Diabetes leaders respond to recent media coverage about medical device safety and regulation

Australia's diabetes health and research leaders have responded to recent media coverage examining concerns about medical devices and device regulation in Australia, saying the reporting about diabetes technology overlooked the clinical evidence and the one factor that most determines whether technology helps or harms: access to professional support.

Nearly 2 million Australians live with diabetes. Managing the condition well is central to reducing the risk of diabetes-related complications, which arise from dangerous glucose levels, whether too high or too low. Diabetes technology, including continuous glucose monitors (CGM) and insulin pumps, exists to help people manage glucose levels safely and is used extensively by people with type 1 diabetes.

“Like all medical treatments, diabetes technology carries some risk. But the evidence is unambiguous: for most people living with type 1 diabetes, the benefits of this technology far outweigh that risk, particularly when people are supported by a qualified diabetes care team,” Australian Diabetes Society (ADS) CEO Associate Professor Sof Andrikopoulos said.

The data clearly demonstrate that diabetes technology is safe and effective. There are about 140,000 Australians living with type 1 diabetes. Australian Diabetes Clinical Quality Registry (ADCQR) data show more than 90% are using CGM and 36% are using insulin pump therapy. ADCQR data show people with type 1 diabetes using CGM have, on average, 0.7% lower HbA1c than non-CGM users — a clinically meaningful improvement in long-term glucose control and a reduced risk of complications.

Recognising the importance of device safety and performance, Australia's leading diabetes professional organisations published a 2025 consensus statement outlining minimum standards for continuous glucose monitoring systems in Australia and New Zealand. The statement calls for rigorous requirements relating to device accuracy, reliability, safety monitoring, transparency and post-market surveillance to ensure people living with diabetes can have confidence in the technology they use every day.

Dr Matthew Hare, President of the Australasian Diabetes in Pregnancy Society (ADIPS), said “the benefits of diabetes technology are particularly clear during pregnancy, backed by high-quality evidence from clinical trials and strong regulatory processes”.

“England’s National Health Service has now mandated that pregnant women with type 1 diabetes have funded access to the latest insulin pump technology. Their national data show that women who access this technology have 20% fewer severe adverse outcomes such as stillbirth and congenital anomalies. It is essential that pregnant women in Australia have equitable access to both this technology and the specialist diabetes care team needed to support its use,” he said.

Dr Tony Huynh, President of the Australian and New Zealand Society for Paediatric Endocrinology and Diabetes (ANZSPED), said “to support children living with diabetes, we absolutely must ensure that access to technology is increased along with support for children and their carers – in particular, universal access to automated insulin delivery (AID) systems, which are recognised as the standard of care”.

“The decision by the federal government to subsidise CGM for children and young adults with type 1 diabetes has profoundly changed clinical care, reducing hypoglycaemia and the risk of diabetic ketoacidosis (DKA).

“In addition to the clinical benefits, there is a significant quality-of-life benefit. Parents sleep better knowing that their children’s blood glucose levels are being monitored overnight.

“We should also be exploring opportunities to improve access to CGM for people living with type 2 diabetes who could benefit from this technology, ensuring that access is accompanied by the education and professional support needed to use it safely and effectively.”

Australian Diabetes Educators Association (ADEA) CEO Melanie Gray Morris said “technology is not a substitute for clinical care, and it was never meant to be one”.

“To get the safety and outcome benefits this data shows, people living with diabetes need to be supported by a diabetes care team that includes a Credentialled Diabetes Educator (CDE),” she said.

“For people with type 1 diabetes, that means care from both an endocrinologist and a CDE. When technology-related issues occur, they are often associated with gaps in education, training, support or follow-up rather than the technology alone. The answer to that problem is better access to health professional support like CDEs, not less technology.”

Australia's diabetes health and research leaders are calling on government, industry and the health system to ensure that access to diabetes technology is matched by equivalent investment in the diabetes workforce—including CDEs, endocrinologists and other members of multidisciplinary diabetes care teams—so that every Australian using this technology has the professional support to use it safely and effectively.

They also supports strong regulatory oversight and minimum performance standards for diabetes technologies to ensure Australians can continue to benefit from safe, effective and reliable devices. For further information, see the Australian and New Zealand CGM Minimum Standards Consensus Statement.

Download this media release as a PDF.

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About ADEA

The Australian Diabetes Educators Association (ADEA) is the regulatory body for the Credentialled Diabetes Educator (CDE®) certification. CDEs are health professionals who have undertaken a rigorous credentialling program and have specialist knowledge in the field of diabetes education. The mission of ADEA is to support, promote and empower its members, and to lead and advocate for best-practice, person-centred diabetes education and care.

About ADIPS

The Australasian Diabetes in Pregnancy Society (ADIPS) is the peak organisation and leading voice for health professionals and researchers in Australia and New Zealand who are committed to advancing care and improving outcomes for women living with diabetes and their children. ADIPS is a not-for-profit, member-based organisation. Since 1987, ADIPS has brought together professionals from various disciplines to share knowledge, develop clinical guidance and advocate for people impacted by diabetes in pregnancy.

About ADS

The Australian Diabetes Society (ADS) is the peak national medical and scientific body for diabetes in Australia. ADS is a member-based organisation comprising endocrinologists, scientists, researchers, diabetes educators, allied health professionals and primary care practitioners. The organisation's mission is to prevent diabetes and its complications; provide excellence in education for health professionals; promote collaboration, research, clinical guidelines and standards; work with its unified partners, Diabetes Australia and ADEA, to improve diabetes treatment and care; advocate for health policies relating to diabetes and its prevention; and support people living with diabetes to live well.

About ANZSPED

The Australian and New Zealand Society for Paediatric Endocrinology and Diabetes (ANZSPED) is the peak professional organisation for clinicians and researchers working in paediatric endocrinology and diabetes across Australia and New Zealand. ANZSPED promotes high standards of clinical care, education, research and advocacy to improve outcomes for children and young people living with diabetes and endocrine disorders. It also supports the development and dissemination of evidence-based care and information.