Podcasts about type zero

TYPE ZERO & INTERVENTION / THE NAUGHTY LIST #23 ON TOXIC SICKNESS / DECEMBER / 2024 by TOXIC SICKNESS OFFICIAL

In this episode of Diabetics Doing Things, Rob welcomes Jon Jensen back to the podcast. They discuss the challenges of running a business, dealing with stress, and how being active impacts blood sugar levels. They emphasize the importance of movement, hydration, and clean supplements for overall health. Topics discussed: 1. Challenges of running a business as a person with diabetes 2. Impact of stress on blood sugar levels and business decisions 3. Importance of movement for physical and mental well-being 4. Clean supplements and their role in maintaining health 5. Positive effects of simple activities like walking and hydration 6. Support for diabetes-owned businesses 7. Personal experiences with fitness, mindset, and health Key takeaways: * Stress and lifestyle factors can significantly impact blood sugar levels and overall health. * Movement, hydration, and clean supplements play a crucial role in managing diabetes and promoting well-being. * Small actions like going for a walk or staying hydrated can have a significant positive impact on mood and health. * Supporting diabetes-owned businesses and sharing feedback can create a positive loop of motivation and satisfaction. References: * Type Zero Health * Catalina Crunch * The Inner Game of Tennis by Timothy Gallwey 00:00  Exploring Inspiring Stories of People with Diabetes Worldwide 00:03  Exploring the Intersection of Diabetes, Entrepreneurship, and Stress with Type 0 Health Founder 03:27  Managing Chronic Stress and Diabetes in Today's Information Overload World. 06:37  The Impact of Information Overload on Blood Sugar Management. 09:49  The Power of Visualization and Confidence in Performance 12:59  From Visualization to Growth: A Founder's Journey with Type 0 Products 22:59  Revolutionizing Fitness with Type 0: From Mindset to New Products 25:05  Struggles of Creating Clean and Effective Supplements in the Health Industry 30:23  Empowering and Supporting Diabetes-Owned Businesses and Athletes in the Community 33:48  Revolutionizing Health with Type 0: A Passion for Movement and Clean Supplements 39:10  The Power of Walking: Simple Yet Impactful Health Benefits and Overcoming Gym Anxiety 42:32  The Power of Small Habits for Mental Health and Well-being. 46:35  The Impact of Entrepreneurship and Paying It Forward: A Conversation with Rob Howe

In this episode of Diabetics Doing Things, Rob welcomes Jon Jensen back to the podcast. They discuss the challenges of running a business, dealing with stress, and how being active impacts blood sugar levels. They emphasize the importance of movement, hydration, and clean supplements for overall health. Topics discussed: 1. Challenges of running a business as a person with diabetes 2. Impact of stress on blood sugar levels and business decisions 3. Importance of movement for physical and mental well-being 4. Clean supplements and their role in maintaining health 5. Positive effects of simple activities like walking and hydration 6. Support for diabetes-owned businesses 7. Personal experiences with fitness, mindset, and health Key takeaways: * Stress and lifestyle factors can significantly impact blood sugar levels and overall health. * Movement, hydration, and clean supplements play a crucial role in managing diabetes and promoting well-being. * Small actions like going for a walk or staying hydrated can have a significant positive impact on mood and health. * Supporting diabetes-owned businesses and sharing feedback can create a positive loop of motivation and satisfaction. References: * Type Zero Health * Catalina Crunch * The Inner Game of Tennis by Timothy Gallwey 00:00  Exploring Inspiring Stories of People with Diabetes Worldwide 00:03  Exploring the Intersection of Diabetes, Entrepreneurship, and Stress with Type 0 Health Founder 03:27  Managing Chronic Stress and Diabetes in Today's Information Overload World. 06:37  The Impact of Information Overload on Blood Sugar Management. 09:49  The Power of Visualization and Confidence in Performance 12:59  From Visualization to Growth: A Founder's Journey with Type 0 Products 22:59  Revolutionizing Fitness with Type 0: From Mindset to New Products 25:05  Struggles of Creating Clean and Effective Supplements in the Health Industry 30:23  Empowering and Supporting Diabetes-Owned Businesses and Athletes in the Community 33:48  Revolutionizing Health with Type 0: A Passion for Movement and Clean Supplements 39:10  The Power of Walking: Simple Yet Impactful Health Benefits and Overcoming Gym Anxiety 42:32  The Power of Small Habits for Mental Health and Well-being. 46:35  The Impact of Entrepreneurship and Paying It Forward: A Conversation with Rob Howe

Oliver is back with more Demon Slayer! Starting with the new stuff now: The Mist Hashira, a young swordsmith and... a training doll..?

The Animation Deliberation trio give their thoughts and opinions on the second episode of Demon Slayer's Swordsmith Village arc!Use my special link staywhelmed12 to save 12% at blendjet.com. The discount will be applied at checkout!

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This is the official Podcast for Casual Anime Fanatics. We hit your ears with fresh episodes at the start of every week. So if you're wanting a fantastic and casual podcast for all things anime, Look no further. This is “THAT ANIME PODCAST”  you've been searching for.In this episode of THAT ANIME PODCAST,  The Casual Anime Fanatics discuss Episode 2 of Season 3 (The Sword Smith Village Arc) of Demon Slayer, titled "Yoriichi Type Zero" Join us every week as we deep dive into each episode of this 11 episode season!Episode Synopsis:Tanjiro trains on the 6 armed mechanical combat doll, Yoriichi Type Zero, with the blessing of the swordsmith, Kutetsu. That Anime Podcast:IG: https://www.instagram.com/thatanimepodcast/Discord: https://discord.gg/H9k5nknzSz

Welcome to the Hashira Half Hour! We are so excited to be kicking off Demon Slayer's third season, the Swordsmith Village Arc, with the first brand new episode in over two months!In today's episode,  we discuss Episode 2,  Yoriichi Type Zero! Join Emily, Hannah, and Bryan to discuss the mysterious training tool passed down through the keepers of the swordsmith village for generations, and see how it may help Tanjiro to become stronger.Please like, follow, and subscribe, as well as follow us on our socials - https://linktr.ee/hashirahalfhour

Christina Martin joins Alex Burket on the Rise to the Challenge Podcast. Christina and Alex share a similar journey as type 1 diabetics and Christina talks about her story through Type 1 Diabetes. She talks about the positives and challenges and motivations it has given her to create the Type Zero Foundation. We talk about her career as a pro dancer and how her passion became even more. We also talk about being on American Ninja Warrior as the first female Type 1 diabetic. Christina talks about so much more on the Rise to the Challenge.  Check out the links below to learn more about Christina Martin:  - Linkedin: Christina Martin - Instagram: @typezeroninja

We all know that finding products that fit our diabetic needs an be a challenge. Even more so when we start moving more. I know for myself when I was in the gym heavily, pre-workout supplements were difficult to use. They either had too many stimulants or they were too sweet and sent my numbers up. Season 4's first guest is here to stop all of that. I sit down with Jon who is the founder of Type Zero Health. Type Zero provides workout supplements that are safe to use for anyone, especially diabetics. Being type 1 as well, Jon wanted to create something that would help people move more. Be sure to give Type Zero a try AND you can get 20% off your Amazon purchase using code HINDSIGHT20 KEY POINTS Getting to know Jon and the creation of Type Zero Balancing the ingredients and the taste The products of Type Zero and it's future  CONNECT WITH TYPE ZERO https://typezerohealth.com/ (typezerohealth.com) https://www.instagram.com/typezerohealth/ (instagram.com/typezerohealth) USE CODE: HINDSIGHT20 for 20% off any Type Zero products on AMAZON Find more at http://www.healinginhindsight.com/ (www.healinginhindsight.com) CONNECT WITH THE SHOW Instagram https://www.instagram.com/healinginhindsight/ (@healinginhindsight) https://www.facebook.com/healinginhindsight/ (Facebook.com/healinginhindsight) YouTube: https://www.youtube.com/channel/UCU5NGS16hrObu1i3Eq2C7ug/ (Healing in Hindsight™) SUPPORT THE SHOW https://www.buymeacoffee.com/healinhindsight (www.buymeacoffee.com/healinhindsight) Healing in Hindsight™ is managed by hosthttps://taylordaniele.com/ ( Taylor Daniele™) and Produced byhttps://weare8studios.com/ ( We Are 8 Studios) This podcast uses the following third-party services for analysis: Podcorn - https://podcorn.com/privacy Chartable - https://chartable.com/privacy

For the first time in several years, a new pump company is making a reach into the US market. Meet Ypsomed, the Swiss company teaming up with Lilly Diabetes. Their device, The YpsoPump, is available in Europe and Canada and has some unique features. But when it launches in the US, likely in 2022, it will only use Lilly insulin. That kind of proprietary design is unique and is raising eyebrows. Stacey talks to Simon Michel, Ypsomed's CEO (she'll talk to Lilly in a separate interview airing in a few weeks). In Innovations this week, what is an inverse diabetes vaccine? And could you be part of a trial for one? Learn more about City of Hope's Inverse Vaccine trial here  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! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android 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  0:22 This is Diabetes Connections with Stacey Simms.   Stacey Simms  0:28 This week, my first interview with Ypsomed, the Swiss company teaming up with Lilly diabetes to bring a new pump to the US. A few features make YpsoPump unique, including their infusion sets which can help to cut back on insulin waste.   Simon Michel  0:43 Yes  it's terrible. It's throw away so much insulin all the time. But you can disconnect Of course from your body, you change a cartridge, you put it back on. And that's how you don't lose your insulin in the tube.   Stacey Simms  0:54 That's Ypsomed CEO Simon Michel, we talked about more features and he answers questions about the partnership with Lilly in innovations. What is an inverse diabetes vaccine? And could you be part of a trial for one This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.   Welcome to our first full episode of 2021 Happy New Year. I'm so glad to have you here. Here we go. Another year of the podcast. My goodness, I'm your host, Stacey Simms. And as always, my goal here remains the same. We aim to educate and inspire about diabetes, with a focus on people who use insulin. any of that line sounds a little bit different if you're used to my intro where I talk exclusively about type one. But you know, more and more people with other types of diabetes are listening as the show is growing. And I think that's really important to acknowledge and to kind of dial back and see who we're serving here. My son was diagnosed with Type 1 14 years ago, my husband lives with type two diabetes, I do not have any type of diabetes. I'm the broadcaster in the family. This year on the show, I'm going to be focusing a lot on new technology, I think the delays that we saw in 2020, because of COVID are going to result in a lot more news than was originally planned or expected for 2021. You know, a lot of that innovation, a lot of those FDA submissions and approvals are getting stacked up, especially as we're looking at the second half of 2021 and into 2022. So you know, why not get ready. And you all have told me that you are very interested in episodes about technology. In this episode, we're gonna learn all about Ypsomed and their plans for the US market. I have an interview scheduled with their US partners, Lilly diabetes, to talk more in depth about the proprietary nature of this pump. You can only use Lilly insulin in it in the United States. That's interesting. We talk about that here in the interview. And then there are a bunch of questions that Ypsomed, really cannot answer that are more for Lilly. So I'm excited. I'll be talking to them soon. And just in the technology front, you're going to hear from the folks from Tandem. I've got a Medtronic interview, I'm excited to share with you. And as we look forward, of course, I will still be doing the personal stories interviews because I love those too. But please let me know if there are companies that you would like to hear from this year, and we will get them on and yes, Big Foot beta bionics. I'll be talking to everybody. Okay, Ypsomed in just a moment. But first Diabetes Connections has a new sponsor this year. Yes, I am so happy to welcome our newest partner Dario, I cannot wait to tell you all about them. You know, we first noticed Dario a couple of years ago at a conference and Benny thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed. You get a glucometer that fits in your pocket, unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it and personalized reports. Based on your activity. Find out more go to my daario.com forward slash Diabetes Connections. My guest this week is the CEO of Ypsomed. And if someone is a leading maker and developer of injection and infusion systems, pumps and pens around the world, and not just for diabetes, as you'll hear, they've been in the space for a very long time. But we're talking to them because I know I have listeners around the world and I appreciate you all so much and many of you may have experienced with this pump, but we are us centric and Ypsomed announced that it is partnering with Lilly diabetes to bring their pump to the US market. That announcement raised some eyebrows when it came out this fall because it will be the first pump in the US that will only be used With one type of insulin that can only be used with one type of insulin, and the US market is the only place where that will happen, this pump will be available in other countries that already is with different types of insulin. In other words, to be clear, you'll only be able to use Lilly insulin, such as human log in the US, if so, mid pump. Now, Ypsomed has been around for a long time before this, of course, many of you who've been in the space for a long time will recognize some of the technology names and the brands that come up here. I was really excited to talk to the CEO, of Ypsomed Simon Michel, for the very first time, he's been the CEO since 2014, at the company since 2006. And as you'll hear, he kind of grew up in the company. And here's our conversation. Thank you so much for spending some time with me. I'm excited to have you on the show and learn more about this. Thanks for being here.   Simon Michel  5:53 Thank you, Stacey. I'm to give us a chance to talk and explain to what we're doing. Yeah.   Stacey Simms  5:58 So let's just start with the basics if you could tell me about Ypsomed because we're really not that familiar with it here in the US. So if you wouldn't mind taking me through. Let's start with the the company history before we talk about the product because you are not a new company. You've been around for a while.   Simon Michel  6:14 Yes, I'd love to Absolutely. Thank you. So my father in 1985. Around the time when MiniMed founded the first company, the first pump in in Europe Disetronic. Some of you might still remember the name. And we were quite a successful pump company. And we sold the pump company at the Disetronic to Rouche in 2003, Rouche is still a name in Europe, roughly 80,000 patients on the product. But as they didn't really innovate anymore, we decided to go back into pumping in 2010.   Stacey Simms  6:44 When you went back into the pump business, what was the product at the time.   Simon Michel  6:48 So we did two things in 2010, we signed with Insulet. We took over the DC distribution of the Omnipod in Europe. So basically build up the business for for Insulet. between 2010 and 2017. When we've given it back to them, and the parallel we have started to develop our own YpsoPump so in back into tubed pumping and thought what can we do better? What can we do better in terms of pumps? What is the community needing tomorrow? versus the old Disetronic pumps, what can we do better?   Stacey Simms  7:17 What did you find that you could do better? We're going to talk about what the pump looks like and what it does, but big picture.   Simon Michel  7:24 So when we look at Ypsomed today for a whole, we make roughly 400 million in revenue, we grow at roughly 15% per year. So quite a healthy company despite of COVID we still grow and we have two businesses and it's quite important to understand we do both pumps and pens. today. I'd say you're by far largest pen and auto injector manufacturers in the world. We close roughly seven out of 10 deals in the pen space that's pens for insulins, solostar pen some of you might know it's also many of the Chinese pens, pens all over the world but all the injectors for autoimmune diseases migraine Astham, osteoporosis, So this is our device business. And the other half of our company the other 12 million is where we are very invest in pen needles in blood glucose monitoring and heat pump systems. And this we sell in Europe very successfully now for the past years in Europe and our own brand was owned subsidiaries and own people.   Stacey Simms  8:20 I'd like to know more about maybe we'll talk more about the pens a little bit later on. But when you started talking about the pumps and the systems that you started making in the 2000s I'd love to get back to what was lacking in the pump market. What did you think needed to change that you could do differently and better.   Simon Michel  8:37 So a couple of things you know, I mean to the pump was very much medical device centric. It's a very strong technic focus site is designed by engineers, great engineers from America from Switzerland from Germany, great people that think about what features we can add. But in the end of the day, we use these devices daily we don't really want to know and hear and feel and about this device. So number one criteria for us was to make it small and light. Ypsopump is roughly 80 grams. I don't know what this is in American weight measures but it's a it's a roughly half the weight of a Medtronic pump. I mean that gives you some kind of feeling very important, you wear it all day. The other thing is simplicity. We don't need all those features. I mean if you look at the at the iPhone, some of these phones they have many features but they only show the features that you actually use. So really simple in a way what is really required you don't need eight basal menus, you need two or three. Some might use but the big, big majority of us don't need this vast opportunities.   Stacey Simms  9:38 When I look at the the pump that we're talking about today. It does look tiny, it does look light and I did the I had to convert as well using my iPhone and that weight that 80 gram weight is point .176 pounds so very, very, very light. It looks like it's smaller, it looks like obviously it's lighter and doesn't have a touchscreen. It Looking at his buttons?   Simon Michel  10:01 Yes, absolutely. So it has a touchscreen. It's used like your mobile phone, you have one button to turn it on and off. That's basically it. But other than that you have a regular touchscreen, which works at night perfectly.   Stacey Simms  10:13 It's basically white on black. So it's a very good contrast that you see, is the pump controlled by phone? Is it controlled remotely? Or is it still used as the touchscreen?   Simon Michel  10:22 So yes, very important. We are a compared to other manufacturers, we are a iPhone app centric company. So you everything you do we do from your phone. So you have your Dexcom data on your phone, you give your bolus from your phone, you do your basal rates from your phone, that's that's our strategy, we have the firmware updates that go via phone onto the pump and back. It's very much app centric. The reason is we can be much, much faster and adding elements and adding new functions, new features, you don't need to change the device, you know, you don't want to change device or every year, simply too costly. This is why we set it up that way.   Stacey Simms  10:59 So that's a huge deal. Because here in the States we're all waiting for, you know bolus by phone, we're waiting for pump control which Tandem and maybe Omni pod will have and hopefully 2021. But just to be clear, you have that already.   Simon Michel  11:12 So we have the apps and the whole app control features are now launched in q1 in all over Europe. Yes. All the other things integrate the integration. The data this is this is in place the apps is in the market. But the integration of this bolus button and the CGM together is Dexcom is launched now in the beginning of ‘21, q1.   Stacey Simms  11:32 But let's talk I brought up the United States market. Let's talk about this partnership with Lilly, what is that partnership going to look like? And we can talk about consumers in a moment. But what will that partnership look like? For you all? Tell me about the system? What will the Lilly IP so mad Dexcom system look like when you bring it to the States?   Simon Michel  11:52 Well, basically, for my relationship, it's simple Ypsomed innovates and be manufacturer really supports in innovation and does the marketing and sales it was for us crystal clear from the beginning Ypsomed is a European company, it would be very tough for us to enter the big US market. So if you're looking for a partner, and luckily Lilly was looking for a pump, so we found each other a year ago Ypsomed would be the is the comet actually registered a product to the FDA, the expected approval in the second half of 22. But it's a fully branded Ace pump. So Dexcom is integrated as a bolus calculator calculator, the remote bolus  function as a Type Zero controller that will follow by mid 23. And it is a Lilly product from a user perspective, but it's manufactured in Switzerland.   Stacey Simms  12:35 It's so interesting to hear you say these things that a few years ago would have been very foreign to us. I think my audience is familiar now the ACE designation, Type Zero, which is the software that's inside. It's incredible, just to take a moment and think how far things have come   Simon Michel  12:52 across fast pretty fast. Yes,   Stacey Simms  12:53 goodness. But to be clear, Type Zero is the I would call that a hybrid closed loop software. So that's the software that will in very plain terms, work with the Dexcom to increase insulin or decrease insulin to try to keep people more in range. I just want to be crystal clear about that.   Simon Michel  13:11 None of those days. Absolutely. I mean, I mean, Type Zero belongs to Dexcom. And of course Type Zero is further working on on new versions of the controller. It's a constant enhancement. At the moment, the features that you described are the ones it's the low suspend function. It's the hybrid adaptation of the baseline rate. There's the micro bolus element, there are a couple of features which have one goal to bring us to bring patients with type 1 diabetes in in time and range   Stacey Simms  13:35 the ACE  designation, and I get a little confused on this. So I apologize in advance. That's all about interoperability. Right That's about making these new technologies compatible with other devices.   Right back to our conversation, but first Diabetes Connections is brought to you by Gvoke HypoPen, and almost everyone who takes insulin has experienced a low blood sugar that can be scary. A very low blood sugar is really scary. That's what Gvoke HypoPen comes in Gvoke HypoPen is the first autoinjector to treat very low blood sugar Gvoke HypoPen is pre mixed and ready to go with no visible needle means it's easy to use. How easy is it, you pull off the red cap, 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 HypoPen logo. g book shouldn't be used in patients with pheochromocytoma or insulinoma visit gvokeglucagon.com slash risk. Now back to Simon talking about interoperability and the East controller.   Simon Michel  14:40 Well, I mean, the great thing is that it's much easier to add different devices or different controllers to it. Once you have the ACE type designation you can actually change or upgrade a controller as it only is doing a lot of research on on controllers. So think about the might use their own controller in the future. Together with their new insolence. You can Think about situations where you can do better therapy better time and range when you combine new insulins with new controllers to actually use the insulin data to make better controllers. And also on the sensor side, it's possible that other sensors would come to the system at the moment, we love our partnership with Dexcom. It's great. It's really works perfect. But it's just it just shows an openness, that it's basically easy to add something else.   Stacey Simms  15:22 I have another question you may not be able to answer. I will be talking to Lilly about this. And it's really a question about them. I was at Lilly's headquarters in Cambridge, the headquarters for this project a couple of years ago, where they showed us their pump prototype because at the time they were working on building their own hardware. And obviously that project, I don't know if it's put aside I'll ask them about that. But this is not that pump. Correct. This is not the the pump that Lilly developed their partnership with you is using your hardware? If so meds pump, not this Lilly, it was a little circle disk pump that they showed us at the time.   Simon Michel  15:56 Yes. If the pump is purely manufactured by IP summit, it is the product designed here in Switzerland, that will be the pump that Lilly will use. You're absolutely right, Lilly was working on our own pump program, patch pump type program for many, many years. But you have to ask them they recently paid to our knowledge, they recently recently stopped the project, and are now fully focusing on our joint partnership to bring a cement Lilly pump to US patients.   Stacey Simms  16:25 I appreciate you answering that. I know that's more of a question for Lilly, and we'll talk to them about that for sure. But you know, insulin affordability is a huge issue in the United States. And we are we are struggling with that and a lot of our health care system right now. But making a pump that only uses one type of insulin is going to limit options. And I gotta be honest with you, I think people are, it's it may not be seen as a very popular feature. You know, we have insurance issues in the United States. I just went through this with my son, where we'd been on one insulin for many years. And then my insurance company said, No, you you have to use this other insulin. And that can happen here. Are you concerned about that at   Simon Michel  17:02 all, this will happen, of course, but it is ultimately beneficial for a health care system. And I can make the comparison with mobile phones. So if you have a mobile subscription, and you have your fixed lens subscription or internet subscription, you get a better deal. Now, this approach is to really bundle all these elements, and it will ultimately very much be much better beneficial for people with diabetes, it will be better for the healthcare system as of lower cost. So it's definitely not increasing the cost. Yes, it is increasing, its increasing to some extent, your choice of insulin, whether it's a short acting insulin for novel from Lilly, I fully agree but it will lower costs for healthcare system because of the bundle approach. It's a really innovative partnership. Where is the entity manufacturer really decides to go the full way the first time in history? And this will be beneficial for us us healthcare system for sure.   Stacey Simms  17:49 That's really interesting. So they'll have to work with insurance companies to say if you cover this pump, you must cover this insulin. Again. Again, I have to talk to Lilly but I would imagine Yes,   Simon Michel  17:59 well, of course that's a fair question. But I mean really wouldn't invest so much in a partnership if they wouldn't want to sell their core asset which is their insulin and in a prefilled cartridge, it will work with our pump. So it is the way this relationship is built up. But again, for Americans and for the healthcare system, I personally only see benefits in the end of the day in terms of cost.   Stacey Simms  18:23 That prefilled cartridge is something that is not currently available on any pump system in the US It was here for a while with some older pumps that are not on the market anymore.   Simon Michel  18:33 Well it was our pump Yes, it was the Disetronic pump with the three ml humalog cartridge was available in America between I would say 1998 and 2004 ish before Rouche stopped it, it will come back but it will come back in 1.6 format in a shorter version. We basically have this in the market already in Europe together with Novo Nordisk . So there's a novel called pump cart that works with our pump that's available in the market now since 2017. And is going the same way now this is a huge benefit to work with prefilled you don't have to fiddle around and fill your cartridges you could just take it out of a fridge make it a bit warm, put it into pump and that's a huge benefit.   Stacey Simms  19:12 It was very popular I think I want to say the Asante snap pump also had it for a while and that's the one that I look at because   Simon Michel  19:20 yeah your idea right it wasn't it wasn't this one was not a market so it was not so successful. This pump You're right. I mean the issue was with the D Tron pump, it was a bit too big, you know, it's three ml cartridge, the 1.6 is shorter. That's how we can build such a small pump. And the good thing about a pump is with our infusion set, you can actually keep the tube on. So you can change the cartridge you can keep the tube on you don't have to throw away the insulin which is in your tool because you can change the cartridge. Keep the cube you're using and you don't lose insulin.   Stacey Simms  19:49 Okay, I have many questions. Wait, let's go through those all at once. And I will get to the keeping the inset on but staying with the cartridge for a moment. So that's 160 units In the cartridge and you said take it out of the fridge, pop it in the pump, is it good in the refrigerator for a long time, because right now if people kind of pre fill when they're not supposed to the cartridges that are available on the market will start to break down. I'm assuming that's not the case.   Simon Michel  20:15 Well, it's, as we are used with pens a single expired expired date of two to three years. It depends on market by market, but you can keep it as your pen,   Stacey Simms  20:23 I was thinking two to three weeks for a filled cartridge right now, we're not supposed to do that with the Tandem or the Medtronic pump.   Simon Michel  20:30 It's a prefilled closed system as we are used with prefilled three ml cartridge. Some of you may use a reusable durable pen. Of course there you need regular in Europe, quite a lot of people use durable pens. And now it's Medtronic coming this Companion, you will see more and more durable pens in America as well. This smart pen trend will definitely lead to more cartridge based pens where you exchange the cartridge. So it's a standard closed cartridge system. You can keep it for two or three years in the fridge.   Stacey Simms  20:57 So talk to me about keeping the inset on. When you're changing out the cartridge. You're not priming the tubing, you're not doing things like that,   Simon Michel  21:05 yes, we built in a valve in a way that you can take the connector off the pump, you exchange the cartridge, you put the connector back on the pump, and there's no air coming into the tube to kick can continue to pump Of course you would disconnect it, you orbit set has a nice feature disconnect at the head. It has a 360 degree rotation feature. So it never cranks. But you can disconnect Of course from your body. You change a cartridge, you put it back on. And that's how you don't lose your insulin in the tube.   Stacey Simms  21:35 That's wonderful people you know, it's very difficult when you're losing units upon units when your primary   Simon Michel  21:41 yes and no, it's terrible. You throw away so much insulin all the time. So you can use this tool for seven days. So two or three cartridges. Of course it depends. If you if you need more insulin, you use it for two or three colleges if you use less insulin, use it for so it's just I think seven days is what is what makes sense.   Stacey Simms  21:59 Tell me a little bit more about that inset because I I've said for years and years that insects are the weak link of pumping, they leak. They don't work so well. You mentioned it rotates. Talk to me about your inset   Simon Michel  22:10 is a fully agree it's definitely the space where part manufacturers have to spend much more effort in innovation. Our infusion set is today a three day infusion set we work on a five and seven day version to just keep it longer on it's also regulatory work that has to be done here. It has a skin color. plaster so it doesn't show so much if you wear it. When you're at the beach. It has a 360 degree rotation at the head. So it really doesn't crink that's quite nice. It pops up clicks very nicely. You can click it behind your back without looking at, you hear it and it's safe and close. It has a Blue tube so it doesn't show so much on black clothing. A couple of nice features.   Stacey Simms  22:52 Is the skin tone one skin tone?   Simon Michel  22:55 It is a I would say it's a as neutral as possible one skin tone. Yes. I mean, it's better than white. You know, I think White is really shiny like we are used from other part manufacturers. It's just a more neutral skin tone.   Stacey Simms  23:08 Yeah, I know. You know what I'm asking though? I mean, is a Caucasian. Is it more peach than brown?   Simon Michel  23:14 Yes, yes. Yes. Yes, it is.   Stacey Simms  23:17 All right. Well, your first feedback is you have to work on that for especially for the US market and other markets. So I'll give you that piece of feedback.   Simon Michel  23:23 But input Thank you. No, you're absolutely right. It's a very good remark. I think I guess we are not so much used. From a diversity perspective over here in Western Europe. I think it's a very, very important remark you're making. And I definitely think it's possible to do that. I think it's a great idea.   Stacey Simms  23:38 That would be wonderful. Because, you know, I chuckled as I said it, but I appreciate you taking it seriously. It's difficult to talk about these things. And I find myself sometimes I shouldn't have left, they're trying to defuse the situation a little bit. But we are a very large and diverse country over here. And we have lots of   Simon Michel  23:55 love. No, no, no, I fully agree. And they beat this doesn't stop bad skin color. I think it's a great idea. And I don't see a reason why we should innovate on that to something we have never seen over here. It's not a topic that we get from customer feedback over here in Europe, but it's a great input. Thank you.   Stacey Simms  24:10 I appreciate you taking it that way. So let's talk about the pens for a moment because we tend to focus on this show a lot about pumps. But at the same time, you have already mentioned so many interesting things about pens. Do you plan to bring you mentioned smart pens, you've talked about the different types of pens that Ypsomed makes already outside of diabetes? Is any of that available in the US market or do you plan to bring it here,   Simon Michel  24:34 so from the insulin pens today, only the Solostar pen from Sanofi is on the market. It's a disposable pen. Also the to chill pen so the for the other type of Sanofi insulin. Other than that we are at the moment in discussion with several parties. For our smart pen. We have a smart pen for a 1.6 ml version and a three ml version, which connects to the app and the cloud. Of course, you have all the benefits of a smart pen you can use the CGM data including all the injection data which we really need. I mean, you need both sides, you need to be GMC champ data as well as the injection data when you have injected IV correctly. In fact, we have a lot of nice features on the pen tells you if it's styled correctly or not. There's a lie. It shows your holding time. How long enough to hold on many nice features you can do with smart pens today.   Simon Michel  25:21 Yeah, because a lot of people don't still want pumps attached to them. And a pen is a real option   Simon Michel  25:26 Yeah, absolutely. I mean, worldwide, we have 50 million people that take shots every day, but only 1.5 million user pump. So I think a lot of the vast majority uses pens, so it definitely have to innovate more in that space. And I'm so happy now that Medtronic decided to do to make that step to make that move, and also Novo Nordisk making the move. Now Lilly will come with a solution and the space is now moving. And that's very important.   Stacey Simms  25:51 It's okay, if you can't answer this, but can you give us an idea of what an Ypsomed smart insulin pen would do? I mean, we've The only frame of reference we have here in the States right now is companion medical, as you mentioned with Medtronic, could you give us an idea of what features might be available?   Simon Michel  26:07 Yes, absolutely. I mean, this pen is available in the analog version, so the non digital version in China for over 10 years, it's a very robust pen the piston drop, push back with your finger, it has a bayonet coupling for the cartridge. It has a spring driven support for injection. So it don't need to force if you have, or if you're old or don't have strength anymore. You just put a button in checks with a spring support. Very nice feature, we have a large display, which works at night, you have a light that gives the signal whether your dial is correct or wrongly, it's red and green, it shows how long you have to check that it stops blinking when it's injected fully out of his holding time, I think is the old time is very important. You have its Bluetooth connection, of course to the app connects automatically, it stores everything on the pen and on the app. So all the features that you are used from Companion are now in there, as a will be a great, great product that we are working on here. And hopefully be able to introduce to America, we will take two two and a half years to come. We have to go through registration program together and still need to make the decision what partner will be the one that will bring it to the market. You know,   Stacey Simms  27:14 I should have asked you right at the beginning. But I'm curious, do you have any kind of personal connection to diabetes?   Simon Michel  27:21 Well, not personally, not not nobody in our family has type 1 diabetes, we have a couple of uncles and aunts that are on insulin on type two. But you know, I spent my whole life with diabetes. I think when I was 10 years old, I was throwing the first insulin pump. I still have this picture somewhere I can check and send it to you. It was it was an H Tron pump. Remember 1987. So I was my whole life. I mean, we went to the factory pump factory with my father, when I was a boy, my brother and me We ran around. And so he was my whole life. And then I went to university and I started in telecom industry. And it was very clear for me that I will come back. So I'm in this in this industry now really, for almost two decades. But we don't have diabetes, but I'm very, very connected to it.   Stacey Simms  28:02 That's great. I would love to see that photo or anything that you might want to share for sure. So I guess that leads me to this question, which is what gets you excited. I mean, your family has been in this business for so long, you've seen it change, you're bringing something brand new to the United States in a couple of years. But what gets you out of bed every morning that you're still excited to work in this space.   Simon Michel  28:22 I believe we are extremely privileged here to be able to work on products and services that make life easier for people with diabetes. And this is our business for 30 years. It's a family business we are stock listed but the majority of the shares in our in our family. So we do have a large responsibility on it. It's just great to see we are 2000 people now here working every day tried to make better devices, better solutions for people with chronic diseases also outside of diabetes and it's it's a huge privilege and motivation to work on it.   Stacey Simms  28:53 Well I feel like I just scratched the surface starting to talk to you about the partnership with Lilly and the pump and the pens. So I hope I can circle back maybe next year and check in on the progress and and talk to you as you get closer to bringing this to the US.   Simon Michel  29:06 Yes, let's do that. That's right to give an update. Once we filed we tried to file in summer 21 we still sorority and they will definitely be a good time again to give you an update.   Stacey Simms  29:17 Wonderful. Thank you so much for your time. It was wonderful to talk to you and I'm so excited to learn more.   Simon Michel  29:22 It's a pleasure talking to you.   Simon Michel  29:29 You're listening to Diabetes Connections with Stacey Simms.   Stacey Simms  29:34 So what do you think? I'll be posting in the Facebook group to get your questions for my upcoming interview with Lilly and that is Diabetes Connections the group Do you think it's possible that overall, this pump system will turn out to be less expensive as Simon thinks. I certainly hope so. But any kind of proprietary idea on a market that is already so limited just makes me nervous. And I said this when I was at Cambridge a couple of years ago looking at their prototype for the pump that they're no longer developing, apparently, I think they got into this pump partnership, because they know the writing's on the wall for insulin price controls may be too strong a word, but limitations. I won't get into it too much here. But you know, we've had this conversation many times before, I think that there's going to be legislation at the state level, if not the federal level, to really change how insulin and other medications other treatments are priced. So we shall see. And oh, my goodness, I hope our conversation about skin tone on the inset came off. Well, I mean, these things are awkward, as I said in the interview, but once he said skin colored, I mean, most of the inserts are just bright white. So once he said skin color, I had to ask, I had to follow up. I hope that came off. Okay. And look, we can seem to take it very seriously. So we shall see. Wouldn't that be nice if medical devices could be a little more discreet on the skin on any color skin tone? Okay, up next, let's talk about an inverse vaccine for diabetes and explain what that is. But first Diabetes Connections is brought to you by Dexcom. Do you know about Dexcom clarity, it's their diabetes management software. And for a long time, I really did think this was just something our endo used. You can use it though on both desktop or as an app on your phone. And it is an easy way to keep track of the big picture. I try to check it no more than once a week. Although I'll be honest with you, there are times when I'm checking it every day, it really does help me and Benny dial back, I look for longer term trends. And I try not to overreact to what happened for just one day or you know one hour, the overlay reports help context to Benny's glucose levels and patterns. And then you share the reports with your care team, which makes appointments a lot more productive. managing diabetes is not easy. But I feel like we have one of the best CGM systems working for us find out more, go to Diabetes connections.com and click on the Dexcom logo.   In our Innovations segment, this week, I want to talk a little bit about something called an inverse vaccine. This is a City of Hope, phase one trial. And the City of Hope is an organization that is looking to try to find cures for type one, I will link up more information in the show notes about them. And we really should talk to them. I it's hard for me to believe we haven't had them on the show yet. So that's going on the list. But basically, this would use someone's own immune cells, a beta cell protein, and vitamin d3 to potentially treat type one, I'm sure that is a very simplified explanation. But these inverse vaccines are trying to stop certain immune responses rather than activate them. When you think about a regular vaccine, right, like the flu shot are the COVID-19 vaccine that we talked about just last week, what they're doing is trying to stimulate the immune system, right, here's a germ learn how to fight it, go immune system, right, the inverse vaccine is, here's something coming in, don't do anything stand down. Again, this is a very simplified version of what they're trying to do. But they are recruiting, they can't start the actual trial, they say until the pandemic is under control a much more but they are recruiting and they are screening patients right now. So I'm going to put up a link in the show notes. And as always, you can go to Diabetes connections.com. And look at the episode homepage. If you're listening on an app, a lot of them are great to listen to, but the show notes aren't so hot. So if you have any trouble, just head on over to the homepage. As usual. The trial I should say is open to adults with type one between the ages of 18 and 45. You have to have been diagnosed in the last one to four years. There's a lot more listing after that. And by the way, this is a follow up on a small study in the Netherlands where they they looked at safety. So you know if you get into this definitely keep us posted. I'd love to know more. A couple of quick housekeeping things before I let you go this time around. I am taking part in a free summit at the end of this month. It is the fearless diabetic summit. And I will be posting more about that in the group. And on our website. This is a really interesting summit that is trying to answer the question, what would you tell yourself if you could go back to your first two weeks of diagnosis, and they talk to 30 different people in the diabetes space, you know, experts and educators and NGOs and athletes and I think I'm the only parent that they talk to. But it's a really interesting concept. And I'll talk more about that as the month goes on. I'll put a link in the show notes to the fearless diabetic summit. Also, if you haven't seen it yet, I have a free ebook Diabetes Connections extra that I put out late last year and this is a set of transcriptions and they are proofed and they're beautifully laid out easy to read. They are the extra episodes that I did a little while ago all about the basics of diabetes management ketones. What is insulin? What are lows? How do you use a CGM to its best practice insulin pumps, all that kind of stuff. I think it's a really good read for newer diagnosed families and for you to give to people in your life that you would like to better explain diabetes to it is an email signup. But you know, I don't spam anybody, most of you are on the email list already. But if you want to send that out, I'll always put the link in the show notes to that as well. That is the free ebook. And finally, I'm this close to announcing my new project. And it really doesn't have anything to do with diabetes. But if you're interested in podcasting, you'll want to sign up, I am going to be teaching a course this year, I'm teaching two courses actually, on podcast, monetization, get paid to podcast, I have been really interested in this subject, because I've helped a lot of people kind of behind the scenes for the last couple of years to do this, ethically to do this. Well to do it in a way that makes sense so that your listeners don't have to pay anything, but that if you want to spend enough time on your podcast to make it quality, you eventually are going to look at options like this. And you know, like diabetes, there's some snake oil in the space. There's some stuff out there. That's pretty questionable. And I want to help people do this with transparency with disclosures to do it right. So stay tuned for more than that. I will not be hammering you with this. You’re here for diabetes news, but I wanted to let you know, and I'm really excited about it. Thank you so much to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.   Benny  36:32 Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

Tracklist: 01 Crossfiyah - Depths of Truth 02 Angerfist - Bite Yo Style (Dyprax Rmx) 03 Hellsystem feat. Tieum - Time to Prove 04 StereoType - Get Fucked Up 05 Dyprax & T-Junction - Nightwalker 06 Cemon Victa - Hardcore Battlefield (T-Junction & Rudeboy Remix) 07 Komarovski - Viva La Revolution 08 DJ Myosuke - Hardsound Primary (Hellsystem Remix) 09 Crossfiyah - Dominate 10 Nocturnal Ritual - The Crime (Who I Am) 11 NeoX - Bad person 12 Angerfist & Dyprax - Claim You 13 Dyprax - Running Scared 14 NNN - Bite Your Face 15 The Melodyst - Cocaine Soundtrack 16 Art Of Fighters & Meccano Twins - Hear Me Coming 17 Dave Dope - Back To The Hardcore Artist Page: - facebook.com/DjTypeZero/ - mixcloud.com/TypeZero/ - youtube.com/channel/UCuu-zLq5IfP3F80l-n9XYIg?view_as=subscriber - @Dj-type-zero ***** TRACKLIST BELOW ***** #TheDarkChronicles #Annihilation #ItsAllAboutTheMusic ------------------------------------------------------ - The Dark Chronicles - Facebook: - facebook.com/Annihilation.TheDarkChronicles Soundcloud: - soundcloud.com/user-541779419 ------------------------------------------------------ - Annihilation - Facebook: - facebook.com/Annihilation.ItsAllAboutTheMusic - facebook.com/groups/Annihilation.ItsAllAboutTheMusic Soundcloud: - soundcloud.com/theannihilationproject ------------------------------------------------------ Other pages samiliar to The Dark Chronicles: Hardcore Revival - The Mainstream and Millennium Community (20002014): - https://www.facebook.com/groups/159612771397007/ Industrial Crossbreed: - https://www.facebook.com/groups/856359544431515/ ------------------------------------------------------

Join us today as we discuss the Nym Type Zero Gamble from Kakegurui XX Season 2. We are covering episode 3 'The Untouchable Girl' and episode 4 'The Connected Girls'. Yumeko is poisoned during the gamble and Saotome must fill in for her with Suzui to defeat Miri and Miyo! Slow Blink Anime Podcast [043] FOLLOW US! Twitter: https://twitter.com/slowblinkanime Facebook: https://www.facebook.com/slowblinkanime/ Instagram: https://www.instagram.com/slowblinkanime/ Reddit: https://www.reddit.com/r/slowblinkanime/ LISTEN ON THE GO! Apple Podcasts: https://podcasts.apple.com/us/podcast/slow-blink-anime-podcast/id1493645804 Spotify: https://open.spotify.com/show/6iA2ZFL3DtcK8OkyPaWA4u Google Podcasts: https://www.google.com/podcasts?feed=aHR0cHM6Ly9hbmNob3IuZm0vcy8xMjMxNjgxOC9wb2RjYXN0L3Jzcw== Intro/Outro Music: https://www.free-stock-music.com/ghostrifter-official-morning-routine.html Morning Routine by Ghostrifter Official | https://soundcloud.com/ghostrifter-official Music promoted by https://www.free-stock-music.com Creative Commons Attribution-ShareAlike 3.0 Unported https://creativecommons.org/licenses/by-sa/3.0/deed.en_US

Tandem's Control-IQ system was approved by the US FDA in mid-December. In this episode, Stacey talks to Molly McElwey Malloy, Tandem's clinical outcomes manager with behavioral sciences. Check out Stacey's new book: The World's Worst Diabetes Mom! Control-IQ technology is an advanced hybrid closed-loop system that uses an algorithm to automatically adjust insulin in response to predicted glucose levels to help increase time in the American Diabetes Association-recommended target range (70-180 mg/dL).* Check out Tandem's YouTube channel, featuring new videos about Control IQ Join the Diabetes Connections Facebook Group! This is our last episode of 2019! Stay tuned for new sponsors, new segments and new weekly mini-episodes. Sign up for our newsletter here To use Control-IQ, you must have the Tandem t:slim x2 insulin pump and you must have the Dexcom G6 CGM. The Control IQ software is as simple as a download from your computer to the pump.. it does not require a purchase of new hardware.. no new pump needed. You do need to have a prescription from you doctor. If you are an in-warranty customer the Control IQ update s free. All software updates released through 2020 are free to in-warranty t:slim X2 users. It doesn’t matter when you choose to download the update. The no-cost is determined by our release date, not your download date. ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android   Episode transcription (Note: this is a rough transcription of the show. Please excuse spelling/grammar/punctuation errors) (Time codes listed refer to times within the interview, which starts 5:30 into the episode) Transcript: This episode of Diabetes Connections is brought to you by the World's Worst Diabetes Mom. Real life stories of parenting a child with Type One Diabetes, available now as eBook paperback and audio book, Learn more at diabetes dash connections.com Welcome to our last episode of 2019 and it's a big one all about Control IQ the new hybrid closed loop system from Tandem recently approved by the FDA. I'm talking with Molly McElwee Malloy from Tandem. And I'm going to try to keep this intro short. I know you all just want the information. But I do have a few housekeeping and other things to get to. You can always skip ahead if you wish, I will not be insulted. But first while my regular podcast listeners insulted first when things like this happen when there is a Big news in the community. We get a lot of new listeners. So I want to go through some basics first. Hi, I'm your host, I'm Stacey Simms. My son was diagnosed 13 years ago, right before he turned two. He is now freshman in high school. He is 15. And boy, time has really flown. My husband lives with type two diabetes, I don't have diabetes. I have a background in broadcasting, local radio and TV news. And that is how you get the podcast. We are four and a half years into this podcast. We have more than 260 episodes. So I would encourage you to head on over to diabetes dash connections. com If you're brand new, scroll through. There's a very robust search feature. So if you want to type in Tandem and see what we've done over the years leading up to this release, or any other topic pertinent to diabetes, you can go ahead and do that it's very easy to search through. It's very easy to search through, and everything you'd want to know about the podcast, including how to subscribe for free on whatever app you want to use. Joining the Facebook group all about me, it's all there on the website. Okay, let's talk about Control IQ. What is it? Control IQ technology is an advanced hybrid closed loop system. It is the software within the pump. It uses an algorithm to automatically adjust insulin in response to predicted glucose levels. So we're going to talk about that to help increase time in range. Time in range and the recommended target range is 70 to 180. And yes for the International listeners we have quite a few. This is a USA centric episode Control IQ is rolling out in the US. We will be staying up to date on when it is available in the rest of the world where Tandem is already in your marketplace. But this is a USA centric episode so when you hear us talking about numbers, that's the system that we're using. For Control IQ you must have the Tandem t slim x2 insulin pump and you must have the Dexcom G6 CGM. The Control IQ software is as simple as a download from your computer to the pump. It does not require a purchase of new hardware, no new pump is needed. You do need to have a prescription from your doctor and you will hear more about that if you are an warranty customer, the Control IQ update will be free. All software updates released through the end of 2020 are free to in warranty t slim X to users. It doesn't matter when you choose to download the update. The no cost is determined by Tandems release date, not your download date as we're right at the beginning of 2020. That probably doesn't matter to most of you listening but I think it's important to point out. Control IQ is FDA approved for those 14 and up. It is not a replacement for diabetes management. And it is not a cure. It is not a cure. There is so much information about this online already from Tandem. I will be linking up a lot of stuff on the episode web page. They have YouTube videos. There's so many features that we don't even get to in this interview. I mean, the tubing fill, you can now set that to vibrate so it doesn't beep when you fill the tubing and change the cartridge which I know Benny just so excited about but in this interview, we really just scratched the surface. So please know I will be doing follow ups and there's a lot of supplemental information on the website. Quick note about Molly McElwee Malloy, who I'm talking to from Tandem, she was diagnosed 22 years ago this week as a young adult. And as you will hear, being in an artificial pancreas trial, changed her life. It changed her career path, everything. And she is one of many, many people who has been with this project for a very long time. We do spend the first four minutes of this interview on that subject on who Molly is and getting to this point. And if you're dying to get Control IQ info, again, go ahead and skip ahead. But I think her story is an important part of all of this and I think it sets up all the information very well. One more thing. There will be a full transcription available for this interview. A lot of you have been asking for that. That's a new feature I'm making available for the podcast in 2020. So stay tuned on that for every episode, but this transcript will be right on that episode web page. The best way to read it go to diabetes dash connections. com scroll down and click on this interview to open it up. All right here is my interview with Tandems, Molly McElwee Malloy, Stacey Simms 0:01 Molly, thank you so much for joining me. I can only imagine how busy you are and how full your inbox is. Molly McElwee Malloy 0:08 It's a really exciting time. For sure. Absolutely. No doubt. Stacey Simms 0:15 Well, congratulations. We're very excited. I mean, personally and professionally. I can't wait to talk to you about this. So let's just jump right in. I do have to ask you though, for people who may not be familiar, tell me a little bit about your background because Boy, you have been with this project. Really, I want to say almost since day one, tell me about your involvement with what has led to Control IQ for Tandem. Molly McElwee Malloy 0:39 So I'm, I'm sort of what you would call like the obsessed fan who went rogue. So I, I was in an artificial pancreas prior in 2006. And full disclosure, because no surprise to anybody who knows me but I have a bit of OCD. And for me, that was manifesting is testing my blood sugar 30 times a day. Wow. And yeah, it was really out of Control. Or as most, you know, endocrinologist say, I was a perfect patient with zero Mental Health Quality, but life like it definitely was impacting my quality of life. But I participated in one of these trials. And it was, you know four IVs and somebody at your bedside for 32 hours and the whole nine yards, but for me, it was life changing that for a period of time, I could relax for the first time and just let somebody else take Control. And everything was fine. And I sort of just realized that deep breath at that time was exactly what I needed. And I and I was like, Well, I'm going to do whatever it takes to work on this project. So you know, at the time, I was a professional musician, which makes getting into science.. Stacey Simms 2:05 Be vert interesting, Molly McElwee Malloy 2:06 Just a super, super easy transition (laughs). As logical obviously, as you've spent your life, being a musician that makes sense to just go into science. So I went back to school for nursing and continued to participate in trials through nursing school. And then when I graduated they hired me on at the Center for diabetes technology at the University of Virginia, which is where all of this magic was taking place. And I have not looked back. So they hired me in 2010 have been acquainted with the algorithms since 2006 as a patient, and here we are, it's almost 2020 it's 2019. And it's finally getting to market so I've done that and I worked with a startup called Type Zero technologies, which commercialized The algorithm licensed it the Tandem diabetes care. And then I jumped over to Tandem to pursue commercializing the algorithm. So, a little bit of like a dog with a bone, go and fill it out. But it was sort of my glimpse at sanity. Like, this is what sanity, this is what my life could look like with diabetes. If something was managing it in the background, I was really only worried about the big things. And I saw that and I was like, that is exactly what I will do. That's what I'm gonna be doing. I will do this all the time until it gets there. And it is. It's been a very long journey. very rewarding journey. Very difficult journey, but to be here today, wearing the device is magical. Stacey Simms 3:54 Okay, I'm gonna stop you there. I could talk to you for a long time about the process. But as you listen, I know you want to get to Control IQ. So I will just say, I've talked to Molly a couple of times before and I will link up the other episodes because the background on this, as you mentioned, type zero, you know how Tandem came to have that software, the development of all this, it's really important. And it's really interesting to listen to. So I will link those episodes up. But let's talk about Control IQ, so many questions. What are the what are the first steps? What's going on right now. Molly McElwee Malloy 4:27 So because of this all happening right around holidays, what we're doing with him doing kind of behind the scenes and, you know, as we speak up through the beginning, or first two weeks of January is we're educating the whole you know, diabetes educator and endo workforce, getting everybody up to date, getting everybody ready, making sure we're on the same page. So that when you go to your endocrinologist and say I want this you know that customer, they are well informed of what's going on. So all of that's been going on in the scenes like, you know, just earlier today I was on the phone with 10 different doctors trying to make sure that we all understood everything. So we're, we're educating as fast and as seriously as we can. We have an excellent online training program. So you as a customer, if you are current X2 user base, like you are just x to the end user will get an email, and I believe it's the first the second week of January way of January 13. That week, you'll get an email saying, hey, go ahead and login, update your information, make sure everything correct when you get the prescription will, you know will we talk to your doctor and will help you if you're an existing customer with we have that information kind of fully loaded, ready to go. You could also log into the portal, the customer portal and you know, go ahead and start that process. I'm interested, I want this and talk to your doctor. That's all that's one place. It is super easy scripts with your doctor that gets loaded. It's an automatic process. Once we have that, if you've already got that, like a blanket prescription from your providers practice is already going with us and we're trying to initiate that next two weeks. That's already there, we will automatically check on the background and then it will, you know, provide us with going ahead and giving you the green light to issue the next email which will be your training is ready. And then you will do the online training. And it will give you the ability to learn all about Control IQ. It's very interactive, you can't hit play and walk off. I know people do this on other training like I know we have webinars and we push play and we walk off we do the dishes when we come back. You cannot do that with this. It actually won’t advance to the next part until you've done x, y, z that is asked you to do. We've designed that for a reason so that you actually come away with the knowledge you need to operate the the algorithm and integrated into your life. So then you will answer a couple of questions and take a quiz. And you will have had to pay attention to get this information correct. And if you don't, you can go back and re learn until you do answer the questions correctly. Once you do pass the quiz and the module, you will then get the download code which is specific to your serial number of your pump. So I know there's been some questions, people sharing about work arounds, can you share it? The answer is no, no. You can't share it. It is your learning and your code is specific to your serial number. So all of that lines up perfectly to allow you to download the software update. And that will be, you know, everything will walk, walk through all the steps and pretty obvious, but for those who think that this some idea that someone will get a code and then we could post it on the internet somewhere and share it like, sorry Debbie Downer you're gonna have to get this on your own. Like, we work smarter than that and the FDA is smarter than that, and they're not gonna allow one code to rule them all. Yeah, so everybody's gonna have to do this upon their own and because it requires a prescription you have to go through all this stuff. Stacey Simms 8:37 When you mentioned training healthcare providers, and this might be a really dumb question, Molly, so forgive me, but is do they go through a more in depth training? It just seems like a couple of weeks to try to get all of these endocrinologists and CDs on board is a tall task. Do they all have to be trained before they can write the prescriptions and then what is their training like Molly McElwee Malloy 8:59 this have to be trained before they can write the prescriptions we want them to be trained before, obviously, we'd like them to have knowledge before they write the prescription, but they don't, they need the training to be able to treat patients, right. And I want them to be we want them all to be informed before they write the prescription to know if this is a good choice for the patient. But you could always write the prescription and then the person doesn't do the update. Right. So there's, you know, there's, there's always a couple ways to be kept it at the end if they don't intend to write the prescription. But writing the prescription with knowledge is always excellent. And we want to be aware, it's really, you know, an hour and a half two hours of their time. It's not a whole day thing. I know with other systems, there's been some feedback about like the links of training being really long and and we took all that into consideration. You know, we got the beautiful gift of not having to go first. Right? So we got to see what happens with the market with feedback before we did it. And we implemented a training and the good news with Control IQ is, it's not difficult. You do have to understand some concepts and some differences. Right, but it's not hard. Stacey Simms 10:27 I guess my concern was that people would be calling their health care providers and saying, Are you trained? Are you trained? Did you do this yet? Because you could see that happening. Molly McElwee Malloy 10:35 Yeah, and the good news is that we're getting them trained. So and it's on there's an online module they can take to do this. Like it doesn't have to be me on the phone with somebody train them, although we are doing that for them for larger offices that need, you know, to have that interaction, but there is an online module that they can take to get trained. So we do have a provider but site that has been launched. We've been very patient centric and very patient forward and our website and our outreach, and we are adding new dimension to both Tandem and our website, and how we are looking at our business. So, you know, to be honest, when you do this business, there's, there's at least three customers you're looking at, right? There's a patient, there's the provider, and there's the payer, and all those things need to be addressed. And we've been very patient centric. And now we are and we are continuing that we're just expanding to be very have people that are actually focused on providers. And so there is a portion of our website now dedicated to health care providers, and their education and resources specific to them. So that is launched that is up and running, and it's actually a very elegant website a host of resources for healthcare provider. Stacey Simms 12:10 Alright, so let's get to the moment at hand - Control IQ. How does it work? Talk to me a little bit about you know, the pump settings or what do we have to do you? What is the? What is the basis of Control iQ? Molly McElwee Malloy 12:24 Yeah, so this is the beautiful thing and I love all things that are based in science reality and truth, right? Like, I don't like we and Tandem doesn’t like this either, but we don't like you know, don't let trick and we don't like you not be able to see what's going on. So the beautiful thing about Control like you would like about all of Tandem technology is that it stays in the science and the foundation that you know in love, which are pump settings that you already understand. So the traditional rules that healthcare providers have used and I can provide you a link to article that’s helpful on you know 15 and 1800 you know, rules that they've always used and you know, implement duration action that is built in on the foundation of many many many decades of science. So, the all of that I can provide you some links and educate people about that what does that mean but your traditional insulin to carb ratio, sensitivity factors and basal rates all still apply. We use that the Control IQ technology uses your pump foundations and your foundations order the basal rate into the carb ratio, correction factor to operate from right so those are specific to you, they always have them they always should be. And that is where we you know, we start the game of Control IQ technology. So Using those settings, Control IQ technology, what we making adjustments from your baseline parameter, so your baseline parameters are exceptionally informative of how Control it technology will work. Stacey Simms 14:12 So we've been using a pump, let's say, you know, our personal case for 12 and a half years, we're pretty good at the settings. You know, we're going to talk about insulin on board because that's an interesting change. But we have our ratios and our, you know, our sensitivity factor. People like us, you know, a lot of people who are used to changing things on their own, you're basically saying we're not gonna have to learn to use the pump that we know so well. Molly McElwee Malloy 14:38 Correct. Right. So all the settings that you know and love are great. And you will move forward with those right? Okay, people coming from other systems, like maybe different pump or multiple daily injections, things like that. You're going to want to establish some really good baseline settings and make sure that those are accurate. So you particularly, if you're coming, I could say you're coming from a competitor's product like that, that has automated insulin delivery, you want to make sure that those settings are good to go. Because the previous, you know, previous other things that you may have used, only altered on board and carb ratio, right. So if you're only pulling two levers, the other things may not be totally, you know, set in stone and based and in the reality that you need. So, moving forward, you will need to make sure that the patient has, you know, your patient which would be your son or myself, that user has the pump parameters and settings that are based in in what you would want to use. So somebody is moving from a different product. We just want to do a double check and there's going to be in the healthcare profession. We'll have a little checklist to go through and we'll ask them, you know, you're coming from a different product, please look at the baseline settings and make sure that they are perfect for the patient. In your situation, you're just going to be moving from you know, base like you to Control like you. And those settings will apply. I will say a note for your super super savvy listeners who have used Basal IQ. And something we've noticed just in real world data as we've looked at people who data people have up to their basal rate to allow for, you know, like you to go to be like suspend, resume, suspend, resume and kind of hug that line at 80. A lot of people have done that. And I want to talk to that community real quick and say, Look, I know what you did with Basal IQ with riding those basal rates high to hug that line at 80. I saw that we saw that. You did that. We know why you did that. Just look at them. One more time before Control IQ because Control IQ is going to be adding, right? It can add insulin. So just before you go on your merry way with Control IQ like you double check your baseline settings, are they where you want them to be before you go right knowing that a system can add insulin to it. Stacey Simms 17:20 Okay, so you mentioned a lot of people, a lot of my listeners like to ride that 80. Molly McElwee Malloy 17:27 Let's talk about people, man, a lot of people love that they want like, they want that super, super tight Control and I get it. I totally get it. But you got particular, you know, space of listeners needs to be open to the idea that we're now going to be adding insulin right? So if you've kind of made these aggressive pump settings with Basal IQ and now you're going to be just on your merry way. We don't want you to experience hypoglycemia, right? That, you know, we don't want to put anybody into hypoglycemia land. My personal least favorite experience of, of diabetes? Well, let's, let's not do that. Stacey Simms 18:10 Right. But the question then is, what are the targets? I thought Control IQ wasn't really going to let you ride that 80. Can you talk a little bit about I mean, obviously, nothing's perfect hypoglycemia can happen hyperglycemia can happen, but what is it aiming for? Molly McElwee Malloy 18:29 If your listeners can pull up the little chart, the patient pamphlets that I that I gave you, there's one of them that has a really good visual of what that looks like. And just so that we can go from soup to nuts, the person who has now downloaded Control IQ technology, all you have to do is turn it on. It’s either on or off. Just to preface all of this before we get into target and all of that. There's no kick out with Control IQ technology. Control IQ technology works, so long as we have CGM. And I will say that as long as we have a continuous stream of CGM, or we will continue processing that data. But if there are 20 minutes or more of missing data from that CGM and those who are very savvy with Dexcom know that you can kind of get internet readings occasionally. I'm not talking about reading, you've got a loss of CGM for more than 20 minutes, we're going to revert to your pump settings. And so we can get that until we can get that information back up and running. But if we miss a value or two when we come back, and we've got that information, we're running full steam ahead We're good to go. If we have any data point in that 20 minutes that pops up, you're still in. It are still in the game. They're still playing. But there's no kick out. Right? Stacey Simms 20:14 So as you mentioned that, just to be clear, there's no auto mode or manual mode to kick out of. So if you lose the CGM signal for that period of time, as you said, What did you say 20 minutes. Molly McElwee Malloy 20:26 It has to be greater than 20 minutes Stacey Simms 20:28 if you lose CGM signal for 20 minutes, it just goes back to regular Tandem pump, all the settings are in it. When the signal comes back, it automatically starts Control IQ, you don't have to do anything else. Molly McElwee Malloy 20:40 Correct. You could sleep through the whole process, right? You do you right. Like if we lose it, we'll we'll get it back as soon as possible. We're going to alert you that there’s no CGM available, right? Right. We're gonna alert you that this happening. But if you're sleeping or you're doing something else and you are not paying attention to it, we’re going to keep running with the ball in that process without having to like all these bells and whistles, and there's no modes, right? Control IQ is on or you can turn Control IQ off. There's no mode. Stacey Simms 21:16 Alright, so let's talk targets. Molly McElwee Malloy 21:19 Yes. So there are several targets, the one you will call the main target is the number 112.5 which in the pump, it's going to default to 110. Why because you don't have 112 point fie as an option. 112.5 for those who are interested is a weighted average between 80-120 with the least amount of hypoglycemic outcome. So if you're a statistician or mathematician and you love numbers you can a bunch of scenarios of hypoglycemia and when it will likely going to happen in all these different situations which is what did happen to come up with this number you would come up that 112.5 had the least amount of hypoglycemic outcomes in the greatest amount of time in range and you know successful euglycemia. Yeah, so 12.5 it is. And it will show up as 110 in the settings 110 will be the target. In the settings that you set up for Control IQ it is non-negotiable. We have different ranges for things that we're using throughout the way the system progresses, but as far as looks on the settings on the pump, is going to show up as 110. Now when you enter the system, as long as you're in euglycemia land, like as long as you're in range and predicting range, which would be predicting 70 to 180, we’ll use your pump, right your pump study should be adequate. But the minute your predicted to be outside of the range. And this is where this graphic is really helpful. If you’re predicted to be 70, right, less than 70, we're going to start decreasing basal insulin. It's predicted when you start going below 112.5 right. And then when you get to 70, we're going to stop basal delivery. And this is during this time, right? So the during regular Controller to you, if you are predicted to be less than 70, you start going down less than 112.5 we're going to decrease basal, and we'll eventually halt basal. Now if you're above 112 point five and you're heading up, and you're predicted to be above 160, we're going to increase that insulin delivery and increase that in the background until you hit a prediction of 180 and that's not you hitting 180. That's the prediction heading 180. If the prediction hits 180 then we can give an automatic correction bolus once an hour during waking time and I'll go over more about what that means in a minute. But predictions to be above 180 one at if there was, you know, not been another bolus in the last hour, we can give one at that point to try to keep blood sugar more in range. So the range 70-180 again, 112.5 is euglycemia. Going below that, you know, we start decreasing if you're predicting below the lower than 70 we're going to, you know, stop basal insulin delivery, you’re predicted to be above 160, we're going to be increasing basal insulin delivery of your predicted to be above 180. We're going to deliver an automatic correction bolus once an hour during the waking time. And by that I mean when you're not using exercise or sleep. There's three activities in Control IQ and they are Control IQ or what I call wake time. There's sleep and there's exercise. And those three things have three different targets. Because if you think about it, those three activities have very different applications for your blood glucose. So, waking time 70 to 180. That's sort of where we aim for all things during the day to accommodate for blood glucose fluctuations with meals and stress and schedules and everything like that. Sleep is something you program. So you can have just like you would program a basal rate. So if your basal rate normally changed from three to 4pm, every day… the sleep is, you can program that right. So mine is programmed for 10pm to 6am. So from 10pm to 6am I'm sleeping and it will automatically go into sleep, it will automatically come out of sleep. I don't have to do anything. And during sleep, we're going to target 112.5 to 120 which is a much tighter range, but we're not giving automatic correction boluses during sleep, Stacey Simms 26:02 can you tell me a little bit about the thinking there? It seems obvious. But is it just because a person is sleeping and can’t adjust the pump? I'm trying to figure out the logic? Molly McElwee Malloy 26:14 The logic of not having the autocorrection? So the logic around not having the autocorrection overnight is about being super conservative with the FDA and their comfort level . But also, the algorithm really drives a really tight range during that time because there's not a lot of interference, right? You think about sleep it's like for blood glucose is the easiest time to manage diabetes, right? because nothing's happening. Although you are asleep, so technically difficult because the operator is asleep, right but as far as what's happening with diabetes, sleep should be a pretty steady state. So if we can automate going into and out of and having a really timeframes for that period of time, then we can kind of optimize time in range by, you know, six hours a day being really tightly Controlled, or however long the sleep activity is. And we noticed in the in the clinical trial, those people who had a sleep schedule and not everybody did, and you do not have to set one. But those people who had a sleep schedule had significantly more time in range. So that's just something to notice. No, you don't have to set one right? Could you have automatic corrections going all night long and being awake, I'm sure you could do that. If that that's how your diabetes works. Great. My diabetes, your diabetes, somebody else's diabetes, they're all going to be different, right? We all have different versions of how we metabolize things and how we sleep and how we process and our activity and you know, sometimes, you know, the sky's blue and sometimes it's not and it just depends. That's life with diabetes, some things will work with some people, somethings won’t. We did have in the clinical trial have some people we refer to as Sleeping Beauties who had sleep going 24 hours a day and and that would put you at the you know, like the 112.5 to 120 all the time, no automatic corrections but you would get basal increases and basal decreases to try to keep you in that range. And for some people, that's great. You know, that's where you want to live, that's fine. You will not get the automatic correction, you will need to give that correction when you need it. It's not going to be enough to accommodate that. But hey, if you're sleeping beauty and that works for you, that's fine. Then there is exercise. Exercises is a button you press. You go into options you press exercise – start. I'm exercising now and then I will leave it on exercise and when I want to stop I will go in and I will stop exercise. And while I'm exercising will be a little Running Man on the side of the screen to show me that I am exercising. And that will tighten the reins to 140 to 160. To help prevent hypoglycemia, it also engages what we call the brakes or the prevention of hypoglycemia by 10x. So if you think of a car rolling down a hill, and if you think of getting your brakes tightened 10 X, the minute you start going downhill, you're going to stop, right? It's going to be like that, stop, it's gonna be really, really grippy. And that's the way it works doing exercise. We anticipate hypoglycemia. Now you can still get an automatic correction bolus, and you can still get an increase in basal during exercise because there are people who will go high during exercise. With the pediatric sports particularly, you notice a big difference between game day and practice day. Like game day there's a lot of adrenaline there's usually a lot higher blood sugars and practices it’s low blood sugars. So You know, this is why that's still going on in the background, starting in an hour before starting at the time of exercise, leaving it on an hour after all of that's going to vary depending upon the person and the activity and you're going to have to play with that and see what works for you. You know different strokes for different folks. And some people won’t need to put on the exercise right they'll be fine where they are. It just depends on what you're doing your body, your diabetes, what's going on. And as to when you start it and when you stop it or if you use it. Likewise, you know you could put exercise on 24 hours a day if you wanted to, if you needed to ride a little bit higher or you know were feeling very cautious about something you know, and you want it to be, driving all day or something you know, like I just want to be a little bit higher today Stacey Simms 30:53 Your kids first sleep over Molly McElwee Malloy 30:55 your kids first sleep over and you want that automatic bolus, they're going to snack. And, you know, if you think about it, like if I think about my kids there, they are active 24 hours a day until they crash, right? So if they're super, super active, and I'm getting, I'm getting frequent lows from that activity, I might put them in exercise all day, right? So depending on what's going on with that patient that time and what works for you, they'll be different. They'll be different reasons why different activities are better for some people than other people and when you want to use them, but they're all available to you to use as you want to because we all deserve choice, and we all should have Control over what happens with our diabetes. Stacey Simms 31:43 It's really interesting. Okay, I'm trying to get through the list because I have I have 14 questions for everything you answer. So I know we'll talk again, but I do want to ask you about insulin on board and I will set this up by saying in the last few months, I've been reading up a lot on this in anticipation of what we're going to talk about here, because Benny's insulin on board, which is as you listen, you may not realize there's a setting in the pump, all pumps, where you try to figure out how long the insulin that you're giving is lasting, and this is with MDI as well, but the pump does it automatically - you have to tell it and then it keeps track. So we have always said Benny's at three hours. And then when he hit puberty, we kind of tightened it up. And I've learned that it really didn't matter what we said, or what we thought that everybody's insulin on board, studies show, is about five hours. And so that's what's in Control IQ? Molly McElwee Malloy 32:40 Yeah, it's at five hours. So if you look at some data, and again, I can provide you with links to some published data on that, the data says it's between four and a half and six hours. So let's split the difference and call it five hours. So we're using five hours for several reasons. One it’s established data we can rely, on you can hang your hat on it. Also, it's a static number, right? So if you are, if you are trying to aim for targets with a multitude of patients, a multitude of patients and you're trying to automate an algorithm, you cannot then vary IOB without causing some pretty crazy ripples, right? So it's going to work for some people, some people not, we want something that works for most people, right? Like, I understand that Control IQ is an amazing solution for a lot of people. And if some people are like, I'm so much better when I do it myself. Do it yourself. That's fine, right? Like that's why we have choice. But in order to design a system for the masses, you're going to have to go with the large majority of scientific evidence, right, which again, shows insulin on board somewhere between four and a half and six hours. So going with five hours and keeping that static when you're aiming for different ranges, and you're allowing people to do different basal rates and carb ratios and sensitivity factors, you will have to lock something in and we've locked IOB. And that gives you some really good results, obviously, but and for skeptics, I will say this, you know, try it. Try it and see what you think. Because it may not be as different as you think. Stacey Simms 34:27 well, I’ve been shocked to find out that the entire looping community, and the do it yourself folks, all of those systems are based on five hours, pretty much. Molly McElwee Malloy 34:37 Right, right. And you do have to assume some, you have to make some assumptions, right when you're writing an algorithm that's going to modulate insulin for the masses. And one of the assumptions is how long does this thing last? If you change that, all the other math has to change. And that makes it a very unstable algorithm. A very unstable system. And then it’s not for the masses, right? So that is why it's locked in and there's a lot of scientific evidence. And the DIY community has embraced us too, you know, at that five hour time frame. Stacey Simms 35:13 In terms of the rollout Molly, I remember when we got Benny's pump about a year before Basal IQ was available. And as I was looking back, it was a pretty seamless process for us. In that I remember it was FDA approved. We got the email, we got the prescription from our doctor then Tandem said here's your code, and we downloaded it and the whole process took from FDA approval to on Benny’s pump, with no special treatment, was 35 days. I'm not going to hold you to that. I'm not asking you to keep to schedule, but I am going to ask and I think 35 days was pretty great. Is there anything that you all learned from the Basal IQ roll out that people who went through that can expect to experience differently this time around or did it work pretty smoothly? Molly McElwee Malloy 36:00 Yeah, so I mean, you always learn, right? You always learn, and we're always learning and Tandem is excellent at collecting data and then understanding, you know, and learning from it. So one of the things that we did, we did learn there is that we needed a more robust patient portal. And so we've done that we've built a more robust portal, and we've built a lot of automation in the background. So doing things like if you entered, you know, I'm going to update this and your physician had a blanket statement on board. And, you know, we could automatically line those two things up. It doesn't have to be a separate step it just automatically Yes. Okay, you're good. We have this checked in our records checking. We have this and this is on file, and we can do all of it. So there wasn't a lot of automation that there is now and there were maybe a couple extra steps involved in getting people either approved or making sure we had all the documents and we've streamlined all that. So it should be a very seamless process. The update itself could take eight minutes, but it shouldn't take much longer. You know, it's the eight minutes from, you know, whatever you're on now the Control IQ, and then you know, and then just reschedule it and doing the online training right before that, that's, you know, a little bit of chunk of time, but I think 35 days is pretty good. So we got approval this past Friday 13th. And we plan to roll out those emails to existing customers a week of the 13th. So it might be coming at close, but I think you can probably you could probably figure on the 35 days. Stacey Simms 37:43 (laughs) I'll give you some grace for the holidays. I mean, the last approval was August, so we only had to worry about back to school. I'm not too worried about 35 on the dot. I did want to ask you a couple of questions from the Facebook group, the diabetes connections Facebook group, you've answered a lot of them, but I had a really good question from Tim who was asking about in the clinical trial, he said, You know, people were able to familiarize themselves with the pump in the system about two to eight weeks, I guess. So he said, what took place during that period? And how much interaction with healthcare professionals was required? So I guess the question really is, how much do I need to interact with my healthcare professional? How much do I need to ramp up and learn before Control IQ will work well for me, we've mentioned you know, there are variables. Molly McElwee Malloy 38:29 So I think, and I think looking at that run-in phase, that was what it was called that two to eight weeks is that when you were taking people from multiple daily injections, introducing them to CGM technology, introducing them to pump technology and getting pump settings straight. So that was the longer run in period for people who were completely naive to both CGM and pump technology. And they could they could be allowed up to eight weeks, I don't think most of them completed their run-in phase much faster than that. And most people have people that already had pump or CGM or some knowledge of one or the other could go but at a much faster speed. So it was just getting them up and running and comfortable with the technology and the physician or whoever was overseeing at that site felt comfortable that, yes, this person is ready to proceed to the next step and go ahead and use an automated system. So that just allowed for all walks of life to come in and to do this trial. And that's really what that was about as far is, you know, how many connections how many touch points with an HCP. You know, I can't speak specifically to each situation. But typically, in a run-in phase when you're getting people up and running that have never used technology before, you might check in with them every couple of days and then do a download at the end of the week and then check those settings. So And I would suggest at a later time you having one of those sites, the principal investigators on to talk about the studies it’s fascinating. And they could really get into the weeds of these details, because I think Tim had a really good question about that. As far as the average person though, getting up and rolling, the big thing with Control IQ technology, is you have to have good pump settings. Right. So that may be a couple of touch points you maybe have to have with your HCP if you've never had a pump before, right? Or you're and you're just waiting for the first time. Or if you've had pretty poor settings, and maybe pretty poor Control along and you've never really sat and been like, Huh, I wonder if these are right, or your HCPs never sat down with you into like, let's take another look at this. That that may take you a visit or two but if your pump things are pretty good, you should be fine to go And then you can check in with your doctor. At your comfort level, right, like there's no recommendation. As long as you feel like you're doing well, then great. There is a mobile app that will roll out with this. It's embedded into the technology update for Control IQ that will give people access to this mobile app, which will be available on Android and iOS. But this will allow for automatic uploads to the cloud. So the data will be going seamlessly to the cloud. You could also then see it on your phone. You cannot yet bolus from that phone or dismiss alerts or alarms. But you can see what is happening from that phone. And it will, it's a ways to send data to the portal so that your data is always updated. And so you know, your healthcare provider can check in and say how you doing and I see this is happening or I see that's happening and you can all beon the same page without actually, we go into the office or upload your pump or any of that stuff. Yeah, I believe it that process. Stacey Simms 42:08 That was going to be my next question. But my understanding is that the phone app is going to be just for healthcare providers as it's rolled out, and then consumers can use it down the road. Is that not correct? Molly McElwee Malloy 42:19 No. So there are two parts to this. So the app will be on the patient's phone, right. That's how the data gets the cloud. So the space is going to have visibility to their data. The data going to the cloud goes to the HCP portal, right. So that's the healthcare professional portal, the portal that we offer up to professionals so they can manage all their patients in one place. Right. So they log in, they can see data as long as you have Wi Fi available Wi Fi is both publicly and people having it at home or you can choose to use cellular data. You can send your data for the cloud every five minutes. Stacey Simms 43:04 I just want to be clear. So when I get my Control IQ, let's say, let's say I get Control IQ by the end of January, when I get Control IQ on Benny's pump, he will be able to look at his cell phone, not do anything with it, but he will be able to view his pump data in real time on his cell phone. Molly McElwee Malloy Yes. Stacey Simms Yeah, that is amazing. Okay, so I know that many people who are newer might think, well, that's not so amazing. But I mean, after 13 years, you know, we had these dumb pumps and no CGM to have Benny be able to look at his phone and say oh is was my battery charged. Do I need insulin? You know, even the simplest things. And then the idea is down the line. And maybe you can give us a peek into the future. As you said, You can't bolus from it, but possibly someday, soon. Molly McElwee Malloy 43:50 Oh, we are working on integrating the ability to do a mobile bolus. Yes. Stacey Simms 43:58 All right. I'll leave that there for now because I know Talk to you another hour about it. But then my last question on the phone is, what about remote data from the pump? Can a parent caregiver, you know, friend spouse, once the Tandem information is on the user's phone, can it be shared. Molly McElwee Malloy 44:15 So we are working on a remote monitoring feature. But at this time, it will just be available on the patient's phone, and it will be a way to get the data to the cloud. Now you could log in to see connect and look and see what's going on with Benny at school. If he's if he's got Wi Fi going. It's not really meant to be a remote monitoring system is approved for that. But you know, Stacey Simms 44:44 (laughs) I’m just thinking of all the parents I know All I care about is is it charged and is there insulin in it, but I know a lot of people really want to see, you know, everything but that's really interesting. Molly McElwee Malloy 44:52 It could be that you know, and then some people know how to like do the mirroring on their phone to another device and you know, there's going to be people will figure that out. And we will eventually have a formal system for that. And again, nothing is intended to be remote monitoring or you know, per share type viewing. It’s supposed to be a, you know, a secondary viewing device of seeing the data. But you know that data is going somewhere and you can log into that place. So, you do with that with whatever you want to, but you'll be able to see that data if he's got Wi Fi going. Stacey Simms 45:32 All right. before we let you go. I have to ask you, we started this whole conversation about you talking about, you know, finally relaxing when you use an automated system in 2006. So here we are. 13 years later, Molly McElwee Malloy 45:50 I know. Stacey Simms 45:53 You've been using Control IQ I shouldn't make that assumption, but have you been using Control IQ? Molly McElwee Malloy 45:58 I do have Control IQ Okay, Stacey Simms 46:00 and I'm asking you this I know I may be limited in what you can say and I understand that. Are you as relaxed and feeling more in Control of your diabetes as you had hoped? Back in 2006? Molly McElwee Malloy 46:15 You know and.. sorry, it makes me little choked up. I am in a place I never knew existed, right? This is a place that I dreamed about. I'm not worried about what's happening with my blood sugar. I'm not worried. We had my daughter's third birthday this past weekend, and I didn't worry about, was my bolus enough for the cupcake because like it had my back, right? Like, I was like, if it's, you know, this more than this, whatever, it's got me if it’s less than this, it’s got me like, I didn't worry the whole day and I stayed in range the whole day and Got to enjoy my daughter's birthday without worrying about my diabetes. So that was pretty awesome. And that's where I want to live, right? Like I have other things to do. Everybody has other things to do than to try to be their own pancreas and their own organ. So let's relieve that burden and then you just interact with it with meals with exercise, you know, when you need to. It's much more of a relief than I imagined because in 2006, I was hooked to laptop. Stacey Simms 47:35 Oh my gosh. That’s right! Molly McElwee Malloy 47:37 Yeah, I was hooked to laptops with four IVs in my arms. And I was willing to do that. And I would have walked around like that. So this is some space age invention that never entered my mind that this could have happened but it is beautiful, very eloquently done. I have to hat tip to the engineers at Tandem, who took you know, years and years and years and years of research to work, you know, work done in neat tidy ways, right? And then put it into a system and made it this eloquent and this beautiful. Where I don't have to think about the 50 things I would have thought about before, you know, is my laptop plugged in and my plugs into the right USB port, my, you know, the things you've got to think about if you are plugged into bigger machine. Sure, like, I don't want to think about any of that. And, and during research, you know, seeing in all the different iterations. You know, we still had even we have a cell phone, we still had the fanny pack, right? Because you had to keep the receiver and the phone near each other and all this other stuff going on and the pump. And now I'm just walking around with a CGM and a pump on and it's doing it and I don't have to worry about any additional things to keep up at it's pretty great, it's pretty awesome. This is a place that I never dreamed, I never even dreamed of. And I'm just so happy to be here. Stacey Simms 49:10 Molly, thank you so much for joining me for spending so much time talking about this. It's been remarkable to just for the few years that I've followed along in your journey, it's been wonderful to watch. So thank you so much. And I cannot wait to get this for my son! Molly McElwee Malloy 49:29 that I can't wait to see what you say. Because, you know, we're like to 2.0 we’ll make 3.0 We'll see what's going on. So your feedback, everybody's feedback is so valuable. Stacey Simms 49:40 I would have liked to have ended on that emotional note that you have there. But we do have to say, for for many people who have been in this community for a long time, who are emailing you and me saying, Why can't I get the target under 100? Why cant I do this? I want this feature. I want that feature. It's not that they're that people are greedy. It's just that you know, you know we all we all want this so badly. It's a great reminder that this is the first step. This is this is the beginning of the automation. So, you know, I want it all too, but I get it. And I just think it's fantastic. So yeah, this is this is the first one with Tandem. Let's see what happens to the future. So gosh, it's so exciting. Molly McElwee Malloy 50:21 It really is. And I could say to people who want to customize everything, want to do everything good. Look, the future is coming. And it's coming faster than we then we could have dreamed up and I realized we waited a long time. Trust me, me of all people. I know how long we have waited. But this is a really solid system that we get to build upon. It’s going to be a phenomenal ride. Like I would invite them to try it. See if you can relax a little and see if it brings you any kind of peace of mind. And then we'll work on getting the targets exactly where you want them. Stacey Simms So much more information on the website please check it out. And I know many of you have unanswered questions you know you really want to do a super deep dive you want more we will dig into the research as Molly mentioned, I promise we will do mentioned I promise we will be doing follow ups on this as a tandem family. You know, we'll have Benny fool around with it. let you know what he thinks I'm hoping to get him to do a review. As soon as we get control IQ, which, you know, we're not jumping the line, we're there with all of you. So hopefully by the end of the month, beginning of February, I'm really hoping that we'll have control IQ on his pump. And, you know, that brings me to just a quick personal note on Ben, he was diagnosed 13 years ago, in December. So December of 2006, is when we heard those words, you know, your child has type one diabetes. And I remember a few bits of information from that day, we were not told, thankfully, we were never told, oh, the cure is five years away we were we were never told that and I had been a medical reporter for many years, and I'd covered type one diabetes. And I'd actually covered failed products like the gluco-watch and things like that. So I had my my knowledge around me and I knew there was going to be no cure in the next five years. So we didn't have that. But our endocrinologist did tell us that the artificial pancreas was in the works. And he said three to five years. And we would probably have that. And I have been hopeful, you know, cautiously optimistic, I didn't hang my hat on that. And I knew we'd have to learn to live well with diabetes without an artificial pancreas. But when I think now to 2006, knowing that that is when Molly, within that trial, and other people that I've been so lucky to meet and talk to, since people like Tom Brobson, so many people at JDRF, who were involved in the early early artificial pancreas project, , it kind of boggles my mind to think that I could go back to Stacey in 2006 in that hospital room and say, Look, it's not going to be here as soon as you hope. But your son's going to be fine. And you're going to get to talk to these people that right now are testing it out. I mean, to me, it's just wild. And more importantly than than me still me getting to talk to all these people much more importantly, is that the people with type one as you listen my son get to use it. I'm so excited for control IQ. I'm so excited for anything that takes any bit of burden away from people with diabetes. I'm not looking for the world's lowest A1C? I really know that I am looking for a healthy A1C  that lets my son lives a life he wants without diabetes being a pain in the ass without his mother texting him 400 times a day did you bolus Did you check? Right all that nagging stuff? I don't want him thinking about it 24 seven. When you talk to people who loop when you talk to people who've used open APS, right, these do it yourself systems. Their first response to you isn't, look at my fantastic A1C, although they're usually very good. It's, well, I get more sleep. Wow, I think about diabetes less. Wow, I worry about my kid less. And that, to me is what it's all about all of these decisions. I’m getting emotional thinking about it. All of the decisions that everybody who has diabetes, forget the parents that the people with diabetes have to make and that burden that is on you. I hope systems like this. Just relieve it a little bit. It's a good first step. It's not the end there is a long way to go. But that's what I am hopeful for. Okay. But that's what I am hopeful for. And I know that I'll hear from you. You wonderful do it yourselfers who will be figuring out ways to you know, hack the sleep mode and change the exercise mode and figure This stuff out. So we will move forward with lots more information in the weeks and months to come. You know, I don't have a way to wrap this up with a big bow. I don't have a way to end this year by, you know, saying something incredibly motivational and giving you a boost into the new year. But I do have to say that it's so exciting to end 2019 with the approval that frankly, I've been waiting for all year, and I know many of you have as well. And seeing that as another step forward. And looking forward to 2020 and what may come. Our next full episode will air on January 7, but later this week, I'm going to be releasing a new minisode I'll be doing more of these in the new year just really short episodes where I share some thoughts or some advice. love to know what you think about all that. Big thanks as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. wishing everybody a happy and healthy New Year. I'm Stacey Simms and I'll see you back here in 2020. (disclaimer) At times I mentioned tandem diabetes care. However, I am not compensated by tandem for my actions. And tandem does not support or control this content. I have created the content and it is based on my personal experiences and observations. Transcribed by https://otter.ai

The Type Zero Technologies artificial pancreas project is one of the many racing to market. Their technology comes from years of research, still ongoing, at the University of Virginia. This summer, they announced a new partnership with Tandem. Molly McElwee Malloy, who has type 1 herself, is the head of patient engagement for Type Zero. She talks about the studies, the progress and the emotional and mental side of artificial pancreas projects. Plus, necessity is the mother of invention and diabetes moms are nothing if not resourceful. In our Community Connection, the inventor of Diabetic Dabs talks about how she come up with this idea. Liz Sacco shares the story of how her son's diagnosis led her to find a why to clean up after finger sticks.  

Welcome to Episode Ten of Diabetes By the Numbers.Today we have our first returning guest.  It's Molly McElwee Malloy, Head of Patient Engagement at TypeZero Technologies in Charlottesville, Virginia.  TypeZero is in the news this week for two big undertakings.First, there's a 12.7 million dollar artificial pancreas study funded by the National Institutes of Health.  It will begin very soon.  In this study, they'll be testing TypeZero's inControl platform, using a spiffy new device. This study will include as many as 240 participants!  The studies will take place in nine locations... six in the USA, and three in Europe.  To find out more about participating in this important research, scroll to the bottom of this post.The second big piece of news is this: Type Zero is entering into a partnership with CellNovo, which makes an integrated diabetes management system in Europe.  They've gotten a lot of good press here in the USA, and we talk about that and what this partnership means for TypeZero.  Have a listen. Reference Material - Click for more information on this topic Find out more about the inControl diabetes management platform by going to the Type Zero Technologies website:TypeZero.com Clinical trial participants are necessary and appreciated!  Though the study will take place in several locations, the overall management of the trial will be handled through the Jaeb Center for Health Research.  To contact the Jaeb Center to volunteer to participate, Send an e-mail to:Info@jaeb.orgTo find out more about artificial pancreas testing through the University of Virginia's Center for Diabetes Technology, send an e-mail to:artificialpancreas@virginia.eduCellNovo makes a diabetes management system that includes a patch pump, an activity monitor, a hand held cell-enabled handset, and a continuous glucose monitor.  Data can be shared via the cloud.  To learn more about CellNovo, go to:CellNovo.comFollow Molly McElwee Malloy on Twitter:@MollyMacT1D  

Everyone living with and affected by diabetes is excited about artificial pancreas research and the various innovations spawned by this remarkable technology. In this episode of Diabetes By The Numbers, I'm joined by Molly McElwee Malloy, who has just recently stepped into her latest role as Head of Patient Engagement at Type Zero Technologies.  She is an RN and Certified Diabetes Educator who has been living with diabetes since 1998.  She knows the relationship of diabetes, analytics, and technology like almost no other person I know. Type Zero is the continuation of artificial pancreas research started at the University of Virginia at their Center for Diabetes Technology.  In our conversation, we talk about the birth of Type Zero, its InControl platfrom including InControl Advice and InControl Cloud, and the timeline for development, testing, and submission for approval to the U.S. Food and Drug Administration. Type Zero Technologies:typezero.comInterested in participating in a Type Zero clinical trial?  Send an e-mail to:artificialpancreas@virginia.edu   ©Stephen Shaul

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