Tandem's Control IQ at One Year: "The Real-World Data is Even Better Than the Clinical Data"

It's been a year since Tandem Diabetes Care released their Control IQ software, hybrid closed loop technology to help increase time in range. What have they learned about how people are using the system? Molly McElwee Malloy, Manager of Clinical Outcomes at Tandem Diabetes Care, is back on the show to answer your questions and to talk about what's next in the Tandem pipeline.

Tandem Diabetes Pipeline

What diabetes tech to expect in 2021

Our innovations segment: using your CGM to get more out of exercise and.. a new study for people with rare forms of diabetes..

CGM and exercise

RADIANT Study

Fearless Diabetic Summit

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

-----

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

Get the App and listen to Diabetes Connections wherever you go!

Click here for iPhone Click here for Android

Episode Transcription:

Stacey Simms 0:00

Diabetes Connections is brought to you by Dario health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen, the first premixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.

Announcer 0:22

This is Diabetes Connections with Stacey Simms.

Stacey Simms 0:27

This week, it's been a year since Tandem diabetes released their Control IQ software, hybrid closed loop technology to help increase time it range.1 since that day, as we do around here. We've all been asking for changes. Tandem says they're listening,

Molly McElwee Malloy 0:43

can it be more aggressive? Could it be less aggressive? Good, you know, do this or that I pick my targets. Could I put a timer on exercise? Could I do all that? We are looking at all of those things. I would say nothing's off the table right now.

Stacey Simms 0:56

Molly McElwee Malloy, manager of political outcomes at Tandem is back to talk about possible changes to controlling q to answer your questions, and to look ahead at other tech in the Tandem pipeline

In our innovations segment using your CGM to get more out of exercise, and a new study for people with rare forms of diabetes.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Welcome back to another week of the show. I am so glad to have here. If you are just finding us if you are new to Diabetes Connections, welcome. We aim to educate and inspire about diabetes with a focus on people who use insulin, my son was diagnosed with type one right before he turned two back in 2006. My husband lives with type two diabetes, I don't have any type of diabetes, but I am the broadcaster in the family. And that is how you get the podcast.

It's funny to look back on this year. Because not only did none of us have any idea what 2020 would really be like, but more to my point here, as I'm taping this on January 15. And planning to release on the 19th. This was a time when many of us in the community were just refreshing the Tandem page over and over again. Because Control IQ had been approved. And many of us had already talked to our endocrinologists about it and tried to get the prescriptions. And if you remember that time, especially on social media and some of the Tandem groups, it was a bit bananas. But we have been using Control IQ for a year. Now Benny got his set up at the very end of January, as I recall.

And they are not a sponsor of the show. They do not pay me to say this. But it's been absolutely amazing for us, it has really made a big difference. And you know, I don't share numbers. I'm not all about the numbers and straight lines with him. But I do want him to be healthy. And I think we were doing great before but just back from the endo this time around about a week ago as you're listening now, his lowest A1C ever. And the time before that was his previous lowest A1C ever. And the best part is he's doing less work. And I am I swear I'm doing less nagging. If you ask him, he will tell you otherwise. But I promise you it's true. So I'm thrilled to talk about control IQ. I'm really excited that all of the pump companies are moving in this direction, it would be amazing for everyone to have access to this kind of technology. That is a discussion for another time. Probably

Another little bit of personal news, Benny got his driver's license. I know I can't believe it either. Here in North Carolina, you get your permit. If you want at 15, you can actually take drivers at 14 and a half. But you get your permit at 15. And you can get your license at 16 right now, because of COVID. They are not even doing road tests. I know isn't enough bananas. But what happens is you get your basically your junior driver's license, you can't drive at night, which is what he would have been issued anyway, if he passed a road test. And they cannot move on to the next level the after nines until they get a road test. In fact, I believe what he has expired in six months without a road test. So he'll have to take one. He's a decent driver, you know how superstitious I am. So I'm not going to say more than that. But I'm confident we've got a whole system with diabetes we have we've had these discussions, and he's just so excited about it. And I'm really thrilled for him that this step has taken but as a parent, and for those of you who have known him since he was two, how did this even happen?

Okay, we're gonna talk to Molly from Tandem in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen and almost everyone who takes insulin has experienced a low blood sugar you know, that can be scary, but a very low blood sugar. It can be really scary, and that's where Gvoke Hypopen comes in Gvoke is the first auto injector to treat very low blood sugar. Gvoke is pre mixed and ready to go with no visible needle. That means it's easy to use. How easy is it, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it. Find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvokeglucagon.com slash risk.

My guest this week is the manager of clinical outcomes at Tandem diabetes care. And she lives with type one, Molly McElroy is I am grateful to say a frequent guest. And if you're a longtime listener, you know, her career and her life has been shaped by the technology that is now control IQ. That's not really an exaggeration. She was one of the first to test out an artificial pancreas system. And she changed her career path because of it.

And my first interview with Molly was in 2016, when type zero technology announced their partnership with Tandem, and I will link up the previous episodes, we've done a bunch with her all about this software, you can find those links, as always, in the episode, show notes, wherever you're listening, the app should have show notes. If it's difficult to find, just head over to Diabetes connections.com. And every episode now has a transcript and lots of links and notes to help you out. Please stay though, to the very end beyond the interview because there are a few questions Molly had to check on. She couldn't answer at the time. And they sent me that information. And I will give that to you later on in the show. Of course, as I said, there's a transcript so you can check it out that way as well.

Molly, thank you so much for coming back on to talk to me a year ago, you and I spoke about Control IQ it had basically just been approved. And you were kind enough to jump on that in late December. So thanks for coming back on.

Molly McElwee Malloy 6:26

Oh, you're welcome. I'm very excited to be back on this.

Stacey Simms 6:29

Yeah, well, lots of lots of questions, of course, from listeners and from me. But let's just start by taking a moment to kind of reflect what's the last year been like for you guys at Tandem?

Molly McElwee Malloy 6:39

You know, it's been really crazy great is the best way I could describe it. There's a lot of excitement for control IQ, and rightfully so. And there's a lot of the feedback via social media about people's experience. And it's been really, overwhelmingly positive. It's also been kind of emotional, because this has been a rough time for everybody, right? Like last eight months or so that we've been in. I've been calling it seclusion. But it's, you know, everybody working from home. And that's been a really high stress situation, particularly for people with chronic disease, and myself included. So I've really been grateful that control like has been out and approved. And a useful tool during this time. Because just you know, stress influences glucose. And so it's been a big, huge help for a lot of people, particularly during this time. So it's been crazy great. And it's been busy. But sure, I would love to experience control, like you and all the interaction with healthcare providers in person. But it's been great just talking to people on the phone or on video or teams. And it's been really good that we've been really busy. Yeah, sure. All right.

Stacey Simms 7:43

So what I'd like to do is take a look back, get some information from you about control IQ, and then kind of take a look forward because we know the product and the product line is evolving. So let's just start by asking you, what have you learned about control? IQ obviously had all the study information. But looking back at 2020? How are people using it? How is it working out? What is the data telling you,

Molly McElwee Malloy 8:07

you know that this is the funniest thing, and this is not something that you can plan or you could guess but our real world data is better than our clinical trial data. And I'll say that again, because it's just, it feels a little crazy to say that out loud, because that's usually not the case, right? clinical trials are very well managed. And you know, there's protocols and everybody's sticking to stuff. But it turns out when you put this put control, like you in the real world where people are experiencing significant hyperglycemia, or even hypoglycemia, it does even better. So I mean, the clinical trial population was pretty well controlled, right? And we were still able to improve on that. But when you put it into the real world where people are doing, you know, they're real people, they're doing all kinds of real things, and we're able to get even better outcomes. It's surprising. It's awesome. It's a really cool experience, and definitely unexpected.

Stacey Simms 8:59

Yeah. So let's dig into that. Can you tell us in terms of I guess you're measuring things like time and range? Can you give us a little bit more information about what you mean by they did better?

Molly McElwee Malloy 9:09

So for one, it's it's time and proven time and range, right. So in our pivotal trial, we had about 11% over baseline improvement on time and range from a very good well control group, which is awesome. But in real world, it seems to be closer to 13%. Sometimes a little bit better. We've got some results from D Q&A which is a third party vendor that does research and they're affiliated with Diatribe. And they did some survey results about time and range by insulin pump therapy and it's been really cool to have like a 33% getting 81 to 90% time and range 31% getting 71 to 80% of 11% getting 91 to 100% which is crazy. So you know all of that And it just is amazing because it really does. It whips up on the competition. But it also just shows that, you know, this works even better in the real world.

Stacey Simms 10:08

Any idea why? I mean, are people using sleep mode? Are people figuring out different ways to use it better? I'm just curious what you think might be happening?

Molly McElwee Malloy 10:19

Yeah, I don't think it's the using sleep, you know, 24, seven or something. I think using a sleep schedule has been very successful. But I think the reason for this is that largely, and not everybody was correcting aggressively, right. So while there are that subset on Facebook, or social media that are trying to get that, you know, super, super tight range, there are plenty of people who, between meals, we're not correcting, and now they're receiving those corrections. And there's some evidence that we were able to publish. And I think we showed an ADA, but that persons with type two diabetes are benefiting from this. And that's because they're getting the corrections between meals, which we don't typically ask people with type two diabetes to do that. So getting that tighter control is really, really helpful. And again, not everybody does that.

Stacey Simms 11:11

Yeah, I have one of those people in my house, who not everybody does that. I mean, we I tease Benny all the time, and he knows that I I talk about him on the show like this, he will happily, let me say that Control IQ has helped him significantly because he often boluses after he eats or forgets to bolus or didn't correct between lunch and let's say, bedtime, even if he gave himself insulin for dinner. And it really has made that burden lighter. And it's certainly not perfect. I have friends whose kids are much more engaged with their diabetes, I guess is a way to say it where they, they will you know, they'll bolus every two to three hours, or they're looking at their watch every 20 minutes. But he's never been like this. And it's really improved his quality of life. Because I'm not, I'm not willing to make him do that.

Molly McElwee Malloy 11:57

Well, and if you think about the long term, decrease the complications because of this going on in the background is sort of automating this. I mean, that's a huge improvement and quality of life. One of the things I'm really excited about is to watch this going forward to see how we can measure decrease long term complications from this, you know, the not just like seeming variability, but with those micro macrovascular complications. But this is long term complications from diabetes from having high blood sugars. And, you know, that's just something that we've never been able to really control for before. So this is going to be very cool to watch and see how it plays out.

Stacey Simms 12:36

No doubt. All right. We've gotten a little bit inside baseball, but I think most people listen to the podcast will understand some of the shorthand, I'll try to explain as much as I can. But if there are things that we mentioned, that you are not understanding, I'm going to link up lots of stuff in the show notes. But one of those things is sleep mode. And I just want to take a second to talk about that. Because you and I, when we talked last year, you said that there were some people using sleep mode, which will adjust basal but will not give you boluses, they were using a 24 seven in the studies, you called them sleeping beauties. And there have been many, many people in the real world settings who use that we do not we actually don't laugh at me, we stopped using sleep mode for sleep. Because as great as it was working for Benny with what you called a seclusion, we found that he was eating at interesting hours, you know, 1am 3am I mean, he went full nocturnal for about a month there way back when I want to say like June or July. And so we turned off sleep mode because we needed that bolus power at weird times. So it's been really funny how you can kind of use the system in a way that works for you. But getting back to my question, what have you learned about sleep mode? Is there anything you can share with us?

We'll get her answer to that question and what she can share in just a moment. But first Diabetes Connections is brought to you by Dario health and we first noticed Dario a couple of years ago at a conference. And then he thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed. You'll get a glucometer that fits in your pocket, unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it and personalized reports. Based on your activity. Find out more, go to my daurio.com forward slash Diabetes Connections. Now back to Molly answer my question - we were talking about what Tandem has learned about the use of sleep mode?

Molly McElwee Malloy 14:44

Yeah, yeah, there's lots like I've learned I just want to share quickly that I've seen in looking at lots of reports with lots of health care providers that during what I've been calling seclusion or hibernation this this COVID time that people schedules are very, very different. They're eating at different times. And that sleep, as originally intended right is not what it looks like during this time. So there's a lot of people who have benefited from not using sleep when they're eating right through the night, or snacking, or staying up extra late or, like really altered schedules, right. So we've seen that some people have turned sleep off, and that's been successful for them.

So sleep, what sleep is doing is it's based off of fasting metabolism. And it's using this 112 to 120 sort of target. And it's really, it's a really tight range. But it's doing this through modulating basal. And the reason it's only modulating basal and not giving corrections is because someone is sleeping, and they're not, we're not anticipating postprandial spikes, and we're not anticipating exercise or activity. And so it's really, really meant for when you are kind of static, and you are sleeping. Now, that said, Not everybody's sleeping normally, particularly during COVID. And so it doesn't always work that way. And then some people want to have sleep 24 seven, so that the basal is modulating, but that they're responsible for the corrections. And if you're willing to glance and see if you need a correction every two hours, that can work really well. But if you want to alleviate that burden, right, then, then sleep maybe isn't the best thing for you to use 24 seven, so it really depends on the user and the user's interaction.

But the other thing I wanted to mention about sleep for users is that one of the things that we've noticed, and how people are using sleep is that if their schedule have has changed drastically with COVID, that they may need to reevaluate that sleep pattern as to what time it is. So for instance, if someone previously wasn't snacking at 10pm, and now they are starting sleep a little later may make sense because they may need an additional correction before going to that, you know, that's one circumstance I've seen a lot of. And another one is, there are some patients who can't go to bed with a positive IOB. And what I mean by that is, you know, going to bed with any insulin on board that is not related to carbohydrates, right, so for correction, and for them starting sleep sooner, and you know, obviously not eating right before bed, makes sense, because they're not getting any corrections before bed. So there's sort of really two very different types of insulin sensitivities, right, the person who's eating and then needs the additional correction, who may want to start sleep later. And then the person who isn't eating after dinner, and really doesn't want any additional corrections before they go to bed, starting it sooner. So I've also seen that very interestingly playing out in the public realm, and it's it's interesting to see how people are using it to make it work for them.

Stacey Simms 17:44

Yeah. What about exercise mode? Have you learned anything about how people use that we don't often use exercise mode.

Molly McElwee Malloy 17:50

Yeah, exercise is interesting, because it's sort of like a temporary basal rate, if you will, which you set indefinitely, right? until you start it and you stop it. And we hope in future versions, we'll be able to put a timer on this. But for right now, you start and stop it. And so you could be in sleep for 24 seven, if you wish, I have seen that be useful when people want to keep an a higher target, and want to be a bit more aggressive and preventing hypoglycemia, right. So that's an interesting thing that has and can be used selectively, whether it's for exercise, or just because you would like to keep up, you know, you need to be a little bit more conservative on the hypo end. And you really do want to have a higher target, you know, and COVID times looking at how particularly the aging population is trying to stay at home rather than go into care, using something that's going to keep them a little safer on the lower end and elevate that glucose level a bit has been useful, and just allowing people to remain, you know, in a safer range with preventing hypoglycemia.

Stacey Simms 18:51

I'm curious to see if there are any best practices, or any advice for starting the system. A lot of people who switched from Basal IQ or other pumps or no automated system, you know, just a regular Tandem x2, and I'll put myself in this camp. We were one of the first people on this in late January of 2020. We started on Control IQ before my endocrinologist or shouldn't say that way. We started on Control IQ before Benny's endo was trained. So I was in touch with him, but he was like, tell me what you find out basically, like, show me Show me Benny settings like we're gonna adjust as much as we can. But what are people saying? What are what are the you know, what are the experts saying? Trust me, my endo doesn't take advice from Facebook. But you know, it was one of those situations where we're learning together. And luckily, he trusts us to do that. But then he had, you know, we put his regular settings in, and we had massive overnight lows. And we had to adjust because of that five hour increment. We had to adjust. Basically everything works like a dream now, but it was a different transition than I had anticipated. I'm curious if you learned anything from that and what your advice might be now?

Molly McElwee Malloy 19:56

Yeah, one of the things we noticed, particularly people going from Basal IQ to To Control IQ as in basal IQ, they'd sort of artificially inflated their basal rates to sort of hug that line at 80, right or, because because it can always turn off, right? It's always preventing hypoglycemia, so why not have that basal rate a bit more. And with control IQ, it really takes that information and says, okay, that's where you are at baseline. And if that's really overly aggressive for where you are at baseline, then you're going to have hypoglycemia. So getting optimized settings is super, super important. And we do still see that people going Basal IQ to control IQ, that they've had really aggressive basal rates, and you need to back off of that, or even really aggressive meal. boluses, right. So sometimes getting that reevaluated with your healthcare provider, or diabetes educator, can be really, really helpful. But also coming from other AI D systems where you may not have as much information about, you know, what's going on with your basal rates or anything like that. But really just going when in doubt, wipe it out, you know, go back to basics with your settings, and with your provider and making sure those are dialed in. Because control IQ is being a metabolic algorithm, it really does behave when we really did design it around sort of insulin titration as we know it. So it's not any, any crazy math, it's not an occult science, it's, you know, it's what your endocrinologist would use now, for titrating insulin and going back to those basics is is really necessary to get a good solid start.

Stacey Simms 21:23

So would you recommend maybe basal testing or just talking to your provider about what they think is best for your settings,

Molly McElwee Malloy 21:29

talk to your provider about what's best for your settings. I mean, I can't give any medical advice on on how to do that exactly. But there, there are known ways to do this, whether it's you getting your basal rate, or your carb ratio, and a correction factor all dialed in. Do that with your provider. I I personally hate basal testing, I will tell you that I don't like basal testing. The reason I don't like it is because when people are basal testing, they are altering their behavior from normal. And it is not a true test, right? They're trying to avoid hypoglycemia. They're not doing their normal schedule. Because if you get hypo right, you have to treat it's trashed, you have to do it again. And so beta testing is, in my personal opinion, a nightmare, and not a true representation of what the patient is actually needing during that time. So I would I would prefer to do is see how controller hue is changing baseline and then see what that looks like against what's programmed and kind of, you know, look at the difference between the two to get the feedback. So really think basal testing is, you know, in theory, it's a good thing, right? But nobody basal testing is doing exactly what they were doing before that because they're not eating, right, they're trying to be careful about hypoglycemia. Sometimes you're just staying home all day to try to test this out, because you have to do so many finger sticks or what have you. So I don't think it's a really good representation of what's actually going on, I think, you know, looking at your total daily dose of insulin and talking to your healthcare provider, you can get that dialed in much better, with much less frustration. What I did with Benny and

Stacey Simms 22:59

I agree with him on the basal testing, we haven't done it in years and years and years for many of those reasons. But what we did that work nicely is we made changes very slowly. And it can be very frustrating. But it really works well. For us. Again, this is not medical advice. This is me personally what we did. And it really helped, we made one change basically, like he went low at 2am. So I changed the basal rate and we waited like three days, then and even if we went low, we treated but we didn't change the basal rate, then we worked on the insulin sensitivity factor, then like it took us two to three weeks before we thought we might have it and then we adjusted again about a month later. And if you if you can be patient, which is so hard to do, you know, people especially especially, and I'll throw myself under the bus too, especially as parents, we get nervous if anything's out of whack, right? We want everything to be perfect. What happened to my straight lines, and it's really hard to dial into settings, unless you're willing to let some of that perfection slide for a few days or weeks. But I'm telling you do it slowly, it'll come out much better in the long run.

Molly McElwee Malloy 24:03

Right. And if you think about an experiment, like for instance, the one that often comes up in our household is meant to my husband likes to follow recipes. And I hate following recipes. Although I know it's absolutely necessary, right? Because if you don't get the flour and the sugar and everything else, right, it just tastes like dirt. So they when you're baking, because I have done that. But it's very important to follow those recipes because if you alter you know one thing versus another thing, you're gonna get a totally different result. So altering one thing at a time is very important in a scientific kind of experiment, which sometimes dialing and pump settings is absolutely like that. And you need to follow that recipe. You can't willy nilly. It's not an art, right. It's very much a science. There's no there's no artfulness in this.

Stacey Simms 24:51

So looking ahead, and I'm not sure how much you can tell us but I'd love to start by kind of asking you about changes planned to control like you bet He has the first question here. He wants to know when the auto correction, right that auto, I call it the auto bolus, but the auto correction, when that will be stronger, because right now it's 60%. automatically.

Molly McElwee Malloy 25:12

Yeah, 60% because we're also titrating. Basal. Right. So the combination usually gets you closer to 100%. We are currently working on what that looks like, and how we could do that safely. I don't know how quickly that comes to fruition. But I can tell you that we are working on trying to understand how you would increase aggressivity without increasing hypoglycemia

Stacey Simms 25:37

you need a teenager setting, I can tell you that

Molly McElwee Malloy 25:40

we need a teenager aggressivity setting that's, that's for darn sure. Yes, Yes, we do. Well, maybe

Molly McElwee Malloy 25:45

I should start

Stacey Simms 25:46

by really asking you what what are you looking at in terms of improving or changing control iQ?

Molly McElwee Malloy 25:52

So we've we've really listened towards to feed back, right. So one of the things we do at Tandem, which we do really, really well, is we do these surveys all the time, where I'm constantly asking you, and you probably get these, what do you think of this? What do you think of that? What do you want from this, what you want for that, and then we look at the glycemic data, and we do some comparisons, because you can't just take what somebody wants as the absolute that would be best for everybody without looking at glycemic data. So we're kind of looking at both of those things, to see how we could refine Control IQ for something in the future, that works better and something that people don't even more excited about. So we're looking at people's sort of concerns? Or how aggressive can it be? Can it be more aggressive? Could it be less aggressive? gonna, you know, do this or that, but I picked my targets? Could I put a timer on exercise? Could I do all that? We are looking at all of those things? I would say nothing's off the table right now. I don't have any promises as to what comes first. As far as the improvements go, I think, you know, the next thing that we've been working on sort of is that bolusing from your phone, and being able to bolus from the app? Because that's been a big request.

Stacey Simms 26:57

Oh, but I'm asking about that. Don't worry.

Molly McElwee Malloy 27:00

Okay, yeah, because the thing, the cool thing about working as you know, we're a software, pump company, right, software based insulin pump company, which is cool, because you can make changes to software a lot easier than you can make changes to hardware. And so since we're not reliant upon the hardware to change, to make major changes, we could kind of do this in an iterative fashion, you know, one thing and then another thing, and then you know, and build and build and build a better product as we go along. And like you said, before, doing it slowly, carefully, looking to making sure that the changes are appropriate and working for everybody. So we're gonna follow that sort of scientific process, but we're looking at a bunch of different things that we might be able to change or, or make better based on feedback that we've gotten from our users.

Stacey Simms 27:49

One of the things that the other pump companies are coming out with, or if they come out in 2021, is a lower and different range, target range, or target number, you know, Omni pod and Medtronic have said that it'll be lower than, you know, 115, or 110. It'll be down to 100. It might even be adjustable. Can you speak to what Tandem is looking on that?

Molly McElwee Malloy 28:12

I think we're looking at a lot of different things I do. And full disclosure, as everybody knows, I come out of the University of Virginia research school center for diabetes technology, and working with Dr. Boris kabocha, and working with Dr. Mark proton, and Sue brown and Stacy Anderson, and really getting familiar with what is safe, and where people can kind of push the limit and where you can't, I think that 112 point five that we've chosen as being a really safe glucose has been really safe for the majority of the population. And since we're designing for the majority of the population, it's been very successful. So I know there are people who want to choose differently and want tighter targets. Now, when you choose tighter targets, whether it's 100, you know, some people will want 80, things like that, you're going to have to trade off some hyperglycemia. And as a product that gets approved for vast majority of patients, when you increase hypoglycemia, you are inviting adverse events, right? You're inviting possible adverse outcomes. And so you have to be very, very careful and almost ginger with that, and what that's going to mean for your patients and for the whole population. So I approach that cautiously. And I think at Tandem, we're approaching that cautiously as to how do you do that without increasing hyperglycemia? I think other people choosing those targets, you're gonna see the trade off with increased hyperglycemia. At least that's what we've seen so far. And in clinical trials,

Stacey Simms 29:56

it's interesting because people listen to this podcast generally. We are found through the research that I've done, you know, are extremely well educated, you know, very much take control of their diabetes in terms of even willing to do DIY stuff, right? It's a different population.

So as you're listening and you're thinking, well, I want to ride at You know, all day long Give me that flexibility. and wondering, you know, how do we balance that, as you're saying, with the 99% of people with diabetes, type one and type two, who may use this pump, who don't have access to the education or the time to look into it, or you know, many, many, many factors that increased that chance of hypoglycemia, as you said, but the other hand, it's a selling point. And other pump companies are already saying, we were going to be better, right? Or we're going to be more flexible. And I don't know if that's even a question for you, Molly in the position you're in. But it is something that I guess you really have to take into consideration.

Molly McElwee Malloy 30:38

You do. And I can speak more philosophically about this than I can. Anything else. But you know, particularly as a diabetes educator, and as someone with diabetes, hugging that line at 80, or 82, or whatever someone wants to do, you do have increased hypoglycemia. So the most relevant experience I have to pull from is pregnancy, right? during pregnancy, we asked people to stay, you know, very controlled, which you know, is a little bit like magical thinking, because it's very, very difficult. When you get all these hormones raging and everything going on and you're sick this minute, you're hungry, the next and all this stuff is going on, I spent a miserable amount of time and hypoglycemia, this was before any automated insulin system, right? So my daughter just turned four, so we can do the math. And she's my youngest. So I know nothing was on the market at that time, that would have helped me. But that was preventing that, but in letting me ride that really close line, have you know, let's hang out at 72 all day, at personally thought that was a miserable experience, whether it's the neural glycopyrronium, right, so your the lack of glucose to the brain where you're like, I can't remember what's going on or what I need to think about next, or you're constantly tweeting hyperglycemia. Like, it's not a trade off, I would take lightly. It's a risky trade off.

And I would say for for people who are comfortable being in that space, that's fine. And that's a very small amount of people, right. And if you can hug 82 all day, with, you know, whether it's doing some sort of low carb diet and intense exercise or what what have you, that's awesome, you're also not the majority of the population, right? So while I can appreciate that people want that, and they want to be able to set a much lower target, you know, people with euglycemia, right, without diabetes, don't have that either. People with without diabetes do have, you know, 30 40 point range, sometimes with meals and things like that happening. So it's not, it's perfection that I don't know, is a realistic ask for someone with diabetes. Now, people who can do this and do this all the time, I guarantee you, they're spending a tremendous amount of time and thought on it. Again, if you want to do that, and you can do that. And that works for your sanity, then please, by all means, but for a lot of people, you know, like, we have other things that we are going to be focusing on, and it's not going to be diabetes 24. Seven, and the goal of an automated system is to relieve some of that burden. So, you know, it kind of depends on like, Are you okay, with the trade off being low? Are you okay, with more management with being more involved? A lot of that's just going to be decisions, personal decisions someone's going to have to make, but I wouldn't say that the lower target is necessarily advantageous for a large population.

Stacey Simms 33:24

Okay, as you listen, I know, you were screaming at me to go back to bolus by phone. Don't worry. I didn't let it slip by. Let's talk about that. Because the app came out spring-ish of last year for general users. And it's great to look at people love the information. Talk to me about if you can tell us a timeline or any information about bolus by phone?

Molly McElwee Malloy 33:46

Yeah, so one of the cool things about my job is that I get to work with the Human Factors department and we have really good human factors department at Tandem. And we

Stacey Simms 33:56

stop you there human factors, because that always confused me. That means how people actually interact like how stuff feels and looks and how you actually use it,

Molly McElwee Malloy 34:03

and how you understand it. And how logical is something to you? How intuitive is something to you, you know, something as simple as changing where and the menu structure you would put something we test to see if trained, can people find this? Is this intuitive? Does this make sense to you? If we use a new term, right, we test it to make sure that it's understandable the thing might, you know, this is a very much outside of the realm of insulin pump therapy. My favorite illustration of human factors is if you you know any hotel you've ever visited, you pick up the hairdryer that says do not use in the shower, right? Like someone did that there was someone I'm sorry, yes, somebody did that. Right. There's, you know, crazy warnings if you'd like pick up a pillow, it's like you know, do not use while smoking or do not, you know, things like that, but it did happen. So that warning has to occur. So if we change something with insulin pump therapy, or we Add a feature like bolusing. From iPhone, we have to test it very thoroughly to make sure it's safe, effective, understandable and intuitive, because not everybody is going to read the instructions. So we have just completed the mobile bolus testing. And we've done extensive work, testing it in a number of different scenarios, people with type one, type two pediatrics, where they are in charge pediatrics, where the parents in charge, you know, there's a wide range of people who are using the system. And we need to test in all of those different user groups and get feedback. And it went really, really well, which was excellent, which means that it can then get submitted to the FDA. So I suspect that that will be happening somewhat early in 2021, first half of 2021. But I don't have insight or line of sight as to when that is promised. Because the FDA is so so concerned with COVID right now as they rightfully should be, and approving vaccines and things like that. So there's a little bit of a backlog there. And I don't know how that's gonna affect our timeline. But we've been working really hard to get that out. We know people want it, we know people will need it. And it will be a really useful feature. But it's been tested really well.

Stacey Simms 36:08

So and again, I'm, I get a little fuzzy sometimes on the details here. What kind of submission is this? I have learned in the last few years that there are different ways of submitting to the FDA some take longer to approve. I mean, we never know how long it'll take to approve Having said that, but there are some things that are like building on previous submissions is bolused, by phone something so new, that they have to look at it in a new way, or is it building on something you've already asked them about?

Molly McElwee Malloy 36:32

It's a good question. And I'm not part of the regulatory team that is involved in that strategy. I believe that we are building on our previous submission, since this is an on an ace pump, an alternate controller enabled pump and the and the the way that the pump is built. And the way that that is structured for regulatory purposes, is that you build upon last submissions, but I can't speak with authority on that at this time.

Stacey Simms 37:12

The other thing that we are very interested in as a household and a community is that what has been called the T-sport, can you talk about where that is in the process, and that's the tiny tube pump, I guess I would call it, I'll link a picture, if you're not familiar with it, we will link up some more information. But it's not quite a patch pump, there is still a little tube on it. But it's much smaller than the x two and it's made to be worn kind of flush or flatter to the body.

Molly McElwee Malloy 37:28

Right. And the idea behind this is that you could have a variable to be linked right very, very short tube on your body to longer where you just put it in your pocket. So depending upon the patient needs, the reason that it is still has an infusion set is that we know right from feedback that if you have an occlusion with a patch pump, you take that patch pump off and you lose that insulin right, and you lose that whole thing. If you can replace a site, and not all of the insulin that's in you know in contained to their end, then that is an easier fix for somebody, it's also less expensive. So that's something that we've been very keen to keep. And addition, the the idea that you might need a different angle set. So not everybody can use the same sets as successfully as others. This will allow us for some variety there as well. And so we're pleased about that.

Stacey Simms 38:22

And I can just jump in and kind of translate because I know you're you have to be careful about what you can say. But as you're listening, if you're wondering what she's talking about Omnipod goes in one way, there's not an angled set, there's not a steel set, there's not a different set, there are a few more options if you're using a tube pump, if the inset on the pod pump doesn't work for you. And so there's also as you mentioned, the insulin that's in the tubing, you can do I don't know if this is Tandem approved, so maybe don't listen, Molly, but you can do separate site and tubing cartridge changes when you use a tube pump, which is what we have done for years. So when he said of insulin, the pump, we change the cartridge, when it's time to change the inset, we change the inset we don't do those together. So, you know, advantages and disadvantages for each pump. I know Omnipod people love the things that are great about their pump, but those are the differences that you're talking about. Just in case you can't get into the nitty gritty.

Molly McElwee Malloy 39:11

Right, absolutely. And you know, we're big fans of choice at Tandem. So if something works for you, great, excellent. And so one of the reasons that we're so big on choices, because not everything works for every person. So this book allows somebody some choice within that. That option.

Stacey Simms 39:27

So where are you in the in the test? I know you can, you can barely give us full details. But where are we in terms of T-sport? Is it? Is it in testing? Is it is it coming out soon?

Molly McElwee Malloy 39:37

I can't speak to the exact timeline. And part of that is because the FDA is bogged in and down in COVID right now, but we are working on it. I know we're working from a human factor perspective, we're working on what the difference is going to mean for the patient and training for something like this or from the healthcare provider and training and something like this. And that's the aspect that I'm involved in, is you know, how do you train on something that's a little But different like this, and how do you change the training to adapt to that, but everything is in development. The thing about Control IQ and and even basal IQ is right there already tested. So those can be implemented in a new form factor without any problems. So that's something that we don't have to worry about. So it's more of just form and function and things like that.

Stacey Simms 40:19

Here's a dumb question for you. I have heard that T-sport is the name that you all are kind of using internally, and it may not have that name when it's released. Any update on the name? Is there an update on the name? Oh,

Molly McElwee Malloy 40:31

I am not the person that would be able to tell you that. Oh, okay. But I appreciate the question.

Stacey Simms 40:38

I think you should have a contest and you could name it, you know, pumpy mc pump face or something. But yeah,

Molly McElwee Malloy 40:43

exactly. Yeah. Yeah,

Molly McElwee Malloy 40:45

we're shorting

Stacey Simms 40:46

Yeah, surely that's perfect. I was laughing when we talked about that this summer, because it's interesting. And it's such a wonderfully privileged place that I'm in I feel like we're we find out this information. So early in the process, that the branding isn't really even set. So it's when I heard that I thought, Wow, what a cool place to be in some very interesting stuff. Right. I have a few questions from listeners for you. I know you have some more information. We're getting kind of long here. But let me ask you, here's a quick Control IQ question. And this is more advice. I don't know if you can answer this. So this person says, sometimes I like to set a higher basal in advance of when I work out because adrenaline makes my blood sugar spike, can you change that. So we can manually adjust basal rates without having to turn off control IQ, I know my body better than the software having to manually adjust with boluses after and having to guess, since I can't do them based on blood sugar due to iob issues is tricky. And I will jump in and say Molly, Benny, and I do this too, we do some guessing with the manual boluses. So I'd love to hear what you think about this.

Molly McElwee Malloy 41:49

Sure. So there's a couple different directions we can go as one is you can turn Control IQ off and on and do temp basal rates. And there's no penalty, right for doing that. There's no learning time or restart up or, or anything like that, that impact