Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000470190p
Ethics application status
Submitted, not yet approved
Date submitted
15/03/2019
Date registered
21/03/2019
Date last updated
21/03/2019
Date data sharing statement initially provided
21/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
FLASH.V: Flash Glucose Monitoring and Surgery in the Hepatopancreaticobiliary (HPB) Surgery and Liver Transplant Population - Verification Study
Scientific title
A prospective observational study to determine the clinical and numerical precision of intermittent continuous glucose monitoring in the perioperative period in hepatopancreaticobiliary surgery and orthotopic liver transplant patients.
Secondary ID [1] 297719 0
Nil Known
Universal Trial Number (UTN)
U1111-1230-1643
Trial acronym
FLASH.V
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Transplantation
 312039 0
Anaesthetics 312041 0
Condition category
Condition code
Surgery 310603 310603 0 0
Other surgery
Anaesthesiology 310604 310604 0 0
Other anaesthesiology
Metabolic and Endocrine 310605 310605 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study which will look at the precision of a flash glucose monitoring sensor when patients are undergoing surgery. Each participant will have a flash glucose monitoring sensor applied to the upper left arm.

The sensor is applied using the sensor applicator that is supplied with the sensor, in a sterile pack. A thin flexible sterile fibre (5mm long) is inserted just below the skin. Most patients reported that applying the sensor was painless. "In a 2013 US study conducted by Abbott Diabetes Care, 100% of the patients surveyed (n=30) rated that applying the sensor was painless or almost painless, and 93.4% of patients strongly agree or agree that while wearing the sensor, they did not feel any discomfort under their skin." (https://www.freestylelibre.com.au/)

The sensor takes near continuous readings of the patients blood glucose levels. This will be compared at regular time points with standard of care blood glucose readings, thus each participant's standard of care blood glucose measurement will be the control. Participants will be followed from surgery check in time to the first occurring end point from: 14 days post-operation
Intervention code [1] 313959 0
Not applicable
Comparator / control treatment
This is an observational study which will look at the precision of a flash glucose monitoring sensor when patients are undergoing surgery. Each participant will have a flash glucose monitoring sensor applied to the upper left arm which takes near continuous readings of glucose levels. This will be compared at regular time points with standard of care blood glucose readings, thus each participant's standard of care blood glucose measurement will be the control. Participants will be followed from surgery check in time to the first occurring end point from: 14 days post-operation, or discharge from hospital,
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319457 0
Precision of the flash glucose monitoring device relative to the control device for measurements taken during the intra-operative period.

Precision will be measured via clinical and numerical accuracy of the device compared with the control measurements. Numerical accuracy will be determined using a variety of methods including: mean and median absolute relative difference (ARD), Repeated Bland-Altman analysis etc. Clinical accuracy for blood glucose monitoring is often assessed using Clarke or consensus error grid (CEG) analysis where numerical error is assigned different levels of clinical risk.
Timepoint [1] 319457 0
Measured at completion of operating time
Secondary outcome [1] 368252 0
Precision of the flash glucose monitoring device relative to the control device for measurements taken during the critical care period.

Precision will be measured via clinical and numerical accuracy of the device compared with the control measurements. Numerical accuracy will be determined using a variety of methods including: mean and median absolute relative difference (ARD), Repeated Bland-Altman analysis etc. Clinical accuracy for blood glucose monitoring is often assessed using Clarke or consensus error grid (CEG) analysis where numerical error is assigned different levels of clinical risk.
Timepoint [1] 368252 0
Measured at discharge from Intensive Care Unit (ICU) after the primary operation
Secondary outcome [2] 368253 0
Precision of the flash glucose monitoring device relative to the control device for measurements taken during the post operative, inpatient period.

Precision will be measured via clinical and numerical accuracy of the device compared with the control measurements. Numerical accuracy will be determined using a variety of methods including: mean and median absolute relative difference (ARD), Repeated Bland-Altman analysis etc. Clinical accuracy for blood glucose monitoring is often assessed using Clarke or consensus error grid (CEG) analysis where numerical error is assigned different levels of clinical risk.
Timepoint [2] 368253 0
Measured from medical records at discharge or at 14 days post-operation, whichever comes sooner

Eligibility
Key inclusion criteria
Patients scheduled to undergo major HPB surgery, liver transplantation or major general surgery at the Austin hospital within the study timeframe
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients deemed unfit for surgery
Pregnancy
Patients unable to give informed consent
Patient < 18 years
Patients with known severe adhesive allergies

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
- Passing Bablok Regression
- Repeated Measures Bland Altman

NB: There may be an interim statistical analysis to determine the feasibility of the device in this setting.

Description and analysis of glucose variability during each phase of the study will also be completed

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13414 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26016 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 302248 0
Hospital
Name [1] 302248 0
Austin Health Liver Transplant Unit, Austin Medical Research Fund
Country [1] 302248 0
Australia
Primary sponsor type
University
Name
University of Melbourne: Department of Surgery
Address
Liver Transplant Unit
Austin Health
Level 8, Harold Stokes Building
PO Box 5555
Melbourne, Victoria
Australia 3084
Country
Australia
Secondary sponsor category [1] 302107 0
None
Name [1] 302107 0
Address [1] 302107 0
Country [1] 302107 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302924 0
Austin Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 302924 0
Level 8, Harold Stokes Building
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
Ethics committee country [1] 302924 0
Australia
Date submitted for ethics approval [1] 302924 0
31/10/2018
Approval date [1] 302924 0
Ethics approval number [1] 302924 0

Summary
Brief summary
This study aims to determine how well flash glucose monitoring performs in patients during the periods before, during and after surgery, in patient who are undergoing major general surgery with a focus on pancreatic surgery, surgery on the bile duct system and surgery on the liver and liver transplantation. It will compare the results of the flash glucose monitoring with arterial blood glucose and capillary blood glucose levels
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91862 0
Prof Robert Jones
Address 91862 0
Liver Transplant Unit
Austin Health
Level 8, Harold Stokes Building
PO Box 5555
Melbourne, Victoria
Australia 3084
Country 91862 0
Australia
Phone 91862 0
+61 3 9496 5721
Fax 91862 0
Email 91862 0
[email protected]
Contact person for public queries
Name 91863 0
Zoe Anastassiou
Address 91863 0
Liver Transplant Unit
Austin Health
Level 8, Harold Stokes Building
PO Box 5555
Melbourne, Victoria
Australia 3084
Country 91863 0
Australia
Phone 91863 0
+61 433 714 143
Fax 91863 0
Email 91863 0
[email protected]
Contact person for scientific queries
Name 91864 0
Zoe Anastassiou
Address 91864 0
Liver Transplant Unit
Austin Health
Level 8, Harold Stokes Building
PO Box 5555
Melbourne, Victoria
Australia 3084
Country 91864 0
Australia
Phone 91864 0
+61 433 714 143
Fax 91864 0
Email 91864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data relating to participant demographics and outcomes. No data that may be used to re-identify participants will be shared.
When will data be available (start and end dates)?
Data will be available from after the publication of the primary manuscript resulting from the study (anticipated Dec. 2020). Data will be available until 7 years after study conclusion.
Available to whom?
Academic authors
Requests from industry unaffiliated with an academic body such as a University will not be considered
Available for what types of analyses?
Meta-analysis and systematic review
How or where can data be obtained?
Electronic transfer


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.