Diabetes experts set minimum CGM standards to address controversial media coverage

Australian and New Zealand diabetes experts have published minimum performance standards for continuous glucose monitoring (CGM) devices, following the controversial Nine Publishing and 60 Minutes coverage aired during National Diabetes Week.

In a new joint position statement led by A/Professor Sof Andrikopoulos, CEO of Australian Diabetes Society (ADS) and published in the Internal Medicine Journal, leading diabetes organisations recommend that regulators require all CGM devices to meet clearly defined benchmarks before they are approved and subsidised.

CGMs have transformed diabetes management by providing real-time glucose readings, trend data and alerts that help people make treatment decisions without relying solely on finger-prick testing.

Full or partial subsidisation is available for all people with type 1 diabetes and is provided by the Australian government through the National Diabetes Services Scheme (NDSS). In Aotearoa New Zealand, CGM is fully subsidised by Pharmac for people with type 1 diabetes. However, CGM access remains unsubsidised for people with type 2 diabetes in both countries, meaning that individuals in this group must self-fund the cost of the CGM.

“The increased reliance on CGM metrics for clinical decisions to manage diabetes necessitates the consideration and implementation of minimum standards that device manufacturers should meet to demonstrate safety, precision and accuracy,” the authors said.

The joint position statement comes as regulatory pathways have evolved in Australia and New Zealand, allowing more devices to enter the market. The authors argue that overseas approval alone does not necessarily guarantee a device meets the level of accuracy needed for clinical decision-making.

Until July 2024, CGM systems were classified by the Therapeutic Goods Administration (TGA) as Class III (high-risk) medical devices and were required to demonstrate stringent standards of accuracy and safety prior to approval. Each CGM system underwent independent assessment by an expert panel and was required to meet the TGA’s defined ‘Essential Principles’. CGM devices are now classified as Class IIb (moderate-to-high risk) medical devices.

“This reduction in review process and shortened approval period, dependent on overseas regulatory approval such as the European Medical Device Regulation (MDR) and Conformité Européenne (CE) mark for new CGM devices coming into the Australian and New Zealand markets, may require further rigorous clinical and safety review,” the authors added.

Among the recommendations are minimum clinical testing requirements, including studies involving at least 100 participants, thousands of paired glucose measurements across a wide range of blood glucose levels, and transparent reporting of device performance in peer-reviewed journals. The experts also recommends ongoing post-market surveillance and specific evaluation of device performance during pregnancy and in children.

The Australian Diabetes Clinical Quality Registry 2025 Report shows that approximately 87% of people with type 1 diabetes and 7% of people with type 2 diabetes are using CGMs to monitor their glucose levels. Furthermore, in people with type 1 diabetes, CGM use was associated with a 0.7% reduction in HbA1c.

The authors said meeting minimum standards “ensures the safety and clinical benefit for the person with diabetes who is relying on the CGM device for treatment decisions and appropriate use of taxpayer funds.”

The position statement is a collaboration of the ADS, Australian Diabetes Educators Association (ADEA), Australasian Diabetes in Pregnancy Society (ADIPS), Australian and New Zealand Society for Paediatric Endocrinology and Diabetes (ANZSPED), and New Zealand Society for the Study of Diabetes.

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