After years of discussions on the accuracy of blood glucose levels and how accurate they really need to be. It is going in the direction of a mandate that would vary based on use in hospital, lab, or OTC. It appears that a two layer level of jurisdiction and distinction will be made by the FDA. There will be the Home use lay user, and the tight glycemic control designations. The consensus appears to be going to plus or minus 15%. That is compared to today’s limits of plus or minus 20% in the 8 year old ISO standard in use today.
Moving forward it is known that there is a need out there for good point of care accuracy, and it
can be said that even the same meters can produce better accuracy in that environment as compared to the OTC use
Recent challenges and recalls by famous Manufacturers were made because the methods used in the meters, were not measuring the right type of glucose. Most lay people do know that their diets consist of different types of sugars that play no role in diabetes.
This error in measuring the wrong type of sugars, could cause over or under compensation with insulin in diabetic patients as well as varying results based on testing at home compared to values obtained at a commercial lab or hospital.
The issue becomes very important not only for our regular diabetic patients, but also for Gestational Diabetes. This is a glucose intolerance that first occurs in pregnancy.
The self test for the patient is the most important test a patient can use. It involves a simple lancet for blood draw and a glucose meter and glucose sticks. The steps a patient can take to assure accuracy in testing are :
- Make sure the meter is clean.
- Make sure factory calibration is correct by running controls
- The battery should not be weak
- Reagent Strips are not expired
- The amount of required blood is on the stick
- Timing of blood on the strip is correct
- The temperature where the test is done is correct
- The patient is hydrated.
Anyone of the above mentioned conditions, will affect the results of the test.
Controls are simply a bottle of liquid with a known value. You can follow the directions, however: simply said run the test on the controls like a patient, and see if you can obtain a result that is within the range stated on the bottle or a paper that comes with the control. This paper is known as the assay sheet.
The main advantage of self monitoring, is the instant feedback you get. Diabetics can decide on insulin need at anytime of
the day, wherever they are. This gives the patient better control, and adaptation so they can keep an acceptable lifestyle. It can result in better health and reduction in the tertiary conditions caused by uncontrolled diabetes. Many physicians routinely require all diabetic patients have a glucose meter, along with an individualized schedule of when to test. Some patients are once a day, but can be as much as six times per day.
Self monitoring and diet together, can contribute to patients well-being, reducing the chances of diabetic ulcers and kidney failure. There are many meters available on the market to choose from that differ in attributes. They may vary in the amount of blood that is used, the speed at which results are
displayed, the size of font of the displays, their ability to store readings in memory, and download capabilities. Some meters no longer require calibration. Newer meters function as a health PDA, allowing the patients to enter other lab values, dates, and results of health visits. Newer meters may also store the strips right in the meter, thereby allowing the patient to avoid handling the strips. They may also allow for a patient to flag which readings were after eating and which were before a meal. Examples of glucose meters available OTC are Accu–Chek, Invacare TRUEread, and One Touch Ultra.







