/home/dstCommentary I read with interest the recent commentary regarding the safety of nonadjunctive use of continuous glucose monitoring (CGM) data for insulin dosing, 1 and the now-resolved question 2 of whether this use should be included among the labeled indications for the Dexcom G5 Mobile CGM System. Although I agree with some of the points made, I feel that several issues regarding device accuracy and the way in which CGM data are presented and used have not been sufficiently addressed.
Nonadjunctive Use of CGMFirst, the accuracy of self-monitored blood glucose (SMBG) data deserves further scrutiny, and the possibility (and consequences) of egregiously inaccurate SMBG readings deserve acknowledgement. Current-generation SMBG devices perform well under ideal conditions. 3 In the real world, however, deviations from best handwashing practices are common, 4 and even under supervised conditions, many patient-owned SMBG devices do not meet ISO 15197 criteria.5 There are tens of thousands of inaccuracy complaints in the MAUDE database against meters-most of which are unsubstantiated, highlighting one of the limitations of the database.Second, the focus on inaccuracy of selected CGM readings neglects the quantitative and qualitative differences between SMBG and CGM data. From the standpoint of data quantity, the default CGM screen view gives the current numerical estimate and 36 previous glucose values (shown as a trend graph) over the past 3 hours. In routine use, screen views occur an average of 29 ± 18 times per day. 6 The availability of comprehensive glucose data allows CGM users to base management decisions on patterns, rather than just the current point estimate of glucose concentration. Rate of change (ROC) arrows provided on the CGM display may have a greater impact than the glucose value on the need to dose insulin and in determining insulin dose amount, 7 and specific recommendations for basing treatment decisions on these ROC arrows have been published. 8 Even when CGM data were limited to adjunctive-only use, off-label use was common: in one survey, half of the CGM users indicated that they would treat a nighttime low glucose alert without a confirmatory fingerstick, and 34% indicated that they would dose insulin for hyperglycemia without SMBG confirmation.7 A separate survey 9 revealed that 69% of Dexcom CGM users regularly use CGM alone to adjust bolus insulin doses. None of these patients had the advantage of training on when, how, or when not to use CGM for dosing decisions due to the lack of a labeled indication.
AbstractThe 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 socia...