Difference Analysis of System Accuracy Criteria between Self-Monitoring Blood Glucose Test System and Point-of-Care Blood Glucose Monitoring Systems / 中国医疗器械杂志

According to users and places, blood glucose monitoring systems(BGMSs) can be divided into self-monitoring blood glucose test systems(SMBGs) and Point-of-Care Blood Glucose monitoring systems(POC-BGMSs). The Food and Drug Administration(FDA) believes that standards for SMBGs and POC-BGMSs should be different because of different operators, different use environments, different intendance uses and different applicable populations. Now the international standards for evaluating BGMSs include ISO 15197:2013 issued by International Organization for Standardization(ISO), two guidelines on blood glucose monitoring systems issued by FDA, and POCT12-A3 guidelines issued by the American Association for Clinical and Laboratory Standardization(CLSI), ISO standard and FDA guideline-OTC are applicable in SMBGs, CLSI guideline and FDA guideline-POCTI2-A3 are suitable for POC-BGMSs. By analyzing the accuracy evaluation processes of BGMSs based on four standard documents, it is found that the accuracy evaluation of medical BGMSs is more stringent. It is proposed that SMBGs and POC-BGMSs should be supervised separately.

Comparison of Blood Glucose Measurements Using Samples Obtained from the Forearm, Finger Skin Puncture, and Venous Serum / 대한진단검사의학회지

BACKGROUND: Blood glucose testing (BGT) at the forearm minimizes the pain experienced during sampling of capillary blood. We compared the BGT results for forearm sampling with those for standard finger skin puncture and venous serum to evaluate the clinical validity of forearm BGT. METHODS: BGT was performed on the finger (G(F)) and forearm (G(A)) with a portable glucometer in 555 subjects, including 61 diabetic patients, under fasting conditions. BGT with venous serum (G(V)) was followed within an hour in 514 subjects. Simple linear regression, intraclass correlation, and Passing-Bablok regression analyses were performed using the G(A)-G(F) and G(A)-G(V) data. RESULTS: G(A) showed an excellent linear relationship with both G(F) and G(V) with a Pearson correlation coefficient (r) of 0.97 (P<0.0001) in the patient group, which was similar to the findings in the normal group except for the lower r values. The mean bias between G(A) and G(F) and between G(A) and G(V) were within +/- 10 mg/dL in both groups. The intraclass correlation coefficients were slightly smaller than the corresponding r values, but they showed the same tendency in both groups. In the Passing-Bablok analyses, the 95% confidence intervals of the slope and intercept parameters were <+/-20% of unity and <+/-20 mg/dL, respectively, which were within the acceptable ranges. All 3 statistical analyses supported the satisfactory agreement of G(A) with G(F) or G(V). CONCLUSIONS: BGT at the forearm was highly consistent with the standard BGT, thereby confirming its applicability in clinical practice for self-testing under steady fasting conditions.