Latest Project Update
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.