Sechterberger Marjolein K, van der Voort Peter H J, Strasma Paul J, DeVries J Hans
Department of Internal Medicine, Academic Medical Center, Amsterdam, Netherlands
Department of Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands TIAS school for Business & Society, Tilburg University, Netherlands.
J Diabetes Sci Technol. 2015 May;9(3):663-7. doi: 10.1177/1932296814564993. Epub 2014 Dec 23.
The GluCath® intra-arterial continuous glucose monitoring (IA-CGM) system uses a novel quenched chemical fluorescence sensing mechanism to optically measure blood glucose when deployed in the radial artery. The aim of this study was to compare the accuracy of the IA-CGM and the FreeStyle Navigator® subcutaneous continuous glucose monitoring (SC-CGM) system with standard care.
After admission to the intensive care unit (ICU), the IA-CGM was inserted via a 20 gauge radial arterial study catheter and the SC-CGM was placed at the abdominal wall of postoperative cardiac surgery patients with an expected ICU length of stay > 24 hours. Each device was calibrated according to manufacturer instructions. Glucose values of both CGM systems were blinded for the clinical staff. Reference blood glucose samples were collected from the study catheter every 1-2 hours for at least 24 hours and analyzed on a Radiometer ABL blood gas analyzer.
The IA-CGM and SC-CGM sensors were successfully inserted in 8 subjects. Accuracy assessment was performed with 183 paired points: 85.8% of the IA-CGM measurements and 84.2% of the SC-CGM measurements met ISO 15197:2003 glucometer criteria (within 20%) across a 79-248 mg/dl (4.4-13.8 mmol/L) glucose range. Overall ± SD mean absolute relative difference was 12.3 ± 11.3% for IA-CGM and 11.1 ± 8.3% for SC-CGM (difference -1.2%, 95% CI -3.3 to 0.8; P = .24).
The IA-CGM system directly measured arterial blood glucose and did not interfere with clinical care. However, accuracy was similar to that of the less invasive SC-CGM device.
GluCath® 动脉内连续血糖监测(IA-CGM)系统采用一种新型的猝灭化学荧光传感机制,当部署在桡动脉中时可光学测量血糖。本研究的目的是比较IA-CGM与FreeStyle Navigator® 皮下连续血糖监测(SC-CGM)系统相对于标准护理的准确性。
入住重症监护病房(ICU)后,通过20号桡动脉研究导管插入IA-CGM,将SC-CGM放置在预期ICU住院时间>24小时的心脏手术后患者的腹壁。每个设备均按照制造商说明进行校准。两个CGM系统的血糖值对临床工作人员均保密。每1-2小时从研究导管采集参考血糖样本,至少采集24小时,并在Radiometer ABL血气分析仪上进行分析。
8名受试者成功插入了IA-CGM和SC-CGM传感器。使用183对配对数据进行准确性评估:在79-248mg/dl(4.4-13.8mmol/L)的血糖范围内,IA-CGM测量值的85.8%和SC-CGM测量值的84.2%符合ISO 15197:2003血糖仪标准(误差在20%以内)。IA-CGM的总体±标准差平均绝对相对差异为12.3±11.3%,SC-CGM为11.1±8.3%(差异-1.2%,95%CI-3.3至0.8;P=0.24)。
IA-CGM系统直接测量动脉血糖,且不干扰临床护理。然而,其准确性与侵入性较小的SC-CGM设备相似。