Amin Sharifi1, Andrea Varsavsky2, Johanna Ulloa2, Jodie C Horsburgh3, Sybil A McAuley1, Balasubramanian Krishnamurthy4, Alicia J Jenkins5, Peter G Colman6, Glenn M Ward4, Richard J MacIsaac1, Rajiv Shah2, David N O'Neal7. 1. Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia Department of Medicine, St Vincent's Hospital, University of Melbourne, Melbourne, Australia. 2. Sensor R & D, Medtronic Diabetes, Northridge, CA, USA. 3. Department of Medicine, St Vincent's Hospital, University of Melbourne, Melbourne, Australia. 4. Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia. 5. Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia Department of Medicine, St Vincent's Hospital, University of Melbourne, Melbourne, Australia NHMRC Clinical Trials Centre, Sydney, Australia. 6. Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, Australia. 7. Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia Department of Medicine, St Vincent's Hospital, University of Melbourne, Melbourne, Australia dno@unimelb.edu.au.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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