Groups Dislike FDA-Recommended Trial Designs For Low-Glucose Suspend Systems
This article was originally published in The Gray Sheet
Executive SummaryFDA’s recommended trial designs for early versions of “artificial pancreas” devices for type 1 diabetes patients are overly burdensome and will hinder development in the space, device makers and clinical societies say.
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Draft issued Dec. 1 emphasizes flexible clinical trial designs to support approval of glucose monitor/insulin pump combination devices that work together without the need for patient intervention.