Sub-Cutaneous Insulin in Hyperglycaemic Emergencies

The Royal Bournemouth Hospital

Status

Withdrawn

Conditions

Diabetes Mellitus

Treatments

Drug: Levemir

Study type

Interventional

Funder types

Other

Identifiers

NCT00467246

HIPI2

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.