Sharifi Amin, Varsavsky Andrea, Ulloa Johanna, Horsburgh Jodie C, McAuley Sybil A, Krishnamurthy Balasubramanian, Jenkins Alicia J, Colman Peter G, Ward Glenn M, MacIsaac Richard J, Shah Rajiv, O'Neal David N
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia Department of Medicine, St Vincent's Hospital, University of Melbourne, Melbourne, Australia.
Sensor R & D, Medtronic Diabetes, Northridge, CA, USA.
J Diabetes Sci Technol. 2016 May 3;10(3):669-78. doi: 10.1177/1932296815612096. Print 2016 May.
Current electrochemical glucose sensors use a single electrode. Multiple electrodes (redundancy) may enhance sensor performance. We evaluated an electrochemical redundant sensor (ERS) incorporating two working electrodes (WE1 and WE2) onto a single subcutaneous insertion platform with a processing algorithm providing a single real-time continuous glucose measure.
Twenty-three adults with type 1 diabetes each wore two ERSs concurrently for 168 hours. Post-insertion a frequent sampling test (FST) was performed with ERS benchmarked against a glucose meter (Bayer Contour Link). Day 4 and 7 FSTs were performed with a standard meal and venous blood collected for reference glucose measurements (YSI and meter). Between visits, ERS was worn with capillary blood glucose testing ≥8 times/day. Sensor glucose data were processed prospectively.
Mean absolute relative deviation (MARD) for ERS day 1-7 (3,297 paired points with glucose meter) was (mean [SD]) 10.1 [11.5]% versus 11.4 [11.9]% for WE1 and 12.0 [11.9]% for WE2; P < .0001. ERS Clarke A and A+B were 90.2% and 99.8%, respectively. ERS day 4 plus day 7 MARD (1,237 pairs with YSI) was 9.4 [9.5]% versus 9.6 [9.7]% for WE1 and 9.9 [9.7]% for WE2; P = ns. ERS day 1-7 precision absolute relative deviation (PARD) was 9.9 [3.6]% versus 11.5 [6.2]% for WE1 and 10.1 [4.4]% for WE2; P = ns. ERS sensor display time was 97.8 [6.0]% versus 91.0 [22.3]% for WE1 and 94.1 [14.3]% for WE2; P < .05.
Electrochemical redundancy enhances glucose sensor accuracy and display time compared with each individual sensing element alone. ERS performance compares favorably with 'best-in-class' of non-redundant sensors.
当前的电化学葡萄糖传感器使用单个电极。多个电极（冗余设计）可能会提高传感器性能。我们评估了一种电化学冗余传感器（ERS），该传感器在单个皮下插入平台上集成了两个工作电极（WE1和WE2），并采用一种处理算法来提供单一的实时连续血糖测量值。
23名1型糖尿病成年患者每人同时佩戴两个ERS，持续168小时。插入后，进行了频繁采样测试（FST），将ERS与血糖仪（拜耳轮廓链接）进行比对。在第4天和第7天进行FST，期间提供标准餐，并采集静脉血用于参考血糖测量（YSI和血糖仪）。在两次就诊期间，ERS与每天至少8次的毛细血管血糖检测同时使用。对传感器的血糖数据进行前瞻性处理。
ERS在第1 - 7天的平均绝对相对偏差（MARD）（与血糖仪有3297对配对数据）为（均值[标准差]）10.1 [11.5]%，而WE1为11.4 [11.9]%，WE2为12.0 [11.9]%；P <.0001。ERS的克拉克A级和A + B级分别为90.2%和99.8%。ERS在第4天加第7天的MARD（与YSI有1237对配对数据）为9.4 [9.5]%，而WE1为9.6 [9.7]%，WE2为9.9 [9.7]%；P =无显著差异。ERS在第1 - 7天的精确绝对相对偏差（PARD）为9.9 [3.6]%，而WE1为11.5 [6.2]%，WE2为10.1 [4.4]%；P =无显著差异。ERS传感器的显示时间为97.8 [6.0]%，而WE1为91.0 [22.3]%，WE2为94.1 [14.3]%；P <.
与单独的每个传感元件相比，电化学冗余设计提高了葡萄糖传感器的准确性和显示时间。ERS的性能与非冗余传感器的“同类最佳”相比具有优势。
