* The full Flash Newsletter can be found under the NEWS FLASH tab (upper right hand side).
The study continues to build strong relationships with community partner sites across the country, with the first participants recruited despite ongoing challenges posed by the COVID 19 pandemic. The pilot study at Rumbalara – almost nearing completion – has been particularly affected due to the Victorian outbreak, while Maari Ma in NSW has been similarly affected.
The amazing Bernard Kelly Edwards (Flash Informed Consent Video artist) goes live on his Friday morning radio program from 9am. Tracey Hearn and Mariam Hachem stopped by recently to talk all things Diabetes and Flash – you can listen here
The Culturally Adaptive Governance Framework (CAGF) developed for the FlashGM Study has been outlined in a paper published in July. The framework is now also being implemented by the Australian Stroke Alliance (ASA) through their Federal Frontier Health and Medical Research initiative which was awarded a $40 million grant. The CAGF is now being utilised by two national trials and we are excited to be contributing to new initiatives for empowering Indigenous governance principles for health and medical research in Australia.
Further updates include:
- Engagement with new sites in Brisbane and Victoria has begun
- Satellite site addition of Goolum Goolum Aboriginal Cooperative in VIC
- Pilot study updates – 38/40 participants recruited
- Interview with Yvonne, Aleisha, Tracey, Luke and Cath from Apunipima
- EOI sent out for Indigenous Council
- EOI form for new sites – included in NACCHO newsletter
The Flash leadership team thank all those working across our collaborative network in these difficult times. If you have any suggestions for future issues of the newsletter, please get in touch with the team.
The start of 2021 has been a busy one, with a focus on onboarding community sites to the TEAMS platform, site activation and training meetings and the completion of the informed consent video. The team are working hard to get the first participant recruited into the study this month – a major milestone for the collaboration.
- Informed consent video completed with artwork by Bernard Kelly-Edwards, voiceover by Tracey Hearn and animated by Andres Gomez.
- Community partners from Maari Ma, Wuchopperen and St.Vincents Hospital have all engaged in a session around the Culturally Adaptive Governance Framework (CAGF) and have been onboarded to the TEAMS platform.
- The pilot study has recruited 37 out of 40 participants!
- Training videos developed for Diabetes Education with Dr. Sharon Atkinson-Briggs, Ambulatory Glucose Profile video developed by Prof. Steven Twigg, using the Flash Glucose Monitoring System videos by Mariam Hachem. All training videos are accessible via Teams.
- Study database complete (RedCap) with training sessions having begun for staff at sites.
- Ethics amendments were submitted to St. Vincent’s HREC on the 3rd May and were approved on the 19th May 2021. These include changes to the device, amendments to questionnaires and data collected during study visits.
If you have any suggestions, would like to know more about the study or would like to be involved, please feel free to reach out to the FlashGM study team via the ‘Contact us’ page.
Welcome to the first project update of 2021!
We started the year with a team dinner in early February, followed by a planning day. This was a great opportunity to reconnect and regroup before a busy year ahead!
Some important study updates since December:
- Pilot study has successfully recruited 35 out of 40 participants.
- The development of an informed consent video. The video will provide
participants with standardised information about the trial across sites and
facilitate conversation between participant and study coordinator/clinician. The
Learning and Environments team at the University of Melbourne are working
with Tom Day, the study artist and an animator to create a short 2-minute
video for obtaining informed consent for the FlashGM Study. The video will be
ready for use in April.
- The new Freestyle Libre 2 will soon supersede the current Freestyle Libre in
Australia. After discussions with study statisticians and team members, the
FlashGM Study will use the new Freestyle Libre 2’s going forward. The
regulatory approvals are under review with the Therapeutic Goods Association;
however, the device has been widely used in the US and Europe. We are in the
process of obtaining approvals and ethics amendments for the new device.
- Ethics approvals and submissions. Ethics submitted to Cairns Hospital for
Wuchopperen Health Service and Apunipima Cape York Health Council. The
Aboriginal Health and Medical Research Council have approved the study for
Maari Ma Aboriginal Health Corporation. Amendments to Lead HREC will be
submitted in March for the use of the new device and minor protocol changes.
The FlashGM Study website is up and running. Check it out below
The team have been working hard on finalising the case report forms, RedCap
database, training and onboarding materials.
If you have any suggestions, would like to know more about the study or would like to be involved, please feel free to reach out to the FlashGM study team via our contact page.
What a year 2020 has been!
Thank you to everyone who has dedicated their time and effort to the study over the last year, it has been challenging but rewarding. Since the NHMRC funding announcement in January, the study team has worked hard to continue the pilot study at Rumbalara Aboriginal Cooperative and Goulburn Valley Health recruiting over 30 participants. Well done to Donna, Tracey and Rosemary (who has recently left the team).
In June, Austin Health was added as a site for the pilot study. Thank you to all clinicians for referring patients to the study. During the winter months and in the midst of the second lockdown in Melbourne, the team worked hard on developing the protocol and patient facing materials. Ethics was submitted to St. Vincent’s HREC (Ethics) on the 18th August and on the 19th November, we received Lead HREC Approval! This is a significant milestone in moving the study forward to other sites across Australia.
We have continued to discuss the FlashGM study with sites across Australia. Since obtaining HREC (Ethics) approval, the team have had more in depth discussions about the study with Apunipima Cape York Health and Wuchopperen Medical Corporation in Cairns and Maari Ma Aboriginal Cooperative in Broken Hill, New South Wales. Thank you to all the staff who have taken time from their busy schedules to meet with the team and continue their involvement in the FlashGM study. We look forward to starting the trial at your sites in 2021!
As the year winds down, it is often a space to reflect on the year that was. Whilst 2020 tested our ability to adapt, it also tested our abilities to respond. It has made us consider new ways of working, collaborating and connecting with one another. My hope for 2021, is that we can continue to build on these connections, not only remotely but face-to-face and that we can continue to work together on the FlashGM Study! Thank you to all for your efforts! Seasons Greetings and have a safe and Happy New Year
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