Podcast Summary: Diabetes Connections | The Comeback of the T1D1 App

Episode Title: The FDA pulled it, but the diabetes community wouldn't let it go. How the T1D1 app made a comeback
Host: Stacey Simms
Guests: Drew Mendelo (creator of T1D1 app), Mike Mendelo (Drew’s dad)
Date: February 3, 2026

Episode Overview

This episode celebrates the relaunch of the T1D1 insulin dose calculator app, originally created by Drew Mendelo at age 13. The app, which helps people with type 1 diabetes (T1D) on multiple daily injections (MDI) calculate insulin doses, was removed from app stores following an FDA crackdown on unapproved calculator apps. Unlike most, Drew fought for and achieved FDA clearance, bringing the free and ad-free app back to users—with support from the international diabetes community and a Swiss innovation center. Stacey interviews Drew and Mike about the challenges, surprises, and community support they encountered, and looks ahead to the app’s future.

Key Discussion Points & Insights

Why the App Needed FDA Clearance (05:55–06:29)

• The FDA removed most insulin calculator apps two years ago due to lack of regulatory approval.
• Drew’s T1D1 app, created as a teen for his own use, was among them.
• Drew describes the pride in getting FDA clearance:

  “It's the first over the counter FDA cleared insulin calculator. So it's just really cool for me to say, like, I've broken into, I guess, like an area and it really just achieved this, which I thought's a huge accomplishment.” (07:44 – Drew Mendelo)

What T1D1 Does, and for Whom (06:39–07:10, 13:10–14:45)

• Main functions:
  • Insulin dose calculation: Input of blood glucose and carbs eaten, then calculates insulin needed using individual settings.
  • Data tracking and sharing: Allows exporting data to medical providers.
  • Multiple profiles: Customize for different times of the day.
  • Cross-device sync: Parents or school nurses can access the same account.
  • Offline access: Critical for areas with limited internet.
• Target users: Newly diagnosed, teens on MDI, people who choose not to use pumps, those transitioning from pump to injection, and users in countries with limited tech access.

  “This app really reaches a larger audience than I originally intended...if you're on insulin pump and you don't need the app, that's great, but it's really just there for people on MDI.” (13:10 – Drew Mendelo)

The FDA Journey & International Help (07:41–09:58, 11:21–12:32)

• Unexpectedly positive experience with the FDA:

  “The FDA was super helpful for us...when we officially submitted, they got back to us super quickly.” (08:47 – Drew Mendelo)

• Key assistance came from Europe:
  • Swiss innovation hub Diabetes Center Bern connected Drew to Comerge, a Swiss software developer.
  • They provided technical and documentation support, even hosting the Mendelos for a summer in Zurich.

  “...they really are amazing. They've made suggestions, and just the work they've been doing is really valuable, and we obviously couldn't have done it ourselves.” (11:21 – Drew Mendelo)

Why It Stays Free—and Why It’s Hard (19:14–20:24)

• Drew’s philosophy:

  “...when there's something you have to pay for, it's like they're taking advantage of your disease.” (19:14 – Drew Mendelo)

• T1D1 is a nonprofit, but maintenance, support, and expansion are costly. Seeking partnerships, sponsorships, and licensing (not data sales) to keep it free.
• Privacy: No data is sold; all is encrypted and kept private.

  "We don't sell any data to any companies...it's all encrypted for us." (20:35 – Drew Mendelo)

Impact & Expansion Plans (16:40–17:13, 24:11–25:41)

• Before FDA removal, T1D1 reached 74+ countries, many in the developing world. Currently relaunching in the US, but expansion to Europe, Canada, South America, and India is a priority.
• Plans for language translation (starting with Spanish, French, German) and broadening access.

  “My whole goal with T1D1 is to remove the barriers of cost, accessibility, in the future languages...we really just wanted to get this tool out there to people who need it.” (24:11 – Drew Mendelo)

Who Else Made a Difference? (25:41–27:21)

• The Diabetes Center Bern and Comerge (Switzerland) were instrumental.
• Craig Stubing at Beta Cell Podcast helped connect them to Bern’s competition, which led to critical support.
• Dexcom supported the mandatory human factors trial—“shout out to them.” (27:00 – Mike Mendelo)

Life as a College Student with Type 1 (21:15–23:33)

• Drew attends Georgia Tech, majoring in computer science, balancing school, T1D1 management, and college transition.
• Greater independence means self-management of T1D—alarm setup, managing unfamiliar routines, and learning personal responsibility.

  “In college, you really have to be on top of it yourself...You're managing this disease by yourself.” (21:54 – Drew Mendelo)

• Mike shares reassurance in Drew’s ability, looking forward to their Thanksgiving reunion.

Notable Quotes & Memorable Moments

• The Drive to Persevere:

  “Sometimes it's better to not know the limitations, to just say, well, why not? Let's do it." (08:22 – Stacey Sims)

• On Community Support for a Free App:

  “When you're giving something out for free, people are really...willing to just help you with your mission.” (08:47 – Drew Mendelo)

• The Unexpected Allies:

  "It's interesting that a Swiss company would be the ones to help you with US FDA regulation...” (11:40 – Stacey Sims)

• On Competition:

  “We're not mad at competitors...We just want the resources to be available for the community.” (18:44 – Mike Mendelo)

• Keeping It Free:

  “It just feels like they're taking advantage of you and it's not really there for your benefit.” (19:14 – Drew Mendelo)

Timestamps for Major Segments

• 05:55 – The T1D1 app’s journey through FDA clearance and relaunch
• 06:39 – What T1D1 app does and main features
• 07:15 – Mike and Drew on emotions and surprises during FDA process
• 08:47 – Positivity about working with FDA and the importance of community support
• 11:21 – Role of Swiss partners and international collaboration
• 13:10 – Who the app is for, and why that matters
• 15:06 – Step-by-step user experience explanation
• 16:40 – Expansion, reach, and future plans for global access
• 18:29 – On competing apps and why others didn’t come back
• 19:14 – Philosophy and practical challenges of keeping T1D1 free
• 20:35 – Data privacy and handling
• 21:15 – Drew’s life and diabetes management as a college student
• 24:11 – Drew’s mission for T1D1’s future
• 25:41 – Organizations and individuals that helped the Mendelos succeed

Ways to Get Involved and Support

• Tell your endocrinologists or educators about T1D1.
• Leave positive App Store reviews to help with app visibility.
• Send in testimonials: Videos to info1d1.org.
• Support through donations or introduce sponsorship opportunities.

Tone:

Warm, conversational, supportive, and focused on community-driven solutions. Drew is earnest and idealistic; Mike is pragmatic and proud; Stacey is insightful, encouraging, and a guide for both technical and emotional aspects of living with T1D.

This summary covers all major discussion threads, reflects the tone and language of the episode, and highlights practical takeaways for listeners—whether they’re parents, adults with diabetes, advocates, or just members of the wider T1D community.