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Trial registered on ANZCTR


Registration number
ACTRN12612000130864
Ethics application status
Approved
Date submitted
26/01/2012
Date registered
30/01/2012
Date last updated
4/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous glucose monitoring in ICU
Scientific title
To investigate the reliability of continuous glucose monitoring in critically ill patients
Secondary ID [1] 279799 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood glucose control in critically ill patients 285680 0
Condition category
Condition code
Metabolic and Endocrine 285866 285866 0 0
Metabolic disorders
Blood 285887 285887 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is investigating the reliability of continuous glucose monitoring devices, which measure blood glucose every 1-5 minutes, in critically ill patients. Enrolled patients are monitored by multiple continuous glucose monitoring devices for up to 6 days. The aim of this study is to assess device performance and quantify the impact of certain drugs or illnesses on performance. Three devices have been approved for use in the study: Medtronic Guardian real-time, Medtronic iPro2 and Medtronic Sentrino. The study will be recruiting up to 80 patients and is approved to run until 30th June 2015.
Intervention code [1] 284126 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286366 0
Obtain ICU specific glucometer and continuous glucose monitor data to assess the reliability of these devices in this population
Timepoint [1] 286366 0
The study conclusion date has been adjusted to 30th June 2015.
Secondary outcome [1] 295693 0
Non-parametric statistics and widely accepted error metrics (such as mean absolute relative difference) will be used to assess the effects of sensor site comparing sensor data collected from the thigh to that collected from the abdomen.

The impact of illness and medications/therapies will be investigated via multiple regression and correlation methods to assess their impact on performance
Timepoint [1] 295693 0
Secondary outcomes will be evaluated by the proposed end of study

Eligibility
Key inclusion criteria
(i) The participant is treated using intensive insulin therapy, (ii) Expected to remain in ICU for at least 3-5 days, and (iii) a platelet count > 30,000 per micro-litre
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Not expected to survive intensive care, (ii) Unable to obtain consent, (iii) Any conditions that might preclude the use of CGM such as skin lesions affecting proposed insertion areas, (iv) Lack of clinical equipoise, (v) Pregnant subjects, and (vi) subject is receiving treatment that includes Hydroxyurea.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4084 0
New Zealand
State/province [1] 4084 0
Canterbury

Funding & Sponsors
Funding source category [1] 284578 0
University
Name [1] 284578 0
University of Canterbury
Address [1] 284578 0
PO BOX 4800, Creyke Road, Ilam, Christchurch, 8041
Country [1] 284578 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
PO BOX 4800, Creyke Road, Ilam, Christchurch, 8041
Country
New Zealand
Secondary sponsor category [1] 283495 0
Hospital
Name [1] 283495 0
Christchurh Hospital, Canterbury
Address [1] 283495 0
2 Riccarton Avenue, Private Bag 4170, Christchurch, 8011
Country [1] 283495 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286565 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 286565 0
c/- Ministry of Health
Montgomery Watson Building
6 Hazeldean Road
Christchurch, 8024
Ethics committee country [1] 286565 0
New Zealand
Date submitted for ethics approval [1] 286565 0
27/02/2012
Approval date [1] 286565 0
09/05/2012
Ethics approval number [1] 286565 0
URA/12/02/004
Ethics committee name [2] 286585 0
Ethics committee address [2] 286585 0
Ethics committee country [2] 286585 0
Date submitted for ethics approval [2] 286585 0
30/01/2012
Approval date [2] 286585 0
Ethics approval number [2] 286585 0

Summary
Brief summary
Control of blood glucose (BG) to a normal range in critical care has shown distinct benefits, but has also proven difficult to obtain. The risk of severe hypoglycaemia (blood glucose < 2.2mmol/L) raises significant concerns for patient safety. Accurate BG measurements are essential for control protocols to work safely and effectively.
This study will be completed in two parts:
1 – The current method of measuring BG levels (glucometer) will be assessed/validated in critically ill patients. Glucometer measurements will be compared to paired gold standard BG measurements, determined by the blood gas machine. The goal is to improve care through more accurate bedside BG measurement methods.
2 – Continuous Glucose Monitors (CGMs) offer an automated 5 minute measurement rate with the trade off of reduced accuracy. Compared to glucometers, these devices are capable of capturing glycaemic trends that would normally go unnoticed when measuring 1-4 hourly. CGMs will be used as an observational tool in critically ill patients in this study. Each patients will have 3 CGMs attached concurrently (two in the abdomen, one in the thigh), allowing variability of the device to be assessed. Analysis of the CGM data will help our understanding of the CGM error characteristics. If variability is managed effectively, these devices offer the potential to improve BG control while reducing nursing workload.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33684 0
Dr Geoffrey M. Shaw
Address 33684 0
Department of Intensive Care Medicine Christchurch Hospital 2 Riccarton Avenue Private Bag 4710, Christchurch, 8011
Country 33684 0
New Zealand
Phone 33684 0
+64 3 364 1077
Fax 33684 0
+64 3 364 0099
Email 33684 0
geoff.shaw@cdhb.govt.nz
Contact person for public queries
Name 16931 0
Dr Dr Geoffrey M. Shaw
Address 16931 0
Department of Intensive Care Medicine
Christchurch Hospital
2 Riccarton Avenue
Private Bag 4710, Christchurch, 8011
Country 16931 0
New Zealand
Phone 16931 0
+64 3 364 1077
Fax 16931 0
+64 3 364 0099
Email 16931 0
geoff.shaw@cdhb.govt.nz
Contact person for scientific queries
Name 7859 0
Dr Dr Geoffrey M. Shaw
Address 7859 0
Department of Intensive Care Medicine
Christchurch Hospital
2 Riccarton Avenue
Private Bag 4710, Christchurch, 8011
Country 7859 0
New Zealand
Phone 7859 0
+64 3 364 1077
Fax 7859 0
+64 3 364 0099
Email 7859 0
geoff.shaw@cdhb.govt.nz

No data has been provided for results reporting
Summary results
Not applicable