Clinical studies of a bionic pancreas for automated glucose management in cystic fibrosis-related diabetes mellitus

项目摘要 最近的数据表明，糖尿病在因严重COVID-19疾病住院的患者中很常见， 住院期间的高血糖与该患者人群的不良结局相关。如同 其他感染，确保良好的血糖控制将是重要的，以优化病人的护理入院， COVID-19;然而，频繁的血糖监测是耗时的，需要穿戴个人防护用品 设备（PPE），并使医护人员暴露于感染。Dexcom G6持续葡萄糖监测 (CGM)系统每5分钟提供一次实时葡萄糖数据，并被批准用于2岁和 在门诊中年龄较大。FDA已经认识到使用CGM的潜在价值， 远程监测COVID-19住院患者的血糖，并发表声明称，如果CGM 公司为希望实施血糖CGM的医院提供设备和技术支持 监测以支持COVID-19医疗工作。使用Dexcom G6监测患者的血糖水平 远程实时可以显着改善糖尿病管理，提醒供应商的高或低， 血糖值，减少频繁的亲自手指针刺血糖检查的负担，限制病毒暴露， 医疗保健提供者和保护PPE。然而，由于缺乏数据证实这一设备的准确性， 在医院环境中，特别是在患有COVID-19的重症患者中，将该技术引入 在医院和ICU环境中的临床使用需要系统的方法来评估准确性和安全性， 广泛使用。 我们已经制定了一项计划，将Dexcom G6引入马萨诸塞州总医院的临床使用 (MGH)，使用迭代质量保证流程和全面的数据收集，以确保安全和 在这个人群中的功效。这将提供及时的真实数据，以指导其他医疗保健组织， 在COVID-19危机期间使用这项技术。在这项建议中，我们将追求以下三个目标：（1） 我们将在ICU和医疗楼层的患者中建立G6 CGM的准确性， 可能影响CGM准确性的因素，并制定校准方案以提高准确性（如需要）;（2） 我们将研究Dexcom G6在危重和非危重患者中非重复使用的可行性， 我们将评估Dexcom G6的安全性和有效性， 在一项针对MGH收治的糖尿病患者的巢式病例对照研究中， 本提案中收集的数据将提供指导家长补助金目标3的关键信息， 建议研究一种人工胰腺装置，仿生胰腺（BP），在囊性纤维化患者相关 糖尿病与COVID-19患者相似，CF患者经常因呼吸系统损害而住院， 缺氧和血液动力学不稳定。BP利用Dexcom G6进行葡萄糖监测， Dexcom G6在住院COVID-19患者中的准确性和性能将非常有价值 为了实现R 01的这一目标。

Project Summary Recent data suggest that diabetes is common in patients hospitalized with severe COVID-19 illness, and hyperglycemia during hospitalization has been associated with poor outcomes in this patient population. As with other infections, ensuring good glycemic control will be important for optimizing the care of patients admitted with COVID-19; however, frequent glucose monitoring is time consuming, requires donning of personal protective equipment (PPE), and exposes healthcare workers to infection. The Dexcom G6 Continuous Glucose Monitoring (CGM) System provides real-time glucose data every 5 minutes and is approved for use in patients ages 2 and older in the outpatient setting. The FDA has recognized the potential value of using CGM to allow hospital staff to remotely monitor glucose in inpatients with COVID-19, releasing a statement that they will not object if CGM companies provide devices and technical support to hospitals who want to implement CGM for glucose monitoring to support COVID-19 healthcare efforts. Using the Dexcom G6 to monitor patients’ glucose levels remotely in real-time could significantly improve diabetes management by alerting providers to high or low glucose values, reducing the burden of frequent in-person fingerstick glucose checks, limiting viral exposure of healthcare providers, and conserving PPE. However, given the lack of data confirming the accuracy of this device in the hospital setting, particularly in critically ill patients with COVID-19, the introduction of this technology into clinical use in the hospital and ICU setting requires a systematic approach to evaluate accuracy and safety prior to widespread use. We have developed a plan for introducing the Dexcom G6 into clinical use at Massachusetts General Hospital (MGH), using iterative quality assurance processes and comprehensive data collection to ensure safety and efficacy in this population. This will provide timely, real-life data to guide other health care organizations in the use of this technology during the COVID-19 crisis. In this proposal, we will pursue the following three aims: (1) we will establish the accuracy of the G6 CGM in patients admitted in an ICU and on a medical floor, identifying factors that may impact CGM accuracy and instituting a calibration protocol to improve accuracy if needed; (2) we will investigate the feasibility of non-adjunctive use of the Dexcom G6 in critically ill and non-critically ill patients admitted with COVID-19; and (3) we will evaluate the safety and efficacy of the Dexcom G6 in hospitalized patients with COVID-19 in a nested case-control study of patients with diabetes admitted to MGH. The data collected in this proposal will provide critical information guiding Aim 3 of the parent grant, which proposes to study an artificial pancreas device, the bionic pancreas (BP), in patients with cystic fibrosis related diabetes. Similar to those with COVID-19, patients with CF are often hospitalized with respiratory compromise, hypoxia, and hemodynamic instability. The BP utilizes the Dexcom G6 for glucose monitoring, so acquiring data on the accuracy and performance of the Dexcom G6 in hospitalized COVID-19 patients would be very valuable for informing this aim of the R01.