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Trial registered on ANZCTR
Registration number
ACTRN12619001490167
Ethics application status
Approved
Date submitted
29/09/2019
Date registered
29/10/2019
Date last updated
9/07/2021
Date data sharing statement initially provided
29/10/2019
Date results information initially provided
9/07/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Diagnosing hyperglycaemia in patients with chronic liver disease
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Scientific title
Assessing dysglycaemia in patients with severe chronic liver disease: A feasibility study comparing the oral glucose tolerance test (OGTT) with glycated haemoglobin (HbA1c) and interstitial glucose measurements.
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Secondary ID [1]
299436
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
diabetes
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liver disease
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Condition category
Condition code
Metabolic and Endocrine
312972
312972
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0
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Diabetes
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Oral and Gastrointestinal
313054
313054
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Summary of measurements of glycaemia to be undertaken during this study; i) Laboratory HbA1c (glycated haemoglobin), ii) 75gm OGTT (oral glucose tolerance test), iii) Libre Pro interstitial glucose monitoring over 14 days, with results obtained using the Libre Pro system.
1. What these tests mean from a participant perspective:
i) HbA1c. Single venous blood sample as part of the baseline blood test at the start of the half day research clinic visit.
ii) 75gm OGTT. This will be undertaken during the half day research clinic visit. Baseline venous glucose blood test, followed by 75gm glucose drink that may take 5 minutes or so to consume, followed by a second and third venous plasma glucose blood test at 1 hour and 2 hours.
iii) Libre Pro interstitial glucose monitoring. Once the participant has finishing drinking the 75gm glucose drink, the sensor will be inserted into the subcutaneous tissue of the upper arm (usually non-dominant arm). This procedure takes a few minutes. The sensor will remain in situ for 14 days, then posted back by the participant to the research clinic.
2. Total duration of the intervention is around 14 days. It concludes with a phone follow up with the participant, to discuss their perceptions of interstitial glucose monitoring versus OGTT as a diagnostic test. In addition, this phone follow up provides an opportunity to review participant's laboratory study results.
3. Administration of the intervention. This will be led by GCP trained research nurses and also a medical student summer student who will be working under the nurses' supervision. The participant will attend for a half day visit at the Endocrinology Specialist Test Centre, Christchurch Hospital campus. The participant will remove the interstitial glucose sensor at 14 days and return the sensor to the investigators, by post. Abnormal results emerging from the study will be followed up by one of the research doctors taking part in this study.
4. Fidelity. Each participant will have a research file for noting details such as dates and times of their intervention, time and content of phone follow up. Any deviations from the protocol will be noted in their file. The 75gm OGTT will be administered as per local special test centre protocol. Blood samples will be analysed at an accredited clinical laboratory (Canterbury Health Laboratories, Christchurch, New Zealand).
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Intervention code [1]
315685
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Diagnosis / Prognosis
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Comparator / control treatment
This feasibility study will undertake a semi-descriptive comparison between the 'gold standard' OGTT test and HbA1c and interstitial glucose results.
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Control group
Active
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Outcomes
Primary outcome [1]
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Participant perceptions of testing preferences when comparing the Libre Pro with the 75gm OGTT. This will be assessed using a short (10 minute) semi-structured phone interview.
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Assessment method [1]
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Timepoint [1]
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14 days after commencing interstitial glucose monitoring.
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Primary outcome [2]
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Preference for yearly diabetes test as assessed by semi-structured telephone interview.
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Assessment method [2]
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Timepoint [2]
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Day 14
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Secondary outcome [1]
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OGTT results ('gold standard', analysed using WHO criteria)
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Assessment method [1]
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Timepoint [1]
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Day 1
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Secondary outcome [2]
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Comparison of diagnostic accuracy of the laboratory HbA1c and estimated HbA1c derived from interstitial glucose monitoring, with the 'gold standard' diagnostic test e.g. the OGTT
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Assessment method [2]
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Timepoint [2]
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Day 2
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Eligibility
Key inclusion criteria
Severe liver disease defined as: Biopsy Stage 4 cirrhosis or liver stiffness measured as greater or equal to 12.5kpa on Fibroscan.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
A pre-existing diagnosis of diabetes.
On medications or treatments or underlying disease that is likely to shorten red cell survival or interfere with interpretation of laboratory HbA1c. .
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
By using a 'professional' interstitial glucose system such as the Libre Pro, participants will be blind to their interstitial glucose results until the end of the study. This will ensure that participants have no knowledge of their interstitial glucose results during the study, so they have no direct information about glucose values that might interact with their lifestyle choices during the 14 days of study.
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Primarily descriptive
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
25/11/2019
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Actual
13/01/2020
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Date of last participant enrolment
Anticipated
3/02/2020
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Actual
26/05/2021
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Date of last data collection
Anticipated
3/02/2020
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Actual
26/05/2021
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Sample size
Target
25
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Accrual to date
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Final
21
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Canterbury
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Diabetes Christchurch
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Address [1]
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21 Carlyle St, Sydenham, Christchurch 8023,
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Country [1]
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New Zealand
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Primary sponsor type
Hospital
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Name
Endocrinology services, Canterbury District Health Board
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Address
Outpatient building, 2 Oxford Terrace, Christchurch 8011
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
304099
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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New Zealand Health and Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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02/10/2019
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Approval date [1]
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07/10/2019
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Ethics approval number [1]
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19/NTA/148
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Summary
Brief summary
Chronic liver disease including cirrhosis may be associated with an HbA1c test (a diabetes blood test that looks indirectly at long term glucose values) that underestimates true (venous or interstitial) glucose. In patients on anti-retroviral agents, this finding is likely to be due to haemolysis and associated changes in red cell turnover. In patients with cirrhosis but not on anti-retrovirals, the mechanism for this ‘artefactual’ low HbA1c is poorly understood. Currently, has been suggested that the 30% of patients with cirrhosis and diabetes (much of which is undiagnosed), be diagnosed using an oral glucose tolerance test, rather than an HbA1c blood test.
This feasibility study explores whether or not interstitial glucose can be used as an alternative method of diagnosing diabetes and impaired glucose tolerance, in this population of patients with cirrhosis. The study will also explore the relationship with HbA1c. A better understanding of possible discordance between HbA1c and venous glucose value in patients with chronic liver disease, will aid the diagnosis and management of pre-diabetes and diabetes in this population.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Helen Lunt
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Address
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Diabetes Outpatient Clinic
Outpatient Building
Canterbury District Health Board
2 Riccarton Ave
Christchurch, 8011
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Country
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New Zealand
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Phone
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+64 3 3640860
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Fax
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+64 3 3640171
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Helen Lunt
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Address
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Diabetes Outpatient Clinic
Outpatient Building
Canterbury District Health Board
2 Riccarton Ave
Christchurch, 8011
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Country
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New Zealand
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Phone
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+64 3 3640860
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Fax
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+64 3 3640171
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Helen Lunt
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Address
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Diabetes Outpatient Clinic
Outpatient Building
Canterbury District Health Board
2 Riccarton Ave
Christchurch, 8011h
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Country
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New Zealand
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Phone
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+64 3 3640860
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Fax
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+64 3 3640171
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This is a small feasibility study. It is anticipated that the study is unlikely to generate a lot of 're-usable' data that is of broader interest.
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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.
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