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

住进普通病房/非重症监护病房(Non-ICU)的患者中，超过25%的人有病史 截至2012年，1250亿美元是与糖尿病相关的住院费用 美国的糖尿病患者。高达30%的住院糖尿病患者出现低血糖，这是一种情况 这与更高的医院费用、更长的住院时间以及更高的发病率和死亡率有关。 减少住院环境中的低血糖事件导致医院开发低血糖预防 政策；然而，政策受到不常见的护理点(POC)毛细血管血糖检测的限制 在普通病房里。连续血糖监测(CGM)设备代表了另一种监测方法 血糖水平。只有有限数量的研究考察了CGM装置在非ICU中的使用情况 布景。在所有这些研究中，与POC相比，CGM在检测低血糖方面被发现更好。 然而，由于CGM的结果是盲的(警报被关闭)，调查人员和 参与者，没有进行预防低血糖的干预措施。此外，还有一个主要限制是 CGM技术是由于蓝牙，CGM接收器/监视器需要放置在病人的房间里 技术信号强度限制，护士必须频繁进入病人的病房，以便 检查CGM血糖值。在目前的奖项申请中，我们描述了一种创新的发展 一种系统，允许将CGM血糖值从患者的床边传输到 位于一个中央护理站--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联合 通过低血糖预防方案，可以减少内科病房的低血糖，而不会导致 高血糖-导致更好的临床结果。具体地说，我们假设：(1)退伍军人 与随机分为对照组的退伍军人相比，随机服用GTS的患者低血糖发生率较低(标准护理)； (2)将被随机分配到GTS的退伍军人不会因为以下原因而经历更频繁的高血糖 经常应用低血糖预防方案的退伍军人与随机进入 对照组；以及(3)GTS的使用将减少低血糖引起的癫痫发作的频率。 住院-减少住院时间和住院死亡率。我们将研究244名患有DM2的退伍军人 患低血糖的风险更高。同意退伍军人将根据人数被分成两组 低血糖的危险因素(≤2危险因素，≥3危险因素)，然后按1：1进一步随机 随机化方案(122名退伍军人随机到GTS，122名随机退伍军人到标准护理- PoC血糖监测)。对于对照组的参与者，追溯CGM装置将是 用来比较两组之间的血糖结果。我们的主要结果是 两组低血糖事件发生率比较。其他令人感兴趣的结果是低血糖的时间， 正常血糖、高血糖和重度高血糖、住院时间、癫痫发作活动相关 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 在住院环境中预防低血糖--这是一种与不良临床结果相关的情况。 我们相信，我们的建议具有很高的创新性。该试验可能导致未来在住院患者中更广泛地使用CGM 糖尿病患者有较高的低血糖风险，类似于我们使用心脏遥测技术 发生心律失常的风险增加的患者。

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.