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Trial registered on ANZCTR


Registration number
ACTRN12624001362583
Ethics application status
Approved
Date submitted
16/10/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Dhirrabuu Maaruma-li: Identify the most promising approach of improving diabetes risk factors for Indigenous Australians with type 2 diabetes using Flash Libre continuous glucose monitoring and a 10-week intensive lifestyle program
Scientific title
Dhirrabuu Maaruma-li: Clinical efficacy of addressing diabetes risk factors for Indigenous Australians with type 2 diabetes using continuous glucose monitoring and a 10-week intensive lifestyle program
Secondary ID [1] 313194 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 335488 0
Condition category
Condition code
Metabolic and Endocrine 332047 332047 0 0
Diabetes
Public Health 332147 332147 0 0
Health service research
Physical Medicine / Rehabilitation 332148 332148 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to identify the most promising approach of improving diabetes risk factors for Indigenous Australians with type 2 diabetes using
LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program. Up to 90 participants who identify as Aboriginal and/or Torres Strait Islander, have been diagnosed with type 2 diabetes and have recently recorded a HbA1c >7.5% will be recruited from multiple locations.
This study follows a basket trial methodology with 2 groups assessed at each stage: participants taking insulin &/- sulfonylureas and other diabetes medications; and participants on other diabetes medication (NOT taking insulin &/or sulfonylureas). Fifteen participants will be recruited for each group at each stage.

All participants will use both the Freestyle Libre Pro iQ blinded sensor, and the Libre 2 unblinded sensor. Both sensors uses a wired enzyme technology, coated with glucose oxidase, to measure interstitial blood glucose levels, and are worn on the upper arm for 14 days. All participants will have diabetes education sessions on the use of the device by the Diabetes Educator or Chronic Care Nurse.

The Freestyle Libre Pro iQ will be worn for a period of two (2) weeks prior to commencing the lifestyle program, and again for the last 2 weeks of the lifestyle program.
Participants will be provided with a Freestyle Libre 2 unblinded sensor every 2 weeks, commencing from Week 0 (the beginning of the lifestyle program). Participants will be informed to scan with purpose, at least 10 times per day. Participants will be provided the option of using the Abbott reader or the Freestyle Mobile App (FreeStyle LibreLink) on their smartphone (Android or iOS operating system compatible). Participants will be asked to bring the device (mobile phone and/or reader) to study visits which occur each week. They will be shown how to replace their sensor every 2 weeks.

The 10-week intervention will be delivered within the AMS by a nurse or allied health professional depending on the availability of staff. Each staff member will undergo training in a 4-hour face to face seminar. It will be completed within the Aboriginal health service as outcomes are improved when programs are provided in a culturally safe environment.
Initial screening, weekly weigh-in, weekly phone call, and referral for medication reviews will form the main role for medical centre staff. Initial screening will consist of height, weight, blood pressure, HbA1c, fasting glucose, fasting lipid profile, Full Blood Count (FBE), Urea Electrolytes and Creatinine (UEC), Liver Function Test (LFT) and urine albumin:creatinine ratio. Weekly weigh in sessions will occur during the 10 weeks of the porgram and be approximately 15 20 minutes in duration. Participants are required to attend the weekly weigh ins but if they cannot attend they can have a phone consultation. They are not required to participate in any other support activities unless they would like to.In these weekly visits, the nurse will measure weight, glucose levels and blood pressure. There will also be a discussion on upholding to the meal plan and exercise program and any assistance or support the patient might require. If the patient has experienced consistent fasting blood glucose levels less than 6.0mmol/L in the morning (2-3 consecutive days), then an appointment will be made with the GP for a medication review. The GP providing guidance and support at each medical centre is an investigator on the study and the participant’s usual GP. They will continue to provide support to the participant through to the completion of the study.

The meal plan is provided via a website or in print form. The meal plan has been designed with input from dietitians, and consists of fresh, unprocessed foods that are accessible within the local supermarket. A range of recipes are provided to the participant for them to choose the ones most suited to them. The participants are provided with options for 3 main meals and 2 snacks per day. Depending on the recipes chosen, their kilojoule intake may range from 5000kj-6300kj per day. The meal plan is administered via the program app, however if a dietitian is available at the study site they will provde additional feedback and support.
The meal plan is designed so that each participant can easily individualise it to suit their own requirements. Adherence to the diet will be measured through food recall questionnaires.

Education on lifestyle strategies will be provided to the participants through short daily videos via email, and video messages to their mobile phone as well as feedback during their weekly consultation. The topics cover strategies for many of the common misconceptions and obstacles surrounding weight loss.

Support is an important component of any successful lifestyle intervention and in this program, it is provided via the weekly weigh ins, a closed Facebook group, and text messages.

Participants will be encouraged to walk for 20-30 minutes each day and complete a short body weight resistance program 2-3 times per week. The body weight resistance circuit is designed to start at a low skill level and consists of exercises such as wall push-ups, squats, and crunches. If the participant has greater capacity, there are options to make the circuit more challenging.
It is not a requirement of the study that participants complete the walking program or the body weight circuit, however they will be encouraged by the health care professional employed by the Aboriginal health service to complete some form of physical activity each day. If they have been exercising prior to commencing the study they will be encouraged to continue with that activity. As participants establish a foundation of physical fitness and mobility they will be encouraged to participate in activities they have an interest in, at an intensity they can tolerate. This format removes many barriers to regular physical activity and will improve the sustainability of following their choice of physical activity. Where an exercise professional is available, instruction on body weight circuits or additional exercise formats will be provided by an exercise physiologist, physiotherapist, or fitness intructor. Adherence will be measured by a 60% participation rate as reported by the participant at each weekly weigh in.
Intervention code [1] 329766 0
Treatment: Other
Intervention code [2] 329767 0
Lifestyle
Intervention code [3] 329768 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339651 0
Primary outcome for participants treated with insulin &/- sulfonylureas and other diabetes medications:

The proportion of participants achieving an optimal clinical outcome, defined by achieving ALL of the following:


1. Absolute increase in Time in Range by 10% or more (Time in Range defined as percentage (%) of time in range (target) for blood glucose levels (3.9–10 mmol/L), as recorded by their continuous glucose monitor):
OR no worsening of Time in Range with at least 50% decrease in drug (insulin &/or sulfonylureas).

2. No severe hypoglycaemic episodes requiring third party assistance



Timepoint [1] 339651 0
Assessed continuously for two weeks prior to the commencement of the intervention, and then continuously for weeks 9 and 10 of the intervention.
Primary outcome [2] 339735 0
Primary outcome for participants treated with diabetes medication excluding insulin &/or sulfonylureas: Proportion of participants achieving an optimal clinical outcome, defined by achieving ALL of the following:

1. Absolute increase in Time in Range by at least 10%
AND
2. No severe hypoglycaemic episodes requiring third party assistance
Timepoint [2] 339735 0
Assessed continuously for two weeks prior to the commencement of the intervention, and then continuously for weeks 9 and 10 of the intervention.
Secondary outcome [1] 440738 0
Mean change in percentage (%) of time in range (target) for blood glucose levels (3.9–10 mmol/L)
Timepoint [1] 440738 0
Assessed continuously for two weeks prior to the commencement of the intervention, and then continuously for weeks 9 and 10 of the intervention.
Secondary outcome [2] 440739 0
Change in number of severe hypoglycaemia events (ADA, 2019), defined as a severe event characterised by altered mental and/or physical status requiring third-party assistance (ADA, 2019), ambulance call out or hospital presentations from baseline to 10 weeks post-commencement of the intervention.
Timepoint [2] 440739 0
Baseline and 10 weeks post-commencement of the intervention.
Secondary outcome [3] 440740 0
Mean change in percentage (%) of below range for blood glucose levels, defined as <3.9 mmol/L.
Timepoint [3] 440740 0
Assessed continuously for two weeks prior to the commencement of the intervention, and then continuously for weeks 9 and 10 of the intervention.
Secondary outcome [4] 440741 0
Mean change in percentage (%) of time below range for blood glucose levels, defined as <3.0 mmol/L.
Timepoint [4] 440741 0
Assessed continuously for two weeks prior to the commencement of the intervention, and then continuously for weeks 9 and 10 of the intervention.
Secondary outcome [5] 440742 0
Change in percentage (%) of time above range for blood glucose levels, defined by >10.0 mmol/L.
Timepoint [5] 440742 0
Assessed continuously for two weeks prior to the commencement of the intervention, and then continuously for weeks 9 and 10 of the intervention.
Secondary outcome [6] 440743 0
Change in percentage (%) of time above range for blood glucose levels, defined by >13.9 mmol/L.
Timepoint [6] 440743 0
Assessed continuously for two weeks prior to the commencement of the intervention, and then continuously for weeks 9 and 10 of the intervention.
Secondary outcome [7] 441257 0
Proportion of participants achieving systolic blood pressure target of <130 mmHg and diastolic blood pressure target of <95 mmHg.
Timepoint [7] 441257 0
Assessed weekly from baseline to 10 weeks post-commencement of the intervention
Secondary outcome [8] 441258 0
Proportion of participants achieving lipid targets, defined as total cholesterol <4.0mmol/L and/or triglycerides <1.7 mmol/L and/or low-density lipoprotein (LDL) < 1.8mmol/L.
Timepoint [8] 441258 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10).
Secondary outcome [9] 441259 0
Proportion of participants who are on target to achieve diabetes remission, defined as an HbA1c of less than 6.5% (48mmol/mol) without the need for glucose lowering medication.
Timepoint [9] 441259 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10)
Secondary outcome [10] 441260 0
Proportion of participants achieving weight loss of greater than or equal to 10% initial body weight.
Timepoint [10] 441260 0
Assessed at Baseline, and then at the completion of the intervention (week 10)
Secondary outcome [11] 441261 0
Change in medication dose
Timepoint [11] 441261 0
Assessed at Baseline, and then at the completion of the intervention (week 10)
Secondary outcome [12] 441263 0
Mean change in Quality of Life assessment
Timepoint [12] 441263 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10)
Secondary outcome [13] 441264 0
Treatment fidelity
Timepoint [13] 441264 0
Assessed weekly from baseline to completion of the intervention (week 10)
Secondary outcome [14] 441610 0
Mean change in Quality of Life assessment
Timepoint [14] 441610 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10)
Secondary outcome [15] 441611 0
Mean change in Quality of Life assessment
Timepoint [15] 441611 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10)
Secondary outcome [16] 441612 0
Mean change in Quality of Life assessment
Timepoint [16] 441612 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10)
Secondary outcome [17] 441613 0
Mean change in Quality of Life assessment
Timepoint [17] 441613 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10)
Secondary outcome [18] 441614 0
Mean change in Quality of Life assessment
Timepoint [18] 441614 0
Assessed prior to commencement of the intervention (baseline) and then at the completion of the intervention (week 10)

Eligibility
Key inclusion criteria

1. Identify as Aboriginal and/or Torres Strait Islander;
2. Confirmed diagnosis of type 2 diabetes;
3. HbA1c equal to or greater than 7.5% (53 mmol/mol) at screening or from a recent test taken two weeks prior to screening confirmed by laboratory pathology, not point of care;
4. Written/verbal informed consent;
5. Body mass index: BMI >23 kg/m2;
6. Age >= 18 years;
7. Ability to complete a 6-minute walk test;
8. IT literate (participants are required to be able to fully use smartphone or tablet);
9. Ability to commit to trial visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

1. Does not identify as Aboriginal and/or Torres Strait Islander;
2. Confirmed diagnosis of type 1 diabetes, or subtype (i.e. Maturity-onset diabetes of the young (MODY), Latent Autoimmune Diabetes in Adults (LADA));
3. Taking high doses of vitamin C supplements (>500 mg per day);
4. Active malignancy requiring chemotherapy;
5. Known allergy to medical grade adhesives;
6. On varying doses of corticosteroid therapy;
7. Haemoglobinopathies;
8. Pregnancy or actively planning pregnancy as HbA1c is not reliable during pregnancy;
9. Myocardial infarction within the past 6 months;
10. Severe medical conditions such as unstable heart failure (determined by treating team);
11. eGFR less than 15 mLs/min/1.73 m2;
12. Recent positive COVID-19 test within the last 8 weeks;
13. Recent history (6 months) of illicit substance abuse;
14. Bariatric surgery within the last 5 years;
15. Severe retinopathy or maculopathy;
16. Unable to undertake physical activity;
17. Not deemed suitable by usual treating doctor;
18. Inability to commit to trial visits.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/01/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317641 0
Government body
Name [1] 317641 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF) – 2022 Indigenous Health Research Fund – Stream 3
Country [1] 317641 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319955 0
None
Name [1] 319955 0
Address [1] 319955 0
Country [1] 319955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316339 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 316339 0
Ethics committee country [1] 316339 0
Australia
Date submitted for ethics approval [1] 316339 0
30/04/2024
Approval date [1] 316339 0
26/09/2024
Ethics approval number [1] 316339 0
Ethics committee name [2] 316341 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [2] 316341 0
Ethics committee country [2] 316341 0
Australia
Date submitted for ethics approval [2] 316341 0
30/04/2024
Approval date [2] 316341 0
19/09/2024
Ethics approval number [2] 316341 0

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

Contacts
Principal investigator
Name 137582 0
Mr Ray Kelly
Address 137582 0
University of Melbourne, Grattan Street, Parkville Victoria 3010 Australia
Country 137582 0
Australia
Phone 137582 0
+61 03 9035 5511
Fax 137582 0
Email 137582 0
ray.kelly@unimelb.edu.au
Contact person for public queries
Name 137583 0
Ray Kelly
Address 137583 0
University of Melbourne, Grattan Street, Parkville Victoria 3010 Australia
Country 137583 0
Australia
Phone 137583 0
+61 03 9035 5511
Fax 137583 0
Email 137583 0
ray.kelly@unimelb.edu.au
Contact person for scientific queries
Name 137584 0
Ray Kelly
Address 137584 0
University of Melbourne, Grattan Street, Parkville Victoria 3010 Australia
Country 137584 0
Australia
Phone 137584 0
+61 03 9035 5511
Fax 137584 0
Email 137584 0
ray.kelly@unimelb.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


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.