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Trial registered on ANZCTR


Registration number
ACTRN12619001490167p
Ethics application status
Submitted, not yet approved
Date submitted
29/09/2019
Date registered
29/10/2019
Date last updated
29/10/2019
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnosing hyperglycaemia in patients with chronic liver disease
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.
Secondary ID [1] 299436 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 314633 0
liver disease 314634 0
Condition category
Condition code
Metabolic and Endocrine 312972 312972 0 0
Diabetes
Oral and Gastrointestinal 313054 313054 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 315685 0
Diagnosis / Prognosis
Comparator / control treatment
This feasibility study will undertake a semi-descriptive comparison between the 'gold standard' OGTT test and HbA1c and interstitial glucose results.
Control group
Active

Outcomes
Primary outcome [1] 321544 0
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.
Timepoint [1] 321544 0
14 days after commencing interstitial glucose monitoring.
Primary outcome [2] 321610 0
Preference for yearly diabetes test as assessed by semi-structured telephone interview.
Timepoint [2] 321610 0
Day 14
Secondary outcome [1] 375328 0
OGTT results ('gold standard', analysed using WHO criteria)
Timepoint [1] 375328 0
Day 1
Secondary outcome [2] 375568 0
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
Timepoint [2] 375568 0
Day 2

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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. .

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
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.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Primarily descriptive

Recruitment
Recruitment status
Not yet 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] 21887 0
New Zealand
State/province [1] 21887 0
Canterbury

Funding & Sponsors
Funding source category [1] 303945 0
Charities/Societies/Foundations
Name [1] 303945 0
Diabetes Christchurch
Address [1] 303945 0
21 Carlyle St, Sydenham, Christchurch 8023,
Country [1] 303945 0
New Zealand
Primary sponsor type
Hospital
Name
Endocrinology services, Canterbury District Health Board
Address
Outpatient building, 2 Oxford Terrace, Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 304099 0
None
Name [1] 304099 0
Address [1] 304099 0
Country [1] 304099 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304444 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 304444 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304444 0
New Zealand
Date submitted for ethics approval [1] 304444 0
02/10/2019
Approval date [1] 304444 0
Ethics approval number [1] 304444 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96966 0
A/Prof Helen Lunt
Address 96966 0
Diabetes Outpatient Clinic
Outpatient Building
Canterbury District Health Board
2 Riccarton Ave
Christchurch, 8011
Country 96966 0
New Zealand
Phone 96966 0
+64 3 3640860
Fax 96966 0
+64 3 3640171
Email 96966 0
helen.lunt@cdhb.health.nz
Contact person for public queries
Name 96967 0
A/Prof Helen Lunt
Address 96967 0
Diabetes Outpatient Clinic
Outpatient Building
Canterbury District Health Board
2 Riccarton Ave
Christchurch, 8011
Country 96967 0
New Zealand
Phone 96967 0
+64 3 3640860
Fax 96967 0
+64 3 3640171
Email 96967 0
helen.lunt@cdhb.health.nz
Contact person for scientific queries
Name 96968 0
A/Prof Helen Lunt
Address 96968 0
Diabetes Outpatient Clinic
Outpatient Building
Canterbury District Health Board
2 Riccarton Ave
Christchurch, 8011h
Country 96968 0
New Zealand
Phone 96968 0
+64 3 3640860
Fax 96968 0
+64 3 3640171
Email 96968 0
helen.lunt@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
No Results