OneTouch® UltraMini™ Blood Glucose Meter
The first glucose testing in laboratories was a procedure known as the folin wu test. This test was cumbersome for even the confines of a testing laboratory. It involved boiling in a special tube with chemicals in it, setting up standards and graphs so that the results could be calculated, and producing a protein free filtrate to be tested. This type of testing improved quickly over the years. This type of testing is recorded in scientific papers back as far as 1955.
Diabetes today is of epidemic proportion. Methods to monitor glucose, which is very important to patients management of this disease, have become more accurate and very specific to the glucose molecule of interest.
Bayer's Microlet® 2 Adjustable Lancing Device
Some companies and their scientists have worked hard to develop methods that measure the correct glucose, others companies have worked hard to develop easier methods for use by the patient. Today, accurate measurements can be achieved anywhere. Monitors have become portable and samples taken from patients for testing can now use whole blood which has removed the need for centrifugation. Lancet devices have improved and made sample collection for testing simple for the patient and has also reduced the pain caused by self inflicted dermal penetration.
The need for portability and simplicity of glucose monitoring was first seen in 1971. The Ames Company, which eventually became Bayer, then Siemens, developed a Reflectance Meter. In the Mid 1960’s the Ames Company introduce a product called Dextrostix which was primarily used to measure sugar constituents in human urine. This product was Ames first venture into monitoring blood glucose. Dextrostix were a simple product, designed for use by a physician, not by a patient. The procedure simply involved placing a drop of blood on a paper strip, waiting one minute for a blue color to develop and then comparing the color to a chart that had various hues of blue. The deeper the blue color, the more glucose was present.
In 1970, the difficulty in reading the blue color and the subjective results caused by human error were reduced by the introduction of the reflectance meter to read the paper strip and give a numerical reading based on the actual color. The reading was “digital” and used a needle that was on a scale. It can be best described as a reading like a volt meter. The volt meter in this unit was nothing more than a photocell, which reacted to the amount of light bounced back from the strip.
Ames was a division of Miles Corporation and this product eventually became the first known blood glucose meter. The Ames Corporation did become somewhat obscure as time passed. Miles sold that division to Bayer and Bayer sold it to Siemens. The first meter was called A.R.M. (Ames Reflectance Meter). This approach followed a scientific pattern known as Beers Law which was established by Beer and Lamberts Laws of Colorimetry. This should not be confused with the science of optical density or light transmittance. The only similarity was that colors were developed with direct or indirect proportions to the concentration of the analyte, in this case glucose being measured.
Not surprisingly, the Japanese developed a product shortly after called the EYETONE. The EYETONE was introduced to Ames and a marketing agreement was reached between the 2 companies. The obvious attraction to Miles was that this instrument was less expensive than previous instruments. Secondly, it was a little smaller then the A.R.M. instrument which was bulky for use in the physician’s office. It was also battery operated and had performance problems.
As physicians used this instrument, it became evident that improved portability and a more user friendly approach, would improve the possibility of placing the unit in patients hands for improved Diabetes management. The improvement in patient care would be dramatic. The EYETONE was sold directly to patients by Miles, however, a prescription was required as well as a written understanding that reinforced that the patient and the physician had certain educational responsibility by the doctor. The idea caught on very fast in Europe, which may have been because of Socialized Medicine and the availability of physicians willing to adopt this technology.
A new company in Europe developed a meter and tried to find distribution in the U.S A. by a group named Lifescan. The sale of this Meter by Lifescan was very successful, however the real financial opportunity for this company was in the sale of the testing strip. Miles refused Lifescan’s bid for a private label product, but as fate would have it, a German Company named Boehringer Mannheim was able to develop a new strip called Chemstrip bG.
This new strip added a great new feature to glucose testing. The patient did not have to wash the blood off the strip at the end of the timed sequence. Instead all you needed to do was blot it with a cotton ball. This technology also gave 2 color reactions, one in beige and one in blue, which reduced subjectivity and allow the reader to compare two reading in two distinct colors.
It would seem like a good marriage between Lifescan and Boehringer, however: once again Lifescan met with the obstacle in the refusal of Boehringer to continue with the arrangement. Realizing the size of the developing market, Lifescan reacted by looking for a manufacturer in Japan that would make the strips for them and was successful in the relationship. The Japanese company also offered to make the reader for them. So the whole package was graciously accepted. For the first time Miles/Ames had a full competitor. It was felt however, that the Chemstrip product was a product more applicable to the manual read market for patients and had the biggest effect on placing the test into the patients hands directly.
ACCU-CHEK® Aviva System Blood Glucose Monitoring System
It took Boehringer Mannheim 6 years to develop a reader. Meanwhile Miles came out with the patient oriented “Glucometer”. Most readers are still called Glucometers today, even though it is a trademark product. The ACCU-CHEK was the Boehringer Mannheim equivalent market response to the Glucometer. The only real advancement today by manufacturers was the introduction of biosensor technology. MediSense introduced the first biosensor, with Bayer and Lifescan also named as developers of the biosensor technology in patent claims.
Blood glucose monitoring is as important as the discovery of Insulin. Without monitoring technology no one would know how much or how often insulin should be administered. Dosage of insulin is established though a variety of tests, however monitored the patient by checking glucose levels is critical to effective management of the disease. Diet is also vitally important in the management of this disease.
Many companies now offer low cost glucose strips and analyzers. Some companies package their products for the market in a way that the patient thinks that the analyzer is free. Not always is that the best deal. There are analyzers like the Sure Check that can be purchased at a low cost, but the continuing cost of glucose strips is much lower than the name brands. In a recent product notice by the FDA some major manufacturers it was found that some analyzers were reacting with other non-specific sugars and producing erroneous results. You can find out more about this FDA action by reading our next blog.
