Insulet unveils early 'artificial pancreas' feasibility data

Insulet's hybrid closed-loop system is based on its tubeless insulin-delivering pod device.

Medtronic’s hybrid closed-loop system was the first “artificial pancreas” to snag FDA approval, but it may not be the last. Insulet announced positive data from the first feasibility study of its own hybrid closed-loop system for adults with Type 1 diabetes.

The Omnipod Horizon hybrid closed-loop system is based on Insulet’s Omnipod Insulin Management System, which uses a pod worn on the body to deliver insulin rather than a catheter. It continuously administers the hormone based on an individual’s settings and allows the patient to request bolus doses with a wireless, hand-held device.

The 36-hour study involved 24 adults with Type 1 diabetes. The participants used a modified version of the Omnipod device, a Dexcom glucose sensor and Insulet’s predictive control algorithm, according to a statement.

The data showed patients using the system spent less time in hypoglycemia than they did before the study, the company said. And they stayed in their target blood glucose control range 69% of the time, while keeping overnight glucose under control 90% of the time.

“These very positive results, particularly in the overnight period, demonstrate the potential for the Omnipod Horizon System to improve clinical outcomes in patients with type 1 diabetes,” said Bruce Buckingham, M.D., the principal investigator and a professor of pediatric endocrinology at the Lucille Salter Packard Children’s Hospital, Stanford University, in the statement.

While promising, the findings are still early, and the system has more clinical tests ahead. “This is a safe system providing significant reductions in hypoglycemia both during the day and night, and the system made significant improvements in overnight glucose control, decreasing glucose variability and bringing fasting glucose values into range,’ Buckingham said.

Medtronic’s system scored the FDA green light in September and the company plans to launch it this spring.