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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764556
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : October 14, 2009
Information provided by:
St George's, University of London

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.

Condition or disease Intervention/treatment Phase
COPD Hyperglycemia Drug: Insulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tight glycaemic control
Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM
Drug: Insulin
Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)

Primary Outcome Measures :
  1. The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate [ Time Frame: During trial ]

Secondary Outcome Measures :
  1. The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia) [ Time Frame: During trial ]
  2. The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia). [ Time Frame: During treatment ]
  3. Mean 24 hour capillary glucose concentrations [ Time Frame: During treatment ]
  4. Proportion of capillary glucose measurements in target range (4.4-6.5mM) [ Time Frame: During treatment ]
  5. Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system [ Time Frame: During monitoring ]
  6. Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring [ Time Frame: During monitoring ]
  7. Quantification of acceptability of the study intervention to patients [ Time Frame: during study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764556

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United Kingdom
St George's Healthcare NHS Trust
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
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Principal Investigator: Emma H Baker, PhD, FRCP St George's, University of London

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Emma Baker, St George's, University of London Identifier: NCT00764556     History of Changes
Other Study ID Numbers: SGH-ClinPharm-1
EudraCT 2007-004956-35
Ethics 07/H0715/93
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009
Keywords provided by St George's, University of London:
Tight glycaemic control
Acute hospital ward
Additional relevant MeSH terms:
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Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs