Sub-Cutaneous Insulin in Hyperglycaemic Emergencies
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00467246
- Lead Sponsor
- The Royal Bournemouth Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients presenting with a diabetic emergency aged 18 and above.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to normoglycaemia Reduction of recurrence of ketoacidosis and hyperglycaemia.
- Secondary Outcome Measures
Name Time Method To investigate time to treatment in patients presenting with a hyperglycaemic emergency