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

October 13, 2009 updated by: St George's, University of London
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • St George's Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Investigators

  • Principal Investigator: Emma H Baker, PhD, FRCP, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGH-ClinPharm-1
  • EudraCT 2007-004956-35
  • Ethics 07/H0715/93

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperglycemia

Clinical Trials on Insulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe