Real-World Evaluation of a Near-Infrared Spectroscopy–based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes
5 affiliations
- 1Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío, Sevilla, Spain
- 2Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Spain
- 3Telematic Engineering Department, University of Seville, Spain
- 4GLUCUBE, Seville, Spain
- 5Unidad de Gestión Clínica de Cuidados Intensivos, Hospital Universitario Virgen Del Rocío, Sevilla, Spain
Abstract
Background:: Self-monitoring of blood glucose remains widely used in many individuals with type 2 diabetes (T2D), although the burden of capillary testing often limits the frequency of measurements. Noninvasive technologies may improve glucose monitoring. This study evaluated the analytical performance and applicability of a near-infrared spectroscopy–based noninvasive glucose monitoring device.
Methods:: In this prospective, open-label clinical investigation, 52 adults with T2D performed 4 daily paired glucose measurements for more than 21 days using the investigational device and a reference capillary glucometer (Ascensia Contour Next). Following individualized calibration (10 paired measurements), post-calibration measurements within the 70 to 400 mg/dL range were included in the primary analysis. Accuracy was assessed using a combined mean absolute difference/mean absolute relative difference (MAD/MARD) metric, Parkes consensus error grid (CEG), and DTS error grid analyses.
Results:: Forty-eight participants were included in the primary analysis, contributing 2,616 paired post-calibration measurements. The mean age was 58.0 ± 9.9 years, and 31.3% were female. The overall combined MAD/MARD value was 16.3, calculated by applying MAD to paired measurements with reference glucose values <100 mg/dL and MARD to paired measurements with reference glucose values ≥100 mg/dL. Overall, 69.8%, 86.3%, and 94.5% of measurements were within ±20%, ±30%, and ±40% of reference values, respectively. Parkes CEG analysis classified 69.9% of measurements in zone A, 29.1% in zone B, 1.0% in zone C, and none in zones D or E. Accuracy improved after the first week. No device-related adverse events were reported.
Conclusion:: The device demonstrated a favorable clinical risk profile, stable analytical performance, and good safety under real-world conditions. Although analytical precision remains lower than current continuous glucose monitoring systems, its fully noninvasive design supports further development as a complementary monitoring strategy for individuals with T2D unwilling or unable to use invasive monitoring technologies.
Trial Registration:: ClinicalTrials.gov (NCT07075796).
Related
- Functional near-infrared spectroscopy as a tool for monitoring treatment-related neurofunctional changes in posttraumatic stress disorder and trauma-related symptomatology: a narrative review.
- The future of wearable sweat sensors in intensive care units: Toward a new era of noninvasive, continuous real-time monitoring
- In vivo evaluation of noninvasive temporal interference stimulation for tibial nerve-mediated bladder reflex modulation in rats
- Continuous intra-arterial versus noninvasive blood pressure monitoring for preventing hypotension during anesthesia induction in patients aged ≥ 75 years undergoing noncardiac surgery: a randomized controlled trial.
- Near-Infrared Spectroscopy-Guided Selective Distal Perfusion in Femoral Venoarterial Extracorporeal Membrane Oxygenation: A Feasibility Study
BibTeX
@article{amuedo2026realworld,
title = {{Real-World Evaluation of a Near-Infrared Spectroscopy–based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes}},
author = {Sandra Amuedo and Mónica Enríquez Macías and José Manuel Fornés and Arturo Moreno Arteaga and Jesús Riesgo Barrau and Virginia Bellido and Fernando Losada Viñau and Luz María Hidalgo Pichardo and Alfonso Soto Moreno and Antonio Puppo Moreno and Alfonso Pumar López},
journal = {Journal of Diabetes Science and Technology},
year = {2026},
month = oct,
doi = {10.1177/19322968261496268},
url = {https://doi.org/10.1177/19322968261496268},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Real-World Evaluation of a Near-Infrared Spectroscopy–based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes
AU - Sandra Amuedo
AU - Mónica Enríquez Macías
AU - José Manuel Fornés
AU - Arturo Moreno Arteaga
AU - Jesús Riesgo Barrau
AU - Virginia Bellido
AU - Fernando Losada Viñau
AU - Luz María Hidalgo Pichardo
AU - Alfonso Soto Moreno
AU - Antonio Puppo Moreno
AU - Alfonso Pumar López
PY - 2026
DA - 2026/10/25
JO - Journal of Diabetes Science and Technology
DO - 10.1177/19322968261496268
UR - https://doi.org/10.1177/19322968261496268
AB - Background:: Self-monitoring of blood glucose remains widely used in many individuals with type 2 diabetes (T2D), although the burden of capillary testing often limits the frequency of measurements. Noninvasive technologies may improve glucose monitoring. This study evaluated the analytical performance and applicability of a near-infrared spectroscopy–based noninvasive glucose monitoring device. Methods:: In this prospective, open-label clinical investigation, 52 adults with T2D performed 4 daily paired glucose measurements for more than 21 days using the investigational device and a reference capillary glucometer (Ascensia Contour Next). Following individualized calibration (10 paired measurements), post-calibration measurements within the 70 to 400 mg/dL range were included in the primary analysis. Accuracy was assessed using a combined mean absolute difference/mean absolute relative difference (MAD/MARD) metric, Parkes consensus error grid (CEG), and DTS error grid analyses. Results:: Forty-eight participants were included in the primary analysis, contributing 2,616 paired post-calibration measurements. The mean age was 58.0 ± 9.9 years, and 31.3% were female. The overall combined MAD/MARD value was 16.3, calculated by applying MAD to paired measurements with reference glucose values <100 mg/dL and MARD to paired measurements with reference glucose values ≥100 mg/dL. Overall, 69.8%, 86.3%, and 94.5% of measurements were within ±20%, ±30%, and ±40% of reference values, respectively. Parkes CEG analysis classified 69.9% of measurements in zone A, 29.1% in zone B, 1.0% in zone C, and none in zones D or E. Accuracy improved after the first week. No device-related adverse events were reported. Conclusion:: The device demonstrated a favorable clinical risk profile, stable analytical performance, and good safety under real-world conditions. Although analytical precision remains lower than current continuous glucose monitoring systems, its fully noninvasive design supports further development as a complementary monitoring strategy for individuals with T2D unwilling or unable to use invasive monitoring technologies. Trial Registration:: ClinicalTrials.gov (NCT07075796).
SN - 1932-2968
ER -