Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital
2019年6月3日 更新者:Donald Brand, PhD、Winthrop University Hospital
Many hospitals have begun giving insulin to nearly all patients with diabetes while they are in the hospital even if a patient does not use insulin at home.
Controlling blood sugar with insulin when a patient is hospitalized is believed to reduce the risk of complications and death, but research has not demonstrated these benefits except in patients who are critically ill.
The purpose of this study, therefore, is to evaluate whether such insulin therapy actually does reduce in-hospital complications, deaths, need for intensive care, or length of stay in the hospital.
研究概览
详细说明
The primary aim of the proposed study is to determine if physiologic insulin therapy administered to general hospital inpatients 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.
研究类型
观察性的
注册 (实际的)
40391
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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New York
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Mineola、New York、美国、11501
- Winthrop-University Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Hospitalized patients with type 2 diabetes mellitus admitted to a medical or surgical service
描述
Inclusion Criteria:
- Type 2 diabetes
Exclusion Criteria:
- Pregnant
- Admitted directly to an intensive care unit
- Length of stay <2 days
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Historical control group (H)
Winthrop patients with diabetes hospitalized between August 1, 2010 and March 31, 2011
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Intervention group (I)
Winthrop patients with diabetes hospitalized between August 1, 2011 and March 31, 2012
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Parallel control group (P-sub-H)
Patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 at 7 control hospitals located in the New York City metropolitan region
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Parallel control group (I-sub-H)
Patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 at 7 control hospitals located in the New York City metropolitan region
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Transfer to intensive care unit (y/n)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Assigned "y" if patient is transferred to an intensive care unit for any length of time; otherwise, assigned "n".
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Upon hospital discharge (median length of stay, 5 days)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Day-weighted proportion of blood glucose values within target range (100-180 mg/dL)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Upon hospital discharge (median length of stay, 5 days)
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Proportion of inpatient days involving any hypoglycemia (blood glucose<70 mg/dL)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Upon hospital discharge (median length of stay, 5 days)
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Proportion of inpatient days involving severe hypoglycemia (blood glucose<40 mg/dL)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Upon hospital discharge (median length of stay, 5 days)
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Proportion of inpatient days involving any hyperglycemia (blood glucose>200 mg/dL)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Upon hospital discharge (median length of stay, 5 days)
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Proportion of inpatient days involving severe hyperglycemia (blood glucose>300 mg/dL)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Upon hospital discharge (median length of stay, 5 days)
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Development of any complication (y/n)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Upon hospital discharge (median length of stay, 5 days)
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In-hospital death (y/n)
大体时间:Upon hospital discharge (median length of stay, 5 days)
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Upon hospital discharge (median length of stay, 5 days)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Donald A Brand, Ph.D.、Winthrop University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年7月1日
初级完成 (实际的)
2017年8月15日
研究完成 (实际的)
2018年6月30日
研究注册日期
首次提交
2016年7月29日
首先提交符合 QC 标准的
2016年8月15日
首次发布 (估计)
2016年8月16日
研究记录更新
最后更新发布 (实际的)
2019年6月4日
上次提交的符合 QC 标准的更新
2019年6月3日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.