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Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards (IPS2008)

Primary Purpose

COPD, Hyperglycemia

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Insulin
Sponsored by
St George's, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Glucose, Insulin, COPD, Exacerbations, Tight glycaemic control, Acute hospital ward

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St George's Healthcare NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tight glycaemic control

Arm Description

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

Outcomes

Primary Outcome Measures

The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate

Secondary Outcome Measures

The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)
The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).
Mean 24 hour capillary glucose concentrations
Proportion of capillary glucose measurements in target range (4.4-6.5mM)
Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system
Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring
Quantification of acceptability of the study intervention to patients

Full Information

First Posted
October 1, 2008
Last Updated
October 13, 2009
Sponsor
St George's, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00764556
Brief Title
Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Acronym
IPS2008
Official Title
Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St George's, University of London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hyperglycemia
Keywords
Glucose, Insulin, COPD, Exacerbations, Tight glycaemic control, Acute hospital ward

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tight glycaemic control
Arm Type
Experimental
Arm Description
Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)
Primary Outcome Measure Information:
Title
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
Time Frame
During trial
Secondary Outcome Measure Information:
Title
The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)
Time Frame
During trial
Title
The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).
Time Frame
During treatment
Title
Mean 24 hour capillary glucose concentrations
Time Frame
During treatment
Title
Proportion of capillary glucose measurements in target range (4.4-6.5mM)
Time Frame
During treatment
Title
Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system
Time Frame
During monitoring
Title
Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring
Time Frame
During monitoring
Title
Quantification of acceptability of the study intervention to patients
Time Frame
during study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma H Baker, PhD, FRCP
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George's Healthcare NHS Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16449265
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.
Results Reference
background
PubMed Identifier
22021788
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.
Results Reference
derived

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

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