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Completed

NCT Number: NCT00764556

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St George's Healthcare NHS Trust

London, SW17 0RE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)

Primary outcomes

  1. The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate

    Time frame: During trial

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Acronym: IPS2008

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 2, 2008
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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