TGA APPROVES LIFE SAVING TECHNOLOGY FOR PREGNANT WOMEN WITH TYPE 1 DIABETES
Ypsomed
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In an Australian first, the Therapeutic Goods Administration (TGA) has approved the Ypsomed mylife Loop system for use 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.
“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.
“The mylife Loop system helps manage blood sugar levels more precisely during pregnancy, constantly monitoring glucose levels and automatically adjusting insulin accordingly – and it is easily controlled using an app on the user’s phone – taking away a lot of the stress and guesswork for the mother-to-be.
“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.”
Professor of Medicine (Diabetes and Antenatal Care) Helen Murphy runs a diabetes pregnancy research program in the UK, where the NHS recommends the use of pregnancy-specific hybrid closed loop systems for all women with preexisting Type 1 Diabetes.
Professor Murphy said when it comes to automated insulin delivery systems, there is only one system that is effective for both mums with T1D and their babies before, during and after pregnancy.
“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."
The mylife YpsoPump insulin pump, the mylife CamAPS FX mobile application and the Dexcom G6 Continuous Glucose Monitoring (CGM) sensor have been approved by the TGA for use in managing glucose levels in people with Type 1 diabetes (including during pregnancy in T1 diabetes).
Controlled by the user through an app on their smartphone, the system monitors glucose and adjusts insulin delivery to help keep glucose levels within the recommended range. The app is available for both Apple iPhones and Android smart phones.
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Media contact: Katie Kimberley 0417 467 215 [email protected]