Precision, Accuracy, and User Acceptance of the OneTouch SelectSimple Blood Glucose Monitoring System

Abstract

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. 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. 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. 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.