Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards

COPD Clinical Trial

— IPS2008  

Official title:

Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764556
• Other study ID #: SGH-ClinPharm-1
• Secondary ID: EudraCT 2007-004
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2008
• Last updated: October 13, 2009
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2009
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Hyperglycemia

Intervention

Drug:
• Insulin
Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)

Locations

Country	Name	City	State
United Kingdom	St George's Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. Epub 2006 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate		During trial	Yes
Secondary	The frequency of symptomatic hypoglycaemia (capillary glucose=3.3mM AND symptoms consistent with hypoglycaemia)		During trial	Yes
Secondary	The frequency of asymptomatic hypoglycaemia (capillary glucose=3.3mM without any symptoms consistent with hypoglycaemia).		During treatment	Yes
Secondary	Mean 24 hour capillary glucose concentrations		During treatment	No
Secondary	Proportion of capillary glucose measurements in target range (4.4-6.5mM)		During treatment	No
Secondary	Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system		During monitoring	No
Secondary	Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring		During monitoring	No
Secondary	Quantification of acceptability of the study intervention to patients		during study	No