ICCK Transactions on Systems Safety and Reliability
ISSN: 3069-1087 (Online)
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TY - JOUR AU - Li, Mengya AU - Song, Guozheng AU - Liu, Peizhi AU - Zhu, Kehan AU - Zhang, Aibo PY - 2025 DA - 2025/12/29 TI - Non-invasive Continuous Glucose Monitoring (CGM) System Reliability Analysis Based on the DFMEA Model JO - ICCK Transactions on Systems Safety and Reliability T2 - ICCK Transactions on Systems Safety and Reliability JF - ICCK Transactions on Systems Safety and Reliability VL - 1 IS - 2 SP - 128 EP - 135 DO - 10.62762/TSSR.2025.581880 UR - https://www.icck.org/article/abs/TSSR.2025.581880 KW - non-invasive CGM system KW - DFMEA KW - RPNs KW - failure analysis KW - risk prioritization AB - Non-invasive continuous glucose monitoring (CGM) systems offer the advantage of non-invasive, real-time dynamic glucose monitoring, marking a significant advancement in diabetes management. However, the complexity of their sensing principles and operational mechanisms make systems vulnerable to various factors, which may introduce measurement bias or cause system interruptions and thereby compromise patient safety and monitoring effectiveness. To address these challenges, the Design Failure Mode and Effects Analysis (DFMEA) method is employed to identify and prioritize risks by assigning expert-based scores to critical components, ultimately enabling targeted improvements for high-risk failure modes to ensure system safety. This paper decomposes the key functional modules of the non-invasive CGM systems, identifies the potential failure modes within each module, and utilizes expert evaluation of severity, occurrence frequency, and detectability to determine Risk Priority Numbers (RPNs). Based on the RPNs, corresponding improvement strategies are proposed for high-risk failure modes, with the aim of mitigating system risks and enhancing the overall reliability of the non-invasive CGM systems. SN - 3069-1087 PB - Institute of Central Computation and Knowledge LA - English ER -
@article{Li2025Noninvasiv,
author = {Mengya Li and Guozheng Song and Peizhi Liu and Kehan Zhu and Aibo Zhang},
title = {Non-invasive Continuous Glucose Monitoring (CGM) System Reliability Analysis Based on the DFMEA Model},
journal = {ICCK Transactions on Systems Safety and Reliability},
year = {2025},
volume = {1},
number = {2},
pages = {128-135},
doi = {10.62762/TSSR.2025.581880},
url = {https://www.icck.org/article/abs/TSSR.2025.581880},
abstract = {Non-invasive continuous glucose monitoring (CGM) systems offer the advantage of non-invasive, real-time dynamic glucose monitoring, marking a significant advancement in diabetes management. However, the complexity of their sensing principles and operational mechanisms make systems vulnerable to various factors, which may introduce measurement bias or cause system interruptions and thereby compromise patient safety and monitoring effectiveness. To address these challenges, the Design Failure Mode and Effects Analysis (DFMEA) method is employed to identify and prioritize risks by assigning expert-based scores to critical components, ultimately enabling targeted improvements for high-risk failure modes to ensure system safety. This paper decomposes the key functional modules of the non-invasive CGM systems, identifies the potential failure modes within each module, and utilizes expert evaluation of severity, occurrence frequency, and detectability to determine Risk Priority Numbers (RPNs). Based on the RPNs, corresponding improvement strategies are proposed for high-risk failure modes, with the aim of mitigating system risks and enhancing the overall reliability of the non-invasive CGM systems.},
keywords = {non-invasive CGM system, DFMEA, RPNs, failure analysis, risk prioritization},
issn = {3069-1087},
publisher = {Institute of Central Computation and Knowledge}
}
ICCK Transactions on Systems Safety and Reliability
ISSN: 3069-1087 (Online)
Email: [email protected]
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