The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards
- Conditions
- Acute exacerbations of chronic obstructive pulmonary disease. Stress hyperglycaemia. Insulin-induced hypoglycaemia. Cystic fibrosisMedDRA version: 9.1Level: LLTClassification code 10010953Term: COPD exacerbationMedDRA version: 9.1Level: LLTClassification code 10060439Term: Stress induced hyperglycaemiaMedDRA version: 9.1Level: LLTClassification code 10022484Term: Insulin hypoglycaemiaMedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis
- Registration Number
- EUCTR2007-004956-35-GB
- Lead Sponsor
- St George's, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Physician diagnosis of AECOPD as primary reason for admission
- Able to enter study within 24 hours of admission
Cystic fibrosis
1) CF diagnosed by 2 of: clinical features, positive sweat test, genotype;
2) Current pulmonary exacerbation, at least 3 of: increased cough/sputum; fever; weight loss; absence from education/work due to illness; tachypnoea; new findings on chest examination; decreased exercise tolerance, decreased pulmonary function tests/oxyhaemoglobin saturation or new finding on chest radiograph [3],
3) >18 years
4) Admitted to hospital for intravenous antibiotics for pulmonary exacerbation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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
- Level of English not sufficient to understand verbal and written information
- 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method