Journal of diabetes science and technology · 2024
Accuracy and Feasibility of a Novel Glucose/Lactate Continuous Multi-Analyte Sensing Platform in Humans.
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Lu Jean C, Morrison Dale, Halim Bella, Manos Georgina, Obeyesekere Varuni, Kannard Brian, Shah Rajiv, Wolfe Kate, Morrow Blake, Pagliuso Ben, Liang Bradley, Nava Bella, Lee Melissa H, Ekinci Elif, Jenkins Alicia J, MacIsaac Richard J, O'Neal David N
Аннотация
BACKGROUND AND AIM: Continuous glucose monitoring systems (CGMs) have been commercially available since 1999. However, automated insulin delivery systems may benefit from real-time inputs in addition to glucose. Continuous multi-analyte sensing platforms will meet this area of potential growth without increasing the burden of additional devices. We aimed to generate pilot data regarding the safety and function of a first-in-human, single-probe glucose/lactate multi-analyte continuous sensor.
METHODS: The investigational glucose/lactate continuous multi-analyte sensor (PercuSense Inc, Valencia, California) was inserted to the upper arms of 16 adults with diabetes, and data were available for analysis from 11 of these participants (seven female; mean [SD] = age 43 years [16]; body mass index [BMI] = 27 kg/m2 [5]). A commercially available Guardian 3 CGM (Medtronic, Northridge, California) was also inserted into the abdomen for comparison. All participants underwent a meal-test followed by an exercise challenge on day 1 and day 4 of wear. Performance was benchmarked against venous blood YSI glucose and lactate values.
RESULTS: The investigational glucose sensor had an overall mean absolute relative difference (MARD) of 14.5% (median = 11.2%) which improved on day 4 compared with day 1 (13.9% vs 15.2%). The Guardian 3 CGM had an overall MARD of 13.9% (median = 9.4%). The lactate sensor readings within 20/20% and 40/40% of YSI values were 59.7% and 83.1%, respectively.
CONCLUSIONS: Our initial data support safety and functionality of a novel glucose/lactate continuous multi-analyte sensor. Further sensor refinement will improve run-in performance and accuracy.
METHODS: The investigational glucose/lactate continuous multi-analyte sensor (PercuSense Inc, Valencia, California) was inserted to the upper arms of 16 adults with diabetes, and data were available for analysis from 11 of these participants (seven female; mean [SD] = age 43 years [16]; body mass index [BMI] = 27 kg/m2 [5]). A commercially available Guardian 3 CGM (Medtronic, Northridge, California) was also inserted into the abdomen for comparison. All participants underwent a meal-test followed by an exercise challenge on day 1 and day 4 of wear. Performance was benchmarked against venous blood YSI glucose and lactate values.
RESULTS: The investigational glucose sensor had an overall mean absolute relative difference (MARD) of 14.5% (median = 11.2%) which improved on day 4 compared with day 1 (13.9% vs 15.2%). The Guardian 3 CGM had an overall MARD of 13.9% (median = 9.4%). The lactate sensor readings within 20/20% and 40/40% of YSI values were 59.7% and 83.1%, respectively.
CONCLUSIONS: Our initial data support safety and functionality of a novel glucose/lactate continuous multi-analyte sensor. Further sensor refinement will improve run-in performance and accuracy.