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.

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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 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.

Gary and I take on one of the most important skills in modern diabetes management: understanding and using your data. We break down how to analyze CGM and pump data to identify patterns, trends, and problem areas without getting overwhelmed by numbers. The conversation covers basal insulin, bolus timing, insulin to carb ratios, correction factors, and what metrics like time in range and glucose variability actually tell you about your settings. We also discuss when to make adjustments on your own and when to involve a diabetes educator.

Learn about the Eversense 365 CGM

Learn about Omnipod 5 (today's sponsor)*

Learn About Integrated Diabetes (Gary’s Practice)

Send in YOUR questions!

Join the Diabetech Newsletter

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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.

Using biometrics like heart rate, stress, and activity to automate insulin delivery in real time, Rheos is a next-generation AID system designed to learn and adapt directly from the body. I sit down with Jonathan Fitch, Founder of GlucoSense, to explore how this settings-free, AI-powered AID system uses wearable data to continuously adapt insulin needs throughout the day. We get into features like logging meals by photo or voice, planning workouts through an in-app LLM, and how the system dynamically adjusts dosing based on real physiological signals. Jonathan also shares how a life-threatening seizure during college pushed him to rethink diabetes automation—and how that experience shaped Rheos’ goal of dramatically reducing the daily management burden.

Learn about the Eversense 365 CGM

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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.

Insulin pump access in the U.S. is changing fast, with more companies moving to pharmacy benefits and making it easier than ever for people with diabetes to start—or switch—systems. While this shift brings more choice and flexibility, it’s also exposing serious challenges around safety, training, and continuity of care. As AID systems become more complex and less interchangeable, switching pumps isn’t as simple as transferring settings anymore. In this episode, Diana Isaacs, PharmD, CDCES joins me to break down what’s really happening as pump transitions become more frequent and why both users and healthcare providers are feeling the strain. We talk about why confusion is increasing, where transitions often go wrong, and what needs to change to make pump switching safer and more effective for everyone.

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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. 

Co-host Gary Scheiner, CDCES, and I break down basal insulin and why it is the foundation of insulin therapy. We explain what basal insulin does, how it controls liver glucose between meals and overnight, and why incorrect settings can cause constant highs and lows even with advanced diabetes tech. We also cover common basal insulin mistakes, how pumps and automated insulin delivery systems handle basal differently, and answer listener questions about what your data can tell you when basal is off.

Learn about Omnipod 5 (today's sponsor)*

Learn About Integrated Diabetes (Gary’s Practice)

Send in YOUR questions!

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.

2025 delivered major innovations in diabetes tech as well as surprising twists and today we explore the wins, the fails, and what these trends mean for people living with diabetes. I sit down with Kamil Armacky of Nerdabetic to unpack everything from Libre 3 Plus expanding pump integrations, updates and sensor recall, to Dexcom’s new 15-day sensor and how the community feels about it. We also dive into major industry shifts, including Medtronic Diabetes separating to form MiniMed, Omnipod’s roadmap for Omnipod 6 and beyond, and Eversense taking full control of its implantable business. This is a big one!

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.

What happens when diabetes tech doesn’t do what you need—and you decide to build the solution yourself? I sit down with Pablo Medina, who was recently diagnosed with type 1.5 diabetes and built his own iPhone app to fix gaps in insulin patch tracking. We get into his misdiagnosis journey, his experience with devices like InPen, Cequr Simplicity, and why he’s now trialing the Omnipod 5 AID system. Pablo walks me through how his insulin patch tracker app works, the challenges of building and publishing a diabetes app, and why patient-driven innovation matters. This conversation highlights what happens when people with diabetes combine lived experience with technical skills to push diabetes technology forward.

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.

Medtronic, soon-to-be MiniMed, officially launched its brand-new Instinct CGM in the U.S., a 15-day, no-calibration sensor that pairs seamlessly with the 780G insulin pump. I sit down with Medtronic’s Laura Endres to break down everything. Laura gives us a live demo of the Instinct applicator, explains how it integrates with both the 780G and the upcoming MiniMed Go smart pen platform, and shares why Medtronic partnered with Abbott to bring this sensor to market so quickly. We also get into how Instinct compares to Simplera, why users might choose one over the other, and what the roadmap looks like for next-generation pumps, algorithms, and the upcoming MiniMed spin-off.

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.

On our new show Optimizing Diabetes Tech (ODT) my co-host Gary Scheiner CDCES and I discuss how people with diabetes can take full advantage of their continuous glucose monitors to make managing Diabetes easier and safer. We get into how to react to alarms, adjust settings, and the features you need to know about. We also answer your questions about CGMs.

Learn about Omnipod 5 (today's sponsor)*

Learn About Integrated Diabetes Services (Gary’s Practice)

Send us YOUR questions!

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.