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. 2017 Jan;11(1):160-164.
doi: 10.1177/1932296816667749. Epub 2016 Sep 25.

Regulation Catches Up to Reality

Steven V Edelman  1
Affiliations

Regulation Catches Up to Reality

Steven V Edelman. J Diabetes Sci Technol. 2017 Jan.

Abstract

The FDA recently conducted an Advisory Panel meeting to evaluate the safety, efficacy, and benefits of granting a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system. If approved, this claim will allow users to make day-to-day treatment decisions, including insulin dosing directly from the glucose values and rate of changes arrows generated by the CGM device, without the requirement of a confirmatory measurement with a self-monitoring blood glucose (SMBG) meter. Sporadic SMBG testing gives limited data, while CGM gives a value every 5 minutes and has alerts, alarms, trending information and allows caregivers to follow the user in real time 24/7. This indication will lead to more wide spread use of CGM and improve overall care with protection of hypoglycemia.

Keywords: CGM; FDA panel meeting; SMBG; nonadjunctive claim.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
One suggestion for patients using CGM on how to adjust their meal and correction insulin does based on trend arrows. The concept is to use the anticipated glucose value in 30 minutes based on the ROC curves when calculating how much insulin to give at meal time and when correcting for incidental hyperglycemia.
See this image and copyright information in PMC

References

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