Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement

Abstract

Background: Accurate self-monitoring of blood glucose (SMBG) is a key component of effective self-management of glycemic control.

Methods: The OneTouch Verio Reflect and OneTouch Ultra Plus Reflect BG monitoring systems were evaluated for accuracy in a clinical setting. Subjects also used the meters for a one-week trial period and reported their level of satisfaction with meter features.

Results: Both systems were accurate over a wide glucose range and met lay user and system accuracy BG standards described in ISO15197:2015. Subjects felt that the features of a meter with a dynamic color range indicator and personalized guidance, insight, and encouragement could provide significant benefits to them in the management of their diabetes.

Conclusions: Both meter systems were accurate over a wide glucose range and the features of the meter and messages were well received by patients in a short take-home trial.

Clinical trial registration: Clinicaltrials.gov NCT0351542.

Trial registration: ClinicalTrials.gov NCT03515421.

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

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, BG, and LS are full-time employees of LifeScan Global Corporation. HC is a consultant to LifeScan.

Figures

Figure 1.

OneTouch Verio/Ultra Plus 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.

System accuracy blood glucose bias plot. Blue dots represent blood glucose results within the ±15 mg/dL (n=597; open circles, n=3. (b) OneTouch Ultra Plus Reflect. Blue dots, n=598; open circles, n=2. YSI, Yellow Springs Instruments.

Figure 3.

Consensus error grid plot glucose plot. (a) Verio test strips; (b) Ultra Plus test strips. Zone A: no effect on clinical action; zone B: altered clinical action—little or no effect on clinical outcomes; zone C: altered clinical action—likely to affect clinical outcomes; zone D: altered clinical action—could have significant medical risk; and zone E: altered clinical action—could have dangerous consequences.N = 600 data points (200 per test lot). All data points fall within zone A. YSI, Yellow Springs Instruments.