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

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD, Hyperglycemia

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tight glycaemic control<br>Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM | Drug: Insulin<br>* Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate |  | During trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose, Insulin, COPD, Exacerbations, Tight glycaemic control, Acute hospital ward