Sub-Cutaneous Insulin in Hyperglycaemic Emergencies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Keywords

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Diabetes emergencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levemir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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David Kerr, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Bournemouth Hospital

Martin Taylor, MD

Role: STUDY_DIRECTOR