Insulin Therapy in the Hospital Comparing Two Protocols
2009年9月8日 更新者：John H. Stroger Hospital
Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.
研究概览
研究类型
介入性
注册 (预期的)
60
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
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Illinois
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Chicago、Illinois、美国、60612
- John H Stroger Jr. 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 至 80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:
Uncontrolled blood sugar:
- Random blood sugar ≥ 200mg/dl
- Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours.
- Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.
- Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.
- Patient is able to eat and oral feeding is expected.
Exclusion Criteria:
- Patients receiving inpatient oral hypoglycemic agents
- Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis
- Patient with chronic liver disease
- Patient with hypoglycemia unawareness
- Pregnancy
- Patients who are on "NPO" for medical reasons.
- Patient is expected to stay in the hospital for less than 3 days.
- Patient on a new inpatient insulin regimen for > 36 hours.
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 |
|---|---|
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有源比较器：2
The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals.
The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
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The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals.
The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
|
|
实验性的：1
The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made).
The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff
|
The study group will receive Insulin Glargine as basal insulin.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
其他名称：
Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made).
The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The rate of correct timing of insulin and food administration
大体时间：Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
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Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
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Pre and post- prandial glucose levels
大体时间：Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
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Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Length of hospital stay
大体时间：Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
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Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
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Nursing staff satisfaction scores for evaluation of the two methods
大体时间：24 hours after last patient is discharged
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24 hours after last patient is discharged
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Hypoglycemia rates.
大体时间：From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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High excursions of blood sugars (>300 mg/dl).
大体时间：From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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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：Leon Fogelfeld, MD、John H Stroger Jr. Hospital
- 学习椅：Evelyn Lacuesta, MD、John H Stroger Jr. Hospital
- 学习椅：Yannis Guerra, MD、Rush University Hospital
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
2006年12月1日
初级完成 (实际的)
2009年3月1日
研究完成 (实际的)
2009年6月1日
研究注册日期
首次提交
2009年2月9日
首先提交符合 QC 标准的
2009年2月11日
首次发布 (估计)
2009年2月12日
研究记录更新
最后更新发布 (估计)
2009年9月9日
上次提交的符合 QC 标准的更新
2009年9月8日
最后验证
2009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.
NPH insulin and regular insulin的临床试验
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Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbH完全的
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Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完全的
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Mannkind Corporation完全的