Trial Review

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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
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.
Secondary ID [1] 312095 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 333729 0
Condition category
Condition code
Metabolic and Endocrine 330412 330412 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 329485 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 339357 0
The primary outcome is the difference in HbA1c in Intensive Management compared
with Usual Management from baseline to 65 weeks.
Timepoint [1] 339357 0
Baseline and 65 weeks post commencement of study
Secondary outcome [1] 439634 0
Weight
Timepoint [1] 439634 0
Baseline and 65 weeks post commencement of study
Secondary outcome [2] 439643 0
Cardiac structure and function
Timepoint [2] 439643 0
Baseline and week 65 weeks post commencement of study
Secondary outcome [3] 439644 0
Quality of Life measures- Change in EQ-5D scores
Timepoint [3] 439644 0
Baseline 14,40 and 65-weeks post commencement of study
Secondary outcome [4] 439645 0
Retinal Imaging
Timepoint [4] 439645 0
Baseline, Week 40 and Week 65 post commencement of study
Secondary outcome [5] 439646 0
Cost Analysis
Timepoint [5] 439646 0
Entire costs throughout the study will be assessed from Baseline week to 65 post commencement of the study
Secondary outcome [6] 439647 0
Cost Analysis effectiveness
Timepoint [6] 439647 0
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
Secondary outcome [7] 440065 0
Diastolic function
Timepoint [7] 440065 0
Baseline and 65 weeks post commencement of study
Secondary outcome [8] 440066 0
Pulmonary pressure
Timepoint [8] 440066 0
Baseline and post 65 weeks of commencement of study
Secondary outcome [9] 440067 0
Left atrial volume
Timepoint [9] 440067 0
Baseline and 65 weeks post commencement of study
Secondary outcome [10] 440068 0
Left ventricular mass
Timepoint [10] 440068 0
Baseline and 65 weeks post commencement of study
Secondary outcome [11] 440069 0
Left ventricular dysfunction (LVD)
Timepoint [11] 440069 0
Baseline and 65 weeks post commencement of the study
Secondary outcome [12] 440070 0
Myocardial mechanics
Timepoint [12] 440070 0
Baseline and 65 weeks post commencement of the study
Secondary outcome [13] 440072 0
Quality of Life - Change in SNAPE scores
Timepoint [13] 440072 0
Baseline, 14, 40 and 65 weeks post commencement of study

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
24/12/2027
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 316453 0
Charities/Societies/Foundations
Name [1] 316453 0
TDM Foundation (Time-Division Multiplexing)
Country [1] 316453 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country
Australia
Secondary sponsor category [1] 319675 0
None
Name [1] 319675 0
Address [1] 319675 0
Country [1] 319675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315244 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 315244 0
Ethics committee country [1] 315244 0
Australia
Date submitted for ethics approval [1] 315244 0
17/06/2024
Approval date [1] 315244 0
23/08/2024
Ethics approval number [1] 315244 0

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

Contacts
Principal investigator
Name 134114 0
A/Prof Neale Cohen
Address 134114 0
Baker Heart and Diabetes Institute 99 Commercial Road Melbourne Victoria 3004
Country 134114 0
Australia
Phone 134114 0
+61 03 85321816
Fax 134114 0
Email 134114 0
neale.cohen@baker.edu.au
Contact person for public queries
Name 134115 0
Erin Boyle
Address 134115 0
Baker Heart and Diabetes Institute 99 Commercial Road Melbourne Victoria 3004
Country 134115 0
Australia
Phone 134115 0
+61 03 85321800
Fax 134115 0
Email 134115 0
erin.boyle@baker.edu.au
Contact person for scientific queries
Name 134116 0
A/Prof Neale Cohen
Address 134116 0
Baker Heart and Diabetes Institute 99 Commercial Road Melbourne Victoria 3004
Country 134116 0
Australia
Phone 134116 0
+61385321800
Fax 134116 0
Email 134116 0
neale.cohen@baker.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.