Medtronic has enrolled its first patient on the ASPIRE study of its MiniMed Paradigm x54 System, which aims to identify the clinical data needed for US Food and Drug Administration approval.
The MiniMed combines a continuous glucose monitor and insulin delivery system with Medtronic’s low glucose suspend automation, a system that halts the delivery of insulin if blood-glucose levels drop below pre-defined parameters.
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This investigational device exemption study will assess the efficacy of this function in reducing the duration and severity of hypoglycaemia.
Low glucose suspend automation is available in 35 countries outside of the US as part of Medtronic’s Paradigm Veo System.
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