Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Overview
- Phase
- Phase 2
- Intervention
- Insulin
- Conditions
- COPD
- Sponsor
- St George's, University of London
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Tight glycaemic control
Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM
Intervention: Insulin
Outcomes
Primary Outcomes
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
Time Frame: During trial
Secondary Outcomes
- 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)
- The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)(During trial)
- 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)
- Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system(During monitoring)