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. 2021 Jan;15(1):11-18.
doi: 10.1177/1932296820947112. Epub 2020 Aug 12.

Proof of Concept for a New Raman-Based Prototype for Noninvasive Glucose Monitoring

Stefan Pleus  1 , Sebastian Schauer  1 , Nina Jendrike  1 , Eva Zschornack  1 , Manuela Link  1 , Karl Dietrich Hepp  2 , Cornelia Haug  1 , Guido Freckmann  1
Affiliations

Proof of Concept for a New Raman-Based Prototype for Noninvasive Glucose Monitoring

Stefan Pleus et al. J Diabetes Sci Technol. 2021 Jan.

Abstract

Background: Noninvasive glucose monitoring (NIGM) in diabetes is a long-sought-for technology. Among the many attempts Raman spectroscopy was considered as the most promising because of its glucose specificity. In this study, a recently developed prototype (GlucoBeam, RSP Systems A/S, Denmark) was tested in patients with type 1 diabetes to establish calibration models and to demonstrate proof of concept for this device in real use.

Methods: The NIGM table-top prototype was used by 15 adult subjects with type 1 diabetes for up to 25 days at home and in an in-clinic setting. On each day, the subjects performed at least six measurement units throughout the day. Each measurement unit comprised two capillary blood glucose measurements, two scans with an intermittent scanning continuous glucose monitoring (CGM) system, and two NIGM measurements using the thenar of the subject's right hand.

Results: Calibration models were established using data from 19 to 24 days. The remaining 3-8 days were used for independent validation. The mean absolute relative difference of the NIGM prototype was 23.6% ± 13.1% for the outpatient days, 28.2% ± 9.9% for the in-clinic day, and 26.3% ± 10.8% for the complete study. Consensus error grid analysis of the NIGM prototype for the complete study showed 93.6% of values in clinically acceptable zones A and B.

Conclusions: This proof of concept study demonstrated a practical realization of a Raman-based NIGM device, with performance on par with early-generation CGM systems. The findings will assist in further performance improvements of the device.

Keywords: Raman spectroscopy; continuous glucose monitoring; mean absolute relative difference; noninvasive glucose monitoring; performance; self-monitoring of blood glucose.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: GF is general manager and medical director of the Institute for Diabetes Technology (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out clinical studies on the evaluation of BG meters, with CGM systems and medical devices for diabetes therapy on its own initiative and on behalf of various companies. GF/IfDT has received speakers’ honoraria or consulting fees from Abbott, Ascensia, Dexcom, i-SENS, LifeScan, Menarini Diagnostics, Metronom Health, Novo Nordisk, PharmaSense, Roche, Sanofi, Sensile, and Ypsomed.

SP, SS, NJ, EZ, ML, and CH are employees of IfDT.

KDH receives a consultant fee as Scientific Advisor for RSP Systems.

Figures

Figure 1.
Figure 1.
CEG distribution of paired points of (a) outpatient performance, (b) in-clinic performance, and (c) overall performance. All paired points correspond to results obtained during validation phase. CEG, consensus error grid.
Figure 2.
Figure 2.
Mean glucose values (±SD) for BGMS, iscCGM system, and the NIGM prototype in a period of 30 minutes prior to and 450 minutes after the intake of a carbohydrate-rich breakfast. Subjects were fasting overnight. Each data point is based on time points for which each of the three values were available (n = 2 to n = 15). Orange arrows indicate time points for insulin delivery (30, 60, or 90 minutes after start of meal intake). BGMS, blood glucose monitoring system; iscCGM, intermittent scanning continuous glucose monitoring; NIGM, noninvasive glucose monitoring.
Figure 3.
Figure 3.
Time in range during the meal challenge for BGMS, iscCGM system, and the NIGM prototype. BGMS, blood glucose monitoring system; GED, glucose excursion day; iscCGM, intermittent scanning continuous glucose monitoring; NIGM, noninvasive glucose monitoring.
See this image and copyright information in PMC

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