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

This study has been completed.
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00764556
First received: October 1, 2008
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia) [ Time Frame: During trial ] [ Designated as safety issue: Yes ]
  • The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia). [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]
  • Mean 24 hour capillary glucose concentrations [ Time Frame: During treatment ] [ Designated as safety issue: No ]
  • Proportion of capillary glucose measurements in target range (4.4-6.5mM) [ Time Frame: During treatment ] [ Designated as safety issue: No ]
  • Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system [ Time Frame: During monitoring ] [ Designated as safety issue: No ]
  • Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring [ Time Frame: During monitoring ] [ Designated as safety issue: No ]
  • Quantification of acceptability of the study intervention to patients [ Time Frame: during study ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764556

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Emma Baker, St George's, University of London
ClinicalTrials.gov 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
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Hyperglycemia
Pulmonary Disease, Chronic Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014