First diabetes device for pregnant women TGA approved, but subsidy gaps limit access

In a national first, the Therapeutic Goods Administration (TGA) has approved a medical device for managing glucose levels in people with Type 1 diabetes during pregnancy.

“The mylife Loop system is proven to significantly improve the management of diabetes for women, reducing the risks to both mother and baby, and now it has been approved by the TGA,” said Ypsomed Managing Director Sylva Bardzamian.

Australia faces one of the highest rates of Type 1 diabetes globally, with more than 3,000 new diagnoses in the past year alone. Currently, over 137,700 Australians live with the condition – a number that continues to rise.

The mylife Loop system integrates three key technologies: the mylife YpsoPump insulin pump, the mylife CamAPS FX mobile application, and the Dexcom G6 Continuous Glucose Monitoring (CGM) sensor. Together, they form a hybrid closed loop system that can be fully managed from a smartphone.

“Women with Type 1 diabetes are more likely to face pregnancy complications, so staying in a pregnancy-specific glucose target range is so important for the baby’s development and the mother’s health,” added Bardzamian.

While many Australians living with type 1 diabetes have affordable access to CGM, they cannot afford insulin pumps. Only around 24% of people living with type 1 diabetes are currently able to access this technology. This is significantly lower than in comparable countries including the United States where an estimated 63% of adults and 58% of children and young people use an insulin pump to manage type 1 diabetes.

“Ypsomed is asking the Federal Government to expand its diabetes subsidies scheme to ensure all women with T1D who are pregnant or planning a pregnancy can benefit from the mylife Loop technology,” added Bardzamian.

This call aligns with a broader push from Diabetes Australia, the Australian Diabetes Society, and the Australian Diabetes Educators Association, all of whom are urging expanded subsidised access to insulin pumps and automated insulin delivery (AID) systems for Australians living with Type 1 diabetes.

The clinical benefits of AID systems are well established. By linking insulin pumps to CGM, AID systems automatically adjust insulin doses in real time based on glucose readings – reducing the burden of constant manual calculations and improving glycaemic stability. With more than 90,000 Australians already accessing subsidised CGM, experts argue it is time insulin pump therapy became equally accessible.

Professor Helen Murphy, Professor of Medicine (Diabetes and Antenatal Care) in the UK, leads a diabetes pregnancy research program where the NHS recommends hybrid closed loop systems for all women with pre-existing Type 1 diabetes.

“mylife Loop quite literally saves babies’ lives – there is no other system that can match it for clinically relevant improvement in maternal glucose,” said Professor Murphy.

“During pregnancy, women with T1D have much tighter glucose targets than at any other time in their lives. The stakes are also much higher, because mums and babies’ lives quite literally depend on getting the right dose of insulin at the right time for the right mum.”

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