Commentary Regarding Shapiro, "Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?"
- PMID: 28654305
- PMCID: PMC5588837
- DOI: 10.1177/1932296817695341
Commentary Regarding Shapiro, "Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?"
Abstract
The FDA recently expanded the approved use of Dexcom's G5 Mobile continuous glucose monitoring (CGM) system to allow for diabetes treatment decisions. This decision is expected to reduce the burden of SMBG testing and increase the adoption and persistent use of CGM. The safety of nonadjunctive CGM use was questioned because of sporadic large discrepancies between CGM and SMBG values. These data were viewed in the context of complaints found in the FDA MAUDE database and social media postings. This commentary provides additional perspective on the inferences that can be drawn from these reports and the risk of nonadjunctive use of CGM data.
Keywords: FDA decisions; continuous glucose monitoring; nonadjunctive use; self-monitored blood glucose.
Conflict of interest statement
Comment in
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The Safety of Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Still Not Resolved.J Diabetes Sci Technol. 2017 Jul;11(4):856-857. doi: 10.1177/1932296817704446. Epub 2017 Apr 18. J Diabetes Sci Technol. 2017. PMID: 28420260 Free PMC article. No abstract available.
Comment on
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Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?J Diabetes Sci Technol. 2017 Jul;11(4):833-838. doi: 10.1177/1932296816688303. Epub 2017 Mar 1. J Diabetes Sci Technol. 2017. PMID: 28540756 Free PMC article.
References
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- US Food and Drug Administration. FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions [press release]. 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534056.htm. Accessed January 11, 2017.
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