The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Time to normoglycaemia
研究概览
简要总结
Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.
详细描述
This is a randomised trial concerning patients presenting in A & E with a diabetic emergency, either a Diabetic Ketoacidosis (DKA) or a Hyperosmolar Non-Ketotic Coma (HONC). Once informed consent has been given, each patient will receive standard intravenous treatment. They will also receive a daily sub-cutaneous bolus of either a long-acting insulin or a placebo.
Blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood pH.
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
- Double
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
- •Patients presenting with a diabetic emergency aged 18 and above.
排除标准
- •Patients who do not speak English and need a translator.
- •Patients under the age of 18 years.
- •Patients who are unable to give their consent and who do not have a relative present wiling to give assent.
结局指标
主要结局
Time to normoglycaemia
Reduction of recurrence of ketoacidosis and hyperglycaemia.
次要结局
- To investigate time to treatment in patients presenting with a hyperglycaemic emergency