None listed
Conditions
Brief summary
Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians. High blood glucose levels in Indigenous Australians are a major driver of diabetes complications. In non-Indigenous populations, knowledge gained from continuously monitoring blood glucose levels has led to behavioural change and a reduction in blood glucose levels in individuals with diabetes. Continuous monitoring of blood glucose levels has never been studied in Indigenous Australians. There is an urgent need to find effective ways of improving blood glucose control in this population. The aim of this pilot study is to compare to usual care (SMBG), continuous use of real-time flash glucose monitoring in Indigenous Australians with type 2 diabetes, to determine if flash glucose monitoring will improve HbA1c, achieve blood glucose targets and reduce hypoglycaemic episodes. This study will also evaluate whether flash glucose monitoring is effective, feasible, acceptable and cost-effective in this population. Participants will be randomly assigned to blood glucose monitoring by flash glucose monitoring (Abbott Freestyle Libre) or conventional SMBG. 40 volunteers will be recruited to participate in the pilot study. Participants’ involvement in the study will last 6 months.
Interventions
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 c
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.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed