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

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.