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

医院高风险 2 型糖尿病的连续血糖监测：基于云的实时血糖评估和管理系统 (Cyber​​ GEMS)

• 批准号: 10641776
• 负责人: Adelaide L Fortmann
• 金额: $ 61.76万
• 依托单位: SCRIPPS HEALTH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-27 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10641776
• 关键词: Adopted; Adoption; Adult; Advanced Practice Nurse; Algorithm Design; Algorithms; Ambulatory Monitoring; Blinded; Blood Glucose; California; Cardiac; Clinical; Clinical Trials; Communication; Computerized Medical Record; Continuous Glucose Monitor; Cost Analysis; Coupled; Dangerousness; Data; Devices; Diabetes Mellitus; Effectiveness; Effectiveness of Interventions; Eligibility Determination; Environment; Evaluation; Event; Glucose; Goals; Hand; Health Care Costs; Health system; Healthcare Systems; Hispanic; Hispanic Populations; Hospitalists; Hospitalization; Hospitals; Human Resources; Hyperglycemia; Hypoglycemia; Incentives; Infection; Infection Control; Infrastructure; Insulin; International; Intervention; Length of Stay; Low income; Maintenance; Methods; Mexico; Monitor; Neurologic; Non-Insulin-Dependent Diabetes Mellitus; Nosocomial Infections; Not Hispanic or Latino; Notification; Nursing Staff; Outcome; Outcomes Research; Patients; Phase; Population; Populations at Risk; Process; Protocols documentation; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Research; Resources; Specialist; Standardization; Stratification; Stream; System; Telemetry; Testing; Time; Work; blood glucose regulation; cardiometabolism; clinical risk; cloud based; cost effectiveness; dashboard; design; diabetes control; diabetes mellitus nursing; digital; digital monitoring; effectiveness evaluation; experience; glucose monitor; glycemic control; high risk; high risk population; hospital care; hospital readmission; improved; improved outcome; infection rate; infection risk; innovation; mortality; novel; point of care; point of care testing; prevent; remote monitoring; safety net; success; transmission process; treatment as usual; treatment optimization; trend; wireless transmission

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.

7。项目摘要/摘要 有充分的证据表明，医院的血糖控制不良很常见。鉴于已知 住院期间不受控制的血糖的后果（例如，感染，严重的神经系统 和心脏并发症，死亡率，更长的住院时间，再入院，更高的医疗保健费用）， 卫生系统将大量资源投入开发用于改善葡萄糖学方面的方案。 令人惊讶的是，努力宽度的使用并证明了连续葡萄糖的有效性 目前，任何美国使用CGM的监测（CGM） 医院。因此，开发基于云的实时葡萄糖评估和 管理系统（Cyber​​ Gems）是为了增加现有的有效实时解决方案 流程，提供对现实世界有效性的宝贵测试，同时利用标准化 促进对其他系统和高危人群的可持续性和可扩展性的算法。这 创新的干预措施将使医院护理团队能够立即根据无线 从Dexcom G6设备传输葡萄糖数据，发送到数字仪表板 与现有现实世界医院流程的集成可以立即确定优先级以防止或 正确即将来临的低血糖和严重的高血糖事件。迈向这一长期的第一步 目标是一项随机对照试验，定义为III/IV期确定的临床试验，又 确立这种干预的有效性和有效性。 AIM 1将确定 网络宝石与常规护理（UC）在增加百分比的患者中是在范围内，并降低％ 住院期间低血糖和严重高血糖的时间。同时，AIM 2将 评估网络宝石与UC在降低医院获得感染风险方面的有效性。 所描述的数字仪表板是渐进的，因为它促进了实时的无线传输 大量患者的葡萄糖数据；自动识别并确定优先级 干预患者；并检测到潜在危险的降血糖发作 - 全部降低 Burnen比当前的分层和审查方法。遥测的不间断覆盖范围， 再加上网络宝石中有效且远程糖尿病的专家监督是一种可扩展的，新颖的， 基于团队的方法，以最大程度地使用连续流CGM数据以进行最佳葡萄糖 管理。拟议的工作通过提供证据来推动这些挑战的极限， 通过基于团队的葡萄糖管理方法在服务欠佳和理解的情况下确定 人口，补充旨在改善T2D高危患者的预后的先前数据 和相关的心脏代谢条件。