None listed
Conditions
Brief summary
Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians, and the risk and severity of diabetes complications (cardiovascular disease, kidney failure, blindness) are far greater in this population than in non-Indigenous Australians. We address this problem, targeting Goal 5 of the National Diabetes Strategy. We urgently need effective and convenient ways of improving glycaemic management in Indigenous Australians. New technologies that continuously monitor blood glucose are effective in assisting patients to improve their blood glucose levels through driving changes in behaviour (increasing physical activity), lifestyle (healthier eating habits), and therapy. The devices are worn on the arm and provide continuous, real-time feedback on blood glucose levels, but have not been tested in Indigenous Australians. We will assess the effects of one of these technologies (flash glucose monitoring) on glycaemic control (glycated haemoglobin [HbA1c] levels, achieving blood glucose targets, reducing hypoglycaemic episodes) through a randomised clinical trial in this high-risk population. We will also perform a cost-effectiveness analysis. Indigenous Australians with type 2 diabetes on injectable therapy, and with persistent high blood glucose levels, as indicated by HbA1c >7.5% (n=350), will be equally randomised to use a flash glucose monitor or receive standard care (glucose tested by finger-prick) for 6 months. Anticipated primary outcomes will be a lower, clinically significant HbA1c level with flash glucose monitoring. Anticipated secondary outcomes include achieving blood glucose targets, fewer hypoglycaemic episodes, reduced costs, and improved quality of life. 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.
Interventions
The Freestyle Libre 2 Flash Glucose Monitoring System is the intervention in this trial. Participants randomly assigned to the Flash Glucose Monitoring arm will use the device for 6 months. The Freestyle Libre 2 is the latest in diabetes technology which continuously measures glucose levels without the need for fingerpricking. The Freestyle Libre 2, uses a wired enzyme technology, coated with glucose oxidase, to measure blood glucose levels. The system comprises of a reader and a sensor. The Fre
The Freestyle Libre 2 Flash Glucose Monitoring System is the intervention in this trial. Participants randomly assigned to the Flash Glucose Monitoring arm will use the device for 6 months. The Freestyle Libre 2 is the latest in diabetes technology which continuously measures glucose levels without the need for fingerpricking. The Freestyle Libre 2, uses a wired enzyme technology, coated with glucose oxidase, to measure blood glucose levels. The system comprises of a reader and a sensor. The Freestyle Libre 2 has optional hypoglycaemic and hyperglycaemic alarms when configured and a Bluetooth enabled sensor to send and receive information between the reader and/or a smartphone running the Freestyle LibreLink application, every minute to generate the alarm. The Freestyle Libre 2 has improved accuracy, particularly at the lower end of glucose readings. No alarms will be set for high blood sugars to reduce risk of alarm fatigue, however, participants and clinicians will have the flexibility to adjust alarm settings, including the option of having alarms to detect high glucose levels, based on patient experience and patient preferences. Participants will be advised to contact their treating clinicians if they are concerned about low or high blood glucose levels and/or the Flash Libre 2 system. Participants randomly assigned to the Freestyle Libre 2 arm will have the data from the Freestyle Libre 2 reader downloaded at the 3 month and 6 month (data can be stored for up to 90 days on the reader). Participants will be advised to scan their sensor 10 times a day and/or at least every 8 hours. When participants come in for their 3 and 6 month visit, data will be downloaded and a report will be generated (AGP report - Ambulatory Glucose Profiling Report) which will be provided to the participant and the participants treating health practitioner.
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
1. Indigenous Australian 2. Confirmed diagnosis of type 2 diabetes 3. Age greater than or equal to 18 years and above 4. HbA1c greater than or equal to 7.5% (58 mmol/mol) from either a recent blood test (within 4 weeks of screening date) or blood sample taken at screening determined through laboratory pathology testing. *must be laboratory confirmed HbA1c not point of care testing. 5. Medicated with the same type of injectable therapies ± oral hypoglycaemic agents, for at least 6 weeks prior to screening: i. Insulin alone or with or without oral agents ii. GLP1 analogues (including subclasses) with or without oral agents iii. GLP1 analogues (including subclasses) and insulin with or without oral agents.
Exclusion criteria
1. Age < 18 years 2. Type 1 diabetes mellitus 3. Taking high doses of vitamin C supplements (more than 500 mg per day) 4. Active malignancy requiring chemotherapy 5. Known allergy to medical-grade adhesives 6. On varying doses of corticosteroid therapy 7. Using amphetamines, anabolic or weight-reducing therapies 8. Pregnancy or actively planning pregnancy as HbA1c is not reliable during pregnancy and is the primary outcome. 9. eGFR<15ml/min/1.732 or erythropoiesis stimulating agents or end-stage kidney disease 10. Haemoglobinopathies 11. Active illicit drug use or heavy alcohol use 12. No informed consent
Outcome results
None listed