I speak with the first patient in a groundbreaking type 1 diabetes cure research trial using encapsulated neonatal pig islet cells—without immunosuppression. Six months after his transplant through the OPF-310 study led by Otsuka Pharmaceutical and University of Illinois Chicago, Michael Revland's insulin needs have been cut in half as the cells have begun maturing and producing insulin. We dive into how this porcine islet cell transplant works, why it differs from stem cell and donor islet trials, and the risks and rewards of pursuing insulin independence. He also shares why he declined an immunosuppression-based transplant study and the emotional highs and lows of being patient number one.

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DISCLAIMER: This podcast is not medical advice and is for educational purposes only. Always consult with your doctor before making changes to your health care.

*10-day trial eligibility may vary. Full terms and conditions apply. Visit omnipod.com/diabetech for clinical disclaimers, terms and important safety information. The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller is not waterproof.

I’m joined by Naomi Schwartz, former FDA diabetes reviewer and VP of regulatory strategy at Medcrypt, who shares firsthand insight into how device classifications, De Novo pathways, and FDA warning letters work. We break down why the FDA can feel like a barrier to innovation, how DIY diabetes tech and cybersecurity risks are evaluated, and the difference between wellness devices and regulated medical devices. We examine recent workforce disruptions from DOGE and political pressure—and what all of this means for the future of med tech innovation and patient safety.

Learn about the Eversense 365 CGM

Learn about Omnipod 5 (today's sponsor)*

Join the Diabetech Newsletter

Follow Diabetech: Instagram | Tik Tok | YouTube | Facebook | Threads

DISCLAIMER: This podcast is not medical advice and is for educational purposes only. Always consult with your doctor before making changes to your health care.

*10-day trial eligibility may vary. Full terms and conditions apply. Visit omnipod.com/diabetech for clinical disclaimers, terms and important safety information. The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller is not waterproof.

I speak with Portal Diabetes about how its next-generation implantable pump could bring this technology back—smaller, smarter, and potentially fully closed loop using CGM data. Because insulin is delivered into the intraperitoneal cavity, it acts far faster and clears the body quicker than subcutaneous insulin, which could mean fewer highs and lows and far more spontaneity. I ask them how the pump works, what the surgery and refills look like, and what real users have shared about living with an implantable pump. We even do a live demo—so if you want to see it in action, check out the video on YouTube or clips on my social channels.

Learn about the Eversense 365 CGM

Learn about Omnipod 5 (today's sponsor)*

Join the Diabetech Newsletter

Follow Diabetech: Instagram | Tik Tok | YouTube | Facebook | Threads

DISCLAIMER: This podcast is not medical advice and is for educational purposes only. Always consult with your doctor before making changes to your health care.

*10-day trial eligibility may vary. Full terms and conditions apply. Visit omnipod.com/diabetech for clinical disclaimers, terms and important safety information. The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller is not waterproof.