![]() It also significantly reduces the resources needed for retraining diabetes patients, their health care providers, and the diabetes educator teams. The referencing method of the glucose meter is changed from whole blood to blood plasma.įor patients with diabetes, these upgrades offer a clear benefit: they can avail of substantial technological improvements without having to acquire new glucose meters and invest time and effort in learning how to use them. The effect of incorrect coding of blood glucose meters on the accuracy of blood-glucose self-testing Poster presentation. (Haak T, Gerlach H, Krichbaum M, Hermanns N. ![]() Internal data 2007.) A study by Haak et al., sponsored by Bayer, showed that the mean absolute deviation of the ACCU-CHEK Aviva glucose meter is 9.5%, if coded according to instructions, and 10.8% if miscoded. Effect of miscoding on ACCU-CHEK ® Aviva system accuracy. However, this assessment with currently released lots demonstrates that even if the ACCU-CHEK Aviva glucose meter were miscoded, the probability of incorrectly altering a clinical action is low. Maximum system accuracy requires correct glucose meter coding, reinforcing the need to code in accordance with the labeling instructions. Bias within this study ranged from ☑5 mg/dl at glucose levels below 70 mg/dl to ☑5% at higher glucose levels these values fell within area A of the consensus error grid and support the results of the worst-case scenario simulated by the mathematical modeling. In addition to the theoretical modeling described earlier, a study was performed using spiked venous blood with four glucose solutions and two control solutions to assess the performance of extreme mismatches between the test strip code parameter and the test strip. No values (actual or estimated) fell into risk categories D or E. The worst-case estimated likelihood of observing a category C error throughout the shelf life was calculated as 16.0 ppm. ![]() The only risk category C event that was likely to affect clinical outcome was a low glucose level (i.e., ≤70 mg/dl). This was computed as the product of the individual probabilities. The overall probability of a risk category C event is the aggregate of the probabilities of each of these factors coming true. The prevalence of blood glucose values <70 mg/dl Historically, coding processes have evolved from printed, changeable color scales that were adaptable to batch-specific conditions, batch-specific code numbers that have to be entered manually into the glucose meter, bar codes that are read by the glucose meter ( Figure 1), to electronic code chips containing the batch-specific code ( Figure 2). In clinical evaluation of a glucose test system, the parameters that are encoded will already have been established and validated. This set of parameters defines the glucose test strip “code”. The second method consists of using the measurements of the quality assurance department to establish a set of parameters that best defines the relationship between the signal change induced on the glucose test strip and the blood glucose concentration. ![]() This means the manufacturer of the glucose test strips must adopt strict production tolerances and consequently reject batches of glucose test strips that do not conform to these stringent criteria. In the first method, the production differences are kept so small that their influence on the blood glucose measurement values is not clinically relevant. In glucose test strip manufacturing, therefore, the quality assurance department conducts an extensive series of measurements over the entire measurement range of the strip for every batch.īasically, there are two methods for addressing batch-specific differences in the production process of glucose test strips. Within each batch, however, the strip properties remain nearly constant. The numerous raw materials used in the manufacturing process of glucose test strips and the influences to which they are subject can never be held constant-even when the manufacturing conditions are identical-that the same glucose concentration will always elicit the same signal change for every batch. This seemingly simple reaction in the test strip is a highly complex process and depends on several factors, including the absorption of the liquid by the reagent layer, the activity of the enzymes, and the sensitivity of the signal-detection method. 1 Then, the fluid part of the blood containing meter and the blood glucose concentration is calculated the glucose to be measured passes into the reagent layer and presented to the patient. This signal change is evaluated by the glucose of the blood. The reagent layer combines enzymes and blood to a glucose test strip? First, in most glucose test other reagents to elicit a detectable signal change in the strips today, the erythrocytes are separated from the rest test strip. What happens when a patient with diabetes applies of the test strip.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |