Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital: Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS)

7.项目摘要/摘要 有强有力的证据表明，医院血糖控制不佳是很常见的。鉴于已知的 住院期间血糖不受控制的后果(例如，感染、严重的神经系统疾病 和心脏并发症、死亡率、更长的住院时间、再次住院、更高的医疗费用)， 卫生系统投入了大量资源来制定改善血糖测量的方案。 令人惊讶的是，尽管连续葡萄糖的广泛使用和被证明的有效性 用于动态血糖管理的CGM，CGMS目前在任何美国都没有使用 医院。因此，发展基于云的实时血糖评估和 管理系统(Cyber Gemes)是提供一个有效的、实时的解决方案，以增加现有的 流程，以提供对现实世界有效性的有价值的测试，同时利用标准化 促进其他系统和高危人群的可持续性和可扩展性的算法。这个 创新干预将使医院护理团队能够基于无线立即采取措施 将血糖数据从Dexcom G6设备发送到数字仪表盘，其中 与现有真实医院流程的集成可以立即确定优先顺序，以防止或 纠正即将发生的低血糖和严重的高血糖事件。迈向这一长期目标的第一步 Goal是一项随机对照试验，定义为III/IV期最终临床试验，依次 确定这一干预措施的有效性和有效性。目标1将确定以下内容的有效性 网络宝石与常规护理(UC)在增加患者在范围内的时间百分比和减少%方面的对比 住院期间出现低血糖和严重高血糖的时间。与此同时，目标2号将 评估Cyber gem与UC在降低医院感染风险方面的有效性。 所描述的数字仪表盘是渐进式的，因为它促进了实时无线传输 同时提供大量患者的血糖数据；自动识别并确定优先顺序 患者进行干预；并检测潜在危险的低血糖发作-所有这些都在减少 负担比目前的分层和审查方法要多。遥测的不间断覆盖， 再加上Cyber Gems中高效的远程糖尿病专家监督，是一种可扩展的、新颖的 基于团队的方法，最大限度地利用连续流动的CGM数据以实现最佳血糖 管理层。拟议中的工作通过提供证据来突破这些挑战的极限， 在服务不足和研究不足的情况下，通过基于团队的方法来确定血糖管理 补充先前旨在改善T2D高危患者预后的数据 以及相关的心脏代谢性疾病。

7. Project Summary/Abstract There is strong evidence that poor glycemic control in the hospital is common. Given the known consequences of uncontrolled blood sugars during a hospitalization (e.g., infection, serious neurological and cardiac complications, mortality, longer lengths of stay, readmissions, higher healthcare costs), health systems devote significant resources to developing protocols for improving glucometrics. Surprisingly, despite the widespread use and demonstrated effectiveness of continuous glucose monitoring (CGM) for ambulatory glucose management, CGMs are not currently used in any US hospital. Therefore, the long-term goal to develop Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS) is to provide an effective, real-time solution to augment existing processes, to provide a valuable test of real-world effectiveness, while capitalizing on standardized algorithms to facilitate sustainability and scalability to other systems and at-risk populations. The innovative intervention will enable hospital care teams to take immediate steps based on the wireless transmission of glucose data from the Dexcom G6 device, sent to a Digital Dashboard, where integration with existing real-world hospital processes can provide immediate prioritization to prevent or correct impending hypoglycemia and severe hyperglycemic events. The first step toward this long-term goal is a randomized controlled trial, defined as a Phase III/IV definitive clinical trial that in turn establishes efficacy and effectiveness of this intervention. Aim 1 will establish the effectiveness of Cyber GEMS versus Usual Care (UC) in increasing the % time patients are in-range and decreasing % time in hypoglycemia and severe hyperglycemia during hospitalization. Simultaneously, Aim 2 will evaluate the effectiveness of Cyber GEMS versus UC in decreasing hospital-acquired infection risk. The described Digital Dashboard is progressive, as it facilitates real-time, wireless transmission of glucose data of a large volume of patients simultaneously; automatically identifies and prioritizes patients for intervention; and detects potentially dangerous hypoglycemic episodes – all at a reduced burden than current methods of stratification and review. The uninterrupted coverage by telemetry, coupled with efficient and remote diabetes specialist oversight in Cyber GEMS is a scalable, novel, team-based approach to maximize the use of continuously streaming CGM data for optimal glucose management. The work proposed pushes the limits of these challenges by providing evidence, identified by a team-based approach to glucose management in an underserved and understudied population, supplementing prior data designed to improve outcomes among high-risk patients with T2D and related cardiometabolic conditions.