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

Phase 2

Completed

• Conditions: COPD; Hyperglycemia
• Interventions: Drug: Insulin

• Registration Number: NCT00764556
• Lead Sponsor: St George's, University of London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-13
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tight glycaemic control	Insulin	Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM

Primary Outcome Measures

Name	Time	Method
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate	During trial

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St George's Healthcare NHS Trust; 🇬🇧 London, United Kingdom