Insulet's upcoming artificial pancreas system shows gains at all ages in Type 1 diabetes

With new data from its first pivotal study, Insulet showed that its tubeless, wearable insulin delivery system could continuously adapt to changes in glucose levels, and help provide more time in a healthy blood sugar range for adults and children with Type 1 diabetes.

The upcoming Omnipod 5 system, currently under review by the FDA, includes a waterproof, closed-loop insulin pump that attaches to the skin of a person’s back and communicates directly with a Dexcom continuous glucose monitor, while a smartphone app can be used to deliver boluses when needed.

The company collected data from two groups of patients with Type 1 diabetes, separated by age, including 128 adults and adolescents between 14 and 70, and from 112 children as young as 6. Participants used the Omnipod 5 at home for three months after using their standard therapies for two weeks, including pumps and multiple daily insulin injections.

Insulet said that after switching, adults and adolescents saw an additional 2.2 hours per day within a healthy blood sugar range, plus lower average glucose readings and an overall reduction in HbA1c from 7.16% to 6.78%. Additionally, periods of low blood sugar were cut nearly in half. 

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Children, meanwhile, gained an additional 3.7 hours per day in the target range, and saw HbA1c improvements from 7.67% to 6.99%, while reducing the daily burden in having to personally monitor and calculate insulin doses.

“With the algorithm built into the Pod itself, it is easier than ever for people with diabetes to rely on automated insulin delivery to manage their blood glucose levels and keep them in range,” said the study’s principal investigator, Gregory Forlenza, M.D., an assistant professor at the University of Colorado’s Barbara Davis Center for Diabetes. The trial’s data was presented at the annual meeting of the Endocrine Society.

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The pivotal study was briefly paused early last year, after the company found an anomaly in the device’s software, which could in rare instances cause the automated system to use an incorrect blood glucose value when calculating insulin delivery. Insulet said no adverse events were reported by the time the study was paused.

Insulet said it plans to launch the Omnipod 5 system—formerly named the Omnipod Horizon, and which previously received a breakthrough device label from the FDA—in a limited release before the end of June. Meanwhile, the company is currently recruiting participants for a study of the system in Type 2 diabetes.