Recent changes in Medicare regulations for suppliers of diabetes meters and strips have accelerated the concern of diabetes technology leaders that current testing controls are inadequate to insure blood glucose meter accuracy post market sale. This comes amid the heightened awareness in the Food and Drug Administration (FDA) of the need to strengthen the overall accuracy guidelines for these devices.
Medicare’s competitive bidding rules have recently reduced the number of approved mail-order supply houses to just 18. These suppliers have to meet the cost containment rules issues by Medicare. To do this they have chosen two strategies: one to streamline the extent of their stock and the other to choose meters that are at the best price point. The overall outcome of these policies is that many older people with diabetes are being switched from name-brand meters to those of less cost and possibly lesser quality.
An industry funded study reported in the Journal of Diabetes Science Technology in 2013 looked at the post market performance of seven different meter systems. Roche compared its own meter, the Accu-Chek Aviva Plus, to a series of non-brand name meters, Redi-Code, Element, Prodigy Voice, and TRUEbalance. Only three of the meters, including the Accu-Chek, met the FDA’s approval criteria. Currently once a meter passes FDA requirements there isn’t any legislation governing post-market testing.
People with diabetes depend on the accuracy of testing results to guide treatment options. Falsely elevated or depressed readings can lead to inappropriate actions on the user’s behalf. For example if the meter indicates a low reading when the blood glucose is within the normal range, inappropriate intake of unneeded carbohydrates can spike the glucose level unnecessarily. Accuracy in testing is especially important in patients with a history of hypoglycemia, pregnant patients and small children.
Current standards for blood glucose meters were established by the FDA in 2003 in conjunction with the International Organization for Standardization (ISO). Today’s requirements state that a blood glucose system (meter and strips) must meet an accuracy standard of being within 20 percent of reference values (laboratory) for numbers at or above 75mg/dl and within 15mg/dl below 75 mg/dl.
The FDA has been working on revising the current requirements since 2010 and the ISO has already come out with new standards. Whether the FDA will accept the ISO’s recommendations or adopt a different set of standards only time will tell.
In the meantime, you may want to make sure your testing technique is accurate and that you are aware of any conditions that may influence the accuracy of the results your meter provides. For example, extreme temperature, humidity and altitude can cause meter error and it won’t necessarily be in a specific direction. Meters utilizing glucose oxidase technology can over estimate glucose at both high altitudes and low temperatures but those meters using the glucose dehydrogenase enzyme can lead to unpredictable results. Interfering substances such as vitamin C and uric acid can also produce erroneous results. There are also medical conditions, anemia for one, which can interfere with the blood glucose readings. Reading the instruction manual will alert you to the situations that may affect your meter results.
If you think your meter is inaccurate use the control solution to make sure the meter is working properly. If the meter tests out okay, but you still think there is a problem with your meter, you can compare your meter results with the results of blood glucose test done by a clinical laboratory. If they don’t match, it might be time to get a new meter.
And if you are a Medicare patient who is happy with your current meter, there is no requirement to switch. Medicare requires that all of its blood glucose meter suppliers carry at least 50 percent of the available testing supply brands on the market (if there are 30 meters on the market, the suppliers have to carry at least 15). Physicians can also specify a particular meter brand when writing a prescription. The suppliers are then forced to either provide the brand or find the patient another supplier that carries that brand.