Precision, accuracy, and user acceptance of the OneTouch SelectSimple blood glucose monitoring system

Abstract

Background: The OneTouch® SelectSimple™ blood glucose monitoring system (BGMS) is a device for self-monitoring of blood glucose designed for ease of use. Alarms alert subjects to low [20-69 mg/dl (1.1-3.8 mmol/liter)], high [180-239 mg/dl (9.9-13.2 mmol/liter)], and very high [240-600 mg/dl (13.3-33.1 mmol/liter)] blood glucose readings.

Methods: Repeatability in blood and intermediate precision with aqueous controls were examined using blood from one donor adjusted to different glucose concentrations, and tested with 10 meters and 1 test-strip lot. System accuracy was evaluated with blood samples from 100 diabetes patients tested on 3 test-strip lots, compared with a reference system (YSI 2300 STAT). To test user accuracy, patients (n = 156) and health care professionals (HCPs) tested subject blood with the SelectSimple twice. Health care professionals evaluated subject BGMS technique after a 3-5 day home-testing period. Users evaluated the instructions for use and responded to a user acceptance questionnaire.

Results: In repeatability and intermediate precision testing, the SelectSimple BGMS had a coefficient of variation of ≤ 5% or standard deviation of ≤ 5 mg/dl. In the clinical accuracy study, 100% of measurements <75 mg/dl (4.2 mmol/liter) were within ± 15 mg/dl (0.8 mmol/liter) of reference value, and 99.6% of measurements ≥ 75 mg/dl (4.2 mmol/liter) were within ±20%. Patients were able to use the BGMS appropriately and evaluated it as easy to use. Acceptance of the SelectSimple BGMS was within predefined limits.

Conclusions: In these studies, the SelectSimple BGMS met all criteria for precision, system, and user accuracy, was easy to use, and was well accepted by patients.

Figure 1

OneTouch SelectSimple BGMS.

Figure 2

System accuracy of OneTouch SelectSimple using three different test-strip batches: (A) lot 3022344; (B) lot 3022345; and (C) lot 3043510.

Figure 3

Bias plots for: (A) subject self-test and (B) HCP test data. Solid lines represent the boundaries of ISO accuracy criteria; specifically, ±15 mg/dl for glucose values <75 mg/dl (4.2 mmol/liter), and within ±20% for glucose values ≥75 mg/dl (4.2 mmol/liter) of the laboratory reference YSI 2300.

Figure 4

Percentage difference between OneTouch SelectSimple BGMS and YSI 2300 reference values when measured by subjects and HCPs for reference values: (A) <75 mg/dl (4.2 mmol/liter) and (B) ≥75 mg/dl (4.2 mmol/liter). Y-axis shows the proportion of BGMS results falling within the range denoted by the x-axis.

Figure 5

Consensus error grid showing accuracy of OneTouch SelectSimple test results compared with YSI 2300 reference values for: (A) 300 self-tests performed by subjects and (B) 294 tests performed by HCPs.