NCT00813475Unknown不适用
Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study
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
- 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
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
- 否
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
研究点 (1)
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