T1D1 and Comerge AG Announce FDA Submission of First-Ever Over-the-Counter Insulin Calculator App
July 7, 2025
Author: Laura Mendelow, T1D1 Foundation (501(c)(3))
Author: Laura Mendelow, T1D1 Foundation (501(c)(3))
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T1D1, a nonprofit organization committed to empowering people living with Type 1 diabetes, in partnership with Comerge AG and Diabetes Center Berne (DCB), is proud to announce the official submission of its FDA 510(k) application for the T1D1 mobile app—the first ever Over-the-Counter (OTC) insulin calculator designed to support individuals newly diagnosed with Type 1 diabetes.
Once cleared, T1D1 will provide a free, easy-to-use mobile tool that enables users to calculate insulin doses safely, without requiring a prescription—filling a critical gap in the early days following diagnosis when families are often overwhelmed and in need of trusted, accessible support. 
T1D1 Team @ Comerge in Zurich
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Moment of submission to the FDA!
“This is a major milestone not just for our team, but for the entire T1D community,” said Mike Mendelow, Co-Founder of T1D1. “T1D1 was created to help people, especially children and teens, manage their new diagnosis with greater confidence and independence. I remember how scared and overwhelmed we were when our son was newly diagnosed. I wished we had this tool to not only help us calculate easily but to give us peace of mind. We hope to get this into the hands of everyone who needs it, from day 1 of diagnosis.” |
Built in collaboration with Comerge AG, a leading Swiss software development firm with deep expertise in regulated medical device software, the T1D1 app has been designed to meet rigorous clinical standards while remaining intuitive and user-friendly. The development process has included close collaboration with diabetes care professionals, people living with Type 1 diabetes, and caregivers ensuring the app reflects the real-world needs of the community it serves. In addition, the T1D1 team could not have achieved this milestone without their industry partners at Dexcom who graciously led the Human Factors studies allowing the team to complete the FDA application.
“From day one, this project has been about creating something simple, smart, and safe,” said Andreas Pedroni, Senior Data Scientist at Comerge. “We are proud to bring our medical software development experience to such a meaningful mission and to contribute to a product that has the potential to make a real difference—especially for families at the beginning of their diabetes journey.”
The app includes features such as:
With the 510(k) submission now in progress, T1D1 and Comerge are preparing for the next phase: bringing the app to the public following FDA clearance.
- Real-time insulin dose calculations based on user inputs
- Offline capability, ensuring access even in low-connectivity areas
- Personalized settings for insulin-to-carb ratios and correction factors
- Secure data handling and syncing when Wi-Fi is available
- Designed for easy access, no prescription required, and always free to use
With the 510(k) submission now in progress, T1D1 and Comerge are preparing for the next phase: bringing the app to the public following FDA clearance.
“This isn’t just about technology—it’s about equity, access, and easing the burden for people who need support the most,” Mendelow added. “We’re incredibly grateful to Comerge, Diabetes Center Berne (DCB), Dexcom, and the broader T1D1 community for helping make this vision a reality.”
For updates on the FDA review process and to learn more about the app’s upcoming launch, visit www.t1d1.org and follow along on Instagram.