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

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 questionnai...