The accuracy and efficacy of Real-Time Continuous Glucose Monitoring sensor in patients with type 1 diabetes
The accuracy and efficacy of Real-Time Continuous Glucose Monitoring sensor in patients with type 1 diabetes
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DOI：
10.1089/dia.2007.0291
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发表时间：
2008-10-01
影响因子：
5.4
通讯作者：
Sulur, Giri
中科院分区：
文献类型：
--
作者：
Mastrototaro, John;Shin, John;Sulur, Giri
背景资料：Medtronic Diabetes的准确性和有效性（Northridge，CA）实时（RT）-连续葡萄糖监测（CGM）传感器在72名1型糖尿病受试者中进行分析。这是一项回顾性分析，050个时间配对数据点（探头和血糖仪值），在评价探头有效性的门诊研究过程中获得-成人和青少年的增强泵系统。在研究过程中，受试者每2周通过互联网将探头值和自我监测血糖数据上传至CareLink（TM）Clinical（R）Application（Medtronic Diabetes）。结果：探头读数与参考血糖读数在+/- 20%或+/- 30%范围内的总体百分比分别为75.6%和86.8%。最高一致率发生在240-400 mg/dL范围内，其中79.9%的探头读数在血糖仪值的+/- 20%范围内，91.5%的探头读数在血糖仪值的30%范围内。所有受试者的平均绝对相对差异为15.8%，中位绝对相对差异为10.9%。偏倚为-2.13 mg/dL。RT-CGM和血糖仪的配对血糖测量结果表明，总体受试者人群中95.9%的配对点位于Clarke误差网格的A区和B区。共识误差网格分析确定99.2%的配对数据点位于A区和B区。结论：本研究报告了具有大量配对数据点（60，050）的动态葡萄糖探头的准确性。RT-CGM安全且耐受性良好，提供的读数与血糖仪值非常一致。
Background: The accuracy and efficacy of the Medtronic Diabetes (Northridge, CA) Real-Time (RT)-Continuous Glucose Monitoring (CGM) sensor were analyzed in 72 subjects with type 1 diabetes.Methods: This was a retrospective analysis of 60,050 temporally paired data points (sensor and glucose meter values) obtained during the course of an outpatient ambulatory study evaluating the efficacy of a sensor-augmented pump system in adults and adolescents. Subjects uploaded sensor values and self-monitoring blood glucose data to the CareLink (TM) Clinical (R) Application (Medtronic Diabetes) via the Internet, every 2 weeks during the course of the study.Results: The overall percentage of sensor readings within +/- 20% or +/- 30% agreement of reference glucose readings was 75.6% and 86.8%, respectively. The highest rate of agreement occurred in the 240-400 mg/dL range, where 79.9% of sensor readings were within +/- 20% of meter values and 91.5% of sensor readings were within 30% of meter values. The mean absolute relative difference for all subjects was 15.8%, and the median absolute relative difference was 10.9%. The bias was -2.13 mg/dL. Paired glucose measurements from the RT-CGM and meter demonstrated that 95.9% of paired points in the overall subject population fell in zones A and B of the Clarke Error Grid. Consensus Error Grid Analysis established that 99.2% of paired data points were in zones A and B.Conclusions: This study reports the accuracy of a continuous glucose sensor with a large number of paired data points (60,050). RT-CGM is safe and well tolerated and provides readings that are in close agreement with glucose meter values.