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.项目总结/摘要 有强有力的证据表明，在医院血糖控制不良是常见的。鉴于已知 住院期间血糖不受控制的后果（例如，严重神经系统感染 和心脏并发症、死亡率、住院时间更长、再入院、医疗费用更高）， 卫生系统投入大量资源来制定改进血糖测定的规程。 令人惊讶的是，尽管连续葡萄糖的广泛使用和有效性， 动态血糖管理的动态血糖监测（CGM），CGM目前尚未在任何美国使用 医院因此，开发基于云的实时葡萄糖评估和 管理系统（Cyber GEMS）是提供一个有效的，实时的解决方案，以增加现有的 过程，以提供对现实世界有效性的有价值的测试，同时利用标准化的 算法，以促进其他系统和风险人群的可持续性和可扩展性。的 创新的干预措施将使医院护理团队能够立即采取措施， 从Dexcom G6设备传输葡萄糖数据，发送到数字仪表板，其中 与现有的现实世界的医院流程的集成可以提供即时的优先级，以防止或 纠正即将发生的低血糖和严重高血糖事件。第一步，实现长期 目标是随机对照试验，定义为III/IV期确定性临床试验， 确定这种干预的有效性和效果。目标1将确定以下方面的有效性： Cyber GEMS与家庭护理（UC）相比，患者在范围内的时间百分比增加，患者在范围内的时间百分比减少 住院期间发生低血糖和严重高血糖的时间。同时，Aim 2将 评估Cyber GEMS与UC在降低医院获得性感染风险方面的有效性。 所描述的数字仪表板是渐进式的，因为它促进了信息的实时无线传输。 同时采集大量患者的血糖数据;自动识别并确定优先级 患者进行干预;并检测潜在危险的低血糖发作-所有这些都在降低 负担比目前的方法分层和审查。不间断的遥测覆盖， 加上有效的和远程糖尿病专家监督在网络GEMS是一个可扩展的，新颖的， 基于团队的方法，最大限度地利用连续流式CGM数据，以获得最佳血糖 管理所提出的工作通过提供证据， 通过基于团队的葡萄糖管理方法在服务不足和研究不足的 人群，补充旨在改善T2 D高风险患者结局的既往数据 以及相关的心脏代谢疾病。