The FlashGM Study
About the trial
The trial will investigate if a new device called flash glucose monitoring will improve sugar levels compared to finger prick testing. The study consists of 6 visits across 6 months. Indigenous Australians with type 2 diabetes on injectable therapy, and with persistent high blood glucose levels (HbA1c >7.5%), will be randomly assigned to use a flash glucose monitor or standard care (finger pricking) for 6 months.
The research will likely lead to major, cost-effective health gains for Indigenous Australians, and significantly improved health-service delivery for Indigenous and other high-risk Australians. The trial aims to recruit 350 Indigenous Australians with type 2 diabetes across multiple sites in Australia.
Who can participate?
Participants who were randomly assigned to finger pricking will be offered flash glucose monitoring for 6 months at the end of the trial. The anticipated outcomes will be a lower, clinically significant HbA1c level with flash glucose monitoring, achieving blood glucose targets, fewer low blood sugar episodes, reduced costs, and improved quality of life.
Participation requirements are:
1. Indigenous Australian
2. Confirmed diagnosis of type 2 diabetes
3. Age ≥ 18 years
4. HbA1c >7.5% (58 mmol/mol) from either a recent test or sample at screening
5. Medicated with the same type of injectable therapies ± oral hypoglycaemic agents, for at least 3 months prior to screening:
I. Insulin alone or with (±) oral agents
II. GLP1 analogues ± oral agents
III. GLP1 analogues and insulin ± oral agents.
More information
For further information, please contact:
Name: Mariam Hachem
Phone: (03) 94962645
Email: flash-study@unimelb.edu.au
https://blogs.unimelb.edu.au/flashgmstudy/
This research project has been approved by St. Vincent’s Human Research Ethics Committee (HREC) 188/20