NCT01153100已完成1 期
Effectiveness of a Subcutaneously Administered Long-acting Insulin Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)
研究概览
简要总结
The investigators anticipate that the use of Glargine will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip.
- •Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
- •Patients with both types of diabetes will be among those treated with the insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition.
- •Patients will be of age 19 to 80.
排除标准
- •Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drip 2 weeks and longer, pregnancy, Lantus allergy, and concurrent sulfonamide treatment
研究组 & 干预措施
Insulin drip and glargine
Active Comparator
Insulin drip and glargine 0.25 units per kg body weight
干预措施: Glargine (Drug)
结局指标
主要结局
Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)
时间窗: within 48 hours of discontinuation
次要结局
- Reduction in duration of insulin drip therapy and reduction in total and average per hour insulin drip dose(within one week of insulin drip therapy)
- Reduction in ICU length of stay(within two weeks of hospitalization)
- Equal or improved diabetes control(within two weeks of hospitalization)
- Reduction in time to get back to control of glycemia (140-180 mg/dl) if rebound hyperglycemia occurs(within one week post insulin drip)
研究者
研究点 (1)
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