Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000753853
Ethics application status
Approved
Date submitted
19/04/2021
Date registered
15/06/2021
Date last updated
20/02/2023
Date data sharing statement initially provided
15/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Flash Glucose Monitoring (FlashGM) improve glucose management in Indigenous Australians with type 2 diabetes?
Scientific title
Can Flash Glucose Monitoring (FlashGM) improve glucose management in Indigenous Australians with type 2 diabetes? A randomised controlled trial.
Secondary ID [1] 303995 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes
 321608 0
Condition category
Condition code
Metabolic and Endocrine 319347 319347 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Freestyle Libre 2 Flash Glucose Monitoring System is the intervention in this trial. Participants randomly assigned to the Flash Glucose Monitoring arm will use the device for 6 months. The Freestyle Libre 2 is the latest in diabetes technology which continuously measures glucose levels without the need for fingerpricking. The Freestyle Libre 2, uses a wired enzyme technology, coated with glucose oxidase, to measure blood glucose levels. The system comprises of a reader and a sensor. The Freestyle Libre 2 has optional hypoglycaemic and hyperglycaemic alarms when configured and a Bluetooth enabled sensor to send and receive information between the reader and/or a smartphone running the Freestyle LibreLink application, every minute to generate the alarm. The Freestyle Libre 2 has improved accuracy, particularly at the lower end of glucose readings. No alarms will be set for high blood sugars to reduce risk of alarm fatigue, however, participants and clinicians will have the flexibility to adjust alarm settings, including the option of having alarms to detect high glucose levels, based on patient experience and patient preferences. Participants will be advised to contact their treating clinicians if they are concerned about low or high blood glucose levels and/or the Flash Libre 2 system. Participants randomly assigned to the Freestyle Libre 2 arm will have the data from the Freestyle Libre 2 reader downloaded at the 3 month and 6 month (data can be stored for up to 90 days on the reader). Participants will be advised to scan their sensor 10 times a day and/or at least every 8 hours. When participants come in for their 3 and 6 month visit, data will be downloaded and a report will be generated (AGP report - Ambulatory Glucose Profiling Report) which will be provided to the participant and the participants treating health practitioner.

Intervention code [1] 320305 0
Treatment: Devices
Comparator / control treatment
Self-monitoring of blood glucose via capillary blood glucose and using glucose meters and test strips. Standard care comprises instructions to follow usual diabetes care procedures, under the direction of a treating practitioner, if randomly assigned to the standard care arm. . Participants will be encouraged to continue to test their glucose levels as previously advised by their treating clinicians.
Control group
Active

Outcomes
Primary outcome [1] 327216 0
Change in HbA1c level from baseline to 6 months where HbA1c is measured from the blood sample taken to a local accredited pathology company which services the site. Laboratory measurements of HbA1c will be performed using the standardization of HbA1c measurements recommended by the Royal College of Pathologists Australasia and the Australasian Association of Clinical Biochemists. Bloods will be processed in line with local pathology requirements. For this primary outcome, local point of care testing device will not be appropriate.
Timepoint [1] 327216 0
Baseline to 6 months (final visit)
Secondary outcome [1] 394256 0
Efficacy: Percentage (%) of time spent in target glucose ranges from baseline to 6 months (information obtained from the blinded sensor).
Timepoint [1] 394256 0
Baseline and 6 months (blinded sensor information only).
Secondary outcome [2] 394257 0
Safety: Number of events of severe hypoglycaemia, defined as a severe event characterised by altered mental and/or physical status requiring third-party assistance, ambulance call out or hospital presentations from baseline to 6 months. This will be assessed by self-reported questionnaires and hospital records. Self-reported questionnaire will be used. The questions are based on number of times attending a hospital/healthcare center within the last three months. The questions are a generic set of questions required to complete the health economic analysis for this study.
Timepoint [2] 394257 0
6 months from commencement of the trial.
Secondary outcome [3] 394258 0
Health Utility measured in $AUD. This will be assessed by self-reported questionnaires, hospital records and AIHW data. Self-reported questionnaire will be used. The questions are based on number of times attending a hospital/healthcare center within the last three months. The questions are a generic set of questions required to complete the health economic analysis for this study.
Timepoint [3] 394258 0
6 months from commencement of the trial.
Secondary outcome [4] 394259 0
Quality of Life: EQ-5D-5L (EQ-5D 5 levels) questionnaire.
Timepoint [4] 394259 0
This survey will be completed prior to any procedures at randomisation, 3 months and 6 months.
Secondary outcome [5] 394260 0
Incremental cost-effectiveness ratio (ICER): Incremental cost ($AUD) per QALY gained associated with FlashGM compared to SMBG will be quantified based on the health service and hospital costs and health utility measured over the 6-month period of the trial.
Timepoint [5] 394260 0
6 months from commencement of the trial.
Secondary outcome [6] 394261 0
Modified Glucose Monitoring Satisfaction Survey (GMSS)
Timepoint [6] 394261 0
Randomisation, 3 months and 6 months from commencement of the study.
Secondary outcome [7] 395609 0
Percentage (%) of time spent in low glucose ranges from baseline to 6 months (information obtained from the blinded sensor).
Timepoint [7] 395609 0
Baseline and 6 months (blinded sensor information only).
Secondary outcome [8] 395610 0
Percentage (%) of time spent in low glucose ranges from baseline to 6 months (information obtained from the blinded sensor).
Timepoint [8] 395610 0
Baseline and 6 months (blinded sensor information only).

Eligibility
Key inclusion criteria
1. Indigenous Australian
2. Confirmed diagnosis of type 2 diabetes
3. Age greater than or equal to 18 years and above
4. HbA1c greater than or equal to 7.5% (58 mmol/mol) from either a recent blood test (within 4 weeks of screening date) or blood sample taken at screening determined through laboratory pathology testing. *must be laboratory confirmed HbA1c not point of care testing.
5. Medicated with the same type of injectable therapies ± oral hypoglycaemic agents, for at least 6 weeks prior to screening:
i. Insulin alone or with or without oral agents
ii. GLP1 analogues with or without oral agents
iii. GLP1 analogues and insulin with or without oral agents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age < 18 years
2. Type 1 diabetes mellitus
3. Taking high doses of vitamin C supplements (more than 500 mg per day)
4. Active malignancy requiring chemotherapy
5. Known allergy to medical-grade adhesives
6. On varying doses of corticosteroid therapy
7. Using amphetamines, anabolic or weight-reducing therapies
8. Pregnancy or actively planning pregnancy as HbA1c is not reliable during pregnancy and is the primary outcome.
9. eGFR<15ml/min/1.732 or erythropoiesis stimulating agents or end-stage kidney disease
10. Haemoglobinopathies
11. Active illicit drug use or heavy alcohol use
12. No informed consent

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)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/06/2021
Actual
29/06/2021
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
350
Accrual to date
102
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 20958 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 20959 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 35790 0
3084 - Heidelberg
Recruitment postcode(s) [2] 35791 0
3065 - Fitzroy
Recruitment postcode(s) [3] 39583 0
3629 - Mooroopna

Funding & Sponsors
Funding source category [1] 308377 0
Government body
Name [1] 308377 0
National Health and Medical Research Council
Country [1] 308377 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 309200 0
None
Name [1] 309200 0
Address [1] 309200 0
Country [1] 309200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308342 0
St. Vincent's Hospital, Melbourne Human Research Ethics Committee
Ethics committee address [1] 308342 0
41 Victoria Parade Fitzroy VIC 3065, PO Box 2900 Fitzroy VIC 3065
Ethics committee country [1] 308342 0
Australia
Date submitted for ethics approval [1] 308342 0
18/08/2020
Approval date [1] 308342 0
19/11/2020
Ethics approval number [1] 308342 0
Ethics committee name [2] 312468 0
Aboriginal Health and Medical Research Council (AHMRC)
Ethics committee address [2] 312468 0
35 Harvey St, Little Bay NSW 2036
Ethics committee country [2] 312468 0
Australia
Date submitted for ethics approval [2] 312468 0
01/02/2021
Approval date [2] 312468 0
19/02/2021
Ethics approval number [2] 312468 0
N/A
Ethics committee name [3] 312469 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [3] 312469 0
PO Box 902, Cairns Qld 4870
Office Address: Level 7, William McCormack Place 2,
5B Sheridan Street
Cairns Qld 4870
Ethics committee country [3] 312469 0
Australia
Date submitted for ethics approval [3] 312469 0
20/05/2021
Approval date [3] 312469 0
14/06/2021
Ethics approval number [3] 312469 0
HREC/2021/QCH/73566 - 1510

Summary
Brief summary
Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians, and the risk and severity of diabetes complications (cardiovascular disease, kidney failure, blindness) are far greater in this population than in non-Indigenous Australians. We address this problem, targeting Goal 5 of the National Diabetes Strategy.
We urgently need effective and convenient ways of improving glycaemic management in Indigenous Australians. New technologies that continuously monitor blood glucose are effective in assisting patients to improve their blood glucose levels through driving changes in behaviour (increasing physical activity), lifestyle (healthier eating habits), and therapy. The devices are worn on the arm and provide continuous, real-time feedback on blood glucose levels, but have not been tested in Indigenous Australians. We will assess the effects of one of these technologies (flash glucose monitoring) on glycaemic control (glycated haemoglobin [HbA1c] levels, achieving blood glucose targets, reducing hypoglycaemic episodes) through a randomised clinical trial in this high-risk population. We will also perform a cost-effectiveness analysis. Indigenous Australians with type 2 diabetes on injectable therapy, and with persistent high blood glucose levels, as indicated by HbA1c >7.5% (n=350), will be equally randomised to use a flash glucose monitor or receive standard care (glucose tested by finger-prick) for 6 months. Anticipated primary outcomes will be a lower, clinically significant HbA1c level with flash glucose monitoring. Anticipated secondary outcomes include achieving blood glucose targets, fewer hypoglycaemic episodes, reduced costs, and improved quality of life. The research will likely lead to major, cost-effective health gains for Indigenous Australians, and significantly improved health-service delivery for Indigenous and other high-risk Australians.
Trial website
https://blogs.unimelb.edu.au/flashgmstudy/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110374 0
A/Prof Elif Ekinci
Address 110374 0
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg, VIC 3081
Country 110374 0
Australia
Phone 110374 0
+61 03 94962645
Fax 110374 0
Email 110374 0
[email protected]
Contact person for public queries
Name 110375 0
Miss Mariam Hachem
Address 110375 0
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg, VIC 308
Country 110375 0
Australia
Phone 110375 0
+61 03 94962645
Fax 110375 0
Email 110375 0
[email protected]
Contact person for scientific queries
Name 110376 0
A/Prof Elif Ekinci
Address 110376 0
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg, VIC 308
Country 110376 0
Australia
Phone 110376 0
+61 03 94962645
Fax 110376 0
Email 110376 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11409Ethical approval    St. Vincent's HREC Approval Letter attached. 381829-(Uploaded-17-05-2021-14-24-09)-Study-related document.pdf
11684Study protocol  [email protected] Please contact [email protected] or fla... [More Details]
11685Informed consent form https://www.youtube.com/watch?v=u11T7u6expk[email protected] Please contact [email protected] or fla... [More Details]



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.