Diabetes Mellitus
Conditions
Keywords
Diabetes emergencies
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.
Interventions
DRUGLevemir
Sponsors
The Royal Bournemouth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting with a diabetic emergency aged 18 and above.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to normoglycaemia | — |
| Reduction of recurrence of ketoacidosis and hyperglycaemia. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate time to treatment in patients presenting with a hyperglycaemic emergency | — |
Outcome results
None listed