US-based diabetes care company Embecta has received the US Food and Drug Administration (FDA) 510(k) approval for its in-house-developed disposable insulin delivery system.
The insulin delivery device is indicated for adults who require insulin to manage diabetes, including both type 1 (T1D) and type 2 (T2D).
The system features a tubeless patch pump, with a 300-unit insulin reservoir, designed based on feedback from people with T2D and their healthcare providers.
In a recent study, a 300-unit insulin reservoir met the needs of 64% of adults with T2D for three-day wear, while a 200-unit reservoir addressed the needs of 38% of that same population.
Embecta CEO Dev Kurdikar said: “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.
“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.”
The insulin delivery system comes with a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days, as per the user’s needs.
The patch pump features a 300-unit insulin reservoir that accommodates people who have higher daily insulin needs, which is typically true of people with T2D.
In addition, the system comprises a locked-down controller featuring Bluetooth wireless technology with a touchscreen designed to create a simplified interface and user experience.
The patch pump development program also includes plans for a closed-loop version with an insulin-dosing algorithm in a future FDA submission, said the diabetes care company.
Embecta chief technology officer Colleen Riley said: “Our research and development, medical affairs and regulatory teams identified an unmet need within the diabetes community and shepherded this project from concept to clearance with dedication and diligence.
“I want to thank the embecta team for their commitment to serving people with diabetes and thank the FDA for their timely review and clearance of a system that has the potential to reduce the burden of managing diabetes for more people and significantly move innovation in this area forward.”
