首个内置式连续血糖监测仪用于危重症患者的多中心前瞻性关键试验结果。
Results of a multicenter prospective pivotal trial of the first inline continuous glucose monitor in critically ill patients.
作者信息
Bochicchio Grant V, Nasraway Stan, Moore Laura, Furnary Anthony, Nohra Eden, Bochicchio Kelly
机构信息
From the Acute and Critical Care Surgery (G.V.B., E.N., K.B.), Washington University in St. Louis, St. Louis, Missouri; Tufts University Medical Center (S.N.), Boston, Massachusetts; Memorial Hermann Hospital (L.M.), Houston, Texas; and Star-Wood Cardiac Group (A.F.), Portland, Oregon.
出版信息
J Trauma Acute Care Surg. 2017 Jun;82(6):1049-1054. doi: 10.1097/TA.0000000000001444.
BACKGROUND
We have previously demonstrated that tight glycemic control (80-120 mg/dL) improves outcome in critically injured patients. However, many centers have gotten away from aggressive glucose control due to the workload and risk of hypoglycemia. The objective of this pivotal trial is to evaluate the first in human continuous inline glucose monitor (OptiScanner) in critically ill patients.
METHODS
A multicenter pivotal trial was conducted over a 1-year period (2014-2015) at four major academic centers in 200 critically ill patients. Three thousand seven hundred thirty-five glucose measurements were obtained and measured. A paired blood sample was then collected to coincide with the OptiScan measurement. The OptiScanner withdraws 0.13 mL of blood every 15 minutes from a central venous line, centrifuges the sample, and uses midinfrared spectroscopy to directly measure glucose levels in blood plasma. We plotted a Clarke Error Grid, calculated mean absolute relative difference (MARD) to analyze trend accuracy, and population coefficient of variation (PCV) to measure deviations. OptiScanner and Yellow Springs Instrument values were "blinded" from clinicians. Treatment was guided by the standard point of care meters.
RESULTS
95.4% of the data points were in zone A of the Clarke Error Grid and 4.5% in zone B. The MARD was 7.6%, the PCV 9.6%. The majority of data points achieved the benchmark for accuracy. The MARD was below 10%, which is the first inline continuous glucose monitor to achieve this result in a clinical trial. The PCV was less than 10%. We confirmed that the OptiScanner outperformed every 1- to 3-hour glucose measurements using point of care meters which prevents glucose excursions and variability and achieves a higher amount of time the patient's glucose values remain in range.
CONCLUSION
This pivotal multicenter trial demonstrates that the first inline CGM monitor is safe and accurate for use in critically ill surgical and trauma patients.
LEVEL OF EVIDENCE
Diagnostic study, level I.
背景
我们之前已经证明，严格的血糖控制（80 - 120毫克/分升）可改善重症受伤患者的预后。然而，由于工作量和低血糖风险，许多中心已不再采用积极的血糖控制措施。这项关键试验的目的是评估首款用于重症患者的人体连续在线血糖监测仪（OptiScanner）。
方法
在2014年至2015年的1年时间里，于四个主要学术中心对200名重症患者进行了一项多中心关键试验。共获得并测量了3735次血糖测量值。然后采集一份配对血样，使其与OptiScan测量值同步。OptiScanner每15分钟从中心静脉导管抽取0.13毫升血液，对样本进行离心，并使用中红外光谱法直接测量血浆中的葡萄糖水平。我们绘制了克拉克误差网格图，计算平均绝对相对差异（MARD）以分析趋势准确性，并计算总体变异系数（PCV）以测量偏差。OptiScanner和黄泉仪器公司的值对临床医生“保密”。治疗以标准的即时检测血糖仪为指导。
结果
95.4%的数据点位于克拉克误差网格图的A区，4.5%位于B区。MARD为7.6%，PCV为9.6%。大多数数据点达到了准确性基准。MARD低于10%，这是首款在临床试验中达到这一结果的在线连续血糖监测仪。PCV小于10%。我们证实，OptiScanner在预防血糖波动和变异性方面优于每1至3小时使用即时检测血糖仪进行的血糖测量，并且使患者血糖值保持在范围内的时间更长。
结论
这项关键的多中心试验表明，首款在线连续血糖监测仪用于重症外科和创伤患者是安全且准确的。
证据水平
诊断性研究，I级。
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