Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625000691448
Ethics application status
Approved
Date submitted
11/06/2025
Date registered
30/06/2025
Date last updated
30/06/2025
Date data sharing statement initially provided
30/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Identifying the best way to monitor blood sugar levels in people with diabetes after a heart or lung transplant
Query!
Scientific title
Effect of continuous versus point-of-care glucose monitoring on glycaemic control and hypoglycaemia in patients with insulin requiring diabetes after heart or lung transplantation
Query!
Secondary ID [1]
314630
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus
337775
0
Query!
heart transplant
337776
0
Query!
lung transplant
337777
0
Query!
Condition category
Condition code
Metabolic and Endocrine
334099
334099
0
0
Query!
Diabetes
Query!
Cardiovascular
334100
334100
0
0
Query!
Other cardiovascular diseases
Query!
Respiratory
334101
334101
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
During the study, participants will complete 8-weeks of continuous glucose monitoring using the Freestyle Libre2+ and Freestyle Libre PRO iQ glucose monitoring systems. Devices will be applied to the back of the non-dominant arm as per manufacturer's instructions using the sensor applicator. The process is painless.
In one 4-week period participants will be able to see their glucose levels in real-time and adjust insulin dosing and food intake accordingly (Libre 2+). During the other 4-week period, participants will be blinded to continuous glucose monitoring and be required to monitor their glucose levels in the usual fashion using fingerprick capillary blood and point-of-care glucometer testing (Libre PRO iQ). Adherence will be measured using the LibreLink associated mobile phone application, which records "time worn" for each sensor based on the time glucose levels are being recorded during a standard 14-day wear.
The order in which participants complete the blinded and unblinded phases of continuous glucose monitoring will be allocated randomly. There is no washout period between the two sensor phases, and phase 2 will immediately follow phase 1.
Query!
Intervention code [1]
331250
0
Treatment: Devices
Query!
Comparator / control treatment
Participants will serve as their own control in this cross-over trial. For within subject comparisons, phase 1 data accumulated during weeks 3-4 will be compared to phase 2 data collected during weeks 7-8 to assess our pre-specified primary and secondary outcome measures. Weeks 1-2 and weeks 5-6 will be considered run-in periods for participants to become acclimatized to the blinded (PRO iQ) or unblinded (Libre 2+) sensors.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
341768
0
Continuous glucose monitoring measured time in range
Query!
Assessment method [1]
341768
0
Comparison of glucose data captured during a 4-week wear of a blinded (Pro iQ) and unblinded (Libre 2+) continuous glucose monitoring system.
Query!
Timepoint [1]
341768
0
Outcome will be assessed following completion of both study phases. Phase 1 and phase 2 are assigned at random. Phase 1 encompasses a 4-week wear of the blinded (PRO iQ) sensor. Phase 2 encompasses a 4-week wear of the unblinded (Libre 2+) sensor.
Query!
Secondary outcome [1]
448633
0
Continuous glucose monitoring measured time below range
Query!
Assessment method [1]
448633
0
Comparison of glucose data captured during a 4-week wear of a blinded (Pro iQ) and unblinded (Libre 2+) continuous glucose monitoring system.
Query!
Timepoint [1]
448633
0
Outcome will be assessed following completion of both study phases. Phase 1 and phase 2 are assigned at random. Phase 1 encompasses a 4-week wear of the blinded (PRO iQ) sensor. Phase 2 encompasses a 4-week wear of the unblinded (Libre 2+) sensor.
Query!
Secondary outcome [2]
448634
0
Continuous glucose monitoring measured glycaemic variability
Query!
Assessment method [2]
448634
0
Comparison of glucose data captured during a 4-week wear of a blinded (Pro iQ) and unblinded (Libre 2+) continuous glucose monitoring system.
Query!
Timepoint [2]
448634
0
Outcome will be assessed following completion of both study phases. Phase 1 and phase 2 are assigned at random. Phase 1 encompasses a 4-week wear of the blinded (PRO iQ) sensor. Phase 2 encompasses a 4-week wear of the unblinded (Libre 2+) sensor.
Query!
Secondary outcome [3]
448635
0
Continuous glucose monitoring measured 14-day mean glucose
Query!
Assessment method [3]
448635
0
Comparison of glucose data captured during a 4-week wear of a blinded (Pro iQ) and unblinded (Libre 2+) continuous glucose monitoring system.
Query!
Timepoint [3]
448635
0
Outcome will be assessed following completion of both study phases. Phase 1 and phase 2 are assigned at random. Phase 1 encompasses a 4-week wear of the blinded (PRO iQ) sensor. Phase 2 encompasses a 4-week wear of the unblinded (Libre 2+) sensor.
Query!
Secondary outcome [4]
448636
0
Continuous glucose monitoring measured estimated HbA1c
Query!
Assessment method [4]
448636
0
Comparison of glucose data captured during a 4-week wear of a blinded (Pro iQ) and unblinded (Libre 2+) continuous glucose monitoring system.
Query!
Timepoint [4]
448636
0
Outcome will be assessed following completion of both study phases. Phase 1 and phase 2 are assigned at random. Phase 1 encompasses a 4-week wear of the blinded (PRO iQ) sensor. Phase 2 encompasses a 4-week wear of the unblinded (Libre 2+) sensor.
Query!
Secondary outcome [5]
448637
0
Continuous glucose monitoring measured time above range
Query!
Assessment method [5]
448637
0
Comparison of glucose data captured during a 4-week wear of a blinded (Pro iQ) and unblinded (Libre 2+) continuous glucose monitoring system.
Query!
Timepoint [5]
448637
0
Outcome will be assessed following completion of both study phases. Phase 1 and phase 2 are assigned at random. Phase 1 encompasses a 4-week wear of the blinded (PRO iQ) sensor. Phase 2 encompasses a 4-week wear of the unblinded (Libre 2+) sensor.
Query!
Eligibility
Key inclusion criteria
a) Age greater than 18 years.
b) Diagnosis of diabetes mellitus.
c) Treatment with subcutaneous insulin (greater than 10 units per day).
d) Stable insulin dose for at least 6 weeks prior to study enrolment.
e) More than 1-year since heart or lung transplant
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
a) Current or recent continuous glucose monitor use (within 3 months of enrolment).
b) Recent organ rejection (within 6 months of enrolment) or unstable immuno-suppression doses (within 3 months of enrolment).
c) Vitamin C supplementation with doses greater than 500 mg per day.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Trials of continuous glucose monitoring (CGM) in patients with T2DM result in a 6% mean increase time in range and decreases in time above range, time below range, and HbA1c. This small-scale study will assess whether similar effect sizes are observed in patients with post-transplant diabetes and be used to assess the feasibility of a larger trial. The study population will consist of 30 patients and use a cross-over design with each patient acting as their own control.
The order of blinded versus unblinded CGM use will be randomised to prevent bias, although from clinical experience we feel it is unlikely as most patients do not increase standard fingerprick monitoring following completion of a period of continuous glucose monitoring (unpublished observations). To control for this potential confounding effect, the study is randomized, with 50% of participants starting with use of the blinded sensor, and the other 50% starting with the unblinded sensor. If there is a significant difference in results between the two groups during the blinded sensor period, statistical methods can be employed to adjust for the confounding effects of treatment sequence. As a pilot study, outcomes are not specifically hypothesis driven but intended to assess the effect size of the FreeStyle Libre2+ CGM intervention, making formal power analyses unjustified.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/07/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/05/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
1/07/2026
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
28036
0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Query!
Recruitment postcode(s) [1]
44240
0
2010 - Darlinghurst
Query!
Funding & Sponsors
Funding source category [1]
319191
0
Charities/Societies/Foundations
Query!
Name [1]
319191
0
St Vincent's Clinic Research Foundation
Query!
Address [1]
319191
0
Query!
Country [1]
319191
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
St Vincent's Hospital, Sydney
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
321658
0
None
Query!
Name [1]
321658
0
Query!
Address [1]
321658
0
Query!
Country [1]
321658
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
317773
0
St Vincent’s Hospital Human Research Ethics Committee
Query!
Ethics committee address [1]
317773
0
https://svhs.org.au/home/research-education/research-office
Query!
Ethics committee country [1]
317773
0
Australia
Query!
Date submitted for ethics approval [1]
317773
0
07/04/2025
Query!
Approval date [1]
317773
0
21/05/2025
Query!
Ethics approval number [1]
317773
0
2025/ETH00521
Query!
Summary
Brief summary
Following a heart or lung transplant, medications required to prevent rejection increase the risk of developing post-transplant diabetes mellitus. In many individuals, insulin treatment is required to maintain normal glucose levels and prevent diabetes related complications. Insulin treatment is complex and requires self-monitoring of blood glucose levels using fingerprick testing to avoid prolonged periods of high or low glucose levels. This study aims to determine if continuous glucose monitoring increases the amount of time blood glucose levels are maintained within the normal range compared to standard fingerprick glucose testing.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
142098
0
Dr Christopher Alan Muir
Query!
Address
142098
0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Query!
Country
142098
0
Australia
Query!
Phone
142098
0
+61 4 5013 3265
Query!
Fax
142098
0
Query!
Email
142098
0
[email protected]
Query!
Contact person for public queries
Name
142099
0
Christopher Muir
Query!
Address
142099
0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Query!
Country
142099
0
Australia
Query!
Phone
142099
0
+61 2 8382 2622
Query!
Fax
142099
0
Query!
Email
142099
0
[email protected]
Query!
Contact person for scientific queries
Name
142100
0
Christopher Muir
Query!
Address
142100
0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Query!
Country
142100
0
Australia
Query!
Phone
142100
0
+61 2 8382 2622
Query!
Fax
142100
0
Query!
Email
142100
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
PTDM CGM Study - study protocol, version 1.1, 08.05.2025.docx
Informed consent form
PTDM CGM Study - piscf, version 1.1, 08.05.2025.docx
Ethical approval
HREC approval.pdf
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.
Download to PDF