Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans with DM2 at Higher Risk for Hypoglycemia

对接受胰岛素治疗的患有 DM2 且低血糖风险较高的住院退伍军人进行连续血糖监测

• 批准号: 10292898
• 负责人: Ilias Spanakis
• 金额: --
• 依托单位: BALTIMORE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10292898
• 关键词: Arrhythmia; Award; Baltimore; Beds; Blinded; Blood Glucose; Blood capillaries; Bluetooth; Cardiac; Cessation of life; Clinical; Consent; Control Groups; Detection; Development; Diabetes Mellitus; Diagnosis; Discipline of Nursing; Enrollment; Event; FDA approved; Financial Hardship; Frequencies; Future; General Ward; Glucose; Goals; Hospital Charges; Hospital Costs; Hospitalization; Hospitals; Hyperglycemia; Hypoglycemia; Inpatients; Insulin; Intensive Care Units; Intervention; Lead; Length of Stay; Medical; Medical center; Monitor; Morbidity - disease rate; Nurses; Outcome; Outpatients; Participant; Patients; Patients' Rooms; Policies; Prevalence; Prevention; Prevention Protocols; Preventive; Protocols documentation; Randomized; Randomized Clinical Trials; Recording of previous events; Research Personnel; Risk; Risk Factors; Safety; Scheme; Seizures; Signal Transduction; Societies; System; Technology; Telemetry; Testing; Time; United States; Veterans; Wireless Technology; Work; base; cost; diabetes management; diabetic; diabetic patient; glucose monitor; glycemic control; group intervention; high risk; improved; innovation; interest; monitoring device; mortality; novel; point of care; prevent; primary outcome; prospective; standard of care; ward

More than 25% of patients admitted to general wards/non Intensive Care Unit (non-ICU) setting have a history of Diabetes Mellitus (DM); and as for 2012, $125 billion dollars were costs associated with hospitalization of diabetics in the United States (US). Up to 30% of the hospitalized diabetics develop hypoglycemia, a condition that is associated with higher hospital charges, prolonged length of stay, and increased morbidity and mortality. Reducing hypoglycemic events in the inpatient setting has led hospitals to develop hypoglycemia prevention policies; policies which are however limited by the infrequent Point of Care (POC) capillary blood glucose testing in the general wards. Continuous Glucose Monitoring (CGM) devices represent additional ways to monitor blood glucose levels. Only a limited number of studies have examined the use of CGM devices in the non-ICU setting. In all these studies, CGM use was found to be superior compared to POC in hypoglycemia detection. However, as the results of CGM were blinded (alarms were turned off) for both the investigators and the participants, interventions to prevent hypoglycemia were not performed. Additionally, one major limitation of CGM technology is that CGM receiver/monitor needs to be located in the patient's room, due to Bluetooth Technology signal-strength restrictions, necessitating nurses to enter frequently the patient's room in order to check CGM glucose values. In the current award application, we describe the development of an innovative system that allows CGM glucose values to be transmitted from the patients' bedside to a monitoring device that is located at a central nursing station- a system that we call “Glucose Telemetry System” (GTS). We propose the conduction of a prospective randomized clinical trial that will examine whether GTS combined with a hypoglycemia prevention protocol, can decrease hypoglycemia in the medical wards without resulting in hyperglycemia- resulting to better clinical outcomes. Specifically we hypothesize that: (1) Veterans who will be randomized to GTS will have less hypoglycemia than Veterans randomized to control group (standard of care); (2) Veterans who will be randomized to GTS will not experience more frequent hyperglycemia, as a result of the frequent application of the hypoglycemia prevention protocol, compared to Veterans randomized to the control group; and (3) GTS use will reduce the frequency of hypoglycemia induced seizures during their hospitalization – decreasing length of stay and inpatient mortality. We will study 244 Veterans with DM2 who are at a higher risk for hypoglycemia. Consenting Veterans will be stratified in two groups based on the number of risk factors of hypoglycemia (≤2 risk factors, ≥3 risk factors); and then further randomized in a 1:1 randomization scheme (122 Veterans randomized to GTS and 122 randomized Veterans to standard of care- POC blood glucose monitoring). For the participants of the control group, retrospective CGM devices will be used in order to compare glycemic outcomes between the two groups. Our primary outcome is difference in hypoglycemic event rate between the two groups. Other outcomes of interest are times spent in hypoglycemia, normoglycemia, hyperglycemia and severe hyperglycemia, length of stay, seizure activity related to hypoglycemia and inpatient mortality. Discovering novel ways to monitor glucose values in the hospital setting could have a significant impact in preventing hypoglycemia in the inpatient setting- a condition that is associated with adverse clinical outcomes. We believe that our proposal is highly innovative. The trial may lead to future wider use of CGM in hospitalized patients with DM who are at a higher risk for hypoglycemia, similar to the way that we use cardiac telemetry for patients who are at an increased risk for developing arrhythmias.

超过25%的普通病房/非重症监护室（非ICU）患者有以下病史 糖尿病（DM）;截至2012年，1250亿美元是与糖尿病患者住院相关的费用。 糖尿病在美国（US）。高达30%的住院糖尿病患者会出现低血糖， 这与更高的住院费用、更长的住院时间以及更高的发病率和死亡率有关。 减少低血糖事件在住院设置导致医院发展低血糖预防 政策;但受不频繁的床旁（POC）毛细血管血糖检测限制的政策 在普通病房。动态葡萄糖监测（CGM）设备代表了监测的其他方式 血糖水平。只有少数研究检查了CGM器械在非ICU中的使用 设置.在所有这些研究中，发现在低血糖检测方面，CGM的使用优于POC的上级。 然而，由于CGM结果对研究者和患者均设盲（警报关闭）， 参与者，未进行预防低血糖的干预措施。此外，一个主要的局限性， CGM技术是由于蓝牙，CGM接收器/监护仪需要位于患者房间内 技术信号强度限制，护士必须频繁进入病房， 检查CGM葡萄糖值。在目前的奖项申请中，我们描述了一种创新的发展， 允许CGM葡萄糖值从患者床边传输到监测设备的系统， 位于中央护理站-我们称之为“葡萄糖遥测系统”（GTS）的系统。 我们建议进行一项前瞻性随机临床试验，以检查GTS是否联合 通过低血糖预防协议，可以减少医疗病房中的低血糖，而不会导致 高血糖-导致更好的临床结果。具体来说，我们假设：（1）退伍军人将是 随机分配至GTS组的低血糖发生率低于随机分配至对照组（标准治疗）的退伍军人; (2)随机分配至GTS组的退伍军人不会因以下原因发生更频繁的高血糖： 低血糖预防方案的频繁应用，与随机分配至 对照组;和（3）GTS的使用将减少低血糖诱导的癫痫发作的频率， 住院-缩短住院时间和降低住院死亡率。我们将研究244名患有DM 2的退伍军人， 患低血糖的风险更高。同意的退伍军人将根据人数分为两组 的低血糖风险因素（≤2个风险因素，≥3个风险因素）;然后以1：1的比例进一步随机化 随机化方案（122名退伍军人随机分配至GTS组，122名退伍军人随机分配至标准治疗组- POC血糖监测）。对于对照组受试者，将使用回顾性CGM器械 用于比较两组之间的血糖结果。我们的主要结果是 两组之间的低血糖事件发生率。其他感兴趣的结果是低血糖的时间， 血糖正常、高血糖和重度高血糖、住院时间、与 低血糖和住院死亡率。 发现在医院环境中监测血糖值的新方法可能会对以下方面产生重大影响： 预防住院患者的低血糖症-一种与不良临床结局相关的疾病。 我们认为，我们的建议具有很强的创新性。这项试验可能会导致未来更广泛地使用CGM在住院 低血糖风险较高的DM患者，类似于我们使用心脏遥测的方式， 心律失常风险增加的患者。