Background:
Diabetes is a major problem for Indigenous Australians. Clinical trials specifically for Indigenous Australians are necessary to provide evidence for the use of new diabetes technologies and therapies to reduce diabetes and its complications. However, consenting procedures for clinical trials are often time-consuming and not culturally specific. We are conducting a national, multi-centre clinical trial using a wearable diabetes technology, flash glucose monitors, for Indigenous Australians with type 2 diabetes across metropolitan, regional, rural and remote Australia (FlashGM Study, in progress) (NHMRC funded). To ensure standardised and culturally specific consenting, we developed an informed consent video.

Objective:
To implement an informed consent video as part of a large multi-centre, national, randomised controlled trial for Indigenous Australians. The overarching study aims are to assess the effects of flash glucose monitoring on haemoglobin A1c, time in range, reducing low glucose episodes and cost-effectiveness from baseline to 6 months.

Method:
In April 2020, a plain language script was written by Indigenous researchers. An Indigenous artist with lived experience of type 2 diabetes designed the video artwork, with voice-over by an Aboriginal study team member. Video animation and production was facilitated by the University of Melbourne. Video completion occurred in June 2020. Iterative cycles of reviewing and feedback were undertaken by the Study team between May-June.

Results:
The video was designed to supplement the participant informed consent form as part of consenting at the first trial visit. The 3-minute video is hosted on YouTube and includes subtitles (English): (https://www.youtube.com/watch?v=u11T7u6expk [1]). 100 participants across 10 clinical trial sites were consented using the video with positive feedback from clinical trial participants, staff and communities.

Conclusion:
Video consenting is an innovative way of delivering culturally appropriate consent for clinical trials in Indigenous health settings. Consenting for clinical trials must be culturally appropriate and accessible for participants. https://www.youtube.com/watch?v=u11T7u6expk