Hopes, dreams, and reality: the long road to pain-free glucose testing.

Abstract

315 SNAKE OIL, LEECHES, AND BLOOD LETTING, not to mention amputation of limbs without the benefit of anesthesia—these are all previously commonly accepted medical treatments that today conjure up barbaric images of sorcerers and witch doctors. Still, despite the significant advances in medicine that have been achieved since that time, particularly during the last 30 years, there exists a large and growing population of patients with diabetes who are forced to engage in a form of “blood letting” each time they perform a “finger prick,” ie, whole blood glucose (WBG) test. Prior to the availability of WBG devices for patient self-testing (PST), which did not occur until the 1970s with the I-Tone/Ames Reflectance meter and WBG strip sold by Ames/Miles Laboratories, Inc. (Bayer Diagnostics Division [Bayer], Elkhart, IN, today), patients would monitor their WBG levels with visual read WBG test strips and diabetes urine dipsticks. Before that was the “finger taste” technique (if a patient’s urine tasted sweet to the physician, it meant that their WBG level was too high). Much to the delight of the physician, this method was quickly replaced by the urine dipstick as the preferred method to monitor WBG levels. The I-Tone and the Ames Reflectance meter essentially were PST chemistry systems that required AC electricity to operate, required more than 30 m L of blood sample, had accuracy coefficient variants (CVs) of 6 20%, and took approximately 3 to 4 minutes to obtain a result. The advent of the I-Tone, BGTM visual read strip sold by Boehringer Mannheim GmbH and similar devices at the time spawned an entirely new industry that has resulted in a number of “generations” of new products that in general have offered improved precision and accuracy, a continual reduction of required blood sample size, and enhanced features and benefits that promote convenience. The worldwide PST market for WBG monitoring products, which did not exist 30 years ago, today represents approximately $2 billion in annual revenues (growing in excess of 10% per year), and is dominated by four companies that include LifeScan, Inc. (LifeScan, Milpites, CA), Roche Diagnostic Systems (Roche, Indianapolis, IN), Bayer and Abbott Diagnostics Division (MediSense, Bedford, MA) (Fig. 1). This growth is expected to continue because of the combination of a growing patient population, increased educational focus and financial resources from healthcare providers and payers alike, and the more prevalent and earlier use of insulin or oral therapeutic agents that necessitate WBG monitoring. Not having gone unnoticed, this lucrative market has seen a