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Sub-Cutaneous Insulin in Hyperglycaemic Emergencies

Primary Purpose

Diabetes Mellitus

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levemir
Sponsored by
The Royal Bournemouth Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes emergencies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    April 27, 2007
    Last Updated
    April 27, 2007
    Sponsor
    The Royal Bournemouth Hospital
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    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    Withdrawn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

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