Part 4 of IVD Hall of Fame
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Glucose monitors are IVD test systems used to measure the amount of sugar (glucose) in blood. Glucose monitors are used at home by individuals with diabetes or in clinical settings by healthcare professionals. Glucose monitors require the use of a drop of freshly collected blood. Typically blood is obtained from a finger prick with a lancet, although some meters now allow blood collected from sites other than the finger. The drop of blood is placed on a disposable test strip that is inserted into the glucose monitor. The glucose reading is available within seconds.
Prior to glucose monitors, blood tests were available to measure glucose levels, but these were primarily used for diagnosis and critical care management. In 1965, the first blood glucose test strip was developed. The reagent test strips contained an outer semi-permeable membrane, which trapped red blood cells but allowed soluble glucose to pass through to react with the dry reagents. These blood glucose tests were used at point of care facilities and not for patient self monitoring.
Today, glucose monitors are FDA cleared, with the first clearance for the Quickpro Blood Glucose Testing System (Medisense, Inc.) occurring in 1995. Glucose monitors are now readily available over the counter for use by diabetes patients to continuously monitor their blood glucose, allowing them to act on the results to adjust their therapy. And after 40 years, glucose monitors are continuing to evolve, with each new generation giving faster, clearer results while using less invasive sample collection methods.
Glucose monitors have changed how the care of diabetes patients is managed. Upon initial diagnosis, patients monitor their glucose levels and provide their readings to their physicians, who may adjust their medication in an attempt to manage the disease better. Regular blood sugar checks are a useful way to know how well a patient’s diabetes treatment plan is working, and has greatly improved the standard of care and overall health of diabetics.