COPD, Hyperglycemia
Conditions
Keywords
Glucose, Insulin, COPD, Exacerbations, Tight glycaemic control, Acute hospital ward
Brief summary
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.
Interventions
DRUGInsulin
Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)
Sponsors
St George's, University of London
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate | During trial |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia). | During treatment |
| Mean 24 hour capillary glucose concentrations | During treatment |
| Proportion of capillary glucose measurements in target range (4.4-6.5mM) | During treatment |
| The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia) | During trial |
| Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring | During monitoring |
| Quantification of acceptability of the study intervention to patients | during study |
| Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system | During monitoring |
Countries
United Kingdom
Outcome results
None listed