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临床试验/NCT00813475
NCT00813475Unknown不适用

Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital

研究概览

简要总结

To test whether tight glucose control is associated with better clinical outcome compared to less-tight control, among diabetic patients hospitalized in internal medicine wards.

详细描述

Patient characteristics:

Patients admitted to internal medicine departments in public hospitals of Israel who have pre-admission diagnosis of diabetes, or have a random plasma glucose >200 mg/dl on admission

Eligibility criteria

  1. Age: >18 years
  2. Fasting plasma glucose > 140 mg/dl or non-fasting plasma glucose >200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
  3. Able to understand the study objective and methods and willing to provide a written informed consent
  4. No significant liver disease
  5. Serum creatinine <2.0 mg/dl

Exclusion criteria

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: >18 years
  • Fasting plasma glucose > 140 mg/dl or non-fasting plasma glucose >200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
  • Able to understand the study objective and methods and willing to provide a written informed consent
  • No significant liver disease
  • Serum creatinine <2.0 mg/dl

排除标准

  • Significant cognitive impairment
  • History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
  • Known allergy to insulin analogues
  • Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission

研究组 & 干预措施

tight control

Experimental

干预措施: Basal bolus insulin regimen (tight glucose control) (Drug)

standard control

Experimental

basal bolus insulin regimen

干预措施: Basal bolus insulin regimen (standard control) (Drug)

结局指标

主要结局

All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital

时间窗: 1.5 years

次要结局

  • Total # of in-hospital days during 1 year follow-up.The rate of any major clinical events during 1 year follow-up. Hypoglycemic events during index hospital stay(1.5)

研究者

申办方类型
Other Gov

研究点 (1)

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