Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes.

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM
Julia Kölle, Manuel Eichenlaub, Jochen Mende, Manuela Link, Beatrice Vetter, Elvis Safary, Stefan Pleus, Cornelia Haug, Guido Freckmann
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Abstract

Background: FIND, the global alliance for diagnostics, identified the nonmarket-approved continuous glucose monitoring (CGM) system, FiberSense system (FBS), as a potential device for use in low- and middle-income countries. Together with two market-approved, factory-calibrated CGM systems, namely, the FreeStyle Libre 2 (FL2) and the GlucoRx AiDEX (ADX), the FBS was subjected to a clinical performance evaluation.

Methods: Thirty adult participants with type 1 diabetes were enrolled. The study was mainly conducted at home, with three in-clinic sessions conducted over the study period of 28 days. Comparator measurements were collected from capillary samples, using a high-quality blood glucose monitoring system.

Results: Data from 31, 70, and 78 sensors of FBS, FL2, and ADX, respectively, were included in the performance analysis. The mean absolute relative differences between CGM and comparator data for FBS, FL2, and ADX were 14.7%, 9.2%, and 21.9%, and relative biases were -2.1%, -2.5%, and -18.5%, respectively. Analysis of individual sensor accuracy revealed low, moderate, and high sensor-to-sensor variability for FBS, FL2, and ADX, respectively. Sensor survival probabilities until the end of sensor life were 47.2% for FBS (28 days), 71.3% for FL2 (14 days), and 48.4% for ADX (14 days).

Conclusions: The results of FBS were encouraging enough to conduct further performance and usability evaluations in a low- and middle-income country. The results of FL2 mainly agreed with existing studies, whereas ADX showed substantial deviations from previously reported results.

成人1型糖尿病三种连续血糖监测系统的性能评估。
背景:全球诊断联盟FIND将非市场批准的连续血糖监测(CGM)系统FiberSense系统(FBS)确定为在中低收入国家使用的潜在设备。连同两个经市场批准的工厂校准CGM系统,即FreeStyle Libre 2(FL2)和GlucoRx AiDEX(ADX),FBS进行了临床性能评估。方法:30名患有1型糖尿病的成年参与者被纳入研究。该研究主要在家中进行,在28天的研究期间进行了三次临床研究。使用高质量的血糖监测系统从毛细管样品中收集比较器测量值。结果:FBS、FL2和ADX的31、70和78个传感器的数据分别包含在性能分析中。FBS、FL2和ADX的CGM和对照数据之间的平均绝对相对差异分别为14.7%、9.2%和21.9%,相对偏差分别为-2.1%、-2.5%和-18.5%。对单个传感器精度的分析显示,FBS、FL2和ADX的传感器间变化分别较低、中等和较高。FBS(28天)、FL2(14天)和ADX(14天。FL2的结果主要与现有研究一致,而ADX显示出与先前报道的结果有很大偏差。
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来源期刊
Journal of Diabetes Science and Technology
Journal of Diabetes Science and Technology Medicine-Internal Medicine
CiteScore
7.50
自引率
12.00%
发文量
148
期刊介绍: The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
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