ADA: Insulet delivers first outpatient data for its wearable, closed-loop insulin pump

Insulet delivered the first outpatient data and at-home evaluations of its upcoming Omnipod 5—the tubeless, smartphone-controlled, wearable insulin pump formerly known as the Omnipod Horizon.

The waterproof delivery system, which attaches to the skin of a person’s back, is designed to communicate directly with a Dexcom continuous glucose monitor. The device manages the background insulin algorithm itself and can operate in a closed loop on its own while a smartphone app is used to deliver boluses.

Early data on its use by adults, adolescents and children with Type 1 diabetes were presented virtually at the annual Scientific Sessions of the American Diabetes Association. 

The study followed participants over a number of weeks spanning last year’s winter holidays—a time when maintaining a healthy glucose range can be especially difficult for some, according to the study’s presenter, Bruce Buckingham, a professor emeritus in pediatrics, endocrinology and diabetes at Stanford University.

Compared to standard therapy, the Omnipod system helped improve adult participants’ time in a healthy blood sugar range—from 65.5% up to 73.8%—over a four- to nine-week period where they were able to set their own glucose targets based on meals and activity, including overnight. Among children, that time in range was increased from 51% to 70.1%.

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There were no serious adverse events, including no episodes of ketoacidosis or severe episodes of low blood sugar, according to the study.

An additional study of the Omnipod 5 was paused earlier this year after Insulet caught a software glitch that could have caused the system to use incorrect blood glucose values in rare instances.

No adverse events had been reported due to the issue at the time, according to the company, which said the study was about halfway complete when it was paused. 

The study recently resumed earlier this month following a software update. The delay pushed back plans for a commercial launch to the first half of 2021 instead of the second half of this year.