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

This study has been completed.
Information provided by:
St George's, University of London Identifier:
First received: October 1, 2008
Last updated: October 13, 2009
Last verified: October 2009
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 Intervention Phase
COPD Hyperglycemia Drug: Insulin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by St George's, University of London:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00764556

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

Publications automatically indexed to this study by Identifier (NCT Number):
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
Study First Received: October 1, 2008
Last Updated: October 13, 2009

Keywords provided by St George's, University of London:
Tight glycaemic control
Acute hospital ward

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 22, 2017