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}
}