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. 2019 Apr;21(4):222-229.
doi: 10.1089/dia.2018.0401. Epub 2019 Feb 28.

Factory-Calibrated Continuous Glucose Monitoring: How and Why It Works, and the Dangers of Reuse Beyond Approved Duration of Wear

Affiliations

Factory-Calibrated Continuous Glucose Monitoring: How and Why It Works, and the Dangers of Reuse Beyond Approved Duration of Wear

Gregory P Forlenza et al. Diabetes Technol Ther. 2019 Apr.

Abstract

Continuous glucose monitors (CGM) display real-time glucose values enabling greater glycemic awareness with reduced management burden. Factory-calibrated CGM systems allow for glycemic assessment without the pain and inconvenience of fingerstick glucose testing. Advances in sensor chemistry and CGM algorithms have enabled factory-calibrated systems to have greater accuracy than previous generations of CGM technology. Despite these advances many patients and providers are hesitant about the idea of removing fingerstick testing from their diabetes care. In this commentary, we aim to review the clinical trials on factory-calibrated CGM systems, present the algorithms which facilitate factory-calibrated CGMs to improve accuracy, discuss clinical use of factory-calibrated CGMs, and finally present two cases demonstrating the dangers of utilizing exploits in commercial systems to prolong sensor life.

Keywords: Continuous glucose monitoring; Factory calibration; Type 1 diabetes.

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Conflict of interest statement

G.P.F. reports research support from the NIH NIDDK, Medtronic, Tandem, Insulet, Dexcom, Abbott, Novo Nordisk, Type Zero, and Beta Bionics. He has served as an advisory board member for Dexcom, a paid consultant for Medtronic and Abbott, and a speaker for Tandem, Dexcom, and Medtronic. L.H.M. is a Contract Product Trainer for Medtronic Diabetes and consults for Tandem Diabetes Care, Capillary Biomedical, and Clinical Sensors. R.P.W. reports research support from Lexicon, Dexcom, Bigfoot Biomedical, MannKind Corporation, Novo Nordisk, Helmsley Charitable Trust and NIH/NIDDK, advisory board consulting fees from Eli Lilly and Company, and consulting fees from Dexcom. T.K. and S.S. report no conflicts of interest.

Figures

<b>FIG. 1.</b>
FIG. 1.
Distribution of sensor glucose values on days 1–2 of recommended wear compared with days 11–12 of extended wear as well as days 3–10 of recommended wear. Days 11–12 represent a different distribution from days 1 to 2 due to software incorporated into the sensor that uses different calibration on what is presumed to be a newly inserted sensor than for days 3–10.
<b>FIG. 2.</b>
FIG. 2.
Ambulatory glucose profiles over times of the day, grouped by days of wear, with percentiles and mean blood glucose values.

References

    1. Kadish AH, Hall DA: A new method for the continuous monitoring of blood glucose by measurement of dissolved oxygen. Clin Chem 1965;11:869–875 - PubMed
    1. Ginsbergh BH: The FDA panel advised approval of the first continuous glucose sensor. Diabetes Technol Ther 1999;1:203–204 - PubMed
    1. DirecNet Study Group: The accuracy of the CGMS™ in children with type 1 diabetes: results of the Diabetes Research in Children Network (DirecNet) accuracy study. Diabetes Technol Ther 2003;5:781–789 - PMC - PubMed
    1. Facchinetti A: Continuous glucose monitoring sensors: past, present and future algorithmic challenges. Sensors (Basel) 2016;16:2093–2104 - PMC - PubMed
    1. Slover RH, Tryggestad JB, DiMeglio LA, et al. : Accuracy of a fourth-generation continuous glucose monitoring system in children and adolescents with type 1 diabetes. Diabetes Technol Ther 2018;20:576–584 - PubMed

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