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Tandem wins clearance for t:slim X2 pump with Eli Lilly fast-acting insulin in Europe

September 19, 2024 By Sean Whooley

Tandem Diabetes Care t_slim X2 automated insulin pump Abbott FreeStyle Libre 2 Plus
t:slim X2 Insulin Pump from Tandem Diabetes Care with Abbott’s Freestyle Libre 2 Plus sensor. [Image courtesy of Abbott/Tandem Diabetes Care]
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received clearance for the use of rapid-acting insulin with its t:slim X2 pump.

The company can now offer its automated insulin delivery (AID) system with Eli Lilly’s Lyumjev (insulin lispro-aabc injection) ultra-rapid-acting insulin in Europe.

Previously, the t:slim X2 pump had clearance for use with Humalog and Novolog/NovoRapid U-100 insulins globally. It also had approval for Admelog/Insulin lispro Sanofi and Trurapi/Insulin aspart Sanofi U-100 in Canada and select European countries.

Lyumjev won authorization for general use in insulin pumps in the EU in 2020, having also won FDA approval that year. However, manufacturers have to perform extensive testing to verify compatibility with individual insulin pumps and AID systems.

Tandem and Lilly collaborated to support a clinical trial demonstrating the benefits of Lyumjev with Control-IQ automating technology. The companies continue working to secure compatibility for the t:slim X2 pump in other regions and to integrate it with Tandem’s Mobi pump.

“High satisfaction and quality of life benefits were recently shown in a clinical study using Lyumjev with Control-IQ technology,”1 said Dr. Jordan Pinsker, chief medical officer at Tandem Diabetes Care. “Ultra-rapid acting insulin is a popular choice for people living with diabetes due to its fast response time. We are proud to be able to offer Lyumjev compatibility with our t:slim X2 pump as part of an AID system in the EU, providing more flexibility for our customers in these countries.”

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Technology Tagged With: Tandem Diabetes Care

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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