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，糖尿病在患有严重新冠肺炎疾病的住院患者中很常见，而且 在该患者群体中，住院期间的高血糖与不良预后有关。和以前一样 其他感染，确保良好的血糖控制对于优化入院患者的护理将是重要的 新冠肺炎；然而，频繁的血糖监测很耗时，需要穿上个人防护用品 设备(PPE)，并使医护人员暴露在感染之下。Dexcom G6连续血糖监测仪 (CGM)系统每5分钟提供一次实时血糖数据，并被批准用于2岁和2岁以下的患者 在门诊环境中年龄较大。FDA已经认识到使用CGM来允许医院工作人员 远程监测新冠肺炎住院患者血糖，发布声明称不反对CGM 公司为希望实施葡萄糖CGM的医院提供设备和技术支持 监控以支持新冠肺炎的医疗保健努力。使用Dexcom G6监测患者的血糖水平 远程实时可以通过提醒供应商高或低来显著改善糖尿病管理 血糖值，减少频繁的指检血糖的负担，限制病毒感染 医疗保健提供者，以及保护个人防护装备。然而，鉴于缺乏数据证实这一装置的准确性 在医院环境中，特别是在患有新冠肺炎的危重患者中，将这项技术引入 医院和ICU环境中的临床应用需要一种系统的方法来评估准确性和安全性 广泛使用。 我们已经制定了在马萨诸塞州综合医院将Dexcom G6引入临床使用的计划 (MGH)，使用迭代的质量保证过程和全面的数据收集，以确保安全和 在这一人群中的疗效。这将提供及时、真实的数据来指导其他卫生保健组织在 在新冠肺炎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和医疗地板上建立G6 CGM的准确性，确定 可能影响CGM准确度的因素，并在需要时制定校准方案以提高准确度；(2) 我们将研究Dexcom G6在危重和非危重患者中非辅助使用的可行性 入院接受新冠肺炎治疗的患者；以及(3)我们将评估Dexcom G6在 新冠肺炎对糖尿病合并生长激素的住院患者进行嵌套病例对照研究。 本提案中收集的数据将提供关键信息，指导家长赠款的目标3，即 建议研究一种人工胰腺装置--仿生胰腺(BP)，用于治疗囊性纤维化相关患者 糖尿病。与患有新冠肺炎的患者类似，CF患者经常因呼吸衰竭而住院， 缺氧和血流动力学不稳定。BP使用Dexcom G6进行血糖监测，因此采集数据 对Dexcom G6在住院新冠肺炎患者中的准确性和性能进行研究将是非常有价值的 告知R01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.