On September 30, 2025, Tandem Diabetes Care announced that its t:slim X2 insulin pump with Control‑IQ+ automated insulin delivery technology has received FDA clearance for use with Eli Lilly’s Lyumjev (insulin lispro‑aabc) ultra‑rapid insulin in the United States.
The clearance was based on a 13‑week, multicenter study involving 179 participants, which demonstrated high satisfaction and quality‑of‑life benefits when using Lyumjev with the t:slim X2 system. This expands the pump’s compatible insulin options beyond Humalog and Novolog, giving patients and clinicians more flexibility in insulin selection.
By enabling Lyumjev use, Tandem broadens its product appeal to individuals who prefer ultra‑rapid insulin for tighter glucose control, potentially driving additional pump starts and reinforcing its competitive position in the AID market. The FDA approval also supports Tandem’s strategy of offering a comprehensive, choice‑driven diabetes technology ecosystem.
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