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临床试验/NCT00464854
NCT00464854终止不适用

Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
2
主要终点
Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization

研究概览

简要总结

At least 20% of patients hospitalized in the general medical and surgical wards at any given time suffer from diabetes. It has been demonstrated that poor clinical outcome correlates with the degree of hyperglycemia in these patients. Strict glucose control in hospitalized patients improves clinical outcomes in the setting of acute myocardial infarction, cardiac surgical procedures, infection and critical illness in patients hospitalized in intensive care units if insulin is applied intravenously. It is, however, complex to obtain strict glucose control in the general surgical and medical wards. These wards are usually understaffed as compared to intensive care units and therefore are incapable to perform the necessary close monitoring essential in patients treated with intravenous insulin. We intend to test the feasibility of glucose control by multiple daily subcutaneous injections with long acting basal glargine insulin and pre-meal insulin analogues. If good glucose control can be achieved, this would be a valid, more convenient and acceptable alternative to intravenous insulin infusions to obtain good glucose control in diabetic patients hospitalized in general internal medicine wards.

详细描述

Location of the study:

Internal Medicine Wards C of Assaf Harofe Medical Center, Zerifin, Israel:

Inclusion Criteria:

  • Adult (<18 years) Male and female T1 & T2DM patients who can sign an informed consent.
  • Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.

Exclusion Criteria:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

  • Adult (<18 years) Male and female T1 & T2DM patients who can sign an informed consent.
  • Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.

排除标准

  • Diabetic ketoacidosis.
  • Hyperosmolar state due to hyperglycemia.
  • Pregnancy
  • Fertile women who do not use oral contraception or IUD

结局指标

主要结局

Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization

次要结局

  • Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)

研究者

申办方类型
Other Gov

研究点 (2)

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