Blood glucose meters were originally intended to monitor patients diagnosed with diabetes mellitus and have undergone improvements through the years that have made them suitable for self-monitoring (Bimenya, Nzarubara, Kiconco, Sabuni, & Byarugaba, 2003, p. 23). The first patently successful blood glucose monitor was developed by Genetics International with assistance from Cranfield and Oxford Universities (Newman & Turner, 2005, p. 2435). It was designed for use at home was a mediated device that used a "disposable, screen-printed sensor design" (Newman & Turner, 2005, p. 2435). The instrument went through several iterations through the years, from a pen-shaped device to a credit card format, and then to a computer-mouse-shaped device, but the concept itself has remained relatively unchanged (Newman & Turner, 2005, p. 2435). The three types of glucose meters currently in use include the amperometric, reflectance, and colorimetric transduction devices (Bimenya, Nzarubara, Kiconco, Sabuni, & Byarugaba, 2003, p. 23).
Glucose meters are biosensors that detect glucose as it passes through a membrane that selectively permits analyte transport to an enzyme system that produces a response when it interacts with the glucose (Bimenya, Nzarubara, Kiconco, Sabuni, & Byarugaba, 2003, p. 23). This response causes the transducer to generate an electrical signal that amplifies and translates the glucose concentration, then displays it on the meter's screen (Bimenya, Nzarubara, Kiconco, Sabuni, & Byarugaba, 2003, p. 23).
The accuracy of glucose meters is essential for diabetic therapy to be its most helpful, particularly for patients that monitor their glucose levels at home (Lehmann, Kayrooz, Greuter, & Spinas, 2001). The recommendation of the American Diabetes Association as of 1994 is that home blood glucose meters should be able to operate with a total error of <10% at glucose concentrations of 1.6 to 22.2 mmol/l...