FDA to review first insulin pump with Threshold Suspend Automation

If approved by the FDA, an insulin pump that integrates a continuous glucose monitor will be the only system of its kind on the market. The MiniMed 530G system, featuring Threshold Suspend Automation, automatically suspends delivery of insulin if the sensor glucose value is equal to or below the threshold level and could be the next step to an artificial pancreas. Medtronic, Inc. filed the final module of its Pre-Market Approval application, including information from a clinical study that compared the system to conventional pump therapy. The study found that the system reduced the time people with diabetes spent below the glucose threshold. "There is a clear need for new therapies that can stop insulin delivery when glucose becomes dangerously low, which could be of great benefit if a person with diabetes is asleep or unable to react," executive director of the International Diabetes Center at Park Nicollet Health Services Richard M. Bergenstal said.