Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study)

Abstract

Background: The ability of patients to improve glycemic control depends partly on their ability to interpret and act on blood glucose results. We investigated whether switching people with diabetes to blood glucose meters (BGMs) featuring a color range indicator (CRI) could improve glycemic control compared to remaining on their current BGM without color.

Methods: 163 adults with type 1 (T1D) or type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.5-11% were randomized to: One Touch Verio™ (Verio), OneTouch Verio Flex™ (Flex), or controls remaining on their current BGM. Diabetes nurses had standard conversations about diabetes management with all subjects at baseline. No changes in medication, insulin dosing, or SMBG frequency were recommended.

Results: After 12 weeks, subjects who switched to Verio or Flex meters with CRI (n = 108) had a mean change in A1c 0.36% lower than controls (n = 55) ( P = .017). A1c reductions were greatest in T1D subjects (n = 45), with a decrease of 0.50% ( P = .004). T1D subjects using Verio meters (n = 25) contributed a 0.59% reduction compared to controls ( P < .008), whereas T1D subjects using Flex meters (n = 20) had a clinical meaningful reduction in A1c of 0.40% without reaching statistical significance ( P > .05). Verio and Flex users reported taking more action and easier understanding of diabetes management compared to previous BGMs.

Conclusions: This study demonstrated that switching patients to BGMs featuring a CRI resulted in improvements in glycemic control compared to subjects using currently marketed BGMs that do not use a CRI. Registration: Clinicaltrials.gov NCT02929654 https://ichgcp.net/clinical-trials-registry/NCT02929654.

Keywords: blood glucose monitor; color range indicator; glucose ranges; 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: MG is an employee of LifeScan Scotland, Ltd. LBK and BLL are employees of LifeScan Inc.

Figures

Figure 1.

Blood glucose meters (BGMs) at baseline. A total of 163 subjects were randomized to either (A) continue to use their current blood glucose meter for the next 12 weeks (representative BGMs shown) or switch to (B) OneTouch Verio or (C) OneTouch Verio Flex meter for the next 12 weeks. Each of these meters feature color range indicators (ColorSure Technology) to identify whether blood glucose results are low, high, or in range. Within each study site, subjects were stratified based on baseline A1c (7.5 to

Figure 2.

Blood glucose meter (BGM) brands at baseline. Meter brands at baseline are shown for all 163 subjects. Subjects randomized to the control group continued to use the same baseline meter for the next 12 weeks. Subjects randomized to the Verio or Flex group stopped using their baseline BGM and immediately switched to using a OneTouch Verio or OneTouch Verio Flex meter for the next 12 weeks. Subjects were excluded if they had previously used a OneTouch Verio, OneTouch Verio Flex, or OneTouch Select Plus meter. Subjects could be randomized if they had previously used LifeScan branded meter that did not feature color range indicators (eg, OneTouch Ultra).

Figure 3.

Change from baseline in hemoglobin A1c after 12 weeks of home SMBG in subjects with T1 or T2D. Verio, OneTouch Verio blood glucose meter; Flex, OneTouch Verio Flex blood glucose meter; Verio + Flex, combined data from both meter groups. Data shown are mean changes ± standard error of the mean. *Reductions in hemoglobin A1c in subjects using Verio + Flex (P = .017) or Verio meters (P = .018) were statistically significantly different from changes in control.

Figure 4.

Change from baseline in Hemoglobin A1c after 12 weeks of home SMBG in subjects with T1D. Verio, OneTouch Verio blood glucose meter; Flex, OneTouch Verio Flex blood glucose meter; Verio + Flex, combined data from both meter groups. Data shown are mean changes ± standard error of the mean. *Reductions in hemoglobin A1c in T1D subjects using Verio + Flex (P < .004) or Verio meters (P< .008) were statistically significantly different from changes in control.

Figure 5.

Subject responses to survey statements. Percentages shown are favorable responses defined as a response of strongly agree oragree on a 5-point scale (5 = strongly agree, 4 = agree, 3 = neither agree nor disagree, 2 = disagree, and 1 =strongly disagree). All favorable response rates are statistically significant (P < .05).