Medtronic announced that the FDA has approved MiniMed 530G with Enlite, a first-generation artificial pancreas system with Threshold Suspend automation for patients with diabetes aged >16 years. 

This device is the first of its kind because it can automatically suspend insulin delivery when sensor glucose values reach a preset level and when the patient doesn’t respond to the Threshold Suspend alarm.

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The healthcare provider can set the threshold between 60–90mg/dL. Once the threshold is met, the MiniMed 530G system will first alert the wearer with an alarm. If the individual is sleeping, unconscious or otherwise unable to react, the system will suspend insulin delivery for two hours, which can be resumed at any time.

The Enlite sensor is a continuous glucose sensor that has demonstrated 31% improvement in overall accuracy from the previous generation and can detect up to 93% of hypoglycemia episodes when predictive and threshold alerts are on. It is 69% smaller than the previous Medtronic sensor and provides a simpler insertion process with a hidden-introducer needle. The sensor can be worn for six days.

Medtronic is preparing for a launch in the next several weeks.

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