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. Continue reading »












