The accuracy and efficacy of Real-Time Continuous Glucose Monitoring sensor in patients with type 1 diabetes

被引:71
作者
Mastrototaro, John [1 ]
Shin, John [1 ]
Marcus, Alan [1 ]
Sulur, Giri [1 ]
机构
[1] Medtron Diabet, Northridge, CA 91325 USA
关键词
D O I
10.1089/dia.2007.0291
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:385 / 390
页数:6
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