Diabetes Connections with Stacey Simms Type 1 Diabetes

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








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May 11, 2021

After decades with just one not-so-user-friendly option, another shelf stable rescue glucagon enters the market. It’s called Zegalogue, FDA-approved and coming soon in both an auto injector and a prefilled syringe. One additional future use will be in the Beta Bionics iLet pump with two chambers – one for the insulin and one for this glucagon.

Stacey talks with Frank Sanders, President of Zealand Pharma U.S. and Dr. David Kendall, Senior Global Medical Advisor. This interview covers everything from the use of Zegalogue now to cost and a look at how far treatments have come.

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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Episode transcription below

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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 autoinjector for very low blood sugar and by Dexcom keeping you in control with an integrated system for diabetes management.


Announcer  0:21

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:27

This week after decades with just one not so user friendly option, another rescue glucagon enters the market. It's called Zegalogue, one future use will be a pump with two chambers, one for the insulin and one for glucagon.


Frank Sanders  0:43

So, with insulin being one side of that equation, when glucose does go lower, instead of simply shutting off the insulin and waiting for it to clear from the system, you have counterbalance, or the ability to counter regulate with the glucagon infusion in small little delivery boluses.


Stacey Simms  1:02

That's Frank Sanders president of Zealand pharmacy in the US, he and Dr. David Kendall, their senior global medical advisor, join me to talk about everything from the use of Zegalogue now to cost and to look at how far treatments have come. And spotting a diabetes pump in the wild never gets old. I'll tell you a quick story about what happened with us. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Welcome to another week of the show. I'm so glad to have you all here we aim to educate and inspire about diabetes with a focus on people who use insulin. My son Ben in the state is 14 years ago with type one, my husband lives with type two, I don't have diabetes, I have a background in broadcasting. And that is how you get this podcast.

Thank you for the great feedback out last week's not really a bonus episode. But second episode that I've been doing, I changed it up again. And I released Diabetes Connections in the news, many of you have already listened to it. But I'm thrilled that I'm getting reaction. I don't even mind if it's constructive criticism or just I hate it. I really would like to know what you think I'm experimenting throughout the month of May. We're going to do four episodes of in the news live on Facebook first on Wednesdays at 430. And then a podcast episode that will turn around probably Thursday night or Friday morning and get you caught up on the week's news. So please let me know we have a post going in the Facebook group as well.

You know, six years ago, I launched this podcast and I liked that I'm still experimenting with it. And I hope that you do too because the idea is just to get you good information that you can use whether it's long format like we're going to do today, or short headlines, like I'm trying with that in the news stuff. And of course we throw in some personal stories here and there. And after this interview, I'll tell you about Benny's first wrestling match and how you know we spotted diabetes in the wild.

Alright, my guests this week are from Zealand Pharmaceutical, they just got FDA approval a few weeks ago for Zegalogue. The newest shelf stable emergency glucagon, you know, it really is incredible when you think about it the last 40 or 50 years more than that all we've had for emergency glucagon has been the stuff in the red or orange emergency box, the kind that you have to reconstitute yourself you know, and studies show that most people even those trained you don't use it very well especially under stress. And now we have three options vaccine me and G vo hypo pen and Vega log. You're going to hear from Frank Sanders. He's the president of Zealand pharmacy and Dr. David Kendall. He is their senior global medical advisor Frank Sanders has been in the pharmaceutical industry for more than 25 years. He has been with a company called therapeutics he's been with Johnson and Johnson's pharmaceutical arm many of you are familiar with Janssen pharmaceutical. He's been with GlaxoSmithKline and Dr. David Kendall has held many leadership positions in the diabetes community including at mankind at Lilly at the American Diabetes Association and at the International Diabetes Center in Minneapolis. Dr. Kendall and I also go way off topic toward the end because he served as a clinical investigator with the dcct and edic trials here homeless tourists will remember those evidence based on hope episode, which is one of my all time favorites, I will talk about the DCC T and edic trials at the drop of a hat. And I was so excited that Dr. Kendall can too

Okay, quick disclosure gotta tell you, your competitor to this product is a sponsor of this show. In fact, I'm about to read an ad from them. But as you know, Diabetes Connections is here to help you get information about the diabetes community and I don't limit who we talk to because of who spends money on advertising. Now on the flip side, the advertisers are also on board with all of that so I give them a lot of credit to longtime listeners are familiar with all of this, but just in case, I like to talk about it every time and let's keep things on the up and up.

Okay, let me tell you then Diabetes Connections is Brought to you by Gvoke Hypopen and our endo always told us that if you use insulin, you need to have emergency glucagon on hand as well. Low blood sugars are one thing, we're usually able to treat those with fast acting glucose tabs or juice. But a very low blood sugar can be frightening which is why I am so glad there's a different option for emergency glucagon. It's Gvoke Hypopen . Gvoke Hypopen is pre mixed and ready to go with no visible needle, 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 and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit gvokeglucagon dot com slash risk.

Frank Sanders, Dr. Kendall, thank you so much for joining me today. I'm really interested to learn more about this. I appreciate you being here.


Unknown Speaker  5:50

Thank you. We're glad to be here as well. Yeah. Thanks so much,


Unknown Speaker  5:52



Stacey Simms  5:53

You got it. So Frank, let me start with you. If I could just, you know, to give us an overview a little bit. We've never talked before, if you could kind of catch me up on what Zealand is all about. And then we'll talk about Zegalogue.


Frank Sanders  6:05

Yeah, sure. Thank you for the question. I appreciate it, Stacy. So I'll start by saying that Zealand is a global biotechnology company and a world leader in peptide therapeutic development. Well, it may seem like a new company, the company was actually founded in 1998. It is headquartered in Copenhagen, Denmark. And we have our US presence and our company in our corporate office in Boston in the seaport area. So the company has approximately 330 employees worldwide. And our we believe our distinguished advantage is our unique peptide platform that allows us to design and engineer highly innovative peptide and peptide like medicines for, you know, for multiple conditions. So we have a 20 year legacy in r&d and peptide therapeutics, and we're very proud of what we've delivered.


Stacey Simms  6:50

Can you take just a second and I when we hear peptide on this podcast, we just think about that C peptide test, right? That helps figure out if it's type one or type two diabetes, what does a peptide therapeutic be?


Dr. David Kendall  7:02

I'm happy to take that one. And Frank, please feel free to chime in. But Stacy, a peptide in the common ones that I'm sure this audience knows about are things like insulin, glucagon, or modifications there. But they are very simply the proteins. In the body peptides generally referred to proteins which are made up of these building blocks we call amino acids, usually up to 25 to 50 of these amino acid segments plugged together glucagon, which we'll be talking about today, and LC glucagon is made up of 37 of these building blocks. So peptides that are commonly known are just those proteins that circulate in the body or makeup, the structure of the body.


Stacey Simms  7:46

Alright, let's talk about Zegalogue. I think most of my listeners are familiar with the concept of needing emergency glucagon sometimes, but tell me the specifics about Zegalogue

Frank Sanders  7:56

So the clinical profile Zegalogue  is compelling. And we are actually out in active dialogue with payers right now. And we have been in dialogue with healthcare professionals and patients around the profile through market research before we execute a full product launch following approval. And the approval of Zegalogue is based on the results from three randomized, double blind placebo controlled controlled phase three trials, that's a mouthful in both children and adults with type one diabetes. And what's marketed and notable about Zegalogue is the median time to blood blood glucose recovery of 10 minutes that we've seen across all three phase three trials. More specifically, in the phase three trials. 99% of adults recovered in 15 minutes in the main adult trial, and 95% of pediatric patients recovered and 15 minutes in the pediatric trials. So So we believe the dialogue offers patients and caregivers in an important new choice for the for the management of severe hypoglycemia, which is a condition where minutes obviously matter, so we're eager. So the launch the product, in just over a month and late June,


Stacey Simms  9:02

didn't take me into that study a little bit more in terms of how low people were, if you can share that.


Dr. David Kendall  9:09

Happy to do that, Stacy and as Frank mentioned, glucagon, the native peptide or protein that many people have known about, and I'm sure many of your listeners are familiar with has been around and available for treatments since the 1960s. But what Zegalogue and dasiglucagon the active molecule was able to do is make modifications in that peptide chain to ultimately lead to chemical that we felt was suitable for development that went through those clinical testing programs that Frank talked about, and specific to those trials to bring this forward as a medication that could be reviewed and approved for the treatment of severe little bunch of blood sugar, or what we call severe hypoglycemia required that in controlled fashion, taking volunteers, courageous and really volunteers to whom we are incredibly grateful to use an insulin infusion, so give insulin in their vein in a controlled way, bring their blood sugar below a specific level, usually that level is 70 milligrams per deciliter or lower, slightly higher in the studies with children, and do that in as controlled away as possible, then stop that infusion of insulin. And this is really meant Stacy to mimic what might happen in an unexpected, unanticipated severe low blood trigger event. And those individuals then are given a dose either of placebo medicine, or in the case of these studies, Sega log and its pre Approval Form dasiglucagon, and then in those same trials, not for direct comparison, but just to understand what the world was familiar with, we also gave selected individuals, the traditional glucagon from the emergency kit that many people may know, which is the one that requires that it be reconstituted, mixed up, drawn back up in a syringe and then given so the studies took experimental, low blood sugar, let's say on average, the value is just below 70. Got the dose of medication. And then we measured the so called time to recovery that Frank talked about which in all of these trials was how long it took to see that number no matter where it started to come up by 20 points. So a very consistent measure of recovery time. And as Frank said, the median time to recovery was 10 minutes across each of the three larger phase three trials. And you looked at the 15 minute time point, which is a very important one for watching loved ones recover and making sure that they either are responsive or another dose of medicine can be given 99% of adults, 95% of children had recovery


Unknown Speaker  11:55

in that time period.


Dr. David Kendall  11:56

So very important to understand how the trials were done. But ultimately, it led to our review and approval as a treatment for severe low blood sugar.


Stacey Simms  12:06

Wow, I appreciate you going through so thoroughly, I have a couple of questions, because I have a couple of friends who have gone through clinical trials for products like this. I don't know if they were specifically in this one. But as you said, You don't just sit there and say, Okay, give me all that insulin, no, I'm gonna go low. You know, we really have to thank those people. But you mentioned some of them got a placebo. So I know it was a safe environment. But what does that mean? Like they just sat there and went low for a while?


Frank Sanders  12:32

Yeah, I'm always amazed the Food and Drug Administration, their regulators are thoughtful and cautious about how these studies are designed, we are as well, in placebo, obviously, is done only in a controlled setting where we understand what the potential risks of giving, essentially, no therapy might be. But knowing that in these studies, as I said, Even though zega log is approved for the treatment of truly severe low blood sugar, these were not patients that lost consciousness couldn't manage for themselves, but in a controlled setting where we could give them an intravenous injection of glucose if we needed to, or ultimately rescue them with safety glucagon administration, these were individuals who had to understand that they were going to go low, probably feel something they felt before not necessarily feel comfortable, and then know that there was a chance they were getting just saltwater sailing, or potentially getting one of the other two therapies. And obviously, they were monitored very carefully. And we didn't allow this to go on, you know, indefinitely. They were ultimately treated either with glucose by vain or given something to eat.


Stacey Simms  13:42

I'm curious to, again, I appreciate you letting me go down this rabbit hole. There is an interesting conversation all the time in the diabetes community about letting those go. And I know some of you, as you listen gasped. But I mean, there are some times where you'll sleep through a low or you'll just won't notice although you know, you're 7075 and then you'll, you'll float back up because your liver has kicked in it. You know, I'm curious, I know, this wasn't what the study was designed to do. But was there any information from the placebo folks of them kind of recovering without treatment?


Right back to Dr. Kendall answering that question. But first Diabetes Connections is brought to you by Dario. And the bottom line is you need a plan of action with diabetes. We've been lucky that Benny's endo has helped us with that and that he understands the plan has to change as Benny gets older, you want that kind of support. So take your diabetes management to the next level with Dario health. There are published Studies demonstrate high impact results for active users like improved in range percentage within three months reduction of a one c within three months and a 58% decrease in occurrences of severe hypoglycemic events. Try Dario’s diabetes success plan and make a difference in your diabetes management. Go to my forward slash diabetes dash connections. For more proven results and for information about the plan now back to Dr. Kendall, answering my questions about those that kind of resolve on their own.


Frank Sanders  15:13

So the the proportion of people who recovered with placebo therapy was extinguishing Lilo, I will say, at least in the 15 minutes time period, by 45 minutes, either they had recovered or we allowed them to recover. I know a bit more about this, because I spent my early years of research doing these experimental low blood sugar studies. And your comment about letting the logo is not something I certainly would advise as a health care professional, but it does happen. And the risks if it's not a severe low, are often you know, an inconvenience or disrupted sleep or in some cases, complete lack of awareness. The risk there, Stacy is any low blood sugar makes a subsequent low blood sugar more likely. And the typical symptoms and responses that the body has, will diminish when the body has seen multiple episodes of low blood sugar. It's as if the body's saying I've seen this before, I'm going to quit warning you and treating it. And that, as we've learned over time is one of the risk factors for an unexpected and more serious and severe hypoglycemic event. So I would not recommend letting the logo


Stacey Simms  16:24

be either, I want to be very clear. But it is something that is discussed. It's not as though that's something that to be very clear as you listen and to you all to, it wasn't something I said in that I endorse it. It's just that it does happen. And we see that sometimes you don't treat a low and sometimes it bounces back. So I didn't mean to imply that we should be twiddling our thumbs while our kids are low.


Dr. David Kendall  16:48

Right? And you're absolutely right, the body does maintain some of those defenses as ecolog. What we're talking about here is there for those circumstances where the defenses are no longer adequate, someone loses consciousness, the ability to care for themselves. Alright,


Stacey Simms  17:05

let's let's get back on track here. Again, thanks for following me down that rabbit hole. And I'm always fascinated by studies and the process. Frank, let me ask you what so what is this is tell me a little bit about the product itself because we have other products on the market. Now you mentioned already the rescue kit that needs to be reconstituted, there's a nasal spray, there's a shot.


Frank Sanders  17:22

Now this was this is so second log is indicated for the treatment of severe hypoglycemia, and pediatric and adult hit and adult patients with diabetes. Ages, six years and above, we're going to be launching it with two forms available. We're one of those is going to be an auto injector a single dose auto injector and the other will be a single dose prefilled syringe, but both of which can be used immediately without requiring reconstitution that may allow for easier use at that moment when it's needed. And so you know, that really at a basic level, that's that's core to what what Zegalogue is. And we again, believe that based on the clinical study that David David has talked about the study data all three is that what distinguishes like a log is really the the median time to recovery of 10 minutes across all clinical trials and the consistency of response rates and adults in pediatric patients again, referring back to the data that David presented. So we're eager to introduce this product again and a couple short weeks here and offer this begin to offer this to patients and caregivers alike.


Stacey Simms  18:25

shelf life, you know, do I need to put in the fridge? Can you speak to that?


Frank Sanders  18:28

Very good question. So I'll talk a little bit about the storage and stability and David if I if there are details to add, please add but Zegalogue has a three year total shelf life when stored in refrigerated conditions in once removed from refrigerated conditions that can be kept at room temperature for up to 12 months. So stability and storage conditions of Zegalogue provide for options for people with diabetes, you're at risk of severe hypoglycemia to have this available at home, you know, in the refrigerated conditions for up to three years or out of you know, refrigerated conditions, either at home or away from home for up to a year and event that it's needed. So we believe that these dual storage conditions will be attractive to the lifestyle of patients with diabetes


Stacey Simms  19:12

couple of years ago, gosh, was it ready for the pandemic It must have been in the fall of 2019. So not too long ago, I ran into Ed Damiano of beta bionics and asked him you know what's going on? How are things and you know, they've got their own, we're actually talking to them in a couple of weeks. So let's talk about this as well. But my understanding correct me if I'm wrong, is that this is the brand of glucagon that they want to put in the dual hormone pump down the line. I don't know how much anyone can speak to any of this. So feel free to say no, because I know it's it's not coming. Now, this is not what we're talking about here To be clear, but this is one of the most anticipated developments in pump therapy. And I'm curious, can you speak to this is that correct?


Frank Sanders  19:57

Well, let me tell you this and then David, you could you can add to this as well. as you see fit, but yes, I mean that's a glucagon we consider this a platform therapy, you know. So obviously we're launching dasiglucagon in the form of Zegalogue as a rescue therapy for severe hypoglycemia. But it's the first of a long string of other potential launches with dasiglucagon. In the future you had mentioned, the partnership that we have in place with beta bionics that what I will say is that it's a great partnership, we're very pleased with the progress that we're making with this program, as we near the initiation of phase three trials. And so you know, everything is really moving forward at a steady rate there with that partnership. And we also have the David can touch on as well with dasiglucagon a program and place for use in congenital hyper and hyper insulin emia as well. So so the product itself is being studied for multiple applications to benefit multiple patients, not just with severe hypoglycemia, but with other with other specialty and rare disease areas. So it's just the beginning, if you will, it's like a log is this really the beginning for the use of the molecule much, much more to come over the next three to five years. Like Frank said, we're


Dr. David Kendall  21:05

really excited to be in the partnership with beta bionics I had in his team dasiglucagon is the platform and that Frank described, we see it as helping us leverage opportunities across what we call the hypoglycemic spectrum. So testing it, we hope in weeks and months ahead in phase three in the bio hormonal we call it artificial pancreas, the bionic pancreas, with beta bionics, but also for other hypoglycemic disorders, some in the setting of diabetes, like small doses that may be used for exercise or during illness, where it's not an emergency situation, all of these are planned investigations, but not yet part of the approved use of Zegalogue. Similarly, the condition, Frank alluded to congenital hyperinsulinism, where children are born with the dysregulated continuous secretion of insulin, so it's not diabetes, but they suffer recurrent and significant hypoglycemia, then there are very limited therapies. Thankfully, it's an ultra rare disease, but one that is really want for better therapies. And similarly, there are other health conditions where unexpected low blood sugars occur outside of the setting of diabetes. And we think because of some of the unique characteristics that deci glucagon has the stability at room temperature that it can and we hope will be applied, certainly in clinical studies, we hope in the future for patients with some of those conditions.


Stacey Simms  22:38

So it's interesting a couple of weeks ago, maybe a couple months ago, now we spoke to Leo Brown, who was on The Amazing Race, we will he lives with diabetes, I guess, but he has congenital hyperinsulinism. And his they basically removed most of his pancreas. And is that the kind of thing you're talking about where this would be an alternative treatment for somebody like that, perhaps?


Frank Sanders  22:57

Precisely. And so that's one of the approaches, historically to this condition, congenital hyperinsulinism was to remove the offending organ, the pancreas, which, as you witnessed, will leave somebody living with insulin deficient diabetes, so a form of type 1 diabetes that's surgically induced, but it was one of the only available therapies, we feel like that see, glucagon. And other approaches can counteract that hyperinsulinism, particularly in the youngest children, where there are the greatest dangers for these low blood sugars. And we hope either limit the need obviate the need for surgical interventions, and add to the tools that pediatricians in particular can use to manage this incredibly challenging disease.


Stacey Simms  23:45

And just back if I could to beta bionics, can you share anything about Gosh, I feel like we've just been waiting for this for a very long time. In terms of how it works. I know that, again, that's in clinical trials coming up. So you can't talk about a lot, but I'm just trying to picture what I you know, we fill the insulin pump with insulin, then we just fill the other chamber with the gun. I mean, it just to me seems so revolutionary. I'm trying to kind of parse any information that you can share with us.


Dr. David Kendall  24:10

Yeah, it's you're spot on Stacy. It's basically a two chamber pump. So think of how current insulin pumps are programmed. And in fact, with the hybrid closed loop systems, they were tied to continuous glucose monitoring to adjust the insulin delivery and those systems that have that capability. Add to that the same sort of functionality, but with glucagon, or in this case, dasiglucagon infusion that is regulated by the pump and by the glucose measurements. So with insulin being one side of that equation, when glucose does go lower, instead of simply shutting off the insulin and waiting for it to clear from the system, you have counterbalance, or the ability to counter regulate with the glucagon infusion and small little delivery boluses just Like insulin does for higher glucose is so similar to and in fact managed in much the same way as the insulin infusion for high glucose. The glucagon chamber and infusion wouldn't give those doses as glucose values declined, or were at certain levels,


Stacey Simms  25:15

if they're a second inset on the body for that I can't imagine goes to the same inset as the insulin.


Dr. David Kendall  25:21

Yeah, so So all of that is part of the development process. Obviously, these are two separate hormones. And one of the components of dasiglucagon, as Frank talked about is it's, it's stable in this so called aqueous solution, which for you will need that saltwater, the things that circulate in the body. So you know, while in theory, they could come through the same system, the plans in place, and the previous studies have been done with two separate fusion sites. But again, connected to the same pump system. So yeah, there's some sophistication involved. And I think back to pre CGM, when people said I have to wear this device now people often do quite well wearing two devices, their CGM and their pump. So depending on the ultimate design and approach to this, we certainly see the clinical promise as being something that's very encouraging. And then overcoming those engineering and technical challenges will be part of what faces our team with the beta bionics team. Really interesting. I


Stacey Simms  26:22

can't wait to talk to them to to get more information. Thanks for sharing what you could I appreciate? Absolutely. Let's talk about cost and access. What is this going to cost? I mean, I know that a lot of it depends on insurance. You started out by saying you were talking to payers, it's so sad that that's the first thing we have to talk about.


Frank Sanders  26:38

That's a good, it's a good question. These are obviously obviously amongst the first questions we always get when we're launching any product. So so we our strategy, from a pricing perspective, is the price Zegalogue at parity meaning add or are the same as existing products on the market? And we've based this strategy really on the value that psychologic provides? I think you're the bigger question is, is it going to be accessible for patients at launch. And you know, and really, that's, that's the reason why we are out actively engaging managed care customers today, both at payers and pbms, and Medicaid providers. And so I'll share that the the conversations have been have been very good that the profile Tagalog is being received very favorably, and we do expect to have favorable accesses, that is ecolog. At launch, that will continue to build as with any new product launch that will continue to build and improve over the first six months of launch. And I think as as you know, Stacey, from our conversations a little bit earlier, as I'm a caregiver myself, in my in my life, my my wife is been, you know, suffering for from stage four cancer for a number of years, and she's doing doing very well. But we we every day, interact with the healthcare system, and really have to think through barriers to access, whether that those are financial barriers or barriers to delivery of the product through specialty pharmacies, and we are really designing our patient support capability at Zealand. With that in mind, meaning, how do we make sure that when we're launching a product, we're able to provide the resources and forms of financial assistance and other resources to help address any sort of access barriers that may exist. So so there's really don't become transparent, so do we, so to speak, or, or, or a barrier for patients. And it's not just things like financial assistance, we are also putting programs in place to be able to make access easy in terms of product acquisition and distribution, for example, by looking at at home delivery solutions and other things so so we really are going to roll out a patient support system that is really fit for launching a product like this, in this error today where we also have to worry about COVID. So we're ready to go on all fronts in that area.


Stacey Simms  28:50

And we'll link up information as it comes out on patients assistance and access and things like that. But I'm always curious. And I I know the US health system is very complex. But why budget parity, why not launch and say we're gonna be $30? Less? How come nobody ever launches and says we're gonna come out and we're gonna make it affordable out of the box?


Frank Sanders  29:09

Yeah, I mean, we we look very carefully at multiple different pricing options and research it very carefully before we make a decision around it. And the price that we choose, really any company chooses. But in this case, I'll just talk about what Zealand does is the one that we that we think is going to ensure that we are going to get the best access possible for the product at a price point that that is representative of the value, the clinical value that the product brings to the market and that and that really led us to a parody pricing strategy, not a premium pricing strategy, not a discounting strategy, but one that is at parity with the rest of the market. And you know, again, based on the feedback that we've had in advance of setting the price and after setting the price and discussing with managed care organizations, we feel that we got it right.


Stacey Simms  29:56

Yeah, but you didn't get that from patients with all due respect. I can't imagine a patient said that's the right price.


Frank Sanders  30:01

Well, I think if we ask anyone, any consumer about about the price of the medicine, you know, the will will always get the response of, can we why that can cannot be lower? Can it be lower? That's absolutely fair.


Stacey Simms  30:14

Before I let you go, as I was looking through everybody's bio here, David, I can't let you go without asking you about the diabetes control and complications trial and the edic trial, I love to talk about these studies. I have I talked to a lot of parents whose children have been diagnosed, you know, recently, I run a very large Facebook group for Charlotte, North Carolina area. And I always say like, you've got to look at these these amazing trials that were done years ago, that show how much better things are getting. And I would love to just, I don't even know what I want to ask you. But I would love to give you the floor to just say that we didn't even know that a one c mattered, we didn't know the control made a difference. And to me, the edic trial is the one that shows me how much things are getting better. I do my right on any of that.


Dr. David Kendall  30:59

And well, you're talking to a very biased audience of one in me. So I grew up in the dcct edic era, I started in diabetes research in 1981, just as dcct was kicking off. So I've been either close to or seeing patients in dcct edic, through its entire history. And we're now 40 years out from the start of that trial. And yes, absolutely. These are 14 141 of the most courageous, incredible people who committed literally decades of their life to helping us understand what benefits may come from improving glucose control, particularly early on in the course of type 1 diabetes. And what I love is that many of these are patients I know to this day who are celebrating their 17th and 18th birthdays, I'm in the setting of type 1 diabetes. And unequivocally dcct, in my mind is one of the 10 great research studies in medicine, it demonstrated the benefit of having blood sugars as well controlled as possible, as early in the course of diabetes as possible. and maintaining that for as long a period as possible that I always catch that by saying, you know doing it as rationally and safely as possible. And what we're talking about here today, meaning severe hyperglycemia was first really made evident to us in the dcct. where, you know, on average, every patient had a severe event per year during the study, because we were working so hard to control glucose. So it ties back to our topic. And yeah, for the next three and a half hours of this podcast. I'd be happy to add more if you'd like. Frank will never invite me back. So


Stacey Simms  32:48

Oh, no, no. Okay, wait, one more question about the dcct edic. Is there a follow up? Will we get another one of all these people soon? Or is it kind of


Dr. David Kendall  32:58

it continues to this day, and there are various components to it, it is much less thorough and intensive in terms of the follow up, but the 30 and soon 40 year follow up of those patients has been and will be published and presented as the years go ahead. So this is the study that probably will only end when we run out of investigators and individual volunteers for the study.


Stacey Simms  33:26

I gotta say I look at those studies. And I'm so glad you mentioned the brave and wonderful people in them. Because that has my son was diagnosed right where he turned to 14 years ago. And what they have done, has changed his outcome. It's just fabulous. So thank them next time you see I'm telling Stacy and Charlotte. Before we finish it, was there anything about that video segment that we didn't cover?


Dr. David Kendall  33:48

Yeah, I'll close and then toss it back to Frank. But I think one of the things that first attracted me to Zealand but also the work around Zegalogue is that hyperglycemia really remains one of those conundrums, one of the rate limiting features of managing diabetes most effectively, and bringing forth the two legs Zegalogue to help patients have the peace of mind make a plan for when the unthinkable might happen, a severe event. And doing so with the data that we've talked about where you have this very rapid and reliable response to Desi glucagon and the clinical trials for this, like many other emergency therapies, you don't want to have it, but you certainly want it on hand if you need it. So all of that, to me is central to what we're doing, not just with the clinical studies, but with the clinical launch of Zegalogue.


Frank Sanders  34:43

Now very good. I would just just close by saying what excites us about this launch in particular, is that there are 4 million people in the United States with diabetes on multiple daily injections of insulin and these patients are at higher risk of having severe hypoglycemic event. And despite the fact that there are 4 million people in the US with diabetes on on multiple daily doses, only approximately 14% of that population is prescribed a glucagon rescue therapy. So So what's been interesting is and positive is this is with the introduction of newer innovative therapies over the last year and a half, two years, more people are becoming aware of these treatment options, and the market is growing by by 10%. And we believe that that's really just the beginning is the you know, having Zegalogue in the market, that's yet another innovative option has the ability to further grow this by increasing awareness. And we're excited about the positive impacts effect that will have on patients and their caregivers.


Stacey Simms  35:44

Well, Frank Sanders, Dr. David Kendall, thank you so much for joining me and explaining all this. I really appreciate you spending so much time with me. Thank you.


Announcer  35:56

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  36:02

I will link up more information about Zegalogue. And about the DCCT EDIC trials as well. And if you haven't heard our episode, evidence-based hope, I highly, highly, highly recommend it, especially for newer diagnosed people and families. It's not just a look how far we've come kind of thing. But it also puts in perspective, a one see numbers, things right now that you can do to live a long and healthy life with diabetes. And it doesn't mean that you need to always have you know, a super low A1C I think especially as parents, we often lose track of the happy, good life thriving with diabetes, because we're so focused on getting that that time and range and those super low a one season those trials really put it in perspective for me, and what you need to really live well. And it's not what a lot of people on Facebook, what have you believe in just a second, I want to give you an update on how Benny's doing and wrestling has started. And oh my goodness,

but first Diabetes Connections is brought to you by Dexcom. And it really is hard to remember what things were like before we started using Dexcom. I had a woman asked me what was our plan for kindergarten. And we were still a good four or five years away from Dexcom at that point, so it's really interesting to look back because it is so different. Now we were doing something like 10 finger sticks a day when Benny was going to kindergarten. I mean, even when he got older, we still did at least six to eight every day more when he wasn't feeling well or something was off. But with each iteration of Dexcom we've done fewer and fewer sticks. The latest generation the Dexcom g six eliminates finger sticks for calibration and diabetes treatment decisions. Just thinking about Benny's little worn out fingertips makes me so glad that Dexcom has helped us come so far. It's an incredible tool and Benny's fingertips are healthy and smooth, which I never thought would happen when he was in kindergarten. He for glucose alerts and readings from the G6 do not make symptoms or expectations. Use a blood glucose meter to make diabetes treatment decisions. learn more, go to Diabetes and click on the Dexcom logo.


Aren't if you've been listening for a long time or you follow me on social media, then you know that Benny is finishing up his sophomore year in high school and he started wrestling when he was a freshman he got injured right at the beginning of the season. He tore his meniscus. And he was out for the 2020 season, which was right before COVID. They were able to get a full season in and he was part of the team. He was like manager and he went on crutches to every match. And he was pretty incredible season they won the state championships for the first time. It was just a really fun year, but he had to sit on the sidelines. So that was kind of a bummer. But he is back. He's worked really, really hard. And of course with COVID they kept putting off the season. And we always thought there is absolutely no way there's going to be wrestling. So he actually went out and got a job. I've mentioned before he got his vaccine, he's at a grocery store. And he's been working really hard. And so when wrestling came back, it was kind of a tough decision to make. But he was able to work it out with his work schedule. And this kid is so busy, and they had their very first match.

As you're listening it would be last week. So Benny had his very first you know, match. But that's not the story. I want to tell you what was amazing. And by the way, I can't watch wrestling. Do you watch wrestling if your kids wrestle? I can't watch any sport my kids play because I'm the loud mouth mom. So I'm always the one like trying to look at her phone. So I'm not screaming I'm not being rude. I'm not not paying attention. But I'm shockingly I have comments. So I try to keep them to myself. But wrestling is just so gross. It's so rough. I can't stand it. But they come out on the mat and the ref comes out and he's like you know our loved ones with clean Theodora and I'm looking at the ref and I immediately Look at his belt line because there's a T slim pump. He's wearing a T slim next to you know, it's right on his back. And I was sitting very close. So part of me wanted to yell like, excuse me. Hello, sir. But I didn't do anything. I didn't say anything. I did take a couple of pictures which was probably very inappropriate, this poor man, but I couldn't help myself. It was so exciting. They faced two different schools. So it was the match that He was in and then there was another match. They didn't wrestle in, and my daughter had just come home from college. So after that first match, I said goodbye. I said, Okay, if I go and I left, I went home because my daughter, Lea, I haven't seen her in a while. So I wanted to run home to her. And I couldn't talk to the ref, because he went from one match. Immediately, he crossed the gym and went to the other match. Then he came over to kind of talk to me as I was leaving, and I told him and I, you know, it wasn't sure if he'd be like, Mom, it's so lame. You know, who cares. But he lit up, he was excited, and he wants to go say hi, but it was just such a busy night. And these reps are just working, working, working that, you know, as I said, I didn't get a chance to talk to him, but he didn't get a chance to talk to him. So I'm hoping that we see him again, as these wrestling matches go on. But hey, if you're listening ref in Mecklenburg County, North Carolina, drop me a line. And thank you very much for not noticing the bananas lady behind you taking pictures of your back.


Before I let you go quick note I will be speaking at the camp Nejeda event survive and thrive. That is on June 5. It's a virtual event. We are looking forward to friends for life in July, I will be there I'm not sure in what capacity as a speaker yet waiting to hear from them. Because it's very different this year, far fewer speakers, but I will be there as a vendor. So I hope I can meet at least some of you. And please join me tomorrow. If you're listening as this first drops on Wednesday, May 12, as I'm doing every Wednesday in May 4:30pm. Eastern on my Facebook page Diabetes Connections i will be doing in the news, my newscast that I'm trying out and then we'll turn that around and drop it as podcast episode. They're very short. My goal is to make them not only less than 10 minutes, hopefully less than eight or seven minutes. I'm really trying to keep it very tight and just have some headlines. But the top stories of the past week, all types of diabetes really be useful for you to make it bite size make it relevant. So let me know what you think. Thank you, as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here in just a couple of days. Until then, be kind to yourself.


Benny  42:19

Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All rounds avenged

Apr 28, 2021

Ben West was a key organizer and architect of Nightscout and OpenAPS software. Even after all of the DIY and commercial development of the last ten years, he says we've barely scratched the surface of removing the mental and physical burdens from people with diabetes. Among those burdens, he says, is what he calls the onus to bolus - the responsibilities of diabetes that even the most advanced current software can't totally relieve.

Ben is now the CEO at Medical Data Networks which has launched its first venture: T1 Pal. 

Read the Nightscout email Stacey mentioned (click here) 

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

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Episode Transcription (rough draft) below

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Stacey Simms  0:00

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


Announcer  0:21

This is Diabetes Connections with Stacey Simms


Stacey Simms  0:26

this week talking to someone who is deeply technical, but also deeply thoughtful, who has been an incredible part of the Do It Yourself movement over the last 10 or more years. But who says we've barely scratched the surface of removing the burdens mental and physical from people with diabetes. So welcome to another week of the show. We aim to educate and inspire about diabetes with a focus on people who use insulin. I am Stacey Simms. And yes, this show is already a little different sounding here at the top no big intro or tease. And that's because my interview with Ben West is massive. It is very long. It is the longest one I have done so far on this show. But it is well worth your time.

I am so excited to bring you this interview with Ben Ben West was a key organizer and architect of the Nightscout and open APS software. He is now the CEO at medical data networks which has launched its first venture T1Pal, I think Ben influenced or work with or sometimes both just about every person I've talked to under the we are not waiting umbrella. And if you're not familiar with that, if this is your first episode, welcome, but we are not waiting is kind of the rallying cry that became a hashtag back in 2013. And if you are new, I use it as a keyword you can search for it all one word, we are not waiting over at Diabetes and see every episode that has featured those incredible do it yourself, people the community that really rallied together and push the technology side of diabetes forward, I believe many many years ahead where it would have been otherwise, as I said, it is a very long interview. But you know, it's a podcast, listen in chunks. Stop, start, you know, however you want to do it. But please, I really hope you'll listen to Ben because he has so much story to tell and a lot of thoughts on how diabetes care really needs to improve.

In the short time since I spoke to Ben, there has been a bit of a discussion within the Nightscout group about his business. It is part of an ongoing debate about the future of Nightscout and the future of open source in type one, Ben has the full support of the night scout foundation. In fact, they sent out an email on that and some other issues. And I will link to that in the show notes. I think it's a very good read. In addition to touching on this issue, it is a great way to catch up on what's going on in that space. So we'll get to Ben West in just a moment.

But first Diabetes Connections is brought to you buy Gvoke Hypopen . And you know when you have diabetes and use insulin, low blood sugar can happen when you don't expect it. That's why most of us carry fast acting sugar and in the case of very low blood sugar, why we carry emergency glucagon, there's a new option called Gvoke Hypopen, the first auto injector to treat very low blood sugar. Gvoke Hypopen is pre mixed and ready to go with no visible needle in usability studies. 99% of people were able to give Gvoke correctly find out more go to Diabetes and click on the Gvoke logo Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke slash risk. And this is a good time to remind you that this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Ben, it's great to talk to you. Thanks so much for jumping on and sharing some time with me and my listeners.


Ben West  3:55

Oh, thank you, Stacey. I'm happy to be here. Thanks for inviting me.


Stacey Simms  3:59

I'm not even sure where to start. I have so many questions I want to ask you and there's so much history here. So maybe we just start if you don't mind. Back in college when you were diagnosed. You were student right? You were young adult.


Ben West  4:12

Yeah, I was a college student when I was diagnosed and I had all the classic symptoms where I you know, I was going to the bathroom a lot and just didn't know what was happening. My diagnosis story is I went through this for probably a week and one night I realized I had gone to the bathroom like seven times in the one night and I realized that means if that's once an hour like what sleep did I get last night. I'm nowhere near eight hours of sleep. This seems like a serious problem. So I went to a health clinic in my college town. And they said well, you're a skinny young adult, so we don't know what's going on with you. Maybe you did eat something and you didn't tell us I wasn't eating anything either. And they sent me home with some pills and said call us in two weeks. Someone through the grapevine heard that that didn't sound quite right actually came and interrupted one of my music lessons and said, you know, you need to go to the hospital there. Oh, wow, they're expecting you there. So I went to the hospital, and they checked me in over the weekend and diagnosed diagnosed me with type one. Wow,


Stacey Simms  5:13

you were lucky, right? Lucky that they interrupted your lesson there.


Ben West  5:16

Yeah, you know, I mean, I've heard a lot of stories during the work that I do. And yes, as diagnosis stories go that I you know, that's pretty mild. Yeah,


Stacey Simms  5:26

I guess I should ask you some technical questions from the very beginning. What were you using? I assume that in 2003, you didn't immediately start tinkering with an insulin pump. Right? You You went on a more traditional routine at the start?


Ben West  5:38

Well, I actually had to drive 45 minutes to clinic and Little Rock house in a different part of Arkansas going to college. And I had to drive 45 minutes to get to an endocrinologist and the endocrinologist at that time that I thought I was lucky to be getting into the specialist where they actually deal with, they actually specialize in diabetes here. And I met with the nurse, the PA, and the representative from Medtronic was actually in the room. They actually said, You seem like a smart young lad, we'd like to get you out a pump as soon as possible. And it turned out as soon as possible was like nine, you know, nine months later. So I went through the whole syringes and shots and meters and got on the on the pump. But at that time, they actually told me Yeah, the benefit of going on the pump is dispenses insulin automatically. And in the future, we're going to have CGM. There's some CGM already in the works. Those will be here sometime. And then when you get the CGM and the pump combined, it does like all these things together, right, like so I understood right away what they're talking about in that office very early on. Okay, you got you can measure glucose, and you got this pump. And in theory, it should be doing all of these things together. At that time, they even said, You know what, they even have a patient in California right now, it's got a fully implanted version. So sometime in the next five years, we're gonna have a fully implanted CGM insulin pump combo, it'll do all the work for you. This is all just temporary. That's what they told me.


Stacey Simms  7:01

2003 Yeah, just to be clear, though, Ben, the Medtronic rep was in the room with you at your doctor's appointment?


Ben West  7:09

Yeah. Wow. You had some introduction? I was actually I was glad they were honestly, that certainly seemed to be the, you know, take these pills and call us in two weeks approach.


Stacey Simms  7:20

Sure. Yeah. It also beats a bunch of other people who had their doctor say five years to a cure. I mean, yeah, you know, there's a lot of really bad ways to be diagnosed and to have those first conversations, but man, that's fascinating. Who was the person in California who had an implanted pump and CGM? What was this like, fantasy made up? No,


Ben West  7:39

I think I know, I believe him. I, I've toured the Medtronic facilities, again, during the work that I do, and they've invited me over, and they have a hallway of all kinds of awesome stuff that, you know, never made it to market or, you know, there's a lot of cool things that go on behind the doors. I'm still using a 515. I think that was in 2008. So certainly, I I'm a big believer in what they do. There is a lot of potential that I think is clearly been untapped behind this technology.


Stacey Simms  8:12

So fast forward nine months, you jump on to your insulin pump. It's not hooked up with a CGM. At the time I would assume.


Ben West  8:19

No, it the CGM didn't exist yet. Yeah, it wasn't on the market. Yeah.


Stacey Simms  8:23

What was your experience? Like with the pump?


Ben West  8:25

Oh, it's okay. It's fine. I preferred it to the shots. But everything's got trade offs. Right. I had at the time I, you know, was going in or wasn't music major. And I so I had performances that are assessed as part of my official grade. And, you know, I'd go in for these performances, and some one of the teachers would tell me hide that thing. You know, they had wires hanging out, right? And I told him, you know, I'm not trying to hide anything, I shouldn't have to hide it. And he told me, You shouldn't show it off. I thought, wow, here I am going for a performance. And that's, that's the last thing I want to be thinking about right now. Sheesh,


Stacey Simms  9:00

did you win that fight? Or did they make you hide it?


Ben West  9:03

If you're a college student working for a grade? Yeah, you're gonna, you're gonna put it away real fast, right? I mean, that's terrible.


Stacey Simms  9:11

What made you start thinking about tinkering with stuff? Because you started doing that on your own is my understanding, right? This was before you met a lot of people in the community that you started, I don't want to say taken apart, I'll let you tell the story. But you started doing this stuff in 2008 2009,


Ben West  9:28

the winter of 2009 into 2010. I remember that's when I started with a different focus. Actually, I don't know if you've talked to Scott hanselman at all, but he's, he's known. He's known for saying that every person with diabetes ever, right? The first thing they do is they start working on on something less less than the burdens here. And actually, that was true, right? As I was diagnosed, I had some experience as a computer science minor with some programming, and often my side projects, and I remember I built a dashboard. Actually, in 2003, right after I was diagnosed, that allowed me to enter in all the information into a database, right? Because I was walking around with, you know, three by five index cards, trying to write down all these carbohydrates and insulin injections. And it was getting really tedious. But I did that for years with pen and paper and pencil. And I thought, surely, why are the doctors giving me a hand drawn curves on napkins? Like, what is that about? Why are they sketching on these pieces of paper and the way that they were explaining this to me in the hospital, I thought they were going to show me a full on simulation that showed how my body was working. I've been watching too much Star Trek.


Stacey Simms  10:44

Well, you know, I'm with you. We expected things like that, too. When you said you made the dashboard. What did you use for the interface? Was it computer was it?


Ben West  10:53

Yeah, it was this was before web 2.0. This was all PHP and HTML. And I realized I was horrified. At the result, I realized I was never going to use it. It was a wall of inputs, where it's just like tons of inputs. And I wrote for times, and dates and readings. And I realized there's no way I'm going to use that. Look at it. Why would anyone use that. That's why I'm going to use pen and papers, because they're the software for this is very difficult. Then web 2.0 happened, there's a bunch of things in the 2000s, as we approached into 2010, that I, you know, I graduated school, I got into industry moved to San Francisco, the hardest Silicon Valley doing, you know, web dashboards for companies, professionally, where we're really solving people's problems where if you have this complicated problem, you can share the link with a view of that problem, and the tools for solving that problem with someone else. And that ability to share that link made the possibility for solving problems collaboratively possible in new ways, transformative ways that really fundamentally change the workflow for solving problems. So that idea really got into my head professionally, as we kind of approached 2009 in 2010. I had tried my first CGM about five years later, right, so around 2008. And the experience with that CGM was was not great. I had to go through insurance, right, they said, I had to get a new insulin pump to get to the integrated system that would read onto the insulin pump. The insurance said, we're not going to pay for that for this new one. And not only that, but according to our policy, you should never have gotten one. So that seems like an issue. Yeah. So it took us It took another nine months, right. And, you know, it goes to the appeals board. And the appeals board comes back and says no insurance, you should, you know, that's medically necessary, she should pay for it. So I finally got the pump in the CGM. And like a lot of people that I see on social media that are excited by the promise of the benefits of this new technology, I tried to really make it work for me, right, I got all the glue out. Skin all louder than the adhesive and I got the I got it covered, right with all the contact stuff. And then I'm going out for yoga, right and it's hot, and I'm doing you know, bendy stuff. And you know, you take off your shirt is a lot of people do. And then you're in a shirt, you realize you're the only one with like all this stuff. And it's like, it's not just one thing, it's the air, you got your pump over there. And he got your CGM patch over here. And it's like, it's not working out like at night. It's itchy. You know, it tickles. Except it's not tickle, it's you realize it's, it's itchy. And then you realize to your heart that that's actually the chemical burn that's happening with adhesive in your skin. And then the things alarming and I'm getting sick of the readings, I get data, what they call data overload, right where it says 240. And I feel like you know, I don't feel very good. And I take a bunch of insulin. And then, you know, an hour later says, well, you're 230 or whatever. So I don't like that. I still don't like that. So I'm going to take even more insulin. And then yeah, three hours later, you know, your doubt at 60. And the things reading 110. Right. And, you know, you're really not feeling good. This thing, made my life a mess. And I decided I'm gonna have to quit. And I was horrified that I was not going to use this thing that I had gone through so much effort to get to this point to be able to use it and that I wasn't going to get any benefits out of it. And the slap in the face for me as someone that was working on these on these systems of systems that were connected through the internet, and seeing the innovation take off and seeing the technology transform, collaborative decision making. The slap in the face for me was that this data was stuck on this little two inch display in my pocket. And there was like there was no way to get that data where other people could see it or like my doctor could see it where like app developers could put it into the simulator and make a simulator if one was missing, and 2009 and 2010 that really didn't sit with me anymore. So I thought apparently I have some skills here. And, you know, maybe I should try applying them just to see if I can get a time series. You know, wouldn't that be neat? If I can just get a little time series, you know, off the device that I use? Wouldn't that be kind of neat?


Stacey Simms  15:11

All right, I'm gonna stop you there. But as the time series,


Ben West  15:14

just the normal chart that we see where we've got data points along some time. So you've got three hours of time on the chart, just like we see with any other glucose traces data, you've got one dot every five minutes. And that happens, because you get every dot that you see is one of those data points. If you can get a bunch of data points over time, you can generate that time series.


Stacey Simms  15:37

Now I know a lot happened, you know, in those years between 2008 or 2009. And then 2013, when you started a tight pool, can you take us a little bit through that time, how you met people how you got connected with the diabetes community?


Right back to Ben answering that question. But first Diabetes Connections is brought to you by Dario. Health. And you know, one of the things that makes diabetes management difficult for us that really annoys me and Benny isn't actually the big picture stuff. It's all the little tasks adding up. Are you sick of running out of strips, do you need some direction or encouragement going forward with your diabetes management with visibility into your trends help you on your wellness journey? The Daario diabetes success plan offers all of that and more No more waiting in line at the pharmacy no more searching online for answers. No more wondering about how you're doing with your blood sugar levels. Find out more go to my Dario comm forward slash diabetes dash connections. Now back to Ben answering my question about how we found and got connected with the diabetes community.


Ben West  16:48

I need to get more serious about my problem solving. And that means if I want to help, as soon as it seems to get a lot of ground to cover, so if I need help, I need to ask a well formed questions in a targeted way. And I thought, you know, if I need help, the people that can help me are probably other people with diabetes. And so I started looking around on all kinds of social media, I was on to diabetes, for the really early platforms, and several others, there's diabetes has that and there was there are a couple of organizations before Twitter was even really becoming popular. So I kind of reached out on some of those and found some people disagreed with the things that I was expressing they, some people thought that I should just feel grateful for the devices that I had.


Stacey Simms  17:28

I remember this, there was a lot of movement at that time, because I was on some of those boards to where it was, Hey, you know, it's it's okay for now. Like it's better than it was we're not testing with urine. We're not doing right. We're things are changing. Why do you want so much data? He was an interesting time. I didn't mean to interrupt you. But I remember that.


Ben West  17:47

Yeah. It's interesting that for you to say that, thank you for remembering that that really puzzled me. It emphasized for me How important was to frame the right questions. Partly because of that those disputes, I started really focusing on the advocacy of data access. And that became my touchstone issue. Well, up until very recently, I would say, well, I've shifted recently towards embracing language matters a bit more. One of the things I've learned over the last 10 years, I think, is that language matters. And in this data access issue, are actually the same issues with the same solutions. And we will get into that. But


Stacey Simms  18:23

yeah, we'll definitely talk about that. And just trying to, you know, to kind of get the timeline here, but yeah, so you, you've got this really interesting movement within the community, but it's a small part of the community. As I said, I was there. I don't think I grasped it at all. I mean, I had a little kid, my son was a toddler at the time, you know, he was diagnosed in 2006. So I was getting into all of this, but I was definitely more of the rah rah cheerleader, kind of let's do the Big Blue test. If you remember to diabetes, you probably remember that rather than how can I free the data because we didn't have a Dexcom or a CGM for many years.


Ben West  18:53

So at that time, right at the time, I was already familiar with things that have happened in the tech world, the things that, you know, the worldwide web, the web technology that we use, has gone through this where there's lots of companies involved, some of them compete. And in fact, I remember on one of my job interviews, I was shocked to hear the interviewer say, Oh, yeah, we're partners with the, you know, these other people. I said, Wait a minute, are they competitors for this other product? And they said, Yeah, you know, we compete and we cooperate. We do both, you know, it's not, it wasn't an issue in other industries. And somehow innovation that that's unlocked. Now, we have finance, we have healthcare, we have every sector of life we do online now. And if you're not doing it online, it's because you're doing it on your mobile. And actually, it turns out that's done online also. Right, yeah. Behind the scenes. And so that's the same transformation that I saw happening everywhere, regardless of the problem space of even for the most complicated problem spaces. And so I knew that what we need the thing that made that possible on the web, and on the internet on the web, it was Use source. So any web browser that you have, there's a function where you can go in and edit. And you can say view source. And it shows you all of the source code that's used to present that web page for you. It turns out that that's a critical part of that innovation to market pipeline, because more people are able to access the data that makes the thing go, that DIY access, if you will, for the web, that view source that allows anyone to get access to it, that does a couple things. One is that it gives more people access to making things and that network connectivity is what allowed a lot of innovation that we see, in 2008. Nine, that's when I started talking about data 2010. And yeah, through 2013, I started to code switch, which means that I talked about data in the most austere terms possible, in order to attract those other folks that already understood how important that was. So that together with them, I could look to build this ecosystem so that people would start to get it, I knew that if we could deliver a couple of applications that utilize this open architecture, this open ecosystem, the feature set would grow, the popularity would grow. And that would start to shift the things that people were talking about that people would start to talk about, we want access to the data so that we can get things like this, we want access to the data so that we can have bring your own device, we want access to the data so that we can get these innovative systems on the market more quickly.


Stacey Simms  21:37

So put it in perspective for me if you could, one of the touchstones that I come back to again and again, is that D data meeting in 2013? That diabetes mind and Amy tendril put together where we are not waiting was written on the whiteboard. Where were you during that time?


Ben West  21:54

Yeah, I was in the room. There are about a dozen folks in the room. Sarah creepin. Was there a Jana Beck was there, Joyce Lee? Was there, Amy tedric was there? You know, Howard look was there late despereaux. Was there john kostik. And, you know, a bunch of Brandon arbeiter, a bunch of those core typu folks were there. The takeaway, as it's been said many times before, was, you know, john kostik, was there talking about how he had utilized this technology to get some benefits for his son, that was his big story was I really care about my son is my job to deliver these benefits, I'm going to do it somehow, whatever it takes, that's what I'm going to do. And Layne came along and said, You know, we've got this experience with operator fatigue, in control rooms with complex processes that never shut down. And here's the things that I've learned. And here's the display that I put together, and I call it nightscout. And this was before, what we now think of as nightscout didn't really exist. This was before that this was like when there were separate pieces, and like different projects, everyone was just blown away by nightscout. In particular, this idea of what john was doing, getting the data and what Lane was doing, having a really smart interface for it, that and having it operate in real time gave us a really crisp, clear vision of what are the kinds of benefits that we should be talking about that we should be expecting that we should be seeing in the next 12 to 18 months? What is it feasible to make technically. And it turns out some really cool things were technically feasible.


Stacey Simms  23:26

When I speak to people from the DIY movement, or you know, whatever you want to call it. When I talk to you folks, over time, I have learned never to really ask well, what do you do? Right? I know, it's very, very collaborative. And so I stopped asking that question. But I would like to know, if you don't mind, could you share kind of what you were working on? Well, that's


Ben West  23:47

first t data, I was tide pool had just gotten started. So I was actually employee, I was one of the very early employees tide pool. So I was working with tide pool as an engineer trying to launch the MVP, our very first shipping product, we were trying to get that up off the ground from prototype and into production. So I was spending a lot of time on that. On my own time, I was spending a lot of time you know, the reverse engineering stuff, I was spending a lot of time really focusing on on Medtronic pumps, I realized that there were a bunch of devices. And I thought about the network of each kind of device needing some code to work with it. And I had a piece of code for every type of device. And so I was focused kind of on that making sure that I was framing Well, well formed questions, putting them out there saying here's a project just to talk to the Omnipod. Here's a project just to talk to the Dexcom. Here's a project just to talk to the pump. And then here's the thing that can kind of use them all. here's here's some of the title stuff. And so I didn't actually have access to CGM myself, I didn't actually have access to a lot of working stuff. What I had access to was my own research on my pump stuff, which was my main focus and then I had already started networking out and contacting Layne and these other folks, you know, Scott Lybrand and Dana Lewis, meeting all these other folks, and not just in diabetes, you know, for example, Dave bronkart and Hugo compost, I met them going around doing things, advocacy work on data access and privacy and sharing, I would meet those folks and connect them also to the diabetes folks saying, not only is this a unique problem in diabetes, getting your access to your data in healthcare is a problem in other disease states as well. And now what I've come to learn is not only does it affect healthcare, it affects other industries as well. It affects the agriculture industry. Right now, there's a huge issue in the agriculture industry, with farmers not being able to digital tractors and farmers not being able to get their data off of their digital tractor and where it used to be just like the syringe and it used to be a mechanical pump. It used to be a simple mechanical device that anyone could learn about and do it themselves right in front of them, it was obvious how it worked. And that is one of the risks with the adoption of digital technologies. without some support. Without enough documentation, it may not be obvious how it works. So after that D data in the winter, spring started to come around the next year, and I wound up leaving tide pool around April. Now Brandon arbeiter from typo was my roommate at the time. And I remember that about a week after I left tide pool he actually came home with with a bag full of goodies, he came home with a new SIM card, a new cell phone, and he showed me his laptop. And he had all these emails with like source code attached and instructions and websites. And actually, it was kind of a big mess. But I was very excited because this was for the first time all of the pieces in one place. This was the legendary nightscout rig finally in my hands, so I knew exactly what to do. I helped him set up nightscout. I didn't have a working CGM at the time and setting him up with nightscout was actually what convinced me to start using a CGM again, because when I quit, I decided I'm never going to use a CGM. Again, it's not worth it for the discomfort and the quality of life until I can control the data until I can get the data off with nightscout. that possibility came true. And so Brandon came home with that rig. And I helped him set it up. And then I helped set up a bunch of other families. And I converted those emails and those attachments, I converted those into a set of webpages for the very first time, and organized all of the source code. Again, on GitHub, which is the social coding site, I organized all of those projects into well framed projects, the way that programmers would work with these things very, very natively. Very idiomatically. And so I put those up on the web on GitHub, and started calling people over to them. And I showed James wedding and Kate Farnsworth, and Christine dealtrack. Some of these folks, I showed them the new web instructions, and actually walked them through for the first time, once people were able to go on the web, and do a Google search and find it and get all of the instructions in one place. That's when the installs really, really really started taking off. That's when the Facebook group went from 100 to 1000s. And the rest is history right?


Stacey Simms  28:35

down. And this is probably a good time to just say that. I've spoken to several people from the the we're not waiting community, and one of them is Jason Adams, who tells the whole story of the Facebook group, and you know, that community and how that came to be. So we'll link that up for sure. and a bunch of other information. But I remember that too. And it just seemed like he was unbelievable to some as in like, wow, we can finally see this and can you believe we can do it, you know, ordinary people. And you know, you do need to, you know, get some help, but you can do it, you can do it. And then there were other people in the community saying, I can't believe we haven't been able to do this until now. Like I knew we could do this. Like, it was very funny to see the people who really understood kind of the back end of things, at least from my perspective. And once that ball started rolling, it seems like it was just moving really quickly. It was a very exciting time. Do you remember it as one?


Ben West  29:24

Oh, yeah, I mean, tide pool had a one of their global, they pull everyone from across the globe in the area everyone saw about once a year. And so I got to see a bunch of those folks again, and they were all hanging out. And I remember we were on Facebook just watching Facebook blow up. I mean, they're the posts were coming in, he and your grandson was watching this thing. We mocked up little videos of like, here's the next step that we're going to make an automated system with, you know, this is just the beginning and we didn't post it but we were just in awe of the energy that was coming. In behind the post describing nightscout. I mean, here we have what's essentially a webpage. And there's so much momentum behind this project that people were saying things like we're paying it forward, they were saying things like, we are nightscout. And I've never been part of a technology project where people start identifying as the project, I expected the conversation to change, I laid a lot of a lot of stepping stones in place, to enable the conversation to change that we can speak clearly, as people with needs that are unmet, here's what our needs are. But I did not expect people to identify that I am this products that really blew us away.


Stacey Simms  30:42

I'm gonna come back to that, because I think diabetes is very personal. And it was one of the few times where people felt like they not only had a stake in it, but they were also being heard. But I do want to ask you, we've done lots of episodes on nightscout and openaps. And please feel free to jump in if there are things that you would like to share. But you mentioned when we were prepping for this interview testifying for I don't even know how to say this testifying for the 1201 federal DMCA exemption hearing.


Ben West  31:08

Yeah, that's right, is that? Well, like I said, one of the things I started to learn, when I started talking to people, what I would code switch into the data governance language, I started to find that there's other people working on this. There's academics, there's people in other industries, and there's legal scholars. And it turns out, FDA has a role in a lot of what we do in diabetes. But it turns out, there's other regulators that deal with other parts of life, the Library of Congress regulates certain things. And one of the things that they do is they manage these 1201 hearings, our carve outs are ways for the public to say, here's this regulation that exists. But I want to testify to get relief from the regulation that does exist, and the regulation in question, this concept of DMCA, the Digital Millennium Copyright Act, and in part of that regulation, has to do with the technical protections, the technical protective measures that manufacturers place inside of their devices, and the consequences for attempting to manipulate that device, potentially to overcome such a protection. Now, the issue here is that this is a technical means that some firms use to make it difficult to get the data on a very practical level, the one of the things that they can do is they can say, well, we're putting a technical measure in place so that only authorized users can get access to the data. who's an authorized user? Well, the manufacturers, of course, is the patient an authorized user? Well, maybe maybe not. Right? That's kind of the debate that's still playing out to this day. One of the exemptions that I went to testify for was that for medical devices, if what you're seeking to do is to get a copy of your own data, there should be no penalty for doing that. And that exemption was granted. Pardon my ignorance,


Stacey Simms  33:03

is that exemption granted for you? Or was that something that was more blanket for


Ben West  33:07

the Americans, all US citizens,


Stacey Simms  33:09

you think that would be front page news? That's amazing. Very, very cool.


A lot more ahead with them. But first Diabetes Connections is brought to you by Dexcom. If you are a veteran, the Dexcom gs six continuous glucose monitoring system is now available at Veterans Affairs, pharmacies in the United States, qualified veterans with type one and type two diabetes may be covered. picking your Dexcom supplies up at the VA pharmacy may save you a lot of time to connect with your doctor for more information. Dexcom even has a discussion guide you can bring with you to your doctor, get the guide, find out more about your eligibility go to slash veterans. Now back to my conversation with Ben West.


What is nightscout? Right now? No, the commercial offerings have changed a lot. He was title submitting loop to FDA. What is nightscout as a service offering right now or is that even the right word offering?


Ben West  34:20

So do you want to know about nightscout as a service, or just nightscout? What is nightscout as a whole?


Stacey Simms  34:25

What is it right now? What is it? Like? How do you define it right now? Because it's not the rig? Is it still right? It's not like you're plugging into this into that. I mean, what how it's kind of changed in the last few years. So I guess I'm not sure what I'm asking. I pardon my ignorance there. But


Ben West  34:39

when you bring up the rig, you say what is your asking what is nightscout? right now and you mentioned, you know, for example, it used to be the rig.


Stacey Simms  34:46

That's what I think it was nightscout is I think of people printing a case for this for that and then and then you got to be careful because the wire might break at some point.


Ben West  34:55

Sure. So I think of nightscout as kind of two things. There's the philosophic Typical version of nightscout. And then there's like a piece of software that also exists, right? So and what I mean by that is there's the nightscout ecosystem, right. And this includes the people that are using nightscout. It includes the coaches, the school nurses, the teachers, the clinicians, the parents, the guardians, the caretakers, and the patient's themselves, right. And so there's this thing, that is the network of nightscout. And then there's a piece of software. And in fact, there's a whole bunch of pieces of software and devices, right. So there's the cgms, whether it comes from Abbott, or from Lee Ray are from Medtronic, right? There are the insulin pumps, whether they come from Medtronic or maybe Tandem or maybe Insulet, in the United States. And then there's other kinds of devices, too. There's like cloud devices, right? So some of your Dexcom data goes to Dexcom Cloud, some of your Medtronic data goes to carelink, Medtronic cloud. And so nightscout, there's a lot of ways for data to exist in the world of devices, connected devices that data can come from. And then there's this central hub in the cloud. And that's the piece that usually I think of as nightscout. When people say, Oh, I'm going to go file a bug report on nightscout, or developer says, I'm going to go fix a bug on nightscout. Really, they're talking about this cloud native piece of software that draws the graphs that provides you with a web page, the API that all of the other devices then connect to, right. So that forms when all when you have multiple devices that are talking to nightscout, all of a sudden, you have this nightscout network. And the thing that we think of as nightscout is what I like to think of is that cloud piece of software right in the center of it all.


Stacey Simms  36:44

So this might sound silly for someone who hasn't used it, or doesn't really understand what is nightscout. in that setting, as you mentioned, what is it used for? How does it help somebody with diabetes,


Ben West  36:58

one thing a lot of people talk about is data governance, being able to control your data. And that's certainly true, I have found that the most profound thing I have found is that it's really this, this concept of sharing, when you invoke the buddy system in your life, you know, as you travel through life, is it during the transitionary events, when you start a new therapy, when you have a special day, and you want some help, and that these are the kinds of things that people are sharing, it used to be when we first started nightscout, almost 10 years ago, seven, seven years ago, it was all about let's at least share what we know about the past. You know, let's share the alerts and alarms. Those are retrospective, right, you have to have past data to generate an alerting alarm. And that's kind of like current and past data. And people would use that the classic use case there that that made the news was when parents go to the office, and the children are going through the school day, and maybe going through mixed authorities and different just different realms of concerns across as they travel through life. What we have found since then, is that it's not just the retrospective data in terms of keeping current that people want to share. It's actually every aspect of diabetes. Surely, if you had the technology and the power, to share your alerts and alarms with me, surely you can share the tools to help me prevent those alerts and alarms. That's where the future is going is we're gonna see services that allow sharing, not just alerts and alarms, but managing every aspect of diabetes as we transition through every phase in our lives. So this is a really exciting time to be in because nightscout is years ahead of some of the big vendors here, providing feature sets for all of those things.


Stacey Simms  38:47

It seems like that's a good segue into medical data networks. Can you talk about what that is and what the goal is? Sure.


Ben West  38:54

So I've always been interested in this concept of the power of networks. That's one of the things that really got us interested as we started building out the nightscout ecosystem, making sure that we could talk to connected insulin pumps, making sure that we could talk to connected CGM, and talking to people about the data governance and the technology required to do that. In the past, I worked for a company called muraki. They made software defined networking. And that means if you've ever used Wi Fi in a public space, like Pete's coffee, or an airport or something like that, my software has protect your privacy, govern your use of the network govern the speeds at which you can use the network even govern which sites you can visit. And this is very complex techie stuff, but we made a simple dashboard that allowed people to share the process of managing that experience. This is old hat for us. So we created this company medical data networks. What we want to do is wrap up and respect all these years of innovation that have happened in the DIY space and we want to make Set the norm. We don't think that any of this is controversial at this point, the idea that you'd have remote monitoring, the idea that open source would be a fertile ground for the innovative wetlands, right? Some people like to call it. And so that's part of what we're doing. And so now we're offering nightscout as a service. And we make nightscout. press button easy. And we're working with the FDA to make sure that we can operate it fully compliant.


Stacey Simms  40:28

That sounds to me like you're trying to offer kind of a DIY the nightscout for people like me who, when many others who were you know, reluctant to do DIY stuff? Is that what the service is? It's a Is it a paid service that I can kind of this is an awkward way to say, like commercialize or make simpler what nightscout has been?


Ben West  40:48

That's right. So we want to offer Nightscout as a service and reduce the barrier to entry, make the entire experience much more reliable, predictable and consistent. And we want to increase the benefits of remote monitoring for everyone, whether that's caretakers and parents or temporary guardians, or whether it's just people that just want to find their diet buddy on social media and share it with them.


Stacey Simms  41:10

Thank you. So tell me a little bit about what T1Pal


Ben West  41:13

is? Sure, I'd love to. So T1Pal is our first product from medical data networks. And it leverages all the experience that we had building nightscout. So T one path is Nightscout as a service. So you can think of it as the easy way, it's a new way to get started with nightscout. And it eliminates all of the server and database administration and DIY craft. So it makes it as easy as any other platform where you simply sign up, you pay for your subscription, and you have access to all of the benefits that Nightscout brings.


Stacey Simms  41:46

Is it on the app store? Is it something that people buy? How do they get


Ben West  41:50

Dutch the website to one, you


Stacey Simms  41:52

can go on your browser. Either commercial products have kind of caught up I mean, I can remote monitor my son with a Dexcom. And you know, t slim or Tandem has an app that is on my son's phone. And I guess eventually I'll be able to see that Omni pod is sharing more, what makes this one better?


Ben West  42:11

Well, there's a lot of things. One is the if we go to the connectivity piece, right, this idea of interoperability, and the idea of bring your own device, when we talk about sharing, there's a the base level that I start with is bring your own device I want to share with myself, I want to share I have this Samsung or Apple or whoever created a brand new thing, you know, last week, it's a shiny new thing, I want to go get that and bring that into my therapy, that's going to be part of my system. Now, that's really tough for a lot of these vendors I've been just I've been it's ago, I was looking at a brand new error that someone posted that I've never seen before on, you know, a Dexcom app. And it says it's incompatible in some brand new way. So this idea is really tough for the classic manufacturers who developed these really austere quality systems, right, and those quality systems control for change in the system. And the idea is you want to control your own destiny, and eliminate any possibility of variation. And so in a lot of these systems, what that means is we're going to test on exactly these versions. And anything that we add to that means increased workload that we have to go test. And so we create these haves and have nots. In a world that moves as fast as the one that we're living in where bring your own device, bring your own connectivity, this is the norm. Now, I think the industry, we just need more help, we need more players that are experts in this kind of connectivity in this kind of interoperability to make to satisfy the customer's demands. That's really the area that we specialize in is this idea of Bring Your Own Device connectivity. So that's one and then the other is this idea of sharing a lot of these systems, they're built for that initial use case that we discussed, where it's really oriented around the concept of the nuclear family. And you we know you have exactly these many family members and exactly these roles, and that's the way it's gonna work. Or if you want something else that starts to not work very well. You know, if you want the school nurse to have access during school hours, that doesn't really work very well. The idea of sharing, does it really require installing patient? Or is there a web app that works on any device? Those kinds of things, I think Nightscout still has a really compelling advantage. In addition to all the features, she talked about all the watches, there's more than 20 watch faces just for Garmin for Nightscout.


Stacey Simms  44:44

Right and that's just the one brand Garmin there's the all the other ones the Apple Watches smart, the Google wears, etc. fitbits when you see their watch faces, you still need your phone, right? Has anybody gone direct from Dexcom transmitter to phone yet is that maybe some You're working on?


Ben West  45:01

Oh, no, I, I can't say much about that.


Stacey Simms  45:03

Can you confirm it's really hard because that's what I hear from my friends in the DIY space that I've been bugging for five years about this.


Ben West  45:10

What I will say is that this idea of interoperability and connectivity, the idea that you're actually operating a network networks and decentralized systems operate on fundamentally different rules than closed systems that are composed of one unit. And device manufacturers specialize in kind of making these one units or boxes of units at a time. And they fill the shelves with those units, this mode where you start operating in a network with multiple devices that are connected, and you have decentralized emergent behaviors, this is a difficult area. So a lots of technologists that I've worked with agree that nothing's impossible, it's all software, we can make it do anything. But it does require willing participants that are collaborating.


Stacey Simms  45:54

One thing that I have found of talking to you over this time is you're very generous towards the commercial systems, you know, there is no, and I think this is very genuine, there's no bashing, you're not trying to put anybody down, it seems to me and you can correct me if I'm wrong here, this is how I feel. So maybe I'm projecting that there is a really important place for these commercial systems with their very, you know, big, you know, simplicity, they have to be able to be used by a vast majority of people with diabetes, they have to be understood by clinicians. But there is this also really, really important DIY focus that we've seen over the last almost 10 years now. And I do think that I wish there was more cooperation, but they are almost complimentary. And when they're both needed, am I off the mark there? Or am I kind of reading between the lines that you may feel a similar way?


Ben West  46:42

I agree completely. Stacy, what we have is a market full of people with this inhumane disease, right. And this inhumane disease demands all kinds of things on our time and our resources. And because it's inhumane, there's a lot of needs. Now, these companies solve problems in consistent and reliable ways for people. And that's what we need, we need to all as a market, we need a functional market that's working efficiently. That's providing high fidelity health care that provides a reasonable return on investment in terms of the fidelity of care, the more resources that we spend health care and wellness, we should be seeking a return that yields the kind of fidelity commensurate with the spend, right. So in diabetes for a long time it was you could go try and try and try. And you could try as harder and harder and harder as you'd like, a day to day may not be the same, you may not get the same results. And so trying harder is perceived as not worthwhile. Because there's no feedback loop that provides the yield that's required. I think that what we have is a world that's changing with technology really, really fast. And we have an ethical imperative to use that technology in humane and equitable ways. I open sourced all of this software when we got started, because for me, that was part of this, the scientific methodology of it all is someone else should be able to take this software and debug it audited, etc. That was a really important working principle. For me. That's exactly what we need is we need a working process and all of these domains, we need innovation happening. And we need a pipeline that can deliver the benefits of those innovations in an efficient way to the most number of people possible, as quickly as possible. And why? because as we know, this condition, this intensive insulin therapy is just an inhumane condition, it demands too much. And so I'm imagining a world where we can work together, we can have a bolus free up lane free therapy, we can have Bring Your Own Device connectivity, and have full remote control, we can have the supercomputers and the the networks and the people that are connected to our devices and our data work in a collaborative way to prevent repeated hype hyperglycemia repeated insulin reactions, and we can use that data equitably and humanely to deliver high fidelity healthcare. And


Stacey Simms  49:08

that's the vision. You've talked about diabetes 2.0. Is that what you're referring to?


Ben West  49:14

Well, that's an idea. I've been workshopping. I'm hesitant to use the numbers for all kinds of reasons. I have talked to people, not just children and parents, I have now talked to people that have had type 1 diabetes for 40, for 50 years. And they are telling me that this network effect that we have created is one of the most powerful things that's that's happened in their lives. I don't know how to respond other than to try to do more. We've got feedback now from parents and children from people in their middle age and from people that are now experienced 4050 years with diabetes, telling us that this has had such an impact that everyone This should be the standard of care for everyone. And I think When we look at what we're doing today, we're still in the early days, we still haven't really optimized for the next gen system where people are really living their lives really free of the blame and stigma. You don't have the blame for getting a bolus wrong, or for carb counting wrong. Because either because you can share it with someone, you can share this complex dosing decision as it transpires right, you can share it with your buddy, you can share it with an expert you choose, you can share it with someone you trust on demand, or someone could do it for you. That's what we're seeing it for a lot of these parents in school, now it's run day, or it's Testing Day, and the parent can manage all of that stress remotely. That's where we're going even with automated systems. That's what we're seeing. Because the demands as you travel through life, the demands change, and sometimes it's fine to coast and let the machine handle it. Sometimes it's necessary to find, invoke the buddy system and find a friend. Yeah, you know, you've


Stacey Simms  50:57

mentioned a couple times now bolus free blame free. Can I ask you just to kind of dig in on that a little bit more, because I love that concept of if you aren't deciding to give yourself insulin for a meal or for a high, if you can't mess it up? How can you feel bad about it? And I think when you're an adult with type one, or if you're a parent making decisions for your children about this, this guilt, this mental health part of it is so overlooked.


Ben West  51:22

You're so right, Stacy, I call this the onus to bolus Yeah, the onus to bolus so what we've done is we've made out of necessity, we have a system of intensive insulin therapy that requires multiple daily injections. That's been the standard since the introduction of insulin. And then more recently, continuous subcutaneous insulin injection, right? See a society that's classic pump therapy for a brief while we saw the introduction of what's called sensor augmented therapy, sensor augmented pumps, which is where you pair the glucose readings with the insulin pump. And then more recently, we have the introduction of these automated insulin dosing systems, hybrid, full, etc. What all of these systems do is they help address the symptom of diabetes, which is high, uncontrolled glucose. And insulin is the mechanism that we have to bring that glucose back down and under control. It's amazing that this works at all, I sometimes just marvel at how incredible it is that we can manually take this missing hormone insulin, and just dump it in the body almost anywhere, it seems. And it works in the sense that it does provide this temporary relief of controlling that glucose, as we know that balance is extraordinarily difficult, because it is our responsibility to get that right. What happens is, if you get it wrong, it's kind of your fault, especially if you've been given a calculator where your job is you just have to put in the right number. And you know, the calculator will spit out the right number for you. And now it's your job to carb count, or count the number of fat and then deduct the fat and link out the number of fiber and the deductor fiber. And then by the way, for the delay, you know, due to other effects due to the fat, or any alcohol on board, anything like that, or because of sickness or you know what, maybe not feeling well. And actually, you lose your carbs, right? after you eat and you lose the carbs, it just becomes so tricky. One to even know when it is you're going to eat to know how much it is you're going to eat. Three know how that's going to digest. And we could go on and on and on all day about the trouble with this thing. But the problem is, when the language comes up for how we talk about this, we talk about Did you get it correct? You know, we use the words like correction factor, we use the words like correction bolus. I've heard parents actually talk to their children and say go correct yourself. And I've never had that experience, because I was diagnosed in my 20s. But the experience I have had, and this was in my 30s, I was doing exercise in a class and I had an insulin reaction. And you know, I had to take a break out of the class, I really wasn't feeling well, right. And it's really, it's never pleasant when that happens for so many reasons. But one of the biggest is always you're just you're othered you're not part of the group doing the activity anymore. You're often in this weird thing. And often it's involving bloodletting in front of everyone, right? I mean, this is not good. And then so I'm having this conversation afterwards about, you know, here's my CGM. Here's my pump. And, you know, this instructor goes well, Oh, isn't that great? That is doing all that for you. Great. So the reasonable person when they see all of these devices, they're expecting it to do all of this already. Right? That's that's the reasonable person's expectation. I had to have a 15 to 20 minute conversation explaining, well, no, it doesn't really work like that. I have to take the CGM number, I have to guess if it's right. I have to get some blood to make sure. And then I have to do this thing. And then you know, I have to take the right I'm out. And the response right away, this still affects me was. So does that mean you just did up? When I explained how the mechanics works, the onus is on me the onus to pull this is on me to get it right. And the entire system around this is designed to make sure that it's not anyone else's fault. As it should be, it should not be anyone else's fault. If it's going to be someone's fault, it should be mine. But the entire system is designed to dock the way that you interact with the doctors, the therapy that they start you on is designed so that they're not going to kill you. They don't want to kill you. Yeah. And it's designed to just keep you alive, and they'll try to figure things out. You know, after that, let's keep you alive. First, the way that design happens in manufacturing with these vendors, I call it defensible design. It is designed so that they will not be held responsible for something going wrong. That's the way that it's designed.


Stacey Simms  55:53

It's interesting, because so many thoughts flashed through my head when you were talking about those things in terms of blame a lot of parents and I speak on this to try to get them to stop, but a lot of parents call the a one c visit to the endocrinologist their report card, you know, it's mom's report card. And that's a really tough way to look at this. But I understand why. And another thought I had was when we started with control IQ, about a year and a half ago now, I was just gobsmacked on how many decisions it makes it can make something like 300 decisions a day and how we were and I say we because you know, I mean, Ben, he was diagnosed at two. So I'm still going through the process of saying his diabetes, not our diabetes, so forgive me. But you know, he's a once he went down, his time and range went up. But it really showed me how there was no way for me as a parent of a toddler and a little kid and a middle schooler. And there was no way for him as an individual to keep up with that machine. And that machine couldn't even be perfect. And I got to tell you, well, it was frustrating to say okay, the machine can be perfect. It was so freeing to be able to say I had no chance, if that makes sense.


Ben West  56:58

That's why I chose the word inhumane stage, is when you see what it takes for success, you realize you didn't stand a chance. And we have to find ways other than blaming each other. We have to use technology and in this in this way to make this possible.


Stacey Simms  57:15

Thinking that way, then, let's talk a little pie in the sky here. Obviously, Dream stuff with technology isn't gonna happen next year, or maybe even the next five years. I don't know what the timeline is. But what do you want to see? I mean, can you give me some, and I'm going to put you on the spot, but maybe some concrete examples of how that bonus to bolus could be lifted?


Ben West  57:35

Well, there's, there's a number of ways to address this. You mentioned other technologies, other therapies, there's certainly so many capabilities, we're adding to our tool belt, whether that's new therapeutics, I've heard of people taking other hormones, other injections, supplementary injections, that that seems to really work. Well. For some folks, we've got faster insolence coming relatively soon, some folks are working on, you know, micro dosing, glucagon. And then there's there's other types of therapeutics as well. So there's all kinds of things it's really difficult to know, a lot of that is out of my wheelhouse. I'm a software person, I know how to manage cloud, we know how to do transformational services, digital transformation, right, we know how to manage really complex stuff, using technology to provide a collaborative decision making process, it's in the power of the web, or society as a whole. That's why I wanted to become a technologist and work on the web as a whole was this idea of the collaborative power of sharing. That's my big bet. That's the thing that I get really excited about, I see automated dosing systems are coming faster insulins are coming. And those are all great, they're going to be so profound and helping people. But at the end of the day, with these therapies, you're still facing exactly that you're facing a lifelong journey with other people with this experience. And my big bet is that this need for sharing is so fundamental that that's why sharing is being adopted in every part of software that we look at every piece of technology that we get first. It's like a solo experience. And then eventually, it becomes like a collaborative social experience. that's been true of a lot of different kinds of software. And I think that we're going to see the same thing in diabetes care that we'll see clinics that will embrace the digital technology, so that instead of having appointments once every 90 days, or once every six months or once a year, whatever it is that you're going to get connected to the people you trust in the experts you need just in time and on demand. So if you're someone if you're using one of these fancy pumps that's connected to supercomputer and connected to a network, there should be an agreement for how this is going to work. If you're going low. lifetimes per night. What is the pathway for someone to intervene for us to deliver the help that you need? Because I'm pretty sure no one wants to go for an insulin reaction for a sixth and seventh night. Yeah, I'm pretty sure there's some consent that can be arranged. There's got to be some design there. Right, where we're going to eliminate this. When I think about the remote overrides, and the overrides features that are happening right now we're, you know, we're playing around with things like sleep mode, things like exercise mode, those are dosing decisions. When you decide to invoke sleep mode, or invoke exercise mode, the algorithm is changing its dosing slightly, it turns out that all dosing decisions are just really, really hard. You can't turn on dosing. On exercise mode, when you start exercising, you have to turn it on hours ahead of time, right? Like those kinds of things. Maybe we could share access to those things. One of the examples that I've been learning about recently is, is this remote overrides where the teenager is doing testing, and it's stressful on test day, and your attention is supposed to be on taking the test. It's not supposed to be on managing diabetes, and in fact, playing around with diabetes devices, which is how it's gonna look like to the proctor to the school that you're just playing around with devices, that becomes an issue. Can you trust the proctor to handle these devices, etc? Well, guess what, with remote overrides this idea of remote controls and sharing your dosing decisions, that becomes a non issue. I've heard of parents and teenagers coming up with a plan for the day, okay, it's testing, here's what's going to happen. Here's the schedule we're going to go through, and the parent is able to help coax the automated dosing machine through the day. And all of a sudden, what I don't know how else to handle it. Because that's the nature of life is that Sure, you can schedule some things, you can automate some things. But there's all these edge cases, as you travel through life that demand more they demand attention from humans. And if as long as that's true, it's also true that humans are going to want to share that experience.


Stacey Simms  1:02:04

I have to ask you, Ben, are you saying that there is a system out there that someone could remote, not just communicate but control the insulin pump from from home?


Ben West  1:02:15

Yeah, it's real. You could set exercise mode or eating student mode, things like that.


Stacey Simms  1:02:21

Well, you can set exercise mode before you get somewhere but you can't like I can't at home, like my son right now. Is out running around the neighborhood. I can't say exercise mode go. I know, we are you mean in the future?


Ben West  1:02:34

Not with Tandem but with Nightscout. And that's


Unknown Speaker  1:02:36

what I'm saying. Okay.


Ben West  1:02:38

Yeah, part of what I mean by it's several generations ahead. It's years ahead. In terms of, you know, night with nice guy, you can actually do these things, you can share dosing decisions as they transpire as life demands.


Stacey Simms  1:02:50

I'm still not clear though. I mean, I can not to share the decision, like the son says, I'm doing it, but I'm in my home five miles away, and I press a button on my phone and my son's pump changes when it's doing.


Ben West  1:03:01

I think that's one of the key insights with diabetes as well, Stacy, is that those decisions don't always happen at the time of when something is happening. Sometimes your dosing decision takes place five miles away, or hours before,


Stacey Simms  1:03:14

but I'm still not clear, but I'm so sorry. With Nightscout. Can I control my son's pump from five miles away? At the moment?


Ben West  1:03:21

Yes, you can. You can tell it to go into exercise mode telogen, sleeping mode, things like that. Yes. Okay.


Stacey Simms  1:03:28

Yes. Perfect. That's exactly what I was asking. Okay, sorry, for my ignorance. That's great. Sorry, there's, there's there's a whole other philosophical argument that we could have in the future about how much control parents should have At what age and but that's a different story altogether.


Unknown Speaker  1:03:41

Yeah. So


Unknown Speaker  1:03:42

the choice to make there I want that


Ben West  1:03:44

choice. Right. This is where the really interesting conversations really begins right here is what is your personal data governance policy? What are the boundaries that families want to implement? And like, that's why I mentioned this particular story between this teenager, and I believe it was their mother, they actually have this conversation about like, okay, here's the day schedule, what are our roles for the day? Right? Isn't that such a beautiful thing? To say? Oh, you know, I think it's gonna be a stressful day for me. Could you just handle that?


Stacey Simms  1:04:13

Oh, it's fabulous. Go ahead.


Ben West  1:04:16

Could you just go ahead and handle that, for me? That's something that even as a professional adult, I want access to that kind of therapy. I would love to be able to say, you know what, I got a stressful day to day, could you just handle it for me? The same way that I can buy an Uber, I can get an Uber for the day, I think I should be able to get something like that for the day. I think that's coming. I'm interested in building it. So I do think that's what's coming, though. I think that's those are the kinds of things worth getting excited about. Yeah,


Stacey Simms  1:04:44

I used to give my son what I call the diabetes free day. And it was any time that he was stressed or had been doing things by himself, like he used to go to summer camp for a long time and, you know, not diabetes camp, but a camp where he was responsible for everything. And he was all burned out when he came home. So I would Two or three days of diabetes free, which we meant, and he was still doing finger sticks at the time, he wouldn't do any finger sticks, he wouldn't count any carbs, he wouldn't even touch his pump. And by the end of two days, he was like mom, mom, leave me alone. But he always liked it, you know, for a couple of days. And so if you can give us another diabetes free day, maybe when he's in college, Ben, I would love them.


Ben West  1:05:19

I think that's representative of the masses. I take care of myself most of the time, but every every once in a while, that's what vacations are for. And that restorative power of those vacations. I think that's something that people on intensive insulin therapy deserve.


Stacey Simms  1:05:34

We started this interview by kind of looking back at the beginnings of we are not waiting and and talking about all of the people that are part of that story, and your involvement and everything. You know, you mentioned it's almost 10 years already seven years, maybe since nightscout. When you're looking back, any thoughts on where we are? Now I know we've already said there's a long way to go. But from where I sit, I'm a lot happier with what I have just commercially for my son's diabetes than I was in say, you know, 2011, and I'm curious what your thought is for your own care.


Ben West  1:06:08

I'd like to see several more improvements. We have a problem with supply rationing of all kinds, whether that's CGM supplies, in my case, I ration my CGM supplies very, very carefully. I just cannot imagine when I add up the math, it seems pretty obvious that you don't have enough sensors to provide enough glucose monitoring, in order to make your automated dosing machine work all year round without any breaks. That's something that I'd like to see fixed is no this concept of it's just really difficult for people with diabetes to get enough supplies, whether that's glucose monitoring, or even access to insulin. On a basic level, you know, I have to start there, in some ways.


Stacey Simms  1:06:56

Yeah. And I really, you know, it's funny, it's not at all what I was thinking, and it is the number one thing we need to fix. Last night, Ben, I got in my car at nine o'clock, and brought pump in sets and cartridges to a mom whose insurance company was given her grief, and they had just, you know, it didn't the thing hadn't come, and she needed supplies. And I'm in my car, and a widow driving through town with a little lunchbox bag of diabetes supplies, I have a great group here, we'll help each other, but that shouldn't have to happen.


Ben West  1:07:25

And then for the for community members to be forced into the gray market like this. There's so many patients, and then to be demonized by industry, when there's real needs in the real world here that we're just trying to meet. So we need more collaboration across the board, that's for sure.


Stacey Simms  1:07:44

Alright, so as we wrap this up, and before I let you go, knowing that that's that's pretty serious. Here's a pretty silly one. We are not waiting was the hashtag that took off any predictions for what the next the next hashtag is going to be? love to see honest a bolus hashtag want us to have all this? Yeah, we'd like to get rid of that one. We'd like to use it and then get rid of it.


Ben West  1:08:03

That's right. Language matters and order symbols.


Stacey Simms  1:08:06

And thank you so much for sharing so much time with me. I followed you for years. I'm such an admirer. Even though I feel sometimes like I don't understand half of what's going on. But we you and so many others have done has just pushed this technology and the help for people with diabetes, so far ahead of where it would have been left to, you know, commercial devices. So I'm excited to have a chance to just say thank you for doing that. And thanks for talking with me.


Ben West  1:08:29

Thank you so much, Stacey. I really appreciate your work, too. I've heard so many of the interviews from people that I know and love. So this is truly so special to be a part of this. And I'm so grateful that you've taken up this project. So thank you as well. Oh, my gosh, thank you.


Unknown Speaker  1:08:50

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  1:08:55

I could talk to Ben west for hours. And in the interest of full disclosure, I will tell you that we did speak for probably a total of an hour and a half. The first time Ben and I talked, I got a little bit in the weeds after about 30 minutes. And most of the interview became me not understanding a lot of what was happening with nightscout. And I'm telling you this because you know me, I'm always in the interest of full disclosure, and I love behind the scenes stuff with podcasts or interviews shows, we agreed together that we would do another interview, I went through the transcript, I gave Ben a copy of the transcript and we kind of figured out what we had left out. And so I went back and recovered the nightscout. If you really want to pinpoint it, it happens right after the Dexcom commercial. That's where the second interview picks up about 3035 minutes into the first interview. We didn't leave anything on the cutting room floor that was important or would have changed the flow of the interview. But I think I was much more focused than was of course fine twice, but I was much more focused the second time around and you could even hear me and some of that Not understanding. It's so embarrassing sometimes, but not understanding what he is seeing. But I leave all of that in because I think that while many of you, as you listen are super technical, there's a lot of people who really don't understand everything that is being offered non commercially and DIY still. So that is why I left a lot of that in. Thank you so much for listening. I will link up a lot of what we mentioned over at Diabetes Of course, there is a transcript as there is beginning in January of 2020. Every episode has one I'm still working to get the backlog done, but we will get there. Huge thanks to Ben west for really spending so much time with me and sharing so much information. Just so happy to have finally gotten him on the show. All right. Thank you as always to my editor John Bukenas for audio editing solutions. I'm Stacey Simms. I'll see you back here in just a couple of days for one of our classic episodes. Until then, be kind to yourself.


Benny  1:10:57

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

Apr 22, 2021

Eight years ago, you could use a CGM but you couldn't share the data. Dexcom transmitters didn't connect to phones and parents and caregivers couldn't Follow anyone. That started to change - and change quickly - in 2013. That's when John Costik posted a photo on Twitter. That photo showed John's laptop, at home, monitoring his son Evan's blood sugar while Evan was miles away, at daycare.

John soon linked up with others who were also working on improving existing diabetes tech. That was the start of Nightscout and a host of other "We are not waiting" improvements, many of which are now integrated into commercial offerings.

This interview with John is from October of 2015. He has since left his job as a supermarket software engineer and is currently the director of digital product development at Beta Bionics. That's the company founded by Ed Damiano that's developing the iLet insulin pump.

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Episode Transcription Below


Stacey Simms  0:00

This episode of Diabetes Connections is brought to you by inside the breakthrough, a new history of science podcast full of did you know stuff.


Announcer  0:13

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:19

Welcome to a classic episode of Diabetes Connections. As always, though, we aim to educate and inspire about diabetes with a focus on people who use insulin. These classic episodes are something new this year, we are bringing back some interviews that are from the very first year of year and a half of the show. We started in 2015, coming up on six years. So there's a lot of episodes that newer listeners haven't heard. And it's kind of fun to go back and give some perspective. I like revisiting. I'm emailing everybody that was featured. If they're getting a classic episode, I'm sending them a text message or a DM or email or you know, I'm just getting in touch with them to say anything you want to share, you know, any new stuff. And it's been really fun to reconnect with some of those previous guests.

I’ll be honest with you, I have really hesitated about bringing by older tech type episodes into this run of classics. We did a lot of interviews, like we do now with the pump companies and technology and things like that. And I think it could just be kind of confusing if you're a newer listener, or if you know, you put a classic episode on and you're thinking it's new. But I mean, let's say I run an episode from 2015, when Dexcom, for example, is talking about an upcoming piece of technology that now in 2021, is outdated or never happened. So I'm purposefully avoiding most of those interviews. If you're interested, though, there's a great search box. I'm really proud of the website. It's very robust, you can go and search the 372 episodes that we have put index calm, see how its evolved over time, put in animists and find out what happened, you know, that kind of stuff. Some of those types of interviews, though, especially from the Do It Yourself community are, in my opinion, very valuable and very much worth revisiting. So that is the topic for this week.

All right, come with me now let us go back to the olden days of diabetes back before 2013. Now I know most of you that's not the olden days for real. But you think about what has changed since then. Before 2013. It was a time where continuous glucose monitors were used. They were around we were at the time using I want to say the g4 Platinum pediatric. But you know, you could use it, you had a nifty little receiver, but you could not share the data. And it I don't believe in 2013 it was on anybody's phone, you definitely couldn't share. Then we saw the tweet. I've been on Twitter since 2008, thanks to my radio days, but I can't say that I was following john Costik at this time, but he was retweeted by somebody else I knew. And I saw this amazing thing. It was a dad watching his young son's blood sugar. On the dad's laptop. The kid was in daycare, the dad was at home, they were across town from each other in 2013. I started following that dad, john Costik. And of course, I was far from the only one john linked up with others who were also working on improving existing diabetes technology. And all of that was really the start of nightscout and a host of other we are not waiting type improvements, many of which are now integrated into commercial offerings. We are going to revisit that time with john Costik in just a moment and catch up on what he's doing now.

But first Diabetes Connections is brought to you by inside the breakthrough on the surface. This podcast is a collection of fun, entertaining and even surprising stories from the history of science. But host Dan riskin digs deeper and he really does entertained while drawing connections between these stories and the challenges faced by modern day medical researchers. The latest episode it was just released a couple of days ago. It is wild Dan explains why it took a dozen people 200 years to discover and then undiscovered a planet. I love this podcast. I'm so glad to partner with them. You can search for inside the breakthrough anywhere you listen to audio wherever you found this podcast and if you are listening through the website or social media, click on Diabetes, Connections COMM And you'll see the insight the breakthrough logo. By the way, good time to remind you this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

A couple of things to know before we jump into the interview, I did reach out to john Costik of course, as I mentioned, and he said let's let folks know I'm hard at work on the islet and its digital products. He is currently the Director of digital product development at beta bionics. He would love that and he says hope you're doing well Stacey and if you are not familiar in the islet is the product from Ed Damiano. We've had him on the show a couple of times beta bionics is the company that is now developing it The islet is finishing some clinical trials this year and should be submitted to the FDA. Pretty soon I am speaking to the folks at beta bionics about coming on the show and giving us an update. So we will work on that as well.

But also remember, this is from the fall of 2015, there are going to be dated references. I just want to kind of keep that in your brain. Because while it's fascinating to take a look back, you have to keep in mind as you listen, this is nearly six years ago, but I gotta tell you, I'm just as excited listening back to this interview as I was when I first saw that tweet, John Costik. I am thrilled to have you as my guest this week. Welcome to Diabetes Connections.


John Costik  5:41

Oh, thank you. so thrilled to be here.


Stacey Simms  5:43

Thank you very much. Let's talk about how this all started. Your son was diagnosed in 2012. He was four. But unlike a lot of people who have children diagnosed at any age, you had more technical knowledge than a lot of us. Can you take us through first, you know your diagnosis story, what happened to lead you to find out that your son have diabetes? And then you know, what made you think to look at the equipment and think well, this isn't good enough.


John Costik  6:11

Right? So it was late summer, end of August 2012. And Evan was showing sort of those classic signs that now we know are classic signs, right that he was thirsty all the time peeing all the time and just, you know, little get more lethargic as the day went on. And the 24th was a Friday and my wife Laura went over to pick them up from daycare surprise him with an early lunch. And when she got there that the instructor said, He's so thirsty, he's crying. So she called me and I was out for a run on the canal path. And I remember, she told me what was going on. I said, That's not good. And, you know, he's been really thirsty and really sweaty. past couple days, let's I said just, you know, both of our guts, were telling us, let's get into the doctor. So she called our primary care. And on like most appointments, where they're like, Well, yeah, we'll see you in a couple days, they were really quick to say, Okay, come in, at one o'clock, then, you know, so like a one hour delay from the time they called. So little did we know they I mean, they knew pretty much right away what it was. So as soon as they got there, of course, he had to go to the bathroom. So they did urine check. And he was clearly spilling sugars than they needed to finger check. And he maxed it out. And they basically said, we're gonna call the hospital, you get in the car and just go to the ER, we'll tell them. You're on your way.


Stacey Simms  7:42

Did you know anything about diabetes at that point?


John Costik  7:45

No, no. And this was Laura was at the doctor. So she called me I was at work at this point. And it was just like, getting hit in the head basically. And yeah, my, my knowledge of diabetes was very limited, much some family members that were type two, and I knew there was no type one and type two, and one was curable, one wasn't. And that was mostly because growing up my mother, my mother, she still is a nurse, but she's retired. But she was the school nurse. And there were a couple kids with type one. And I remember just hearing stories of her having to, you know, go to people's homes to pick up their insulin for them if they forgot it. So understanding that type one was distinctly different, I at least knew that much. But the next three days at the hospital, obviously, they put us through the type one boot camp, and send you on your way, basically with vials of insulin, and, in our case, humalog pen, and we had to sort of figure it out from there. Yeah, they gave us the general guidelines for how much insulin he may or may not need, how much lantis to give him. And we were on our way.


Stacey Simms  8:53

Now, it seems like you started on a continuous glucose monitor pretty quickly, how soon after you got home? Did you start thinking about that?


John Costik  9:00

So it was mentioned to us while we were at the hospital by the endocrinologist that diagnosed HIV. And at the time was the Dexcom. Seven, and the I think it was still the Medtronic soft sensor at that point. So those were the only two that were shown to us. And he said, okay, it's a lot of information up front. So we actually went with shots and did a lot of finger checking, initially. But one of the one of the things we recognized real quickly, was the ability to to log this data and communicate this data was sort of hampered you know, if the nurse was writing things down in a log book that didn't inform Laura and I how Evan was doing during the day. So the first thing I did was set up a website for logging, you know, nutritional data, finger checks and how much insulin we were giving him. So that was within probably a week after diagnosis had some semblance of that. And that was to prepare him for going back to daycare. So we could all stay in the loop. So that system would send Lauren an email, a text message whenever a treatment was entered.


Stacey Simms  10:11

Alright, so then a few months later, though, you decided to go with the Dexcom. g4.


John Costik  10:15

Yeah, we started looking around, so around November when I got approved. So I immediately signed up for all the diabetes technology, news letters and everything I could and started, you know, as, as my mind kind of settled down from the diagnosis. You know, I started looking to see what can we use to keep him safer, healthier, both in the short term and long term. And the g4 was approved, I believe it was November in that ballpark of 2012. So I began the process almost immediately to get that it took a while to get it through insurance. Because they actually like to see hypoglycemia before they'll give you tools to avoid it.


Stacey Simms  10:52

I know. And if you do, too well, they want they might take it away. That's the craziest part.


John Costik  10:56

No, no, your son's still healthy doesn't need the thing that's keeping him healthy. Yeah. So. So unfortunately, or, you know, he did have a low in January, that basically put us over the edge. Then they approved it, and we had it in, you know, the second or third week of February 2013. And that's when we began using that. And does that mean immediately it was sort of a revelation to have this second order data, this trend data along with the blood sugar, just so to know directionally where he's going. And you know, what's happening in those periods that we were blind to before. So immediately after meals, we'd see these big spikes that come right down. But, you know, got our mind spinning on, what can we do to improve that? And at the same time, when we sent him to school, is there any way for us to have continued access to the CGM data?


Stacey Simms  11:52

Now you both you and your wife both have backgrounds in engineering? Correct. And so this was something that you looked at, and what did you think of the system because somebody like me, you know, I was a communications major in college, I've worked in broadcasting my whole life. I looked at the CGM. And I thought, Wow, this is so great. How could it get any better? You looked at and thought this is the dumbest device in terms of talking to anything else?


John Costik  12:14

Right, but but I understood the position that everything sort of has, has to go through that growing cycle. So I understood that. So I also my wife worked at an FDA regulated company. So we had some idea that putting a medical device online and presenting that data to people is more daunting for the commercial entity than it would be for us as individuals to just extend it. So we I mean, we were never, I never really railed against Dexcom. In at the time, I think they had sort of shown off some semblance of share, or there'd been some patents that came along that indicated that they were clearly moving towards remote monitoring at some point. But it wasn't something I was going to wait for. Right. So I have the CGM. Now this great device, I have a laptop that can talk to it. And I know, I can take that data off and send it to a cloud service. Or, in our case, we just started with a simple Google spreadsheet that we sent the data to. And then I wrote an iPhone app that pulled that data down and your web app, so the school could just see, you know, his current blood sugar and trend. So we integrated that with with our care portal website. And that was powered by a laptop top load. So initially, I just used a repurposed Dexcom zone, what I call a DLL, linking library dynamic linking library. So that's basically just a program that allows you to interface programmatically with the receiver. So I just repurposed that wrote a fairly simple Windows application to just pull that data every five minutes, and then upload it to that. Like I said, that Google spreadsheet.


Stacey Simms  14:02

Okay, so I'm just curious, was it hard for you to do that? Did it take you a long time? Or did you sit down and tap the tap tap? You know, you're done. You got it?


John Costik  14:10

It wasn't, wasn't challenge. So my background in software, I it was relatively recent background, but it was all focused around windows code, and specifically writing these sorts of libraries for other hardware devices. So I understood if I took their library and put it into what what I would call, you know, a software project, that I wouldn't be able to see exactly the interfaces that could pull that data into my own application. So it really only took probably an hour or two, to write to write the basic windows uploader.


Stacey Simms  14:46

And then you put this picture on Twitter. I don't know how long after that said, Look at what we're doing. Isn't that interesting? And did you expect the reaction that you got which was basically jaws dropping around the country, saying how Do I do that?


John Costik  15:01

Yeah, that's, I took some pictures of the windows one initially. And that didn't get a ton of attention. And when when I started going after a truly ambulatory like a mobile solution, that is what really drew people in. So I knew Evan was going to kindergarten, I wanted him to be able to remotely monitor, monitor, monitor, no matter where he was, was, he was on the bus, in class moving around, so I knew, you know, even a really small laptop wouldn't cut, it just wouldn't be convenient for him. But if I could get a small cell phone, smartphone and do that, great. So I started in Android was really the only choice they make much easier to communicate with USB devices and other accessories. So I started working on that, beginning of May, in about a week or two into may, I had sort of unraveled how Dexcom was communicating with the device and, and what that communication looked like and how to interpret that, and then send it along to to a web service to a cloud service. So those tweets got people's attention. And I think I chimed in on on a bulletin board somewhere. And that's when Wayne Desborough reached out and said, Hey, I'd really like to do the same thing for my son, he's his room is too far for the receiver to be in our room and reach him. So we'd like to do to build a remote monitoring system.


Stacey Simms  16:36

Okay, so let me stop you there and tell me if this is all correct. Lane despereaux. Now with Bigfoot biomedical, yep. He has an engineering background as well, I think you work for Medtronic for a while, but he had designed his own home display system. He He's the guy who came up with the nightscout name, right. But he didn't connect it to the internet.


John Costik  16:56

Now, he, he did so ln really took my uploader and created that open source nightscout back end. So the the website you see today is is an evolution of his original design, and uses the same architecture. So a Mongo database, and a Node JS application sitting on a web server somewhere, and allowing people to view you know, their data or their loved ones data. Okay, so that that core was was Lane's work. And later, he brought on Ross nailer, software engineer, and they sort of refined that and got it to that point where, where it could could go live. So for my part, they, they took my uploader code, you know, I gave that to them. And I took their chart code, and put that into, into our home system. And that's sort of where it took off. So in the middle of the summer, I started using the Pebble watch, because I my whole goal this whole time was just how simple can I make this? How glanceable and easy can I make this for everybody involved, because I don't want to stare at the chart all day at work, I just want to know when something's up, I want to go on my day, but know that this system will tap me on the shoulder when it needs to. So Pebble watch was was a good way to do that. Because you can make it vibrate and do all sorts of things to get your attention.


Stacey Simms  18:25

Okay, so now you've got it on your Pebble watch laying despereaux and other people that you've mentioned, are coming up with their own additions. When did what we now recognize as nightscout? When did that all come into play? Was it a few weeks or months after you all kind of shared your codes?


John Costik  18:45

So I think lane started using that name fairly early on. And we all met Finally, actually, Lane was in Rochester, New York for a sailing competition that I believe he won at the end of August 2013. So he actually was at our house for Evans first diversity. And that was a great time when he and I got talking about, you know, everything, right? Very, just an amazing individual really inspired me and opened my eyes to like, Look, there's a lot of people trying to do this. And right now, between the two of us, we have all the components to make it happen. So it was very inspiring, because up until then, I mean, I was a software engineer at a supermarket. Right? Yeah, that wasn't something I'd considered. You know, I lived in a small town. I never really looked beyond that. I liked my simple life. And part of my response to Evans diabetes was I want my simple life back. So these were the tools I wanted to build that I needed to take it back. Right. Yeah. But now seeing this really large unmet need across the entire, you know, population of people with diabetes. He's in there and their loved ones woke me up to that. And then in November, I went to the data exchange, which is hosted by tide pool and diabetes mine. And then diabetes, mine has their Innovation Summit the same, you know, in that same couple days cycle. And that really sort of sealed the deal for me to see what type who was doing, starts trying to integrate all this data. And I'm like, wow, okay, this is really happening. So I can either join in, or, or not, right, and it just seemed like an obvious thing to, you know, pitch in and see what we could do. So, at that point, it was really just a matter of refining that code, to a certain point where other people could make it work. And personally, I didn't think it would ever grow beyond, you know, a sort of core really technically savvy group of people that could set up their web server set up the cloud service, right, and compile a Java application for their Android phone.


Stacey Simms  21:04

Well, that's what's what's remarkable about this whole movement is that, you know, as you say, this core of people, is making it all available to people who have no real technical knowledge, who are completely intimidated by the whole thing, but want access to this information to the point where they're willing to get in a Facebook group and say, Hey, can you help me? And then people do it, people help. And it's been really remarkable to see how it's grown and how people like you are not just sharing your code, but sharing time to set up all of these systems. When you look back now. I mean, can you imagine that? There's something like 14,000 people in the CGM in the cloud Facebook group. I know not everybody's using the system. But they're they're looking at this stuff. Did you think I would get this big?


John Costik  21:50

No, no, not Not a clue. I mean, Laura and I, we had some inkling that what we built was awesome. Because it really enabled Evan to have as close to like that standard school kindergarten experience, as we could have ever imagined after his diagnosis, right? Oh, he had to carry, you know, a little bag around, but he would have had to anyway, right, he'd always need his glucagon and glucose and finger checker. So it wasn't too much more of a burden to put a cell phone and and the the CGM monitor in their hand. Good. Yeah. So just enabled him and we worked with the school nurse, and we refined, you know, our web application and our care portal, to really be something that that she was comfortable using. And something you know, that that informed us, you know, in real time of what was going on in school. So it's really just a nice experience. And again, like, like the daycare experience we've had an amazing experience with, with the Lavanya School District, the nurse in particular, she's just a wonderful person just wants everyone to be happy and healthy, and every kid in that school, so she's, she's like Laura nine. Now. She just she knows his diabetes really well, because she can just glance at and she gets a really good sense for what's going on in his day and how he's feeling and how that will impact his blood sugar. And there's almost never an occasion where we have to chime in or even text her to say, Hey, can you give him a grammar to, you know, and if we do do that she's already on her way down, are already calling down to make it happen. So it's just it's just been an amazing thing for him and for us, and it's been wonderful.


Stacey Simms  23:34

How's he doing these days? He's in second grade now.


John Costik  23:37

Yeah, second, he's doing a good. So it's, it's nice with the share receiver, we can use the Bluetooth connection so that that Reagan's gotten smaller and simpler for you know, it's wireless now. So we really can get his, you know, physical burden of the devices to a minimum at this point. It's also improved outcomes tremendously is a one C is great, you know, his standard deviation is time and range, all these things improve by having this sort of, always on and easy access to, to all this diabetes data.


Stacey Simms  24:13

And you mentioned the Dexcom share, we should note that Dexcom share Medtronic has is coming out with a system that is similar, where instead of doing it yourself, they're setting it up for you. But that and I don't know if I'm explaining this correctly, but there are still features that you all have set up and that the nightscout folks have set up that are not included in the share, is that correct?


John Costik  24:36

The main missing feature that people really enjoy, is that what folks refer to as raw data. So the ability to see some data during either a restart or a warm up period, or during the dreaded triple question marks. You know, there's there's some visibility data, you're not totally blacked out from that data with nightscout. Whereas, as the standard Dexcom, system will do that.


Stacey Simms  25:11

Let me turn this around for just a moment and play devil's advocate. While many people, obviously 1000s of people use nightscout, and are excited about the Dexcom, share, there are a lot of people who have type 1 diabetes, I'm going to put teenagers in this category, probably a lot of them who feel as though this is a bit overbearing, and who feel as though there needs to come a time when you know, parents, or others, you know, maybe don't have access to their numbers, or that this creates a situation where there's just so much hovering. Now, it's difficult for me to ask you about that, because you're doing this for your family, you didn't do this for everybody else. What's your take on that? And even still pretty little, but what's your take on


John Costik  25:57

that? My take is always in law. And I've always said, you have to you have to find the systems and build your own system to an extent, you know, whether you're selecting devices, or features on those devices, that that suits you, in that time in that context of I have a teenager with diabetes, I have a young child with diabetes. So if you have a teenager that is very trustworthy, and manages their diabetes really well, you know, maybe you're, you're not going to look at that remote monitoring, it's an essential piece. Right. And for folks that may be worried more about their teenagers. I mean, at some point, you you, you do have to stand up and say like, Look, I'm I'm your parent, hovering or not, I want to keep you safe and alive. And I think there probably is a balance that you have to find with the individual child. Right? So if they feel it's really invasive. You How can we make the system less invasive, maybe they don't always have an always on access, but they get alerted to you know, impending hypoglycemia? Right. So there's always ways that since it's an open source system, people could take the system and, and really fine tune it to their particular needs. And for us, with epanet his age, it's less about hovering, and more about actually giving him more freedom. Because us, knowing what his blood sugar is allows him to just be a kid. Right? And it's, we don't he doesn't get bothered nearly as much as he would if we didn't have it. So so there is that sort of aspect that I think gets overlooked, you don't realize that it actually enables more freedom, in most cases?


Stacey Simms  27:45

I think that is a great point. Because it's a parenting question, right? It's not a technical question. The system exists, and it's great. And how you use it is up to you I've shared before I have never used nightscout. It's not something that I first when it first came out, I looked at that and said, we'll break that in about three seconds, if we can even get it set up. It's just not us. And when shear came out, I was one of the people who got the cradle and use it overnight, loved it and never really felt like I needed to get an upgrade because my son is at a point where he's at a terrific school. He's in fifth grade. And I did not feel that I needed to remote monitor because he's at an age. And listen, I can get criticized for this. Or I think it's better for him to make some mistakes, in what I know, after all these years is an incredibly safe and supportive environment. But I got the share receiver. And I use it, as you said, finding it gives him more freedom. There's a tradition in my town, where the fifth graders walk from school on Friday afternoons to our little town and are allowed for like two hours the town tolerates them running around, going to the soda shop, yes, we have a soda shop, going to the green going to the library on their own. And I didn't want him doing that, without at the very least a way to contact me. And we have both found that having the share system. And he only really takes a cell phone to school on Friday so I can see it. He doesn't even need to check in. I know what's going on. I'm not too worried about it. We text about well, what are you going to eat? And how are we going to deal with that. But it's made it so much easier. So as somebody who doesn't remote monitor on a regular basis, that little tool has given him freedom if he was two years old. I mean, my son's diagnosed before he was two, would I feel differently? Probably. But it's it is I think it's more a parenting question than a technical question. So maybe it wasn't fair to ask. You


John Costik  29:36

know, I think it's fine because ultimately I mean, I'm, I'm a parent, there's a lot of all this came out of what I felt were our needs as a family. Definitely one of our, you know, one of our family members safe and happy and to improve the quality of life at all. It does come down to how people you use the tool. It can be very invasive, if you're a parent that is constantly paying that kid to do so. Right So the technology can enable hovering as much as reduce it, I think,


Stacey Simms  30:06

yeah. And ask me again in middle school and ask me again in high school. So you know, these things changes as the kids change, right. And as the setup changes, hey, you also share your information. With some recent guests of mine, I talked to Dana and Scott from the open APS project that do it yourself pancreas system, and they're basically working on the you're operating an artificial pancreas system that Dana has worn for almost two years. Now they close the loop last year, what do you think is going to happen next? What do you look at in technology? And say, yeah, that's going to happen? And I'm going to have that forever? And


John Costik  30:42

that's a good question. So obviously, you know, I want us all to be put out of business, just cure it. Exactly. But if if, if there's a functional cure, whether it's bigfoots product, or Dr. damianos product, or somebody else, you know, whether it's encapsulated islet cells, you know, via site, if they figure it out, and are able to do an implant that reduces the insulin need, significantly, if not eliminated, those those are the sort of things that that make me excited, and I look forward to those and, and Scott, and Dana very clearly showed, like, Look, you need to get this AP stuff rolling, because it can be tremendously beneficial to people with diabetes, right? It reduces their burden makes them much healthier keeps their blood sugar's in range, with a much higher percentage, right? Yeah. So early on, they were I think it was Scott reached out to me saw a couple tweets, he tweeted back and said, hey, how can I get this? So he was one of the folks that I shared the uploader code with early, you know, before it was publicly available for it was open source. You know, I knew you looked into his background, and we talked and it was very clearly the software wise, he was savvy. And so I was happy to share that with with him. And Jason calibres was another person that I gave the uploader to earlier. And Jason Adams, who founded the Facebook group, was another one of these folks that early on, had really reached out to me and got me rolling.


Stacey Simms  32:15

Oh, let me interrupt you here. Why not? Why not? Make it more proprietary? I mean, why? Why make it so easily available? When, obviously, people were clamoring for this and probably would have paid you for it? I feel like I should be twirling my mustache. When I asked you that question.


John Costik  32:32

That was a question. We got a lot, actually. So when people saw our system, even before we made it open source, they said, Oh, that's a million dollar idea. I said, Yeah, but it's not really my idea. Right? Everybody's had this idea. Scott hanselman had the idea 15 years ago, you know, so people we've very smart people know that better, we can access our data, the healthier we're going to be. So this was just, I just happened to be in the right time and right place. And to be honest, I'm not particularly entrepreneurial. So I wasn't super motivated to go out and start my own company and raise funds to get this done and dig my heels in with regulatory issues. You know, it just, again, it was it was me trying to get our simple life back and starting a business around it was would have been a huge risk. And that's something that I was particularly interested in doing.


Stacey Simms  33:22

Are you happy with how it turned out?


John Costik  33:24

Yeah, yeah. I mean, if I had tried to commercialize it, how many people would be using it? Maybe not? Right, maybe it would have fizzled, and people would still perhaps be waiting for the G phi or the share. If if that group hadn't come up and sort of opened the FDA his eyes to that need. So yeah, I think it's, at this point, the best possible outcome I could have imagined and the appreciation from folks, and I don't deserve nearly any that I get, you know, it was a small part of the story. It just happened to be, you know, early on, but just that outpouring of gratitude, I mean, no one could have paid me enough to counter that.


Stacey Simms  34:05

And you are no longer doing software for Wegmans. Which is is that correctly, first of all, which is a fantastic supermarket up in upstate New York and across really the lot of the Northeast that people are familiar with, and I used to shop there all the time when I lived in New York, but you're not there anymore. What are you doing?


John Costik  34:22

So I've moved over to the University of Rochester Medical Center. So I was looking for something in health care, because I knew, you know, that's kind of where my heart was at this point was really to help find similar needs throughout health care. So I didn't want to just do type 1 diabetes work. I really wanted to dig in and see see what else we could do. Across the wide spectrum of, of conditions and, and whatnot. So there was a position open. At the University of Rochester Medical Center, a new group called the Center for Clinical innovation. I came in and got talking with, with the leaders of the group, this surgeon, Dr. Dave Minton. And then Chris de Silva. Were the primary folks in the group. And we kind of hit it off. And I showed him what I built for Evan. And they said, Hey, I think you'd be a perfect fit for our group. And the rest is sort of history. So I left Wegmans at the beginning of June and have been here and working on software that's very patient centric. And


Stacey Simms  35:35

I'm not just for diabetes,


John Costik  35:37

no, not just for diabetes. So the main piece of software that our group has written, will go out to all the clinics, or potentially all the clinics, they'd have to opt in to all the clinics at the University of Rochester Medical Center. So the entire health system, which is a big system, so we've built a tool that can aid all the clinics in gathering and interpreting patient reported outcome data. So that's, that's been a big push. And then I do have some projects that I can't announce yet, for those that are diabetes related, because they obviously know that that's always going to be a passion. So if I can work with the endocrinology groups here, to sort of advanced them along in their technology and how they use it at the clinical level, and how we can ease the movement of patient data to them. And while keeping the patient data, very patient centric, and give them ownership of that data is is sort of sort of a goal there. But there will be some, I'll have some announcements at some point.


Stacey Simms  36:39

That's great. Well, congratulations. It sounds like the perfect job. And it's wonderful for the rest of us who are waiting to see what you're working on.


John Costik  36:46

Yeah, no, it's it's been great. And it's a it's a dream job. I can't complain.


Stacey Simms  36:51

It's nice when those things can happen. Well, I'm curious, does your daughter she's just a couple years older than Evan, right? Does she want the technology if she asked me for a cell phone and that sort of thing.


John Costik  37:01

She does have a cell phone and Pebble watch. But we don't make her run. You know, our watch face on it. But it's for an in basically and we told her it said this is you know, since you have to sit with your brother on the bus anyway, if there were ever an issue where his blood sugar started dropping quickly, we we gave her a tube of glucose tabs and, and a cell phone so we can we can get ahold of her on the phone. You text her and say, Hey, give your brother half a glucose tab, which we've only ever had to do maybe once or twice.


Stacey Simms  37:31

But she said she still likes him probably because I have an older sister younger brother situation here in my house. And when they were under 10 she was super helpful. And now she's a teenager. It's like nothing to do diabetes. It's just your stinky younger brother.


John Kostic  37:43

Yeah, yeah, I could. It seemed that coming.


Stacey Simms  37:47

Still help him she'd always help him. But


John Costik  37:49

I think they're both I mean, I'm biased and all but they're both very sweet and compassionate. How old?


John Costik37:54

Are they?


John Costik37:56

Nine and so yeah,


Stacey Simms  37:57

of course. Yes, of course. Then they always will bait


John Costik38:01

breaking breakfast time where they can just they're just nice. Okay, yeah.


Stacey Simms  38:08

It's all good stuff. It's all good stuff done caustic. Thank you so much for joining me. I spent a lot of time in upstate New York and central New York. So it's fun to talk to you from the Rochester area, right?


John Costik 38:18

Yeah, you weren't circulator.


Stacey Simms  38:20

I was in Syracuse, Utica. My husband is from Utica.


John Costik  38:23

Yeah, my dad went to cert Su and


Stacey Simms  38:25

excellent. Me too. That's great. Well, thank you so much for joining me and I can't wait to see what you're working on. Next. Please let me know. And we'll get the word out.


John Costik38:32

All right. Thank you very much.


John Costik38:39

You're listening to Diabetes Connections


John Costik38:41

with Stacey Simms.


Stacey Simms  38:44

Quick behind the scenes story about this episode from back in the day. I remember when my editor and I think it was I don't remember it was John Bukenas. Sorry, john, as you're editing this, I don't remember if it was john. Or if I was still working with somebody else at that time. I listened back I proof. Listen, I call it to every episode kind of like proofreading your work. And I got it back. And I was so excited because as you know, I'm so excited by the DIY stuff, even though I don't understand half of it. And I couldn't wait to listen to it till I got home and I was at Benny's baseball game. And it was such a great mom. I'm like, No, I have to listen to this. So I'm listening. I'm walking around near the baseball field, kind of watching the game kind of on my phone. And this was at the time when we did not have share. But he did certainly did not have a cell phone. And we used to hang the Dexcom receiver by a clip on the dugout on the wire mesh of the dugout. We just just hang it there and like casually walk by occasionally or just really rely on the alarms to go off. I love baseball for diabetes. For a slow game. Somebody pauses so many times to treat. I mean, the only thing that's problematic is sliding. And you can kind of figure that out by putting the Dexcom or putting your pump site in different places. But I will never forget right by Davidson Elementary School in the ballroom builds over there walking around and listen to playback of that original episode back in 2015.

Okay, well thank you to my editor john Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I will see you back here next Tuesday for our very next episode. Until then, be kind to yourself.


Benny 40:23

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

Mar 23, 2021

The very first treatment to prevent type 1 diabetes for any length of time is in front of the FDA right now. Teplizumab has been show to prevent the onset of type 1 diabetes in people shown to be at high risk of developing it. Stacey talks to Dr. Henry Anhalt of Provention, the company behind the filing. Dr. Anhalt is a pediatric endocrinologist and has a lot to say about what this would mean to his patients.

Listen to our previous episodes on Teplizumab

In Innovations, a round table on insulin pricing with Congresswoman Katie Porter. It didn't have her famous white board, but participants pulled no punches.

Watch the full panel here: 

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

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

Join the Diabetes Connections Facebook Group!

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Episode Transcription: 

Stacey Simms  0:00

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


Announcer  0:21

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:27

This week, the first treatment to prevent type 1 diabetes for any length of time is in front of the FDA right now. We're going to talk about the clinical stuff. But there's a lot of emotion wrapped up in this development as well.


Dr. Henry Anhalt  0:40

I was trained to make people who have type 1 diabetes feel that they're never doing a good enough job, that they're at risk of developing all these complications. And you know, when you get to the point in your career, you realize that not only did that not help hurt, and then really being in a position to hopefully be able to make a fundamental difference and how that goes down. It's really hard to articulate, I have to say,


Stacey Simms  1:05

That's Dr. Henry Anhalt of Provention, the company behind Teplizumab. He's also a pediatric endocrinologist, we'll talk about Teplizumab what is in front of the FDA and why this treatment is so promising.

In innovations. A round table on insulin pricing with Congresswoman Katey Porter didn't have a whiteboard as She's famous for, but pulled no punches. You're gonna want to hear this.

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

Welcome to another week of the show. I am always so glad to have you here. As you know, we aim to educate and inspire about diabetes with a focus on people who use insulin. I'm your host, Stacey Simms, my son, Benny was diagnosed with type one right before he turned two, back in 2006. My husband lives with type two diabetes, I don't have diabetes, but I have a background in broadcasting. And that is how you get the podcast.

We are coming up on year six of the show. And I gotta tell you, I don't get I don't get too excited about breakthroughs or treatments anymore, because we've covered a lot of stuff that frankly hasn't panned out the way we had all hoped. But this is a little bit different. Because Teplizumab is a drug that has already been shown to prevent type 1 diabetes for three years. And for some people, they are coming up on four years. What does that mean? How do we know it's preventing it? Why is it so exciting? And you know, could this mean a breakthrough for everyone with type one, there's a lot to unpack here. So we'll get to that in just a little bit. But we've talked about Teplizaumab before with the folks from trial net, I'll link up this previous episodes at Diabetes There's always an episode homepage for each and every episode, which more recently will have the transcription. But for every episode has important links and more information for you.

quick heads up. If you are listening as this episode goes live tonight, Tuesday, I will be with a JDRF with a couple of chapters. Or maybe it's just one chapter now things have moved around a lot for JDRF. But I'll be with the Nevada, Arizona and New Mexico chapters tonight, talking about the world's worst diabetes mom, we're going to have a fun discussion about the book. And if you are in one of those chapters, you're going to get the paperback for free. If you're not in one of those chapters come along. Anyway, I've got some audio books to give away. It's always just fun to talk to you. I'll be reading from the book but having a discussion as well type one talk, it's different times because of the different states and because of where I am. So it's 530 in Nevada and Arizona, and 630 in New Mexico, it will be 830 here in Charlotte, North Carolina, I may be in my pajamas, but I hope you can join me for that. And again, I'll put a link and I've got that out on my social. I've been talking about that on social media for a couple of days.

I've mentioned a couple of times this year that we're focusing on technology. And a lot of that is because 2021 is going to see a lot of FDA approvals, things have been backed up because of COVID. Um, so this year, and next year, I think we're going to see many things kind of bunched up. But some of that technology isn't mechanical, right? It's medical or what we would think of more as biological perhaps. And that's what we're talking about today.

But first Diabetes Connections is brought to you by Dario health. And over the years. I find we manage diabetes better when we're thinking less about all the stuff of diabetes tasks. That's what I love partnering with people who take the load off on things like ordering supplies, so I can really just focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door one on one coaching so you can meet your milestones, weekly insights into your trends, with suggestions on how to succeed. Get the diabetes management plan that works with you and for you. Darrius published study Demonstrate high impact clinical results, find out more go to my forward slash diabetes dash connections.


My guest this week is the executive director of medical affairs for Provention Bio. He's also a pediatric endocrinologist and Dr. Henry Anhalt is also very involved with Camp Nejeda. He's on the board there. I believe he was the medical director at one point, but we have spoken to Dr. Anhalt before in that capacity. My cousin goes to camp there he did growing up, I will link back on our episode about camp with Dr. Anhalt because it's a really good one. And especially if you're thinking about diabetes camp, if your local campus happening this summer in person, that's a good one to listen to as well. Provention is a biopharmaceutical company dedicated to autoimmune disease. And they are applying for what's called a biologics license application for to please him up for the delay or prevention of type 1 diabetes in at risk individuals that is in front of the FDA right now. There is a gold date here that the FDA has assigned to them of July 2. So we shall see what happens between now and then. But there's an awful lot to talk about unexplained. Here's my discussion with Dr. Henry Anhalt.Thank you so much for joining me and welcome back to Diabetes Connections, it's good to talk to you again.


Dr. Henry Anhalt  6:21

Likewise, Stacey, it's a delight to be back with you again.


Stacey Simms  6:25

Well, I'm so interested in this news, which you know, it's hard to get excited after all this time for me. But this is exciting news. But let's kind of set the stage. If I could talk to me a little bit to just start off here. My listeners are familiar with T one detect the program that JDRF came on the show and talked about in in late December about a new screening initiative and prevention is the company that is I guess, you know, doing the heavy lifting here and doing the work to screen people. Can you talk a little bit about the importance of this project?


Dr. Henry Anhalt  7:00

Well, Stacy, the first thing I wanted to do is to point out that in addition to the T one detect program, we have the type one website, which will also give people who are going to that website, additional information about screening, it's important that we take a shift in how it is that we look at type 1 diabetes. And as we all know, mostly everyone's experience. And certainly, that's been the case with my patients as a pediatric endocrinologist, they present and they come to attention when they've been having symptoms, when they're not feeling well, when they are noticed to be losing weight. And a parent says, gee, something's wrong, and they go to a doctor and oftentimes are going from one doctor to another until unfortunately, kids and adults are getting sicker and sicker and then ultimately end up in an ICU setting. That's what we used to think about as type 1 diabetes. But we now know that type 1 diabetes is really in three stages, we know it's an autoimmune disease. But the three stages are really important to highlight, because the first stage is when someone has two antibodies that are directed at the pancreas. And those two antibodies are amongst a number of antibodies. But if you have two or more, you have stage one diabetes, even in the absence of having any symptoms or abnormal blood sugars. And we'll come back to that in just a second. Stage Two is when you have those antibodies or more, and you'll have some abnormal blood sugars, but not high enough to either have symptoms, or for anybody to even recognize. And then stage three is, as I mentioned a moment ago, when typically people have symptoms and they end up sick unfortunately, and seeking medical attention. We won't know whether or not someone is in stage one, stage two or stage three, unless they do things like you just suggested and participate in the T one detect program or have their antibodies tested so that they can identify and understand where they are along that continuum. And so we now classify type 1 diabetes as soon as you have two more antibodies, but even in the absence of having abnormal blood sugar, so it's important because as therapies become more and more available, and we know that there are a whole bunch that are now coming along, some of them are pending approval. So for example, Teplizumab which is before the FDA right now. And we hope that the FDA will look at the body of evidence and the safety and the efficacy. And we currently are targeted to have an approval date in the first week of July. But it's also important to realize that there are lots of other medications that are soon to follow, that may also be of use to people who are along this continuum. for us and for the people that we care about. In the type one community, the ability for a drug like Teplizumab provided that the FDA looks at the data and says, yep, we believe it's safe and effective to prevent people from progressing from stage two to stage three. Without that, we won't know who would be a good candidate for that kind of intervention.


Stacey Simms  10:58

I always get a little confused. And I know that for somebody like me, who's a lay person, it seems like we're early on in the research. But the question I always have about the antibodies is I remember years ago with trial net, and they would say things to us like, well, years ago for me when I was learning about trial that they would explain it like, well, kids usually get tested more often than adults, because things can change with children. If somebody has the antibodies, do they always develop the symptoms of type 1 diabetes? Or do we not know that yet,


Dr. Henry Anhalt  11:28

the uptake of testing or the routine screening for people at risk has not been adopted widely. And that's important to highlight. And that's why the JDRF is in the middle of this educational campaign is because the fact is that for all intents and purposes, our colleagues that pediatric endocrinology adult endocrinologist are not thinking about getting antibodies, and certainly in children who you would expect, are at greatest risk. Those who have a first degree relative with type 1 diabetes, a sibling or a parent where we know that their risk of developing type 1 diabetes is 15 fold greater than the general population that it would be more widely adopted. But that's unfortunately not the case. And in adults, are point people don't think so one of the challenges with adults who ultimately develop type 1 diabetes is that the family practice dogs or the endocrinologists who may be are not involved, likely not to be involved, because they are in seeing people who are adults who develop diabetes until their 50s, or maybe their 40s. And they're not thinking about type 1 diabetes, the greater challenge with adults is around the assumption that if you're in your third decade or fourth decade of life, that you do not have type 1 diabetes, but we know that that's not the case, because people into their 50s and 60s are developing type 1 diabetes and are continuing to make insulin but unquestionably have type 1 diabetes.


Stacey Simms  13:21

I'm curious, when T one detect was announced, a lot of people in the diabetes community thought and I agree with them. It was so interesting, it was such a great idea. Like let's get more screening, let's get more screening. But when I talked to JDRF, they said no, we will we want everybody in the diabetes community. But we want people outside the diabetes community to start thinking about this, what can be done to try to push this message into families that you know, don't think that they have to worry about diabetes? How are you all doing that?


Dr. Henry Anhalt  13:49

Yeah, what I really focus on Stacey is the folks who are at risk, okay. And those are the ones with first degree relatives, because we know we have data from global programs where they're doing population screening, they're screening everybody, not only second and third degree relatives of people who have type one, or even first degree relatives, they're screening entire populations. And that's terrific within the context, at least right now, of research programs that are well funded. But we're facing a battle ahead of us as we get people to adopt. And we get the payers and the payer community to recognize the importance, which is part of the educational effort. However, we really need to focus right now for the hearing now, because that's achievable, attainable, and the therapeutic agents that are either before the agency now or that are coming are the ones that are going to be the most likely to benefit. And that's why I think right now at risk is the most important population to look at. Got it.


Stacey Simms  14:57

Let's talk about what's in front of the FDA. I remember A couple of years ago trying to pronounce Teplizumab, and then getting really I know, but getting really excited as it seemed to, and you please fill us in, but it looked like the research was showing this is preventing that movement, as you said, from stage two to stage three, so people have the antibodies that show that they have type 1 diabetes, but it kept them from progressing to showing symptoms for two years. And then it looked like three years recently, am I getting all that right?

Right back to the doctor and hold 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 that can be scary. A very low blood sugar is really scary. And that's where Gvoke Hypopen comes in. It's the first auto injector to treat very low blood sugar. Gvoke hypo pain is pre mixed and ready to go with no visible needle. That means it's easy to use in usability studies, 99% of people were able to give Gvoke correctly, I'm so glad to have something different, find out more go to Diabetes and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit gvoke slash risk.

Now back to Dr. Anhalt. And I just asked him if I was kind of getting your right that Teplizumab had delayed the onset of type one in people for up to three years.


Dr. Henry Anhalt  16:29

You're getting that spot on Stacey. And I think that here, it's important to stress that how do we know that they're actually having this delay? Are there any markers that we can look at. And C peptide is the key, because for the listeners, it's important to highlight that this molecule or this protein c peptide is a measure of how much function your beta cells have, how much of your actual insulin is being produced. And the studies have shown and the authors concluded that in fact, those treated with Teplizumab had stabilization of their c peptide production, and in some cases actually improved c peptide confirming that the beta cell function is being preserved. And suggesting I may add that beta cell function is being restored. So it wasn't only this delay, but it was a delay that was marked by a direct measurable compound or protein that indicates beta cell health and beta cell function.


Stacey Simms  17:40

When we talk about Teplizumab, what is that? It's I assume it's more than, you know, a pill that you would take once and never have to do again. Is it a treatment? What how do you how do people take it?


Dr. Henry Anhalt  17:50

So Teplizumab and I had a really hard time pronouncing that I started working at Provention Bio in December. And I'm finally getting around to it right. And it wasn't only narrow, actually that I heard about Teplizumab when I was working back in 2008, at a hospital in New Jersey, there were these clinical trials ongoing with tech lism ab. And at the time, I became really familiar and saw what the potential that this drug had. But to answer your question directly Teplizumab is administered by IV infusion over a period, at least in the trials over a period of 14 days as one single infusion. So that's the way that the trial that we're talking about the data that we're discussing, that trial had a 14 day single infusion, so IV infusion every day for 14 days straight. That was the data that we talked about was the outcome of that trial. Ultimately, though, the FDA will make the decision of based on the data that exists, how many days of infusion, etc. Got it.


Stacey Simms  19:14

But to be clear, when we're saying it's three years later, those people that they're measuring three years later had, it's still from those first and only two weeks.


Dr. Henry Anhalt  19:23

That is correct. So people had a two week infusion, and this population was followed out. For quite some time, actually, the recruitment took seven years, but this population has continued and when you have this rolling admission into a trial, it becomes a little bit difficult to to characterize, but suffice it to say based on the appropriate data analysis, that's the conclusion that the authors came to and obviously incredibly encouraged by those results. So with the follow up time, We have nearly a year later, it shows now approximately three years,


Stacey Simms  20:05

I may be jumping to conclusions and correct me if I'm wrong. But I'm sitting here thinking, if my son Benny had gotten something like this at 23 months, and we could have delayed the onset of type 1 diabetes, until he almost went to kindergarten like that, to me, I know that there's more implications down the road, but just the idea that he would be able to communicate a little bit better. With me, maybe he could pronounce diabetes, there would be some other things that we could have some really difficult stages that we could have skipped. And I know that you're looking for a lot more than that going forward. But man, that's so remarkable to think about. And I know everybody listening is thinking in their own families, the milestones that can come in three years, it's really interesting stuff.


Dr. Henry Anhalt  20:49

Stacey, I have to pause when I listen to you tell that story. Because for me, I have only a glimpse of the burden that people living with type one, or parents or caregivers experience, I have a glimpse, because I have the privilege of stepping into the sanctity of a family and being open to hearing these things. But to your point, what is that? What does that mean to a child or to a family that you can have a delay of two years or three years? Or even longer than that? What does that mean? So this ability to do that the data indicating that this can do that can do exactly what you're talking about? It can delay to a time where kids can be more able to communicate signs of hypoglycemia, a kid in college, perhaps, delay until after college, and so on and so forth. So how do you put a measure on what that means for a family? You know, what that means? Two years or three years being insulin independent? How can you describe that to someone who doesn't quote unquote, get it? What that means to a family? So I know, just like you would, from personal experience, what I've heard from my patients and their families, how much that could potentially have meant, and how much that can mean to them going forward?


Stacey Simms  22:31

It really is. It's, I was gonna say, it's fun to think about, I'm not sure that's the right way to say it. Because in my mind, it's kind of fun, because I think about how silly my son was at that age, but it is really encouraging to think about, I'm curious, are there any concerns, side effects, anything that people need to be aware of when it comes to the prism app?


Dr. Henry Anhalt  22:54

So you know, I think that every drug has potential risk and benefit. And we have to be fair and recognize that, however, in the data that's been published, from the trial that we've been discussing the tn 10 study, it was shown that the side effects were manageable, that they were easy to address resolved on their own. And that's consistent with all the other studies that have used Teplizumab. So from our perspective, and looking at the data, we feel that it's appropriate to say, yes, there is always a risk, that the side effects that were seen in any of the trials were expected. And were easily manageable


Stacey Simms  23:48

as we wait to see what the FDA will do. Are you still looking for people to be in studies?  You know, my audience is always very interested in that. Are there more studies that people can take part in?


Dr. Henry Anhalt  24:05

Yeah, so we currently have a study ongoing, it's a multinational study multi site in the US called protect. And this study, as opposed to the data that we've been talking about that showed you can prevent progression from stage two to stage three. This is a study for people who are newly diagnosed between the ages of eight and 17 within the first six weeks, and I would urge people if they have any questions, or they need any information to reach out and Stacey you and I can talk about what the best way to have that information or those queries directed because when we talk to people about going online and looking at clinical it becomes As a very, very difficult website to navigate.

But suffice it to say that this is a trial where kids between the age of eight and 17, newly diagnosed are given an infusion or placebo of Teplizumab. And they are given another dose, about six months or a year later. Again, this is an infusion. However, it's a 12 day infusion, rather than a 14 day infusion. And there are two infusions over the year. And in that study, were measuring c peptide. And as I mentioned earlier in the podcast, c peptide, is a measure of beta cell function. And so the most important measure for us is beyond hemoglobin A1C how are those beta cells working? How is the residual beta cells producing insulin at this point? And how do they produce insulin after the treatment has given as measured by what we call area under the curve of C peptide production? The amount of C peptide over time, responding to drinking a whole lot of sugar, and seeing where it is that the that the C peptide is produced? I think that that's really an important piece.

I also, Stacey, if I may take liberty and talk about Provention Bio for just a moment. Yes, please do. Because it comes back to camp a little bit. And you may wonder, like, what's the connection? When I first started at Provention Bio, we had a town hall. And you know, if 45, 50 people I don't remember. And the CEO, Ashley Palmer was talking about the importance of us understanding the type one community and I was like, okay, you know, that's words, know, sounds good. And I said, Okay, is a company dedicated to type one? Okay, that sounds good. And so I chatted the group, and I said, you know, I'm on the board of Camp Nejeda, most of us live in the tri state area, I'd be more than happy to host you and to have you guys pink benches, and, you know, do all kinds of cleanup the garbage in between sessions. And he said, You know, that's not here. That's part of your job. And I said to myself, I've worked in other companies that have been in the diabetes space, I have never heard a CEO get up and say, this is your job. It was mind blowing. And I knew then, you know, I was in the right place. Right. So with that sort of as a backdrop, we are really committed to type one. The innovation here is, I think, a landmark in the fact that it will be the first disease modifying if we get the approval, which we hope, the first therapeutic intervention in type 1 diabetes, since the development of insulin, and potentially the only one that is going to be disease modifying. But we're not just there.

And as we spoke about, were in front of the FDA now with the hope that we'll get approval for the at risk population. But we're also in clinical trials to see the ones who are newly diagnosed. So if unfortunately, they've gone on to stage three or symptomatic, or we're also working on a vaccine for coxsackie virus. And so coxsackie has been thought of as a precipitating agent or, or an infection that could potentially provoke or create an immune response that ends up being adversely affecting the pancreas. And the crazy thing is that as a pediatrician, first we would see coxsackie virus all the time. But you know, I have the good fortune of working in a company with a lot of really smart immunologists and I joke and I say, you know, if I would have known immunology was so interesting, maybe I would have paid more attention in medical school. But the fact is, here's another way that we're looking at type 1 diabetes, and the commitment there to innovation is truly remarkable. And I would be remiss if I didn't have the opportunity to state that on this podcast, because I think that speaks to the motivation and it speaks to the genuine commitment to people and their caregivers living with type one.


Stacey Simms  29:53

You mentioned camp, and as we've mentioned a couple of times here you are a pediatric endocrinologist. So you Between the two of those things. You've seen a lot of families over the years, you have probably had a lot of nervous moms and quiet dads in your office with little kids too, grumpy teenagers and independent young adults. I'm curious when you talk about something like to please him on. And you mentioned, as you said, this could be the first therapy, disease therapy it for type 1 diabetes. I know you don't have type 1 diabetes, but boy, are you part of all of those families? Can you speak a little bit about what that means to you?


Dr. Henry Anhalt  30:31

Well, I often joke with people that, you know, I would be more than happy to do anything, including working in my parents’ lingerie store, then taking care of people with type 1 diabetes, not because I hate type 1 diabetes, I do. But it's because I see what happened, what families go through. So for me, what it means to me. If again, if we get approval, I'll feel like I've I finally was able to do something, you know, when you get to the point in your career, when you're working with families who have type one diabetes, and you come to the honest realization that you can't fix it, you no surgeon can go in there and cut it out. But you can't fix it. And the burden really sits with the family, the grumpy teenagers who didn't ask for this. So we're dealing with the intimacy issues, college issues, you name it, the high school kids who are trying to deal with their all the complex issues of psychosocial adjustment to high school and body image, etc. It's unbelievable. So for me as a treating physician, anything, anything. And it's not only templates, a map, but anything that could make them living with diabetes just a bit easier to lift, a little bit of the burden would be incredibly meaningful to me. And that's sort of how I got into this, I was trained to make people who have type 1 diabetes feel that they're never doing a good enough job, that they're at risk of developing all these complications. And you know, when you get to the point in your career, you realize that not only did that not help it hurt, and then really being in a position to hopefully be able to make a fundamental difference and how that goes down. It's really hard to articulate, I have to say,


Stacey Simms  32:31

Did your parents really own a lingerie store?


Dr. Henry Anhalt  32:33

They did. Olga’s corset and specialty shop two Eastern European immigrants who came here penniless trying to build a life for themselves in the golden land.


Stacey Simms  32:45

Isn't that marvelous?


Dr. Henry Anhalt  32:46

That's wonderful. It sure is. It sure is. Yep. Yep. All they wanted us to see their kids, you know, get an education. And of course, you know, me becoming a doctor. I mean, my dad almost ran up to the podium when I got my diploma. He just couldn't contain himself. So yeah, absolutely.


Stacey Simms  33:05

All right. I think we've got everything and more.


Dr. Henry Anhalt  33:08

Yeah, I mean, I would leave you Stacey with, if nothing else, to really, really get the word out for people to screen for dogs to really hear from their families. You know, why don't you screen, I have another kid that to us. And I think to the whole community, now, there's potentially something that can happen. You mentioned trial net, and trial net has done an amazing job in getting tech lism ab to where it is now. And they've done an amazing job at moving the screening field forward. But it's got to get out of the realm of research alone now because now where they're now where potentially at the threshold of a whole bunch of therapies that we hope will get approved and capitalism AB hopefully, if the FDA is happy with the data, and convinced that the drug is safe and effective, which we have great confidence that they will or others coming right behind. So the screening is so critical, Stacey,


Stacey Simms  34:15

thank you so much for joining me, we will link up all of the information and spread the word as best we can. But thanks for explaining everything and come on back, knock on wood. If everything goes through the FDA, come on back and share what's next.


Dr. Henry Anhalt  34:27

I would be delighted to do that.


Unknown Speaker  34:35

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  34:40

More information on everything we talked about at Diabetes You can learn more about teplizumab and provention. It's really fascinating stuff. And you know, it's not as easy as you know, one shot and you're done or one pill a day. I mean, it is as he mentioned, a an in hospital procedure, but imagine two weeks of that And then two, three, maybe four years, maybe more of prevention of type one. I mean, what an incredible beginning. I don't get my hopes up often you know me if you've listened for a very long time I I wouldn't say I'm cynical, but I'm certainly not running after every development. But I feel like we've been watching this one for so long, I'm almost ready to put my rose colored glasses on, we'll see, I'll keep you posted on you know what comes out of this, what the FDA decides, and you know, there's going to be a lot more information down the road.

Up next in innovations. f It is time to get cynical again, I'm going to be talking to you and bring you some audio about a roundtable on insulin pricing. So stay tuned for that. But first Diabetes Connections is brought to you by Dexcom. And you know, when we first started with Dexcom, back in December of 2013, the share and follow apps were not an option. They hadn't come out with the technology yet. So trust me when I say using share and follow apps makes a big difference. I think it's really important to talk to the person you're following or sharing with, get comfortable with how you want everyone to use the system. And even if you're following your young child, these are great conversations to have at what numbers will you text, how long will you wait to call that sort of thing. That way, the whole system gives everyone real peace of mind. I'll tell you what I absolutely love about Dexcom share, and that is helping Benny with any blood glucose issues using the data from the whole day and night and not just one moment. Internet connectivity is required to access separate Dexcom follow app. To learn more, go to Diabetes and click on the Dexcom logo.


Last week, a new group or at least new to me called investigate insulin now partnered with the American economic liberties project and held a discussion about the impact of insulin pricing. I'm going to read you the description from their website.
“Nearly 7 million Americans suffering from diabetes need insulin to live but a cartel of drug companies who control the production of insulin, Eli Lilly Sanofi and Novo Nordisk have made the lifesaving drug criminally expensive by colluding with each other to hike prices in lockstep over and over and over for years.

On March 18, at 12:30pm, the American economic liberties project and the investigate insulin now campaign hosted a discussion focused on the dangerous impacts of the insulin cartel racial inequalities in insulin access, and what Congress and the new Biden administration must do to hold these corporations accountable and address concentration in this critical industry.”

And that is the quote from the website. I'm going to link this up, you can watch the entire discussion. It is less than an hour, but it features Congresswoman Katie Porter, who you may recognize from her whiteboard. Many people just know her from that. But she's part of the oversight Subcommittee on economic and consumer policy. And then the remarks here are from people with the American economic liberties project to an international insulin advocates, the executive director of Social Security works. So there's a lot of people talking here I want to bring you one short clip. This is about a minute long. And this is Matt Dinger. He is a patient, as you'll hear, he is an advocate, and he is a board member at T one International. He has just said that he doesn't know anyone who uses insulin, who hasn't rationed it at one time or another. And he sets up His comments here by saying that at one point he had no insurance for just one month he was switching jobs, and he knew that he would have no insurance for a month. And that resulted in him rationing insulin ahead of time. So he would have a stockpile, and then also rationing after he got the job and had the insurance because he knew his deductible would mean he would be paying $1,000 a month for insulin for the first few months.


Matt Dinger  38:51

I'm lucky to be in the position that I'm in. And even so I'm a job loss away from financial ruin. Because the concentration of economic power when it comes to the price of insulin lies almost entirely in the hands of three companies. I am completely beholden to them. And I'm terrified by that every single day. Corporate concentration and monopolistic behavior by the big three insulin manufacturers allow them to set prices as high as possible, with no fear of losing market share. This includes things like shadow pricing, which is increasing the prices in tandem with one another instead of competing to set the lowest price, pay for delay agreements, lawsuits, taking biosimilar insulins off the market, patent games to extend their product exclusivities long past when they would normally expire.

As someone who has worked in healthcare for the entirety of my professional life. I understand the price of innovation. And let me tell you leveraging anti-competitive practices in order to give your CEO a pay package of $23.7 million isnt innovative. and businesses that would do that while their consumers are dying aren't companies, they’re cartels,


Stacey Simms  40:01

it's pretty powerful stuff. I'll link it up. If you want to watch it, it is less than an hour. The investigate insulin now campaign is a coalition of a bunch of different organizations. And I think we're going to be hearing a lot more from them, because these are some pretty big names that are backing them. And while there's a lot of hope that the new Biden administration will move on some of these, there really has been no indication from Democrats or Republicans, in my opinion on the federal level that we will see strong action taken. So I'll continue to keep you posted on this one as well. I can't imagine the insulin companies are going to take kindly to being called a cartel. I thought that was some very interesting language.

Alright, before I let you go reminder that I will be speaking live to some JDRF folks out west tonight, that's linked up on social media and in this episode, as well. And if you know, if you're listening a couple of days or weeks after this episode airs, I'd love to come to your chapter virtually, or maybe in person down the road. So please reach out we do have an event tab at Diabetes And you can always request me to come speak or just you can ping me anywhere, email me directly. I love talking to groups. It's always so much fun. I always learn something as well.

In our classic episode this week, we're going to be talking to a Broadway performer Maddie Trumbull, and she has played lead roles and Wicked and Newsies. And we'll check in with her and see how she has been doing this interview was five years ago now. And of course, the last year has been you know, we've seen Broadway completely shut down. So I checked in with her and I'll let you know what she is up to in our classic episode airing in just a couple of days.

Thank you, as always to my editor John Bukenas from audio editing solutions. thank you as always for listening. I'm Stacey Simms. I'll see you back here soon. Until then. Be kind to yourself.


Benny  41:57

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

Mar 18, 2021

Julie Allred received two separate islet cell transplants ten years ago. How is she doing today?

Diagnosed at age 10, Julie was told she would never have children and she wouldn't live to see age 30. She’s proved her doctors wrong on both counts – her daughter was married a few years ago – but she did have a lot of trouble with unpredictable and debilitating lows in her 30s. These lows were so unpredictable and dangerous that she not only stopped driving, she barely left her house. Then she found out about a clinical trial of islet cell transplants.

This interview was first aired in January 2016

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Episode transcription:

Stacey Simms  0:00

This episode of Diabetes Connections is brought to you by Inside the breakthrough, a new history of science podcast full of did you know stuff.


Announcer  0:13

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:19

Welcome to a classic episode of the show. As always, I'm thrilled to have you here. Glad you could join me. And these classic episodes are where we revisit terrific interviews, really great guests from the early years of this show that you might have missed the first time around.

There is a new excitement right now about islet cell transplants, this thinking has been around for a while. But the problem has been that once the cells are transplanted, they're immediately attacked, you know, so the islet cell trials of the late 90s and early 2000s, didn't pan out the way that we had hoped. But new science, new technology is showing a ton of promise. And we're going to do some future episodes on what's in the works. There are at least two really big projects moving to clinical trials. I'm thrilled about this because it always seemed like it made so much sense. And this kind of stuff was around right as we were coming into the community, me and Benny and my family 14 years ago, it was kind of the tail end of when they realized that while it worked well for some, it wasn't going to be the cure type of research for many, many people that it had shown so much promise to be. But it really is important to remember that islet cell transplants worked really, really well for some people and you're going to hear from one of them today.

I spoke to Julie Allred in January of 2016. More than five years ago now. She was diagnosed at age 10. And she was told she would never have children and that she would not live to see 30. She has proved her doctors wrong on both counts. Her daughter was married herself few years ago. But Julie did have a lot of trouble as she moved into her 30s with unpredictable and debilitating lows. These low blood sugars were so unpredictable and so dangerous that she not only stopped driving, she barely left her house, you'll hear her talk more about that this was not your typical low that almost everybody who uses insulin has experienced. Then she found out about an islet cell transplant clinical trial. She shares the whole story and I'll give you more of an update on how she's doing in just a moment. Spoiler alert. She's doing amazing.

This episode of Diabetes Connections is supported by inside the breakthrough a new history of science podcast full of did you know stuff. The most recent show is all about unpopular science. One of the stories, it's bonkers. It's about a scientist who discovers the importance of washing your hands. The death rate at his hospital drops once he starts telling people to do this. But then they think he's insane. They discredit his theory and they lock him up and they stop washing their hands. You have to hear it. You can find inside the breakthrough wherever you found this podcast, and this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Judy Allred had two islet cell transplants, one in 2011 and one in 2012. She is going to tell the whole story here in just a moment. But I want to give you a quick update on how she is doing now. 10 years later, she says she still uses just a few units of basil insulin a day. She does wear an omnipod but she says she uses it just for basal. She very rarely boluses. And she says the only time she goes low is if she quote makes a bad decision when bolusing for food because she's so rarely does it anymore. This really changed her life. I should also mention that I know Julie because she was our elementary school nurse. That's who I got to send a little Benny to when he was in grade school. How lucky was I?

Julie Allred. Thank you so much for joining me.


Julie Allred  3:57

Thank you for having me, Stacey. I'm excited to talk with you. Yeah, I think this


Stacey Simms  4:00

is gonna be fun. It's always great to. For me, it's always interesting to learn things about people with type 1 diabetes, but it's also fun when I get to talk to to a friend. So thanks for agreeing to do this. Tell me your story. Yeah, tell me your story. You were diagnosed with type one, when you were just 10 years old, right?


Julie Allred  4:20

I was 10 years old and that was in the late 70s. So why can I tell people always that was before we had all the technology of course that we have today before we had manmade and storm. No glucometers we didn't even have Diet Coke. You know, what was that good old unsweet tea with a saccharin tablet. Those were your choice.


Stacey Simms  4:42

That's amazing to think about. How did you how did you manage diabetes before home meters.


Julie Allred  4:50

There was no homie here correct. So I use urine that we put in the test tube with some little tablet sets. He has done turn colors and it was a good gang. If you only do that, if you felt bad, there was no certain schedule to when you tested your urine. And as you're probably aware, urine sugar in your urine shows up about six hours after it shows up in your blood. So really, when you tested that urine and found out, you know, you had sugar there, it was well beyond the time that your blood sugar would have been half. And you didn't do anything about it. When you saw it there, you just made you aware, there was that insulin you took in the morning insulin, you took it bedtime. And in the middle of the day, there was nothing, there was no sliding scale, there was no carb counting. Nothing like that we ate by the exchange diet, which some people may be familiar with, and maybe not the day, but so many carbs, so many fats, and many fruits and vegetables. So all the things that everybody is familiar with now all the technology, all the things we have to keep ourselves healthier and and make things easier for non existent bands.


Stacey Simms  6:04

Now I've heard you speak and you've talked about how the doctor said you were not expected to live to 30 that you would never have children. Of course, you do have a great a daughter who I've met. But But did they really tell you that? Or was that something you were just aware of?


Julie Allred  6:20

They never told me I found that out and my 30th birthday party. Because my husband had a birthday party for me, of course, my family came my daughter was three at that time. So uh, my mom's sitting in the corner crying, you know, we're having a party, I'm like, what's wrong. And that's when I found out when she told me there, that when you were diagnosed, they shared with us that you were not expected to live to age 30. And that you definitely would not be able to have children that was just not in the cards for people who are diagnosed. And again, you know, diagnosis, disposable syringes were the new thing. So just all the technology that that has come about, exist in the time that I've been living with diabetes is amazing.


Stacey Simms  7:07

I'm just trying to have the perspective that your, your mom,


Julie Allred  7:10

your mom had? Well, I think about that. And you know, you mentioned I'm a school nurse, my school nurses, when I was a little girl that That being said, I didn't check my blood sugar at school. So mom packed my lunch, I ate that. But other than that there was not really anything, per se to do for me at school, you know, unless I complained about not feeling well, or something the teacher would call her but they're just the things that are available today. The things that we do today to manage things so closely. We're just not available Batman. So yeah, it was not a concern.


Stacey Simms  7:46

I'm just trying to think of her being told you would not live to be 30. And then being at your party, must have been an incredible ride for her. But as you got older, you began to have some real difficulties living with diabetes. I know you had a lot of episodes of low blood sugar. Tell me about that.


Julie Allred  8:05

My dad, so I did very well, I actually, you know, got a insulin pump in 1990, of course, glucometer in the early 80s. So I was kind of always trying to stay on the cutting edge with technology and have the newest latest and greatest thing to help me manage. And I did really well. I still was doing really well as far as how I had managed, not that I always did absolutely everything I should the best I should. But I had been fortunate enough to not to experience any of the complications that are a lot of times associated with type one didn't have any problems with my kidneys, I had great steel. None of those things that a lot of times people began to have problems with as they move into 30 plus years with type one. And I was 34 years with type one, the problem that I was experiencing, experiencing was those unrecognizable low blood sugars. And that started probably in 2007 or eight somewhere around there. It it became more difficult for me to know when I was having a low blood sugar, the symptoms changed. And they became less evident to me. And as time went on, they just eventually just went away. I didn't have any signs or symptoms until I was so low that I couldn't help myself. I would get to the point where I realized that I needed to do something that at that point, I couldn't do anything for myself. I had to rely on someone else. So you were in that slow traveling.


Stacey Simms  9:46

You were driving, right?


Julie Allred  9:49

I was driving. And many times I would even was married that's my daughter who was now will be 21 next week at that time she was you know in her Team so not driving yet but a couple times we'd get to a stop sign or a stoplight and she would put the car in park and take the keys away and call my husband because she knew you know that it wasn't safe. And I did have a couple episodes where I ran off the road. Fortunately for me, and others never hurt myself or anyone else. But it the discussion, the next discussion at my doctor's appointments going to be taking my driver's license away, because that was unsafe.


Stacey Simms  10:27

It's so scary to hear about.


Julie Allred  10:29

All that being said, I still had the latest and greatest, I still have the newest pilots. I had a dexcom CGM. At that point. I was doing all I needed to do. And of course, my medical team was doing all they need to do to help me. It was just that that was my complication. I guess you can put it that way. But I just was not able to feel those lows and do anything about them. And enough time to help myself.


Unknown Speaker  10:55

Is that how you get into work was


Julie Allred  10:57

not an option either. Yeah, I was working about 10 hours a week was all I could manage?


Stacey Simms  11:02

Is that how you were able to get a trial?


Julie Allred  11:05

Yes, that is how I was able to get into the trial because I laugh and tell you how to be a fairly healthy, unhealthy diabetic to qualify for the study that I participated in. That being said, you could not have any kidney issues, all those things that I talked about that I was fortunate not to have experience. But the low blood sugar. The hypoglycemic unawareness was the key to qualifying for the study I participated in. So they asked me about how many low blood sugars I thought I had in the past year, that one of my first visits, I have no idea. I was horrible. I was mad at writing down my blood sugars. But we went back and looked at at the month, at one month that had passed. And from that guesstimated that over a 365 day period, I probably had 300 I think we came up with 386. Wow. was until a by definition for them a low of anything. 54 below.


Stacey Simms  12:05

Oh my gosh.


Julie Allred  12:07

Right. Wow. How did you


Stacey Simms  12:09

feel during this time? Was this something that you were used to? Or was it did you feel lousy every day?


Julie Allred  12:17

No, I said, I felt bad. And and the left felt bad. But I didn't realize how bad I felt. A lot of it was my normal. I slept a lot. You know, when I was at home. I felt like I never slept well. And I guess I probably didn't two, between two and three a 3am was probably my worst time. That's when I would have the most severe loads. And of course, you know, everybody else is asleep, too. So that makes it even more difficult. But I just always my, my constant thought was when I could lay down if I got up to do something, it was how quick Can I get finished with it. So I can sit back down so I can lay back down. Because to me all I saw, you know, 15 minutes of laying back down, and I'll feel better. And that was just never the case.


Unknown Speaker  13:10



Julie Allred  13:12

I didn't do and the probably the year, year and a half before my transplants I was became pretty isolated. I didn't say that at the time. But I say that now, I just didn't go and do things. I didn't go out of the house a lot would find an excuse not to go to a party or you know not to go to dinner with somebody because I was always afraid of what was going to happen when I was there. And I of course didn't do anything by myself. Nothing. I didn't even go to the grocery store alone. Somebody was with me all the time. So that was very frustrating for me. And for my family. Of course, let's talk


Stacey Simms  13:50

about the clinical trial, you have been through two procedures right for transplanted pancreatic islet cells, the cells that produce insulin in 2011 and 2012. And I'm gonna I'm gonna walk through this, so tell me if I get this right. But this is the operation where basically they they put the islet cells into your into the liver, right, which helps. And then they take over the job of making insulin. When you went through this, did you know was it the kind of trial where and I forgive me for my ignorance? Are there people getting placebo islet cells? Or is it all everybody gets the real thing because you're going through surgery and you know,


Julie Allred  14:33

right? Everybody gets the real thing? That's correct, because these are human hours that are that are donated from organ donors just like any other organ would be donated. So they use the whole pancreas normally for a pancreas transplant. But a lot of times even when you have a donated pancreas, it can't be used because in the process of organ donation, you know, of course thanks at a higher level some things at a higher level level than others, the kidneys and pancreas work together in the body and to to isolate both of those organs. Of course, the kidneys are more useful, you have two kidneys, those can go to two separate people, all the necessary blood vessels that are needed to do those transplant go to the kidneys. First, the pancreas is next on the list. So a lot of times even though you have a pancreas that may be suitable to use, you don't have all the necessary blood vessels that go with them. So that keeps it from being available for transplant as a whole organ. So what they do is use that organ and isolate the eyelet sales from that pancreas and transplant them. And that is how I received the alpha cells I received. How, yes, that's what see those on the waiting list for a heart or, or lung or kidney or whatever, and the head has to be matched in the same way you have to go through all those all those same steps. And then check with your organ donor.


Stacey Simms  16:00

Do you then after the surgery take immunosuppressant medications?


Julie Allred  16:06

Yes. How is that because everyone that


Stacey Simms  16:09

I'm sorry, Julie, everyone that I've heard talking about this, they always say, Well, that sounds great. But the drugs you have to take to prevent rejection are so harsh. How is your life since then?


Julie Allred  16:21

Well, it took a little bit in the beginning to get all those things regulated. And and I'm not saying it was easy. But it was a lot easier than what I had been going through. So taking those five or six pills a day seemed like nothing to me, compared to the life I had been living compared to the to a low blood sugars to not being able to work, all those things that have, you know, had gone on before. I did have a little problem with Jia upset in the beginning. But again, it's just getting all their things regulated, you know, for each individual. And that happens with anybody with a transplant. And once that happens, I did not experience any terrible side effects. I still take those medications on two times a day on a daily basis. And they're just part of just part of my life. Now, a lot of people say, Oh, you have to take pills now. I do. But all those other things that were issues or are not issues anymore. And I guess it depends on how you look at it. And it was a wonderful trade off for me. I would do it 100 million times over again, all the all the bad parts, the good parts, were just a million times better. Well, here we are five years ago, there were issues right here we are almost five years later. And when I been here, kind of not participated in that study, I would say I would not be unfortunately. And I am I have a driver's license, I work a full time job I volunteer I'm engaged in, in the life of my child and able to participate and do things that I have always wanted to do. But always felt a little bit hesitant to do and especially in this, you know, four to five years prior to the transplants that I just didn't allow myself to do those things. So people say well, you have a normal life, not really life like I've ever known. That's a good point.


Stacey Simms  18:21

Tell me about what you do for diabetes because I remember reading that initially at least after the surgery you still worn insulin pump Do you still check your blood sugar? What do you do now? Do you consider yourself cured?


Julie Allred  18:34

If you can't say cure technically and no I'm not because I did were the insulin pump after the first transplant because even though those eyelets were working, I didn't get the equivalent number of hours to what you know a normal person would have. So I continue where my insulin pump I went from taking 75 units and on a day to 11 units between that first and second transplant and then after the second transplant I was insulin free for 96 days completely insulin free. Again I had a little issue with some of the medications and of course the major side effect to those medications or damage to your kidneys and or pancreas. So they did damage I had some toxicity to one of the medications and they believe they damage the islets a little bit. So I started back on insulin and June after the second transplant unsavoury of 2012. And I've taken a small amount of insulin at bedtime since then,


Stacey Simms  19:39

but that's it. You're not wearing an insulin pump currently.


Julie Allred  19:41

I'm not wearing it and so on top. I do not have low blood sugars. I do not have high blood sugars. Do I eat whatever I want. Not whatever I won't I just don't think that's in me. I mean, there's still that there's still always that After in the bathroom, I'm always thinking about what I'm eating, how many cards bed what you know, what would that do? What is it going to do now? Because that's part of being in the study? Is there not a lot of answers what to expect in the future? That's part of participating in the study is, we will let them know what to expect in the future just by following us. And there were 273 participants in the study that I've participated in. So we're part of what's going to happen in the future. They're getting all that information from us. So yes, they still follow me. Yes, I still check my blood sugars and provide them with that data.


Stacey Simms  20:36

But would you mind if I asked him, please don't answer if it's too personal. What is your typical blood sugar?


Julie Allred  20:42

And my last day once he was 6.20? Wow. Yeah, right there. Again, right on the edge. Technically, if you look at the textbook standard, Dima non diabetic, maybe not. But I'm a million times better than I've ever been absolutely. Great.


Stacey Simms  21:00

Before we leave this part behind, because I definitely want to talk about the school nurse component. Tell me about the


Unknown Speaker  21:09

visit the rosebowl


Unknown Speaker  21:11

talk, tell me about right.


Stacey Simms  21:12

Yeah, the Rose Parade. Tell me about the Donate Life. Rose Parade, the float that you were in for Donate Life.


Julie Allred  21:19

Right. So in 2000, January 2014, I was the first islet cell recipient to add on the Donate Life float in the Tournament of Roses Parade. And so I ratters on that. Riders on that float are all transplant recipients, and all the float as well, or floor graphs or pictures of donors that are honored on the float. And then there are also people who walk around the float and those people are living donors. So they've all usually donated kidney. And Donate Life has had a float in the rows pray for I believe this was the 12th or 13th year. So I was sponsored by Emory Transplant Center to go and represent Emory transplant and outsell recipients on the donate lifeflight. What was that? That was amazing. Very, that was an amazing experience. So you know, I've always watched the Rose Parade on TV and think how fabulous that is and and realize it Yeah, that's a big deal. That's a big parade. But I had no idea until I went participated in the whole event. And we were there for six days, you know, a few days leading up to the price. So I was honored to be able to help decorate the float place all those, you know, some of those roses on that float. So the donatelife float, the bottom of the float is always decorated with resins that are dedicated either in honor of memory or memory of someone. So they all have a personal tag with a handwritten note. And so I was honored to be able to place those verses on the float. And the rule is that you read every note on every rose before you put it on the float. So that was that was really a special experience for me, David, my husband got to go with me and help. As we decorated, we spent three days helping decorate the float. And then of course, I read it on the slide on New Year's Day. But again, a tremendous once in a lifetime experience to meet so many wonderful people from all over the country and other parts of the world as well. transplant recipients, donor families and those special living donors. Wow,


Stacey Simms  23:28

that's an incredible experience. I was so exciting to see you part of that. So Julie, we've known each other for few years, because of the local jdrf chapter, you've done so much work with them. And, you know, I was on the board for a while there and we've kind of circled around each other. But then a couple of years ago, you became our school nurse. And so I have to put a caveat out there as we begin this conversation, I promise I'm not going to ask you anything specific. I understand the HIPAA laws and I understand the constraints you may be in. Because you know people may know what school you work at. But I just thought it would be a great opportunity. Because I talked to a lot of parents who have difficulty dealing with their school, the school nurse or the school principal, or teachers don't seem to understand the needs of kids with type 1 diabetes, they they may insist that the kid go to the nurse for every single thing. They may be frightened of the kid. And I was just curious if you could share some advice. I know you and I have such a wonderful relationship and we never give you any trouble and our child is an angel so we'd have to go down that road.


Julie Allred  24:34

But they all of course,


Stacey Simms  24:36

what but you know, it's interesting before, I should point out, we have four kids at our school with type 1 diabetes, all of whom manage very differently. It was very different, right? Not even in terms of the technology because there's different pumps. One child has been on MDI until very recently, transitioning from injections, but every parent is so different. And it's been a lovely experience because the school has Never said to any of us, you need to do it this way. What's your advice for parents, though, for working with this, right?


Julie Allred  25:06

The biggest piece of advice I can give to parents is to meet with your teacher and meet with your school nurse. I guess I'm sort of at an unfair advantage when it comes to managing my children and helping them manage at school and the relationship I can have with them, because I've lived with type 1 diabetes, and that that does give me a very different perspective. As you know, and as most of the parents know, the understanding that the the general population has a type one is sometimes a huge misconception. And, and to help them understand the communication between between the parent, the teacher and the school nurse is the key. They have to be able to understand and you are the person to help them understand your child. The other part is that every child is different. And I think that's hard. Sometimes for teachers, especially a little bit hard for the nurses as well, because there is no black and white with type one. Every child is different, every day is different. Sometimes every minute is different. And you just have to be able to go with the flow a lot of times and so there's not all you can't always answer every question for them and give them give them an example of everything that might happen. You know, in a school day, it's all about communicating again, with a parent, the teacher, thing about that school nurse as a teacher communicating with the child. Like your son, a lot of these children are diagnosed at a very early age. And even sometimes by the time they get to kindergarten, they've been doing this a while. Yeah, they know a lot about type one. They know a lot about how domains things themselves. And sometimes that's hard for people to understand that a kindergartener really can't check their own blood sugar, they really do understand, you know, how this technology works, that these kids do. So having that relationship with the child, for the school nurse to have that relationship and the teacher, to have that relationship with the child and keeping the lines of communication open, I think is the most important thing. Again, because they all managed differently. Nobody way is right or wrong, nobody has better than another's. It's all based on that that particular individual child and what works best for them.


Unknown Speaker  27:35

What I love about you, and if you


Julie Allred  27:37

can continue what you do at home, if you can continue that at school, it just makes it so much easier for everybody, for the parents and for the children. And the teachers, I think and the nurses say eventually that it makes it easier for them as well.


Stacey Simms  27:50

Oh, yeah, you don't want to change management, I was just gonna say, what makes me laugh. And what I love about you, too, is you do know this so well, that, you know, My son has gone through times where he's been, oh, my diabetes, or he'll give somebody that puppy dog eyes. Oh, and you don't get into any of that. It's great. You're just like, Look, I know what you're doing. I know where I've been, you know, go back to class or, you know, we'll deal with it or whatever. And I think that that perspective is so valuable and wonderful, they really appreciate that. But if if a parent is, really, I think a lot of this comes from fear. That there there may be, as you said, misconceptions, and I see a lot of parents, especially online, who will write things and they're just on Facebook, they don't really mean it, I think half the time, like I'm going to go to school, you know, I'm going in swinging, or I'm really upset, and I'm going to give them a piece of my mind. Can you speak to that for just a moment, just in terms of, you know, trying to, I always tell people, you know, approach as a team, even if you hate these people, they got your kid for eight hours a day.


Julie Allred  28:52

Right? They do. And I can say, not as a parent of a child with type one. But as, as a type one who works with these children that have type one and, and I know, I feel like where they're coming from a little bit better, maybe then not better than a parent does. But in a different way than a parent. I get it that it's hard to trust someone the first time that you send them out of your sight. To know that they're going to be taken care of like you take care of them at home. So again, approaching it like you said, as a team, sit down with everybody don't have the separate meeting with the teacher and the nurse, everybody meet together so that you're all hearing the same thing at one time you come up with a plan that works for everybody, because a lot of times nurses not aware of every the schedule in every classroom, and a lot of times everybody in the second grade does things pretty much the same, but a lot of times they don't So again, it's knowing all the specifics of what goes on even hour to hour during the day and how we can best manage that during the day. And then what do we do? If there's a problem? You know, who's responding, who's gonna call Who? And then even comes down to sometimes, you know, does the nurse needs to call the parent? Or does the teacher need to call the parents? And just coming up with the sample the answers to questions like that, but don't get you bogged down during the day, when there's so many other things going on. Meaning as a team, listening, what the child has to say to is very important, because they're the one living in that environment. They know what they're comfortable with. They know how comfortable the teacher how comfortable they are with the teacher, how comfortable they are with the nurse, how long does it take them to get to the nurse? If they're not in their classrooms, if they're in another area of the building? You know, how long does it take to get there? What should we do then involve the child because again, these kids are smart. Most of them are very independent. And they have a lot of good ideas and information that I think we need to consider and take into, you know, taking into consideration when we're making the plan for the for the school day. It's great advice. A lot of it is to I think people are very intimidated by the fact you know, especially a new teacher, maybe who's never dealt with this. Again, sharing with him and showing them bringing the child before school starts if you can, if they're newly diagnosed tremor day or two before they're going to be there a whole day, and let them see the child checking their own blood sugar, administering their own insulin, using their insulin pump, that they really are independent. A lot of times when they do they need a second set of eyes. Do they need adult supervision? Yes, they do. But many times, that's just what it is supervision, double checking. These kids know what to do. Yeah, that's


Stacey Simms  31:59

a great point. We've done that with a lot of teachers. And once they realize that they're that they're not going to become a nurse or doctor while they're to die. That really assuages a lot of fear.


Unknown Speaker  32:09

So Julie, what's next for you? Does


Stacey Simms  32:11

this those trials continue indefinitely? Do you go back for periodic checkups? Are you scheduled for more surgery if I can be super nosy and ask


Julie Allred  32:20

right now, just yearly checkup? am considering another transplant that's kind of out there on the horizon? It may be a little while. And then there are all those things like encapsulated owlets that are going on right now. So there will be another adventure for me, let me just say that I'm just not sure what it is yet. But in the meantime, I'm happy to be working in school to be sharing my experience with these kids. And people say you know, you've had such success. Yes, I have. Has it changed my life? Absolutely. It has has it changed the life of my family? Yes. But it's also changed the lives of other people. I said, this goes way beyond me. Hopefully it's changed, eventually will change your life safety and the lives of all the kids and all these parents and they're dealing with this on a daily basis. And whatever they learn from me, whatever successes I have, whatever mistakes that we've experienced, we learn from it all. And so the hope is that down the road, we're all going to have the experience of living those days without type 1 diabetes. That's that's just what I'm looking forward to.


Stacey Simms  33:38

You know, I love doing this podcast, but it is hard to be a news interviewer when I'm trying not to cry. I tell you, Julie, when you talk about this, I don't know if it'll be this type of transplant, or it'll be encapsulation. But I know that the information that comes from people like yourself, who who sacrificed I know, you say it's good that you did it. It's wonderful. But you've sacrificed a lot to to get to this point. I know that information will help people and thank you so much for doing that.


Julie Allred  34:09

Absolutely, I would I would do it a million times again. Julie, thank


Stacey Simms  34:13

you for talking to me for sharing your story for making me cry. That wasn't fair. I really appreciate you joining me today.


Julie Allred  34:21

Absolutely appreciate you speaking with me and appreciate our friendship, and all that you do for the tight bond community. I mean, you are the go to person in this area. And we love hearing you and we we truly appreciate all the information that you get out to us, sometimes on a minute to minute basis. It's really it's valuable information. And if people ask me again, why I'm still you know, involved because it's, it's part of who I am. I want the best, not only for myself, but for all of you as well. And it's just it takes it takes the whole community to support each other and we need to continue that support and we thank key for all you do to provide support to the type one community.


Stacey Simms  35:03

I'm leaving it there because I'm gonna start bawling.


Unknown Speaker  35:10

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  35:16

I'm gonna link up some stories that were done on Julie in the past and some information on clinical trials and islet cell transplantation. I'll put that on the show notes at Diabetes And the episode homepage as always has a transcription, I do have to share one embarrassing story. It's embarrassing for me. I remember hearing Julie speak for the very first time Vinnie was not yet in elementary school, so and she was not even at that school yet as a school nurse. But I heard her speak at a jdrf event. And I'm embarrassed because I kind of didn't believe her. I was in a moment of time. And I don't know how you reacted when your child was diagnosed, or when you had your own diagnosis. I did not want to hear about cure, I was very cynical, I was closing my heart to those things. I just didn't want to hear it. I just wanted to get through the next couple of years of learning how to do this and keeping him healthy. And that was just my reaction. And when she spoke about islet cell transplantation, I was not in the right place to hear the message, as some people might say, and I talked to her afterward, I don't think she even knows this. And I was just kind of politely nodding. And people were saying, you know, oh, you should talk to her for your blog, because I was blogging at that time. And, you know, it was on the local radio. So you talk to Julia, what a cool story in my head, I'm going well, I'm not gonna do this. This is false hope this is good for anybody. And this is going to work. You know, I think I was just in the wrong state of mind. And so I'm glad I spoke to her. I'm glad I learned more about her story. And that, of course, when I started the podcast, she was one of my first guests very excited about the future of islet cell transplantation. Sure what she went through is not a cure, and it didn't work for everybody. But you can hear how much her life changed. Absolutely amazing. I'm thrilled. Think about all the stuff that they learned from it. Just great.

Okay, coming up next week, I'm talking to the people from Pro vention. I say it very clearly, it's not prevention, it's prevention. This is the company behind to please him up, which I say as clearly as I can. That is the drug that is showing such promise of delaying the onset of type 1 diabetes. It is in front of the FDA right now. We'll be explaining the whole thing. But the great folks from prevention. By the way, the gentleman who works there that I'm talking to is not only a pediatric endocrinologist, he is a diabetes camp guy. He's the director of a big diabetes camp. And so he gets it and he gets emotional just like the rest of us. I really enjoyed talking to him. That's next week. Thank you so much to my editor john bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.


Benny  37:46

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

Mar 2, 2021

Right now, the very first diabetes technology with roots in the do-it-yourself community is in front of the FDA. Tidepool CEO Howard Look joins us to talk about what, if approved, will be a prescription mobile app controller: Tidepool Loop.

We get details on the submission, including everything from how you’d actually get this app to whether you’ll be able to set your own blood sugar target ranges to which devices Loop could work with, international possibilities and much more.

Learn more about Tidepool Loop 

Watch this interview on our YouTube channel 

Our first conversation with Howard Look from 2016

Howard announces Tidepool will shepherd Loop to the FDA (2018)

Howard mentioned Tidepool documents. Find those here

In Tell Me Something Good a teenager with type 1 has a big idea about a Funko Pop character and some positive news for diabetes camps this summer.

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

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

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  0:21

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:26

This week, the first Do It Yourself based diabetes tech goes to the FDA. We will get details on the submission of Tidepool Loop  , including everything from how if approved, you'd actually get this app to whether you'd be able to set your own blood sugar target ranges,


Howard Look  0:43

we did  in our submission to the agency proposed flexible set point. We are in review right now. That is something new, and most companies before us have submitted with fixed set points or a limited set of set points. That is something that we are discussing with the agency we're not yet cleared, so I can't tell you how that discussion will go.


Stacey Simms  1:05

That's Tidepool CEO Howard Look. He also answers questions about which devices this version of Loop  could work with, international possibilities and a lot more. in Tell me something good a teenager with type one has a big idea about a Funko Pop character and some positive news for diabetes camps this summer. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Welcome to another week of the show always so glad to have you along. We aim to educate and inspire by sharing stories of connection with a focus on people who use insulin. My son was diagnosed with Type One Diabetes just before he turned to my husband lives with type two diabetes, I have a background in broadcasting. And that is how you get the podcast.

This week's subject is one that a lot of you are really excited about. I was going to say it's something that you've been waiting for. But I know a good portion of my listeners are part of the we are not waiting movement, and are using a DIY version of Loop  already. For those who are not. What is Loop ? Well, that's a big question and I will direct you to a bunch of our past episodes. With the we are not waiting hashtag you can just go to Diabetes there's a search box on the upper right hand side of the website. And I have put all one word hashtag we are not waiting as a search term for any episode that deals with that with the DIY community. Of course, you can also Google Tidepool Loop  , that sort of thing. But as simply as I can try to define it here, Loop  is one of a couple of programs created by the community. This is not something that's commercially available, and it helps insulin pumps and continuous glucose monitors communicate. DIY Loop  uses a Riley link another external piece of hardware to help with this. And it works with Omnipod and older Medtronic pumps. There are other programs openAPS Android APS, which work with older Medtronic pumps. That is a very quick and very light to say explanation of it.

So I urge you if you're interested, although Howard always does terrific job of explaining more when I do talk to him here, I just want to make sure that you understand kind of all of the groundwork, this is not something that have popped up in the last couple of months. In fact, in late 2018 Tidepool , which was well known by then as a nonprofit, open source, a call it an information hub for people with diabetes, they announced they would shepherd DIY Loop  through the FDA making it a lot easier for non diy yourself types to access what is really life changing technology. And now just over two years later, they've submitted and I don't know if an information hub is the best way to describe Tidepool , but it was started because there was no place at the time to view diabetes data in one place, I don't believe there really is still you can see data from your pump, your CGM, your meter all in one uploadable place and use interactive graphs and see trends and patterns in a way that was never available before. And I don't think it's available as robustly anywhere else. And then you can share with your healthcare team and invite other people and your healthcare providers to look at your charts and your graphs and your data. So that's how Tidepool s started.

And if you want to hear the whole story about how they stepped up to take this new task on, again, I will link up these specific episodes at the homepage for this one at Diabetes By the way, this is also a video interview, you can check that out at the Diabetes Connections YouTube channel, I'll put a link in the show notes there as well.

I do want to give a quick disclosure here. I did a project for title in the spring of 2019. I was helping out with some research interviews in the community, that sort of thing. I bring it up because they paid me as a freelancer. And while they've never paid me for the podcast, I think it's important to always let you know about that kind of thing. By the way, I'm very good at community interviews and freelance projects like So reach out if you ever need a hand.

Okay, Howard Look in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen. And you know, almost everyone who takes insulin has experienced a low blood sugar and that can be scary. A very low blood sugar is really scary. And that's where Gvoke Hypopen comes in. Gvoke is the first auto injector to treat very low blood sugar. Gvoke hypo pen is pre mixed and ready to go. With no visible needle. That means it's easy to use, how easy is it, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it, find out more go to Diabetes and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit gvoke slash risk.


My guest this week is co host Howard book here to talk about the very exciting submission of a Loop  app to the US FDA, there is so much to talk about here. But Howard, let me just first welcome you to the show. Thanks for coming on.


Howard Look 6:05

Hi, Stacey. It is so great to be here. I'm so excited to see you again. And so grateful for you having me on your show.


Stacey Simms  6:12

Thank you. You know, it's funny to look back. And we have a lot to talk about. But I should say as we're getting started here, I have talked to you many times, but twice for the podcast and the first time was almost five years ago now. So as we go through this conversation, and as you're watching or listening, there's gonna be a lot of presumed knowledge, I think we're not going to try to explain everything. So I will link up the previous episodes where we talked about title and it's early days, and then the announcement a couple of years ago about this. But I think that even just a quick, cursory Google search will get you up to date before you listen to the interview. But there's a lot here. So Howard, thanks again. Let's dive right in. My


Howard Look 6:52

pleasure. Thanks for having me.


Stacey Simms  6:53

What did you all submit? Tell me about what actually went to the FDA.


Howard Look 6:58

I have learned more about how FDA submissions go than I ever imagined my whole life. So we submitted what is known as a 510 k application, which is a big set of documents that says to the FDA, here's what we have built. And here's how we built it. And here is the work that we did to show clinical evidence to show software cybersecurity, what's called verification data, how we know that the software is working as intended. It describes what it looks like, how it works, what the requirements are. And all of that ended up being about a 2000 page submission, which sounds like a lot, but I've heard that other submissions are far far bigger. So we feel like it was a well crafted submission. And we are now in the thick of what is called FDA interactive review. So we sent in our submission on December 17. Turns out that was a snow day in Washington DC. So that was our thing. So our lawyers office used a courier  to get a DVD ROM and deliver it to silver springs, Maryland. And what the FDA got was a bunch of documentation about Tidepool


Stacey Simms  8:14

you submitted Tidepool Loop  , this is an app, what is you know, what do you I guess we can fast forward what would the finished product be?


Howard Look 8:22

So Tidepool Loop  is a mobile application once it is cleared by the FDA and I have to be super clear it has not yet been cleared by the FDA It is currently under review. So it is not yet available. But once it is cleared Tidepool Loop will be a mobile application for iPhone. And people will be able to get it just like you get any other iPhone app by going to the App Store and downloading it, it will be prescription required. So you'll have to go to your endo or your doctor and say this is something I would like and get a prescription code. And then people will be able to download that app from the App Store. And what Tidepool Loop  will do is it'll connect to insulin pumps and continuous glucose monitors. And it's what's called an automated insulin delivery device or some people call it other people call it closed loop or artificial pancreas. But basically it's software that automatically controls insulin delivery based on glucose values. And based on predicting how your body is going to react to insulin and carbohydrates. And it automatically uses an algorithm or math a fancy word for math to decide how much insulin you should get. So long winded answer Tidepool Loop is a mobile app that controls insulin delivery.


Stacey Simms  9:40

Well, it's not long winded at all because I know there's a lot more to it than just that even But to be clear, when I think about this, and we'll go I would love to talk more about the history and DIY and and so much of that. It basically is the brains of the operation. So you have your pump, you have your CGM but you need that program. So you know, we have the controller queue we have horizon with Omnipod, if I'm getting that right used to be type zero, which we may see in other pumps, this is that


Howard Look 10:07

that's exactly right. There's there's three pieces to an automated insulin delivery system. There's the insulin pump, which I think most people are familiar with, but it holds a reservoir of insulin. And sometimes it's something that you clip to your belt, like a Medtronic pump or a Tandem pump. And sometimes it's a self-contained unit, like an Omnipod that sticks right on your skin. So that's component number one is the insulin pump. component. Number two is the continuous glucose monitor. And the one that I think a lot of people are familiar with is the Dexcom G6, that's a super popular continuous glucose monitor or CGM, but there are others out there as well. And then the third piece is this controller piece in the middle. And what the controller does is it reads the data from the CGM. It also takes other information such as what your insulin to carb ratio is, what your insulin sensitivity factor is, knowledge about your basal rates. And it combines all that information using math and determines how much insulin you should be getting. And what's cool about it, people living with type one diabetes are used to that and used to doing the math on a napkin to figure out what their dose should be. But what's cool about it is that the software does it for you. And in the case of most automated insulin delivery systems, it does it automatically every five minutes, which is great, because that's a lot of math, and it's doing it for you. And it's also paying attention to how your body is reacting to what happened previously. And that's why it's called a closed loop system. It delivers insulin it it determines information. And then that brings that information back into the system to determine what it should do on the next iteration of the loop .


Stacey Simms  11:49

And it really has been amazing. I mean, we use I mentioned control IQ. And I had no idea even though I had been told I could make you know, 300 decisions a day, one every five minutes, and then an additional one every hour. I remember the first morning I checked, and it kept Benny at like, let's say one 10th or 105. Great number I was so excited to see. And I thought oh, well, it didn't have to work very hard last night, because he was just cruising.

And I went into the pump.


Stacey Simms  12:12

And it had adjusted every five minutes. It's incredible. I don't know why I had, I hadn't thought about it that way that it would have to work just as hard right to keep him at that number. And it's not something that most people really have the inclination to sit there, you know, and do all day long. It was amazing to me just in a way. Howard, I gotta tell you, and you look at this as a parent of a child with type one, it kind of assuage my guilt of not being perfect all these years. Oh, yeah.


Howard Look 12:40

Yeah, I know exactly what you mean. So our daughter, Katie, she's 21 now but she was diagnosed with type one when she was 11. And I totally I know exactly what you're talking about, as a parent, that feeling of why can I get this right? How can I do more? What Why is this so hard? And the answer is, because it's frickin hard. It is really hard work. And these systems are taking that really hard work and bottling a whole bunch of it up into these decisions that it can make every five minutes. And even they have to work hard. If you actually look at what the systems are doing. They're adjusting insulin delivery up or down every five minutes. And they're doing their best. And it's still really hard. And so yeah, I know exactly what you're talking about, and realizing what we as parents did getting up multiple times during the night giving correction doses trying to get it right. Like we all deserve a gold star for that because it is frickin hard work. You know, and everyone living with type, of course will start to because not just as parents, like people living with type one, doing this


Stacey Simms  13:46

for decades, exactly with no breaks. So I have a lot of specific questions about title that my listeners have sent in. I'm cautious about getting too specific. I'm going to ask you, you may have to say can't answer that. Can you answer that? But before I do, I'd love to take a moment and talk about the significance of this being something that started as part of the DIY community.


I was looking back and my podcast started in 2015. But we are not waiting and started really that that same came in 2013. But people working on things like this before that. Yeah. What's the significance? As you see it, of my understanding is this is the first kind of crowdsource DIY diabetes component.

I'm not really sure what else to call it to go in front of the FDA. It seems like we should just kind of stop and mark that.


Howard Look 14:31

I agree. There is so much to celebrate about the story. And what you just mentioned, is one of the huge components. So Tidepool Loop is based on an open source project that was known as Loop. I usually call it DIY Loop just to differentiate it, but it was just known as Loop. And there's a wonderful medium blog post by Nate Ratcliffe, who is the original author of Loop  and he talks about how the works He did was built on top of the work that people did before him, people like Ben West and john Costik, who figured out how to control diabetes devices over wireless communication protocols. And then Pete Schwab who's the, his daughter is named Riley and Pete went and taught himself hardware design so that he could invent the Riley link, which made it possible to control at first Medtronic insulin pumps and then later Omni pod pumps remotely from an iPhone over Bluetooth. So it's this really incredible story of innovation of people figuring out how to make this happened.

There's a whole other wonderful blog post that for your technically minded readers about the reverse engineering efforts that went into figuring out how to control the Omnipod, and how to add that functionality into Loop , which at the time only could control Medtronic pumps. And so it just goes on and on and on. There's a gentleman named Joe Moran, who was instrumental, he's been living with type one for decades, and he was instrumental to that effort. And so there's the open APS community and the Android APS community, Dana Lewis and Scott Liebrand, who I know you've met. And the story is that when the community really wants to do something, they just go figure it out, it's the most it to me the most incredible example of tenacity and innovation, and grit, and everyone working together for the greater good. And all of that transpired with people just doing their thing on their own, you know, nights and weekends, or, you know, none of them all of those names that I mentioned, it wasn't their day job to go do that. They did it because they wanted to help improve lives, their own lives, or the people they love living with with type 1 diabetes. And so what we did at Tidepool is we saw how popular Loop  or DIY Loop  was, my daughter started using it when she was still in high school, six years ago, and was getting incredible results, a bunch of other type coolers. Were using it.

And we thought to ourselves, you know, what, we're in a really interesting position as a nonprofit, as an open source organization that has chosen to engage deeply with the FDA that we could take this open source project built by the we're not waiting community, and we could actually bring it into our regulatory quality system. And we could take it to the FDA and say, Hey, FDA, we actually would like to make this broadly available, we would like to put it in the App Store. And we started floating this idea with everyone with the we are not waiting community, with the device makers that would have to cooperate with the FDA, with the funding organizations like JDRF. And the Helmsley charitable trust. And across the board. Everybody thought it was a great idea. And so that was really, to me, it was just so heartwarming to know that everybody agreed, yes, this needs to happen. It can't these great systems that are helping our kids sleep through the night and helping us achieve, you know, really great, lower burden control of our diabetes, that we want to do our part to now pay it forward and help make it broadly available. So I was just I couldn't be more thankful and grateful to that entire community. So I often say we are standing on the shoulders of we're not waiting giants.


Stacey Simms  18:30

That's great.

All right. So now let's get down to the nitty gritty because people want to know what this is really going to look like. Let's start by talking about understanding that things change. And I'm sure that you want to work with everybody down the road, when or if this is approved. What are they approving? Is it for use with just Omni pod? I know you have an agreement with Medtronic, what starts out of the gate?


Right back to Howard answering that question. But first Diabetes Connections is brought to you by Dario. Health. And over the years, I find we manage diabetes better when we're thinking less about all this stuff of diabetes tasks. That's why I love partnering with people who take the load off and things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you. All the strips lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends, with suggestions for how to succeed get the diabetes management plan that works with you and for you. Daria has published Studies demonstrate high impact clinical results, find out more go to my forward slash Diabetes Connections. Now back to Howard Look talking about what devices will pair with Tidepool Loop .


Howard Look 19:48

So the first thing I have to be super careful because this is not yet an FDA cleared product and the FDA has very strict rules about marketing a product before it's actually available. So I'm just gonna make a statement upfront that I will probably repeat over and over, I'm going to describe the process to you that we are going through. But I'm not yet describing a product that is cleared by the FDA. And we are not yet approved to market this. So I'm what what we can do because we're a nonprofit because we're radically transparent. We share everything that we're doing with the community. So all of our engagement with the FDA, for example, we've publicly, openly published on our website. So your listeners who want to actually see what we've talked to the FDA about can go to documents, and see all of the interactions we've had over the years that I'm about to describe. So here's what I can say, openly, transparently. publicly, we have announced that Tidepool , the organization has development agreements with Dexcom, with Medtronic, and with Insulet. What I can't say is the other device makers that we are also working with, I can just say that there are other device makers, every device maker has their own timeframe about when they are comfortable talking about it. And so the first pair of device makers that we announced where Insulet, Omnipod, and Dexcom, with the Dexcom G6. And that's really notable because they have already gone to the agency, and they themselves have submitted their devices for clearance in this interoperable ecosystem. So I should if you want me to, I should probably take a little sidebar here and talk about interoperability and how


Stacey Simms  21:36

you may certainly take us out into what I call the Mr. Potato Head. Diabetes technology, so the floor is yours.


Howard Look 21:43

Super. So the FDA really gets a huge amount of credit here, because they went to industry to all of us in the diabetes device business, and they said, Hey, all y'all device, diabetes device companies, this is way too hard when you come to us with these big giant submissions for these big giant systems that include all of those components that I talked about earlier, the pump, the CGM, the controller, and everything that has to go with it. So we the FDA would like you to start thinking differently. And what they did is they issued what are called de novos, which is where they make a new product classification de novo literally means from the new and so it's a new product classification for interoperable components, and they created three different components, the eye CGM, or integrated continuous glucose monitor, the ACE pump, or alternate controller enabled insulin infusion pump and the AGC the interoperable automated glycaemic controller. So those three de novos are critical because they allow a company like us to say, hey, FDA, I'm not coming to you with an entire system that does all three things together. I'm just coming to you with one piece. So we have submitted an AGC the interoperable automated glycemic controller Dexcom submitted the IC gm Insulet submitted an ace pump and has also been talking about their future Ace pump roadmap, Tandem did the same thing. what's notable about Tandem is they submitted an ace pump and an AI AGC. So you were mentioning the type zero algorithm earlier the algorithm that is known as control IQ started its life as the type zero algorithm. So they submitted both an ace pump, which is the Tandem x two platform and the AI AGC which is known as control IQ technology, which, as you know, started its life as the type zero algorithm. So we owe a huge debt of gratitude to the agency for creating that interoperable pathway.


Stacey Simms  23:48

I'm going to probably ask you a bunch of questions that you will answer just like that. And I'll try my best not to know that while there is a large component of people very interested in the history, and the alphabet, the alphabet soup and everything you went through. There's also a large amount of people who say, when this thing comes out, can I slap it onto my Omni pod and use it? Yes. So the question then becomes, does it matter what type and again, if you can answer this I totally understand. Does it matter what type of pod they're using? Because we have dash we have on arrows and we don't use Omni pod, so I may be getting this wrong. And then we have Octopod, five with horizon coming out later this year. So you know, people are saying Howard, what do I stock up on?


Howard Look 24:31

I see. So let me so I can't specifically say what will be cleared by the FDA because it hasn't been cleared yet, but I can tell you what the intent of Tidepool Loop   is. So Tidepool Loop  is intended to be an IEC and interoperable automated glycemic controller. And in order to be that type of device, it can only work with IC GM or Ace pumps. So it will not be able to work that with anything that does not have an ace pump does it And it will not be able to work with anything that does not have an IC GM designation. Got it?


Stacey Simms  25:06

Okay. And then my next question is, and this comes back to I think I asked you this the very first time when you announced, you know that you were hoping to shepherd Loop to the FDA. And it's an interoperability question that I still can't wrap my brain around. I'll give you the example of Omni pod. So I'm very excited this fall, I get my Omni pod five with horizon. It's got its own hybrid closed Loop  system, or whatever they're calling it these days. And then I hear Oh, Tidepool  is out. And I want to go to the app store and get Loop . Do I flip a switch on my Omni pod? PDM? Or do I have to? Do I have to right now, because I know you're talking to interoperability in the future and everything. But what happens now? Can I switch to it? Or do I have to pick one and then stay in that?


Howard Look 25:47

I don't believe people will be locked in the so there is no Well, I shouldn't speak for Insulet, right, there is no switch on the PDM pods. The way pods work is they can pair to one controller at a time. But pods are disposable. So if you pair one controller to a pod, you can pair the next pod to a different controller. So that would be the idea there, there's no switch that you flip, the idea with type will Loop would be as a different kind of controller that you wouldn't need to use your PDF, you would use type of Loop  on your phone. Great.


Stacey Simms  26:19

I think everybody's gonna hopefully they all want to go to phone anyway. And that's what everyone seems to be working for. And I know most of my questions that are also for Omnipod. And you really can't answer them. So we will talk to Omnipod down the road and find out more. So let's go back to a bunch of questions about the targets because one of the things that people love so much about DIY, is that they can really set these target ranges for how they want and other things. Um, can you speak to that? What kind of flexibility as compared to what people understand with DIY Loop? May they experience the Tidepool Loop?


Howard Look 26:47

Yeah, it's a super question. The first thing I will say is, we totally understand how the community loves having the flexibility of choosing their own target range set points. And we believe in that as well. That is definitely something that type schoolers who use DIY lube, understand the value in that my daughter uses DIY Loop . I've been very public about that. We did in our submission to the agency proposed flexible set points. We are in review right now, that is something new, and most companies before us have submitted would fix set points or a limited set of set points. That is something that we are discussing with the agency, we're not yet cleared. So I can't tell you how that discussion will go. What I can tell you is the agency has been great. They have been so good. During this review. I know a lot of people like to dump on the FDA. I will not do that. Because my experience with the agency has been these are hard working really dedicated public servants that really want the best, safest and most effective solutions for the community. And the questions they have asked us about our clinical study day about how we built the product about cyber security is all completely reasonable. And so I know they are seriously considering it. And we're hoping we will know the answer to how


Stacey Simms  28:13

well it's interesting too, because as I mentioned kind of offhandedly. Everybody's working towards bullets from phone and control from I'm sure many of them the more I guess I can't say commercial and leave you all out now. But many of the traditional commercial systems are working toward that. Can you share a little bit how it looks on the phone? Because that's so novel for so many of us that haven't even thought about that before? Use it before in our phones?


Howard Look 28:35

Yeah, well, it's a little tricky. I wish I could just bring it up on screen. And what I will tell you is for your listeners that are used to what DIY looks like Tidepool Loop will look extremely familiar. There's there, you, you know, we've changed some colors and move some icons around but it'll still look extremely familiar to anyone who has seen DIY Loop  before. For folks who haven't seen what Loop  looks like, you can go to our website, there's a screenshot of the home screen. And obviously once it's cleared, we will publish all kinds of more information about what all the screens look like. But anyone who has seen DIY Loop  and understands the home screen with the glucose chart, the insulin chart with the buttons that let you bolus and do target pre meal targets etc. It'll all look extremely familiar and type


Stacey Simms  29:28

is it Apple and Android


Howard Look 29:30

we submitted only for iPhone for now. And the reason for that is DIY Loop  is only for iPhone. So the fastest path to us submitting and to getting it out into the community was to go with what already existed. That said we absolutely are committed to building an android version. We're also committed to going outside the US which is also the next question I usually get asked. And so we are a small company. We like any good small company. staying focused on one thing at a time and making sure we do that one thing well, so that one thing right now is getting it in the app store in the US, approved by the FDA, and then moving on to Android and outside the US is absolutely on our roadmap. And stay tuned. I don't want to over set expectations about when all that's gonna happen, we definitely will get to it.


Stacey Simms  30:21

Excellent. Yes, that was stuff. That was one of the questions. I'm curious, though, for somebody, you know, I don't even use my son's pump anymore. He's 16. I don't even see anything anymore. But I'm curious, in your studies with folks and somebody who's used DIY or your daughter is used for a long time. Is there anything different when you do use your phone as a controller? Other than convenience, I'm wondering if there's anything noticeable and different about it?


Howard Look 30:45

Well, I think what people report people who have been using DIY live, because no one has used a Tidepool Loop on their body yet, but people who use DIY Loop  report that the freedom and convenience of having the interface on the thing that you're carrying anyway, is really wonderful. And Loop  also includes an Apple Watch component. And I know a lot of people find that really liberating to be able to manage your diabetes right from your wrist. So I think what we've heard from DIY Loop  users is, hey, look, I've got my phone with me all the time. Anyway, I'm looking at my phone all the time anyway. It's just so nice to be able to just interact with my diabetes using this thing that I use all the time anyway. Wow.


Stacey Simms  31:26

So just to be clear, you can control it from the watch as well, or That's it? Yes. Okay. Yes,


Howard Look 31:31



Stacey Simms  31:32

In the clinical trials, or the testing that you had to do for the submission, what came out, I mean, there was so much kind of, I don't know, it's off the record information for DIY. But I imagine that with tight pull Loop  you really show did you have to demonstrate better control or just safety.


Howard Look 31:47

So this is another fascinating part of the story and how the community contributed to the success of Loop  the FDA very early on, when we started talking to them about the possibility of submitting, we said to us very clearly, we love real world evidence. And so the clinical study data that we submitted with the 510 k application for Tidepool Loop  , it's actually clinical data that came out of the Loop  observational study of the Do It Yourself Loop  community. And this is really an incredible study because it had over 1000 people in it, over 700 of whom were actively uploading data. And the amount of data in the study is staggering. As a matter of fact, the total person years or person days of study data in this study, if you take the control, IQ, pivotal study, the bazel, IQ, pivotal study, the Medtronic 670 g, pivotal study, and add it all up. The Loop  observational study of DIY Loop  has three times as much data submitted as those studies are three times as much data that's part that was collected during the study. So it's really a staggering amount of data. And we are really just overwhelmingly indebted to the community to all the people who participated in that study. And that was the foundation for the clinical evidence that we submitted with Tidepool , which is a pretty amazing thing. And I don't know that that has been done in that way before. Now, the data that is from that study has been published. So for your listeners who want to learn more, there are a couple places you can go the Job Center for Health Research to publish the paper, and I'm sure a quick Google search will turn it up. It's called the Loop  observational study. It's also on clinical And if you want to see the presentation that was shown at last year's attd, and Madrid right before Coronavirus, broke, or was in full swing, February of last year, that's on our slash documents. So to answer your question, what was interesting, what was interesting is how broad the use of Loop  was, it was down to people under two years old and there were people in their 70s. There were people from all walks of life, it was just really fascinating to me, remember, this is a real world study. This was not a controlled intervention study. There wasn't a randomized control arm and people not using it. It was just observing life of people using it. And so to me that was the fascinating part is that so many people were willing to raise their hand and say, I want to help donate my data. And I'm going to show you how it works for me.


Stacey Simms  34:36

And we'll link up those studies that you mentioned, but I assume that they were good studies, in other words that people were happy with their agency, their time and range, ease of use safety, all that stuff,


Howard Look 34:46

the data, it looks great. There's some really fascinating outcomes. The way it works with the agency is only the FDA can say what's safe and effective. So we present the data to them. Here we say here's why We think it is safe and effective. But at the end of the day, the FDA is the one that gets to say, Yes, we agree. And therefore you are now FDA cleared. You know,


Stacey Simms  35:08

you've already mentioned this several times, but Tidepool  has always stood out for being very open source, very open with information, publishing everything that you can saying as much as you can. I am curious that now that you have gone through something like this, are you happy that you did it that way? Would you do it that way again,


Howard Look 35:28

so the part about being an open and transparent organization I love, I think it is a great way to go. And I know it's not for every company, there's great value to big commercial companies like Apple choosing to keep their product plan secret, and then doing a huge launch and saying, tada, here's what we've done. For us as a small nonprofit with the mission of supporting the diabetes community, I think it's a great way to go. Because it allows us to be really clear that look, our motives are not about profit, our motives are about doing the right thing for the community. And to me, the openness and transparency just makes all that completely clear. There's another part of the story, which is doing it as a nonprofit, we happen to be doing both. We're open and transparent. And we're a 501 c three nonprofit, that part is tricky. I will be honest, especially during the pandemic, a lot of nonprofits including us have been hit hard. And that's been really challenging. It is much easier for a for profit company to weather a storm, if they've got a venture capitalist willing to give them funding or they can take out a loan as a nonprofit that has been challenging. Would I do it the same way? Again, I totally would, none of us could have predicted the pandemic. So it is what it is.


Stacey Simms  36:47

So with your nonprofit status, if I decide after FDA approval, and I can go to the app store with my prescription from my doctor, Uh huh. am I paying for it? Is my health insurance paying for it?


Howard Look 36:59

So here's where we are. And I will be open and transparent about this, which is we don't know yet. So as a nonprofit, our goal is to make the software as broadly available as we possibly can. We are engaging in commercial deals with some of these device makers so that they will actually give us money when people start using lube because obviously, we're bringing new customers to them that are going to keep buying supplies and pumps and cgms from them, we would love to keep the price as low as possible. And if there's any way we can do it, we want to make it free. We're not sure we can yet we've got to project out how it's going to go we do have a we we have people on staff and we have to pay them we're not going to do it has a way of making money the way a for profit company would we don't have to answer to investors, we don't have to answer to the stock market, we would only do that if it helps us be a self sustaining organization. And it helps us continue to deliver on our mission.


Stacey Simms  37:59

Somebody it's fascinating to think about the questions you start asking when you start going down this road of as you said, nonprofit and open source, everything else is an on that road. There are rumblings they're not really there yet of other possibly DIY routed projects that are waiting to see what happens with you guys. Right? So if you can, it's kind of like when Medtronic gotten sick, 70 approved. And then other people said, okay, we can now take our product. And we'll probably get it through the FDA with a lower, you know, time and range without calibration and things like that. Do you think that? Is this going to be the start of a different kind of diabetes technology? approved by the FDA? Like in five years? Could we have different like, you've already mentioned open APS and different things that you've built on. I wonder if there's somebody working on something today that because of the title submission would have an easier time coming through. So I asked about three questions in there. Sorry,


Howard Look 38:51

I, I sure hope that this is the start of a revolution in how new diabetes technology is created and delivered to market, whether it ends up being open source projects, or it's because we've shipped like we share all of our source code, we share our regulatory quality management system openly, we will publish our 510 k submission once we get through interactive review and clearance. And we're doing that because we want to help other people. Like for us, it's a win if there's lots more technology coming out that gives the diabetes community more choice. And that allows our kids and people living with diabetes and to have better solutions that fit better in their lives. That's a big win. Like we've got no ego invested in this. I want lots of companies, whether for profit or nonprofit, whether based on open source or closed source, it kind of doesn't matter. What I want to see happen is innovation. And I want that innovation to happen more quickly and get into the hands of people who can use it more quickly. So that's the wind for us.


Stacey Simms  39:57

As we start to wrap up here my interaction portability questions still are out there. And again, I know that you cannot speak to different products, and that's fine. I mean, you can and that's fine too. But when I think of true interoperability, and my ecosystem is limited just because of what my son uses, but I think of Okay, if I want to use this controller, but whether it's Tidepool Loop   control, IQ, or Omni pod horizon, whatever, and I want to use a Libra, and I want to use this pump or I want to use a Dexcom. Or I want to use the Dana pump or whatever. There's, there's all these pumps, and CGM is coming to market. Are we going to see that anytime soon?


Howard Look 40:35

I am very optimistic that true interoperability is on its way. And one of the huge reasons we are doing what we're doing is to show that that is actually doable, you should be able to pick the pump that's right for you, you should be able to pick the CGM that's right for you, you should be able to pick the controller and the user experience that's right for you. I do imagine that there is a world where you can say you know what, I'm the pregnant mom living with type one, or I'm the athlete living with type one and I have very different needs, and the system should be able to adapt to you. And you should be able to choose which thing is stuck to your body to work best for you. So I am very, very optimistic that interoperability is happening. And we are pushing on it and we and I believe the FDA wants to tap into. That's why they made these interoperability pathways.


Stacey Simms  41:27

I remember when I saw one of your presentations on the shoulders of giants presentations A while ago, one of the things that people really like in addition to the the wonderful blood sugar control they get from DIY lube, they really like the icons, there's like ice cream and pizza. There's all this neat little stuff in the app Are you able to share it with you could just save any of the cute stuff.


Howard Look 41:48

Oh, there is a cute, the cute stuff is still there. Like I said the experience of Tidepool Loop   will look very familiar to users of DIY Loop . And one of the things that people love about DIY Loop  is the ability to use emojis to indicate the type of food you're having, whether it's the lollipop for fast acting carbs, or pizza for the very long acting carbs, and all the emojis in between. So that's something that people love about DIY Loop . And we have maintained that in in Thai polish.


Stacey Simms  42:22

I said it was my last question. I lied. I meant to ask you. The first time I talked to you in 2016. We were talking about Tidepool  as an a data company. Right? I want to see my data I want to free the data is that still part of the mission? Is that still something that's part of the core of title moving forward?


Howard Look 42:41

It absolutely is. So at title we like to say Our mission is to make diabetes data more meaningful and actionable. And seeing all your data in one place is still absolutely part of our mission. pypo web and title uploader are incredibly popular. As a matter of fact, we have about three times as many users now as we had before the pandemic started. Because when there's a pandemic, it turns out, you need a way to upload your data remotely. And so that is absolutely still a part of what we're doing and making diabetes data meaningful. actionable is still absolutely part of what we do. Awesome.


Stacey Simms  43:24

Well, Howard, you've been so generous with your time I appreciate it so much. Just one more thing is your how's your daughter doing? You've got you've got three kids. Yeah, one child was dying with type one. But everybody You're like an empty nester, almost.


Howard Look 43:37

We are an empty nesters. But Katie is doing great. Thank you for asking. She's in college, and she is doing wonderfully. I will tell her you asked about her.


Stacey Simms  43:48

Oh, absolutely. Thank you so much for sharing all the information. Come on back, when and I will say when you get FDA approval, and we can share lots more details. But I think this is phenomenal. I'm so excited to just kind of be part of the information stream over the last couple of years. And it's just been so much fun to follow this. So thanks for coming on, Howard.


Howard Look 44:08

Well, thanks for all of your amazing questions. And it's just been so great to have you been with us and sharing our story over the years and so we're really, really grateful to you and all your listeners.


Howard Look 44:24

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  44:30

Lots more information at Diabetes I know you had many more questions. I got so many questions in the Facebook group for this topic. But once I went down the road with Howard, I realized there were a bunch that he would not be able to answer. Frankly, most of them were for Insulet or for the makers of Omni pod. So I reached out to them and I will continue to ask them to come on the podcast. It's been a while I think they're waiting until they get FDA approval for their next product. But I'm working on it and I hope to talk to them as soon as I can. I Know You all have questions. And boy, it's a really exciting time. I hate that the technology. And title is not an example of this. I hate that a lot of the technology got backed up because of COVID. But man, this is going to be a very exciting year or two as things that have been kind of delayed, get released, which is why I'm doing this focus on technology this year. So I'm very excited about it. And I cannot wait to see so many questions there about what the FDA actually approves. And we know Tidepool  with all of their wonderful open source and access to information we know that they will let us know. And I'll pass it along as soon as I learned anything.

All right, let's talk about Tell me something good. We're gonna have a story or two about summer camp diabetes camp, and a teenager with type one has an idea for a Funko Pop, that you're going to love. Diabetes Connections is brought to you by Dexcom. And one of the most common questions I get is about helping children with type one to become more independent. These transitional times are tricky elementary and middle school then middle to high school, you know what I mean? Using the Dexcom really makes a big difference. For us. It's not all about share and follow although that is very helpful. But think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four or five finger sticks at school, or for a second grader to just show the care team the number before Jim, you know, at one point Benny was doing up to 10 finger sticks a day, and not having to do that makes this management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at Diabetes and click on the Dexcom logo.


This is normally the time of year where people are signing up for camp. I know certainly for us, we're already our summer is planned by the end of February when my kids were younger with this both school aged kid and we both worked full time. You know I had summer programs done by this time, but of course it was COVID everything has changed. So it tells me something good. I was excited to share this week that I'm hearing about more summer camps that plan to be in person. And diabetes camps are certainly tricky, because while everybody should be taking lots of precautions because of COVID. You know, people with diabetes really need to take more precautions. So I was thrilled to find out just a couple that I'll pass along and I'll put more of these in the Facebook group. Hopefully we can get more as the information comes in. And as you learn what your local campus doing, we can share that info.

But Texas lions camp, which is the one that among other people, Dr. Steven ponder runs, they are doing something really interesting this summer, they have decided to open it up for family camp. And my understanding about this is that the whole family can come. But each family will stay in its own cabin, they will get together as socially distanced appropriate, if that's the right way to put it for activities and things like that. But within the cabin will be the family unit that's already spending time together. And so you wouldn't have to wear your mask within the cabin, you know, that sort of thing. And I think it's a really creative approach. I'm pretty sure they've had an amazing response to this. They may already be mostly filled, but you can definitely check it out. I'll put the link there. What a fun and interesting way to step up for this challenge

and camp kudzu in Georgia, which is a very close to my heart camp. I'll tell you about that. why in just a minute. But they have decided to have teen camps, family camps and four weeks of summer camp. So if all goes well, I'm sure things will look a little different, but they are going ahead with their camp program as well. And I bring up kids though, because I didn't know this for the first couple of years Benny went to camp. It's down the street from his regular non diabetes camps that I've talked about many, many times. Now camp kudzu is hosted at other camps. So it's not really their camp. I believe it's camp. Burnie it's their camp grass that they use in beautiful Cleveland, Georgia. And Benny goes to camp Coleman, which is just down the road. And I didn't realize that for the first couple years. I gotta tell you, I would have put My nervous heart at rest. To know that I was sending him away for a month and there were 100 people with diabetes down the street.

I did end up calling them I want to say was the last year Benny went so 2019 because of course he didn't go last summer. His insulin pump broke the very last day of Camp the last full day of camp. I don't know if he knocked it into something. We never figured out what happened but it just it just crapped out. And I called them to see if somebody could lend him a pump and they had their program had just ended a couple of days earlier. So he was fine. He did shots for the 24 hours before he came home and Tandem. I tell the story. By the time he got out of the shower, he came home he jumped in the shower, by the time he got out the pump was delivered. So we'd love how great they are with customer service. Our local diabetes camp hasn't made a decision yet as far as I know for what they are doing. But I'm sure that they are going to make that announcement pretty soon. So if you know what your camp is doing, you know we'll share it let me know I'm really hoping that as many kids as possible I can go back to diabetes camp this summer. But if your camp isn't having in person, I know it's not ideal. Do the virtual be part of this community however you can. It's so great for kids and for adults to certainly

our other Tell me something good is really cool. Now I am not the biggest follower of Funko Pop collectibles. I actually thought they were pop Funko which tells you all you need to know I have two in my office Actually I have Queenie Goldstein, from Fantastic Beasts and Where to Find Them from that Harry Potter spin off That's an inside joke with my family. I have Deathstroke because death strokes real name is Slade Wilson. My husband's name is Slade. So that's his funko pop and ended up here somehow anyway, all of this to say that I want to share the story of Ethan Savage. Ethan is 17 years old, and he was diagnosed with type one in September of 2019. He has a campaign to get the folks at Funko to create one of these figurines about type 1 diabetes. And if you haven't seen this, I'll put this in the Facebook group as well. But these are super popular, just about every pop culture character now has one of these. They're not bobble heads, but you know, the head is big, the body is smaller. They're very cute. And they're very popular. So Ethan has written to the company, he's got an Instagram account, he's showing them an example of what it could look like. And it's I guess it's Ethan. It's this kid, a guy. And he's got, you know, a pump on he's kind of lifted up a shirt and showing it off. I kind of say the guy looks cute, but kind of fierce, too. It's a really well done rendition of what this could be. And Ethan has been selling posters of the concept to raise money for JDRF. And he's got a diabetes educator who wants to give the figure here to newly diagnosed kids instead of as he says a lame stuffed animal from the kitchen.


In the letter that he shared with me that he wrote to Funko he says we're convinced this could make a great pop or series with a bigger opportunity. Most importantly, it'll raise awareness for good cause and bring you new fanatics. Haha, links below. I think this is phenomenal. I'm going to link up the Instagram account. And hopefully we can amplify the efforts here because I could see a whole line of kids with type one adults, even the celebrities that we've gotten the community Supreme Court Justice Sotomayor, what a great pop she would make. I think that'd be hysterical. I do have to tell you that one of the reasons that Ethan came to my attention is because I went to school with his dad. And it's unbelievable in the last couple of years to people off the top of my head, I can think of that I went to high school. I mean, really, I went to grade school all the way through high school with these folks, their kids have been diagnosed with three of us in the class of 1989 from York High School, have kids with type one now, I guess not that unusual, but it really brought it home for me. So thanks, Jonathan for sending this along and connecting me with Ethan and Hey, who knows what's gonna happen. If you have a Tell me something good, please send it to me Stacy at Diabetes, or post it in the Facebook group. And it's Diabetes Connections, the group.


Stacey Simms  52:23

Looking ahead next couple of days, we're gonna have another classic episode out for you. And that's coming on Thursday. And then we are continuing with the focus on technology have some really interesting stuff coming up in the next couple of weeks, I spoke to the people from City of Hope they've changed their name, but you probably know them both mostly by that and mostly by the claim they made a few years ago that they were gonna have a cure for type one within six years. I had to talk to them about that they have some really interesting new research going on. And I did talk to them about that claim. Because I actually think that did them a lot more damage than they should have set themselves up for to me that was a mistake. And they talked about it. They talked about why but we are almost really it's five years in now. So I'll be bringing you that story. I am talking to beta bionics the folks behind the islet damianos company about what's going on with them this year. And as I said, reaching out to Omni pod and helping to get a lot more technology stories for you in the weeks to come.

In the meantime, thank you as always to my editor John Bukenas from audio editing solutions and thank you so much for listening. I'm Stacey Simms. I'll see you back here in a couple of days until then, be kind to yourself.


Benny 53:33

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

Feb 25, 2021

You may know Jerry the Bear as part of Beyond Type 1. But this learning and companion toy for children with type 1 diabetes got his start as a college project. Ten students from Northwestern University entered the first every DiabetesMine Design Challenge back in 2009 and won the most creative design. A few of those students continued on and – as you’ll hear – started a new company called Sproutel.

In addition to Jerry the Bear, Sproutel makes My Special Aflac Duck for pediatric cancer patients and Purrble to help children self-soothe.

This interview with Sproutel CEO Aaron Horowitz and Chief Creative Officer Hanna Chung first aired in November 2015.

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

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

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

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Episode Transcription: 

Stacey Simms  0:00

This episode of Diabetes Connections is brought to you by Inside the Breakthrough, a new history of science podcast full of Did You Know stuff.


Announcer  0:13

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:19

Welcome everybody. This is going to be a fun classic episode of the show. I'm really glad to have you along. It's been fun this year to take a look back at some of these interviews. These classic episodes, as you likely know by now are from the very first year or two of the podcast. Most of them are from the very first full year of lunch. And it's great to take a look back and revisit some of the cool people that we talked to a lot of you are newer to the show, or at least haven't been here for every single one of these. What are we 355 episodes. So I'm really happy to bring these classic episodes back out with an update.

So hi, I'm your host, Stacey Simms, and my son was diagnosed with Type 1 14 years ago he is now 16 my husband lives with type two diabetes, I do not have diabetes, I have a background in broadcasting. That's how I came up with the podcast. And this episode is all about Jerry the bear a learning and companion toy for children with type 1 diabetes, you may be familiar with Jerry and I put some pictures in the Facebook group over Diabetes Connections of the group. But Jerry started out looking a little well a lot different and having different functionality. You may know Jerry has part of beyond type one. Now it's a program under them. They're helping with distribution and lots of other good stuff.

But Jerry got his start as a college project. 10 students from Northwestern entered the very first diabetes mine design challenge back in 2009. And they won the most creative design back then a few of those students continued on and as you'll hear started a new company Sproutel that continues to this day. And in addition to Jerry, the bear Sproutel makes my special Aflac Duck for pediatric cancer and purple for finding calm. I will link both of those up at Diabetes you can get more information and check them out. They are they're adorable. They're really helping kids and families who need them. And as always, you know, episode homepage will have all the details.

I did reach out to Aaron Horowitz. He is the CEO of Sproutel he's one of the people you'll hear from in this interview when I asked him for an update. And he says since this time, of course, they've added quite a few things. Most recently, they've added a continuous glucose monitor to Jerry. And they put in another software update that helps kids learn about washing their hands, and I guess washing Jerry's hands to about washing their hands more often that sort of thing. And he indicated that there is a big update coming later this year. So I will circle back with Aaron. And hopefully we'll do another interview and get some more info on Jerry. I will let Aaron explain much more about the history of the company in that classic interview in just a moment.

But first, this episode of Diabetes Connections is brought to you by inside the breakthrough, a new history of science podcast. And the latest episode goes in a very interesting direction using the TV show friends to reveal how we really feel about scientists. I'm not sure that Ross is really the best example of this, but they they get it done. Marie Curie was an outsider in ways you never imagined sort of like Ross on the show. I really do love this podcast. It's historical wisdom mixed with modern insight with quite a few laughs along the way. Really great production value. Search for insight the breakthrough anywhere you listen to podcasts.

And by the way, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

My guests in this classic interview are the CEO of sprout tell Aaron Horowitz. And Hannah Chung, who at the time was chief creative officer had a left Sproutel in the middle of 2020. I reached out to her I haven't heard back yet. So I will post an update in the show notes when I do hear from her and let you know where she is heading. Next is really fun to kind of go back in time and hear the story of Jerry, the team's appearance at the White House. And a lot more. Aaron and Hannah, welcome to Diabetes Connections. I am excited to talk to you both again.


Aaron and Hannah:

Absolutely. As are we,


Stacey Simms  4:25

Hannah and Aaron. Let's start at the beginning. Let's start with the idea. How did you come up with the idea for a stuffed animal that kids could play with and learn from?


Aaron Horowiz  4:35

So it actually started by talking to families of kids with type 1 diabetes. We we went into the homes of bunch of these families and as we were playing with kids, we observed that they were taking care of their teddy bears of their stuffed animals as if they also had diabetes. So they were pretending to prick the the paws of of their teddy bears pretending to give them insulin injections. Some kids were even actually taking little pieces of cardboard and paper and drawing insulin pumps that they would then staple to their bears first. So it that was kind of really this this lightbulb moment for us of wow, you know, these, these kids are mirroring everything that's that's going on in their lives that they don't yet have control of. So can we bring that play experience to life? And can we do it in a way that is educational, that is comforting. But most importantly, that's really fun.


Stacey Simms  5:28

You know, it's funny, I hadn't thought about this in a long time, Aaron, but when you bring that up, my son had an Elmo doll, and Elmo from Sesame Street, and he was 23 months when he was diagnosed, and that Elmo got checked and got juice boxes, which made a mess, and got insets put on him. So it makes perfect sense that playing kind of helped these kids get through what they couldn't understand.


Unknown Speaker  5:50

Absolutely. You know, like, as kids, we roleplay so many things, you know, right, we roleplay tea parties, we roleplay you know, dressing our animals up and making weddings for them. And for kids with with conditions like diabetes, like, like Benny did with Elmo to roleplay diabetes,


Stacey Simms  6:07

when it was the idea of spread towel always to help medically and to help with play. And then you come up with the idea for type one, play? No, actually,


Hannah Chung  6:16

the reason why I started spread tell was we really wanted to work on Jared the bear so and our mission was to really bring Jerry into the hands of all kids. And from there, we realized incorporating company allows erinite to work with this full time and you know, bringing awesome mentors, investors on board to help us feel the business. And from there just talking to a lot of families talking to a lot of kids, you have realized that the application of play into health can be so many different can help a lot of people not only for kids, but also for adults and the elderly. So from there, you know, working under the beret type 1 diabetes really allowed us to see the potential into coming into, you know, like applying this to help all kids to be healthy. And you know, and have a long term vision of helping all people to use play to help them to come healthy and well. So yeah, a little little Jared type 1 diabetes really allowed us to have the vision for scratch help. That's great. Okay.


Stacey Simms  7:15

So Jerry has changed quite a bit. There is a new Jerry right now still loyal to that wonderful idea of learning through play. But tell me about the first Jerry, what, you know, what did Jerry look like? And what did he do Aaron?


Unknown Speaker  7:30

Yeah, so well, I'll say that there are, quote unquote there two first Jerry's. There's the first Jerry the bear prototype. And then there's the first bear that we shipped. And I have a real soft spot in my heart for the first jar, the bare prototype. So I'll just touch on that for a second. Our first bear that we ever made, was when Hannah and I were still in school, we had no idea how to solder how to make a circuit boards, even even how to sew a bear. And so we were learning everything as we went along. And what we created I'm staring at it now in our office is like a two foot hard chested like behemoth of a bear eyes that we cut out of a Furby so that it blinked its head was attached to its body with with actually with metal nails. It was it was quite creepy looking. And we had made so many mistakes about our understanding of type 1 diabetes, because at that point, we didn't have kind of the intrinsic knowledge from the community. So for example, when we tested with our first our first user, Gerry's blood glucose level was only two digits. In fact, his screen was only two digits big. And actually, this, this little boy said, I would be hypoglycemic and go into the hospital. That was my, like, face total facepalm you know, we had missed the mark. But it taught us so so much about one, just the immense amount of knowledge that we had to learn so that we can then create something that actually had an impact. But it also showed us that despite the fact that Jerry was big and clunky and looked super scary, this this child was still really excited by the fact that there was a bear that also had diabetes. So that's, that's our technical for our first Jerry,


Stacey Simms  9:08

I'm looking at the timeline you recently posted on Facebook, and I'll link this up at Diabetes if it's okay, is that the first Jerry the one that's really big and kind of light colored all the way on the left? It is He is creepy looking


Hannah Chung  9:22

at that photo, because the girl is so cute, it makes the photo look really cute. But the bear itself is just take out the little kid part is kind of not that cute.


Stacey Simms  9:32

But I it's fabulous to see where you're going. I mean, even then, you know, this is a toy. This is a really sweet idea. And then it's changed. It was um, it became a little smaller and a little bit more responsive, I guess is what I'm looking for at least it had three numbers for the blood glucose.


Unknown Speaker  9:50

Absolutely. Yeah. So it got a lot more responsive. The bear that we ended up shipping. Really we went we had gone through 29 different iterations of product Type and the real difference between some of our early prototypes. And what we actually ended up creating and sending out to families was that the existence of a storyline. So the jury that that kind of existed in the world for the past few years, it has this curriculum with I say curriculum, but I mean animated storybooks. It's got 21 animated storybooks, where you train Jerry for the all star games, which are kind of like the Olympics. But the sports are things like climbing trees and diving with sharks. And we teach about diabetes skills, because each of these storybooks jargon meets up with a new friend like love with a monkey or George the vegetarian shark. And they teach Jerry about both a sport and a diabetes skill. So what we ended up sending out had this kind of all of these storybooks and the way that you unlocked the storybooks was that you had to care for Jerry correctly. So there's kind of this game mechanic that's built in where children are not only caring for Jerry, who, by the way, has a blood glucose level has fingers that you can prick to check, check that foods that you could swipe over his mouth and insulin injection spots. They're not only doing justice, what they did with their stuffed animals or with their Elmos, where they're mirroring all of their all of their care procedures. But they're doing it to unlock these the storybooks, which for them are kind of the carrot and the incentive at the end of doing this. But for us, that's that's really the way that we can convey some of the really complex things that that you need to learn.


Stacey Simms  11:23

That's really interesting. So the new iteration of Jerry, you've expanded from just type one, as Hannah mentioned a few moments ago, you're really trying to work toward overall good health. Hannah, tell me what's new about Jerry this time? Yeah, it's


Hannah Chung  11:38

a new Jerry. A couple of things. He's cuter, smarter, and with a more affordable price point. So the biggest thing that has changed is around this curriculum. So one, so the new Jerry, his base curriculum is around general health. So he touches social emotional development, nutrition, exercise, sleep and mindfulness. And from there families can customize Jerry to have a condition like type 1 diabetes, or food allergies, and yours were modular. And and it kind of allows families to kind of customize Jerry to mesh their own child. So you know, we can't so that we can build a world where everyone can have a Jerry but not all, Jerry is the same, which is really cool. And the way the new drivers interaction wise, Jerry had a belly device called a portal is kind of like a window to see what's going on in Jerry's world. So using this portal, you can kind of scan Jerry's brain and different body parts like the mouth and his stomach to see what is going on inside. Similar to the first year of the bear, you can still feed him, you can see how he's feeling. But if having the portal be detachable from the body, it kind of allows more physical movement for a child to interact with Jerry, which is really nice. And New Jersey also washable, which is a huge feedback that we've gotten from especially for educators, you know, if you want it to be used in a hospital setting, and washability is a big part was but we're wipeable with Clorox and things like that. Now this new Jerry is washing machine washable, which is really exciting. And


Stacey Simms  13:09

yeah, that is because who would think of that, but but you absolutely if you have somebody who's using it in a in a healthcare setting in an office or a hospital, or you know that Elmo went in the washing machine a million times because they get kind of gross.


Hannah Chung  13:21

Yeah. And then lastly, some of the looks of Jerry has changed. So the previous year was really cute. But we knew that Jerry could be the first Jerry was more geared towards kids who are younger, like five year olds, and now the New Jersey we want to help our age, the target age we're looking after is between three and four and nine. And even though that might be only a five years difference, it's a huge difference in the kids role and what kids can understand what kids are interested. So what we've done is we design a character that could be more appealing for all kids in that age range. So Jerry looks more expressive. And Jerry kind of have this longer arms like a monkey arm which I really love because he's more huggable. And so all in all, from design to interaction to the modular aspect of the curriculum has been the biggest part for us for ended up in designing the new dairy that we have.


Stacey Simms  14:17

Aaron Talk to me a little bit about food allergies, there are so many health conditions, unfortunately that affect kids. Why? Why did you move to include allergies?


Unknown Speaker  14:28

Yeah, when we look at different conditions that that kind of might be able to be addressed or to be helped out with with Jerry, we look at kind of two factors. One is the emotional implications and the other is the educational implications. And so food allergies very similar to type 1 diabetes, there's there can be unfortunately a lot of stigma for example, things like the peanut free table we've heard a lot of horror stories from families of isolation cause from eating at school. or children not understanding or really believing that other children have food allergies. So there's this whole kind of emotional and emotional coping component, which we really feel that Jerry kind of provides some of the biggest impact there just because of the comfort, because of this mirrored care that they have something else that is someone else. That's, that's just like that. And then the second is, is the educational component. And that really boils down, you know, for kids with food allergies, it's things like reading nutrition labels, and also very similar to diabetes and knowing how to articulate how you feel, and knowing when to to go and ask for ask an adult for help. This is really kind of universal across a lot of conditions. But you know, particularly in food allergies, there's every label or every piece of food that you put into your mouth, you're going to want to read the label, you know, see if it has whatever your allergen might be. And there is kind of this also really interesting correlation with, you know, an action that's tied in with mealtime, right. So for diabetes, you might be checking your glucose level and, and taking insulin for food allergies, you're doing it around mealtime, you're reading these nutrition labels, you're making sure that you're sitting in a place that's allergen free, you're making sure that the people around you don't have allergies, you you need to have washed your hands to make sure that you didn't touch anything. So there's all of these just kind of procedural things that we see a real alignment in the value that that we've seen Jerry provide for children with type 1 diabetes already.


Stacey Simms  16:26

And so far, how has it been? I know you've just put it out there. And you've been part of the diabetes community for a few years, where you've been very well received, how have you been received in the allergy community?


Unknown Speaker  16:37

So we've certainly had parents that are incredibly excited. I'll say this, we're kind of stole almost as funny term, but like making a name for ourselves in the food allergy community. We haven't yet gone to a conference dressed as teddy bears.


Unknown Speaker  16:50



Unknown Speaker  16:51

wait, what we did things like children with diabetes and ADHD,


Stacey Simms  16:55

I should stop you and say, This is how I met Hannah and Aaron a few years back when they were dressed like Jerry, the bear at a conference, which was so much fun. And you definitely had to stop by and talk to them to find out what was going on. So yeah, you need to go to food allergy conference and do that.


Unknown Speaker  17:11

Absolutely. That's kind of I think that that's how I think about kind of putting a stake in the ground. Moving into moving into new territory, we got to Don the bear suits, we got to go to a conference and maybe have a dance off with another mascot.


Stacey Simms  17:25

But But have you have you had any feedback from parents of kids with food allergies yet?


Unknown Speaker  17:29

So absolutely. So before we ever kind of decided to move into that into the food allergy realm, we actually interviewed, gosh, a range of families, a ton of families, and the people that we talked to were, you know, ecstatic that we were creating something for food allergies, and actually told very, very similar stories to the families that we had originally interviewed of kids with type one, that their children would pretend that their stuffed animals had a peanut allergy or a shellfish allergy. And they would pretend to have them go into anaphylaxis and give them an epi pen. And so we really saw this this need being presented and are excited by kind of the their excitement for for Jerry and and of course, it's jury's not out in in the world alive and kicking yet for kids with allergies. So we won't see kind of the rubber really hit the road until about june of 2016 when we're when we're shipping these bears, but the excitement is really good to see. And Hannah,


Stacey Simms  18:22

Aaron talked about the modules and the storybooks. To unlock the original Jerry Is this the same idea with the food allergies as well,


Hannah Chung  18:31

very similar. And so kind of similar to type 1 diabetes, you know, in the way we teach type 1 diabetes is around talking about your feelings and having a vocabulary, practicing the routines to help you you know, the daily routines you have to go through. And we also have different storybooks, I've touched upon social situation that you need to know to kind of apply the concepts that you have learned in the different social settings. It's the same framework, but that was more geared to the food allergies. So checking your blood sugar level and giving insulin might be around washing your hands, it also gives me an epi pen and you have the allergy reactions of seeing how your stomach is doing and how your body parts are having whether you have hives or not. that's similar to you know, seeing what is going on in Jerry's pancreas. And we still teach the same vocabulary. Similar vocabulary is to kind of explain how you're feeling what kind of symptoms you are having at that moment. And the same thing, storybooks around birthdays or Halloween trick or cheating and things like that, that touches upon the social emotional situation that kids need to know.


Stacey Simms  19:30

You know, I probably should have asked this at the beginning of our interview, but I want to make sure to bring this and you both have a personal connection to diabetes. And Hannah, could you talk a little bit about yours you have diabetes in your family?


Hannah Chung  19:42

Yes, I do. So both my father and my grandparents have type two diabetes and they were diagnosed in their 40s and 50s. Consider late onset. Both my grandparents passed away from the complications behind type two diabetes such as heart attack and hypoglycemia shot. To be honest, I was so young at the time. When my grandfather passed away, which I was in sixth grade, and I did not know anything about type two diabetes at that point until he, I saw he passed away, my dad a year after he was diagnosed, and he decided to change his whole lifestyle to exercise more and walk 15 miles without taking pills to really adjust his lifestyle to be healthy. And from the process. Of course, I saw him, you know, feeling frustrated and feeling isolated when he did everything possible, right. And his blood sugar level was not nice at the end of the day. Yeah. So from that, our whole family decided to change our diets too, because my dad had to support my dad emotionally to make sure he's getting the cheers that he needs to go power through the day. So two months after my dad lost about 40 pounds, and even 14 years today, he's still practicing the same routine, which is really amazing. Oh, yeah. And from the process. And you know, not only I learned so much what type two diabetes, but also the importance of having the community around you who can support you, and, you know, cheer for you regardless what the outcomes were. So from there, I just learned a ton about the people who are affected by this kind of cut credit conditions and want to help kids to help support them to


Stacey Simms  21:16

Wow, what a great story of family support that you were able to really rally around him and help out and proud to be still in that routine. All these years later is fantastic. That's great. And Aaron, your story's a little different. But you know what it's like to get injections. Tell us about that.


Unknown Speaker  21:31

Yeah, so when I was a child, I had another type of endocrine condition is called human growth hormone deficiency. And so basically, my, my body wasn't producing growth hormone, at least at the typical rate. And so for a period of time, my childhood, about five years or so i, i self administered injections every day to grow. So definitely, definitely taught me a lot and gave me a lot of empathy for kind of any type of chronic condition. And, you know, certainly, certainly a learning curve, I'm so inspired by kids with, with type 1 diabetes, because they were diabetes, like a badge of honor. And for me growing up, I felt so self conscious about this, it was something that I tried to hide from everybody. And in fact, I don't think I told anybody until I was writing our first grant application, or, you know, contributing to that for Jerry to bear. And so I'm continuously inspired by the kids that we meet with type 1 diabetes, and now with with food allergies, and kind of how much confidence and how empowered they are. And so I'm so excited about what we might be able to do with Jerry tea to enhance that even further.


Stacey Simms  22:39

You've mentioned a couple times that you were in college, and you were students together, when this all came up. How do you I mean, I was in college, I didn't have any big idea like this and change the world and help families. How do you do that? Where do you like 19 years old, and you're sitting around one night, everybody else is playing beer pong. And you're like, oh, we're gonna we're gonna make this huge thing. How did that happen? What are you both majoring in? And and how did the idea come about at that time,


Unknown Speaker  23:03

so I'll say, it started very, very small. Hannah actually co founded a nonprofit organization called design for America, which is all about using design thinking, to solve problems in your local community that have some type of a social impact with the potential to scale beyond. So lots of lots of boxes to check, but really, really exciting organization. And it's totally extracurricular. So there are teams, kind of interdisciplinary teams that are formed that go out in your free time after classes to go try to solve problems, everything from you know, sanity, sanitation, inside of a homeless shelter to things like type 1 diabetes education for kids. And Hannah and I kind of rallied around this problem while we were in school, and kind of through this through this extracurricular, these activities, we slowly but surely, pursued, pursued Jerry in it, you know, at first, we never had these grand intentions of starting a company, right? This was this was a passion project. It was, oh, let's make one prototype and see what happens. And it was like, oh, maybe we should make a second one. That second one looks kind of cool. And it reached a point at prototype number three, when I was like, Well, you know, like, all of our time is kind of going into making these bears and he's just classes aren't quite as interesting anymore. Why don't we Why don't we start to make these bears full time. And so it really, you know, is a was something that was just a passion of ours that spiraled out of control and into awesomeness.


Stacey Simms  24:36

That's great. And it sound right to you. But you both did graduate, right? You didn't just dump the dump the school and go off to do the bears.


Hannah Chung  24:43

We did graduate. We did. And we physically left a little bit early. And so Aaron and I both graduated in spring of 2012. And the last quarter, we moved to Providence. We've been displaying Northwestern in Chicago. So we are taking our classes over Skype, being in Providence working very full time. So there was a pretty awesome journey to do that. But it was cool because we have, you're very transparent about how you're billing Jerry and the type of mentors you're working with. So the school was very supportive to let us continue Jerry in a really unique method that any of our other students were doing. So I think having this approach was really great. And they did mention that we have to be highlighting us doing, you know, going through this route, we have to come back to graduation in person to get our diploma, which was not a bad deal at all. Um, but yeah, to your question about what we have studied, and I studied mechanical engineering with the emphasis on Human Centered Design, but I was a very, very weird engineer, where I was not too excited about bolts and nuts. And I loved illustrating and an animation. So in mechanical engineering, we do a lot of like computer aided design. And for me, that was just illustrating in 3d for a product, which is super fun. And I also have done some research around how to build products that is emotionally appealing for kids. So I was part of the research for for a little bit while I was a student, so I was a very a soft hearted, more, you know, I love people type of engineer in the group. So and Aaron, do you have Aaron, Aaron has a cooler major than I do. So we were both studying mechanical engineering, and then in our senior year, and, you know, throughout he and Jerry, Jerry, like Aaron really got excited about robotics. And he found that that's the area that he's really passionate about. So he ended up making up his own major called mechatronics, and user interaction design, which really helps people how to play with robots and different creating different robots that is really engaging with people. So that's a major dead air and creators. So. So that's our that's our backgrounds and what we have studied so far. Wow,


Stacey Simms  26:57

this story just gets cooler and cooler. And then, and then, in 2015, this year, you guys went to the White House? How did that happen? Aaron, tell me about meeting President Obama. And he's holding Jerry the bear.


Unknown Speaker  27:12

Oh, man. Yeah, I think not. Not in my wildest dreams. Did I ever think that was gonna happen?


Unknown Speaker  27:17

Same here.


Unknown Speaker  27:19

So we had, we had gotten a very mysterious email that they were putting together an event at the at the White House to honor it was called the first ever White House Demo Day. And it was to honor entrepreneurs from from diverse backgrounds, mainly companies with founded by either other women or people of color. And so we know the first step is a phone interview. And I was super nervous. And I was actually at the time on a on a bus, mega bus from New York to Providence. And so whispering into the phone, I delivered our little pitch and hung up and just like facepalm once again, because I was like, oh, man, like, that was probably the worst mistake I ever gave. I was like whispering on a Megabus. And about maybe a week before the event we were we were told that we were selected. And so had an eye or dancing around the office, we're so excited. And just a few days before the event, we got a call from from it from an unknown number. And the voice on the other end was somebody that was that was putting together the event and they said, Hey, we had this crazy idea. Can you can you program Jerry the bear? We were like, yeah, like, you know, that's that's what we do. And they're like, Can you can you make Jerry wish President Obama Happy birthday. And we were we looked at each other. We're like, yes, like, we can do it.


Hannah Chung  28:42

As a team, we're just a guess. Do we have to say yes to and we'll figure out the rest afterwards.


Unknown Speaker  28:47

And so we we they said they couldn't guarantee any anything would happen. We put together Hannah made an awesome little animation of President Obama dancing with Jerry. We had two different voice recordings. One is Jerry wishing. The President just happy birthday. The other was Marilyn Monroe singing Happy Birthday, Mr. President. We sent those to the communications team and they totally nixed Marilyn Monroe.


Unknown Speaker  29:11

And so


Unknown Speaker  29:13

they come to me and we go to the White House, and they were about 32 companies. We weren't sure, you know, up until a few minutes before that we would actually get to get to meet the president. But luckily, there were, I believe six companies that that have the 32 that that got him to meet him. And we were one of them. And we were just ecstatic. We're like looking at each other and they're sending out aids to us that are saying, Okay, give us your pitch. Like we're there, you know, making sure that it sounded good and that we weren't gonna say anything because it was televised. We're gonna say anything that was politically incorrect. And to be honest, I'll give I'll give my perspective on the actual meeting and I'll let Hannah share hers. Everything went by and like just such a surreal blur. And I think actually the most memorable thing for me was, you know, I we kind of split split up our presentation into Can I introduce what we're doing had a carried on and talked about the impact and give a demo of Jerry, and President Obama was standing in the middle of us. And so after I kind of finished talking to him, he was interacting with Jerry. And so his back was turned to me. And all I kept thinking is how close is too close to stand? So I was just like I was trying to lean in, and I was the entire time. I was like, the thought going through my mind and like, oh, man, how close is too close?


Unknown Speaker  30:31

tackle you.


Unknown Speaker  30:31



Stacey Simms  30:33

And what was your perspective?


Hannah Chung  30:35

I think for me, I remember I'm kind of going along with lo and Aaron's point, you know, up until we got the confirmation that we were meeting the President, we'd never really gotten the confirmation that we're meeting the President, it was more of a higher chance to meet the president. So an hour before when we were pitching it, I realized, you know, I never gave a picture president and Aaron, I have not practiced anything about this pitch. So it was either gonna go really authentically well, or we don't. But I realized, because I was holding Jerry, I felt less stressed because I was holding a teddy bear in public and Jerry was kind of absorbing all of my nervousness from my belly to tears comforting companion, so and I felt less nervous because I was holding a teddy bear. But uh, even the demo was really cool. And I was, like, part of me was, you know, speaking really well, explaining Jerry the bear, but also just making sure that the demo goes really, really well. And there's no mistakes. And but yeah, overall, it's similar to Aaron. Everything went by so quickly. And afterwards, it took me a couple of hours to really realize, Oh, yeah, like, we just met the president. And he really liked he was impressed with Joe the bear like that. That really happens. They took it took me like a good six hours to really digest that. Oh, that didn't really happen.


Stacey Simms  31:52

Did he wind up during the bear sing? Did you get him to sing the song?


Hannah Chung  31:56

He did? And the President? Really? Yeah. He was laughing. He was laughing and he really liked it. And but yeah, but the the aftermath is really cool, though. So you know, after the event, all this articles from a lot of different big press channels are coming out. And they actually used our photo with the president and with Jerry as a main photo for almost all the articles. And so from there, we had a huge exposure about the bear and, and that was really helpful for us. Because not only, you know, we got to represent our company as one of the startup companies pushing the diversity in tech force, but also got built a lot of awareness about kids health and what Jerry does in the community. So it was a it was a very awesome event.


Stacey Simms  32:41

That's amazing. I do love the picture. We'll link that up as well. So you can you can see it at Diabetes. Hey, before I let you both go. I have to point out we did meet a couple of years ago at friends for life when you guys are dressed up like the bears. But it turns out Aaron and I have a crazy connection. We both went to the same high school. Different years as you heard him say he graduated college in 2012. You both


Unknown Speaker  33:05

both have the same teacher.


Stacey Simms  33:06

Yeah. We have the same favorite teacher from high school, our social studies teacher, Mr. Fagin. How crazy is that? Aaron?


Unknown Speaker  33:13

Oh my gosh, it is wild. I remember, the most of the fondest memory I have of Mr. Vega was that he would wear a different sweater to class every day of the year. That's so many sweaters.


Stacey Simms  33:28

And we grew up in New York. So he needed this sweater. So it was cold. But he was I mean such a great teacher and I took his AP history classes that would you took.


Unknown Speaker  33:35

That's exactly what I took. And it was what it was one of my favorites. My sister took it and she was that was, you know, the thing that she said was, you know, you got to take Mr. Fagles history class, I was like, Okay, yeah, I didn't know what I was getting myself into. But I knew it was gonna be good.


Stacey Simms  33:47

I love it. Thank you so much for joining me today for talking about Jerry the bear. Is there anything else that you wanted to make sure to mention before I let you go,


Unknown Speaker  33:55

we're so thrilled to have had for the past couple of years, just the immense support of the diabetes community in the diabetes online community. It's, it's really alarming not alarming. It's It's comforting. It's It's awesome to feel so welcomed as outsiders coming in so quickly. And I don't know if I can relate a similar experience any other time in my life. You know, the first time we went to friends for life, it was literally like we gained a new family. And so I think we're both so incredibly grateful for that and, and so excited to kind of keep all of those all of those relationships as we enter this next chapter of Jerry's life.


Stacey Simms  34:33

That's fantastic. Thank you so much for joining me, Hannah and Aaron. I appreciate it and I can't wait to see what's next. Thanks.



You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  34:50

More info on Jerry and Sproutel and what's next for all of them at Diabetes I will link up some articles that take a look back and others that do take a look. forward because as I mentioned, Sproutel has several other projects that they have been successful. And it's really remarkable when you think about the the start that these guys got when they were I can't call them kids anymore when they were in college and launching something like this. And now to have it not only succeed with one product, but others and really rolling along. It's a remarkable story and I'm really excited that I got to meet them in those bear suits way back when.

All right, our next episode coming out on Tuesday of next week, I am scheduled to talk to tide pool very excited to get back on the technology news. We are doing a deep dive into technology all this year on the show and title has submitted loop to the FDA. So will this be the first Do It Yourself routed initiative to get FDA approval in the United States. We'll talk about it and that episode is coming up on Tuesday. Thanks as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I will see you back here on Tuesday. Until then, be kind to yourself.



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

Feb 2, 2021

When Swiss pump maker Ypsomed launches brings it's business to America, likely in 2022, it'll be with Lilly Diabetes as their partner. The Ypsopump will be the first pump in the US that only takes one brand of insulin. This week, we spoke with Mike Mason, president of Lilly Diabetes about that decision, more about how the actual pump system will work and their timeline.

Stacey also talks about how they were able to use a coupon to keep Benny on humalog - it wasn't as easy as some have said. And she has advice to make it work for you.

Plus, new A1C guidelines for kids with diabetes.

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

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

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Episode Transcription:

Stacey Simms  0:00

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


Announcer  0:21

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:27

This week, Swiss pump maker Ypsomed is teaming up with Lilly Diabetes to launch an insulin pump. Here in the US, it'll be the first pump that only takes one brand of insulin is Lily about the thinking behind that decision.


Mike Mason  0:41

We look at this ad we don't look at it necessarily as limiting options, we look at bringing up a new option to the marketplace that as an integrated solution can provide a new way to be able to control the blood sugar. So that's how we look at it.


Stacey Simms  0:57

That's Mike Mason, president of Lilly Diabetes, we talked about what that integrated solution is more about how the actual system will work, and of course more about its unique proprietary nature.

I'll also catch you up on our insulin coupon experience and talk about new A1C guidelines for kids with diabetes.

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

Welcome to another week of the show where we aim to educate and inspire about diabetes with an emphasis on people who use insulin. This year, I'm doing a heavy focus on technology. So this episode is a bit of a follow up, or maybe a partner to the one we did in January with Ypsomed. As was announced late 2020 Ypsomed and Lilly diabetes are teaming up to bring the existing YpsoPump which is used in Europe and Canada and some other countries around the world to bring it here to the US hopefully to submit to the FDA later this year, and be in the marketplace in 2022. The Ypsopump, as you heard in that episode already has a lot of features that are very popular. It's a very lightweight pump, it has the hybrid closed loop system, similar to Tandem t slim, similar to what Omni pod is hoping to launch later this year. So there's a demand for this kind of pump. But the question is what's going to happen because of the proprietary nature, as you'll hear in this interview, and as we talked about with Ypsomed, this pump will only take Lilly branded insulin.

So to that end, and did you know that I have a weekly newsletter they do. And this year, I added a poll to it, which is really very popular. I'm so excited to see this. And when we did the episode with Ypsomed,  I asked in the newsletter about your opinion on it, would you use a pump that only took one type of insulin? And I gotta say the results were really interesting and I thought kind of surprising. So 40% of people said yes if it's a great pump that is worth it 48% said maybe I'd have to feel confident about my insurance coverage and 12% said no way I thought the no way would be a bigger number so we'll keep those polls going I have a link always in the show notes about signing up for the newsletter it's very easy to do I don't spam you come on you know it's just me. I do send out a newsletter though with the week's show some thoughts about it that poll and some other information you know, as social media shows us all fewer posts frankly from the pages that we like and the people that we follow. This is a great way to make sure that you do not miss an episode and that you know what's going on with the show at all times.

Okay, Mike Mason from Lilly 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 and that can be scary. A very low blood sugar is really scary. That's where Gvoke HypoPen comes in Gvoke is the first auto injector to treat very low blood sugar Gvoke HypoPen is pre mixed and ready to go with no visible needle and that means it's easy to use. How easy is it to pull off the red cap and push the yellow end onto bare skin and then hold it for five seconds. That's it. Find out more go to Diabetes and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke glucagon comm slash risk.

My guest this week is the Senior Vice President of Eli Lilly and company and the president of Lilly diabetes. Mike Mason has been with Lilly since 1989. we last talked to Mike on the show back in 2018. It was our first conversation about the price of insulin. And we of course bring that up here in this interview. But we are mostly focusing on the pump and the partnership with Ypsomed and what it's going to take to bring it to the US although I promise I do talk about pricing and accessibility and everything you want to know. Mike, thanks so much for joining I'm really interested to learn more appreciate you coming on and spending some time with me.


Mike Mason  5:04

Happy to do it, Stacy, appreciate what you do for people living with diabetes.


Stacey Simms  5:08

Let's just start by talking about the partnership here with Ypsomed. How did this come about? Tell me about that, you know, the basics. And I guess we could start with really just, you know, why are you at really excited about this?


Mike Mason  5:21

Now we're excited about it. I mean, what we do is we step back, and we take a look at where the unmet needs are in the marketplace, today, and then how science and technology is developing. And what we saw was that, unfortunately, a good percentage of people who who live with type one and type two diabetes for own insulin are not in good control. And so we saw an unmet need there. And we saw enough advancements in cgms, as well as technology that we felt that putting insulin together with a CGM, and in good software and analytics, that we hope can provide better outcomes with really less burdensome for someone who lives with type one or type two diabetes. So that's why we were interested in getting into this space. And as we were looking at options, we thought it was best for us to pursue a partner that had a good pump that was on the market today, who was an excellent developer and manufacturer of pumps. And we found the perfect partner in Ypsomed. So we we really liked their pump. They're an excellent Swiss bass manufacturer, and we think it's a good cultural fit for us, we think we really will work quite well together. And we're both very customer focused and want to make sure that ultimately, what's most important is helping people who live with diabetes achieved the control,


Stacey Simms  6:49

before I asked you about the functionality of the pump. And before I asked you about the features of the pump, and more about the partnership, I'm just curious if we could go back, I was at the blogger event that Lily had in Cambridge, in 2018, where you showed us kind of the prototype of a pump that you were working on with a different company, can I ask, What happened to that is that not going forward in any way, shape, or form now,


Mike Mason  7:13

oh, we very much hope that that product goes to the marketplace, the rights to the DEKA pump has gone back to DEKA, we really value our partnership with them. We think it's a very advanced pump. And we think it could really help people living with diabetes. And we know the DEKA is advancing, planning on, you know, advancing that pump to the marketplace. For us, we reflected back on how we can, you know, best use our capabilities to help people with diabetes and other therapeutic areas. And as we were facing COVID, we reflected on our ability to develop a new antibody in nine months and get that to the marketplace and manufacture that and we felt that as a company, our development, and manufacturing focus should really be on developing new medications versus new new pumps and new devices like that. So we decided our deck arrangement, we were responsible for the manufacturing and a good part of the development. And we felt it was better for us to find a partner who already had a pump, who is a manufacturer and developer, and for us to say primarily focus on building the integrated system and really having that experience with the people living with Type One Diabetes and type two diabetes.


Stacey Simms  8:34

So any DEKA pump that goes forward, will that still be used with the proprietary cartridges that we're going to talk about down the road? I mean, it's slowly still involved with the DEKA pump whatever comes to market, or is it basically all in their hands now,


Mike Mason  8:47

it's in their hands at this point.


Stacey Simms  8:49

Let's talk a little bit more about that. Ypsomed partnership. As you listen, we did an episode with them. They went through a lot of the factors and different functionality of the pump. So I'm not going to go through that all again here. But I am curious, Mike, if you could talk a little bit about the algorithms in the pump. In other words, how might it be different from the other pumps that are coming to market tandems control? IQ software is one the Omni pod horizon, that sort of thing.


Mike Mason  9:14

Yeah, I mean, I think algorithm will be critically important at the end of day what's what's most important is that you you build an integrated system and cannot help someone achieve better control. And what we think is we can use our 97 years of experience with insulin to build algorithms that that do a very good job of controlling insulin and blood blood sugar. And so that's our plans if we as we develop new products like Lyumjev our new ultra rapid insulin. This provides us to potentially provide unique algorithms that can really maximize the potential of a product like longevity.


Stacey Simms  9:52

So let me ask you the the biggest question for my listeners is all about the proprietary nature of the pump. And before we get into that, let me just ask you a few details about it. But only use humalog or will it use other insulins you mentioned, Lyumjev things like that.


Mike Mason  10:06

Yeah, let me tell you a little bit about the pump and why we were excited about the pump, we think it's a very good form factor. It's a small pump, it has a kind of icon based screen that makes it very easy to use for people who were. But one of the most interesting parts of the pump for us was the fact that they  that uses a 1.6 millimeter cartridge. So it's a prefilled cartridge, that then gets plugged into the pump. And what that allows is allows someone to change if their reservoir goes down. So if the cartridge runs out, they can add new insulin independent of their infusion shed change. So if you think about the future of infusion sets, we think that will grow from three days to longer than three days, just like we saw the wear of cgms increase. Well, that doesn't help if your reservoir if you have to change your infusion set every time you use your your reservoir up. And so we believe that the 1.6 ml cart and the fact that they can, you could do kind of a hot change and change that independently. infusion pump should be a really nice feature for someone living with Type One Diabetes, or even in particular type two diabetes who uses larger amounts of insulin on a daily basis, be able to get the full life on an infusion set and be able to add insulin very easily into the pump. So that was one of the primary features that we liked. And so right now that 1.6 ml cartridge isn't on the market. And so in our press release, we communicated that we needed to make sure that we did launch that 1.6 ml cartridge in our insulins, both humalog and loon jet to make sure that that people could use our products in that pump.


Stacey Simms  11:51

When it comes to market. It will only let me ask it this way. Right now in Europe and in Canada, though it takes the prefilled cartridge the same pump of novo, right I mean, these 1.6 milliliter cartridges exists elsewhere. This is a US only type of modification. Is it a different kind of pump that's manufactured in the US? How does that happen?


Right back to Mike answering that question. But first Diabetes Connections is brought to you by Daario health. The bottom line you know you need a plan of action with diabetes. We've been really lucky that Benny's endocrinologist has helped us with that and that he understands the plan has to change has been he gets older you want that kind of support so take your diabetes management to the next level with Daario health they're published Studies demonstrate high impact results for active users like improved in range percentage within three months reduction of a one see within three months at a 58% decrease in occurrences of severe hypoglycemic events, try Darias diabetes success plan and make a difference in your diabetes management go to my forward slash Diabetes Connections for more proven results and for information about the plan now back to Mike about how the mechanics of the proprietary nature of the pump will work


Mike Mason  13:17

well in the us right now there's that 1.6 ml cartridge isn't on the market place so we'll have to see you know is that advances is still kind of early on in development so we don't really know what instance will be available in the US for this you know in this cartridge size. But what do you think is important is first of all, I don't think anyone should be worried if they're on novels insulin or any other instance there's going to be plenty of pumps really good quality pumps for them to use so I wouldn't have you know anyone be concerned about their ability to have a high quality pump to use with their insulin what what we see is we we see an opportunity to provide a you know, an integrated, very simple to use pop another option for people living with type one and type two diabetes to have a an integrated, simple experience to improve their their blood control.


Stacey Simms  14:08

Yeah, no, I think it's it looks like a fantastic pump. It's tiny, it's light. I know people in Europe who used to love it. I love the idea of having more pumps in the United States. But just to be clear, so I guess the the question about the proprietary nature that we keep referring to is it just because there's no prefilled cartridges of other insulins available in the United States? I mean you probably cannot answer this so I'm gonna say this out loud and you can say no comment or nothing but if I have a yep so mid pump that is approved in here and let's say 2022 and I bring in novo rapid or you know Novo Nordisk branded insulin from Canada in the same kind of glass insulin cartridge and I stick it in the pump I've made my IP so med Lily pump now compatible with other insulins.


Unknown Speaker  14:56

Okay, didn't you comment on that


Mike Mason  15:00

Wow, yeah, you're expecting a lot of people moving bringing product over from from Canada, I, you know, it's still we're still very early on in our apps is at this point, things are gonna have to develop and we'll get a better answer that question down the road.


Stacey Simms  15:14

Got it? Okay, I know, I know, you cannot speculate you have to be so careful on what you say. And I appreciate you coming on and answering these questions. But I mean, I'm sure you can understand in a market that has three available insulin pumps in the United States that when one comes in, people have questions about why should I switch to him? And the biggest question that I have seen is, well, pumps usually have a four year warranty. And my insurance changes every year, whether I have with the same insurance or not, the terms often change, including what insulin they want me to use, we just went through this with my son this year, we had been using one type of insulin for a long time, and they switched us to another brand. And, you know, it's disconcerting, and it's a little, you know, it's, it would make I'll be honest with you, Mike, it would make me hesitant with the United States healthcare situation being what it is right now, to go to a pump, that would lock me into one kind of insulin, you guys have got to be thinking about that. What are the discussions? Like? Can you share anything about that?


Mike Mason  16:12

Well, let me tell you kind of how we think about I mean, we, our goal is develop an integrated solution, I kind of look at it a little bit like the computer market, where, you know, early on, you know, you were able to and you still can today is build a an integrated system, you know, you can pick the monitor, you want the processor you want. And my brother continues to do that. And he has a great computer that works really well for him. And for myself, that's not what I'm looking for a computer, I've got four kids and a lot to do. And I want something that's just gonna work, I don't necessarily care what the processor is, or what the monitor is. And so that, you know, I kind of went to a Mac 1520 years ago, because it was simple solution. So it was another option out there, I think, you know, Apple provided a another option to people who needed to get work done and wanted to use a computer, we kind of look at that the same way. On the pump side, I think you're gonna have people who are want to have each component and be able to build that. But if we look at some segment of the market, and in particular those people with with type two diabetes, we believe a simple solution can provide, you know, a real good answer for those individuals. So what we look at this ad, we don't look at it necessarily as limiting options, we look at bringing a new option to the marketplace that as an integrated solution can provide a new way to be able to control their blood sugar. So that's how we look at it.


Stacey Simms  17:40

So let's talk a little bit more about that integrated system. When I spoke to Ypsomed, they talked about it using a Dexcom having a very robust app, it looked like you were able to bolus by phone or you would be by the time it comes to the United States. Is the partnership with Dexcom exclusive or do you think you might work with other companies like Abbott, you know, on their libri and different cgms that could be integrated into the system?


Mike Mason  18:04

Yeah, right now it's a three way partnership between us and and you have submit and then with your leveraging Dexcom CGM. At this point, we'll have to see how things progress and whether or not we bring Abbott or other CGM into the system.


Stacey Simms  18:22

Ypsomed is also very much a pen company. And when I remember in that 2018 event that I've talked about before, Lily was also talking about integrative pens and things like that. Is that part of this deal here too? Or is it just a pump?


Mike Mason  18:36

Now, this was just an exclusive partnership.


Stacey Simms  18:38

So when when you were looking at it, so med pump, as we mentioned, it's very light, it's very intuitive. Have you tested it? Or have they tested it in the US market yet? Is that something that you'll be doing in terms of, you know, human factors and how people respond to it? And that sort of thing?


Mike Mason  18:53

Yes, we have to, you know, it'll be submitted to the regulatory agencies in order to gain approval in the US market. And as part of that, it will be tested in the US through human factors. And we think it will, will do quite well. We've done a lot of market research and interviewed people who use pumps are who are interested in using pumps. And we think that the attributes of the product are going to be well received in the US market. You know,


Stacey Simms  19:19

again, I don't know how much you can answer on this question. But when you bring a pump like this that's been used in many other countries for several years, is the testing different than say, you know, what you were what you were originally planning from Cambridge with the DEKA pump, a brand new pump, something that hadn't been on the market yet. I would imagine that it's a I don't want to say a little smoother, but it's got to be different. When it's already been out there and used in 1000s of people.


Mike Mason  19:42

The information is helpful, but the application is similar for every pump, no matter where it's approved, or whether it hasn't been approved before. So you know, the FDA requirements are the same no matter what


Stacey Simms  19:52

got it. I'm curious to know the cartridge that we've been talking about that isn't available in the United States yet. Are there other applications For Lilly for that, I mean, that 1.6 unit cartridge? Is that something that could then be used in pens? Are there other uses for it? Or will you be making it just for this pump?


Mike Mason  20:09

I mean, initially it will be used for this pump or any other device that uses 1.6 volt cartridge, you will evaluate every time you put a new form factor of insulin out there, we'll look and see if there's other opportunities that better meets the needs of people living with type one and type two diabetes. So we'll see no immediate plans at this time.


Stacey Simms  20:28

Okay, are there other devices that use it currently, I'm not familiar, not currently.


Mike Mason  20:32

But it's no reason why someone couldn't produce a third party, you know, we usable 1.7 card. That is


Stacey Simms  20:42

it's interesting. You mentioned people with type two quite a bit in this conversation. And I know in my conversations with manufacturers with tech companies, more and more people with type two are using insulin pumps and are using devices like Dexcom. And you In fact, I'm really trying to talk about more people who use insulin rather than the specific types. We talk about devices like this, which honestly, it's kind of hard for me after all these years. Can you talk a little bit about the appeal to that market? How do they use this kind of pump? In other words, most people I know with type two who need insulin, don't bolus for every meal, they don't necessarily use the same amount of insulin as type with people with type one. I'm curious if there's any information you could share on that market?


Mike Mason  21:21

Yeah, I think what we see is, first of all the needs while the disease is different, the needs of someone to control their blood sugar, both for postprandial as well as for basil is still there, especially for those who are later stages other type two diabetes. And so we feel that no matter who someone is, if they're on insulin, the big thing they want is to kind of stop thinking as much about taking insulin three or four times a day, you know, that's something that weighs on a lot of people mind. And we think it's important to be able to reduce that burden, but also improve care. And that's what we think, integrated insulin management system can do that's wrapped around a pump, whether that's for type one, or type two. Now, your question around, you know, what's different about type two diabetes, the big difference is the amount of insulin that they take on a daily basis. And because of that, I think the reservoir size and the ability to change that independent of the infusion set is an important feature of this pop and one that we think both type one and type two, but in particular type two beddings can really,


Stacey Simms  22:33

you know, it's interesting, when I spoke to the folks at Tandem recently, they brought up their control IQ software for people with type two, and how it's really helped. Because most of the time, it's just that people with type two aren't bolusing for their meals, or for correction dosing. And so being able to have that automatically has really helped. It's something that I mean, just conversationally, it was something that I really hadn't thought of, with an automated system like that. It's interesting. Yeah, it's


Mike Mason  22:56

interesting, when we speak a lot with people using insulin, the needs on a daily basis aren't that different, and the thought process and how they manage that, you know, isn't that different, but you're right, you know, and unfortunately, taking insulin is very complex, and it changes on a daily basis, as you know, well, and that's what we hope, we hope we can alleviate some of that burden that people have of controlling their blood sugar and their and their diabetes. In the


Stacey Simms  23:24

United States. You know, anytime a new product comes to market, in addition to submitting to the FDA, you have got to work with the insurers to get these things covered. And I'm curious if your conversations about getting the med pump insured, also factor around making sure that anyone who ensures it can make sure going back to what we asked about at the beginning. We'll also cover Lilly insulin as a some kind of package. When I spoke to the CEO of episode med, he had kind of implied and this was speculative, and he admitted that, but he was kind of hoping I guess is the way to say it, that it would be more affordable in the United States because it could be packaged up with healthcare insurers. Any thoughts on that?


Mike Mason  24:05

Yeah, I mean, I mean, first of all, we'll make sure that there's obviously insulin supply for for the pump. And so we'll make sure that that comes hand in hand so that someone doesn't have a pump that they can't use their insulin on. So what will definitely solve that problem, as we go to the marketplace, I think, you know, we haven't had any specific discussions with payers on this particular product just yet. But what we've had, generally, in this area is you know, payers are frustrated with their ability to help their members get good control on insulin. And they believe that that better control on insulin can lead to better overall healthcare cost. If you look at the total cost of the therapeutic and devices as well as all the cost of office visits and the very costly, you know, company Patients have diabetes. And so they're excited to not only provide better care of the hope of better care, but also the hope of reduced total medical costs.


Stacey Simms  25:10

As we start to wrap up here, just a couple more questions. I got notification, we saw some ads on social media about this is separate from the pump about renewing any coupons for the new year. Can you speak to that a little bit? While I've got you here, you know, for 2021, the lily coupons that are out there? How do people do that?


Mike Mason  25:29

Yeah, all they need to do is call our Lilly diabetes Solution Center. If anyone has trouble paid for a Lilly insulin, you can call up early diabetes solutions center. It's staffed with people who are healthcare professionals who will understand the needs and be able to get your solution on the phone or to email that to you with without any paperwork to fill out or anything like that. And so if they do need if one of the things they need is that to get an updated coupon, they can just literally call them and we also are putting more and more options on the website. And we can get you more information on that. Stacey.


Stacey Simms  26:06

Yeah, that'd be great. If you could send me the links. And I'll I don't know, Mike, if you know, but I wound up using that coupon in the fall. Oh, yeah, as I said, My insurer switched us we switched in September to a new insurer. And they wanted us to switch to Nova log, which we hadn't used in many years. And I'll be honest, is a little bit of an experiment, I decided to try it. For whatever reason, it wasn't that easy. It took me a couple of weeks that I needed. prior authorization my pharmacist helped out it was we went back and forth quite a bit. But we did get it done. And I'm back to paying about $35 a month for Benny's insulin for my son's insulin, which was great. But it kind of brought me back to the conversation I had on a conference call with Andy Viacari  Last March, I want to say when you know, COVID had first hit and we were all really concerned about and unfortunately, it would bore out with employment in the economy. And the question I asked him at the time was just why not do away with all of these coupons. And because it really while it was difficult, I was able to use it would not have been able to get the Lilly insulin without it with my new insurance. So it did work. But I asked him at the time, I'll ask you now, why not just lower the price across the board to $35? And make it easy for everybody?


Mike Mason  27:19

Yeah, I mean, for us, it's a complex healthcare system out there. And we lower lowest price which we have was Insulin lispro that's one of the options that we've had, we dropped our list price by 50%. And, you know, we think that the sweetest solutions that we have, you know, with lowering our list price with listen into the lice pro as well as all the options that we have that are very targeted at the gaps in a system, which is the uninsured people, high deductible plans. And Part D, that we can create the best possible out of pocket experience, no one should have to pay more than $35 for literally insulin 43% of people who usually insulin doesn't pay anything for based on the health insurance. So, you know, we've looked at the problem. And we believe that this is the best solution we have out there.


Stacey Simms  28:07

I mean, I hear you, I get it, it's very complicated. You're not operating in a vacuum. But you've said several times that you want to help people get better control, the insurers want to get people in better control. One of the reasons people aren't in great control is because it's really expensive, even though, you know, if you have insurance, you're paying for it, you're paying for the high deductibles. I don't need to tell you we've had these conversations many times before. But I got to believe that this is not a sustainable system. And you know, I don't really have a question there for you, Mike. But I really hope that next year, we're not having the same conversation. And I know you don't want to have it either. So you know, I'm not not because you don't want to answer the questions, but because I I imagine that you know, that even if the price was lowered to $35, that Lilly would be fine. In business.


Mike Mason  28:51

I mean, first of all, if anyone has any concerns with, you know, 40 million insulin, call our Lilly diabetes solutions center, you know, with the most recent Part D demo project that the CMS introduced in January this year, no one whether you're in Part D, or commercial or uninsured and have to pay more than $35 for the insulin. You're right. I don't think the healthcare system right now is sustainable, whether it be for diabetes or other chronic diseases, we shouldn't put the medications that are designed to improve quality of life and to reduce overall total healthcare costs. We shouldn't have those at a high price that people can afford. And so I hear you know, that we are advocating strongly and working with our other healthcare system partners, whether that be you know, pbms and insurance companies as well as employers and the government on this topic, and it is a very important topic. And I hope, you know, as the Biden administration comes in, that we can have very good conversations and make progress.


Stacey Simms  30:00

Mike, thank you so much for spending so much time with me. I know I kept you over a few minutes and I appreciate you you're hanging on and answering those questions. Thanks for being here.


Mike Mason  30:07

Thanks, Stacey appreciate it. appreciate everything you do for people living with diabetes.


Unknown Speaker  30:16

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  30:21

More information about Lily and Ypsomed their partnership at Diabetes The episode homepage, of course, has a transcript and more information, lots of links. But this is a story that we will of course, be watching over the next two years until this pump comes to market who knows what it will really come to market as things change along the way. But I'm fascinated by the proprietary nature as you can tell, because I'll tell you our Insulin story and in just a couple of minutes, you know, if you're using one type, your insurance company can switch you to a different type, it can be very difficult.

So we'll see another point I just wanted to mention, I didn't bring this up during the interview. But when Mike talked about the uniqueness of being able to change the cartridge, independent of the inset, there is something unique there about the YpsoPump, and I'll talk about that in a second. But it's not exactly as he explained it, you can do that with any tube pump with the Medtronic that are out there right now with the Tandem t slim any tube pump the way we have done it and we have always done it since using atomists. Gosh, almost 14 years ago. Now, when the cartridge runs out of insulin, we change the cartridge. When the inset hits three days, we change the inset and we don't do them together. Not everybody does it that way. Many, many people change them together, they have worked out exactly how much insulin they need, or they just feel more comfortable doing it together. Whatever is your pleasure. But the thing about the episode med pump that is different. My understanding is that when you do that you do not waste the insulin that is in the pump tubing, there is a different way there is something about it. That means you do don't have to push through and prime all of that insulin because I know what the Tandem you do waste insulin because of all the priming. So I just wanted to kind of clear that up and address that. As you listen. I know many of you were thinking that's not unique, but that's what he's talking about.

I have also reached out to DEKA, that is the company that was originally partnering with Lilly, we mentioned that the interview to have a new pump and pen system in the US is very different looking pump, it was cylindrical that was I don't know if that's the right way to say it like a disk, it looked almost like a tiny tin, you know when that's coming to mind is like a tobacco chew tin. Or maybe maybe mints is a better way to put it like almost smaller than your palm, but small, thin and circular. And that was the pump that they were working on really interesting. So I've reached out to DEKA to see if they're going to continue that work. And DEKA, just as an aside is the company from Dean Kaman D. k. Dean came in. He is the person who invented the insulin pump years and years ago, very first one and he's invented a bunch of things, including the Segway. So I'll link up stuff about him to very interesting, I'd love to have him on the show. But that's neither here nor there about Lilly.

I do know that many of you get frustrated when we talk to them, because you want me to just talk about insulin pricing. As you can tell, you know, Mike says what he's going to say. And I will continue to ask about it. We'll continue to talk about it and send me your questions. I'll see whatever I can do our insulin story coming up in just a moment. But first Diabetes Connections is brought to you by Dexcom. And it really is hard to think of something that changed our diabetes management as much as Dexcom share and follow. It is amazing to me that it helps us talk less about diabetes. And that is really one of the wonderful things about share and follow as a caregiver, parent, spouse, you know, whatever, you can help the person with diabetes manage in the way that works for your individual situation. It's about communication, and finding out how they want to share the information. Even your kids this is a decision that you can make together and talking it out really, really helps internet connectivity is required to access Dexcom follow separate follow app required. Learn more at Diabetes and click on the Dexcom logo.


In our innovation segment this week, I'm going to get to our Insulin story. But I also want to mention that there's new guidelines for the A1C when it comes to kids. This was kind of quiet. I was surprised it didn't get a lot of attention. I posted it on social and it was kind of met with a big shrug. The American Diabetes Association has lowered the target A1C guidelines for children with Type One Diabetes. I will read from the summary here. The goal in recommending stricter glucose control was to ensure children with type one have better immediate and long term health outcomes with fewer health complications and reduced mortality rate. The number has gone from 7.5% for children to less than 7%. And I think as you listen you know, the podcast audience, frankly is extremely well educated you guys are up so much stuff. And many of you are already striving for less than seven, you're striving for less than six. We are not striving for less than six. But I think that this is something that many of you are saying, Well, of course, but I gotta tell you, I'm a little disappointed in the way they released this.

They talk about why they say things like these stringent measures are not always practiced by caregivers of 20 patients or diabetes providers due to concerns and fear, it may cause sudden or dramatic drops in sugar levels. And promise, I'm not gonna read the whole report, but they don't talk about better education. They don't talk about access to CGM, to insulin pumps to integrated systems. There's no wording here in the reports about cost, or making sure you have an a pediatric endo, who will give you these things and educate you. I got really annoyed, frankly, reading this, and we'll revisit this, I'll probably reach out to some of the endos who worked on it, I hope to and talk about Yeah, guidelines are great goals are great. But how are you really going to get us there? Because we all know that the A1C needs to be lower right? I am hoping that some of you who have kids with an eight or higher A1C are nodding and going, Yeah, well, what about help for me? How are we supposed to do this alone? I just don't think it's enough to say here's the number. I think they need to give much more help and support. Maybe that's a pipe dream. I know, most pediatric endocrinologists are great people who really want to help. And you know, they see us for this teeny tiny amount of time. But let's follow this one along because it's just it's, it's just so frustrating to know that we have a place we want to be, but how do we get there?

And you know, one of the reasons we get there, and Mike said this in our interview is, you know, we need to make sure people have better access to insulin, so they can live better with diabetes. Well, sure. We went through this recently in my family and I will not go through this beat by beat I did like 10 or 15 minutes on this as a Facebook Live and told the story about a when we were switched, our insurance company switched us from humalog to Novalog, I told the whole story very lengthy double not do that here. I'll tell it in a shorter way. If you want to see the whole story, I'll link it up. But I realized I never told the rest of the story here on the actual podcast.

So here we go. In the fall, in early September of 2020, we had a change in our insurance, a change of employment meant we were now buying our own insurance. And we actually had a great experience. We did this several years ago and had a disastrous experience. It was so expensive, and nothing was covered. I was really excited that this time around, we found something great. We used an insurance broker. And I would highly recommend that maybe we'll do a show on that I'm making all sorts of notes on future shows. But somebody helped us he didn't know a lot about diabetes, but he knew what we needed. So that was great. And my husband lives with type two as well, as you likely know. But this new insurance company did not have human blog as the one they wanted us to get. It was no vlog. And I posted the pricing on social media. It was like, you know, $35 a month for Nova log, and 13 $100 a month for human log. So it was quote covered, but you know, at a different rate. And we were going to go ahead and do that Benny had used Nova log for I want to say the first seven years of his diagnosis, and then our insurance switched us. But he's been doing really well. Everything's chugging along, and I thought, Gosh, I really don't want to switch him.

And I was kind of at sixes and sevens not really knowing what to do. And I was talking to my parents about this. And my dad said, I heard on your podcast that if you have commercial insurance, you can get any insulin with a manufacturer's coupon for $35 a month. And I thought Dad, you're the best. Thank you for listening to my podcast. And of course you are correct. And then that week, I spoke with beyond type one about their new website, get So I went on, get and filled in all the information and a coupon popped up from Lilly. I printed it out and it said go right to the pharmacy and get your insulin. And I know how these things work. So I didn't go to the pharmacy, I called the pharmacy and said Is this legit, and they went, you know, tickety tickety tick and the computer. Sorry, Stacey, this isn't going to work for you. And I know the pharmacist there very well. We've been so fortunate. I've known him for all of Benny's diagnosis. I want to say all 14 years, it's been the same guy. So we really went back and forth and tried to figure out what was going on. It was a quirk in the way our insurance wanted to build it.

So I called Lily. They said no, it should be fine. Here's the codes to give the pharmacist everything should be fine. They called the pharmacist he said No, those codes are not going to work. And they didn't what he told me to do. And this is what worked. Our endocrinologist had to call it a brand new prescription. We were going off the old one that we'd been using, you know for the whole year many years. So he had to call it a new prescription. He had to call in a prior authorization. And then after that when they reran the coupon, it worked just fine. Everybody's different. The pharmacist and the folks that Lily told me that every insurance, every state, sometimes the pharmacies run these different ways. So if you run into a brick wall, definitely keep pushing. And I'm telling you as a listener of this podcast, if you do run into a brick wall Lily and their coupon, email me Stacey at Diabetes Let's make sure you're talking to the right people, because it took me a while to find the people that really dig down and do this at Lilly. That's their job. And how ridiculous is this that this is somebody's job to figure out How to get around all these coupons and use them in the ways that they're meant to be used, rather than just dropping the list price. I mean, it makes me crazy to talk about, I'm already going too long. Bottom line is we got the coupon to work.

And then it worked a second time. I called my pharmacist the other day, because it was time to renew and I said, Hey, you know, I've heard that you have to renew in the new year, is it going to work? And he said, it's going through just fine. And then he laughed. He's like, let's run it without the coupon. I said, Why? Why? He was just curious. He's like, yep, it's still, you know, 13 $100 a month without the coupon. I said, Well, don't put it in without the coupon. Don't even bother. So that's the story. It leads me back to what happened if I was using the app, so pump with Benny. And then in September, my new insurance company said, No, you have to use no dialogue. And I didn't know, I didn't have a podcast. I didn't know I could do all that. I didn't know I could get the coupon or what if the coupon goes away, there's no guarantee it's going to be there. And then I'm stuck with a pump that I can't use the insulin that my insurance company makes me use. So obviously, we don't know. That's a lot of speculation. But those are the concerns I have. Have you used one of these coupons? How about the nofo coupon what's working for you guys? I'll start a thread in the Facebook group. But you can always you know, ping me and let me know what's up with you. Or if you need help that way. It's just ridiculous. Maybe next week, instead of innovations. I'll bring back Tell me something good. We need the good news stories, too.


As I mentioned last week, we are about to start classic episodes. The first one will be this Thursday. And that is an episode I taped almost five years ago with Ernie Prado. He is a rocket scientist for real at NASA. Great guy. It was so much fun to talk to him. He has a terrific story. What I love about his story is it's not the perfect diabetic. He really struggled. And he talks about why and how he kind of got out of that. I think it's one that as a parent of a child with type one. I love those kinds of stories because I don't expect perfection in my kid. And I really like to hear about other people who all due respect, Ernie, who really messed it up and are okay, are doing fine now. So that's on Thursday.

You don't have to listen to it on Thursday. Obviously, whenever you have time, we're going to be putting out a lot more episodes. So when you have time, listen to podcasts. We'll be here for you. thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. Until next time, be kind to yourself.


Benny  42:22

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

Jan 19, 2021

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


Fearless Diabetic Summit

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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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 and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit 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 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 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 impacts Control IQ if you turn it off and on for those periods of time. So that is absolutely an option. It's just it's super easy to do. Another thing that we've seen people do successfully is set up a secondary profile that is a bit more conservative or a bit more aggressive, depending upon the patient needs. And then switching into that profile for that period of time. And leaving Control IQ on so there's a lot of different ways you could do this, you could even do a secondary profile, and then put it into exercise, right? Like you could do conservative plus that temp basal, right, or you could do aggressive plus that 10 basal rate. So all of that is it's entirely possible. But knowing that you can turn it off and do the basal rate as you please and then resume it confidently, you know, that's still an option for you. I do know that people do want a bit more control over that. And so and, you know, allowing for some sort of ability to have a temporary basal rate is on the list of things that we would like to do. Great.


Stacey Simms  43:03

Another question was I am still using basal IQ. And this person is really curious about what percent of Tandem users are using control IQ. And and you've kind of touched on this. But do you have any statistics about user satisfaction rates for control? iQ?


Molly McElwee Malloy   43:18

Yeah, so D q&a, again, affiliated with diatribe, third parties who, you know, has done some user satisfaction surveys, and I will get you the exact number. But this user satisfaction with Control IQ is very high, very, very high. And I would say the majority of people have changed over to control like you. But there are still patients on base like you and I can't speak to the exact percentage, but there are reasons why somebody may want to choose based like you to just have that suspension rather than also, uh, you know, having the, the auto correction or something like that. So there's cases for both, and that's why they're both still being offered. But I can't speak to the exact number of people who have not switched over, but most people are switching over to control like you.


Stacey Simms  44:02

Are there any plans to make it more flexible in terms of switching back and forth? Because once you go from basal IQ we did this once you put the software in your pump and switch to Control IQ you can't go back to basal IQ. Are there any plans to change that?


Molly McElwee Malloy   44:16

Not at this time. The reason being is that you wouldn't need a script, write a prescription to do that. And when you upload your property went to your provider. If you went between one thing and another and another all the time, we would really have to differentiate those reports and make sure that the healthcare provider was familiar with why each was different because they would impact how you would titrate insulin so it adds a lot of complexity on the therapy end. And so we have not made a move to to make that something that you could toggle between. Got it.


Stacey Simms  44:51

And another question came in which I thought was really interesting about accessibility for people who are blind and I know in the past, there was a meter that I think talked about There was more audio is Tandem looking at more accessibility for people who don't have any vision or low vision.


Molly McElwee Malloy   45:07

Yeah, yeah. So Tandem is making technology user friendly for those with different abilities. And we're absolutely have this on our radar, persons with low vision or no vision, right, using a touchscreen could be difficult. And we're exploring ways to leverage apps and existing consumer technology that might be able to solve those unmet needs. It's definitely definitely something that we are looking at and can appreciate that that's something that we need to do.


Stacey Simms  45:32

Very cool. Another question came in, and this is based on an older press release. So I'm not sure if you can speak to it. But apparently JDRF in Tandem years ago, like eight years ago, put out a news release about a dual hormone, insulin pump. What we're seeing if you're familiar with the iLet beta bionics is because the only one at least in the US where they're trying to develop a pump with insulin and glucagon with more stable glucagon now on the market, any chance that Tandem is working on a dual chambered pump.


Molly McElwee Malloy   46:02

So the big message here is that that eight years ago, I think, for the press releases when Tandem was being used with two separate pumps in the iLet studies, right, right, they ran the Tandem pumps, and one was full of glucagon and one was full of insulin. And they were putting two pumps on one person,


Stacey Simms  46:13

I remember that picture. Wow.


Molly McElwee Malloy   46:21

So that's where that came from. So but our our micro delivery technology is really well suited for to hormone therapy, we currently are only approved for you 100, right? insulin and only indicated for insulin per FDA. But you know, it's a fundamental challenge for people developing dual chamber devices. And there's not an approved hormone available for use in pumps at this time. So it all be very investigational. But we do have, you know, this microdelivery technology, which is well suited for doing something like dual hormone, but I think there's a lot of things that need to get addressed before even that becomes something that we can put in a trial.


Stacey Simms  47:02

And then it's something that I started talking about this summer, I've mentioned this interview with I did with Steph Habif from Tandem. And I will link that up. It was kind of we call it the first look under the hood for Control IQ that we did this summer. And she's the Senior Director of Behavioral Sciences. But we brought up some of the questions about who gets into clinical trials and who actually tests these things out and the information that you get in terms of diversity. And so this question here, I'll read the whole question from a listener. I've heard some rumblings that most of the people who tested Control IQ were white, I would love to know that Tandem has plans to diversify this more. This is a huge issue in general for trials of any kind, and stuff this summer started to address that in terms of Tandem knows it. They're trying to be more diverse. Can you follow up on that? And let us know what's going on?


Molly McElwee Malloy   47:50

Yeah, and your listener question is totally right on, right. The FDA is on this as well. They recently told Moderna, you know, you have to go back with your COVID vaccine and get get more people, right, you have to get people of diverse backgrounds and and ethnicity. And so that's true in clinical trials overall, need to be all more inclusive. And it's true that most automated insulin delivery trials today have been largely white, and that includes our adult pivotal trial. One of the things we're seeing changing from both an FDA perspective, as well as research and industry is that there's active pivoting to change the approach. And there's more guidance on changing the approach. The FDA has issued guidance on diversity and inclusion in clinical trials, which I'm sure you could post in the show notes. But that's a really interesting sort of, if you will mandate from the FDA to please be more inclusive, but for those in the community who may have attended that D data event from diabetes mine, and I can send you a link to the YouTube video, Dr. brandmark, who's at Children's Hospital in Washington, DC presented on diversity inclusion, specifically in diabetes technology research, and it was very illuminating on how white those trials are right? And what we need to do to better accommodate and to be more inclusive in a lot of different communities.

From a Tandem perspective, we are very committed to this, particularly in our post market studies, we encourage principal investigators to do the same who are looking at different research and the FDA is mandating it so it absolutely will be happening right? The FDA says you will be providing a trial with this type of diversity you will be doing that so I think that the that everybody is aware that this needs to happen and we're trying to figure out how best to do it and be responsible stewards and industry but for a long time you're right I mean, you know diabetes technology and automated insulin delivery trials were largely white, you know, you have to be able to take off of work right? Whether you're bringing your kids to your appointment or not. And so those are jobs with that allow some flexibility. You have to be able to afford to miss work right? You have to have paid some sort Lead, whether it's sick or personal days and, and all of that does impact the person that you recruit. Right. So being able to alleviate some of that maybe it's provide compensation, the FDA suggested providing compensation for parents that can't take off time from work or, you know, meeting people where they're out whether it's in qualified public health centers, or at schools or wherever, to make it easier for them to attend, whether it's clinical appointments or whatnot, but meet people where they're at and have people run the research that look like the people who will be in the research, right? So diversified that field as well. There's a lot that needs to be done here. And Tandem is absolutely committed to making this a priority.


Stacey Simms  50:42

That's great to hear. I'm interested in following up more about it not just with Tandem, you know, I feel like it's also a question of finding people who, you know, I have the same frustration with this podcast, how do I reach new communities? How do I find people who would maybe benefit from the information but don't know why I exist? Because I don't run in those circles, right? I mean, we tend to run in the same circles, and we need to branch out and not make people find us. But But fight. Right. So it's really, I think it's also a question of finding more. Look, I'm not an expert on this by any means. I probably shouldn't speculate. But it's also a question of, you know, finding staff that is of different races, me finding more guests that are of different races and are, are in different communities. It's for us to do the work, not to ask them to come to us. And so I'm really glad that Tandem is doing that and is on top of that. So thanks for answering that.


Molly McElwee Malloy   51:37

Yeah, there's a sea change coming in society and diversity and inclusion, and that will absolutely be translated at Tandem.


Stacey Simms  51:45

we've been talking for a long time, you've been really generous with your time. Just another quick question from a listener. And that is about the mobile app. I'll be honest with you, Benny doesn't use it a lot. He says he's waiting for bolus by phone. But someone said it wasn't that fast. In terms of uploading. Have you heard about that? Is that something that you're looking at?


Molly McElwee Malloy   52:03

Yeah, absolutely. And the reason that I think some people are experiencing that is that they haven't downloaded, they're pumping some time in, right. So whenever it last downloaded, it's going to append that data going forward. And so if you have a year's worth of data, or you have six months worth of data, that's not gotten to the cloud, that takes a while to get up there. So if you could download your pump First, if you've not downloaded in a long time to connect, or upload your pump, rather than that sort of relieves that burden to append the all the data that has never been there before. So if you could do that, and then let it sync, day after day, it will be much faster. It'll be much, much faster,


Stacey Simms  52:45

And we did that I should probably get on that. But it's Yes. Good. Hey, really, before I let you go, Molly, we haven't spent a lot of time on this interview, because you've been generous in the past to come on the show for really many years now. But I haven't spent time talking to you about your personal experiences. But as you mentioned, you know, you've been in this community not just living with diabetes, but you've been in the testing for the artificial pancreas projects for for what has become Control IQ for a very long time. Would you mind if I asked you just one more time? What is this like for you? We've had this elusive piece of software in the market with real people using it for a year. You've been testing it for I want to say almost 10 years. What's it like for you?


Molly McElwee Malloy   53:30

Yeah, yeah, it's professionally, 10 years, and personally, for 14. So it's a bit of a surreal experience. But it's also it's very cool, because I can see the improvements that need to be made. And I can see how they can be made. And it's been really, really cool to teach health care providers, and particularly, which is a big part of my job about reading the data and looking at insulin needs. And how do you make this look like you are how do you make this work with bass like you are? How do you make this work? easiest for your practice. And it's just been just to put it into practice has been really awesome. Because it's, we do get notes from users on social media and otherwise about how it's impacted their life and that they feel like a normal person now and that's all I've ever wanted, right as a person with diabetes is to like, give me back my personhood, where I'm not thinking about diabetes 24 seven, and I feel like Control IQ does that. You know, it's not Is it the be all end all? No, we will improve upon that. But you're never done right. But the fact that so many people have expressed that has been really rewarding. And I really want to see that carry forward and in all of our products that we relieve reduce burden for people with chronic disease. There's no other disease in the world where we asked somebody to do all the things we asked in diabetes. You know, if you have a heart condition, we don't ask you to beat your own heart. You know, we don't there's nothing else that we ask this much of people and then that we possibly make them feel bad or shame them for not achieving these things, which is kind of crazy. So reducing that burden and making this a more realistic disease to manage, is all I've ever wanted.


Stacey Simms  55:06

Well, I can't thank you enough for your personal participation in testing this out for years and years, as you said, 14 years and for being so accessible and coming on to answer all of these questions. So Molly, thanks so much. I look forward to talking to you more. I look forward to more improvements and exciting releases from Tandem. I know you'll keep us posted. I really appreciate your time.


Molly McElwee Malloy   55:26

Absolutely. Anytime. Thank you.


Announcer  55:34

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  55:39

Lots more information in the show notes. I'll link up some helpful things from Tandem and more information for you. And I did have a couple of follow ups. As you heard, Molly couldn't answer every question I had. So I got a couple of notes for Tandem that I want to share with you. Now, bolus by phone was submitted in the third quarter of last year. That is called mobile bolus. I don't know if there's a branded name for it. I did ask about that. But I hadn't heard back. But that has been submitted. It's in front of the FDA right now they're hoping to hear back in the first half of 2021. You know, it's hard as Molly did save with COVID, delaying everything, it's gonna be really hard to tell, as always, when the FDA will approve these things. But I'm so excited about that.

And I'm interested to see what it looks like practically, I'm going to say this with no knowledge of what was submitted, I do not have an inside track on what it would actually look like. So this is my speculation. You know, I imagine you just take out your phone and use it like your pump. Right? You can you'll have the full functionality. I don't know if that's really the case, I would imagine the FDA might be cautious. I don't know. But man, I just envisioned Benny, you know, he's got his phone in his hand half the day anyway. So beep beep, you know, let's go. Maybe that'll be their branding: beep beep Let's go.

They also let me know that Tandem is still planning to submit the Tsport to the FDA in the first half of 2021. And they are hoping for a quick turnaround possibly launching by the end of this year, which would be really exciting and nice to have another option there.

And a listener asked me about this. I didn't get it in time for this interview. But I did have a chance to ask Tandem about their agreement with Abbott, if you'll recall, Tandem and Abbott have an agreement to integrate with the Libre not just with the Dexcom. So there is apparently no update on that right now. But they are anticipating having one in the fourth quarter of 2021. We talk a lot about interoperability on this show. And you know, of course the dream is if a certain CGM isn't working for you, and another works better, you'll be able to slap that on and press a button on the pump. I don't think it's going to be that easy. But maybe down the road, I really do hope that we'll have more options. But if you had asked me five years ago, if the pump market would look like it's about to look right now, I think I would be pretty happy about that not just because of the great technology that's here from Tandem.

And we've been talking about what's next for Medtronic and Omni pod. But because we have more pump players coming to market, I am so excited to be talking to the folks from beta bionics and from Big Foot later on this year. So we will keep you posted. Innovations coming up next. Speaking of moving forward, we're going to be talking about exercise and CGM new guidelines for that and rare diabetes Could this be you it's really interesting what they're saying here.

But first, Diabetes Connections is brought to you by Dexcom. And we have been using the Dexcom G6 since it came out and we love it. It is amazing. The G6 is now FDA provided for no finger sticks for calibration and diabetes treatment decisions. We've been using the Dexcom for seven years now and it just keeps getting better. The G6 has longer sensor where that 10 day were now the sensor applicator is so much easier to use than it was in the past. We do love those alerts and alarms and that we can set them how we want if your glucose alerts and readings from the G6 do not match symptoms or expectations use a blood glucose meter to make diabetes treatment decisions. To learn more, go to Diabetes and click on the Dexcom logo.


Ran Across something I thought was really interesting for our innovations segment this week, and that is the RADIANT study. I will link this up. But radiant is recruiting people who have been diagnosed with diabetes, but they don't fit the usual characteristics of type one or type two. Apparently, this is not uncommon. I mean, most people really fit into the type one diabetes or type two diabetes. You've heard of Lada and 1.5 if you've listened to this show, but many types of diabetes are unknown, called a typical diabetes, and I really have never heard anything about this. So there's a new study called radiant, which stands for rare and a typical diabetes network and they want to discover more about what's going on here. You know, how do we better help these people? How do we treat this stuff, there's a lot more information on who qualifies are, how do you know i will link that up in the show notes, please check it out. And let's spread the word. Because this is really something that I think could make a big difference for people who are, you know, misdiagnosed or aren't getting the most from their treatment like, oh, it sounds like you have type two, but this isn't working for you. Let's get the word out and check out that link.

The other story in innovations is about new guidance for people with type one, and using continuous glucose monitoring for exercise. So there hasn't been a lot of information about this, you know how to use your CGM to safely and really exercise well. So this is new guidance from the European Association for the Study of diabetes and the International Society for pediatric and adolescent diabetes, basically, the European counterpart to the American Diabetes Association, and that second group has a narrower focus on younger people as you would assume from the name. But there are a lot of American researchers that you've heard of as the co authors on this, like JDRF CEO, Dr. Aaron Kowalski and Dr. Bruce Buckingham, who we just adore on this show. So anyway, there's a lot of information on this, I'm not going to go through what it says because I will link it up in the show notes and on the episode homepage. But it really gives you guidance in terms of if this than that, but also allowing for the complexity, because everybody with diabetes is just a little bit different, especially your exercise is going to be different to what it really like is it's not just about the exercise in the moment, they also talk about what to do later in the day and overnight. So good guidance here. Our innovations segment is for tips, tricks, hacks, studies, new stuff in the community. I also have our Tell me something good, which will return next week, please make sure you send me your good news stories for that I have a bunch that I've been holding on to can't wait to share next week. But I always like to hear from you. You can reach me Stacey at Diabetes, or drop into the Facebook group Diabetes Connections, the group and let me know what's going on.

Before I let you go quick reminder that the Fearless Diabetic summit is happening at the end of this month. This is a virtual summit that is free, you got a bunch of speakers, the videos are made, I was so excited to participate in this. And you can watch them for free for a couple of days, as many as you want. And then after that there is a fee to access. But you can check it out. I'll put a link in the show notes. But I think this is a great idea you can get kind of the appetizer and see what you like about it. And then if you want to delve further, you can go ahead and you know and pay for the content. I was not paid for my involvement, I was excited to take part I do have some goodies and freebies and stuff like that for people who are participating. So you can check that out. Also, mine I think is the only parent video that's in there. But there's lots of great information from athletes and endos and CDEs, you know, regardless of age.

Also, if you have a podcast or you're thinking of launching a podcast, diabetes, or otherwise watch my social posts, because by the time this episode airs, my new venture should be out there I am taking the dive to help other podcasters learn how to talk to sponsors, how to make money, frankly, from their shows, and how to do it ethically. And well, there's a lot of snake oil out there hanging, it's a lot like diabetes, there's a lot of not so great players out there in the podcasting space. And I'm excited to kind of help give people good advice that can help them get great shows out there and make them solid and make them more than a hobby. So watch for that. All right, lots to come. We're getting a great response for this tech heavy emphasis in 2021. Because my goodness, there's a lot out there. But we have much more than that. I'll be talking to some people with some great stories as well. And as usual, if you've got one or you've have something or a topic you'd like to hear, please reach out. I'm here for you. This podcast is to help, you know share our stories and get great information out there in this community. And if I'm not serving you, then I am not doing my job.

thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. Say a prayer for me as Benny is now behind you. Oh, my gosh, I did not know how nervous I would be about this day. I think I'm doing all right. We'll see. All right. I'll see you back here next week. Until then, be kind to yourself.


Benny   1:04:15

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

Jan 5, 2021

For the first time in several years, a new pump company is making a reach into the US market. Meet Ypsomed, the Swiss company teaming up with Lilly Diabetes. Their device, The YpsoPump, is available in Europe and Canada and has some unique features. But when it launches in the US, likely in 2022, it will only use Lilly insulin. That kind of proprietary design is unique and is raising eyebrows. Stacey talks to Simon Michel, Ypsomed's CEO (she'll talk to Lilly in a separate interview airing in a few weeks).

In Innovations this week, what is an inverse diabetes vaccine? And could you be part of a trial for one?

Learn more about City of Hope's Inverse Vaccine trial here 

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

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

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Episode Transcription:

Stacey Simms  0:00

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


Announcer  0:22

This is Diabetes Connections with Stacey Simms.


Stacey Simms  0:28

This week, my first interview with Ypsomed, the Swiss company teaming up with Lilly diabetes to bring a new pump to the US. A few features make YpsoPump unique, including their infusion sets which can help to cut back on insulin waste.


Simon Michel  0:43

Yes  it's terrible. It's throw away so much insulin all the time. But you can disconnect Of course from your body, you change a cartridge, you put it back on. And that's how you don't lose your insulin in the tube.


Stacey Simms  0:54

That's Ypsomed CEO Simon Michel, we talked about more features and he answers questions about the partnership with Lilly in innovations. What is an inverse diabetes vaccine? And could you be part of a trial for one This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.


Welcome to our first full episode of 2021 Happy New Year. I'm so glad to have you here. Here we go. Another year of the podcast. My goodness, I'm your host, Stacey Simms. And as always, my goal here remains the same. We aim to educate and inspire about diabetes, with a focus on people who use insulin. any of that line sounds a little bit different if you're used to my intro where I talk exclusively about type one. But you know, more and more people with other types of diabetes are listening as the show is growing. And I think that's really important to acknowledge and to kind of dial back and see who we're serving here.

My son was diagnosed with Type 1 14 years ago, my husband lives with type two diabetes, I do not have any type of diabetes. I'm the broadcaster in the family. This year on the show, I'm going to be focusing a lot on new technology, I think the delays that we saw in 2020, because of COVID are going to result in a lot more news than was originally planned or expected for 2021. You know, a lot of that innovation, a lot of those FDA submissions and approvals are getting stacked up, especially as we're looking at the second half of 2021 and into 2022. So you know, why not get ready. And you all have told me that you are very interested in episodes about technology.

In this episode, we're gonna learn all about Ypsomed and their plans for the US market. I have an interview scheduled with their US partners, Lilly diabetes, to talk more in depth about the proprietary nature of this pump. You can only use Lilly insulin in it in the United States. That's interesting. We talk about that here in the interview. And then there are a bunch of questions that Ypsomed, really cannot answer that are more for Lilly. So I'm excited. I'll be talking to them soon.

And just in the technology front, you're going to hear from the folks from Tandem. I've got a Medtronic interview, I'm excited to share with you. And as we look forward, of course, I will still be doing the personal stories interviews because I love those too. But please let me know if there are companies that you would like to hear from this year, and we will get them on and yes, Big Foot beta bionics. I'll be talking to everybody.

Okay, Ypsomed in just a moment. But first Diabetes Connections has a new sponsor this year. Yes, I am so happy to welcome our newest partner Dario, I cannot wait to tell you all about them. You know, we first noticed Dario a couple of years ago at a conference and Benny thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed. You get a glucometer that fits in your pocket, unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it and personalized reports. Based on your activity. Find out more go to my forward slash Diabetes Connections.

My guest this week is the CEO of Ypsomed. And if someone is a leading maker and developer of injection and infusion systems, pumps and pens around the world, and not just for diabetes, as you'll hear, they've been in the space for a very long time. But we're talking to them because I know I have listeners around the world and I appreciate you all so much and many of you may have experienced with this pump, but we are us centric and Ypsomed announced that it is partnering with Lilly diabetes to bring their pump to the US market.

That announcement raised some eyebrows when it came out this fall because it will be the first pump in the US that will only be used With one type of insulin that can only be used with one type of insulin, and the US market is the only place where that will happen, this pump will be available in other countries that already is with different types of insulin. In other words, to be clear, you'll only be able to use Lilly insulin, such as human log in the US, if so, mid pump. Now, Ypsomed has been around for a long time before this, of course, many of you who've been in the space for a long time will recognize some of the technology names and the brands that come up here. I was really excited to talk to the CEO, of Ypsomed Simon Michel, for the very first time, he's been the CEO since 2014, at the company since 2006. And as you'll hear, he kind of grew up in the company. And here's our conversation.

Thank you so much for spending some time with me. I'm excited to have you on the show and learn more about this. Thanks for being here.


Simon Michel  5:53

Thank you, Stacey. I'm to give us a chance to talk and explain to what we're doing. Yeah.


Stacey Simms  5:58

So let's just start with the basics if you could tell me about Ypsomed because we're really not that familiar with it here in the US. So if you wouldn't mind taking me through. Let's start with the the company history before we talk about the product because you are not a new company. You've been around for a while.


Simon Michel  6:14

Yes, I'd love to Absolutely. Thank you. So my father in 1985. Around the time when MiniMed founded the first company, the first pump in in Europe Disetronic. Some of you might still remember the name. And we were quite a successful pump company. And we sold the pump company at the Disetronic to Rouche in 2003, Rouche is still a name in Europe, roughly 80,000 patients on the product. But as they didn't really innovate anymore, we decided to go back into pumping in 2010.


Stacey Simms  6:44

When you went back into the pump business, what was the product at the time.


Simon Michel  6:48

So we did two things in 2010, we signed with Insulet. We took over the DC distribution of the Omnipod in Europe. So basically build up the business for for Insulet. between 2010 and 2017. When we've given it back to them, and the parallel we have started to develop our own YpsoPump so in back into tubed pumping and thought what can we do better? What can we do better in terms of pumps? What is the community needing tomorrow? versus the old Disetronic pumps, what can we do better?


Stacey Simms  7:17

What did you find that you could do better? We're going to talk about what the pump looks like and what it does, but big picture.


Simon Michel  7:24

So when we look at Ypsomed today for a whole, we make roughly 400 million in revenue, we grow at roughly 15% per year. So quite a healthy company despite of COVID we still grow and we have two businesses and it's quite important to understand we do both pumps and pens. today. I'd say you're by far largest pen and auto injector manufacturers in the world. We close roughly seven out of 10 deals in the pen space that's pens for insulins, solostar pen some of you might know it's also many of the Chinese pens, pens all over the world but all the injectors for autoimmune diseases migraine Astham, osteoporosis, So this is our device business. And the other half of our company the other 12 million is where we are very invest in pen needles in blood glucose monitoring and heat pump systems. And this we sell in Europe very successfully now for the past years in Europe and our own brand was owned subsidiaries and own people.


Stacey Simms  8:20

I'd like to know more about maybe we'll talk more about the pens a little bit later on. But when you started talking about the pumps and the systems that you started making in the 2000s I'd love to get back to what was lacking in the pump market. What did you think needed to change that you could do differently and better.


Simon Michel  8:37

So a couple of things you know, I mean to the pump was very much medical device centric. It's a very strong technic focus site is designed by engineers, great engineers from America from Switzerland from Germany, great people that think about what features we can add. But in the end of the day, we use these devices daily we don't really want to know and hear and feel and about this device. So number one criteria for us was to make it small and light. Ypsopump is roughly 80 grams. I don't know what this is in American weight measures but it's a it's a roughly half the weight of a Medtronic pump. I mean that gives you some kind of feeling very important, you wear it all day. The other thing is simplicity. We don't need all those features. I mean if you look at the at the iPhone, some of these phones they have many features but they only show the features that you actually use. So really simple in a way what is really required you don't need eight basal menus, you need two or three. Some might use but the big, big majority of us don't need this vast opportunities.


Stacey Simms  9:38

When I look at the the pump that we're talking about today. It does look tiny, it does look light and I did the I had to convert as well using my iPhone and that weight that 80 gram weight is point .176 pounds so very, very, very light. It looks like it's smaller, it looks like obviously it's lighter and doesn't have a touchscreen. It Looking at his buttons?


Simon Michel  10:01

Yes, absolutely. So it has a touchscreen. It's used like your mobile phone, you have one button to turn it on and off. That's basically it. But other than that you have a regular touchscreen, which works at night perfectly.


Stacey Simms  10:13

It's basically white on black. So it's a very good contrast that you see, is the pump controlled by phone? Is it controlled remotely? Or is it still used as the touchscreen?


Simon Michel  10:22

So yes, very important. We are a compared to other manufacturers, we are a iPhone app centric company. So you everything you do we do from your phone. So you have your Dexcom data on your phone, you give your bolus from your phone, you do your basal rates from your phone, that's that's our strategy, we have the firmware updates that go via phone onto the pump and back. It's very much app centric. The reason is we can be much, much faster and adding elements and adding new functions, new features, you don't need to change the device, you know, you don't want to change device or every year, simply too costly. This is why we set it up that way.


Stacey Simms  10:59

So that's a huge deal. Because here in the States we're all waiting for, you know bolus by phone, we're waiting for pump control which Tandem and maybe Omni pod will have and hopefully 2021. But just to be clear, you have that already.


Simon Michel  11:12

So we have the apps and the whole app control features are now launched in q1 in all over Europe. Yes. All the other things integrate the integration. The data this is this is in place the apps is in the market. But the integration of this bolus button and the CGM together is Dexcom is launched now in the beginning of ‘21, q1.


Stacey Simms  11:32

But let's talk I brought up the United States market. Let's talk about this partnership with Lilly, what is that partnership going to look like? And we can talk about consumers in a moment. But what will that partnership look like? For you all? Tell me about the system? What will the Lilly IP so mad Dexcom system look like when you bring it to the States?


Simon Michel  11:52

Well, basically, for my relationship, it's simple Ypsomed innovates and be manufacturer really supports in innovation and does the marketing and sales it was for us crystal clear from the beginning Ypsomed is a European company, it would be very tough for us to enter the big US market. So if you're looking for a partner, and luckily Lilly was looking for a pump, so we found each other a year ago Ypsomed would be the is the comet actually registered a product to the FDA, the expected approval in the second half of 22. But it's a fully branded Ace pump. So Dexcom is integrated as a bolus calculator calculator, the remote bolus  function as a Type Zero controller that will follow by mid 23. And it is a Lilly product from a user perspective, but it's manufactured in Switzerland.


Stacey Simms  12:35

It's so interesting to hear you say these things that a few years ago would have been very foreign to us. I think my audience is familiar now the ACE designation, Type Zero, which is the software that's inside. It's incredible, just to take a moment and think how far things have come


Simon Michel  12:52

across fast pretty fast. Yes,


Stacey Simms  12:53

goodness. But to be clear, Type Zero is the I would call that a hybrid closed loop software. So that's the software that will in very plain terms, work with the Dexcom to increase insulin or decrease insulin to try to keep people more in range. I just want to be crystal clear about that.


Simon Michel  13:11

None of those days. Absolutely. I mean, I mean, Type Zero belongs to Dexcom. And of course Type Zero is further working on on new versions of the controller. It's a constant enhancement. At the moment, the features that you described are the ones it's the low suspend function. It's the hybrid adaptation of the baseline rate. There's the micro bolus element, there are a couple of features which have one goal to bring us to bring patients with type 1 diabetes in in time and range


Stacey Simms  13:35

the ACE  designation, and I get a little confused on this. So I apologize in advance. That's all about interoperability. Right That's about making these new technologies compatible with other devices.


Right back to our conversation, but first Diabetes Connections is brought to you by Gvoke HypoPen, and almost everyone who takes insulin has experienced a low blood sugar that can be scary. A very low blood sugar is really scary. That's what Gvoke HypoPen comes in Gvoke HypoPen is the first autoinjector to treat very low blood sugar Gvoke HypoPen is pre mixed and ready to go with no visible needle means it's easy to use. How easy is it, you pull off the red cap, push the yellow end onto bare skin and hold it for five seconds. That's it. Find out more go to Diabetes and click on the Gvoke HypoPen logo. g book shouldn't be used in patients with pheochromocytoma or insulinoma visit slash risk.

Now back to Simon talking about interoperability and the East controller.


Simon Michel  14:40

Well, I mean, the great thing is that it's much easier to add different devices or different controllers to it. Once you have the ACE type designation you can actually change or upgrade a controller as it only is doing a lot of research on on controllers. So think about the might use their own controller in the future. Together with their new insolence. You can Think about situations where you can do better therapy better time and range when you combine new insulins with new controllers to actually use the insulin data to make better controllers. And also on the sensor side, it's possible that other sensors would come to the system at the moment, we love our partnership with Dexcom. It's great. It's really works perfect. But it's just it just shows an openness, that it's basically easy to add something else.


Stacey Simms  15:22

I have another question you may not be able to answer. I will be talking to Lilly about this. And it's really a question about them. I was at Lilly's headquarters in Cambridge, the headquarters for this project a couple of years ago, where they showed us their pump prototype because at the time they were working on building their own hardware. And obviously that project, I don't know if it's put aside I'll ask them about that. But this is not that pump. Correct. This is not the the pump that Lilly developed their partnership with you is using your hardware? If so meds pump, not this Lilly, it was a little circle disk pump that they showed us at the time.


Simon Michel  15:56

Yes. If the pump is purely manufactured by IP summit, it is the product designed here in Switzerland, that will be the pump that Lilly will use. You're absolutely right, Lilly was working on our own pump program, patch pump type program for many, many years. But you have to ask them they recently paid to our knowledge, they recently recently stopped the project, and are now fully focusing on our joint partnership to bring a cement Lilly pump to US patients.


Stacey Simms  16:25

I appreciate you answering that. I know that's more of a question for Lilly, and we'll talk to them about that for sure. But you know, insulin affordability is a huge issue in the United States. And we are we are struggling with that and a lot of our health care system right now. But making a pump that only uses one type of insulin is going to limit options. And I gotta be honest with you, I think people are, it's it may not be seen as a very popular feature. You know, we have insurance issues in the United States. I just went through this with my son, where we'd been on one insulin for many years. And then my insurance company said, No, you you have to use this other insulin. And that can happen here. Are you concerned about that at


Simon Michel  17:02

all, this will happen, of course, but it is ultimately beneficial for a health care system. And I can make the comparison with mobile phones. So if you have a mobile subscription, and you have your fixed lens subscription or internet subscription, you get a better deal. Now, this approach is to really bundle all these elements, and it will ultimately very much be much better beneficial for people with diabetes, it will be better for the healthcare system as of lower cost. So it's definitely not increasing the cost. Yes, it is increasing, its increasing to some extent, your choice of insulin, whether it's a short acting insulin for novel from Lilly, I fully agree but it will lower costs for healthcare system because of the bundle approach. It's a really innovative partnership. Where is the entity manufacturer really decides to go the full way the first time in history? And this will be beneficial for us us healthcare system for sure.


Stacey Simms  17:49

That's really interesting. So they'll have to work with insurance companies to say if you cover this pump, you must cover this insulin. Again. Again, I have to talk to Lilly but I would imagine Yes,


Simon Michel  17:59

well, of course that's a fair question. But I mean really wouldn't invest so much in a partnership if they wouldn't want to sell their core asset which is their insulin and in a prefilled cartridge, it will work with our pump. So it is the way this relationship is built up. But again, for Americans and for the healthcare system, I personally only see benefits in the end of the day in terms of cost.


Stacey Simms  18:23

That prefilled cartridge is something that is not currently available on any pump system in the US It was here for a while with some older pumps that are not on the market anymore.


Simon Michel  18:33

Well it was our pump Yes, it was the Disetronic pump with the three ml humalog cartridge was available in America between I would say 1998 and 2004 ish before Rouche stopped it, it will come back but it will come back in 1.6 format in a shorter version. We basically have this in the market already in Europe together with Novo Nordisk . So there's a novel called pump cart that works with our pump that's available in the market now since 2017. And is going the same way now this is a huge benefit to work with prefilled you don't have to fiddle around and fill your cartridges you could just take it out of a fridge make it a bit warm, put it into pump and that's a huge benefit.


Stacey Simms  19:12

It was very popular I think I want to say the Asante snap pump also had it for a while and that's the one that I look at because


Simon Michel  19:20

yeah your idea right it wasn't it wasn't this one was not a market so it was not so successful. This pump You're right. I mean the issue was with the D Tron pump, it was a bit too big, you know, it's three ml cartridge, the 1.6 is shorter. That's how we can build such a small pump. And the good thing about a pump is with our infusion set, you can actually keep the tube on. So you can change the cartridge you can keep the tube on you don't have to throw away the insulin which is in your tool because you can change the cartridge. Keep the cube you're using and you don't lose insulin.


Stacey Simms  19:49

Okay, I have many questions. Wait, let's go through those all at once. And I will get to the keeping the inset on but staying with the cartridge for a moment. So that's 160 units In the cartridge and you said take it out of the fridge, pop it in the pump, is it good in the refrigerator for a long time, because right now if people kind of pre fill when they're not supposed to the cartridges that are available on the market will start to break down. I'm assuming that's not the case.


Simon Michel  20:15

Well, it's, as we are used with pens a single expired expired date of two to three years. It depends on market by market, but you can keep it as your pen,


Stacey Simms  20:23

I was thinking two to three weeks for a filled cartridge right now, we're not supposed to do that with the Tandem or the Medtronic pump.


Simon Michel  20:30

It's a prefilled closed system as we are used with prefilled three ml cartridge. Some of you may use a reusable durable pen. Of course there you need regular in Europe, quite a lot of people use durable pens. And now it's Medtronic coming this Companion, you will see more and more durable pens in America as well. This smart pen trend will definitely lead to more cartridge based pens where you exchange the cartridge. So it's a standard closed cartridge system. You can keep it for two or three years in the fridge.


Stacey Simms  20:57

So talk to me about keeping the inset on. When you're changing out the cartridge. You're not priming the tubing, you're not doing things like that,


Simon Michel  21:05

yes, we built in a valve in a way that you can take the connector off the pump, you exchange the cartridge, you put the connector back on the pump, and there's no air coming into the tube to kick can continue to pump Of course you would disconnect it, you orbit set has a nice feature disconnect at the head. It has a 360 degree rotation feature. So it never cranks. But you can disconnect Of course from your body. You change a cartridge, you put it back on. And that's how you don't lose your insulin in the tube.


Stacey Simms  21:35

That's wonderful people you know, it's very difficult when you're losing units upon units when your primary


Simon Michel  21:41

yes and no, it's terrible. You throw away so much insulin all the time. So you can use this tool for seven days. So two or three cartridges. Of course it depends. If you if you need more insulin, you use it for two or three colleges if you use less insulin, use it for so it's just I think seven days is what is what makes sense.


Stacey Simms  21:59

Tell me a little bit more about that inset because I I've said for years and years that insects are the weak link of pumping, they leak. They don't work so well. You mentioned it rotates. Talk to me about your inset


Simon Michel  22:10

is a fully agree it's definitely the space where part manufacturers have to spend much more effort in innovation. Our infusion set is today a three day infusion set we work on a five and seven day version to just keep it longer on it's also regulatory work that has to be done here. It has a skin color. plaster so it doesn't show so much if you wear it. When you're at the beach. It has a 360 degree rotation at the head. So it really doesn't crink that's quite nice. It pops up clicks very nicely. You can click it behind your back without looking at, you hear it and it's safe and close. It has a Blue tube so it doesn't show so much on black clothing. A couple of nice features.


Stacey Simms  22:52

Is the skin tone one skin tone?


Simon Michel  22:55

It is a I would say it's a as neutral as possible one skin tone. Yes. I mean, it's better than white. You know, I think White is really shiny like we are used from other part manufacturers. It's just a more neutral skin tone.


Stacey Simms  23:08

Yeah, I know. You know what I'm asking though? I mean, is a Caucasian. Is it more peach than brown?


Simon Michel  23:14

Yes, yes. Yes. Yes, it is.


Stacey Simms  23:17

All right. Well, your first feedback is you have to work on that for especially for the US market and other markets. So I'll give you that piece of feedback.


Simon Michel  23:23

But input Thank you. No, you're absolutely right. It's a very good remark. I think I guess we are not so much used. From a diversity perspective over here in Western Europe. I think it's a very, very important remark you're making. And I definitely think it's possible to do that. I think it's a great idea.


Stacey Simms  23:38

That would be wonderful. Because, you know, I chuckled as I said it, but I appreciate you taking it seriously. It's difficult to talk about these things. And I find myself sometimes I shouldn't have left, they're trying to defuse the situation a little bit. But we are a very large and diverse country over here. And we have lots of


Simon Michel  23:55

love. No, no, no, I fully agree. And they beat this doesn't stop bad skin color. I think it's a great idea. And I don't see a reason why we should innovate on that to something we have never seen over here. It's not a topic that we get from customer feedback over here in Europe, but it's a great input. Thank you.


Stacey Simms  24:10

I appreciate you taking it that way. So let's talk about the pens for a moment because we tend to focus on this show a lot about pumps. But at the same time, you have already mentioned so many interesting things about pens. Do you plan to bring you mentioned smart pens, you've talked about the different types of pens that Ypsomed makes already outside of diabetes? Is any of that available in the US market or do you plan to bring it here,


Simon Michel  24:34

so from the insulin pens today, only the Solostar pen from Sanofi is on the market. It's a disposable pen. Also the to chill pen so the for the other type of Sanofi insulin. Other than that we are at the moment in discussion with several parties. For our smart pen. We have a smart pen for a 1.6 ml version and a three ml version, which connects to the app and the cloud. Of course, you have all the benefits of a smart pen you can use the CGM data including all the injection data which we really need. I mean, you need both sides, you need to be GMC champ data as well as the injection data when you have injected IV correctly. In fact, we have a lot of nice features on the pen tells you if it's styled correctly or not. There's a lie. It shows your holding time. How long enough to hold on many nice features you can do with smart pens today.


Simon Michel  25:21

Yeah, because a lot of people don't still want pumps attached to them. And a pen is a real option


Simon Michel  25:26

Yeah, absolutely. I mean, worldwide, we have 50 million people that take shots every day, but only 1.5 million user pump. So I think a lot of the vast majority uses pens, so it definitely have to innovate more in that space. And I'm so happy now that Medtronic decided to do to make that step to make that move, and also Novo Nordisk making the move. Now Lilly will come with a solution and the space is now moving. And that's very important.


Stacey Simms  25:51

It's okay, if you can't answer this, but can you give us an idea of what an Ypsomed smart insulin pen would do? I mean, we've The only frame of reference we have here in the States right now is companion medical, as you mentioned with Medtronic, could you give us an idea of what features might be available?


Simon Michel  26:07

Yes, absolutely. I mean, this pen is available in the analog version, so the non digital version in China for over 10 years, it's a very robust pen the piston drop, push back with your finger, it has a bayonet coupling for the cartridge. It has a spring driven support for injection. So it don't need to force if you have, or if you're old or don't have strength anymore. You just put a button in checks with a spring support. Very nice feature, we have a large display, which works at night, you have a light that gives the signal whether your dial is correct or wrongly, it's red and green, it shows how long you have to check that it stops blinking when it's injected fully out of his holding time, I think is the old time is very important. You have its Bluetooth connection, of course to the app connects automatically, it stores everything on the pen and on the app.

So all the features that you are used from Companion are now in there, as a will be a great, great product that we are working on here. And hopefully be able to introduce to America, we will take two two and a half years to come. We have to go through registration program together and still need to make the decision what partner will be the one that will bring it to the market. You know,


Stacey Simms  27:14

I should have asked you right at the beginning. But I'm curious, do you have any kind of personal connection to diabetes?


Simon Michel  27:21

Well, not personally, not not nobody in our family has type 1 diabetes, we have a couple of uncles and aunts that are on insulin on type two. But you know, I spent my whole life with diabetes. I think when I was 10 years old, I was throwing the first insulin pump. I still have this picture somewhere I can check and send it to you. It was it was an H Tron pump. Remember 1987. So I was my whole life. I mean, we went to the factory pump factory with my father, when I was a boy, my brother and me We ran around. And so he was my whole life. And then I went to university and I started in telecom industry. And it was very clear for me that I will come back. So I'm in this in this industry now really, for almost two decades. But we don't have diabetes, but I'm very, very connected to it.


Stacey Simms  28:02

That's great. I would love to see that photo or anything that you might want to share for sure. So I guess that leads me to this question, which is what gets you excited. I mean, your family has been in this business for so long, you've seen it change, you're bringing something brand new to the United States in a couple of years. But what gets you out of bed every morning that you're still excited to work in this space.


Simon Michel  28:22

I believe we are extremely privileged here to be able to work on products and services that make life easier for people with diabetes. And this is our business for 30 years. It's a family business we are stock listed but the majority of the shares in our in our family. So we do have a large responsibility on it. It's just great to see we are 2000 people now here working every day tried to make better devices, better solutions for people with chronic diseases also outside of diabetes and it's it's a huge privilege and motivation to work on it.


Stacey Simms  28:53

Well I feel like I just scratched the surface starting to talk to you about the partnership with Lilly and the pump and the pens. So I hope I can circle back maybe next year and check in on the progress and and talk to you as you get closer to bringing this to the US.


Simon Michel  29:06

Yes, let's do that. That's right to give an update. Once we filed we tried to file in summer 21 we still sorority and they will definitely be a good time again to give you an update.


Stacey Simms  29:17

Wonderful. Thank you so much for your time. It was wonderful to talk to you and I'm so excited to learn more.


Simon Michel  29:22

It's a pleasure talking to you.


Simon Michel  29:29

You're listening to Diabetes Connections with Stacey Simms.


Stacey Simms  29:34

So what do you think? I'll be posting in the Facebook group to get your questions for my upcoming interview with Lilly and that is Diabetes Connections the group Do you think it's possible that overall, this pump system will turn out to be less expensive as Simon thinks. I certainly hope so. But any kind of proprietary idea on a market that is already so limited just makes me nervous.

And I said this when I was at Cambridge a couple of years ago looking at their prototype for the pump that they're no longer developing, apparently, I think they got into this pump partnership, because they know the writing's on the wall for insulin price controls may be too strong a word, but limitations. I won't get into it too much here. But you know, we've had this conversation many times before, I think that there's going to be legislation at the state level, if not the federal level, to really change how insulin and other medications other treatments are priced. So we shall see.

And oh, my goodness, I hope our conversation about skin tone on the inset came off. Well, I mean, these things are awkward, as I said in the interview, but once he said skin colored, I mean, most of the inserts are just bright white. So once he said skin color, I had to ask, I had to follow up. I hope that came off. Okay. And look, we can seem to take it very seriously. So we shall see. Wouldn't that be nice if medical devices could be a little more discreet on the skin on any color skin tone?

Okay, up next, let's talk about an inverse vaccine for diabetes and explain what that is. But first Diabetes Connections is brought to you by Dexcom. Do you know about Dexcom clarity, it's their diabetes management software. And for a long time, I really did think this was just something our endo used. You can use it though on both desktop or as an app on your phone. And it is an easy way to keep track of the big picture. I try to check it no more than once a week. Although I'll be honest with you, there are times when I'm checking it every day, it really does help me and Benny dial back, I look for longer term trends. And I try not to overreact to what happened for just one day or you know one hour, the overlay reports help context to Benny's glucose levels and patterns. And then you share the reports with your care team, which makes appointments a lot more productive. managing diabetes is not easy. But I feel like we have one of the best CGM systems working for us find out more, go to Diabetes and click on the Dexcom logo.


In our Innovations segment, this week, I want to talk a little bit about something called an inverse vaccine. This is a City of Hope, phase one trial. And the City of Hope is an organization that is looking to try to find cures for type one, I will link up more information in the show notes about them. And we really should talk to them. I it's hard for me to believe we haven't had them on the show yet. So that's going on the list.

But basically, this would use someone's own immune cells, a beta cell protein, and vitamin d3 to potentially treat type one, I'm sure that is a very simplified explanation. But these inverse vaccines are trying to stop certain immune responses rather than activate them. When you think about a regular vaccine, right, like the flu shot are the COVID-19 vaccine that we talked about just last week, what they're doing is trying to stimulate the immune system, right, here's a germ learn how to fight it, go immune system, right, the inverse vaccine is, here's something coming in, don't do anything stand down. Again, this is a very simplified version of what they're trying to do. But they are recruiting, they can't start the actual trial, they say until the pandemic is under control a much more but they are recruiting and they are screening patients right now. So I'm going to put up a link in the show notes.

And as always, you can go to Diabetes And look at the episode homepage. If you're listening on an app, a lot of them are great to listen to, but the show notes aren't so hot. So if you have any trouble, just head on over to the homepage. As usual. The trial I should say is open to adults with type one between the ages of 18 and 45. You have to have been diagnosed in the last one to four years. There's a lot more listing after that. And by the way, this is a follow up on a small study in the Netherlands where they they looked at safety. So you know if you get into this definitely keep us posted. I'd love to know more.

A couple of quick housekeeping things before I let you go this time around. I am taking part in a free summit at the end of this month. It is the fearless diabetic summit. And I will be posting more about that in the group. And on our website. This is a really interesting summit that is trying to answer the question, what would you tell yourself if you could go back to your first two weeks of diagnosis, and they talk to 30 different people in the diabetes space, you know, experts and educators and NGOs and athletes and I think I'm the only parent that they talk to. But it's a really interesting concept. And I'll talk more about that as the month goes on. I'll put a link in the show notes to the fearless diabetic summit.

Also, if you haven't seen it yet, I have a free ebook Diabetes Connections extra that I put out late last year and this is a set of transcriptions and they are proofed and they're beautifully laid out easy to read. They are the extra episodes that I did a little while ago all about the basics of diabetes management ketones. What is insulin? What are lows? How do you use a CGM to its best practice insulin pumps, all that kind of stuff. I think it's a really good read for newer diagnosed families and for you to give to people in your life that you would like to better explain diabetes to it is an email signup. But you know, I don't spam anybody, most of you are on the email list already. But if you want to send that out, I'll always put the link in the show notes to that as well. That is the free ebook.

And finally, I'm this close to announcing my new project. And it really doesn't have anything to do with diabetes. But if you're interested in podcasting, you'll want to sign up, I am going to be teaching a course this year, I'm teaching two courses actually, on podcast, monetization, get paid to podcast, I have been really interested in this subject, because I've helped a lot of people kind of behind the scenes for the last couple of years to do this, ethically to do this. Well to do it in a way that makes sense so that your listeners don't have to pay anything, but that if you want to spend enough time on your podcast to make it quality, you eventually are going to look at options like this. And you know, like diabetes, there's some snake oil in the space. There's some stuff out there. That's pretty questionable. And I want to help people do this with transparency with disclosures to do it right. So stay tuned for more than that. I will not be hammering you with this. You’re here for diabetes news, but I wanted to let you know, and I'm really excited about it.

Thank you so much to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.


Benny  36:32

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

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