Acute exacerbations of chronic obstructive pulmonary disease. Stress hyperglycaemia. Insulin-induced hypoglycaemia. Cystic fibrosis MedDRA version: 9.1 Level: LLT Classification code 10010953 Term: COPD exacerbation MedDRA version: 9.1 Level: LLT Classification code 10060439 Term: Stress induced hyperglycaemia MedDRA version: 9.1 Level: LLT Classification code 10022484 Term: Insulin hypoglycaemia MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
Trade Name: Actrapid 100 IU/ml, Solution for injection in a vial
Pharmaceutical Form: Solution for injection
Trade Name: Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solu
Sponsors
St George's, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: This is a pilot study with the overall aim of tesing the feasibility and safety of using insulin to achieve normal levels of blood glucose (4.4 – 6.5mM) in patients admitted to medical wards with acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Specifically, the objectives of this pilot study are: 1. To trial a clinical protocol for normalisation of blood glucose with insulin on medical wards at St George’s Hospital, and to adapt it to ensure target blood glucose values of 4.4 – 6.5mM are reached. 2. To determine the frequency of hypoglycaemia in patients undergoing effective normalisation of blood glucose with insulin. ;Primary end point(s): Severe hypoglycaemia – neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate. | — |
Countries
United Kingdom
Outcome results
None listed