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比较经皮传感器和 90 天植入式葡萄糖传感器的准确性。

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor.

机构信息

University of Padova, Department of Medicine (DIMED), Padova, Italy.

University of Padova, Department of Information Engineering (DEI), Padova, Italy.

出版信息

Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):650-657. doi: 10.1016/j.numecd.2020.09.006. Epub 2020 Sep 12.

Abstract

BACKGROUND AND AIMS

Continuous glucose monitoring improves glycemic control in diabetes. This study compared the accuracy of the Dexcom G5 Mobile (Dexcom, San Diego, CA) transcutaneous sensor (DG5) and the first version of Eversense (Senseonics,Inc., Germantown, MD) implantable sensor (EVS).

METHODS AND RESULTS

Subjects with type 1 diabetes (T1D) and using EVS wore simultaneously DG5 for seven days. At day 3, patients were admitted to a clinical research center (CRC) to receive breakfast with delayed and increased insulin bolus to induce glucose excursions. At CRC, venous glucose was monitored every 15 min (or 5 min during hypoglycemia) for 6 h by YSI 2300 STAT PLUS™ glucose and lactate analyzer. At home patients were requested to perform 4 fingerstick glucose measurements per day. Eleven patients (9 males, age 47.4 ± 11.3 years, M±SD) were enrolled. During home-stay the median [25th-75th percentile] absolute relative difference (ARD) over all CGM-fingerstick matched-pairs was 11.64% [5.38-20.65]% for the DG5 and 10.75% [5.15-19.74]% for the EVS (p-value = 0.58). At CRC, considering all the CGM-YSI matched-pairs, the DG5 showed overall smaller median ARD than EVS, 7.91% [4.14-14.30]% vs 11.4% [5.04-18.54]% (p-value<0.001). Considering accuracy during blood glucose swings, DG5 performed better than EVS when glucose rate-of-change was -0.5 to -1.5 mg/dL/min, with median ARD of 7.34% [3.71-12.76]% vs 13.59% [4.53-20.78]% (p-value<0.001), and for rate-of-change < -1.5 mg/dl/min, with median ARD of 5.23% [2.09-15.29]% vs 12.73% [4.14-20.82]% (p-value = 0.02).

CONCLUSIONS

DG5 was more accurate than EVS at CRC, especially when glucose decreased. No differences were found at home.

摘要

背景与目的

连续血糖监测可改善糖尿病患者的血糖控制水平。本研究旨在比较 Dexcom G5 Mobile(Dexcom,圣地亚哥,CA)经皮传感器(DG5)和第一代 Eversense(Senseonics,Inc.,Germantown,MD)植入式传感器(EVS)的准确性。

方法和结果

患有 1 型糖尿病(T1D)且正在使用 EVS 的患者同时佩戴 DG5 传感器 7 天。第 3 天,患者被收治入临床研究中心(CRC),接受延迟和增加胰岛素推注的早餐,以诱导血糖波动。在 CRC,患者每 15 分钟静脉取血一次(低血糖时每 5 分钟取血一次),使用 YSI 2300 STAT PLUS™葡萄糖和乳酸分析仪进行 6 小时监测。在家中,患者每天需要进行 4 次指尖血糖测量。共有 11 名患者(9 名男性,年龄 47.4±11.3 岁,M±SD)入组。在居家期间,所有 CGM-指尖匹配对的中位数[25 百分位数-75 百分位数]绝对相对差异(ARD)为 11.64%[5.38-20.65]%,DG5 组和 EVS 组分别为 10.75%[5.15-19.74]%(p 值=0.58)。在 CRC,考虑到所有 CGM-YSI 匹配对,DG5 显示出的 ARD 中位数总体小于 EVS,分别为 7.91%[4.14-14.30]%和 11.4%[5.04-18.54]%(p 值<0.001)。考虑到血糖波动期间的准确性,当血糖变化率为-0.5 至-1.5mg/dL/min 时,DG5 的性能优于 EVS,ARD 中位数分别为 7.34%[3.71-12.76]%和 13.59%[4.53-20.78]%(p 值<0.001),当血糖变化率<-1.5mg/dl/min 时,ARD 中位数分别为 5.23%[2.09-15.29]%和 12.73%[4.14-20.82]%(p 值=0.02)。

结论

在 CRC,DG5 比 EVS 更准确,尤其是在血糖下降时。在家中没有发现差异。

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