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Stacey Sims
From the very beginning, they mean everything to you. And that means you'd do anything for them, especially if they're at risk. So when it comes to type 1 diabetes, screen it like you mean it. Even if just one person in your family has type one, you are up to 15 times more likely to get it, too. Screen it like you mean it, because one blood test could help you spot type 1 long before you need insulin. Talk to your doctor about how to screen for type 1 diabetes because. Because the more you know, the more you can do. So don't wait. Visit screenfortype1.com to learn more. Again, that's screenfortype1.com.
This week on Diabetes Connections. Two years ago, the FDA pulled down just about every insulin calculator app. A lot of them just disappeared rather than seek official approval approval. But one of them, created by a teenager with type one, is back. I'm talking with Drew and Mike Mendelo about the relaunch of T1D1, a free insulin dose calculator app. They share what it was like to navigate the FDA process, how they got international help to do that, and what's next. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your healthcare provider. Welcome to another week of Diabetes Connections. I'm your host, Stacey Sims. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin.
A couple of weeks ago, I was.
Supposed to travel to Maryland to go to a breakthrough T1D summit up there. That was the weekend of the big winter storm that really came through. I mean, it came through the east Coast. I know tons of you got buried with snow. Lots of my friends in the northeast, but we had ice here in the Southeast and I couldn't travel. And I was so bummed because I was really looking forward to that first in person event of the year. I love going to these. So if you've got a breakthrough T1D chapter and you're looking for summit speakers or panelists, hit me up. I would love to come to your town. I shared a little bit about that on social media, but I also wanted to give you a little bit of a personal update, you know, if you're new around here. My son Benny was diagnosed with type one right before he turned two. That was way back in 2006. He is now 21. He's totally independent. I don't even follow on Dexcom or anything like that. He had an endo appointment and he still sees his pediatric endo. We are so lucky that Dr. Vanderwell has let him stay until he's through college. And I don't even go to those appointments anymore. I thought about going to this one, but I had something else going on and I just. Hey, Dr. Vanderwell, if you're listening, I miss you. I mean, you know, you see somebody four times a year for 19 years, you know, so we gotta catch up. Maybe I'll take you to lunch. But I did give Benny a couple of questions that I wanted answered and it was a great checkup. He is doing so well right now. It's a combination. We've talked about this on the show of aid technology, GLP1 medication. He is taking that and dare I say, a little maturity. I mean, he's always been a great kid. He's always been very easygoing. We never had any real diabetes, you know, rebellion. But you know, when you have a kid who's two and you do everything for them and then you're trying to teach independence for those in between years from like 10 to 16, I'll say maybe a little bit more than that. You know, there's been some bumps along the road. You all have been here, you know what I'm talking about. But for those of you with younger kids, it is amazing to really watch them grow up and thrive. Of course he still makes fun of me. Of course he still thinks I worry too much. But, eh, that's just being a mom. Okay, if you are a mom of a child with diabetes or a woman with type one, don't miss our Mom's night Out events. How's that for a segue? But look, the first one. We are two and a half weeks away from the first mom's night out of the year. That is in Silver Spring, Maryland. We're calling that Washington D.C. but you know, you know, we do these in the suburbs, so don't miss out. Head over to diabetes-connections.com, click on the events tab. Join us in Silver Spring. Nashville's March. Detroit is September, Seattle is October. And you can always use the promo code podcast to save 15% off. We have a great group coming to D.C. really nice mix of moms and women with type one. And I cannot wait to meet you all in less than three weeks. All right, my guests are Drew and Mike Mendelo. We first talked to them in 2024 when the FDA had pulled down their app and all the insulin calculator apps. But unlike most of the others, Drew forged on to get FDA approval and to get T1D1, which is type one, day one back in the app stores. He created the original app at age 13. He's a college freshman now. I was thrilled to catch up here. How he did it, the community support he received, who this is really for and what he needs from us. Now you're going to hear from Drew and a little from his dad Mike right after this.
Drew Mendelo
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Stacey Sims
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Drew and Mike Mendelo, welcome back to Diabetes Connections. Big year. Since we've talked, a lot has happened. Thanks for joining me to bring us up to speed. I appreciate it.
Drew Mendelo
Yeah, thanks so much for having us on. It's been really exciting to be along this whole journey.
Stacey Sims
Drew, let me start with you. The app is back. I'm not sure how much of the story we will go back and tell, but kind of bring us up to speed. Where do things stand right now? If I go into the App Store or Google Play, I'm going to find it, I'm going to be able to download it, no issues.
Drew Mendelo
Yeah, it's fully out there. Search T1D1 either store. In the iOS store the full name is T1D1 mobile. But the full kind of I guess wrap up story is the FDA clearance we officially got cleared about. Yeah in mid August and then about a month ago actually now it fully released live again in both stores.
Stacey Sims
Remind us, give us an overview. What does the app do and did anything change since you first started working on this? I'm sure a lot has improved.
Drew Mendelo
Yeah, sure. So the main function of the app is still calculate your insulin. Of course the app is completely free and there's no ads and the whole app is made to be very simple and easy to use. So the main functions is to calculate your insulin, to track all your data very easily and Then be able to send this to your medical providers or doctors, all with having your own customized settings. And so the app is really just there to help you manage your life with type 1 diabetes better and really just take one more thing off your back.
Stacey Sims
Mike, what was your reaction when after all of this time and work, you got the clearance?
Mike Mendelo
We were in shock, honestly. We couldn't believe that we finally hit this finish line. And then pretty quickly we realized, oh, man, now the real work starting right, really, it's been five years just fighting for clearance, and then now we got to get it out there. We got to make sure everyone knows it's. It's there and just reach as many people as we can. And then, yeah, we sort of never got a break. We gotta hit hit the road on the next, next part.
Stacey Sims
Drew, how about you? Did you allow yourself a minute to celebrate?
Drew Mendelo
Oh, we celebrated for, for a bit. We, we had a video call with, with the team out in Switzerland who, who helped us get all the FDA documentation. But it really has been a surreal experience. I mean, when I created this, I was 13. I didn't, I didn't even know it needed FDA clearance. And just the idea, I'm sure of me thinking that at the time was it was just completely out of the question. It really is surreal for me to say the app is fully FDA cleared and it's breaking into this new market. 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.
Stacey Sims
It really is. Sometimes it's better to not know the limitations, to just say, well, why not? Let's do it. Sure, it can be done. And then to find out later, well, it was probably a long shot, but you're not deterred in the beginning. What surprised you along the way? When we talked last year, you know, you were in the process, but it seemed like there was a long way to go. I think if this were easier, more people would do it. What surprised you or was difficult about it?
Drew Mendelo
Drew? I think one of the main things that surprised me, and this has kind of been from the beginning as well, almost like a whole journey thing is when you're giving something out for free, people are really, they're really just there and willing to just help you with your mission when they could see you're not. I'm not gaining anything financially from the app. I'm purely just putting this tool out there for other people to use. Other people are super willing to help spread the word or partner on things and really just help in any way possible, which has been really cool and obviously helpful for me. But the other thing is, during the FDA process, specifically, your whole, I guess, like, notion, or at least for me, of the FDA is like, it's usually slower and it's kind of a painful process. And while it. It did, the whole process of us getting documentation was kind of long. The FDA was super helpful for us. I mean, when we officially submitted, they got back to us super quickly. It was pretty crazy. And they were. I mean, just unofficially, like, just through emails, they would answer some questions we would have. It was really just a great experience for us that. That we didn't think we were going to have. We didn't think it was going to be as easy, but they really were there for whatever we needed, which was really awesome. And I think that helped a lot, make everything, I guess, more accurate and quicker and kind of speed the process up.
Stacey Sims
Mike, do you want to add anything to that?
Mike Mendelo
That's what I would have added, actually, was that the FDA was great to work with. I mean, I think they get a bad rap sometimes. But the other thing is just that we didn't have a time pressure to get this out. And so we were. We were just ready to play the long game.
Drew Mendelo
Right.
Mike Mendelo
So I think we realized we're just. We stick with it and keep reaching out to our network. We'll eventually get it done, whether it's in 2 years, 5 years, or 10 years.
Stacey Sims
Tell me about the team in Europe you mentioned, Drew.
Drew Mendelo
Yeah, so originally, after the app first got taken down for needing FDA clearance, that's when we looked around, we realized we couldn't make this FDA documentation by ourselves. And I entered the innovation competition at the Diabetes Center, Bernie. And they're. They're out in Switzerland. Bern, Switzerland. And so they connected me with the team Comerge, who is a software development team, and that's who I've been working to rebuild the app. And then they made all the FDA documentation needed. So both those companies out in Switzerland were the teams we worked really closely with to get this full FDA process through, pretty much. And they really have been amazing. I mean, we. We've made, like, lifelong friends with them. They weren't really just partners on this business we're working on. 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. So getting this accomplishment done, we all celebrated together. It felt like a really, like, family kind of project.
Mike Mendelo
Yeah. To add to that, we spent the last summer in Zurich, the four of us, Drew, his brother, and myself and.
Drew Mendelo
Laura and our dog.
Mike Mendelo
So we all got to go and experience the team firsthand. And like Drew said, they're real friends over there. They understand the mission and are willing to just help us get it through.
Stacey Sims
It's interesting that a Swiss company would be the ones to help you with US FDA regulation. I know that there was a competition involved. They're well known DC Burn for what they do, but no US Company reached out, or was that just the way the chips fell?
Drew Mendelo
We reached out to a bunch of different companies. A lot of companies were really willing to help us after we got FDA clearance. And then also with, like, helping spread the word. A lot of companies are very generous with that. But in terms of actually going through the process, it's really hard to get someone to fund this process, especially because there's no real, like, financial investment for them, because T1D1 is a nonprofit now, so there's no, like, real investing in the app and then getting a return later on. So it was really hard to get that kind of piece. And when the diabetes center Burn offered to fund the process to get the documentation, I mean, it was just amazing. That was everything we were looking for.
Stacey Sims
I want to come back to the free aspect of this in the nonprofit, but tell us a little bit more about what it does, because the podcast audience is interesting. They are, you know, very well educated. We've done surveys. Most people listening are using automated devices. A lot of them are using DIY automated devices. So this is not a tool necessarily for people who have access to insulin pumps, CGMs. I mean, the last time we used an insulin calculator was when my son's. I don't think his pump died, but I think he didn't have another infusion set with him. And so he did have a pen. So we were, you know, doing injections. This app is not necessarily for the people who are listening. Right. But there's a huge audience for this.
Drew Mendelo
Yeah. So the app isn't for people on insulin pumps. You're correct. But what we found is my original intended audience, the targeted audience is newly diagnosed, mainly teenagers with type 1 diabetes, who, at the beginning stages is a very high percentage on mdi. It's really hard to get the insulin pump mainly with insurance and other reasons from the beginning, even if you do want it very strongly. But then also after creating the app, I realized there's a huge population I'm sure you're aware of, just people who choose not to be on insulin pumps or can't afford insulin pumps or don't have access to insulin pumps. So that's been a whole audience, and especially with the older audience who have had type one way before insulin pumps were a thing. So it just feels like kind of a huge change that they don't really want to mess it up. Like, they've had this whole routine going and they want to stay on mdi. So this, this app really reaches a larger audience than I originally intended. But also the other thing is people with, with insulin pumps kind of like you mentioned, where for me at least, I've broken my pump two different times playing soccer. And so when something like that happens, or if you just decided to take a break off of insulin pump, because I know a lot of people do that as well, that's just a good way for you to transition back to MDI without having to, like, go back to square one. And you can still easily give yourself injections and feel confident without, you know, writing out the formula or going to the calculator app on your phone and doing it all yourself and really just there if you need it. 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 who. Who need just to kind of get one thing off their back and make their life a little bit easier.
Stacey Sims
I'm sure that I could ask you for an explanation that would take, you know, a long time. So I'm. I hate to ask you to boil it down, but take us through a little bit of what a person would expect using the app. I assume you'd put in your, you know, some basal rates, some math that your doctor gives you, and then, you know, I'm eating 35 carbs. Here's how much it would I should inject. Is there more to it than that?
Drew Mendelo
Yeah. So you enter your. Your basic settings, you enter your correction factor, your blood glucose target and your carb ratio, all at the beginning. It's like a little onboarding section. And then when you go to actually calculate your insulin, you just enter your current blood sugar and then how much carbs you're eating, if you are eating any. And then when you click calculate, it'll show you the amount you should give yourself based on the calculation. And there's features to round it how you'd like in which there's features to actually show the formula itself so you can see how it got to that number. And then there's also extra features like multiple calculator profiles where if you have different numbers throughout the day, which I know, especially at the beginning diagnosis, they would change all my numbers for every part throughout the day. It was crazy. So it makes it really simple for you to change your numbers throughout the day. And then another thing about the app that I didn't mention before that's been really helpful for the audience I was mentioning is it has capability of using Wi Fi or if you're in an area without WiFi, you can still continue to use the app. So this is really huge because Wi FI capability itself allows you to share an account with someone else. So let's say your parent or school nurse, they can access your account. So if you're a kid and you go to school, your nurse can help you calculate and you go home and you can do it with your parents. It's the same account. You don't need a different app. But then also if you're in an area, let's say like a third world country or somewhere where you don't have access to the Internet, you can still continue to use the app and, and really just continue to use this tool whenever you need it. So that was another big thing effort. As I mentioned before, do you have.
Stacey Sims
Stats on where people are using it? Are there a lot of people in developing countries?
Drew Mendelo
Yeah. So before, before the app actually got taken down for FDA clearance, it reached over 74 different countries and a lot of it was in third world countries. I think the majority of our audience was in the U.S. but there was, there was a huge audience that, that I didn't originally realize that really could use this app in other countries. Um, but, but right now, currently the app is only in the US because it's just FDA cleared. And that is something that we're working on the future to get other clearances like the CE mark for Europe, Canada, South America, India even. We're really looking to expand into other countries again.
Stacey Sims
I remember when we talked last year that you were not the only app that was taken down that was kind of like this. You know, there were different apps with different functionality, but the FDA kind of realized you were all there and said, oh no, we gotta take a look at this. Did anybody else come back? I mean, I don't want to give any air to your competitors, so to speak, but do you feel like there is a robust market for this or are you kind of out there on your own. Right.
Back to our conversation in just a minute.
But first, a word from our community.
Alex
Hi, Stacey. This is Alex. I have been a type 1 diabetic since 1990, so I got it when I was 6. I wanted to let everyone know about the small business that my wife and I run out in our suburbs of Chicago. In Roselle, we are Maple Leaf Coffee Roasters, and we've been in business since 2018, importing and roasting coffee in small batches and selling to our community in the Chicago suburbs. We also run a cafe out in another suburb, too, and we're hoping to open another one. So always like to be able to tell people that diabetes is not something that will inhibit you from achieving your dreams, even if those dreams are doing something that's not working for somebody else like us. Hope to hear this on the show and really appreciate all the work that you do for the community. Thank you.
Drew Mendelo
To my knowledge, I don't know of any that that came back from getting taken down. I know there's a lot of apps that are associated with a physical product, like in pen, for example, but to my knowledge, I don't know any. Do you. Do you know dad of any of those?
Mike Mendelo
I think there's one or two that are not FDA cleared, so they're unofficial, but they are out there. We're not mad at competitors. We're happy that the tools are out there. We just want the resources to be available for the community.
Stacey Sims
Let's talk about that. I know when you were 13, this seemed like a good idea to make it free, and now you are officially a nonprofit. I don't know how to ask this, because I think it's great that it's free, and I hope it stays that way. But, you know, you're in college, Drew, your parents, you know, everybody needs money for college and beyond. Why keep it free?
Drew Mendelo
I think the main reason for keeping this app free with no annoying ads is it really just feels like when there's something you have to pay for, it's like they're taking advantage of your disease. And I know personally, for me, if I have to pay for all the supplies and all these doctor's appointments and all these extra visits for just the complications of type 1, and then I have to also pay for this one tool that's just trying to help me. It just feels like they're taking advantage of you and it's not really there for your benefit. Feels like it's more there for their benefit. So for me, I think it's a huge mission of mine to keep this app completely free. But the main problem is, as I'm sure you're aware, it is pretty expensive to keep an app free. As it turns out, we have maintenance costs, FDA requires customer service, and then all these features we want to add and expand to other countries that all cost money, which the app currently isn't making any. So we are looking at things like to license the app out to other apps and partnerships and sponsorships, where it would still keep the app free to the end user, but it would be other ways to generate money to just keep the app free and maintain itself, really. But that is kind of like our next goal, and that's what we're looking to get in the future.
Stacey Sims
I always like to ask, though, if it's free, like, what happens to the data that people are putting in there? Who owns that? And do you sell it to companies? Can you give us a little disclosure there?
Drew Mendelo
Yeah, sure. So we don't sell any data to any companies. We don't use any of the data personally. It's all encrypted for us. So there's no. Obviously there's no, like, name along with the data that we could get ourselves. And yeah, we really want to keep that private because it is healthcare data that is secure and there's a lot of policies around it.
Stacey Sims
It's a question that I think is worth asking because we've learned over the last. I don't know, at least I've learned in the last 10 years, if it's free. Generally you are the product. So it's really different, right, to have something like this where the product is the product and not the user if it's free. I mentioned. Drew, you're in college. Give us an update. How are you doing? What are you majoring in? What are you studying?
Drew Mendelo
Yeah, sure. So I'm a freshman at Georgia Tech here. I'm a computer science major and it goes along with the half, but I love it here. I've made a bunch of friends. It's definitely been a lot to manage with T1D1 and media stuff and other calls and then schoolwork and internship search and then other clubs I'm a part of. It really has been kind of a lot for me, but I found my rhythm. I really do love it here. It's super cool. It's like in the middle of Atlanta, too. I literally went to Atlanta Falcons game a couple days ago, which was really fun. It was super cool.
Stacey Sims
Was there anything in particular you really noticed or had to Change with your type 1 management. Since going to college, I think the.
Drew Mendelo
Big change is, is it's all you. You're fully independent now. I think the one thing that my parents still do for me is literally just order the supplies and then over break or Thanksgiving break, for example, I'll go and pick up the supplies and bring it back for the semester. But everything else, like, you're on your own. Your friends are obviously there to help, but. But you're managing this disease by yourself. So a good example is, is overnights. For example, at, during high school, I mean, I was in the same house as my parents, so if I went low and I didn't, I wasn't there to manage it, which didn't happen that much. But in the off case, my, my parents can come in my room and wake me up and give me whatever I need. But in college, you really have to be on top of it yourself. I set up more alarms. I set up to. To make sure everything. I wake up and I don't, I don't go into a crazy low. But you, you're really just independent. You have to figure out things by yourself. Another example, like when I just got to college, the first week or two, I was messing around with my basal numbers a lot and my correction factor. I was just changing to make sure because there's a lot more walking and eating schedule's all different. There's really just a lot of factors you don't think of, and you just have to do that by yourself. You have to kind of think about it as you're managing this disease by yourself. Yes, there are other people to help you, but you got to figure out your own rhythm and get into your own rhythm really, to continue and manage it how you want to manage it.
Stacey Sims
How about you, Mike? How's college change been for you?
Mike Mendelo
I mean, I miss him because he's, you know, thousand miles away, but it's great to see how well he's doing down there.
Drew Mendelo
Put it that way.
Mike Mendelo
Diabetes wise. I have complete faith in him. He's a smart kid. He knows what the deal is. So, yeah, that part's been great. But I'm looking forward to seeing him in a few weeks for Thanksgiving for sure.
Stacey Sims
That's great. Did you use T1D1 in your college essays, Drew?
Drew Mendelo
Yes, of course.
Stacey Sims
Yeah, come on.
Mike Mendelo
Of course there's some benefit to it. There's some benefit.
Stacey Sims
I love it.
Yeah. My son was determined not to use type 1 in his college essays. And then at the last minute, he was like, oh, my God, I just have to. And I was like, hey, it's part of who you are. You know, it's really. It changes your life. So what is your big Hope here for T1D1 Drew? I mean, you've. You've worked on this for a long time. You were kind of a different person at 13 than you are now. When you started to have the idea and then developed it and everything you learned, where would you really like this to go?
Drew Mendelo
I think the main thing that stayed true to me since I was 13 is keeping it free and reaching as big of an audience as I can to help as many people as possible. That really is my mission. And we're sticking to it. We're trying, kind of, like I mentioned before, we're trying to expand into more countries. We're looking to translate the app as well into. I think the main priority is Spanish, but then other languages like French and German, for example, and really just keeping the app free. I want to see as many people use it worldwide. And kind of like we mentioned before, if some other tool comes up that it's a direct competitor, that's great. That's amazing. It's really my. My goal to just have care out there for people who need it and to remove barriers from accessing this care. So my whole goal with T1D1 is to remove the barriers of cost accessibility in the future languages. And we really just wanted to get this tool out there to people who need it. In the end of the day, I think one of the main ways you can help is telling your doctors and diabetes educators about the app. Let them know it's out there. Also, leaving a quick, like, one sentence review on the App Store and Google Play Store really helps a lot. You'd be surprised how much that helps. And then also if. If you are using the app and you do really enjoy it, quick, like a testimonial little video, if you send it to info1d1.org that'd be super helpful as well. We're getting a whole kind of collage going of people who. Who want to leave feedback on the ad. So those are some ways you can help. And then obviously, if you. If you feel kind enough to donate or you see a sponsorship opportunity too, that would be amazing as well.
Stacey Sims
Hey, before I let you go, something new I'm doing is asking my guests what diabetes organizations have made a difference for them. You know, what organization has made a difference for you all?
Drew Mendelo
For me personally, I would say the Diabetes center of Bern. I think the pretty obvious answer they kind of turned my dream into reality. They helped me get through the last step of the FDA process. And then also, I guess they're not really a diabetes company, but comerge as well, which was the software development team in Switzerland. They helped get the documentation and rebuild the app with me. And like we mentioned, we're all friends with them. They've really been there for us and I really do appreciate all their support.
Stacey Sims
Was it a competition that you entered at DC Burn? Is that how it started?
Drew Mendelo
Yeah, so it actually was a competition, and I didn't end up winning the competition. I got top 20. And just through my story and being the youngest competitor, they were super inspired by the story and that's where they decided to help fund the app, which is really inspiring.
Stacey Sims
Yeah, I remember that. And I mean, is this a nice message out there? If you're listening to, just go for it, right? You don't have to win to get attention and maybe catch somebody's eye. I thought that was really interesting. So very cool stuff.
Mike Mendelo
I was just going to add two things to that. The way we found out about the Diabetes Center Burn competition was through the Beta Cell podcast. I'm not sure if you know Craig at the Beta Cell podcast.
Stacey Sims
Oh, I do know Craig Stubing.
Mike Mendelo
Yes. So he encouraged us to apply. That was sort of another networking thing we did. And then that's kind of where the story started. So that was one another diabetes organization that really helped us. And then Dexcom, surprisingly, I mean, they sometimes don't get the best press, but they were really helpful in this whole process. They did our human factors trial for us, so shout out to them.
Stacey Sims
Very cool. Well, Mike and Drew, I can't wait to see what happens next. Drew, enjoy college. Enjoy coming home for Thanksgiving. Mike enjoyed doing his laundry when he comes home. But I really appreciate you guys jumping on. It was wonderful to catch up and really wonderful to see how this is going. I'm thrilled with what you've been able to do here. Please keep us posted and hopefully we'll talk soon. Thanks for coming on.
Drew Mendelo
Thank you so much for having us. It's been amazing to share an update.
Mike Mendelo
Great talking to you. Thanks, Stacey. Foreign.
Stacey Sims
Of course. I will link up all the information in the show notes, head on over to diabetes-connections.com and click on this episode's homepage if you can't find what you're looking for in whatever app you are listening to. I know the vast majority of you do listen on Apple podcasts and there should be pretty robust interface there in terms of links and all that kind of stuff. But if you have any trouble, head right back on over to the homepage Little Inside Baseball. We've had a really nice surge of listenership since late December and I am thrilled. I know that means you are sharing the show. I know that means you are posting about it. So thank you for doing that even after all this time. We've been doing the show for almost 11 years now. It's fun. It's still fun to see that more people are finding us and tuning in. All right, thank you to my editor John Buchenis from Audio Editing Solutions, and thank you so much for watching for listening, I'm Stacey Sims. I'll see you back here soon. Until then, be kind to yourself. Diabetes Connections is a production of Stacey Sims Media.
Drew Mendelo
All rights reserved. All wrongs avenged.
Stacey Sims
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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
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.
“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)
“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 was super helpful for us...when we officially submitted, they got back to us super quickly.” (08:47 – Drew Mendelo)
“...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)
“...when there's something you have to pay for, it's like they're taking advantage of your disease.” (19:14 – Drew Mendelo)
"We don't sell any data to any companies...it's all encrypted for us." (20:35 – Drew Mendelo)
“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)
“In college, you really have to be on top of it yourself...You're managing this disease by yourself.” (21:54 – Drew Mendelo)
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)
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.