Inpatient Diabetes on Corticosteroids
2019年9月9日 更新者：Hennepin Healthcare Research Institute
Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia.
Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids.
NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.
Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay.
The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
研究概览
详细说明
As above.
研究类型
介入性
注册 (实际的)
85
阶段
- 第四阶段
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
-
-
Minnesota
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Minneapolis、Minnesota、美国、55415
- Hennepin County Medical Center
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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 至 79年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Prior history of diabetes
- Able to provide informed consent
- Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
- Expect to be hospitalized for 48 hours
Exclusion Criteria:
- Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2
- ALT (alanine aminotransferase) > 2 times upper normal for laboratory
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：NPH with steroid dose
Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg |
NPH given per study table based on steroid dose and patient weight in kg.
其他名称：
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl.
Administered qid during study duration.
其他名称：
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有源比较器：Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
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Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl.
Administered qid during study duration.
其他名称：
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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 |
|---|---|---|
|
Mean POC Glucose Level Between Groups
大体时间：Assessed from enrollment to discharge or enrollment to day five.
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Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention.
Values shown are the overall mean point of care blood glucose.
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Assessed from enrollment to discharge or enrollment to day five.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Episodes of Hypoglycemia Between NPH and Control Groups
大体时间：Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
|
Hypoglycemia was defined as point of care glucose less than 70 mg/dL.
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Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
大体时间：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
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Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.
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From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
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Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
大体时间：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
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Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
大体时间：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
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Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
大体时间：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements > 400 mg/dL.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
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Difference in Length of Stay Between NPH and Control Group
大体时间：Measured from the day of admission till the day of discharge
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Time difference of hospitalization between the NPH and control groups.
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Measured from the day of admission till the day of discharge
|
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Mean Point of Care (POC) Glucose Level in Both Groups.
大体时间：On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
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The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.
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On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
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Mean Point of Care (POC) Glucose Level in Both Groups.
大体时间：On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
|
The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.
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On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
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Correlation of C-peptide With Age
大体时间：plasma C-peptide was measured once at the time of enrollment
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plasma C-peptide was measured once at the time of enrollment
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Correlation of C-peptide With BMI
大体时间：Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
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Correlation of C-peptide With eGFR
大体时间：Measured once at the time of enrollment
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Measured once at the time of enrollment
|
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Correlation of C-peptide With Serum Creatinine
大体时间：Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With ALT
大体时间：Measured once at the time of enrollment
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Measured once at the time of enrollment
|
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Correlation of C-peptide With Hemoglobin A1c
大体时间：Measured once at the time of enrollment
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Measured once at the time of enrollment
|
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Correlation of C-peptide With Duration of Diabetes
大体时间：Measured once at the time of enrollment
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Measured once at the time of enrollment
|
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Correlation of C-peptide With Plasma Glucose
大体时间：Measured the time of enrollment
|
Measured the time of enrollment
|
|
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Correlation of C-peptide With Length of Stay
大体时间：Measured once at the time of enrollment
|
Measured once at the time of enrollment
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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：Lisa Fish, MD、Hennepin County Medical Center, Minneapolis
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2014年7月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2013年9月4日
首先提交符合 QC 标准的
2013年10月24日
首次发布 (估计)
2013年10月28日
研究记录更新
最后更新发布 (实际的)
2019年10月1日
上次提交的符合 QC 标准的更新
2019年9月9日
最后验证
2019年9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.