[Retracted] System Accuracy Evaluation of the GlucoRx Nexus Voice TD-4280 Blood Glucose Monitoring System

Table 2

Overview of the number of measurements obtained from the GlucoRx Nexus TD-4280 blood glucose monitoring device that were within the blood glucose concentration categories defined in both the ISO 15197:2003 and ISO 15197:2013 guidelines.

(a)

	DIN EN ISO 15197:2003
	Blood glucose concentration <75 mg/dL; (<4.2 mmol/L); ( = 5)			Blood glucose concentration ≥75 mg/dL; (≥4.2 mmol/L); ( = 100)
Blood glucose concentration categories defined in guidelines	±5 mg/dL; (0.28 mmol/L)	±10 mg/dL; (0.55 mmol/L)	±15 mg/dL; (0.83 mmol/L)	±5%	±10%	±15%	±20%
Number of results within category	1/5	2/5	4/5	38/100	77/100	87/100	93/100
Percentage of results; within category (%)	20	40	80	38	77	87	93

(b)

	DIN EN ISO 15197:2013
	Blood glucose concentration <100 mg/dL; (<5.55 mmol/L); ( = 34)			Blood glucose concentration ≥100 mg/dL; (≥5.55 mmol/L); ( = 71)
Blood glucose concentration categories defined in guidelines	±5 mg/dL; (0.28 mmol/L)	±10 mg/dL; (0.55 mmol/L)	±15 mg/dL; (0.83 mmol/L)	±5%	±10%	±15%
Number of results within category	22/34	26/34	31/34	26/71	59/71	60/71
Percentage of results within category (%)	64.7	76.5	91.2	36.6	83.1	84.5