Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
研究概览
简要总结
Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. The aim of this study is to develop a safe and effective protocol for tight control of blood glucose with insulin on acute medical wards outside the intensive care environment. This will allow us to perform a formal trial to determine whether blood glucose control with insulin reduces death and complications from COPD exacerbations.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of AECOPD as primary cause for admission
- •Able to enter study within 24 hours of admission
排除标准
- •Intensive care unit admission
- •Moribund or not for active treatment
- •Admission expected to last <48 hours
- •Unable or unwilling to give informed consent
- •Known Type I diabetes mellitus
- •Patients with reduced awareness of hypoglycaemia including reduced Glasgow coma scale or those taking beta blockers
- •Patients with renal or hepatic failure at increased risk of hypoglycaemia
研究组 & 干预措施
Tight glycaemic control
Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM
干预措施: Insulin (Drug)
结局指标
主要结局
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
时间窗: During trial
次要结局
- Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring(During monitoring)
- Quantification of acceptability of the study intervention to patients(during study)
- The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)(During trial)
- The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).(During treatment)
- Mean 24 hour capillary glucose concentrations(During treatment)
- Proportion of capillary glucose measurements in target range (4.4-6.5mM)(During treatment)
- Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system(During monitoring)