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接受静脉胰岛素治疗的重症患者中工厂校准的连续血糖监测仪的准确性:两种领先系统的前瞻性临床试验

Accuracy of Factory-Calibrated Continuous Glucose Monitors in Critically Ill Patients Receiving Intravenous Insulin: A Prospective Clinical Trial of Two Leading Systems.

作者信息

Ramesh Gautam, Kobayashi Emily, Sharma Navyaa, Majithia Amit R, Kulasa Kristen, Boeder Schafer C

机构信息

Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Bioinformatics and Systems Biology Graduate Program, University of California, San Diego, La Jolla, CA, USA.

出版信息

J Diabetes Sci Technol. 2025 May 8:19322968251338865. doi: 10.1177/19322968251338865.

Abstract

BACKGROUND

Continuous glucose monitors (CGMs) are increasingly being used to guide glucose management in the hospital. However, uncertainty regarding their accuracy in this setting remains.

METHODS

We conducted a nonrandomized, open-label, clinically blinded prospective trial of the Dexcom G6 Pro (G6P) and FreeStyle Libre Pro (FLP) in the inpatient setting among critically ill hospitalized patients (n = 40) requiring continuous intravenous insulin infusion. In parallel with CGM data, reference serum (Lab) glucose and point-of-care (POC) glucose values were obtained. On completion of the study, CGM and reference values were analyzed to assess CGM accuracy.

RESULTS

A total of 1015 matched G6P-Lab pairs had a mean absolute relative difference (MARD) of 22.7%, 2369 G6P-POC pairs had an MARD of 22.9%, 1006 matched FLP-Lab pairs had an MARD of 25.2%, and 2353 FLP-POC pairs had an MARD of 27.0%. Both CGM systems demonstrated considerable inter-patient variability in sensor accuracy and tended to underestimate glucose in comparison with the reference values. Rarely were low reference values overestimated by either sensor.

CONCLUSIONS

Factory-calibrated continuous glucose monitors may require accuracy validation and per-patient calibration for inpatient use in critically ill patients.

摘要

背景

持续葡萄糖监测仪(CGM)越来越多地用于指导医院内的血糖管理。然而,其在这种情况下的准确性仍存在不确定性。

方法

我们在住院的危重症患者(n = 40)中进行了一项非随机、开放标签、临床盲法前瞻性试验,这些患者需要持续静脉输注胰岛素,试验对象为德康G6 Pro(G6P)和福林利斯自由专业版(FLP)。与CGM数据并行,获取了参考血清(实验室)葡萄糖值和即时检测(POC)葡萄糖值。研究结束时,分析CGM和参考值以评估CGM的准确性。

结果

总共1015对匹配的G6P - 实验室数据对的平均绝对相对差异(MARD)为22.7%,2369对G6P - POC数据对的MARD为22.9%,1006对匹配的FLP - 实验室数据对的MARD为25.2%,2353对FLP - POC数据对的MARD为27.0%。两种CGM系统在传感器准确性方面均表现出相当大的患者间变异性,并且与参考值相比往往低估血糖。两种传感器很少高估低参考值。

结论

工厂校准的持续葡萄糖监测仪可能需要进行准确性验证以及针对危重症患者住院使用时进行个体化校准。

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