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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
6/06/2023
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
Actual
26/03/2018
Date of last participant enrolment
Anticipated
27/12/2021
Actual
7/12/2021
Date of last data collection
Anticipated
30/06/2022
Actual
5/05/2022
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16728 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [2] 24880 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 24881 0
Rumbalara Aboriginal Cooperative - Shepparton
Recruitment postcode(s) [1] 30331 0
3630 - Shepparton
Recruitment postcode(s) [2] 40530 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 305784 0
Government body
Name [1] 305784 0
Medical Research Future Fund
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
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
Ethics committee name [2] 313171 0
Austin HREC
Ethics committee address [2] 313171 0
Ethics committee country [2] 313171 0
Australia
Date submitted for ethics approval [2] 313171 0
26/11/2019
Approval date [2] 313171 0
23/06/2020
Ethics approval number [2] 313171 0
HREC/54334/Austin-2019

Summary
Brief summary
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
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
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 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.