Diabetes Dialogue: Lingo Availability and FDA Clearance for Embecta's Tubeless Patch Pump

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss US availability of the Abbott Lingo and Embecta’s announcement of US Food and Drug Administration (FDA) clearance for their tubeless patch pump with a 300-unit insulin reservoir.

Abbott Lingo Availability

On September 05, 2024, Abbott announced US availability of their over-the-counter continuous glucose monitoring system, the Lingo. Designed for consumers 18 years and older not on insulin, is priced at $49 for 1 biosensor worn for up to 14 days or $89 for 2 biosensors.

The announcement of availability comes less than 2 weeks after Dexcom announced the availability of the Stelo and less than 3 months after Abbott announced the FDA clearance of the Rio and Lingo systems.

Editor's note: During this episode, hosts reference a 15-day wear time for this system, the Lingo can be worn for up to 14 days, according to Abbott.

Embecta Approval

On September 03, 2024, Embecta Corporation announced the US FDA had granted 510(k) clearance for their disposable patch pump for insulin delivery for use in adults who require insulin to manage diabetes. Including both 1 and type 2 diabetes within this indication, the FDA clearance means patients will have access to a tubeless patch pup boasting a 300-unit insulin reservoir designed based on feedback from people with type 2 diabetes and healthcare providers.

According to the company, the 300-unit insulin reservoir will offer a distinct advantage compared to other systems, citing a recent study finding a reservoir of this size would meet the needs of 64% of adults with T2D for three-day wear, while a 200-unit reservoir would only meet the needs of 38% of that same population. In their announcement, Embecta pointed out patch pump development program also includes plans for a closed-loop version including an insulin-dosing algorithm in a future FDA submission.

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.