Insulet first disclosed plans to make a fully closed loop system last year. Chief Operating Officer Eric Benjamin, speaking at an investor event, said the company was starting with Type 2 diabetes because people with Type 1 expect tight glycemic control and have a higher risk of hypoglycemia. The diabetes tech firm shared results of a small feasibility study in March showing that users of the system spent more time in range than people who used standard injection therapy to manage their diabetes.

For Insulet’s pivotal trial, called Evolve, the firm plans to enroll up to 350 adults across 40 sites in the U.S. Study participants must have Type 2 diabetes and use insulin to manage their care.