Drew Mendelow's T1D1 App Achieves FDA Clearance

Five years after Drew Mendelow inspired attendees at our 2023 In-Value-Able Conference with his vision for a diabetes management app, we’re thrilled to announce a major milestone: his app, T1D1, has received FDA clearance. It’s now the first free, over-the-counter insulin calculator app approved for Type 1 diabetes management in the United States.

At our 2023 In-Value-Able Conference, Drew highlighted the gap between existing diabetes technology and accessible management tools. Diagnosed with Type 1 diabetes in 2020 at just 13, he refused to accept the overwhelming challenges of managing his condition. Instead, he set out to create a solution.

The journey from concept to FDA clearance represents much more than regulatory success. It showcases how innovative thinking, strategic partnerships, and determination can make healthcare more accessible for communities worldwide.

From Diagnosis to Innovation

Drew’s story began in September 2020, when he was diagnosed with Type 1 diabetes. Lying in a hospital bed and new to his diagnosis, he faced the daily challenge of calculating insulin doses using complex formulas. He aimed to create an app to help others that were experiencing the same challenges.

The app quickly gained traction, reaching over 45,000 downloads across 50 countries. Drew then learned that FDA clearance was required for the app to continue operating in the U.S. Although this meant temporarily removing T1D1 from app stores, it paved the way for a stronger, FDA-compliant version.

A New Era of Accessibility

As the first over-the-counter insulin calculator app approved for users aged 2 and older, T1D1 fills a critical gap in accessible care tools. Since it’s free, the app eliminates cost barriers that often prevent people from accessing essential resources. T1D1 is set to relaunch on the App Store and Google Play Store this October.

Looking ahead, Drew and his team are focusing on maintaining the app, expanding its reach internationally, and raising awareness about its availability. They invite support from healthcare providers, educators, diabetes organizations, and families to share the app and maximize its impact.

Drew Mendelow’s journey from a newly diagnosed teenager to FDA-cleared app developer illustrates the power of tackling real problems with innovative solutions. His story shows that personal experience, paired with strategic collaboration and persistence, can lead to transformative change in healthcare.

As T1D1 prepares to launch, it marks a turning point in diabetes care. We congratulate him on this incredible accomplishment and look forward to seeing how T1D1 continues to empower the diabetes community. To learn more, visit his site.