Embecta Submits 501(k) Filing to FDA For Proprietary Disposable Insulin Delivery System


The proprietary disposable insulin delivery system promises to be a more convenient, individualized, and accessible treatment option for patients with diabetes.

Last week, Embecta Corp. (embecta) announced in a press release that it had submitted a 510(k) premarket filing to the FDA for its proprietary disposable insulin delivery system.1

In moving forward with its product, embecta hopes to bring a more convenient, individualized, and accessible treatment option to market for patients with diabetes.

“While 9 out of 10 people with diabetes are living with type 2 diabetes (T2D), the majority of the automated insulin delivery solutions currently on the market were designed for people living with type 1 diabetes (T1D),” said Henry Anhalt, DO, chief medical officer at embecta.1 “The broader diabetes care community—including clinicians, caregivers, and people living with T2D—desires more individualized therapeutic options and tools designed to lighten the burden of managing diabetes and to improve outcomes for each of the growing number of people living with diabetes.”

Automated insulin delivery systems have emerged as dominant technologies to help manage diabetes among patients with T1D and T2D in the clinical space. By administering automatic correct doses of insulin to users, delivery systems like continuous glucose monitors and insulin pumps alleviate some of the burden associated with managing the disease.2

Although T2D accounts for 90% of the 463 million-plus cases of diabetes worldwide, most technological research in diabetes management has catered to T1D.3 The lack of understanding on automatic insulin delivery treatment regimens for T2D has contributed to a hesitation among patients and health care professionals to interact with diabetes technologies due to unforeseen complications.3

In turn, this hesitation keeps patients and health care professionals from benefitting from these potentially life-changing technologies.

Despite differences in pathophysiology between T1D and T2D, adapting technologies for T1D to address the specific needs of T2D presents the opportunity to improve patient outcomes. By releasing its proprietary disposable insulin deliver system, embecta aims to seize this opportunity and bridge the technology gap between the 2 diabetes subtypes.

“This patch pump is intended for people who require insulin to manage diabetes and is informed by the unique needs of people with T2D and their healthcare providers,” said Collen Riley, chief technology officer at embecta.1 “We worked with them to address the needs of those who may require more daily insulin and are looking for a simplified and convenient option for automated insulin delivery that offers the ease of use and discretion of a patch pump, along with a larger 300 U insulin reservoir.”

In the future, the company plans to further its patch pump development plan with the introduction of a closed-loop version of its current pump equipped with an insulin-dosing algorithm.

1. embecta announces FDA 510(k) submission for insulin patch pumps. News release. embecta. January 9, 2024. Accessed January 12, 2024. https://investors.embecta.com/news-releases/news-release-details/embecta-announces-fda-510k-submission-insulin-patch-pump
2. Sherr JL, Heinemann L, Fleming GA, et al. Automated insulin delivery: benefits, challenges, and recommendations. A consensus report of the joint diabetes technology working group of the European Association for the Study of Diabetes and the American Diabetes Association. Diabetologia. 2023;66(1):3-22. doi:10.1007/s00125-022-05744-z
3. Daly A, Hovorka R. Technology in the management of type 2 diabetes: Present status and future prospects. Diabetes Obes Metab. 2021;23(8):1722-1732. doi:10.1111/dom.14418
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