoring and metrics for clinical trials: an international consensus statementThe Lancet Diabetes & Endocrinology, Vol. 11, No. 1Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA): A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems3 November 2022 | Journal of Diabetes Science and TechnologyA Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance15 April 2021 | Journal of Diabetes Science and Technology, Vol. 16, No. 5Diabetes Technology Meeting 20212 May 2022 | Journal of Diabetes Science and Technology, Vol. 16, No. 4Application of the Non-Enzymatic Glucose Sensor Combined with Microfluidic System and Calibration Readout Circuit10 December 2021 | Chemosensors, Vol. 9, No. 12Comparisons between accuracy of CGM systems in a pediatric setting can be outdated before they are published. 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Garg20 February 2019 | Diabetes Technology & Therapeutics, Vol. 21, No. S1 Volume 20Issue 6Jun 2018 InformationCopyright 2018, Mary Ann Liebert, Inc.To cite this article:Satish K. Garg and H. Kaan Akturk.A New Era in Continuous Glucose Monitoring: Food and Drug Administration Creates a New Category of Factory-Calibrated Nonadjunctive, Interoperable Class II Medical Devices.Diabetes Technology & Therapeutics.Jun 2018.391-394.http://doi.org/10.1089/dia.2018.0142Online Ahead of Print:June 14, 2018Published in Volume: 20 Issue 6: June 1, 2018KeywordsGlucose sensorClinical accuracyMARDContinuous glucose monitoringno calibrationFactory-calibratedstand-alone10-day CGMPDF download