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《Pro 2 连续血糖监测系统在妊娠中的准确性比较。》

Comparison of Accuracy of Freestyle Libre Pro and Medtronic iPro2 Continuous Glucose Monitoring Systems in Pregnancy.

机构信息

Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.

Department of Biostatistics, and All India Institute of Medical Sciences, New Delhi, India.

出版信息

Diabetes Technol Ther. 2023 Aug;25(8):538-542. doi: 10.1089/dia.2023.0070. Epub 2023 May 4.

Abstract

There are limited data on head-to-head performance of Freestyle Libre Pro (FSL-Pro) and blinded Medtronic iPro2 continuous glucose monitoring system in pregnancy. In this prospective observational study, women with hyperglycemia in pregnancy ( = 42) underwent simultaneous FSL-Pro and Medtronic iPro2 sensor insertion and self-monitoring of blood glucose using Contour Plus meter (reference). The overall mean absolute relative difference (MARD) for iPro2 and FSL-Pro systems were 8.0% ± 9.2% and 19.0% ± 12.7%, respectively. At hypoglycemic range, both sensors performed less accurately (MARD: 18.0% and 16.8%, respectively), whereas iPro2 showed higher accuracy at euglycemic (8.2% and 19.3%, respectively) and hyperglycemic (6.8% and 18.0%, respectively) ranges. On Bland-Altman analysis, iPro2 and FSL-Pro underestimated glucose by 0.01 and 1.09 mmol/L, respectively. The ISO criteria were fulfilled for 88.5% and 44.9% of all values, respectively. To conclude, iPro2 was more accurate; however, both sensors demonstrated inaccuracy at hypoglycemic range, highlighting the need for refinements in the current generation of sensors to address this problem.

摘要

关于 Freestyle Libre Pro(FSL-Pro)和盲法 Medtronic iPro2 连续血糖监测系统在妊娠中的头对头性能,数据有限。在这项前瞻性观察研究中,患有妊娠性高血糖的女性(n=42)同时插入 FSL-Pro 和 Medtronic iPro2 传感器,并使用 Contour Plus 血糖仪(参考)进行自我血糖监测。iPro2 和 FSL-Pro 系统的总体平均绝对相对差异(MARD)分别为 8.0%±9.2%和 19.0%±12.7%。在低血糖范围内,两种传感器的准确性都较低(MARD:分别为 18.0%和 16.8%),而 iPro2 在正常血糖(MARD:分别为 8.2%和 19.3%)和高血糖(MARD:分别为 6.8%和 18.0%)范围内的准确性更高。在 Bland-Altman 分析中,iPro2 和 FSL-Pro 分别低估了 0.01 和 1.09mmol/L 的血糖值。ISO 标准分别满足 88.5%和 44.9%的所有值。总之,iPro2 更准确;然而,两种传感器在低血糖范围内均表现出不准确性,这凸显了当前一代传感器需要改进以解决这一问题。

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