Insulet (PODD) Baird's ADA 2024 Webcast Takeaways summary

SECURE-T2D study and clinical results

• SECURE-T2D was a 305-patient, 13-week pivotal trial with a highly diverse U.S. population, including significant representation from Black, Hispanic, and lower-income groups.

• The study achieved a 0.8% average A1C reduction, with a 2.1% drop in those starting above 9% A1C, and similar improvements for both GLP-1 users and non-users.

• Time in range improved by 20 points, from 45% to 66%, translating to 5 more hours per day in range.

• High insulin users (>100 units/day) saw a 65% reduction in total daily dose, expanding eligibility for Omnipod 5.

• The study demonstrated strong patient satisfaction and willingness to continue therapy post-trial.

Market access, reimbursement, and adoption

• Over 90% of covered lives in the U.S. have access, with most patients paying less than $50/month and a third paying $0.

• On-label approval for Type 2 is expected to significantly boost adoption, especially in primary care, by enabling direct marketing and education.

• Virtual and self-guided training models showed outcomes comparable to in-person onboarding, supporting scalable adoption in PCP settings.

• Pump penetration in Type 2 remains below 5%, but CGM success in this group suggests strong future growth potential.

• Market development efforts will focus on educating both endocrinologists and PCPs to drive broader adoption.

Product innovation and competitive landscape

• Omnipod 5 is differentiated by its tubeless, easy-to-use design and broad glycemic target options, supporting both safety and patient preference.

• The next algorithm update (SmartAdjust 2.0/STRIVE) will introduce lower glycemic targets and other enhancements, with feasibility studies planned.

• Real-world data from a large, unbiased user base informs ongoing product improvements and validates safety and efficacy.

• Closed-loop therapy without bolusing is in early clinical stages, with promising initial results but no set timeline for launch.

• International expansion includes full market release of FreeStyle Libre 2 Plus Omnipod 5 in the U.K. and Netherlands, offering sensor choice.