Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users

Abstract

The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance.Clinicaltrials.gov NCT03851549.

Keywords: accuracy; blood glucose; blood glucose meter; blood glucose strips; self-monitoring of blood glucose.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LK, LS, DK, and HC are full-time employees of LifeScan Global Corporation.

Figures

Figure 1.

OneTouch Verio Reflect blood glucose monitoring systems. (a) ColorSure Dynamic Range Indicator. A changing emoji pointing to the green color bar indicates that the current blood glucose result is in range or is nearing high or nearing low. A message points to the blue bar if the result is low and points to the red bar if the result is high. (b) Mentor tips. (c) Pattern messages. (d) Encouragement and awards.

Figure 2.

Bias plot for the subject self-test dataset. Dots represent blood glucose results. In total, 351 of 354 results fell within ±15% accuracy limit lines (inner dashed line) for three lots. The ±20% accuracy limit line (outer dashed line) is also shown. All 354 results fell within these limit lines. YSI, Yellow Springs Instruments.

Figure 3.

Regression plot for the subject self-test dataset. Dots represent blood glucose results. In total, 351 of 354 results fell within ±15% accuracy limit lines for three lots. Line of identity (y = x) and regression fitted line plot response (in red) are shown. YSI, Yellow Springs Instruments.

Figure 4.

Bias plot for the extreme glucose dataset. Blue dots represent blood glucose results within ±15% accuracy limit lines for three lots. Open circles represent blood glucose results outside these limits. Blue dots, n = 298; open circles, n = 2. YSI, Yellow Springs Instruments.