An interventional study of Blood glucose monitoring and Insulin Glulisine in Chronic Obstructive Pulmonary Disease and Hyperglycemia, sponsored by The Royal Bournemouth Hospital. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-02.
Sponsored by The Royal Bournemouth Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the effect of preventing hyperglycaemia in patients admitted to hospital with acute exacerbations of chronic pulmonary disease.
Hyperglycaemia is associated with increased morbidity and mortality in patients admitted to hospital with acute critical illness, myocardial infarction and stroke. Moreover patients with hyperglycaemia have a significantly longer hospital stay, higher rates of ICU admission, increased in-hospital mortality and are more likely to require transfer to a nursing home. Recently, interventional studies have linked reversal of hyperglycaemia to better clinical outcomes especially in acute myocardial infarction, cardiac surgery and in critically ill patients.
In England and Wales, it is estimated that the number of people with COPD is approaching 1.5 million. The morbidity and economic costs associated with the condition are extremely high with approximately 10% of all acute medical admissions caused by exacerbations of the underlying condition. As a corollary about 15% of patients with COPD need admission to hospital each year.
Acute hyperglycaemia is common among patients admitted with acute exacerbations of COPD. The reasons for this are likely to be multi-factorial including an association between COPD and increased risk of developing diabetes at least in women, the elderly nature of the two populations and the use of glucocorticoids which markedly increases the risk of hyperglycaemia. Admission hyperglycaemia (>11 mmol/l) also appears to predict increased morbidity for patients with COPD admitted to intensive care.
The trial will be a randomised trial of comparison of usual treatment vs intensive insulin treatment for patients with COPD who may or may not have diabetes. Patients will take part in the trial for the first 5 days during their hospital stay.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 51 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →The Royal Bournemouth Hospital is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Blood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose \< 4 mmol/l.
Drug: Insulin Glulisine
Blood glucose monitoring for comparison with treatment arm (1)
Procedure: Blood glucose monitoring
Regular pre and post meal blood glucose monitoring.
Sub cutaneous injection given twice daily for 3 days. Dosage titrated to body mass index and body weight (BMI \< 30 = 0.1 unit/kg. BMI \> 30 = 0.2 unit/kg)
Also known as: Apidra
Rate of re-admission to hospital within 90 days.
Time frame: 90 days after discharged from hospital
Length of stay
Time frame: oct 2009
In-patient mortality
Time frame: look at cause death. for statistical purpose oct 2009
Spirometry at baseline, day 3 and prior to discharge
Time frame: oct 2009
Achieved glucose levels
Time frame: oct 2009
Hypoglycaemic events (<4 mmol/l with or without symptoms)
Time frame: instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.
Frequency of positive sputum cultures
Time frame: oct 2009
Change in CRP and IL-6 levels between baseline and day 5
Time frame: oct 2009
This study is terminated, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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The Royal Bournemouth Hospital