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Trial registered on ANZCTR
Registration number
ACTRN12624001231538
Ethics application status
Approved
Date submitted
13/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
IMPROVE SUGAR- Improving Diabetes Care in Indigenous Communities: Exploring the Impact of Intensive Management Versus Usual Care on Health Outcomes
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Scientific title
Assessing safety, feasibility and Cost-Effectiveness of Intensive Lifestyle and Therapeutic Management on Glycemic Control, Cardiovascular Risk, and Retinopathy in Indigenous Australians with Diabetes in Regional and Remote Communities.
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Secondary ID [1]
312095
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Nil Known
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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:
Type 2 Diabetes
333729
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Condition category
Condition code
Metabolic and Endocrine
330412
330412
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study aims to assess the safety, feasibility, and cost-effectiveness of intensive weekly clinic visits for tirzepatide administration, Blood Glucose (BG) monitoring, and medication administration compared to usual care in Aboriginal and Torres Strait Islander patients with uncontrolled type 2 diabetes.
Intensive Weekly Clinic Visits for Tirzepatide Administration, Blood Glucose Monitoring, and Medication Administration:
The intervention involves 65 weekly clinic visits, each lasting approximately 1 hour. These visits will occur once per week throughout the study period.
Tirzepatide will be administered by a registered nurse who is trained in diabetes care.
Blood Glucose (BG) monitoring will be performed by the same registered nurse during each clinic visit.
Medication administration and adjustments will be overseen by an endocrinologist/clinic physician, with the registered nurse administering tirzepatide .The starting dose of tirzepatide will be 2.5 mg, with potential dose adjustments based on patient response and tolerance, up to a maximum of 15 mg .
Visits will encompass:
Monitoring of clinic attendance records to track patient participation.
Reviewing medical records to ensure consistency in medication administration.
Conducting periodic patient interviews to assess adherence and identify any barriers to treatment.
This study focuses on comparing the outcomes of this intensive management approach with usual care, aiming to provide insights into its potential benefits in improving diabetes control and overall health outcomes in this population.
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Intervention code [1]
329485
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Treatment: Other
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Comparator / control treatment
Usual care (comparator) involves patients attending clinics as per their regular schedule, typically at least once a month for 1 hour. During these visits, patients receive tirzepatide dispensing, Blood Glucose (BG) monitoring, and adjustments to other medications as needed. This approach reflects the standard management of type 2 diabetes in Indigenous Australians in remote communities, focusing on maintaining blood sugar control and monitoring for potential complications.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome is the difference in HbA1c in Intensive Management compared
with Usual Management from baseline to 65 weeks.
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Assessment method [1]
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Blood test
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Timepoint [1]
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Baseline and 65 weeks post commencement of study
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Secondary outcome [1]
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Weight
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Assessment method [1]
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Clinic digital weight scale in kilograms
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Timepoint [1]
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Baseline and 65 weeks post commencement of study
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Secondary outcome [2]
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Cardiac structure and function
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Assessment method [2]
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Resting 2-dimensional and Doppler echocardiography
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Timepoint [2]
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Baseline and week 65 weeks post commencement of study
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Secondary outcome [3]
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Quality of Life measures- Change in EQ-5D scores
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Assessment method [3]
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Questionnaire: EQ-5D (EuroQol 5-Dimension)
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Timepoint [3]
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Baseline 14,40 and 65-weeks post commencement of study
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Secondary outcome [4]
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Retinal Imaging
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Assessment method [4]
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Vision outcome - three image fields per eye as follows: (a) Macula-centred image, (b) Disc-centred image for diabetic retinopathy (DR) status (Early treatment diabetic retinopathy study (ETDRS) grading), (c)Anterior image for documenting the ocular surface and lid pathology and for patient identification. Captured ocular images will be sent to an external ophthalmic clinician or certified grader for grading and follow-up recommendations based on National Health and Medical research council (NHMRC) guidelines for DR management.
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Timepoint [4]
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Baseline, Week 40 and Week 65 post commencement of study
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Secondary outcome [5]
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Cost Analysis
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Assessment method [5]
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Analysis and comparison of intervention (staffing and medication provision) and other healthcare (hospitalisation, other medications, and clinical) costs in UM and IM study arms through medical records data, source notes of participant visits
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Timepoint [5]
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Entire costs throughout the study will be assessed from Baseline week to 65 post commencement of the study
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Secondary outcome [6]
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Cost Analysis effectiveness
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Assessment method [6]
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Quality-of-life, cost, and other outcome data from the trial will form the basis of a microsimulation model to project the long-term (5, 10, 20-year and lifetime) benefits and costs of IM compared to UM. The analysis will be from the Australian healthcare perspective, and the main outcome of this analysis will be the incremental cost-effectiveness ratio, calculated as the incremental cost divided by the incremental quality-adjusted life years of IM compared to UM.
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Timepoint [6]
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Entire costs throughout study between arms IM and UM and predicted costs at timepoints 5, 10 20 years and lifetime between Baseline and 65weeks post commencement of study
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Secondary outcome [7]
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Diastolic function
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Assessment method [7]
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Mitral inflow peak early diastolic velocity (E), Peak late diastolic velocity (A), E/A ratio, Septal and lateral mitral annular early diastolic velocities (e'), E/e' ratio will be assessed on Echocardiogram
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Timepoint [7]
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Baseline and 65 weeks post commencement of study
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Secondary outcome [8]
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Pulmonary pressure
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Assessment method [8]
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Estimated from tricuspid regurgitation velocity on Echocardiogram
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Timepoint [8]
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Baseline and post 65 weeks of commencement of study
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Secondary outcome [9]
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Left atrial volume
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Assessment method [9]
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Biplane method of disks (Simpson's modified rule), indexed to body surface area on Echocardiogram
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Timepoint [9]
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Baseline and 65 weeks post commencement of study
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Secondary outcome [10]
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Left ventricular mass
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Assessment method [10]
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2-dimensional linear method, indexed to body surface area
Definition of LV hypertrophy:
115 g/m2 in men on Echocardiogram
95 g/m2 in women
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Timepoint [10]
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Baseline and 65 weeks post commencement of study
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Secondary outcome [11]
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Left ventricular dysfunction (LVD)
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Assessment method [11]
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(LVD) assessment defined as
Ejection fraction (EF) <percent
Reduced global longitudinal strain (GLS) (less than or equal to 16per cent) on Echocardiogram
Diastolic dysfunction
LV hypertrophy
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Timepoint [11]
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Baseline and 65 weeks post commencement of the study
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Secondary outcome [12]
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Myocardial mechanics
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Assessment method [12]
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Semi-automated 2D speckle tracking technique
Measures:
Global longitudinal strain (GLS) quantified from 3 apical views
Longitudinal strain and strain rate
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Timepoint [12]
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Baseline and 65 weeks post commencement of the study
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Secondary outcome [13]
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Quality of Life - Change in SNAPE scores
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Assessment method [13]
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SNAPE (Smoking, Nutrition, Alcohol, Physical Exercise and Emotions) survey tool
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Timepoint [13]
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Baseline, 14, 40 and 65 weeks post commencement of study
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Eligibility
Key inclusion criteria
Established Type 2 diabetes of at least 6 months duration
HbA1c greater than or equal to 7.0 percent
Age greater than or equal to 18 years Willing and able to adhere to the study protocol
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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
Type 1 diabetes
Heavy alcohol or drug use
History of acute or chronic pancreatitis
Pregnancy, planned pregnancy or breastfeeding
Women of childbearing age not taking adequate contraception
BMI greater than 25kg/m2
Severe renal impairment eGFR < 15 ml/min/1.73m2
Unstable cardiovascular disease – recent AMI, unstable angina, stroke, hospitalisation for heart failure in the past 6 months
Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study.
A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study.
Allergy to tirzepatide
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2025
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Actual
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Date of last participant enrolment
Anticipated
30/06/2026
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Actual
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Date of last data collection
Anticipated
24/12/2027
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Actual
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Sample size
Target
260
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Funding & Sponsors
Funding source category [1]
316453
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Charities/Societies/Foundations
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Name [1]
316453
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TDM Foundation (Time-Division Multiplexing)
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Address [1]
316453
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Country [1]
316453
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Australia
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Primary sponsor type
Other
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Name
Baker Heart and Diabetes Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
319675
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None
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Name [1]
319675
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Address [1]
319675
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Country [1]
319675
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315244
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
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https://svhm.org.au/home/research/researchers/human-research-ethics-committee
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Ethics committee country [1]
315244
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Australia
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Date submitted for ethics approval [1]
315244
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17/06/2024
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Approval date [1]
315244
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23/08/2024
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Ethics approval number [1]
315244
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Summary
Brief summary
The study explores two approaches to diabetes management in Indigenous Australians living in remote communities. Communities will be randomly assigned to either intensive weekly clinic visits, including tirzepatide injections, blood glucose monitoring and other medication oversight, or standard care with usual clinic visits. The primary goal is to determine if the intensive approach improves blood sugar control. Researchers will also assess whether it reduces complications such as kidney, eye, and heart disease. The study aims to provide insight into which strategy offers better health outcomes for 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 Neale Cohen
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Address
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Baker Heart and Diabetes Institute 99 Commercial Road Melbourne Victoria 3004
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Country
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Australia
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Phone
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+61 03 85321816
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Fax
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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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Erin Boyle
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Address
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Baker Heart and Diabetes Institute 99 Commercial Road Melbourne Victoria 3004
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Country
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Australia
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Phone
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+61 03 85321800
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Fax
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Email
134115
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Neale Cohen
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Address
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Baker Heart and Diabetes Institute 99 Commercial Road Melbourne Victoria 3004
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Country
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Australia
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Phone
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+61385321800
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Fax
134116
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Email
134116
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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
Only deidentified data and tabulated data will be published. Deidentified data maybe shared upon request at the discretion of the investigators.
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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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