论文标题

设计和验证人造胰腺系统的开源闭环测试床

Design and Validation of an Open-Source Closed-Loop Testbed for Artificial Pancreas Systems

论文作者

Zhou, Xugui, Kouzel, Maxfield, Ren, Haotian, Alemzadeh, Homa

论文摘要

完全自主的人工胰腺系统(AP)开发以独立调节1型糖尿病患者的葡萄糖水平已成为糖尿病研究的长期目标。进步的一个重大障碍是测试新的控制算法和安全功能的困难,因为临床试验是时间和资源密集的。为了促进易于验证,我们建议通过将APS控制器与两个最先进的葡萄糖模拟器和一个新型的断层注入引擎整合到开源APS床上。测试台能够从六个月内进行的临床试验中重现实际患者的血糖轨迹。我们使用测试台评估了两种闭环对照算法(开放式和基本注释)的性能,并发现更高级的控制算法能够在平均93.49%的安全区域中保持血糖,而平均时间为79.46%,而临床试验的时间为66.18%。断层注射引擎模拟了向美国食品和药物管理局(FDA)报告的真实召回事件,并在危险条件下证明了控制器的弹性。我们使用测试床生成了25年的合成数据,这些数据代表了20种不同的患者概况,具有现实的不良事件情况,这在临床试验中会很昂贵且有风险。拟议的测试床是一个有效的工具,可以由研究社区使用,以证明APS的不同控制算法和安全功能的有效性。

The development of a fully autonomous artificial pancreas system (APS) to independently regulate the glucose levels of a patient with Type 1 diabetes has been a long-standing goal of diabetes research. A significant barrier to progress is the difficulty of testing new control algorithms and safety features, since clinical trials are time- and resource-intensive. To facilitate ease of validation, we propose an open-source APS testbed by integrating APS controllers with two state-of-the-art glucose simulators and a novel fault injection engine. The testbed is able to reproduce the blood glucose trajectories of real patients from a clinical trial conducted over six months. We evaluate the performance of two closed-loop control algorithms (OpenAPS and Basal Bolus) using the testbed and find that more advanced control algorithms are able to keep blood glucose in a safe region 93.49% and 79.46% of the time on average, compared with 66.18% of the time for the clinical trial. The fault injection engine simulates the real recalls and adverse events reported to the U.S. Food and Drug Administration (FDA) and demonstrates the resilience of the controller in hazardous conditions. We used the testbed to generate 25 years of synthetic data representing 20 different patient profiles with realistic adverse event scenarios, which would have been expensive and risky to collect in a clinical trial. The proposed testbed is a valid tool that can be used by the research community to demonstrate the effectiveness of different control algorithms and safety features for APS.

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