Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital

 描述(申请人提供)：超过30%的综合医院住院患者经历过高血糖。这些人遭受更多的住院并发症、更长的住院时间和更高的治疗费用。为了防止这些不良反应，许多医院，包括申请机构，都引入了生理性胰岛素治疗方案(也称为基础推注疗法)，旨在将血糖维持在特定范围内。生理性胰岛素治疗包括每天多次注射以满足胰岛素需求：基础 (隔夜禁食和餐间)、正餐(餐时血糖高于基础值)和纠正(必要时补充胰岛素以纠正高血糖)。目前的国家指南推荐生理性胰岛素-并不鼓励传统的滑动比例方案(仅限校正成分)或口服药物-但指南指出，该疗法对临床结果和医院资源使用的有益效果尚未在普通住院环境中得到证实。最近对相关文献的系统回顾得出了同样的结论，强调在普通住院患者中常规采用强化形式的血糖控制之前，需要进一步研究。由于控制高血糖的策略会导致每12名住院患者中就有一人发生潜在危险的低血糖发作，有时会导致癫痫发作、昏迷、脑损伤或严重情况下的死亡，因此在将其作为医院接受之前，证明这种方法的好处至关重要。 宽泛的护理标准。这项拟议研究的主要目的是确定在综合医院对高血糖患者进行生理性胰岛素治疗是否有利于影响住院并发症和死亡率、是否需要重症监护或住院时间。第二个目的是确定这种疗法产生的益处的大小是否不同(A)在已知的糖尿病患者和新诊断的糖尿病患者中，或(B)在内科患者和外科患者中。这项研究将分析一项自然实验的数据，该实验发生在申请机构引入普遍生理性胰岛素疗法作为治疗高血糖的标准时。一项准实验性的前后研究将比较实施该标准前后(n~6400)合并2型糖尿病患者的住院并发症、死亡率和资源利用情况。在相同的两个时间间隔内，在附近的7家急性护理教学医院测量的结果将提供平行对照数据(n~35,000)。来自对照医院的数据将使评估患者特征或影响该地区医院的其他变量的时间变化是否可以解释可能被错误地归因于干预的影响。鉴于糖尿病在医院中的高患病率，以及用于控制高血糖的通用生理性胰岛素可能不会带来预期的好处，甚至可能弊大于利，回答这个问题是一个重要的目标。

 DESCRIPTION (provided by applicant): More than 30% of general hospital inpatients experience episodes of hyperglycemia. These individuals suffer more in-hospital complications, longer stays, and higher treatment costs. To prevent these adverse effects, many hospitals, including the applicant institution, have introduced physiologic insulin treatment protocols (also referred to as "basal-bolus therapy") intended to maintain blood glucose within a specified range. Physiologic insulin therapy includes multiple daily injections to cover insulin needs: basal (overnight fasting and between-meal), prandial (glucose excursions above basal at mealtime), and correction (supplemental insulin, as needed to correct hyperglycemia). Current national guidelines recommend physiologic insulin- and discourage a traditional sliding scale regimen (correction component only) or oral agents-but the guidelines note that beneficial effects of the therapy on clinical outcomes and hospital resource use have not been proven in the general inpatient setting. A recent systematic review of the pertinent literature came to the same conclusion, emphasizing the need for further research before routinely incorporating intensive forms of glycemic control in a general inpatient population. Since strategies to control hyperglycemia lead to potentially dangerous episodes of hypoglycemia in 1 of every 12 inpatients, sometimes causing seizures, coma, brain injury, or death in severe cases, it is critically important to demonstrate the benefits of this approach before accepting it as a hospital wide standard of care. The primary aim of the proposed study is to determine if physiologic insulin therapy administered to general hospital in patients with hyperglycemia favorably affects in-hospital complications and mortality, need for intensive care, or length of stay. The secondary aim is to determine if the magnitude of benefit derived from this therapy differs (a) in patients with known vs. newly diagnosed diabetes, or (b) in medical vs. surgical patients. The study will analyze data from a natural experiment that occurred when the applicant institution introduced universal physiologic insulin therapy as the standard of care for hyperglycemia. A quasi-experimental before-and-after study will compare in-hospital complications, mortality, and resource use in patients with comorbid type 2 diabetes before vs. after implementation of this standard (n~6400). Outcomes measured at 7 nearby acute-care teaching hospitals during the same two time intervals will provide parallel control data (n~35,000). Data from the control hospitals will make it possible to evaluate whether temporal changes in patient characteristics or other variables affecting hospitals in the region could explain effects that might otherwise be erroneously attributed to the intervention. Given the high prevalence of comorbid diabetes in the hospital and the possibility that universal physiologic insulin for managing hyperglycemia may not deliver the intended benefit or could even do more harm than good, answering this question is an important goal.