Tubeless insulin patch pump receives FDA clearance for type 1 and type 2 diabetes
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Key takeaways:
- The FDA granted 510(k) clearance for a tubeless insulin patch pump system.
- The system includes a patch pump with 300 U insulin reservoir designed to be used for up to 3 days.
The FDA has granted 510(k) clearance for an insulin patch pump for adults with type 1 or type 2 diabetes, Embecta Corp. announced.
The FDA cleared Embecta’s disposable insulin delivery system, which includes a tubeless patch pump with a 300 U insulin reservoir that allows for adjustable basal and bolus insulin for up to 3 days, according to a press release issued by the company. The system also includes a locked-down controller with Bluetooth wireless technology and a color touch screen.
The system’s design was informed by feedback from people with type 2 diabetes and providers, according to the release. A study sponsored by Embecta found the 300 U insulin reservoir would meet the 3-day insulin needs of 64% of people with type 2 diabetes, whereas a 200 U reservoir would meet the insulin needs of 38% of those with type 2 diabetes.
“FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching Embecta as an independent company, and achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes,” Dev Kurdikar, CEO of Embecta, said in the release. “As we continue to advance toward our vision of a life unlimited by diabetes, our team has focused on developing a patch pump that could address some of the most significant obstacles to adopting pump therapy for people who use insulin daily to manage their diabetes. This platform is also serving as the basis for an automated insulin delivery system in development.”
In the release, Embecta said it plans to submit a closed-loop version of its system along with an insulin dosing algorithm to the FDA in the future.
Perspective
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
I am very excited about a new tubeless pump option for people with diabetes. Many of my patients want a tubeless option because of its simplicity compared to tubed pumps. They are easier to fill with insulin and put on. There’s not the worry of getting the tubing caught on things, and it’s easier to utilize different sites on the body.
Prior to this approval, the only tubeless option held 200 U of U100 insulin. While there are concentrated insulins, these are off-label and increase the risk for dosing errors when put into the pump. A 300 U tubeless pump option will be a good solution for people with insulin resistance who require higher doses.
It’s great that this is FDA-approved for type 1 and type 2 diabetes. While this first model will be a manual insulin pump, I am hopeful to see a future approval of this pump as a full automated insulin delivery system.
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