FDA Clears T1D1: The First FREE, Over-the-Counter FDA-Cleared Insulin Calculator App for Type 1 Diabetes Management

For Immediate Release

August 27, 2025
​Author: Laura Mendelow, T1D1 (501(c)(3))
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Gaithersburg, MD USA – [August 27, 2025] – The FDA has officially cleared T1D1 (Type 1 from Day 1). T1D1 is the first FDA cleared over-the-counter mobile app that helps individuals with Type 1 Diabetes (T1D) calculate insulin doses, track daily data, and share insights with healthcare providers—putting powerful, personalized tools directly in the hands of those who need them most. And, it's completely free!

T1D1 is especially impactful for kids and teens newly navigating the complexities of life with diabetes. In fact, it was originally created by a 13-year-old just one month after his own diagnosis—a young person determined to make the daily management of T1D easier and safer for himself and others.

T1D1 worked in partnership with three key organizations:

• Diabetes Center Berne provided the initial funding to support the T1D1 efforts to redesign the app per FDA standards. 
• Comerge AG , the registered manufacturer, enlisted a team of software engineers, regulatory experts, and design professionals to ensure T1D1 was FDA-ready.
• Dexcom graciously conducted the Human Factors study to ensure safety and accuracy. 

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“This isn’t just an app—it’s a lifeline for kids, parents, and caregivers who are suddenly faced with hundreds of critical decisions every day,” said Drew Mendelow, co-creator of T1D1. “The goal is to help people living with T1D feel more confident and supported as they manage their condition in real time.”

T1D1's Mission and Values:

Founder and original developer, Drew Mendelow, had a clear mission in mind when he first developed T1D1 in 2020. His vision was to provide a free, easy-to-use bolus calculator for people with Type 1 Diabetes to help make their lives just a little easier. Throughout all of development over the past five years, Drew stayed true to his values of ensuring the app was simple, reliable, and accessible to all. 
Read more about Drew's story.

Who is T1D1 for?

Although, T1D1 was originally designed to empower youth on day one of diagnosis (with Type 1 Diabetes), T1D1 is FDA-cleared to help those:

• with Type 1 Diabetes, two years and older
• on Multiple Daily Injections (MDI) using fast-acting insulin
• who are caregivers to someone with Type 1 (e.g. parents, school nurses, grandparents, friends, etc.)
• who need help with or want to expedite their insulin calculations 
• who want to log and track their insulin and blood glucose levels
• who want to share data with their healthcare provider

What does T1D1 do?

​T1D1 allows users to:

• Calculate insulin doses multiple times per day using personalized carb ratios, sensitivity factors, and target ranges
• Track blood glucose, carbs, and insulin in one easy-to-use app
• Share data and trends directly with healthcare providers for better-informed clinical decisions

By simplifying the technical side of diabetes care, T1D1 reduces the mental load on patients and caregivers alike—especially during the early weeks and months of adjusting to a new diagnosis. One special feature is that the app works with or without WiFi. Once reconnected, all data will sync. This aligns with our mission of providing full access to all. 

Why does it matter?

Each day, children and families across the country face the overwhelming task of managing T1D without enough accessible, safe tools to support them. T1D1 fills a major gap—bringing together accuracy, ease of use, and community-informed design in a single solution that fits into everyday life.
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​T1D1 is now FDA-cleared as a Class II medical device and is the first over-the-counter insulin calculator cleared for individuals aged 2 and older. This regulatory milestone confirms both the app’s safety and its value in supporting real-world diabetes management.
T1D1 is available at no cost and is designed for use at home, at school, and in partnership with clinical care teams.​

T1D1 is expected to be live in the AppStore and Google Play Store by October 2025.