Omnipod 5 Receives FDA Approval
Editor’s Note: Pod and Dexcom G6 shown without the necessary adhesive in accompanying images.
On Friday, January 28, 2022, Insulet’s Omnipod 5 automated insulin dosing (AID) system received FDA approval for individuals with type 1 diabetes, ages six years and older. Omnipod 5 will launch through the pharmacy channel following a limited market release. Full market release dates (i.e. full public availability) are not yet known. AID systems are also commonly known as closed-loop or artificial pancreas systems.
The Omnipod 5 is the only FDA-approved patch pump—meaning it has no tubing and sits directly on the skin—with a closed-loop insulin delivery system, as well as the only FDA-approved closed-loop system that can be controlled with a smartphone. Users will still be able to use Omnipod’s handheld controller, the Personal Diabetes Manager (PDM), if they prefer.
The approval followed Omnipod 5’s pivotal trial, which published study data in June 2021. In adults, the study showed increased time-in-range (TIR)—the percentage of time a person’s blood glucose level is in a healthy target range—from 65 to 74 percent, which translates to 2.2 hours more TIR per day. Study participants saw an average reduction of HbA1c from 7.16 to 6.78 percent, with mean glucose levels decreasing from 161 to 154 mg/dL.
In children, the study showed similar improvements—TIR increased from 53 to 68 percent or an additional 3.7 hours per day, HbA1c was reduced from 7.67 to 6.99 percent, and mean glucose levels decreased from 183 to 160 mg/dL.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, President and Chief Executive Officer of Insulet, in a press release issued by the company. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”
AID systems integrate with continuous glucose monitors (CGM). With regular readings from a CGM, the pumps alter insulin dosing based on carefully programmed algorithms combined with each person with diabetes’ specific insulin needs, including background basal rate, carb ratios, etc. Previously available closed-loop systems were Tandem’s Control-IQ (which integrates with the Dexcom G6 CGM) and Medtronic’s MiniMed 670G and 770G (which integrates with Medtronic’s CGM, the Guardian™ Connect system). The Omnipod 5 closed-loop technology is called SmartAdjust™.
In each system, when the wearer’s blood sugar levels are predicted to be or are already high, the pump slightly increases insulin delivery. When the wearer’s blood sugar levels are expected to be or are already low, the pump slightly decreases or altogether stops insulin delivery.
Low or high blood sugars also trigger alarms through the CGM, alerting the user that additional action may need to be taken. Closed-loop users can also set the insulin pumps to different blood sugar targets, with specific features dependent on the pump.
By releasing through the pharmacy channel, individuals with health insurance who want to try the Omnipod 5 will be able to bypass the durable medical equipment (DME) coverage system, which typically offers lower insurance coverage (leading to higher out-of-pocket costs) for insulin pumps and insulin pump supplies. For help navigating health insurance coverage with diabetes, visit our health insurance guide, originally created by our partners at JDRF.
This content mentions Insulet, an active partner of Beyond Type 1.
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