Clinical evaluation of a novel test strip technology for blood glucose monitoring: Accuracy at hypoglycaemic glucose levels

System Accuracy of Blood Glucose Monitoring Devices According to the Current and Proposed ISO 15197 Standards

“…3,4 This contrasts with previous LifeScan-sponsored studies evaluating the accuracy of our three BGMSs (A, B, and C), which reported that these systems met the current ISO 15197 criteria, 5 and were particularly accurate at low blood glucose levels. 6 A reanalysis of the same data, 5,6 presented here, further shows that the aforementioned three BGMSs meet the current and proposed ISO 15197 criteria for system accuracy (refer to Table 1).…”

Seven-Year Surveillance of the Clinical Performance of a Blood Glucose Test Strip Product

“…The performance of selected blood glucose meters has recently been evaluated in neonatal blood samples where Hct levels ranged from 18-75% 6 and in an antenatal clinic setting where Hct levels ranged from 31-43%. 7 We previously reported the accuracy of blood glucose test strips at hypoglycemic glucose levels 8 in subjects with Hct levels of 25.0-56.5% and more recently described how BGMS systems using this test strip met precision, accuracy, Hct and interferences criteria in clinical testing according to ISO15197:2015. 9,10 In addition to patient specific-considerations, there is a growing call amongst experts for routine postmarket surveillance to safeguard patients with diabetes from consumer 1 LifeScan Scotland Ltd, Inverness, UK 2 LifeScan Inc, Wayne, PA, USA products that do not routinely meet their labeled accuracy performance in the field.…”

Colorimetric and ultra-sensitive fluorescence resonance energy transfer determination of H2O2 and glucose by multi-functional Au nanoclusters

“…Although the blood glucose level varies at different stages, especially aer a meal, if the fasting plasma glucose concentration is greater than 6 mM and the plasma glucose 2 hours aer meals is greater than 11 mM, the person is deemed to be clinically diabetic. 33,34 By using this method, the glucose concentration is determined from serum samples from ten healthy volunteers and the results (4.02-7.8 mM) are satisfactory, and most importantly, the technique is largely free from the complicated matrix effect arising from the human serum samples.…”