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Trial registered on ANZCTR


Registration number
ACTRN12625000209493
Ethics application status
Approved
Date submitted
28/01/2025
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study testing whether use of a commercially available continuous glucose monitoring device is as effective as traditional blood tests for diagnosis of diabetes in heart or lung transplant recipients thought to be free from diabetes at least 1-year after transplant surgery.
Scientific title
Continuous glucose monitoring as a non-invasive, cost-effective method to simplify and enhance diagnosis of diabetes in patients thought to be free from diabetes at least 1-year after heart and/or lung transplantation
Secondary ID [1] 313827 0
2024/PID03055
Universal Trial Number (UTN)
Trial acronym
TEND CGM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post transplant diabetes mellitus 336470 0
Heart transplantation 336471 0
Lung transplantation 336472 0
Condition category
Condition code
Metabolic and Endocrine 332989 332989 0 0
Diabetes
Surgery 333067 333067 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design: A prospective study comparing the effectiveness of a commercially available continuous glucose monitoring system (Freestyle Libre2, Abbott Diagnostics) to gold-standard 75-gram oral glucose tolerance test for diagnosis of post-transplant diabetes mellitus (PTDM) in heart and/or lung transplant patients thought to be free from PTDM at least 1-year after heart or lung transplantation.

Study participation involves completion of an outpatient 72-hour oral glucose tolerance test (as per professional society recommendations) followed by continuous glucose monitoring via a FreeStyle Libre sensor. The sensor is a minimally invasive device applied during a study visit to the hospital outpatient clinic by a study investigator. The sensor is painless and worn on the back of the non-dominant arm for 2-weeks. Data collected by the sensor is uploaded remotely and shared with study investigators via the LibreView platform. At the end of 2 weeks the participant removes the sensor as per manufacturers instructions and completes a patient experience survey via email link to a secure REDCAP database.
Intervention code [1] 330416 0
Early detection / Screening
Intervention code [2] 330470 0
Treatment: Devices
Comparator / control treatment
75-gram oral glucose tolerance test - participants will be required to consume an oral solution containing 75-grams of sugar. Blood tests will be collected during and 2-hours after consumption to check for elevations in blood glucose level.
Control group
Active

Outcomes
Primary outcome [1] 340526 0
Accurate diagnosis of post-transplant diabetes mellitus. The diagnostic criteria for post-transplant diabetes mellitus (PTDM) using the 75-gram oral glucose toelrance test (OGTT) are: fasting glucose > 7.0 mmol/L or two-hour glucose >11.1 mmol/L
Timepoint [1] 340526 0
Participants will only need to attend 1 study appointment - during which the FreeStyle Libre2 sensor will be applied and connected to the LibreView secure cloud based data capture application and shared with study investigators. Data collection will occur without further patient interaction, as investigators will have access to the sensor glucose levels via remote link to the LibreView platform. Data will be reviewed and compared to 75-gram oral glucose tolerance test results after completion of a 2-week wear of the FreeStyle Libre2 CGM.
Secondary outcome [1] 444349 0
Incidence of impaired fasting glucose (IFG).
Timepoint [1] 444349 0
Assessment will occur following completion of the 75-gram OGTT.
Secondary outcome [2] 444580 0
Incidence of PTDM
Timepoint [2] 444580 0
Assessment will occur following completion of the 75-gram OGTT.
Secondary outcome [3] 444581 0
Incidence of impaired impaired glucose tolerance (IGT).
Timepoint [3] 444581 0
Assessment will occur following completion of the 75-gram OGTT.

Eligibility
Key inclusion criteria
All heart and lung transplant recipients meeting the following criteria will be included:
a) Age greater or equal to 18 years
b) HbA1c less than 6.5% (if performed)
c) Fasting glucose less than 7.0 mmol/L (if performed)
d) Willingness to participate and comply with the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who will be excluded from participation:
a) Those with an established diagnosis of diabetes
b) Those prescribed glucose lowering medications such as metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors and insulin.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2026
Actual
Date of last data collection
Anticipated
15/03/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27557 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 43671 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 318297 0
Charities/Societies/Foundations
Name [1] 318297 0
St Vincent's Clinic Foundation
Country [1] 318297 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
Country
Australia
Secondary sponsor category [1] 320681 0
None
Name [1] 320681 0
Address [1] 320681 0
Country [1] 320681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316935 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316935 0
Ethics committee country [1] 316935 0
Australia
Date submitted for ethics approval [1] 316935 0
18/11/2024
Approval date [1] 316935 0
20/12/2024
Ethics approval number [1] 316935 0
2024/ETH02643

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139478 0
Dr Christopher Muir
Address 139478 0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Country 139478 0
Australia
Phone 139478 0
+61 4 5013 3265
Fax 139478 0
Email 139478 0
christopher.muir@svha.org.au
Contact person for public queries
Name 139479 0
Gabriela Abrahamson
Address 139479 0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Country 139479 0
Australia
Phone 139479 0
+61 2 8382 2622
Fax 139479 0
Email 139479 0
christopher.muir@svha.org.au
Contact person for scientific queries
Name 139480 0
Christopher Muir
Address 139480 0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Country 139480 0
Australia
Phone 139480 0
+61 2 8382 2622
Fax 139480 0
Email 139480 0
christopher.muir@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.