Embecta has secured an FDA clearance for its first wearable insulin delivery system, with a patch pump designed for people with either Type 1 or Type 2 diabetes.
The fully disposable device includes a 300-unit insulin reservoir, which embecta said could last most users with Type 2 diabetes about three days, based on the average amounts taken by people relying on multiple daily injections to control their blood sugar levels.
According to the company, although about 90% of people with diabetes have Type 2, many of today’s automated delivery devices were first designed for people with Type 1—which typically requires smaller daily doses of insulin—resulting in unmet needs within the population of users.
For example, a study from embecta found that a 300-unit reservoir would last three days for 64% of adults with Type 2 diabetes, while carrying 200 units would only meet the needs of 38%.
“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,” CEO Dev Kurdikar said in a statement.
The diabetes company, spun out of BD in early 2022, has a decades-long history of supplying manual insulin pen needles and syringes, among other accessories.
The new wearable, which received a 510(k) clearance as an alternate controller-enabled insulin infusion pump, also connects with a dedicated, touchscreen-operated controller unit.
Looking ahead, Embecta is developing a closed-loop version of its tubeless patch pump, which would automatically respond to readings from a continuous glucose monitor; the company said it plans to submit the system to the FDA for review in the future.
For the insulin-dosing algorithm, the company has been collaborating with diabetes software developer Tidepool. The former Fierce Medtech Fierce 15 winner received an agency clearance for its own artificial pancreas app in early 2023.
Tidepool’s software was also recently featured in a new automated insulin pump designed by Dean Kamen’s Deka Research & Development, which will launch commercially through Sequel Med Tech for people with Type 1 diabetes.
Embecta’s FDA green light comes shortly after the agency’s first clearance for an automated insulin pump in Type 2 diabetes, with Insulet’s tubeless, patch-based Omnipod 5.