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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

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.

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Detailed Description

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Conditions

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COPD Hyperglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tight glycaemic control

Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)

Interventions

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Insulin

Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)

Intervention Type DRUG

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No