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Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards (IPS2008)

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ClinicalTrials.gov Identifier: NCT00764556
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:
St George's, University of London

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date October 14, 2009
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate [ Time Frame: During trial ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00764556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia) [ Time Frame: During trial ]
  • The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia). [ Time Frame: During treatment ]
  • Mean 24 hour capillary glucose concentrations [ Time Frame: During treatment ]
  • Proportion of capillary glucose measurements in target range (4.4-6.5mM) [ Time Frame: During treatment ]
  • Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system [ Time Frame: During monitoring ]
  • Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring [ Time Frame: During monitoring ]
  • Quantification of acceptability of the study intervention to patients [ Time Frame: during study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Official Title  ICMJE Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Brief Summary Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. The aim of this study is to develop a safe and effective protocol for tight control of blood glucose with insulin on acute medical wards outside the intensive care environment. This will allow us to perform a formal trial to determine whether blood glucose control with insulin reduces death and complications from COPD exacerbations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Hyperglycemia
Intervention  ICMJE Drug: Insulin
Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)
Study Arms  ICMJE Experimental: Tight glycaemic control
Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM
Intervention: Drug: Insulin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Physician diagnosis of AECOPD as primary cause for admission
  • Able to enter study within 24 hours of admission

Exclusion Criteria:

  • Intensive care unit admission
  • Moribund or not for active treatment
  • Admission expected to last <48 hours
  • Unable or unwilling to give informed consent
  • Known Type I diabetes mellitus
  • Patients with reduced awareness of hypoglycaemia including reduced Glasgow coma scale or those taking beta blockers
  • Patients with renal or hepatic failure at increased risk of hypoglycaemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764556
Other Study ID Numbers  ICMJE SGH-ClinPharm-1
EudraCT 2007-004956-35
Ethics 07/H0715/93
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Emma Baker, St George's, University of London
Study Sponsor  ICMJE St George's, University of London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emma H Baker, PhD, FRCP St George's, University of London
PRS Account St George's, University of London
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP