In an ambitious endeavor to address the disproportionate impact of type 2 diabetes on Aboriginal and Torres Strait Islander communities, a new study will investigate the efficacy of Continuous Glucose Monitoring (CGM) technology. This research could potentially pave the way for more accessible and affordable healthcare solutions for these communities, who currently lack widespread access to CGM.
Innovative Trial Design
A randomized controlled trial (RCT), leveraging collaborations with a national network of Aboriginal and Torres Strait Islander communities, aims to compare the impact of CGM versus Self-Monitoring of Blood Glucose (SMBG) on various health outcomes. The study will enroll 350 adults with type 2 diabetes who are already on injectable therapy and have haemoglobin A1c (HbA1c) levels of 7.5% or higher. Participants will be allocated to either the CGM or SMBG group for six months. The primary goal is to observe changes in HbA1c levels, while secondary outcomes include frequency of hypoglycaemic episodes, quality of life, and cost-effectiveness.
Significance for Market Access
The lack of subsidy and limited use of CGM technology among Aboriginal and Torres Strait Islander people underscores a critical market access issue. This trial, by evaluating both the clinical and economic benefits of CGM, aims to provide compelling evidence to support broader funding and accessibility. The study involves diverse clinical sites, including Aboriginal Community Controlled Organisations, primary care centers, and tertiary hospitals across various regions of Australia. This diversity ensures the findings are comprehensive and applicable to multiple settings.
The trial’s methodology includes non-masked, parallel-group, two-arm randomization. By focusing on a change in HbA1c as the primary outcome, the study aims to provide clear metrics for evaluating the effectiveness of CGM. Secondary metrics derived from CGM will offer additional insights into the technology’s benefits, potentially influencing market access policies.
Valuable Inferences
Potential Impact on Healthcare Policies
The results of this trial could have significant implications for healthcare policies and market access:
- Evidence from the trial may support the inclusion of CGM technology in subsidized health programs for Aboriginal and Torres Strait Islander populations.
- Successful demonstration of cost-effectiveness could encourage broader adoption of CGM, reducing long-term healthcare costs.
- Improved health outcomes could lead to increased investment in similar technologies, benefiting other underserved communities.
Ultimately, this trial aims to improve diabetes management and quality of life for Aboriginal and Torres Strait Islander people. If successful, it could lead to significant advancements in market access for CGM technology and other innovative healthcare solutions. The trial’s comprehensive approach ensures that its findings will be robust, offering valuable insights for policymakers and healthcare providers alike.
Original Article:
Trials. 2024 Jul 19;25(1):493. doi: 10.1186/s13063-024-08267-7.
ABSTRACT
BACKGROUND: Aboriginal and Torres Strait Islander peoples are disproportionately impacted by type 2 diabetes. Continuous glucose monitoring (CGM) technology (such as Abbott Freestyle Libre 2, previously referred to as Flash Glucose Monitoring) offers real-time glucose monitoring that is convenient and easy to use compared to self-monitoring of blood glucose (SMBG). However, this technology’s use is neither widespread nor subsidised for Aboriginal and Torres Strait Islander peoples with type 2 diabetes. Building on existing collaborations with a national network of Aboriginal and Torres Strait Islander communities, this randomised controlled trial aims to assess the effect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-effective healthcare in an Aboriginal and Torres Strait Islander people health setting.
METHODS: This is a non-masked, parallel-group, two-arm, individually randomised, controlled trial (ACTRN12621000753853). Aboriginal and Torres Strait Islander adults with type 2 diabetes on injectable therapy and HbA1c ≥ 7.5% (n = 350) will be randomised (1:1) to CGM or SMBG for 6 months. The primary outcome is change in HbA1c level from baseline to 6 months. Secondary outcomes include (i) CGM-derived metrics, (ii) frequency of hypoglycaemic episodes, (iii) health-related quality of life and (iv) incremental cost per quality-adjusted life year gained associated with the CGM compared to SMBG. Clinical trial sites include Aboriginal Community Controlled Organisations, Aboriginal Medical Services, primary care centres and tertiary hospitals across urban, rural, regional and remote Australia.
DISCUSSION: The trial will assess the effect of CGM compared to SMBG on HbA1c for Aboriginal and Torres Strait Islander people with type 2 diabetes in Australia. This trial could have long-term benefits in improving diabetes management and providing evidence for funding of CGM in this population.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12621000753853. Registered on 15th June 2021.
PMID:39030640 | DOI:10.1186/s13063-024-08267-7
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