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Trial registered on ANZCTR


Registration number
ACTRN12621000021875
Ethics application status
Approved
Date submitted
22/05/2020
Date registered
14/01/2021
Date last updated
14/01/2021
Date data sharing statement initially provided
14/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
How does Flash Glucose Monitoring affect Blood Glucose Levels of Indigenous Australians with type 2 diabetes?- A Pilot Study.
Scientific title
How does Flash Glucose Monitoring affect Blood Glucose Levels of Indigenous Australians with type 2 diabetes?- A Pilot Study.
Secondary ID [1] 301343 0
Nil known
Universal Trial Number (UTN)
U1111-1252-3931
Trial acronym
FLASH Study Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 317559 0
type 2 diabetes 317560 0
Condition category
Condition code
Metabolic and Endocrine 315646 315646 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised clinical trial. Participants will be randomised to either (intervention) FreeStyle® Libre™ flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) or usual care of self-monitoring blood glucose (SMBG) for 6 months. Participants will be required to attend the study site at visits 0,3 and 6 months. Participants in both the intervention and usual care group will wear the Flash Libre Pro blinded sensor for 2 weeks prior to randomisation to the intervention or usual care group. 2 weeks prior to completion of the study (2 weeks prior to the 6 month visit) participants will wear the Flash Libre Pro blinded sensor. For participants in the usual care group, after partaking in the final study visit, will be offered flash glucose monitoring for 6 months.

For Participants in the Flash Glucose Monitoring (INTERVENTION ARM): Participants will be provided with a FreeStyle Libre flash glucose monitoring system and will be required to apply a sensor to their upper arm. The sensor will be changed by the participant every 2 weeks and participants will be provided with sufficient sensors to enable this process throughout the 6 months study period. Participants may choose to continue undertaking self-monitoring of blood glucose in addition to wearing the sensor, however this is not required for the trial.

Trial visits are expected to take between 30 minutes to 1 hour.

The blinded sensor we will be using is called the FreeStyle Libre Pro (https://www.freestyle.abbott/in-en/products/freestyle-libre-pro.html). The FreeStyle Libre Pro is used for healthcare professionals only. A participant wearing the blinded sensor (FreeStyle Libre Pro) only requires one scan of the sensor upon insertion and one scan of the sensor prior to removal (14 days later) to capture 14 days of blood glucose trends. The blinded sensor will inform how often the participant is within target range, low range range and high range of blood glucose levels over a 14 day period. Participants will continue to monitor their blood sugars as per usual self monitoring blood glucose measurements during this time. All participants can obtain data from their blinded sensor after 14 days of wearing the sensor at the beginning and at the end.
Intervention code [1] 317640 0
Treatment: Devices
Comparator / control treatment
Self Monitoring of Blood Glucose is the usual care (control) treatment for the study.

Participants randomized to the standard care group will use their usual self-monitoring blood glucose method using a TGA approved device to monitor their blood glucose levels. Standard care comprises instructions to follow their normal diabetes care procedures. Participants will be provided with glucose meters and test strips. 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] 323881 0
Change in HbA1c level from baseline to 6 months assessed using blood tests.
Timepoint [1] 323881 0
Change in HbA1c level from baseline (study visit 0) to 6 months (final visit) assessed using blood tests.
Secondary outcome [1] 383135 0
Change in percent of time spent in target glucose (4-10mmol/L), low glucose (<3.9mmol/L) and high glucose (>15mmol/L) from baseline to 6 months (blinded sensor). This data is collected using the blinded sensors.
Timepoint [1] 383135 0
Baseline (study visit at 0 months) to 6 months (final visit).
Secondary outcome [2] 383138 0
Cost-effectiveness analysis using the EQ-5D.
Timepoint [2] 383138 0
All collected data will be assessed from visit 3(randomisation visit), visit 4 (3 month visit) to 6 months (final visit) post-commencement of intervention.

Eligibility
Key inclusion criteria
Indigenous Australians with type 2 diabetes and HbA1c greater than or equal to 7.0% (53mmol/L) AND one of the following:
- Injectable therapy (including insulin) ± oral hypoglycaemic agent, or
- GLP-1 analogue ± oral hypoglycaemia agent, or
- GLP-1 analogue and insulin ± oral hypoglycaemic agent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any of the following:
- Age < 18 years
- Type 1 diabetes mellitus
- Active illicit drug use or heavy alcohol use (> 4 standard drinks/day)
- Active malignancy
- Known allergy to medical-grade adhesives
- On varying doses of corticosteroid therapy
- Using amphetamines, anabolic or weight-reducing medications
- Pregnancy or actively planning pregnancy
- eGFR<15ml/min/1.732 or erythropoiesis stimulating agents or end-stage kidney disease
- Haemoglobinopathies.

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)
The randomisation list will be computer-generated by an independent statistician and carried out centrally to ensure concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16728 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment postcode(s) [1] 30331 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 305784 0
Government body
Name [1] 305784 0
Medical Research Future Fund
Address [1] 305784 0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [1] 305784 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Parkville, Vic, 3010
Country
Australia
Secondary sponsor category [1] 306222 0
None
Name [1] 306222 0
Address [1] 306222 0
Country [1] 306222 0
Other collaborator category [1] 281333 0
Other
Name [1] 281333 0
Rumbalara Aboriginal Co-operative
Address [1] 281333 0
31 Wyndham St, Shepparton VIC 3630
Country [1] 281333 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306058 0
Goulburn Valley Health
Ethics committee address [1] 306058 0
2/2-48 Graham St, Shepparton VIC 3630
Ethics committee country [1] 306058 0
Australia
Date submitted for ethics approval [1] 306058 0
Approval date [1] 306058 0
31/10/2017
Ethics approval number [1] 306058 0
GVH 38/17

Summary
Brief summary
Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians. High blood glucose levels in Indigenous Australians are a major driver of diabetes complications. In non-Indigenous populations, knowledge gained from continuously monitoring blood glucose levels has led to behavioural change and a reduction in blood glucose levels in individuals with diabetes. Continuous monitoring of blood glucose levels has never been studied in Indigenous Australians. There is an urgent need to find effective ways of improving blood glucose control in this population.

The aim of this pilot study is to compare to usual care (SMBG), continuous use of real-time flash glucose monitoring in Indigenous Australians with type 2 diabetes, to determine if flash glucose monitoring will improve HbA1c, achieve blood glucose targets and reduce hypoglycaemic episodes. This study will also evaluate whether flash glucose monitoring is effective, feasible, acceptable and cost-effective in this population.

Participants will be randomly assigned to blood glucose monitoring by flash glucose monitoring (Abbott Freestyle Libre) or conventional SMBG. 40 volunteers will be recruited to participate in the pilot study. Participants’ involvement in the study will last 6 months.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66410 0
A/Prof Elif Ekinci
Address 66410 0
Heidelberg Repatriation Hospital
300 Waterdale Road,
Heidelberg, Victoria, 3081
Country 66410 0
Australia
Phone 66410 0
+61 3 94962645
Fax 66410 0
Email 66410 0
elif.ekinci@unimelb.edu.au
Contact person for public queries
Name 66411 0
Miss Mariam Hachem
Address 66411 0
Heidelberg Repatriation Hospital
300 Waterdale Road,
Heidelberg, Victoria, 3081
Country 66411 0
Australia
Phone 66411 0
+61 3 94962645
Fax 66411 0
Email 66411 0
mariam.hachem@unimelb.edu.au
Contact person for scientific queries
Name 66412 0
A/Prof Elif Ekinci
Address 66412 0
Heidelberg Repatriation Hospital
300 Waterdale Road,
Heidelberg, Victoria, 3081
Country 66412 0
Australia
Phone 66412 0
+61 3 94962550
Fax 66412 0
Email 66412 0
elif.ekinci@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 other documents available
Summary results
No Results