Right now, the very first diabetes technology with roots in the do-it-yourself community is in front of the FDA. Tidepool CEO Howard Look joins us to talk about what, if approved, will be a prescription mobile app controller: Tidepool Loop.
We get details on the submission, including everything from how you’d actually get this app to whether you’ll be able to set your own blood sugar target ranges to which devices Loop could work with, international possibilities and much more.
Learn more about Tidepool Loop
Watch this interview on our YouTube channel
Our first conversation with Howard Look from 2016
Howard announces Tidepool will shepherd Loop to the FDA (2018)
Howard mentioned Tidepool documents. Find those here
In Tell Me Something Good a teenager with type 1 has a big idea about a Funko Pop character and some positive news for diabetes camps this summer.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
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Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by Dario health. Manage your blood glucose levels increase your possibilities by Gvoke HypoPen the first premixed auto injector for very low blood sugar, and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:26
This week, the first Do It Yourself based diabetes tech goes to the FDA. We will get details on the submission of Tidepool Loop , including everything from how if approved, you'd actually get this app to whether you'd be able to set your own blood sugar target ranges,
Howard Look 0:43
we did in our submission to the agency proposed flexible set point. We are in review right now. That is something new, and most companies before us have submitted with fixed set points or a limited set of set points. That is something that we are discussing with the agency we're not yet cleared, so I can't tell you how that discussion will go.
Stacey Simms 1:05
That's Tidepool CEO Howard Look. He also answers questions about which devices this version of Loop could work with, international possibilities and a lot more. in Tell me something good a teenager with type one has a big idea about a Funko Pop character and some positive news for diabetes camps this summer. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show always so glad to have you along. We aim to educate and inspire by sharing stories of connection with a focus on people who use insulin. My son was diagnosed with Type One Diabetes just before he turned to my husband lives with type two diabetes, I have a background in broadcasting. And that is how you get the podcast.
This week's subject is one that a lot of you are really excited about. I was going to say it's something that you've been waiting for. But I know a good portion of my listeners are part of the we are not waiting movement, and are using a DIY version of Loop already. For those who are not. What is Loop ? Well, that's a big question and I will direct you to a bunch of our past episodes. With the we are not waiting hashtag you can just go to Diabetes connections.com there's a search box on the upper right hand side of the website. And I have put all one word hashtag we are not waiting as a search term for any episode that deals with that with the DIY community. Of course, you can also Google Tidepool Loop , that sort of thing. But as simply as I can try to define it here, Loop is one of a couple of programs created by the community. This is not something that's commercially available, and it helps insulin pumps and continuous glucose monitors communicate. DIY Loop uses a Riley link another external piece of hardware to help with this. And it works with Omnipod and older Medtronic pumps. There are other programs openAPS Android APS, which work with older Medtronic pumps. That is a very quick and very light to say explanation of it.
So I urge you if you're interested, although Howard always does terrific job of explaining more when I do talk to him here, I just want to make sure that you understand kind of all of the groundwork, this is not something that have popped up in the last couple of months. In fact, in late 2018 Tidepool , which was well known by then as a nonprofit, open source, a call it an information hub for people with diabetes, they announced they would shepherd DIY Loop through the FDA making it a lot easier for non diy yourself types to access what is really life changing technology. And now just over two years later, they've submitted and I don't know if an information hub is the best way to describe Tidepool , but it was started because there was no place at the time to view diabetes data in one place, I don't believe there really is still you can see data from your pump, your CGM, your meter all in one uploadable place and use interactive graphs and see trends and patterns in a way that was never available before. And I don't think it's available as robustly anywhere else. And then you can share with your healthcare team and invite other people and your healthcare providers to look at your charts and your graphs and your data. So that's how Tidepool s started.
And if you want to hear the whole story about how they stepped up to take this new task on, again, I will link up these specific episodes at the homepage for this one at Diabetes connections.com. By the way, this is also a video interview, you can check that out at the Diabetes Connections YouTube channel, I'll put a link in the show notes there as well.
I do want to give a quick disclosure here. I did a project for title in the spring of 2019. I was helping out with some research interviews in the community, that sort of thing. I bring it up because they paid me as a freelancer. And while they've never paid me for the podcast, I think it's important to always let you know about that kind of thing. By the way, I'm very good at community interviews and freelance projects like So reach out if you ever need a hand.
Okay, Howard Look in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen. And you know, almost everyone who takes insulin has experienced a low blood sugar and that can be scary. A very low blood sugar is really scary. And that's where Gvoke Hypopen comes in. Gvoke is the first auto injector to treat very low blood sugar. Gvoke hypo pen is pre mixed and ready to go. With no visible needle. That means it's easy to use, how easy is it, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it, find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit gvoke glucagon.com slash risk.
My guest this week is co host Howard book here to talk about the very exciting submission of a Loop app to the US FDA, there is so much to talk about here. But Howard, let me just first welcome you to the show. Thanks for coming on.
Howard Look 6:05
Hi, Stacey. It is so great to be here. I'm so excited to see you again. And so grateful for you having me on your show.
Stacey Simms 6:12
Thank you. You know, it's funny to look back. And we have a lot to talk about. But I should say as we're getting started here, I have talked to you many times, but twice for the podcast and the first time was almost five years ago now. So as we go through this conversation, and as you're watching or listening, there's gonna be a lot of presumed knowledge, I think we're not going to try to explain everything. So I will link up the previous episodes where we talked about title and it's early days, and then the announcement a couple of years ago about this. But I think that even just a quick, cursory Google search will get you up to date before you listen to the interview. But there's a lot here. So Howard, thanks again. Let's dive right in. My
Howard Look 6:52
pleasure. Thanks for having me.
Stacey Simms 6:53
What did you all submit? Tell me about what actually went to the FDA.
Howard Look 6:58
I have learned more about how FDA submissions go than I ever imagined my whole life. So we submitted what is known as a 510 k application, which is a big set of documents that says to the FDA, here's what we have built. And here's how we built it. And here is the work that we did to show clinical evidence to show software cybersecurity, what's called verification data, how we know that the software is working as intended. It describes what it looks like, how it works, what the requirements are. And all of that ended up being about a 2000 page submission, which sounds like a lot, but I've heard that other submissions are far far bigger. So we feel like it was a well crafted submission. And we are now in the thick of what is called FDA interactive review. So we sent in our submission on December 17. Turns out that was a snow day in Washington DC. So that was our thing. So our lawyers office used a courier to get a DVD ROM and deliver it to silver springs, Maryland. And what the FDA got was a bunch of documentation about Tidepool
Stacey Simms 8:14
you submitted Tidepool Loop , this is an app, what is you know, what do you I guess we can fast forward what would the finished product be?
Howard Look 8:22
So Tidepool Loop is a mobile application once it is cleared by the FDA and I have to be super clear it has not yet been cleared by the FDA It is currently under review. So it is not yet available. But once it is cleared Tidepool Loop will be a mobile application for iPhone. And people will be able to get it just like you get any other iPhone app by going to the App Store and downloading it, it will be prescription required. So you'll have to go to your endo or your doctor and say this is something I would like and get a prescription code. And then people will be able to download that app from the App Store. And what Tidepool Loop will do is it'll connect to insulin pumps and continuous glucose monitors. And it's what's called an automated insulin delivery device or some people call it other people call it closed loop or artificial pancreas. But basically it's software that automatically controls insulin delivery based on glucose values. And based on predicting how your body is going to react to insulin and carbohydrates. And it automatically uses an algorithm or math a fancy word for math to decide how much insulin you should get. So long winded answer Tidepool Loop is a mobile app that controls insulin delivery.
Stacey Simms 9:40
Well, it's not long winded at all because I know there's a lot more to it than just that even But to be clear, when I think about this, and we'll go I would love to talk more about the history and DIY and and so much of that. It basically is the brains of the operation. So you have your pump, you have your CGM but you need that program. So you know, we have the controller queue we have horizon with Omnipod, if I'm getting that right used to be type zero, which we may see in other pumps, this is that
Howard Look 10:07
that's exactly right. There's there's three pieces to an automated insulin delivery system. There's the insulin pump, which I think most people are familiar with, but it holds a reservoir of insulin. And sometimes it's something that you clip to your belt, like a Medtronic pump or a Tandem pump. And sometimes it's a self-contained unit, like an Omnipod that sticks right on your skin. So that's component number one is the insulin pump. component. Number two is the continuous glucose monitor. And the one that I think a lot of people are familiar with is the Dexcom G6, that's a super popular continuous glucose monitor or CGM, but there are others out there as well. And then the third piece is this controller piece in the middle. And what the controller does is it reads the data from the CGM. It also takes other information such as what your insulin to carb ratio is, what your insulin sensitivity factor is, knowledge about your basal rates. And it combines all that information using math and determines how much insulin you should be getting. And what's cool about it, people living with type one diabetes are used to that and used to doing the math on a napkin to figure out what their dose should be. But what's cool about it is that the software does it for you. And in the case of most automated insulin delivery systems, it does it automatically every five minutes, which is great, because that's a lot of math, and it's doing it for you. And it's also paying attention to how your body is reacting to what happened previously. And that's why it's called a closed loop system. It delivers insulin it it determines information. And then that brings that information back into the system to determine what it should do on the next iteration of the loop .
Stacey Simms 11:49
And it really has been amazing. I mean, we use I mentioned control IQ. And I had no idea even though I had been told I could make you know, 300 decisions a day, one every five minutes, and then an additional one every hour. I remember the first morning I checked, and it kept Benny at like, let's say one 10th or 105. Great number I was so excited to see. And I thought oh, well, it didn't have to work very hard last night, because he was just cruising.
And I went into the pump.
Stacey Simms 12:12
And it had adjusted every five minutes. It's incredible. I don't know why I had, I hadn't thought about it that way that it would have to work just as hard right to keep him at that number. And it's not something that most people really have the inclination to sit there, you know, and do all day long. It was amazing to me just in a way. Howard, I gotta tell you, and you look at this as a parent of a child with type one, it kind of assuage my guilt of not being perfect all these years. Oh, yeah.
Howard Look 12:40
Yeah, I know exactly what you mean. So our daughter, Katie, she's 21 now but she was diagnosed with type one when she was 11. And I totally I know exactly what you're talking about, as a parent, that feeling of why can I get this right? How can I do more? What Why is this so hard? And the answer is, because it's frickin hard. It is really hard work. And these systems are taking that really hard work and bottling a whole bunch of it up into these decisions that it can make every five minutes. And even they have to work hard. If you actually look at what the systems are doing. They're adjusting insulin delivery up or down every five minutes. And they're doing their best. And it's still really hard. And so yeah, I know exactly what you're talking about, and realizing what we as parents did getting up multiple times during the night giving correction doses trying to get it right. Like we all deserve a gold star for that because it is frickin hard work. You know, and everyone living with type, of course will start to because not just as parents, like people living with type one, doing this
Stacey Simms 13:46
for decades, exactly with no breaks. So I have a lot of specific questions about title that my listeners have sent in. I'm cautious about getting too specific. I'm going to ask you, you may have to say can't answer that. Can you answer that? But before I do, I'd love to take a moment and talk about the significance of this being something that started as part of the DIY community.
I was looking back and my podcast started in 2015. But we are not waiting and started really that that same came in 2013. But people working on things like this before that. Yeah. What's the significance? As you see it, of my understanding is this is the first kind of crowdsource DIY diabetes component.
I'm not really sure what else to call it to go in front of the FDA. It seems like we should just kind of stop and mark that.
Howard Look 14:31
I agree. There is so much to celebrate about the story. And what you just mentioned, is one of the huge components. So Tidepool Loop is based on an open source project that was known as Loop. I usually call it DIY Loop just to differentiate it, but it was just known as Loop. And there's a wonderful medium blog post by Nate Ratcliffe, who is the original author of Loop and he talks about how the works He did was built on top of the work that people did before him, people like Ben West and john Costik, who figured out how to control diabetes devices over wireless communication protocols. And then Pete Schwab who's the, his daughter is named Riley and Pete went and taught himself hardware design so that he could invent the Riley link, which made it possible to control at first Medtronic insulin pumps and then later Omni pod pumps remotely from an iPhone over Bluetooth. So it's this really incredible story of innovation of people figuring out how to make this happened.
There's a whole other wonderful blog post that for your technically minded readers about the reverse engineering efforts that went into figuring out how to control the Omnipod, and how to add that functionality into Loop , which at the time only could control Medtronic pumps. And so it just goes on and on and on. There's a gentleman named Joe Moran, who was instrumental, he's been living with type one for decades, and he was instrumental to that effort. And so there's the open APS community and the Android APS community, Dana Lewis and Scott Liebrand, who I know you've met. And the story is that when the community really wants to do something, they just go figure it out, it's the most it to me the most incredible example of tenacity and innovation, and grit, and everyone working together for the greater good. And all of that transpired with people just doing their thing on their own, you know, nights and weekends, or, you know, none of them all of those names that I mentioned, it wasn't their day job to go do that. They did it because they wanted to help improve lives, their own lives, or the people they love living with with type 1 diabetes. And so what we did at Tidepool is we saw how popular Loop or DIY Loop was, my daughter started using it when she was still in high school, six years ago, and was getting incredible results, a bunch of other type coolers. Were using it.
And we thought to ourselves, you know, what, we're in a really interesting position as a nonprofit, as an open source organization that has chosen to engage deeply with the FDA that we could take this open source project built by the we're not waiting community, and we could actually bring it into our regulatory quality system. And we could take it to the FDA and say, Hey, FDA, we actually would like to make this broadly available, we would like to put it in the App Store. And we started floating this idea with everyone with the we are not waiting community, with the device makers that would have to cooperate with the FDA, with the funding organizations like JDRF. And the Helmsley charitable trust. And across the board. Everybody thought it was a great idea. And so that was really, to me, it was just so heartwarming to know that everybody agreed, yes, this needs to happen. It can't these great systems that are helping our kids sleep through the night and helping us achieve, you know, really great, lower burden control of our diabetes, that we want to do our part to now pay it forward and help make it broadly available. So I was just I couldn't be more thankful and grateful to that entire community. So I often say we are standing on the shoulders of we're not waiting giants.
Stacey Simms 18:30
That's great.
All right. So now let's get down to the nitty gritty because people want to know what this is really going to look like. Let's start by talking about understanding that things change. And I'm sure that you want to work with everybody down the road, when or if this is approved. What are they approving? Is it for use with just Omni pod? I know you have an agreement with Medtronic, what starts out of the gate?
Right back to Howard answering that question. But first Diabetes Connections is brought to you by Dario. Health. And over the years, I find we manage diabetes better when we're thinking less about all this stuff of diabetes tasks. That's why I love partnering with people who take the load off and things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you. All the strips lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends, with suggestions for how to succeed get the diabetes management plan that works with you and for you. Daria has published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash Diabetes Connections. Now back to Howard Look talking about what devices will pair with Tidepool Loop .
Howard Look 19:48
So the first thing I have to be super careful because this is not yet an FDA cleared product and the FDA has very strict rules about marketing a product before it's actually available. So I'm just gonna make a statement upfront that I will probably repeat over and over, I'm going to describe the process to you that we are going through. But I'm not yet describing a product that is cleared by the FDA. And we are not yet approved to market this. So I'm what what we can do because we're a nonprofit because we're radically transparent. We share everything that we're doing with the community. So all of our engagement with the FDA, for example, we've publicly, openly published on our website. So your listeners who want to actually see what we've talked to the FDA about can go to tidepool.com/ documents, and see all of the interactions we've had over the years that I'm about to describe. So here's what I can say, openly, transparently. publicly, we have announced that Tidepool , the organization has development agreements with Dexcom, with Medtronic, and with Insulet. What I can't say is the other device makers that we are also working with, I can just say that there are other device makers, every device maker has their own timeframe about when they are comfortable talking about it. And so the first pair of device makers that we announced where Insulet, Omnipod, and Dexcom, with the Dexcom G6. And that's really notable because they have already gone to the agency, and they themselves have submitted their devices for clearance in this interoperable ecosystem. So I should if you want me to, I should probably take a little sidebar here and talk about interoperability and how
Stacey Simms 21:36
you may certainly take us out into what I call the Mr. Potato Head. Diabetes technology, so the floor is yours.
Howard Look 21:43
Super. So the FDA really gets a huge amount of credit here, because they went to industry to all of us in the diabetes device business, and they said, Hey, all y'all device, diabetes device companies, this is way too hard when you come to us with these big giant submissions for these big giant systems that include all of those components that I talked about earlier, the pump, the CGM, the controller, and everything that has to go with it. So we the FDA would like you to start thinking differently. And what they did is they issued what are called de novos, which is where they make a new product classification de novo literally means from the new and so it's a new product classification for interoperable components, and they created three different components, the eye CGM, or integrated continuous glucose monitor, the ACE pump, or alternate controller enabled insulin infusion pump and the AGC the interoperable automated glycaemic controller. So those three de novos are critical because they allow a company like us to say, hey, FDA, I'm not coming to you with an entire system that does all three things together. I'm just coming to you with one piece. So we have submitted an AGC the interoperable automated glycemic controller Dexcom submitted the IC gm Insulet submitted an ace pump and has also been talking about their future Ace pump roadmap, Tandem did the same thing. what's notable about Tandem is they submitted an ace pump and an AI AGC. So you were mentioning the type zero algorithm earlier the algorithm that is known as control IQ started its life as the type zero algorithm. So they submitted both an ace pump, which is the Tandem x two platform and the AI AGC which is known as control IQ technology, which, as you know, started its life as the type zero algorithm. So we owe a huge debt of gratitude to the agency for creating that interoperable pathway.
Stacey Simms 23:48
I'm going to probably ask you a bunch of questions that you will answer just like that. And I'll try my best not to know that while there is a large component of people very interested in the history, and the alphabet, the alphabet soup and everything you went through. There's also a large amount of people who say, when this thing comes out, can I slap it onto my Omni pod and use it? Yes. So the question then becomes, does it matter what type and again, if you can answer this I totally understand. Does it matter what type of pod they're using? Because we have dash we have on arrows and we don't use Omni pod, so I may be getting this wrong. And then we have Octopod, five with horizon coming out later this year. So you know, people are saying Howard, what do I stock up on?
Howard Look 24:31
I see. So let me so I can't specifically say what will be cleared by the FDA because it hasn't been cleared yet, but I can tell you what the intent of Tidepool Loop is. So Tidepool Loop is intended to be an IEC and interoperable automated glycemic controller. And in order to be that type of device, it can only work with IC GM or Ace pumps. So it will not be able to work that with anything that does not have an ace pump does it And it will not be able to work with anything that does not have an IC GM designation. Got it?
Stacey Simms 25:06
Okay. And then my next question is, and this comes back to I think I asked you this the very first time when you announced, you know that you were hoping to shepherd Loop to the FDA. And it's an interoperability question that I still can't wrap my brain around. I'll give you the example of Omni pod. So I'm very excited this fall, I get my Omni pod five with horizon. It's got its own hybrid closed Loop system, or whatever they're calling it these days. And then I hear Oh, Tidepool is out. And I want to go to the app store and get Loop . Do I flip a switch on my Omni pod? PDM? Or do I have to? Do I have to right now, because I know you're talking to interoperability in the future and everything. But what happens now? Can I switch to it? Or do I have to pick one and then stay in that?
Howard Look 25:47
I don't believe people will be locked in the so there is no Well, I shouldn't speak for Insulet, right, there is no switch on the PDM pods. The way pods work is they can pair to one controller at a time. But pods are disposable. So if you pair one controller to a pod, you can pair the next pod to a different controller. So that would be the idea there, there's no switch that you flip, the idea with type will Loop would be as a different kind of controller that you wouldn't need to use your PDF, you would use type of Loop on your phone. Great.
Stacey Simms 26:19
I think everybody's gonna hopefully they all want to go to phone anyway. And that's what everyone seems to be working for. And I know most of my questions that are also for Omnipod. And you really can't answer them. So we will talk to Omnipod down the road and find out more. So let's go back to a bunch of questions about the targets because one of the things that people love so much about DIY, is that they can really set these target ranges for how they want and other things. Um, can you speak to that? What kind of flexibility as compared to what people understand with DIY Loop? May they experience the Tidepool Loop?
Howard Look 26:47
Yeah, it's a super question. The first thing I will say is, we totally understand how the community loves having the flexibility of choosing their own target range set points. And we believe in that as well. That is definitely something that type schoolers who use DIY lube, understand the value in that my daughter uses DIY Loop . I've been very public about that. We did in our submission to the agency proposed flexible set points. We are in review right now, that is something new, and most companies before us have submitted would fix set points or a limited set of set points. That is something that we are discussing with the agency, we're not yet cleared. So I can't tell you how that discussion will go. What I can tell you is the agency has been great. They have been so good. During this review. I know a lot of people like to dump on the FDA. I will not do that. Because my experience with the agency has been these are hard working really dedicated public servants that really want the best, safest and most effective solutions for the community. And the questions they have asked us about our clinical study day about how we built the product about cyber security is all completely reasonable. And so I know they are seriously considering it. And we're hoping we will know the answer to how
Stacey Simms 28:13
well it's interesting too, because as I mentioned kind of offhandedly. Everybody's working towards bullets from phone and control from I'm sure many of them the more I guess I can't say commercial and leave you all out now. But many of the traditional commercial systems are working toward that. Can you share a little bit how it looks on the phone? Because that's so novel for so many of us that haven't even thought about that before? Use it before in our phones?
Howard Look 28:35
Yeah, well, it's a little tricky. I wish I could just bring it up on screen. And what I will tell you is for your listeners that are used to what DIY looks like Tidepool Loop will look extremely familiar. There's there, you, you know, we've changed some colors and move some icons around but it'll still look extremely familiar to anyone who has seen DIY Loop before. For folks who haven't seen what Loop looks like, you can go to our website, there's a screenshot of the home screen. And obviously once it's cleared, we will publish all kinds of more information about what all the screens look like. But anyone who has seen DIY Loop and understands the home screen with the glucose chart, the insulin chart with the buttons that let you bolus and do target pre meal targets etc. It'll all look extremely familiar and type
Stacey Simms 29:28
is it Apple and Android
Howard Look 29:30
we submitted only for iPhone for now. And the reason for that is DIY Loop is only for iPhone. So the fastest path to us submitting and to getting it out into the community was to go with what already existed. That said we absolutely are committed to building an android version. We're also committed to going outside the US which is also the next question I usually get asked. And so we are a small company. We like any good small company. staying focused on one thing at a time and making sure we do that one thing well, so that one thing right now is getting it in the app store in the US, approved by the FDA, and then moving on to Android and outside the US is absolutely on our roadmap. And stay tuned. I don't want to over set expectations about when all that's gonna happen, we definitely will get to it.
Stacey Simms 30:21
Excellent. Yes, that was stuff. That was one of the questions. I'm curious, though, for somebody, you know, I don't even use my son's pump anymore. He's 16. I don't even see anything anymore. But I'm curious, in your studies with folks and somebody who's used DIY or your daughter is used for a long time. Is there anything different when you do use your phone as a controller? Other than convenience, I'm wondering if there's anything noticeable and different about it?
Howard Look 30:45
Well, I think what people report people who have been using DIY live, because no one has used a Tidepool Loop on their body yet, but people who use DIY Loop report that the freedom and convenience of having the interface on the thing that you're carrying anyway, is really wonderful. And Loop also includes an Apple Watch component. And I know a lot of people find that really liberating to be able to manage your diabetes right from your wrist. So I think what we've heard from DIY Loop users is, hey, look, I've got my phone with me all the time. Anyway, I'm looking at my phone all the time anyway. It's just so nice to be able to just interact with my diabetes using this thing that I use all the time anyway. Wow.
Stacey Simms 31:26
So just to be clear, you can control it from the watch as well, or That's it? Yes. Okay. Yes,
Howard Look 31:31
cool.
Stacey Simms 31:32
In the clinical trials, or the testing that you had to do for the submission, what came out, I mean, there was so much kind of, I don't know, it's off the record information for DIY. But I imagine that with tight pull Loop you really show did you have to demonstrate better control or just safety.
Howard Look 31:47
So this is another fascinating part of the story and how the community contributed to the success of Loop the FDA very early on, when we started talking to them about the possibility of submitting, we said to us very clearly, we love real world evidence. And so the clinical study data that we submitted with the 510 k application for Tidepool Loop , it's actually clinical data that came out of the Loop observational study of the Do It Yourself Loop community. And this is really an incredible study because it had over 1000 people in it, over 700 of whom were actively uploading data. And the amount of data in the study is staggering. As a matter of fact, the total person years or person days of study data in this study, if you take the control, IQ, pivotal study, the bazel, IQ, pivotal study, the Medtronic 670 g, pivotal study, and add it all up. The Loop observational study of DIY Loop has three times as much data submitted as those studies are three times as much data that's part that was collected during the study. So it's really a staggering amount of data. And we are really just overwhelmingly indebted to the community to all the people who participated in that study. And that was the foundation for the clinical evidence that we submitted with Tidepool , which is a pretty amazing thing. And I don't know that that has been done in that way before. Now, the data that is from that study has been published. So for your listeners who want to learn more, there are a couple places you can go the Job Center for Health Research to publish the paper, and I'm sure a quick Google search will turn it up. It's called the Loop observational study. It's also on clinical trials.gov. And if you want to see the presentation that was shown at last year's attd, and Madrid right before Coronavirus, broke, or was in full swing, February of last year, that's on our website@titlesearch.org slash documents. So to answer your question, what was interesting, what was interesting is how broad the use of Loop was, it was down to people under two years old and there were people in their 70s. There were people from all walks of life, it was just really fascinating to me, remember, this is a real world study. This was not a controlled intervention study. There wasn't a randomized control arm and people not using it. It was just observing life of people using it. And so to me that was the fascinating part is that so many people were willing to raise their hand and say, I want to help donate my data. And I'm going to show you how it works for me.
Stacey Simms 34:36
And we'll link up those studies that you mentioned, but I assume that they were good studies, in other words that people were happy with their agency, their time and range, ease of use safety, all that stuff,
Howard Look 34:46
the data, it looks great. There's some really fascinating outcomes. The way it works with the agency is only the FDA can say what's safe and effective. So we present the data to them. Here we say here's why We think it is safe and effective. But at the end of the day, the FDA is the one that gets to say, Yes, we agree. And therefore you are now FDA cleared. You know,
Stacey Simms 35:08
you've already mentioned this several times, but Tidepool has always stood out for being very open source, very open with information, publishing everything that you can saying as much as you can. I am curious that now that you have gone through something like this, are you happy that you did it that way? Would you do it that way again,
Howard Look 35:28
so the part about being an open and transparent organization I love, I think it is a great way to go. And I know it's not for every company, there's great value to big commercial companies like Apple choosing to keep their product plan secret, and then doing a huge launch and saying, tada, here's what we've done. For us as a small nonprofit with the mission of supporting the diabetes community, I think it's a great way to go. Because it allows us to be really clear that look, our motives are not about profit, our motives are about doing the right thing for the community. And to me, the openness and transparency just makes all that completely clear. There's another part of the story, which is doing it as a nonprofit, we happen to be doing both. We're open and transparent. And we're a 501 c three nonprofit, that part is tricky. I will be honest, especially during the pandemic, a lot of nonprofits including us have been hit hard. And that's been really challenging. It is much easier for a for profit company to weather a storm, if they've got a venture capitalist willing to give them funding or they can take out a loan as a nonprofit that has been challenging. Would I do it the same way? Again, I totally would, none of us could have predicted the pandemic. So it is what it is.
Stacey Simms 36:47
So with your nonprofit status, if I decide after FDA approval, and I can go to the app store with my prescription from my doctor, Uh huh. am I paying for it? Is my health insurance paying for it?
Howard Look 36:59
So here's where we are. And I will be open and transparent about this, which is we don't know yet. So as a nonprofit, our goal is to make the software as broadly available as we possibly can. We are engaging in commercial deals with some of these device makers so that they will actually give us money when people start using lube because obviously, we're bringing new customers to them that are going to keep buying supplies and pumps and cgms from them, we would love to keep the price as low as possible. And if there's any way we can do it, we want to make it free. We're not sure we can yet we've got to project out how it's going to go we do have a we we have people on staff and we have to pay them we're not going to do it has a way of making money the way a for profit company would we don't have to answer to investors, we don't have to answer to the stock market, we would only do that if it helps us be a self sustaining organization. And it helps us continue to deliver on our mission.
Stacey Simms 37:59
Somebody it's fascinating to think about the questions you start asking when you start going down this road of as you said, nonprofit and open source, everything else is an on that road. There are rumblings they're not really there yet of other possibly DIY routed projects that are waiting to see what happens with you guys. Right? So if you can, it's kind of like when Medtronic gotten sick, 70 approved. And then other people said, okay, we can now take our product. And we'll probably get it through the FDA with a lower, you know, time and range without calibration and things like that. Do you think that? Is this going to be the start of a different kind of diabetes technology? approved by the FDA? Like in five years? Could we have different like, you've already mentioned open APS and different things that you've built on. I wonder if there's somebody working on something today that because of the title submission would have an easier time coming through. So I asked about three questions in there. Sorry,
Howard Look 38:51
I, I sure hope that this is the start of a revolution in how new diabetes technology is created and delivered to market, whether it ends up being open source projects, or it's because we've shipped like we share all of our source code, we share our regulatory quality management system openly, we will publish our 510 k submission once we get through interactive review and clearance. And we're doing that because we want to help other people. Like for us, it's a win if there's lots more technology coming out that gives the diabetes community more choice. And that allows our kids and people living with diabetes and to have better solutions that fit better in their lives. That's a big win. Like we've got no ego invested in this. I want lots of companies, whether for profit or nonprofit, whether based on open source or closed source, it kind of doesn't matter. What I want to see happen is innovation. And I want that innovation to happen more quickly and get into the hands of people who can use it more quickly. So that's the wind for us.
Stacey Simms 39:57
As we start to wrap up here my interaction portability questions still are out there. And again, I know that you cannot speak to different products, and that's fine. I mean, you can and that's fine too. But when I think of true interoperability, and my ecosystem is limited just because of what my son uses, but I think of Okay, if I want to use this controller, but whether it's Tidepool Loop control, IQ, or Omni pod horizon, whatever, and I want to use a Libra, and I want to use this pump or I want to use a Dexcom. Or I want to use the Dana pump or whatever. There's, there's all these pumps, and CGM is coming to market. Are we going to see that anytime soon?
Howard Look 40:35
I am very optimistic that true interoperability is on its way. And one of the huge reasons we are doing what we're doing is to show that that is actually doable, you should be able to pick the pump that's right for you, you should be able to pick the CGM that's right for you, you should be able to pick the controller and the user experience that's right for you. I do imagine that there is a world where you can say you know what, I'm the pregnant mom living with type one, or I'm the athlete living with type one and I have very different needs, and the system should be able to adapt to you. And you should be able to choose which thing is stuck to your body to work best for you. So I am very, very optimistic that interoperability is happening. And we are pushing on it and we and I believe the FDA wants to tap into. That's why they made these interoperability pathways.
Stacey Simms 41:27
I remember when I saw one of your presentations on the shoulders of giants presentations A while ago, one of the things that people really like in addition to the the wonderful blood sugar control they get from DIY lube, they really like the icons, there's like ice cream and pizza. There's all this neat little stuff in the app Are you able to share it with you could just save any of the cute stuff.
Howard Look 41:48
Oh, there is a cute, the cute stuff is still there. Like I said the experience of Tidepool Loop will look very familiar to users of DIY Loop . And one of the things that people love about DIY Loop is the ability to use emojis to indicate the type of food you're having, whether it's the lollipop for fast acting carbs, or pizza for the very long acting carbs, and all the emojis in between. So that's something that people love about DIY Loop . And we have maintained that in in Thai polish.
Stacey Simms 42:22
I said it was my last question. I lied. I meant to ask you. The first time I talked to you in 2016. We were talking about Tidepool as an a data company. Right? I want to see my data I want to free the data is that still part of the mission? Is that still something that's part of the core of title moving forward?
Howard Look 42:41
It absolutely is. So at title we like to say Our mission is to make diabetes data more meaningful and actionable. And seeing all your data in one place is still absolutely part of our mission. pypo web and title uploader are incredibly popular. As a matter of fact, we have about three times as many users now as we had before the pandemic started. Because when there's a pandemic, it turns out, you need a way to upload your data remotely. And so that is absolutely still a part of what we're doing and making diabetes data meaningful. actionable is still absolutely part of what we do. Awesome.
Stacey Simms 43:24
Well, Howard, you've been so generous with your time I appreciate it so much. Just one more thing is your how's your daughter doing? You've got you've got three kids. Yeah, one child was dying with type one. But everybody You're like an empty nester, almost.
Howard Look 43:37
We are an empty nesters. But Katie is doing great. Thank you for asking. She's in college, and she is doing wonderfully. I will tell her you asked about her.
Stacey Simms 43:48
Oh, absolutely. Thank you so much for sharing all the information. Come on back, when and I will say when you get FDA approval, and we can share lots more details. But I think this is phenomenal. I'm so excited to just kind of be part of the information stream over the last couple of years. And it's just been so much fun to follow this. So thanks for coming on, Howard.
Howard Look 44:08
Well, thanks for all of your amazing questions. And it's just been so great to have you been with us and sharing our story over the years and so we're really, really grateful to you and all your listeners.
Howard Look 44:24
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 44:30
Lots more information at Diabetes connections.com. I know you had many more questions. I got so many questions in the Facebook group for this topic. But once I went down the road with Howard, I realized there were a bunch that he would not be able to answer. Frankly, most of them were for Insulet or for the makers of Omni pod. So I reached out to them and I will continue to ask them to come on the podcast. It's been a while I think they're waiting until they get FDA approval for their next product. But I'm working on it and I hope to talk to them as soon as I can. I Know You all have questions. And boy, it's a really exciting time. I hate that the technology. And title is not an example of this. I hate that a lot of the technology got backed up because of COVID. But man, this is going to be a very exciting year or two as things that have been kind of delayed, get released, which is why I'm doing this focus on technology this year. So I'm very excited about it. And I cannot wait to see so many questions there about what the FDA actually approves. And we know Tidepool with all of their wonderful open source and access to information we know that they will let us know. And I'll pass it along as soon as I learned anything.
All right, let's talk about Tell me something good. We're gonna have a story or two about summer camp diabetes camp, and a teenager with type one has an idea for a Funko Pop, that you're going to love. Diabetes Connections is brought to you by Dexcom. And one of the most common questions I get is about helping children with type one to become more independent. These transitional times are tricky elementary and middle school then middle to high school, you know what I mean? Using the Dexcom really makes a big difference. For us. It's not all about share and follow although that is very helpful. But think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four or five finger sticks at school, or for a second grader to just show the care team the number before Jim, you know, at one point Benny was doing up to 10 finger sticks a day, and not having to do that makes this management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at Diabetes connections.com and click on the Dexcom logo.
This is normally the time of year where people are signing up for camp. I know certainly for us, we're already our summer is planned by the end of February when my kids were younger with this both school aged kid and we both worked full time. You know I had summer programs done by this time, but of course it was COVID everything has changed. So it tells me something good. I was excited to share this week that I'm hearing about more summer camps that plan to be in person. And diabetes camps are certainly tricky, because while everybody should be taking lots of precautions because of COVID. You know, people with diabetes really need to take more precautions. So I was thrilled to find out just a couple that I'll pass along and I'll put more of these in the Facebook group. Hopefully we can get more as the information comes in. And as you learn what your local campus doing, we can share that info.
But Texas lions camp, which is the one that among other people, Dr. Steven ponder runs, they are doing something really interesting this summer, they have decided to open it up for family camp. And my understanding about this is that the whole family can come. But each family will stay in its own cabin, they will get together as socially distanced appropriate, if that's the right way to put it for activities and things like that. But within the cabin will be the family unit that's already spending time together. And so you wouldn't have to wear your mask within the cabin, you know, that sort of thing. And I think it's a really creative approach. I'm pretty sure they've had an amazing response to this. They may already be mostly filled, but you can definitely check it out. I'll put the link there. What a fun and interesting way to step up for this challenge
and camp kudzu in Georgia, which is a very close to my heart camp. I'll tell you about that. why in just a minute. But they have decided to have teen camps, family camps and four weeks of summer camp. So if all goes well, I'm sure things will look a little different, but they are going ahead with their camp program as well. And I bring up kids though, because I didn't know this for the first couple of years Benny went to camp. It's down the street from his regular non diabetes camps that I've talked about many, many times. Now camp kudzu is hosted at other camps. So it's not really their camp. I believe it's camp. Burnie it's their camp grass that they use in beautiful Cleveland, Georgia. And Benny goes to camp Coleman, which is just down the road. And I didn't realize that for the first couple years. I gotta tell you, I would have put My nervous heart at rest. To know that I was sending him away for a month and there were 100 people with diabetes down the street.
I did end up calling them I want to say was the last year Benny went so 2019 because of course he didn't go last summer. His insulin pump broke the very last day of Camp the last full day of camp. I don't know if he knocked it into something. We never figured out what happened but it just it just crapped out. And I called them to see if somebody could lend him a pump and they had their program had just ended a couple of days earlier. So he was fine. He did shots for the 24 hours before he came home and Tandem. I tell the story. By the time he got out of the shower, he came home he jumped in the shower, by the time he got out the pump was delivered. So we'd love how great they are with customer service. Our local diabetes camp hasn't made a decision yet as far as I know for what they are doing. But I'm sure that they are going to make that announcement pretty soon. So if you know what your camp is doing, you know we'll share it let me know I'm really hoping that as many kids as possible I can go back to diabetes camp this summer. But if your camp isn't having in person, I know it's not ideal. Do the virtual be part of this community however you can. It's so great for kids and for adults to certainly
our other Tell me something good is really cool. Now I am not the biggest follower of Funko Pop collectibles. I actually thought they were pop Funko which tells you all you need to know I have two in my office Actually I have Queenie Goldstein, from Fantastic Beasts and Where to Find Them from that Harry Potter spin off That's an inside joke with my family. I have Deathstroke because death strokes real name is Slade Wilson. My husband's name is Slade. So that's his funko pop and ended up here somehow anyway, all of this to say that I want to share the story of Ethan Savage. Ethan is 17 years old, and he was diagnosed with type one in September of 2019. He has a campaign to get the folks at Funko to create one of these figurines about type 1 diabetes. And if you haven't seen this, I'll put this in the Facebook group as well. But these are super popular, just about every pop culture character now has one of these. They're not bobble heads, but you know, the head is big, the body is smaller. They're very cute. And they're very popular. So Ethan has written to the company, he's got an Instagram account, he's showing them an example of what it could look like. And it's I guess it's Ethan. It's this kid, a guy. And he's got, you know, a pump on he's kind of lifted up a shirt and showing it off. I kind of say the guy looks cute, but kind of fierce, too. It's a really well done rendition of what this could be. And Ethan has been selling posters of the concept to raise money for JDRF. And he's got a diabetes educator who wants to give the figure here to newly diagnosed kids instead of as he says a lame stuffed animal from the kitchen.
In the letter that he shared with me that he wrote to Funko he says we're convinced this could make a great pop or series with a bigger opportunity. Most importantly, it'll raise awareness for good cause and bring you new fanatics. Haha, links below. I think this is phenomenal. I'm going to link up the Instagram account. And hopefully we can amplify the efforts here because I could see a whole line of kids with type one adults, even the celebrities that we've gotten the community Supreme Court Justice Sotomayor, what a great pop she would make. I think that'd be hysterical. I do have to tell you that one of the reasons that Ethan came to my attention is because I went to school with his dad. And it's unbelievable in the last couple of years to people off the top of my head, I can think of that I went to high school. I mean, really, I went to grade school all the way through high school with these folks, their kids have been diagnosed with three of us in the class of 1989 from York High School, have kids with type one now, I guess not that unusual, but it really brought it home for me. So thanks, Jonathan for sending this along and connecting me with Ethan and Hey, who knows what's gonna happen. If you have a Tell me something good, please send it to me Stacy at Diabetes connections.com, or post it in the Facebook group. And it's Diabetes Connections, the group.
Stacey Simms 52:23
Looking ahead next couple of days, we're gonna have another classic episode out for you. And that's coming on Thursday. And then we are continuing with the focus on technology have some really interesting stuff coming up in the next couple of weeks, I spoke to the people from City of Hope they've changed their name, but you probably know them both mostly by that and mostly by the claim they made a few years ago that they were gonna have a cure for type one within six years. I had to talk to them about that they have some really interesting new research going on. And I did talk to them about that claim. Because I actually think that did them a lot more damage than they should have set themselves up for to me that was a mistake. And they talked about it. They talked about why but we are almost really it's five years in now. So I'll be bringing you that story. I am talking to beta bionics the folks behind the islet damianos company about what's going on with them this year. And as I said, reaching out to Omni pod and helping to get a lot more technology stories for you in the weeks to come.
In the meantime, thank you as always to my editor John Bukenas from audio editing solutions and thank you so much for listening. I'm Stacey Simms. I'll see you back here in a couple of days until then, be kind to yourself.
Benny 53:33
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged