Two trials are planned as part of the NIH-funded study. In the first study, 240 patients with type 1 diabetes will test the safety and effectiveness of the artificial pancreas for six months while going about their regular daily routines. The artificial pancreas will be compared with a standard insulin pump on two key measures: how well blood-sugar levels are controlled and whether the risk of hypoglycemia, or low blood sugar, is reduced.
A second trial will follow 180 patients who completed the first study for an additional six months to test the Harvard University-developed algorithm and determine whether it further enhances blood sugar control.