Abstract
The self-monitoring blood glucose system (SMBGS) with high accuracy can enhance self-management of diabetes to prevent the complications of diabetes. The study evaluated the clinical performance of three newer SMBGS. Correlation and regression analysis showed that newer SMBGS readings correlated excellently with the gold-standard reference values. The Error Grid analysis showed that measurements deemed clinically acceptable approach 100% and suggested newer SMBGS are clinically acceptable devices. Three newer SMBGS had a few specimens value different from reference method by more than 20% (2.48%, 1.82%, 2.16%, respectively), meeting the ISO 15197 criteria (<5%). The coefficients of variation of three newer SMBGS were less than 5% at glucose concentration greater than 50mg/dl, although one of the SMBGS had a greater level of imprecision in the hypoglycemic range. Error grid analysis also indicated that no considerable reading differences were observed between the trained operator and the patients who performed newer SMBGS. Owing to their reduced dependence on tester technique, patients using these system are expected to achieve a level of accuracy and precision similar to trained operator. As compared to the alternate site, the fingertip correlated well with the thenar, hypothenar, forearm. and venous blood value. The Clarke error grid analysis indicated that the results of fingertip and alternative sites were clinically acceptable approach 100%. A majority of patients (97%) stated that the collection of blood from the alternate sites induced less pain than the classic sites. Being instructed on how to use the alternate sites, patients will increase the frequency of daily testing. The novel technique of blood volume detection can provide patients with a superior indication to use the system and improve the reliability and accuracy of SMBGS. The systems used enzymatic methods and were unaffected by several interference. The glucose dehydrogenase performed better than glucose oxidase at 10,000 ft altitude. Patients can recognize interference and take steps to minimize their impact. These researches also provide clinicians with a better understanding of accuracy studies and suggesting what can be done to improve the accuracy of SMBGS in clinical practice. It is expected that these researches can contribute to drug discovery, screening instrumentation or reagents R & D for complications of diabetes mellitus.