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Medtronic announced Wednesday the FDA approval of its MiniMed 670G system, which the company remarked is the "first hybrid closed loop insulin delivery system approved anywhere in the world." The system, which is approved for the treatment of people with type 1 diabetes aged 14 years and older, will be launched in the spring of 2017, Medtronic added.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said "this first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin."
According to the FDA, the approval was based on data from a clinical trial that included 123 participants with type 1 diabetes. The agency said the system was shown to be safe for use in people aged 14 years and older with type 1 diabetes, with no reports of serious adverse events, diabetic ketoacidosis or severe hypoglycaemia. As part of this approval, the FDA is requiring a post-market trial to better understand how the MiniMed 670G system performs in real-world settings, while Medtronic is performing clinical trials to evaluate the safety and effectiveness of the device in children aged seven to 13 years.
The system features the SmartGuard HCL algorithm, of which Richard M. Bergenstal, principal investigator of the pivotal study, said offers "the ability to automate basal insulin dosing 24 hours a day…minimising glucose variability and maximising time in the target ranges." Additionally, the device features the Guardian glucose sensor, which Medtronic said is the "first and only sensor approved by the FDA to control a hybrid closed loop system" and incorporates diagnostic technology that continuously monitors sensor health.
Medtronic added that regulatory approval of the MiniMed 670G system is expected outside of the US in the summer of 2017.
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