977-P: Validation of the Noninvasive Blood Glucose Monitoring Device Nirlus

Abstract

Background: Since the prevalence of diabetes mellitus has dramatically increased over the last decades, reliable non-invasive techniques for blood glucose monitoring are required to overcome problems and obstacles for regularly home-based blood glucose assessment. The aim of this study was the validation of the newly developed non-invasive blood glucose system NIRLUS® (Near Infra Red Light Ultra Sound, NIRLUS Engineering AG, Lübeck, Germany) under well standardized conditions. Methods: 17 healthy normal weight men (BMI: 22.4 ± 1.4 kg/m2) aged 18 to 45 years were enrolled in this study. During an intravenous glucose tolerance test (ivGTT), blood glucose profiles were measured simultaneously by two researchers with the NIRLUS® system (blinded for measured values) and a gold-standard laboratory reference system (reference, EKF-Diagnostics Biosen C-line, Barleben, Germany), respectively. During the course of ivGTT, blood glucose levels ranged from hyper- to mild hypoglycemia. Results:Correlation analysis revealed a strong association between NIRLUS and reference values (r=0.934; p<0.00). Subsequent Bland Altman analysis showeda symmetric distribution without blood glucose level depending deviation (r=0.047; p=0.395) and 95.5% of the NIRLUS/reference pairs were within the difference (d) of d±2SD. Error grid analysis revealed that 93.6% of NIRLUS/reference pairs are located in the area A, and 6.4% in the area B, respectively. No data were allocated in the areas C to E. Conclusion: This proof-of-concept study clearly demonstrates accuracy of blood glucose measures obtained by NIRLUS®as compared to a gold-standard laboratory reference system. Precise non-invasive glucose monitoring by NIRLUS®is feasible and might lower the burden of glucose control in patients with diabetes. Disclosure S. Meyhoefer: Research Support; Spouse/Partner; NIRLUS Engineering AG. B. Wilms: Research Support; Spouse/Partner; NIRLUS Engineering AG. F. Ihling: Research Support; Spouse/Partner; NIRLUS Engineering AG. A. Windjäger: Research Support; Spouse/Partner; NIRLUS Engineering AG. V. Herrmann: Research Support; Self; NIRLUS Engineering AG. A. Augustinov: Research Support; Self; NIRLUS Engineering AG. S.M. Schmid: Research Support; Self; NIRLUS AG. Funding NIRLUS Engineering AG