Full Text View
Tabular View
No Study Results Posted
Related Studies
Sub-Cutaneous Insulin in Hyperglycaemic Emergencies
This study has been withdrawn prior to recruitment.
( Ethics approval denied )
First Received: April 27, 2007   No Changes Posted
Sponsor: The Royal Bournemouth Hospital
Information provided by: The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT00467246
  Purpose

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 Intervention
Diabetes Mellitus
Drug: Levemir

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies

Resource links provided by NLM:


Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • Time to normoglycaemia
  • Reduction of recurrence of ketoacidosis and hyperglycaemia.

Secondary Outcome Measures:
  • To investigate time to treatment in patients presenting with a hyperglycaemic emergency

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467246

Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: David Kerr, MD Royal Bournemouth Hospital
Study Director: Martin Taylor, MD Royal Bournemouth Hospital
  More Information

No publications provided

Study ID Numbers: HIPI2
Study First Received: April 27, 2007
Last Updated: April 27, 2007
ClinicalTrials.gov Identifier: NCT00467246     History of Changes
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:
Diabetes emergencies

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Emergencies
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2009