Safety and Functional Integrity of Continuous Glucose Monitoring Components After Simulated Radiologic Procedures.

Safety and Functional Integrity of Continuous Glucose Monitoring Components After Simulated Radiologic Procedures.
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DOI:
10.1177/1932296820920948
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发表时间:
2021-07
影响因子:
5
通讯作者:
Gray JM
Gray JM
中科院分区:
其他
文献类型:
--
作者:
Thomas C;Welsh JB;Lu S;Gray JM

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我们研究了模拟治疗和诊断放射程序中Dexcom G6动态血糖监测(CGM)系统的可穿戴组件。G6发送器加载模拟葡萄糖数据并连接至探头。将传感器/发送器对暴露于X射线以模拟放射治疗程序,并暴露于射频(RF)和磁场以模拟诊断磁共振成像(MRI)。X射线模拟提供了80戈伊的累积剂量。MRI模拟使用在64或128 MHz下振荡的RF场和1.5或3 T的磁场。在MRI模拟过程中,测量了位移力、感应加热和感应电流。在模拟之后,使用台架测试来评估变送器上的数据完整性和传感器对各种浓度的葡萄糖水溶液的响应性。在接受X射线照射或模拟MRI检查后,传感器/发送器对报告的葡萄糖浓度与对照(未暴露)器械的葡萄糖浓度相似。在3 T MRI模拟过程中,器械经历了306 g的位移力,该位移力不足以将传感器/发送器从基板上移开,射频感应加热<2°C,感应电流<16 pA。MRI模拟前存储在发送器上的数据保持完整。G6 CGM系统的可穿戴组件在暴露于模拟治疗和诊断放射程序后保留基本功能和数据完整性。器械不太可能受到典型成像研究中使用的X射线照射的影响。模拟MRI程序在传感器/发送器对中产生位移力、最小发热和电流。
We investigated wearable components of the Dexcom G6 continuous glucose monitoring (CGM) System in simulated therapeutic and diagnostic radiologic procedures. G6 transmitters were loaded with simulated glucose data and attached to sensors. Sets of sensor/transmitter pairs were exposed to x-rays to simulate a radiotherapeutic procedure and to radiofrequency (RF) and magnetic fields to simulate diagnostic magnetic resonance imaging (MRI). The x-ray simulation provided a cumulative dose of 80 Gy. The MRI simulation used RF fields oscillating at 64 or 128 MHz and magnetic fields of 1.5 or 3 T. During the MRI simulation, displacement force, induced heating, and induced currents were measured. After the simulations, bench tests were used to assess data integrity on the transmitters and responsiveness of sensors to various concentrations of aqueous glucose. Glucose concentrations reported by sensor/transmitter pairs after undergoing x-irradiation or a simulated MRI exam were similar to those from control (unexposed) devices. During the 3 T MRI simulation, the devices experienced a displacement force of 306 g, which was insufficient to dislodge the sensor/transmitter from the substrate, RF-induced heating of <2°C, and an induced current of <16 pA. Data stored on the transmitters prior to the MRI simulation remained intact. Wearable components of the G6 CGM System retain basic functionality and data integrity after exposure to simulated therapeutic and diagnostic radiologic procedures. The devices are unlikely to be affected by x-irradiation used in typical imaging studies. Simulated MRI procedures create displacement force, minimal heating, and current in sensor/transmitter pairs.
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