Clinical trial NCT00764556: Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Official title: Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Hyperglycemia
Keywords: Glucose
Insulin
COPD
Exacerbations
Tight glycaemic control
Acute hospital ward
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
timeFrame: During trial
Secondary outcomes:
measure: The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)
timeFrame: During trial
measure: The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).
timeFrame: During treatment
measure: Mean 24 hour capillary glucose concentrations
timeFrame: During treatment
measure: Proportion of capillary glucose measurements in target range (4.4-6.5mM)
timeFrame: During treatment
measure: Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system
timeFrame: During monitoring
measure: Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring
timeFrame: During monitoring
measure: Quantification of acceptability of the study intervention to patients
timeFrame: during study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
Study officials:
affiliation: St George's, University of London
name: Emma H Baker, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.
citation: Archer JR, Misra S, Simmgen M, Jones PW, Baker EH. Phase II study of tight glycaemic control in COPD patients with exacerbations admitted to the acute medical unit. BMJ Open. 2011 Jul 23;1(1):e000210. doi: 10.1136/bmjopen-2011-000210.