Sub-Cutaneous Insulin in Hyperglycaemic Emergencies

• Sponsor: The Royal Bournemouth Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00467246
• Collaborator: (none)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Levemir	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies

Outcome Measures

Primary Outcome Measures

1. Time to normoglycaemia []

2. Reduction of recurrence of ketoacidosis and hyperglycaemia. []

Secondary Outcome Measures

1. To investigate time to treatment in patients presenting with a hyperglycaemic emergency []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The Royal Bournemouth Hospital

Investigators

• Principal Investigator: David Kerr, MD, Royal Bournemouth Hospital
• Study Director: Martin Taylor, MD, Royal Bournemouth Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00467246
• Other Study ID Numbers: HIPI2
• First Posted: Apr 30, 2007
• Last Update Posted: Apr 30, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: Diabetes emergencies
• Additional relevant MeSH terms: Emergencies; Insulin Detemir

Study Results

No Results Posted as of Apr 30, 2007