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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 20, 2020

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

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This is our last episode of 2019! Stay tuned for new sponsors, new segments and new weekly mini-episodes.

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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.

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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

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!

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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

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.

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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


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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. 

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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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Apr 23, 2019

It's hard to believe, but a natural disaster was the spark to bring a popular diabetes device to the US. A Frio is a handy little way to keep your insulin cool. Dan Katzki was diagnosed with type 1 as an adult an in 1989 – during the San Francisco earth quake – he lost power. 

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Not wanting to go through that anxiety again, Dan and his wife Lisa found the Frio product and brought it to the US. How it was invented is another great story.

Our Community Connection is all about a virtual conference coming up in May. Find out about the Diabetes Empowerment Summit - the conference you can attend in your pajamas.

And Tell Me Something Good includes a huge milestone for a diabetes advocate we’ve spoke to before. 1000 blog posts for Renza Scibilia who's also marking her 21st year with diabetes.

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1:50 Welcome: Stacey shares how the Avengers movie coming out this weeks means a lot to her family. In fact, Marvel has even helped with diabetes. 

7:00 Interview with Dan and Lisa Katzki

39:00 Community Connection: The Diabetes Empowerment Summit

42:00 Tell Me Something Good: Renza Scibilia marks 21 years with type 1 and 1000 blog posts! Plus, Julia shares how she's (in her words) "graduated from the breast surgeon" and what that means to her.

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Apr 16, 2019

This week Stacey talks to renowned researcher, long time pediatric endocrinologist and all around good guy Dr Bruce Buckingham. He decided to become an endo after experiencing diabetes camp early in his residency, more than 50 years ago. 

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Dr. Buckingham tells Stacey he put his first patient on an insulin pump during a clinical trial in 1979! He was principal investigator of the Medtronic MiniMed 670G at Stanford University and he shares his reaction to a recent study that showed some people are struggling with this first commercially available hybrid closed loop.

In our Community Connection this week, an important – and if I’m being honest – a bit of an awkward conversation about race. Comedian Chelcie Rice and I talk about how to get more people of color at diabetes events. He’s great.. I’m the awkward one.

Good info from an event last fall: Diabetics on the Margin (includes links to more information and more people continuing the conversation about people of color living with diabetes. 

Our Tell Me Something Good this week.. Beyond Type 1 makes it the Webby awards and some great T1D kids speak up about how much diabetes camp means to them.

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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1:50 Stacey Welcome

7:00 Interview with Dr. Bruce Buckingham

41:30 Interview with Chelcie Rice

58:00 Tell Me Something Good


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Feb 28, 2019

Back to basics! We’ve started a new monthly series called "Diabetes Connections Extra" where we take a look at the essential facts of diabetes. This time, we take go in-depth on insulin pumps. 

Stacey talks to endocrinologist Dr. Jonathan Ownby about what a pump does, how to get the most out of one and what questions to ask. This bonus episode includes the entire, much longer interview you might have heard excerpted in episode 212. 

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Insulin Pump basics 

2018 Insulin Pump Comparisons (Integrated Diabetes)


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Feb 26, 2019

We take an in-depth look at insulin pumps this week. It's the second part in our series, Diabetes Connections Extra where we do a deep dive into one topic. 

Stacey talks to endocrinologist Dr. Jonathan Ownby about what a pump does, how to get the most out of one and what questions to ask.

Insulin Pump basics 

In our Community Connection, a high profile look at type 1 and heart disease as TV and radio personality Carson Daly shares his family’s story on the Today Show

Plus, Tell Me Something Good featuring a new baby and a good liar.


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1:30 Stacey Welcome - she talks about interoperability and whether that comparable to Mr. Potato Head. Stacey shares Info about Tandem's new ACE designation by the FDA and more about Open Omni.

7:20 Stacey talks about the history of the insulin pump

9:30 Interview with Dr. Ownby

47:00 Stacey talks about Carson Daly's effort to educate people with type 1 about their risk of heart disease

51:00 Tell Me Something Good: Shelby Daniel's mom shares why her daughter is a good liar! You can see more about Shelby and the Savage Race she completed here.

And congrats to Moira McCarthy on the birth on her second granddaughter!

54:00 Stacey asks about emotions when it comes to parenting and diabetes and share some changes she's seen in herself lately.


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Jan 22, 2019

Dexcom CEO Kevin Sayer answers your questions and looks ahead. We talk about issues with the G6 sensors, Medicare, what happened to the Share servers New Year's Eve and he takes lots of questions from listeners. Plus, a look ahead to the smaller G7. That new version will have the transmitter and sensor in one piece. It's due out in late 2020. 

In our Community Connection, catching up with Beyond Type 1. They've got a new CEO and a new push to help with type 2. Stacey talked to Thom Scher a few weeks back about what makes BT1 tick.

Previous interview with Thom Scher

And in our Tell Me Something Good segment, Stacey explains that Will’s Way – a small but mighty charity – is marking a big milestone.

Previous interview with Will's Way

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1:40 Stacey welcome - thanks JDRF Greater Western Carolinas for having us at the recent Type One Nation Summit. Benny was Rufus! Proud mom moment for Stacey. 

6:00 Interview with Dexcom CEO Kevin Sayer

33:15 Stacey talks about Beyond Type 2 

36:30 Interview with Beyond Type 1 CEO Thom Scher

51:00 Tell Me Something Good: Will's Way

53:30 Stacey shares a recent endo visit - lower A1c, almost no lows (thanks to Basal IQ)

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Jan 15, 2019

Did you ever wish you had a Geek Squad on call for diabetes tech issues? Like one of the big box store helpers. David Panzirer with the Helmsley Trust wants to make it happen, starting with CGMs.

David explains why he thinks this will work, who will pay for it, and shares his story; two of his three children live with type 1.

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Plus.. catching up with Bigfoot Biomedical’s Lane Desborough about their subscription model. Stacey also has information about Bigfoot's new agreement with Lilly Diabetes. 

And Tell Me Something Good! Going from DKA to IronMan in just one year?! You'll hear Lauren Dahlin's fantastic story

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1:30 Stacey welcome includes a bit about our trip to Israel (more here from Stacey's FB Live)

5:30 Interview with David Panzirer

Take action - text the word “CGMChamps” to 555-888 or log on to www.cgmchampions.org

35:25 Stacey talks about Lilly & Bigfoot's new announcement

38:45 Interview with Lane Desborough

55:30 Tell Me Something Good all about Lauren who went from DKA to Ironman

58:30 Stacey just attended the JDRF Greater Western Carolinas Summit - contact us if you'd like her to speak at your event 

stacey@diabetes-connections.com 


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Nov 20, 2018

Loop - the DIY app that helps with automated insulin delivery - may become the first do it yourself diabetes solution to go to the FDA. But why did Tidepool decide to take on this challenge? Stacey talks to Tidepool CEO Howard Look about what this decision means, how it’s going to work and what it means for those interested in DIY but not willing to use out of warranty pumps or do a lot of programming ourselves. And of course we’ll explain what Loop actually is.

Read the Medium article Howard mentions here

A French company announces they’re a step closer to approval of their closed loop – we’ll talk about Diabeloop 

And Pandora gets into the podcasting space. Diabetes Connections is one of the few shows selected for the first launch!

Listen to past episodes where we talk to DIY, OpenAPS and We Are Not Waiting advocates and experts.


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1:30 Stacey welcome & explains Loop

6:50 Interview with Howard Look

30:30 Diabeloop explained

35:00 Pandora and podcasts

Become part of the Pandora's Beta testing as a listener


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Oct 30, 2018

Stacey talks to Jen Block from Bigfoot Biomedical with a look at why they plan to be more than a pump company, offering help navigating healthcare and a subscription service. Jen is the VP of Medical and Clinical Affairs. She was diagnosed with type 1 her sophomore year in college, during a cross country road trip. Now a Nurse Practitioner and Certified Diabetes Educator, she shares her story and details about Bigfoot.

In our Know Better Segment, one of the very first studies about LADA – sometimes called type 1.5. We’ll tell you what researchers learned.

And Stacey shares a story about a recent wedding where she made one T1D friend and embarrassed herself trying to track down another.  


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1:40 Stacey Welcome

4:50 Interview with Bigfoot's Jen Block

49:30 LADA study

52:30 Stacey doesn't have diabetes radar but she is very embarrassing when she thinks she does..  

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Oct 16, 2018

Darrell Greene is one of the first people to try Eversense, the implantable long-term CGM from Senseonics. With Eversense, a doctor places the sensor in the upper arm where it stays for three months. More information here.

Darrell explains what the experience is like, how the sensor feels under the skin and shares his story of living with T1D since his early 20s. Darrell is a local news anchor in Memphis, Tennessee and has some fun stories to share about working in the industry. 

Watch the video of Darrell and his doctor explaining Eversense. Darrell even taped the procedure!

Our Know Better segment this week features information about Lilly's faster acting insulin, moving along through the aptly named PRONTO studies.


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1:30 Stacey welcome - information about the podcast on YouTube

5:15 Interview with Darrell Greene

49:00 Information on Lilly's faster insulin - Pronto Studies

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Sep 18, 2018

Big news for Abbott, the makers of the FreeStyle Libre. This summer the FDA okayed a shorter warmup and a longer wear for the glucose monitor. Stacey talks to Tim Dunn, Abbott’s Director of Clinical research. They talk about the challenge of longer wear, the practical info you need to know if you use the Libre, and a look down the road as they partner with companies like Bigfoot.

Plus, a protest planned at the end of the month – all about affordable insulin. We’ll explain how you can help even if you can’t be there in person. Information from T1International here.

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1:30 Stacey Welcome

4:30 Interview with Tim Dunn

40:30 #Insulin4All Protest information 

43:00 Stacey upcoming events & shares why in-person connection is important. She talks about the first time she and Benny met a little boy who wore an insulin pump and what a difference that made for them. 


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Aug 30, 2018

Tandem's Predictive Low Glucose Suspend is out! Stacey and Benny got the software update on Saturday, August 25, 2018 and this bonus episode includes Stacey's thoughts on how the first few days turned out. 

More information on the Basal IQ software here.

Head over to Tandem's portal to sign up to get the update if you already have a Tslim X2 pump and a Dexcom G6

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Aug 28, 2018

Instead of a rescue Glucagon shot, how about a nasal spray? A simple spray for emergency low blood sugar is in front of the FDA right now. We speak with Lilly Diabetes Senior Medical Director Dr. Thomas Hardy about the need for this product, what it is and how it works. 

In our Know Better segment.. a quick tip about Dexom’s G6 - save your papers!! More in Stacey's Facebook live video here.

And a bit about the Bike Beyond documentary.  Stacey says it wasn't what she expected at all. You can buy the DVD here or find out how to host a watch party. 

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1:35 Stacey Welcome - thanks to DiabetesMine and Jacobs Media (& Elsie Escobar) for featuring us in recent columns

5:30 Interview with Dr. Thomas Hardy, Medical Director for Lilly Diabetes

28:30 Stacey shares her mistake when she was training again on injectible glucagon

32:00 Dexcom G6 information - keep your paper

35:30 Bike Beyond - Stacey's review of the documentary

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Aug 7, 2018

One of the problems in carrying low treatments everywhere is actually carrying them. This week, learn about a glucose necklace expected to come to market this fall. Inventor Kris Maynard is a former fire fighter and first-responder who lives with type 1. 

Stacey talks to Kris about the product, gets some advice about medical alert bracelets, tattoos and what we can do before we call 911. Kris shares the frightening low blood sugar that prompted this new product.

Plus a little bit from Benny about sending kid with diabetes to non-diabetes sleep-away camp. He and Stacey chat in the car about what he does to make his four weeks away work out.

And we talk about Jesse Was Here. It's a new program from Beyond Type 1 and Jesse's mom, Michelle Page-Alswager. Michelle's blog referenced by Stacey can be found here. 

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1:40 Stacey Welcome

4:25 Interview with Glucose Revival Inventor Kris Maynard

17:35 Stacey explains Jesse Was Here

22:20 Stacey & Benny talk about camp (in the car on the way there)

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Jul 3, 2018

Tandem answers your questions about the newly approved and not- yet-released Basal IQ system. The FDA took a lot of people by surprise by approving it with the Dexcom G6.

We talk to Tandem's Molly McElwee Malloy about how the system works, when it'll be available to T:Slim users and what's next for the company. Malloy addresses why Tandem decided to pursue integration for Basal IQ with Dexcom's G6 when it had been initially submitted to the FDA with G5 technology.

Plus, in our Know Better segment this week, a Koala with type 1 may become the newest Dexcom poster child. You might have seen Quincy on social media.. now we’ll hear from his caretakers at the San Diego zoo.

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1:30 Stacey Welcome- talks about Diabetes Connections the Game Show happening at Friends for Life. Please join the Facebook Group to find out more and learn how you can play along and win prizes even if you don't come to the conference this month.

4:00 Stacey recaps what Basal IQ is all about.  Molly first spoke to us about it back in February.

6:40 Interview with Molly McElwee Malloy

49:10 Know Better segment with Quincy the Koala's caretakers.  Stacey's friend (and former guest) Trip Stoner has a great take on Quincy (read more here).

59:00 Stacey talks about summer travel, conferences and camp

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May 22, 2018

The Dexcom G6 has been on the market for just about one month. Stacey checks in with company CEO Kevin Sayer for a frank discussion about cost, sensor life and integration with pumps and wearable fitness devices like Fitbit. 

In our Community Connection this week, learn about "Previously Healthy." This multi-media presentation aims to put a spotlight on the death of a North Carolina toddler whose family then pushed legislation called  “Reegan’s’ Rule”

Writer Michelle Boise from Beyond Type 1 joins Stacey to talk about how the article came together and what lessons were learned from this tragedy.

Andi in our Know Better segment, Novo Nordisk is pushing ahead in the stem cell/encapsulation market. 

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2:00 Stacey Welcome

5:00 One Touch #SmallVictories Campaign email:    onetouch@hellommc.com

5:50 Interview with Kevin Sayer

29:00 Stacey talks about her & Benny's experience with the G6

32:00 Know Better - Novo Nordisk encapsulation update

36:30 Community Connection - Interview with Michelle Boise from Beyond Type 1: Previously Healthy

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May 2, 2018

Stacey's son started using the Dexcom G6 five days before taping this episode. She gives their first impressions and talks about an earnings call with Tandem that may give some insight into how that company is trying fastrack G6 pump integration.

This episode also features a promo for a new podcast called Safe at Work. It's a fun look at workplace ups and downs, along with advice and celebrity interviews. Learn more and subscribe to the show here.

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