Zhou Tony, Dickson Jennifer L, Shaw Geoffrey M, Chase J Geoffrey
1 Department of Mechanical Engineering, University of Canterbury, Christchurch, Canterbury, New Zealand.
2 Department of Intensive Care, Christchurch Hospital, Christchurch School of Medicine and Health Science, University of Otago, New Zealand.
J Diabetes Sci Technol. 2018 Jan;12(1):7-19. doi: 10.1177/1932296817738791. Epub 2017 Nov 6.
Continuous glucose monitoring (CGM) technology has become more prevalent in the intensive care unit (ICU), offering potential benefits of increased safety and reduced workload in glycemic control (GC). The drift and higher point accuracy errors of CGM devices over traditional intermittent blood glucose (BG) measures have so far limited their application in the ICU. This study delineates the trade-offs of performance, safety and workload that CGM sensors provide in GC protocols.
Clinical data from 236 patients were used for clinically validated virtual trials. A CGM-enabled version of the STAR GC protocol was used to evaluate the use of guard rails and rolling windows. Safety was assessed through percentage of patients who had a severe hypoglycemic episode (BG < 40 mg/dl) as well as percentage of resampled BG < 72 mg/dl. Performance was assessed as percentage of resampled measurements in the 80-126 mg/dl and the 80-144 mg/dl target bands. Workload was measured by number of manual BG measures per day.
CGM-enabled versions of STAR decreased the number of required blood draws by up to 74%, while maintaining performance (76.6% BG measurements in the 80-126 mg/dl range vs 62.8% clinically, 87.9% in the 80-144 mg/dl range vs 83.7% clinically) and maintaining patient safety (1.13% of patients experienced a severe hypoglycemic event vs 0.85% clinically, 1.37% of BG measurements were less than 72 mg/dl vs 0.51% clinically).
CGM sensor traces were reproduced in virtual trials to guide GC. Existing GC protocols such as STAR may need to be adjusted only slightly to gain the benefits of the increased temporal measurements of CGM sensors, through which workload may be significantly decreased while maintaining GC performance and safety.
连续血糖监测(CGM)技术在重症监护病房(ICU)中已变得更为普遍,在血糖控制(GC)方面具有提高安全性和减轻工作量的潜在益处。与传统的间歇性血糖(BG)测量相比,CGM设备的漂移和更高的点准确性误差迄今为止限制了其在ICU中的应用。本研究阐述了CGM传感器在GC方案中所提供的性能、安全性和工作量之间的权衡。
来自236名患者的临床数据用于经过临床验证的虚拟试验。启用CGM的STAR GC方案版本用于评估护栏和滚动窗口的使用情况。通过发生严重低血糖事件(BG < 40 mg/dl)的患者百分比以及重新采样的BG < 72 mg/dl的百分比来评估安全性。性能评估为重新采样测量值在80 - 126 mg/dl和80 - 144 mg/dl目标范围内的百分比。工作量通过每天手动BG测量的次数来衡量。
启用CGM的STAR版本减少了高达74%的所需采血次数,同时保持了性能(80 - 126 mg/dl范围内的BG测量值为76.6%,而临床为62.8%;80 - 144 mg/dl范围内为87.9%,而临床为83.7%)并保持了患者安全(1.13%的患者经历了严重低血糖事件,而临床为0.85%;1.37%的BG测量值低于72 mg/dl,而临床为0.51%)。
在虚拟试验中重现了CGM传感器轨迹以指导GC。现有的GC方案,如STAR,可能仅需进行轻微调整,以获得CGM传感器增加的时间测量的益处,通过这种方式,在保持GC性能和安全性的同时,工作量可能会显著减少。