Sub-Cutaneous Insulin in Hyperglycaemic Emergencies
Primary Purpose
Diabetes Mellitus
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levemir
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes emergencies
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00467246
First Posted
April 27, 2007
Last Updated
April 27, 2007
Sponsor
The Royal Bournemouth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00467246
Brief Title
Sub-Cutaneous Insulin in Hyperglycaemic Emergencies
Official Title
The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Withdrawn
Why Stopped
Ethics approval denied
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Royal Bournemouth Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes emergencies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levemir
Primary Outcome Measure Information:
Title
Time to normoglycaemia
Title
Reduction of recurrence of ketoacidosis and hyperglycaemia.
Secondary Outcome Measure Information:
Title
To investigate time to treatment in patients presenting with a hyperglycaemic emergency
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kerr, MD
Organizational Affiliation
Royal Bournemouth Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Taylor, MD
Organizational Affiliation
Royal Bournemouth Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Sub-Cutaneous Insulin in Hyperglycaemic Emergencies
We'll reach out to this number within 24 hrs