An artificial pancreas, a device that automatically regulates insulin dosage for Type 1 diabetes patients based on real-time glucose data, may be a reality soon. Medtronic ($MDT) is nearing final data for a pivotal trial of its Hybrid Closed Loop System. It reportedly expects to submit to FDA for approval by the end of June, with an anticipated launch by April 2017.
The 127-patient pivotal trial is slated to have final data on its primary outcome in May; the study just started last June. The 10-site study is slated then to expand to more than 1,000 Type 1 diabetes patients, a report in the local Colorado paper theAurora Sentinel said.
The story came after a recent visit by FDA Commissioner Dr. Robert Califf and Colorado Senator Michael Bennet to one of the pivotal study sites, the Barbara Davis Center for Diabetes on the Anschutz Campus in Aurora, CO.
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