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Diabetes Connections with Stacey Simms Type 1 Diabetes

The T1D news show you've been waiting for! Long-time broadcaster, blogger and diabetes mom Stacey Simms interviews prominent advocates, authors and speakers. Stacey asks hard questions of healthcare companies and tech developers and brings on "everyday' people living with type 1. Great for parents of T1D kids, adults with type 1 and anyone who loves a person with diabetes.
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Now displaying: Category: technology and tools
Jan 23, 2020

Using a shot of long-acting insulin along with an insulin pump sounds like a weird idea. But Stacey found when her son's insulin needs went way up around age 11, that it worked incredibly well for them. She explains the method of untethered, which is also sometimes called POLI (Pumping On Long-Acting Insulin), what led them to believe it would work, and why you don't always need to use a ton of insulin to benefit from it.

More info on untethered here

More info on Tresiba here 

------

Check out Stacey's new book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

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Episode transcription (rough transcript, please excuse any grammar, spelling, punctuation errors)

 

Stacey Simms 0:00
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 as a paperback eBook and audio book. Learn more at diabetes connections.com

Announcer 0:21

this is diabetes connections with Stacey Simms.

 

Stacey Simms 0:27

Welcome to an episode of diabetes connections. I'm your host, Stacey Simms, and this is one of the new episodes I've added for this year. Where in addition to the weekly interview shows that are longer. I have started doing these shorter mini episodes where it's just me talking about one topic, hope you're enjoying them. It's been really fun to get the reactions and hear what people want to hear more about. So if you're brand new, just real quick. My son was diagnosed right before he turned two back in 2006 he is now 15 and a freshman in high school taller than me, and recently got his permit to drive like North Carolina. And our young, young permitted drivers are graduated licensing. But that's not what we're talking about today. Just to give you context on how old he is, and you know where we've been, he was diagnosed 13 years ago.

 

couple of episodes back. I mentioned Tresiba. I was actually talking about a Tell me something good segment on the show, which we do every week. Um, a family was sharing their last night of Lantus because their daughter was going out of pump, and Lantus really burns. So I was talking about Tresiba, which is another newer, long acting insulin as an alternative. And I had a couple of people asked me about that, one through email and a couple online. Don't you use Tresiba, they said, as an untethered method for Benny, and I thought this would be a really good chance to answer that question and talk a little bit more about what's called untethered or POLI. They both kind of mean the same thing. They're a little bit different, but we'll go through them.

I will start out by saying, once again, I am not a medical professional. All of the information I'm giving you here is through my personal experience as a parent of a child with Type One Diabetes. I am not a healthcare provider, please call your endo or your care team to follow up and ask them any questions especially about a topic like this one. But this is the kind of topic I love sharing about because the only reason we tried untethered, which changed my son's life and has just been amazing. Over the last. It's been more than a year now. We started in September of 2018. So the only reason we started it is because another diabetes mom reached out and said, Hey, have you thought about trying this? So Cheryl, thank you very much. I'm just trying to pass along the information here.

So what are we talking about? Well untethered means making use of an insulin pump. pump and taking long acting insulin at the same time, a lot of people use untethered to mean that they only use the pump for boluses. So in other words, all of the basal would be coming from the long acting shot. That's why another term has cropped up which is POLI pumping while on long acting insulin. And that is supposed to mean where you do something a little bit more flexible 50% of Basal from the pump 50% from the long acting, and all of the boluses from the insulin pump, and that's actually what we do, but I still call it untethered. So for the purposes of this podcast untethered is going to refer to any use of an insulin pump with long acting insulin, whether you're doing 20%, long acting 100%, long acting Basal, that sort of thing, just for conversational purposes. I think untethered is an easier way to go. I have been criticized online For calling it untethered, because I guess technically it's not correct, but you know me that has never stopped me before.

Alright, so why would you use it? Right? What this is my question, why would you go through all of the bother that is an insulin pump, right? inserting the inset every three days wearing the pump itself, you know if you've got little kids wearing it in the pouch, or if you've got the Omnipod schlepping the PDM around, you know, why would you do all that and then add a shot of long acting? Well, in my case, I couldn't imagine it until Benny became a teenager because what happened was his insulin needs went up so quickly and went up to numbers I never thought we would see. I didn't know people could take that much insulin and be ok.

And in our case, and this is a layperson opinion, but I stand by it. I think the insets get overloaded. You know when your basal rate is 40 50, 60 or more units a day. Those insets just They don't seem to be able to keep up. We had so many leaks. We had so many issues. And we tried everything. We rotated sites. We tried a longer needle. We tried every two days every one and a half days. But you know, I turned around the insulin would be like leaking down this kid's stomach. And we knew that it just wasn't working. Something wasn't going right. Plus, he has the Tandem tslim X2 which holds 300 units, we had switched from Animas which held 200. I mean, no pump holds exactly about that. It says it was always a little bit less because you have to prime it and blah, blah, blah, if you use a pump, you understand. But with that 300 units, he was still changing out his cartridge so much more often than before. And I knew that something had to give.

And then Cheryl reached out online and said, Hey, I really think you might want to try this. It really might help. So we talked to our endo about it. He recommended Tresiba which was also what Cheryl had recommended which is a newer long acting. And I always laugh because when I talk about Tresiba, I feel like I'm talking about whiskey Right, it's smooth. There's no burn. It's steady. It just doesn't sound like you're talking about insulin. But all those things are true. And it just lasts longer in the body than Lantus or Levimr. And that works really well. For some people, it doesn't work as well. For others. Of course, your diabetes may vary as always. But what's nice about Tresiba is once you hit the steady state, once you've been taking it for three to five days, there's a little bit more flexibility in when you have to take it. In other words, if you take Lantus every day at seven o'clock at night, you really have to take it at seven o'clock at night. There's there's not a lot of wiggle room with it. But of course, it's always better to take it at the same time. But with Tresiba you can miss that dose. We have missed the dose by several hours. And it really has been okay. It just works a little differently in the body and I'll link up more information as to why it's a different makeup. It really does work differently in the body and it's been amazing for us.

So we worked with our endo and CDE to figure out the dosing, because we had to change it gradually over time to get to I believe we started out with 30% basal from Tresiba 70% from the pump, and we gradually moved it up. And now he's 50-50. It really took about three months to find the right dosing because we were hitting moving target, right, we went from 30 to 40 to 50%. And we were changing things all the time. But we saw changes right away. I mean, it was incredible. Once those basal rates in the pump came down, it seemed to work so much more efficiently. I really do believe it was the insets, but even if your insetts are working great, and your basal rate is like 20 a day, you know, if it's different and you're not a teenager, why would you want to try this?

Well, interestingly, the first people I ever heard of doing untethered, were adults. And the reason that they shared with me was, they just had a little bit of trouble, especially at first trusting the insulin pump. You know, think about it. If you've taking shots, your whole life with diabetes. And suddenly you're on an insulin pump. But you know, it's been 10 years or 20 years, it may be difficult to trust it, not just the technology, but you don't see the insulin going in, like you do with shots. So both adults said that they started with untethered, because it was kind of an emotional thing. They wanted to make sure that everything was working, they wanted to kind of ease into the pump. And then one person did that for a couple of months and one person stayed on it. And I have another friend who has really bad anxiety and she found herself worrying. Are my insets working? Do I have a bad cannula, is something's gonna go wrong while I'm sleeping. And her endocrinologist prescribed, untethered to help her with that anxiety and to help her feel better and to know that the insulin is indeed going in. And that's made a huge difference for her too. So there are a lot of reasons why you consider something like this.

But I think the most important thing is to know what's out there to know that this is something that you can do. You don't have to do it forever. You don't have to do it at all. But if you want to try it out, you talk to your endo. And you can do it for a couple of weeks, couple of months. Keep it or not, if it doesn't work for you, nothing ventured, nothing gained. And if it works, it could work amazingly well. Benny hit puberty and oh my gosh, I'm sorry, I don't wanna get too personal on him. But I do want to share this. He hit it like a rocket ship. I mean, it just happened so quickly. It was and he was younger than most kids. And his insulin needs went way up, his numbers went way up, because we really didn't understand what was going on. You know, we were doing everything we felt we were supposed to be doing. I was helping him at the time. So I know it wasn't a question of not bolusing. But whatever we did, you know, once you get high, it's so hard to come back down and that was happening all the time. And in my head I'm thinking, you know, is he eating when I don't know about it, is he not taking insulin, you know what's going on, and it was the basal rates, they just needed to be increased. And once we added Tresiba, and took the load off those insets, his A1C, all his numbers, his time in range, everything went back to pre puberty, even though his insulin needs have gone up, and his teenage hormones are obviously still there.

So he's 15. We just had an endo visit and things are finally beginning it looks like to come back down in terms of insulin use. So I don't know how long will stay on untethered and control IQ coming out is, you know, possibly going to change things for us. But he has said he wants to stay on untethered for at least a month into control IQ, and our endo and our CDE supports that and of course, I do too, so we shall see what happens. But if you're a parent of a teenager, and you're freaking out, because their numbers have started to get really high, and you think, oh, they sneaking food, are they not bolusing, but you know, that doesn't feel right. You just don't think that's really the case of what's happening with your kid and I don't want to talk about sneaking food that's those two words should not be used together. So let's just say eating food without bolusing. That's a different topic for another time for sure. But you You're not sure what's going on with your kid. Do not assume the worst is all I'm saying, do some basal testing, talk to your endo about basal needs. Because if like me, your kid was diagnosed at two. And the first basal rates you ever saw on a pump were 0.025 when they suddenly shoot above needing three full units every hour, it's easy to think this can't be happening. This isn't possible. But it is. And this is just one way to kind of help ease the pressure off the pump. If that's not working the way you and your endo think it should be. It's an alternative to think about that really, really helped us.

It is no fun to take a shot every day. I give Benny so much credit. Although now he rolls his eyes at me. I can't even say like, I'm so proud of you. And he's like, Mom, you're so lame. But you know what I mean, right? It's not me taking the shot. It's not you if you're a parent. So we really have to get our kids on board with this. I'm not above incentives. Try this for a month. You know, here's 25 bucks for Amazon, or whatever works in your family. But I think it's important to at least ask these questions rather than live day in and day out wondering, what are we doing wrong? Feeling like a failure. teen years are tough enough. And I know, you know, using Tresiba isn't gonna solve everything. But I talked to so many parents who just don't realize how high the insulin needs can get. I mean, look, a basal rate of four units an hour. sounds crazy, but it's not that uncommon, using 80 to 100 units a day of basal insulin. It sounds bananas. But for some people, that's what they need. And people who don't have diabetes, their pancreas is are just pushing this insulin out as teens. You have no idea how much insulin your kids’ friends without diabetes is making them his body. They need what they need. So talk to your care team about it. Talk to your kid about it. And if nobody thinks it's a good idea, just remember, I am the world's worst diabetes mom.

Oh, I will would be remiss before I go to not say, while I have sung the praises of Tresiba, like everything else in diabetes land, you're often at the mercy of your insurance company. We were very lucky to find that this was covered. But it is not always it is a much newer, long acting, so you may have to fight for it. definitely make sure your endo is willing to go to bat and help you appeal if need be. If this is something that you really feel strongly about, and they do, too. You don't have to use Tresiba as the long acting to go untethered, it's just what has worked for us, but unfortunately, it is so new that a lot of insurance companies do not cover it yet.

Alright, we are doing these minisodes every Thursday, and every Tuesday, we have our regular length interview shows where I talked to newsmakers, athletes, artists, celebrities, authors, speakers, and everyday people just living with Type One Diabetes. Learn more at diabetes connections.com. You'll also find the episode homepage and links to a lot of what I spoke about here, including studies about untethered and a lot more information so head on over to the website, please be sure to join the Facebook group diabetes connections group. I'm Stacey Simms, and I'll see you back here next week. Until then, be kind to yourself.

 

Benny 14:19

Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

 

Transcribed by https://otter.ai

Jan 16, 2020

 

As we all wait for the release of the newest hybrid closed loop software, Stacey has some thoughts about what she hopes it'll bring to her family's experience.

Transcription below!

Check out Stacey's new 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

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 a paperback eBook and audiobook, Learn more at Diabetes dash connections.com

Welcome to one of the minisodes of diabetes connections. I'm your host, Stacey Simms. And I started these shorter episodes this year, just so I could talk a little bit about stuff that interests me. We still have our weekly episodes every week that are longer and more interview based. But these are just little bits of topics one at a time, where I want to kind of share what's on my mind and then hear back from you whether it's in the Facebook group or elsewhere on social media. If you are new, we have a terrific Facebook group. It's diabetes connections, the group, please reach out and join and you can always reach out via email. or other social media I am Stacey at diabetes dash connections calm. And today I want to talk to you about some thoughts on Control IQ, the new hybrid closed loop system from Tandem.

 

The emails for Control IQ were set to go out this week. So I'm sure there was a lot of online chatter and you know, scrambling for this and did you get your email and that kind of stuff? Did you get your prescription? And do you have it yet? And have you downloaded it? And I thought it would be fun to just take a moment before you know we start sharing our thoughts about Control IQ and trying it you know, just for the record, kind of to get this down. What are my hopes, what are your hopes for Control IQ and really for a lot of these hybrid closed loop systems and before I get into that, for the Hybrid closed loop systems systems. I think that your perspective on this has to depend on when you entered the diabetes community.

I know we have people listening who have been diagnosed for years and years, you know, 50 plus years, 60 plus years. And their perspective is going to be very different than someone whose child perhaps was diagnosed six months ago. So just as a reminder, my perspective is that of a parent whose child was diagnosed 13 years ago, at 23 months, who went seven years with no CGM, because frankly, we didn't we didn't really feel like it was accurate enough to put a second sight on my kid's body. And by age nine, it really became his choice. And then when he chose to do it, I don't think he's taken it off for more than two days. You know, Maybe a beach trip here and there. But we really are huge fans of CGM. And he's had a pump since he was two and a half. So that's my perspective.

Look, I know this is not going to be perfect, right? I mean, all this technology has issues. But what I really hope but I am hoping for is not, you know, perfect numbers, right? I don't think Benny's A1C is going to suddenly go down to 5.8. And that's not my goal. What I'm really hoping from Control IQ. What I'm really hoping we get from Control IQ is less stress, less of a mental burden on both of us, and more freedom for Benny. And let me just talk a little bit about that. Because I if you know me, and you listen to the show, we give him a lot of freedom. But a perfect example is he was at a wrestling tournament. I mean, he's just off crutches recently, but the kid hasn't missed a practice or a meet. He just really likes to go and be part of the team and they put him to work. He's been Great, but he went to a trip where he was catching the bus at school at 6am. They took the kids, this was a Saturday, they took the kids about 45 minutes away. He didn't get home until eight o'clock that night. They feed them on the road. It's a lot of potluck. It's a little bit of fast food, but it's really nice. A lot of parents get together and make homemade stuff. And I pack lunches for Benny too, just because he likes to eat certain things. It's not about diabetes really. and then you know, I try not to hover and check in all day. Obviously, I can see his blood sugar on the Dexcom and he's responsible for remembering and taking care of himself.

And on a lot of these days, and this is this happens really just about every weekend during wrestling season, and usually once during the week they have a match after school to what generally has been happening is he's bolusing after, because he's not sure exactly what he's going to eat, or he forgets, right, and that he's kind of correcting a little bit late. So we haven't had any really crazy highs. I mean, there's one inset issue we had, but he's been kind of floating up to like 210 to 215. And then I'm debating when do I text him because we do have an agreement, we, you know, that is well within my rights to text him, but at the same time, you know, I want to leave him alone. I don't want I don't want to burden him. So it's been a little bit of a struggle and I'm really hoping for his Control IQ evens those numbers out, right, I don't really expect it to take care of you know, if he forgets to bolus and spikes up to 400, which happens every once in a while and he come on, I don't expect it to fix that. But if he's bolusing as he's eating or a little bit after, or he miscalculates carbs, right? I'm really hoping it helps with that. I'm hoping it helps with the excitement spikes and some of the adrenaline spikes from athletics. I don't know what it'll do with that. I'm optimistic but You know, we'll have to see,

What I hear about all the time from people who have done the DIY loops is that they, they don't necessarily have, quote, better control or more in range numbers, because a lot of people who do DIY frankly, I mean, they had really low A1Cs to begin with many of them. I know as you're listening, you're saying not me, okay, I'm just making a generalization stay with me. The point is that they may not see a huge difference in A1C or time in range, but they are seeing better sleep, they are seeing less work, right, more freedom. For Benny, with Control IQ and for everybody with Control IQ, I hope it means less work and less upstairs less mental burden. And for people who do have higher A1Cs, who maybe are newer to pumping or newer to CGM or maybe this is an opportunity for better education. I really hope that those people do see better health and do see better outcomes and do see better outcomes.

I mean, as you listen to this podcast, again, making a generalization Here you are, you know, the top educated people in the diabetes community, not necessarily because of this podcast, but we've done the research. People who listen to this show are extremely well educated, you're seeking out more information, you're in the Facebook groups, you're reading stuff, right, you kind of know what's going on. And if you tuned in to learn about Control IQ, just the fact that you know what it is called, and what it is, means you're better educated than probably, I'm going to throw out a number that I'm making up 80% of people in the diabetes community, community, and those are the folks that if they have access to this technology, which is a whole other thing, story altogether, the cost the access, oh my goodness, the costs the access. I mean, I we must acknowledge that. But if they can get this, those people are going to see huge decreases I think in A1Cs and that's really exciting stuff. Is this a solution? a cure? Of course not. And as I just touched on there, we have bigger issues, the cost of insulin, access to insulin access to this technology, education, education for endocrinologists access to endocrinologists for mostly for adults with type one diabetes, right? I mean, there's so much going on here.

I didn't mean to get off on a tangent, but my expectation for Control IQ is not that we're going to see miracles. We already sleep through the night pretty well. But I'm hoping that he can continue to have the independence that I give him with more time and range with less nagging from me, you know, gosh, in the back of my mind, I'm really thinking about camp later this year. If you're not familiar, Benny goes away to non-diabetes, regular sleepaway camp for a month every year. And he does really well. That's a topic for another time, I probably will do a minisode on camp. But you know, he does run higher for that month. Some of that is our thinking is about safety. But most of that is about he's a kid who's basically responsible. He's a kid. He's basically responsible for his care 24 seven at this camp, and he will often bolus late or forget a correction bolus. I can't wait to see what Control IQ does for him at camp. It's gonna be really exciting.

All right. I know a bunch of you listening are thinking I'm not going to go with Control IQ. I've heard from many people who already see they're going to wait and let it roll out. And then when all the bugs are done, they're going to go ahead and take the plunge themselves. We plan to get it the minute it is available to us. Our endocrinologist, we just saw him at the very beginning of January. He said the prescriptions are in we are all set. So it's possible by the time you hear this, that we already have it and we're using it in Benny's pump, although I doubt it will it will see and I'll post in the Facebook group and I will give a review of course as soon as we possibly can. But man, I'm thrilled to think about this. And if you use another type of insulin pump and you're still listening, you know of course insulin has its own system coming out. Medtronic has a new pump coming out there are more CGM is coming to market. There's gonna be a lot more to talk about, of course when it comes to hybrid closed loops, but we've been waiting for this for a long time, you know, Those loops. But we've been waiting for this for a long time, and I'm so excited to see what it does for Benny.

And you know, Benny would probably be the first to tell you that I am the world's worst diabetes mom. If you'd like to learn more about the book or about me, you can head on over to diabetes dash connections dot com and be sure if you're new especially to check out our extensive archive of shows. You can search by keyword or by subject. We will be back next week with our regular interview longer episodes and those drop on Tuesdays. Beginning This month we have added transcriptions for every episode, and you can see those over at the homepage, just click on the individual episode homepage and scroll down and you will see the text of the episode. A lot of people have been asking for that I'm really excited to provide it to provide it.

Thank you so much for listening. I'm Stacey Simms. I'll see you back here on Tuesday. Until then, be kind to yourself.

 

Transcribed by https://otter.ai

Dec 31, 2019

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

Oct 1, 2019

One Drop made a name for itself with a beautiful design; this summer it became the only diabetes devices in Apple stores. But founder Jeff Dachis says that the mission goes far beyond looking good.

Join the Diabetes Connections Facebook Group!

Jeff explains all that One Drop does and shares his frightening diagnosis story. We also talk about his past as an early internet innovator.

Order Stacey's Book - The World's Worst Diabetes Mom: Real Life Stories of Parenting a Child with Type 1 Diabetes

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00:00 What's on this week?

Stacey welcome: Stacey mentions that two episodes ago she profiled Carson Wedding and said that she was the first person to use the DIY Omnipod Loop. As it's hard to determine exactly who's "first" in the DIY crowd (and not really necessary), Stacey corrects that assertion.

Interview with Jeff Dachis

Tell Me Something Good

Stacey shares a story about watching Law & Order with Benny - the episode was an awful one about using insulin in a very weird way.

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Sep 17, 2019

Would you ask your teenage daughter to be the first to try a new DIY diabetes method? Carson's family did. She's been Looping with Omnipod since last fall; as far as we know, she's the first person to do so.

Pre-order the World's Worst Diabetes Mom, Stacey's New Book!

We’ll talk about being a loop guinea pig, how her parents are doing and more. 

In our Community Connection this week, Stacey talks to Dave Peterson, the GM of the Worcester Bravehearts about his diagnoses with type 1 as an adult.

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Learn more about Open Omni

Learn more about OpenAPS

The Nightscout Foundation

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And tell me something good an intern gets called in to see the boss.. for a great reason.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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Show open: what's on this week?

Stacey Welcome:

Interview with Carson Wedding

Interview with Dave Peterson

Tell Me Something Good!

See you soon - Stacey talk about events (find more here) 

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Aug 20, 2019

Insulet CEO Shacey Petrovic joins us for the first time and talks with Stacey about what's new and what's coming next. Petrovic shares the latest information on Dash, Horizon, Loop and more.

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Shacey also has a personal connection to type 1 diabetes: her father lives with it. She and Stacey talk about the dynamic of caring for a parent with T1D and how technology is changing that.

Vote for us in the Myabetic Diabetes Awards!

DiabetesMine Dash Review

Omnipod Horizon studies

In our Community Connection a little bit of a change from the AADE Conference, they want to change the name Certified Diabetes Educator (CDE) to Diabetes Care and Education Specialists.

And in tell me something good.. an honor for a school – thanks to a big gesture from a little kid.

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00:00 Show open: what's on this week?

1:30 Stacey Welcome - back to school! Listen to our interviews about the ADA Safe at School program here 

4:00 Interview with Insulet CEO Shacey Petrovic

39:30 Community Connection: AADE Conference update

43:00 TMSG: We made the finals of the Independent Podcast Awards!

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Jun 18, 2019

This week – Dexcom’s CEO is back to answer your questions. Kevin Sayer shares lots of news from the recent ADA Scientific Sessions as well as more information about the new G6 transmitter expected later this year. 

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Sayer also shares news about Dexcom’s role with current hybrid closed loops, answers your questions about Medicare and updates to Follow and touches on when we might see the G7 and when we’ll stop seeing the G4.

Learn more about the top research from ADA 2019 

In our Community Connection, a new resource to help you find the best pump, CGM and other diabetes tech for you. It's called DiabetesWise, an initiative from the Stanford School of Medicine funded by the Helmsley Charitable Trust. 

And Tell Me Something Good is all about research that could help the entire diabetes community. Learn about a new prevention study from Trial Net that delayed the onset of T1D for two years.


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00:00 Open: What's on the Show This Week?

1:35 Stacey Welcome - Benny's was at camp when Stacey taped this episode (he's back now and had a blast - more on that next week). More about the transcriptions that started going out last week. Sign up for the newsletter to start receiving these monthly "extras." And Texas Roadhouse restaurant is helping JDRF - donating proceeds from their online gift cards. But this ends June 30th so click here to find out more. 

5:45 Interview with Dexcom CEO Kevin Sayer

42:45 Community Connection all about DiabetesWise

45:35 TMSG: TrialNet's Teplizumab prevention study 


Previous interviews with Dexcom:

CTO Jake Leach - Feb 2019 focuses on Apple "Hey Siri" update and more on trouble shooting G6 sensors

CEO Kevin Sayer - Jan 2019 focuses on G6 rollout, NYE Share/Follow outage and listener questions

CEO Kevin Sayer - May 2018 focuses on G6 launch and Dexcom wearable integration

CEO Kevin Sayer - March 2018 Dexcom G6 Approved

Former CTO Jorge Valdes- June 2017 Apple watch integration discussion, G5 for Android, Dexcom company discussion 


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May 30, 2019

Get the most out of your Continuous Glucose Monitor. Certified Diabetes Educator Gary Scheiner joins Stacey to talk about all the CGMs available in the United States. An excerpt of this interview ran in episode 229. We go further in depth on more issues around CGM and discuss more advice. 

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Gary is the founder of Integrated Diabetes Services, the author of many books including, Think Like A Pancreas and was the 2014 AADE CDE of the Year. This is the full interview with Gary. You can find an excerpt in the previous episode.

Here's Gary's formula for getting your A1C and beating your endo at the bet he jokes about.

Start with your CGM average glucose for 30 days. Multiply by 1.03. Then add 46.7. Then divide by 28.7 to get your A1C. 

To do the reverse and find out your estimated average glucose, The American Diabetes Association has a handy A1c-to-eAG calculator: https://professional.diabetes.org/diapro/glucose_calc


Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! 
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May 28, 2019

Get the most out of your Continuous Glucose Monitor. Certified Diabetes Educator Gary Scheiner joins Stacey to talk about all the CGMs available in the United States. 

Join the Diabetes Connections Facebook Group! 

Gary heads up Integrated Diabetes Services, is the author of many books including, Think Like A Pancreas and was the 2014 AADE CDE of the Year. This interview is an excerpt - the full interview with Gary can be found in the bonus episode immediately following.

In our Community Connection this week, diabetes camp for grownups – why should the kids have all the fun?! A look at some of the programs available including Camp Nejeda's Survive and Thrive, Beyond Type 1 Slip Streams and TCOYD's One Retreat.

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And in Tell Me Something Good, some diabetes camp memories, more than a generation later. And a big award for a kid who doesn’t have type 1 but supports her friends who do.

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1:30 Stacey Welcome - she shares her experience filling out diabetes camp forms. A lot has changed since Benny started at camp 8 years ago!

6:55 Interview with Gary Scheiner

36:00 Community Connection: Diabetes Camps for Grownups

40:00 TSMG: Ariel Flur wins a Blumey Award! Her father was featured on the show back in 2016 for riding in the ADA Tour de Cure.  And a former camper at Camp Nejeda shares his childhood experience with Stacey. Jim Kutudis even sent us pictures! Check out the FB group for more. 

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Apr 30, 2019

This week we take a deep dive into low blood sugar. A frank talk about what hypoglycemia means.. what the dangers are, how to treat and more.

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Stacey talks to Shannon Johnson, a CDE who lives with diabetes herself. Shannon was diagnosed with LADA in hear early 20s and she's now a Certified Diabetes Educator and trains her patients on pumps and CGMs.

Plus, we’ll find out about the TCOYD conference – the first one for people with diabetes and not just medical professionals. Taking Control of Your Diabetes is marking 25 years. Stacey talks with founder Dr. Steve Edleman who was diagnosed as a teen.

And in Tell Me Something Good - huge news from the DIY community. You can now Loop with Omnipod.

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1:45 Stacey welcome - her daughter is graduating high school soon, she's going to two conferences in May: TCOYD in Raleigh and Take Control of Your Diabetes in Orlando. 

7:30 Interview with Shannon Johnson, CDE

32:00 Community Connection with Dr. Steve Edelman, TCOYD Founder

46:00 TMSG: Omnipod Loop

52:25 Stacey continues her thoughts about the Hulk and diabetes after seeing Avengers Endgame (very mild spoilers)


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