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Diabetes Connections with Stacey Simms Type 1 Diabetes

The T1D news show you've been waiting for! Long-time broadcaster, blogger and diabetes mom Stacey Simms interviews prominent advocates, authors and speakers. Stacey asks hard questions of healthcare companies and tech developers and brings on "everyday' people living with type 1. Great for parents of T1D kids, adults with type 1 and anyone who loves a person with diabetes.
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Now displaying: May, 2021
May 28, 2021

It's "In the News..." the only LIVE diabetes newscast!

Give us five minutes and we'll tell you about:
⭐European approval for Medtronic's new no-calibration sensor
⭐FDA considers a drug to prevent T1D
⭐New info about gestational diabetes
⭐A potential type 1 vaccine moves forward
⭐Telehealth update (and what's next after COVID)
Join Stacey live on Facebook every Wednesday and watch "In the News..." Live!
https://www.facebook.com/diabetesconnections

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

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

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Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
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Get the App and listen to Diabetes Connections wherever you go!

Click here for iPhone      Click here for Android

Episode transcription and links below: 

 

May 26, 2021

FB LIVE:

Starting soon slide

Hi, and welcome to Diabetes Connections In the News! A short weekly newscast full of the top diabetes stories and headlines of the past week. I’m Stacey Simms & whether you’re joining me live on Facebook or watching or listening after, I’m here to get you up to speed quickly

XX

In the News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff”

In The News this week..

XX

Bit of breaking technology news today as Medtronic gets European approval for its Guardian 4 sensor. This is their newest sensor which requires no fingersticks for calibration or diabetes treatment decisions. Medtronic says they’ll start integrating this sensor into the 780G pump and InPen offerings in the fall.

No word on a timeline for US approval for the Guardian 4 sensor.

MedT Guardian 4: https://investorrelations.medtronic.com/news-releases/news-release-details/medtronic-secures-two-ce-mark-approvals-guardian-4-sensor-inpen

XX

 

FDA advisory committee may give more information and feedback on the first treatment to delay or even prevent type 1 diabetes as early as tomorrow. They’ll decide if Teplizumab is safe and effective.

This is not full FDA approval, but it’s another step toward releasing what is an IV drug, given as a single 14-day course of infusions.

If you’ve heard us about the TrialNet studies on this on the podcast over the last few years.. that’s what most of the evidence is coming from. Their studies showed a relative 59% reduction in risk for developing T1D and a delay of diagnosis of 2 to 3 years.

https://www.medpagetoday.com/endocrinology/type1diabetes/92784

XX

Another new treatment for type 1 diabetes moves into clinical studies.. this is a vaccine that looks like it prevents the destruction of insulin producing cells in the pancreas.

DiabetesMine has an excellent report on this and we’ll link that up here so you can read the whole thing. But the Swedish biotech company Diamyd has been working on this immunotherapy vaccine for two decades, including a study where they injected it into the lymph nodes of the study participants.

Their large-scale Phase III trials will start this year in Europe and the US and will include more than 300 children and young adults recently diagnosed with T1D.

Diamyd vaccine: https://www.healthline.com/diabetesmine/diamyd-type1-diabetes-vaccine

XX

A new long term study shows that women diagnosed with gestational diabetes are more prone to type 2 and type 1 diabetes later in life. It’s been known for some time that gestational diabetes is linked to the risk of type 2.. but these researchers say auto-antibody testing should be considered in order to have a better understanding of all the risks

In this study, 50% of women who experience gestational diabetes go on to develop type-2 diabetes later in life and almost six percent developed type-1 diabetes. This 23 year long study was presented at the European Congress of Endocrinology

 

Gestational diabetes increases risk for T2 and T1 https://www.eurekalert.org/pub_releases/2021-05/esoe-als051921.php

More info to back up what a lot of patients have been saying for a long time. If an endocrinologist  is negative or belittling, people stop listening to them and even stop going for check ups and prescriptions.

University of Florida Diabetes Institute polled their minority communities recently and found that the main challenge is support from their endo. Or lack of support

These researchers looked at people who missed two or more endocrinology appointments, have experienced diabetes-related complications in the past year and receive primary care at a federally qualified health center.

The study found when people from minority or low-income groups report negative and belittling interactions with their endocrinologist, they stop going to appointments. These researchers say they want to look at implicit bias in care and do something about it.

 

 

Endo attitudes: https://www.wcjb.com/2021/05/21/university-of-florida-study-uncovers-equity-disparity-within-type-1-diabetes-community/

Telemedicine – no surprise – skyrocketed for people with type 1. From less than 1% before the COVID-19 pandemic to about 95% in April 2020, according to study data.

In March 2020, clinics in the T1D Exchange Quality Improvement Collaborative began attending virtual meetings to share progress and best practices with the shift to telemedicine. Researchers collected the monthly number of type 1 diabetes visits and HbA1c values collected from a subset of 11 pediatric clinics and two adult clinics from December 2019 to August 2020.

 

The researchers noted the proportion of telemedicine visits varied widely at each clinic.

About 62% of clinics performed both video and phone visits. Zoom was the most popular platform, used by 62% of centers. More than 95% of clinics also used CareLink, t:connect, Clarity or Glooko to view diabetes data remotely.

Most centers had diabetes educators, registered dietitians and social workers participating in telemedicine. However, only 15% of clinics said a psychologist participated in telemedicine. All clinics provided continuous glucose monitor training through telemedicine and 70% provided insulin pump training.

 

Telemedicine https://www.healio.com/news/endocrinology/20210521/telemedicine-visits-rapidly-increase-at-type-1-diabetes-clinics-during-covid19-pandemic

but first.. quick break – want to tell you about one of our great sponsors who helps make Diabetes Connections possible.

  • Inside the Breakthrough is a podcast that mixes historical wisdom with modern insight – it’s a science show that’s also entertaining. I love it. The latest episode talks about when a belief thought to be settled science turns out to be wrong. And to illustrate that point they talk about the horse poop crisis of New York City. It was real and it resolved in a way no one expected. Listen to Inside the Breakthrough wherever you listen to podcasts..

 Can a game – with competition – really help people live a more healthy lifestyle? A one year trial with people with type 2 diabetes tracks steps and game elements such as points and levels. Some also received social support from a family member or friend. A third group just got the tracking device.

Everyone in the study lost weight and lowered their A1Cs but those who didn’t play the game took fewer steps and tracked less activity overall.

A lot of gamified apps have come and gone in the diabetes space.. these researchers say the competitive aspect may be the key.

Game study for T2 https://www.mobihealthnews.com/news/gamification-step-count-leads-more-activity-diabetes-focused-study

That’s Diabetes Connections – In the News.  If you like it, share it. And feel free to send me your news tips. Stacey @ diabetes dash connections dot com.

Please join me wherever you get podcasts for our next episode -Tuesday – we’re talking to the folks from Banting House, the birthplace of insulin.

Thanks and I’ll see you then!

May 25, 2021

Big news for Bigfoot Biomedical as the US FDA approves their insulin pen cap system called Unity – which also includes a CGM and an app. CEO Jeffrey Brewer explains what Unity is all about, gives us an update on Bigfoot’s pump system and opens up about his family’s story – his son was diagnosed almost 20 years ago.

Plus, in Stacey's first in-person diabetes meetup since COVID, she observed something very interesting about the newer families.

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!

Episode Transcription below: 

Click here for iPhone      Click here for Android

 

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 help make knowledge your superpower with the Dexcom G6 continuous glucose monitoring system.

 

Announcer  0:24

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:29

This week, big news from Bigfoot - FDA approval for their insulin pen cap system called Unity, which also includes a CGM and an app. CEO Jeffrey Brewer says their bundle approach is a bit like Apple’s

 

Jeffrey Brewer  0:42

Apple takes a bunch of different pieces, some of which they licensed and some of which they make and integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well.

 

Stacey Simms  0:56

Brewer shares what Unity is all about gives us an update on Bigfoot’s pump system and opens up about his family story. His son was diagnosed almost 20 years ago,

plus my first in person diabetes meetup since COVID, where I got good news beyond just seeing my people. 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. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. And when I started Diabetes Connections in the summer of 2015 this week's guest Jeffrey Brewer was my second guest, it is hard to describe what the diabetes technology situation was six years ago. If you were around then you probably remember especially this podcast audience, you know, I tried to talk about it, as I mentioned in the teaser, had a meetup last week with some local parents, which was fantastic. And I'll tell you more about that later. And a mom of a child diagnosed in January of this year asked me what DIY was all about. she'd heard about loop he heard about do it yourself. She wasn't quite sure what it was all about. So that was a long and winding conversation.

If you are brand new, and you want to learn more, I recommend searching out the we are not waiting episodes of this podcast. And you can easily search those up at Diabetes connections.com. There's a search box on the upper right. It's a very robust search of our almost 400 episodes now. And you can search we are not waiting as all one word. I've put that in all of those kind of DIY open APS CGM in the cloud. You know all of those types of episodes.

I know that six years ago, this pen cap system is not the Bigfoot FDA approval many of us thought would come through First, if you've been following this story for a while Bigfoot was founded in 2014. It was under a different name. It got the Bigfoot name in 2015. But it was founded by a small group of dads of children with type 1 diabetes, including Bryan Mazlish, who got that nickname Bigfoot via reporter looking for the elusive person Bryan who had developed a do it yourself closed loop which his wife and son with type one were using, and the initial headlines for Bigfoot, were all about bringing that closed loop system to market you can go back and see their initial funding press releases, which say things like you know, “the funding will support final development activities for Bigfoot’s Smart loop, automated insulin delivery service, the world's first Internet of Things medical device system delivered as a monthly service.”

Bigfoot Unity, which is what we're talking about today is going to launch as that monthly service. It's such a great idea to cut down on the complexity, it's going to help so many people on multiple daily injections, but I know that this podcast audience leans very much into the pump closed loop give me all the tech news group. And I think it's important to acknowledge that that said, My guest is Bigfoot CEO Jeffrey Brewer. His son was diagnosed with type one in 2002 and as the former CEO of JDRF. Brewer led the artificial pancreas project there. In life before diabetes, Brewer founded and led early.com startups including city search and goto.com.

We will find out all about Bigfoot Unity in just a moment but first Diabetes Connections is brought to you by Gvoke Hypopen  and you know low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're going to pass out there are a lot of symptoms and they can be different for everyone. I'm so glad we have a different option to treat very low blood sugar. Gvoke Hypopen is the first auto injector to treat very low blood sugar fever. Gvoke Hypopen  is pre mixed and ready to go with no visible needle. before Gvoke, people needed to go through a lot of steps to get glucagon treatments ready to be used. This made emergency situations even more challenging and stressful. This is so much better. I'm grateful we have it on hand. Find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke Glucagon dot com slash risk.

Jeffrey, thank you so much for joining me, I really appreciate it.

 

Jeffrey Brewer  5:05

Thanks for having me. Glad to be here.

 

Stacey Simms  5:07

So I looked back at my notes, you were my second guest on Diabetes Connections back in the summer of 2015, talking about the big plans for Bigfoot and holistic systems, and then lots of things that you said at the time you couldn't really talk too much about. And now here we are. So first of all, thanks for being my guest way back when when, you know, probably have three people listening, I really appreciate that.

 

Jeffrey Brewer  5:29

Well, thank you, and thanks for sticking with us maybe took us a little bit longer than I had hoped. But we're finally here to be able to offer something to people with diabetes, that we hope it's going to improve life and make it a little easier.

 

Stacey Simms  5:43

Definitely. Well, let's talk about that. So we're talking about Bigfoot Unity, would you mind kind of going through who it's for what it does, this is a system that is going to help people who are on multiple daily injections. So what is big for Unity?

 

Jeffrey Brewer  5:57

Yeah, so as you know, had Bigfoot developing a range of solutions to help people whose lives are dependent upon insulin to live safely and, and hopefully better lives. We are in this journey, focusing first on multiple daily injections, basically, intensive insulin therapy, once a day, have a basal insulin, and then given shots at mealtimes, or for corrections of rapid acting insulin, that particular therapy, which about 3 million people in the United States today do on a daily basis, about half people with type two diabetes, about half people with type one diabetes, but it's really the same therapy, we have developed a system that we believe solves a lot of the problems that therapy has, when it comes to the ability of people to determine the right dose for themselves on an ongoing basis, and also for health care providers to support them in doing so over a long period of time. I

 

Stacey Simms  6:53

totally understand because years ago, my son wanted to take an insulin pump break, he has used an insulin pump, since he was two, really six months after diagnosis, we got him on a pump. And we were so frustrated. Because not only did we have to do all the math manually that the insulin pump had done, there wasn't. And this was really before, there were lots of apps and things, there was no way to do all the stuff that the pump does in terms of insulin on board, and that kind of thing. So I assume that those are just a few of the features that Unity will provide

 

Jeffrey Brewer  7:23

some of the things that a pump does BigfootUnity will help to support your right that for people taking shots, it's mostly a glucometer, a piece of paper with some instructions and a couple of insulin pens. There isn't a lot of technology involved in those people's lives right now. And what we've done is develop a package of technologies that includes some devices, and some software that is knitted together for ease of use, to make life convenient for the person to first of all, be prescribed the therapy to be trained how to use the therapy easily and safely, and then to over time be supported by a healthcare provider who has the responsibility of supporting many of these patients, we are bringing technology to a population of people who I think have been largely overlooked, because most of the innovations have been focused on pumps. And that's really been focused on type one and also focused on very highly engaged people with diabetes that frankly, had to do a lot more in order to support the therapy and seen by doctors who are very excited about the technology. But not everybody sees a clinician like that. And not everybody wants to put everything into their insulin therapy that maybe a pump would require.

 

Stacey Simms  8:42

So take me through a little bit of it if you could, when I looked at it, I was kind of making notes that I wrote white cap black cap. So the white cap is for the fast acting and that gives you a dose, like a pump would say here's the suggested dose.

 

Jeffrey Brewer  8:56

Sure Bigfoot Unity is a bunch of different things together at the centerpiece of the system is these taps that are going to be for the particular insulin that a person is prescribed, whether it is an insulin made by Novo Nordisk or Sanofi or Eli Lilly, we have caps that fit all the different disposable insulin pens for both the basal insulin and the rapid acting insulin. First of all, you get these caps that fit the insulin that you've been prescribed. You also get a couple freestyle Li braise, you get a blood glucose meter that talks to the caps as well. You get in this first time experience kit, everything down to the pen needles and the alcohol swabs that are going to be used for parasite before you put on a sensor, literally everything that you need in order to initiate multiple daily injection therapy with the exception of the Insulet itself. It's all in this box. So this box comes to a person with diabetes in their home. We train them to use the system through a digital interface that we've developed support. onboarding to our system but also for people who are cgmp may never have bought a CGM before will literally through a zoom interface, walk them through the first experience with CGM, and then train them on the whole system. And the centerpiece of the system, as I said, as these caps, which basically do a simple thing they keep track of when you last gave yourself insulin. And they do calculations that are necessary in order to recommend how much to take based on your doctor's direction, very simply on the blackcap, which is focused on the basal insulin, you have one button, and you can only press the button and cycle through screens.

So you press the button. first screen says this is when you last took the dose. So it could have been say 23 hours ago, and it's time to take another dose, you press the button again, and it's going to tell you how much you should take. And that's what you were prescribed by your healthcare provider. And what can be updated in the cloud, by your healthcare provider. Rapid acting cap, the white cap is got some additional functionality, but still works the same way. It's got a screen on it, and then you press the button, the first screen is going to have when you last gave a shot, which is particularly important for stacking insulin as you refer to insulin on board. This is one of the big challenges that people who are on shots have is that they don't have a record of when they last took the shot. And so actually making sure that they don't treat the same high glucose reading too quickly, and then end up with too much insulin and end up low. This is something that we help with by actually keeping a person from stacking insulin. So you press this button, it's going to tell you when the last took a dose, if within three hours, you had taken a dose previously, it's going to lock out a correction. And therefore you're not going to make that mistake. This cap also interfaces directly with the freestyle library to or a blood glucose meter, and basically takes that data and directly translates it into a correction dose if you are taking your correction based on again what your healthcare provider had prescribed. So whether it's a correction factor or a sliding scale that was written down on a piece of paper, you don't have to remember or do any calculations, it basically just takes the number from the libri and turns it into here's how much insulin I should take. And if I had previously taken insulin that keeps me from over insulinizing and stacking insulin

 

Stacey Simms  12:16

over insulinizing? Is that an actual word?

 

Jeffrey Brewer  12:22

Yeah, I think I heard that from one of the researchers one time, so

 

Stacey Simms  12:25

we're claiming it if it's not, it's a rage bolus or it’s over-insulinizing

 

Unknown Speaker  12:29

There you go.

 

Stacey Simms  12:30

I didn't mean to interrupt you, sorry.

 

Jeffrey Brewer  12:32

No, no worries, the next step, after you take a correction, maybe you're going to have a meal. And having recommendation for how to dose from mealtime. It actually turns out that small, medium and large is a format that a lot of people are able to understand and work with in terms of how to take carbohydrate content and actually correlate that with an insulin dose. It's actually the minority of people, even in type one, but certainly with type two that carb counts. And so thinking about this in a different way, and a simpler way, where you have maybe small medium and large buckets, and a corresponding number of units for insulin that shows up right on the pen cap. If you want to add the two together, you are going to click the button again. And then it's going to basically add a correction to whatever the meal bolus would be, you're going to pick that value that you're choosing as a patient, because we're not deciding for you, we're just telling you, here's what your doctor would recommend based on all the calculations that you usually would do, if you had to do them. If your doctor were sitting there with you, this is what he or she would recommend you do. But if you know more, because for instance, you know, you're going to be exercising vigorously later, and you want to protect against hyperglycemia a person might decide to take a year or two less. But basically we're going to get them all the information that we can take it and make it actionable for them take as many steps out as we can to just get them to the answer they want. Because I don't actually think people want to know what their blood sugar is. They want to know, what do I What should I do? How much insulin Should I take. And so every step we can remove, and every thing we can take out of this equation to make it easier for people to stay healthy and take the right amount of insulin and then forget about diabetes for another four hours until another meal. That's what we're trying to do. And we're trying to do that for people who take shots, which is most of the world in terms of multiple daily injection therapy is the preponderant therapy for intensive insulin usage.

 

Stacey Simms  14:28

I appreciate you going through so granularly, I have learned that my listeners really like the deep dive anytime there is something new. So thanks for walking us through that. And you've mentioned the CGM. Let's talk about this. This is all integrated with the Libra when people use the Libra does it alert?

Right back to Jeffrey answering my question but first Diabetes Connections is brought to you by Dario health and 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 Dario 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.com forward slash diabetes dash connections. Now back to Jeffrey Brewer answering my question about using the abbot libre here, does it alert an alarm?

 

Jeffrey Brewer  15:40

Very good question. So the way the library works is it gives data in two different manners. One is you take the pen cap and you swipe it over the library. And it gives you an on demand reading for what your glucose is at that particular moment. And that's the value that is used in order to calculate any corrections. But there's another way that libri is communicating, which is directly through Bluetooth to the smartphone. Because we have an app on the smartphone. And that's monitoring. For instance, for hypoglycemia, you have a couple different ways the library is working in order to support a person with diabetes, it's either directly on demand to make the calculation on the pen cap or go into the phone for monitoring for hyperglycemia. These are particular capabilities of the library to

 

Stacey Simms  16:27

his delivery that is in big for Unity. Are there any different features? Or is it the same one that people can buy separately?

 

Jeffrey Brewer  16:34

Well, it's the same libri puck. So the sensor itself, the part that you wear on your body, it's the exact same one that gets prescribed and fulfilled at the pharmacy or wherever else a person gets their lead rays. The difference is that we're not using the reader that avid makes, or the app that avid will have on the phone, the libri in our context is talking directly to our pen caps and to the app on the phone. So it's fully integrated into the system. This is an amazing thing that avid has given us, which is the ability to make it very, very simple for the end user such that you don't have to apps you have to worry about all the training is comprehensively designed such that I learned to use the library and the context Bigfoot system, one training one app, one company that's gonna support the whole system, Bigfoot, and then all the data that gets captured, whether we're talking about insulin data or glucose data, and then made available to clinicians in a unified interface to support them in adjusting the therapy over time.

 

Stacey Simms  17:38

Well, this may be a really dumb question. I know that the Libra you scan with the phone, when it's separate from Bigfoot in Bigfoot Unity, do you scan with the pen? Or is it just automatic,

 

Jeffrey Brewer  17:48

it's with the pen, you scan. That's actually the only way you can get right now what's my glucose reading from the CGM is through that NFC interface on the library puck. And one of the key design elements that we felt very strongly about is that you don't have to open up an app on a phone, in order to give yourself a shot. Literally, you're just carrying that pen which you would have with you for meals during the day, it already has the pen cap on it. So you don't carry another device and you're wearing the Libra on the back of your arm, all you have to do is wear the Libra Ray, and then scan that Libra with the pen cap, then it tells you what to do. And no opening an app on the phone, no unlocking the phone, selecting an app opening and navigating through pages, that adds too many steps. And it's frankly, peep something people don't want to do. So we tried to make it as close to what they're doing today, which is you've already got a pen that you're carrying around, we're not adding another device, you don't have to add any additional steps, all you got to do is wear the LIBOR rate and we take that data and then make advice as to what to do.

 

Stacey Simms  18:54

You know, one of the issues with pens is that they'll switch you insulin brands. So you know the insurance when your will cover human log the next year it wants you to take novolog and the pens aren't the pens different the caps fit and the different pens geoffry.

 

Jeffrey Brewer  19:08

The pens are different between the different manufacturers. And then some cases from the same manufacturer, you have different designs, different diameters and geometries and clearance for the needles. What we've done is besides designing different pen caps for all the different insulins, we have basically supported this as a service offering. So when you're using Bigfoot, if you didn't buy a pen cap, you are a customer for the entire offering. And if you get switched by your insurance company from humulus, novolog or back, we're just going to send you the new pen cap that fits the insulin that you're currently prescribed, which is we think one of the big challenges that people have and we've heard and we wanted to make sure that that was an easy transition for people.

 

Stacey Simms  19:54

That's great. And you've already mentioned the way it's packaged, but I'd like to just talk about that. Little bit more I remember. And it was either when we first talked in 2015, or you know, some point very early on that you all were adamant that this was not going to be piecemeal. And you were also going to make it easier for people to purchase things all together. So this is, this is a terrible way to describe it every in my head, I sort of think of those boxes, the subscription boxes, people get right with my kids, it was like, you'd get little fun comic book stuff in them, right, or you'd get a subscription box of exciting bath luxury items. This is obviously not that this is a box with everything in it, right, everything comes together.

 

Jeffrey Brewer  20:34

That's right, when you first initiate therapy, you don't have to go and get a prescription filled, really braise a prescription field for a blood glucose monitor for test strips for lancets. For pen needles, basically, it's all there in the box. And it's trained and set up in a unified fashion. That frankly, just makes it easier to learn. And it makes it more convenient. And we thought that's an important part of the customer experience. There's a lot of blaming, that takes place of the patient in the world that says, Well, people just aren't working hard enough. They're not doing the things that their clinician told them to do. If they were everything would be better, and diabetes wouldn't be a problem. And frankly, we just don't agree with that. We think that it's too complicated, it's too hard. And that it should be easier. So one of the things that needs to be easier is all the different supplies and getting those and making sure you have the right supply. Having access to the tools is something that needs to take place in order for you to be able to successfully use the therapy, we figure if we make that easier if we make it easier to remember things or you don't even have to remember things because we remind you or we descend them to you without you having to remember all that kind of stuff, I think really adds up to a better experience easier and more convenient use of the system, we firmly believe it's going to end up in better results. Because it's just people are going to do things that are more convenient and easier for them to do. So we make it as easy as possible.

 

Stacey Simms  22:03

any issues getting insurance and Medicare coverage when it's all bundled like this. I mean, I'm asking is did Bigfoot have any issues getting it? And is it covered for people now?

 

Jeffrey Brewer  22:13

Why Yeah, there's a lot of innovation that we're having to undertake in order to be able to deliver this to people. One of the aspects of innovation is that we're working through clinics, or endocrinology practices. And this is how we deliver the solution, the clinician will prescribe and then bill for not only the system, but the services of the clinician to use the system and support the system for the person with diabetes. And then when bill comes in, it comes from the clinician. So in order to make this simple, so that there aren't all these different prescriptions. And there aren't all these different places where you have to get all the different pieces, we're working through the clinician. And in this case, there are already codes that are available called remote physiologic monitoring codes that support the treatment of chronic disease and tools in order to support better treatment in chronic disease. And so we're providing these tools to the clinician, and then the clinician basically delivers them through to the patient. And the billing relationship is between the patient and the clinician. All of it gets simplified and makes everybody's life easier. What we're doing is covered by Medicare and private payers more broadly, because we didn't go and get a code for Bigfoot, what we did get is a plan to go and use codes that are already there that clinicians can access in order to reimburse both for what we're providing, and for the services that they have in order to support the effective usage of the system

 

Stacey Simms  23:46

looking forward, because of course, we can never just let something come out, we always have to see what's next. You know, we talked a lot about interoperability is Unity, going to integrate with different cgms or different systems down the road is that in the plans,

 

Jeffrey Brewer  24:00

not in the immediate plan, what we did is we said, we're going to pick what we think is the best CGM for what we're trying to do, which is simple, easy, cost effective and very scalable across a large population. And the library has some very unique capabilities that that we feel very much support what we're trying to accomplish. And so we did a deep partnership with avid, as I said, they've given us the ability to integrate their sensor into our system in a way that other systems are not integrated closed loop systems. Today, you have a company that sells you a sensor, you have a company that sells you a pump, they have different apps on the phone that are going to govern, you know their respective products, they're going to be uploaded to clouds that sometimes require clinicians to look into different places to see the full picture for data. We're doing something much simpler. Describe what we're doing is more like what Apple does. Apple takes a bunch of different pieces, some of which they licensed and some of which they may integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well. There are other sensors out there and great options for other sensors. We're not trying to say you have to switch to us if you're happy with your other solution. We're trying to go after a population of people who literally don't have any solutions today and are feeling pretty ill served. We think that with all the people out there that are still to use CGM are still to benefit from CGM and the kind of tools we put around CGM. We don't see ourselves as competing with others. We're just trying to get the goodness that we believe we've created out to people who who need it,

 

Stacey Simms  25:39

I got a question from a listener I meant to ask we were talking about scanning depends. And that was, if a person can still use the the libri, to reader and the librelink app to scan the sensor. Or once you do this, if it is only linked with Bigfoot system?

 

Jeffrey Brewer  25:53

Well, in order to get the benefit of the system, you need to use the pen caps, because that's where the data is captured. That's where the recommendations get made. And it works best in the context of the Bigfoot system.

 

Stacey Simms  26:05

So you can't you can't link it to two different things. In other words, you couldn't use the reader and the pen.

 

Jeffrey Brewer  26:10

Not at the same time, you could use the library separately with a library reader and a librelink. app, but not at the same time.

 

Stacey Simms  26:20

I'd love to get an update Jeffrey, if you could on what I believe is called Bigfoot autonomy, which was the pump system that we did first talk about all those years ago? Can I ask you what the plan is for that, or what you could share with us about it, it is called Bigfoot autonomy, right?

 

Jeffrey Brewer  26:35

That is the name that we have picked for it. Yes, autonomy and Unity Unity use for the shots and autonomy is for the pumps, we have, as you know, a pump ourselves, we have developed and done clinical work for algorithms that we have utilized for closed loop insulin delivery. And we've also developed the full package around how to deliver it as a single thing, using a libri. In a very parallel fashion to what we've done with a foot Unity, we had to focus on one product in order to launch the company and to establish ourselves. So we picked this path because we think it gives us the opportUnity to reach the most people most quickly that frankly, don't have other options available to them. And we think we're going to be able to establish a reputation in the marketplace. In the future Bigfoot autonomy is going to complement Bigfoot Unity and present another option for how people can have insulin therapy. That is something we're committed to down the road.

 

Stacey Simms  27:34

So the people that were very enthusiastic, there's this this whole commUnity that was you know, the DIY commUnity and the we are not waiting commUnity, they should not look at Unity and say, well, Bigfoot has stopped with the pump, right? They shouldn't think that this is not going to go forward. It's not still in the plan.

 

Jeffrey Brewer  27:51

Well, the plan is always and will remain that we're offering choice and selection of different opportunities for people that have different needs. Just as Medtronic today, in acquiring the companion in pen now realizes it's not about pumps or pen, it's about both, we've been saying the same thing for quite a while, we're just starting with the pens, and then expanding to the pumps, versus everybody else is now interested in pens and started in pumps, it's really the same thing. It's a different way of serving a particular part of the population that has different needs, pumps are great. And they can deliver a lot of value and a lot of quality of life. However, they're not going to be right for everybody. And there's going to be a lot larger population of people who will still take shots for the foreseeable future, especially globally. And so it's not a matter of either or it's both in our minds,

 

Stacey Simms  28:43

if your son is living with type one for almost 20 years now. And of course, I think most people got familiar with your name when you were at jdrf really pushing the artificial pancreas program. I wonder if you could just take a second to give us some perspective, because I don't know about you. But my son was diagnosed in 2006. And it almost seemed like for the first eight years, maybe even 10 years, there just didn't seem to be that innovation on the commercial side of things. And now, I feel like I know it's it's not there's no cure. I know it's we're not there yet. But I do feel like the technology is finally working hard. You know, we're doing things for my son. And it's not just pump technology, as you said it's pen technology. And I feel like at least he can do a little less work.

 

Jeffrey Brewer  29:25

I feel the same way. There's been a tremendous amount of progress from 2002 when my son was diagnosed in 2012. There wasn't much of any progress. It has been accelerating in recent years. And I give a lot of credit to jdrf and the work that the volunteers supporting jdrf did to advocate to the executive branch to the legislative branch and then directly to the FDA, we were able to establish a very strong platform for collaboration and the way the FDA has prioritized the innovation in diabetes. enabled it with some clear rules of the road. I believe that's what made it all possible. There has been development of technologies that weren't mature before. But if they didn't have a path through to the marketplace, through the FDA process that worked, we wouldn't benefit from all these things. So it has been a journey. And I think it's been, you know, development of technology. It's been developed in the regulatory practices. It's been greater familiarity and openness amongst clinicians, and also the payers who see value and these tools for patients. So a lot of things that had to change, healthcare is much more complicated and difficult to work in than what I previously did in my high tech career. But it's much more rewarding, because I think it's now having a big benefit and a lot of people and we're happy to join the party, as Bigfootbiomedical.

 

Unknown Speaker  30:47

Do you mind if I ask how your son's doing?

 

Jeffrey Brewer  30:48

Yeah, he's actually doing very well with his diabetes, I will tell you that between the ages of like 15 and 22, it was kind of rough. It was a very similar story that I heard from many parents when I was a CEO of jdrf. It's a really challenging condition to live with adolescents and young adults. But he sort of found his way through that, and now has refocused on taking care of himself. And the tools are better now, to enable him to do that. So I think that it's gone hand in hand, his maturation and the development of these tools. And you know, I think he's in a good place. And hopefully, we can make it better over time. You know, it's

 

Stacey Simms  31:27

funny, I'm not quite sure this is gonna come out appropriately. So I'll try to be careful. But it's kind of nice to free in a way to know that even the head of jdrf. And even the guy at Bigfoot has a kid who was a teen, and struggled. And I know that sounds weird. I don't wish anybody to struggle. Like I wish all the kids went through this, and we're fine. And everybody was the poster child. But I appreciate you sharing that.

 

Jeffrey Brewer  31:50

It's important because I don't think that people talk about it enough. How hard it is for families, how hard it is for the kids, and how young adults, their brains are just not meant to cope with a responsibility like this. It's just not right. It's not something that they're ready for. And, you know, so nobody should be surprised that it's very hard. And it certainly journey. I think it'd be better if people understood that from the beginning, you know, because some people yeah, you're right, they think it's just my kid that's having this trouble. But it's not, it's that this is really, really hard for any family. And it frankly, is the rare family, where you have just a completely well adjusted and easygoing kid with type 1 diabetes. That's the rarity, not the norm. We're a company that stems from the patient experience, you know, my knee through my son, obviously, it's not the same thing as having it. But you know, having a child that grew up with it, a lot of people at Bigfoot have insulin requiring diabetes and know what it's like to live with this drug. I think it's given us a really great perspective on some of the softer aspects of the experience have been missed by some of the medical device companies, things about making it easier and less stressful and just more convenient. Because when you got to do something every day, multiple times a day for the rest of your life, it's just a different kind of thing. And even small benefits to simplicity can have a huge impact and adding up to much less burden, emotionally or intellectually. And I think that all adds up to better lives. We can't point to any one thing about Bigfoot Unity and say, this is the thing that really makes the difference. It's really a bunch of different things that are really holistically designed to as a system, the sustainable and usable on a daily basis. And I think that's really the future of chronic disease and, and we're glad to be able to help tell that story.

 

Stacey Simms  33:45

Well, thanks for spending so much time with me. I really appreciate you going through it. And I'm sure we will talk again soon. Jeffrey, thanks so much for being with me.

 

Unknown Speaker  33:57

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  34:03

Lots more information about Bigfoot. I will link it up in the show notes at Diabetes connections.com. I have been hearing some weird things about Apple podcasts player recently and some of the other apps that feed off of apple. If you're having any trouble getting links, or even listening to the show. Everything you need is a Diabetes connections.com transcripts of every show. And always please get in touch with me I can usually help you find what you need. Because these are pretty information, dense episodes. And if you prefer to read, I want to make sure you get the info. And if the app isn't helping you then we can help you in a moment.

Something really amazing about my recent diabetes, parenting meetup, I met some new families and it was really unusual their experience and what they're doing for the rest of us. It's complicated, but I'll tell you in just a minute. First Diabetes Connections is brought to you by Dexcom. And when we first started with Dexcom back in December of 2013, the share and follow ups weren't not an option. They hadn't come out with Technology yet. So trust me when I say using the 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. Even if you're following your young child, I'm telling you, these are great conversations to have, you know, at what number will you text? How long will you wait to call that sort of thing. That way the whole system give everyone real peace of mind, I'll tell you what I absolutely love about Dexcom share. And that is helping Benny with any blood sugar issues using the data from the whole day and night. And not just one moment, internet connectivity is required to access separate Dexcom follow up to learn more, go to Diabetes connections.com and click on the Dexcom logo.

 

Okay, it was jumping out of my skin last week, because I had my first diabetes parent meetup since COVID. I think the last one might have been January or February of 2020. Many of you know I run a very large Facebook group for parents of children with type one in the Charlotte area, I think we have almost 1000 people now when we were starting to pull from all over the state because I have come to find out it's a pretty unique group. If you have a local group that you run, or you're part of what makes it unique is mine is based on meeting in person, I try to really stress and set up you know nothing official, I'm not with any organization, I just say hey, let's meet for coffee here, I stress the idea of let's get together in person, let's get the kids to meet let's get the parents to meet. And it can be kind of hard because not everybody I have found is as I don't know if enthusiastic is the right way to put it or pushy or not shy, maybe it's just I'm not afraid of rejection. If I set up a coffee and I invite you know, the whole 1000 people group, and five people show up or one person shows up, I'm still really happy. And I've come to find out that not everyone feels that way. So don't be shy. Just put your stuff out there, get people to come and meet up with you. It will change your life. It really helps me 14 years into it, I think more than anybody else who comes to these things.

So I set one up, we only had two people come I'm telling you these things are still amazing. But they were both newer diagnosed families. One had a nine year old daughter diagnosed January of 2021, just this past year, and the other had a 16 year old boy who was diagnosed last summer. And it turns out and I knew this before we met we the kids have some mutual friends. And they're both wrestlers. So Benny knew this other kid as well. But what was amazing to me is that both of these families were already enrolled in clinical trials. And they had been presented with this option. So early on. Now we do not live in an area where clinical trials are present. I mean, I've talked about this on the show before it's we've never been able to get in one. We live in Charlotte, North Carolina, most of North Carolina trials and tests and things are in the Raleigh area over by the Research Triangle, or they're in Virginia, at UVA, or Florida. And that's really the closest to us. So that's where these two families both went for separate trials, both at University of Florida health both I believe at trial net, I may have the exact place but both with Dr. Michael Haller, who we've talked to several times before on this show, one of the kids that the 16 year old is in the Teplizumab trial, the other is in the ATG trial. I'm not going to go into detail on both of these, we've actually talked to Dr. Haller about both of them on the show before. So I will link that up in the show notes as well.

But I'll tell you what the ATG trials you've just started. So it's a little too early to tell anything. And of course, this is just with one person. So we should be careful about drawing conclusions. But the 16 year old wrestler, holy cow, so he was diagnosed last year, it's almost a year I believe in In fact, when this episode comes out, it might just be a year. And this is a 16 year old kid. So a teenager who uses probably a lot of insulin, right big kid healthy kid. And I want to say the dad told me that his daily basil is four units. And they're struggling using a pump because he gets such low doses of insulin. They're trying to figure out what to do. Now, who knows, because as I said, it's early on, but it seems to be the thinking that the diploma has really helped make this first year of diabetes, very different than what most 15 or 16 year old kids go through in their first year of diabetes. I'm going to talk to the family. I'll probably circle back around with Dr. Haller again. Because I think that their experience and honestly, it has not been an easy experience. This isn't you know, you go down to Florida, you take a pill you come home, it's a very intense, but brief experience, but they do go I believe, every six months. So I'll tell you more about that as we get there.

But I really wanted to bring up with how amazing that these newer families are helping in this way. Obviously they want to help their own children, but they also understand that this is helping the greater commUnity. These are opportunities that did not exist. 14 years ago, when Benny was diagnosed that did not exist possibly, you know, 10 years ago, we have to pull him up in front of the FDA right now. This is really interesting to me, and I know it is to us. You're listening if you're listening this far into the show, certainly, but man and I know I also live in a more affluent area people have more access to health care and to doctors who know about this stuff. But Wow, I was surprised so happily, so To hear that and and to see that their entry into the diabetes community was also an entry into studies that will help everybody you know whether this stuff works or not, it all helps. So I really appreciate it.

 

 

Okay, before I let you go update on events, my next event is not in person, we're still on zoom for a lot of us but getting in person for more, which is so exciting. On June 5, I'll be speaking at Camp Nejeda. They have a great event for adults with type one, I will link this up in the show notes. And in the Diabetes Connections Facebook group, I'm talking about telling your story and advocacy. So this is more about how to get the media to listen when you want to talk and also maybe just about blogging and speaking Yeah, blogging still Sure why not in podcasting, and tik tok and Instagram, but talking about your story, and advocacy. That's what I'm going to be talking about there. If you're listening in the Charlotte area, we are doing another D parent meetup. That's This Week. If you're listening as the episode first goes live, it'll be Thursday evening. So drop me an email or hit me up on social and I'll give you all the details. And of course, every Wednesday, Diabetes Connections in the news, join me 4:30pm Eastern Time live on Facebook for a very brief five, six minute newscast about what's going on in the diabetes world, all types of diabetes, and that's replayed on social through the rest of the week. And the response to that has been great. So I am going to keep doing it. I'm having a lot of fun with it. All right. 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 next week. Until then, be kind to yourself.

 

Benny  41:40

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

May 20, 2021

It's "In the News..." the only LIVE diabetes newscast!

In six minutes, we'll get you up to date on these stories and more:
⭐A weekly basal insulin moves forward in trials
⭐Bolus by phone comes to one pump system
⭐Big study shows how people managed diabetes during COVID
⭐Saliva test for glucose in trials
Watch the video: https://youtu.be/X0JMDubA1c0
Join us LIVE on Facebook every Wednesday at 4:30pm EDT
Sources & links in the transcript below

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

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

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Episode Transcription below: 

Hi, and welcome to Diabetes Connections In the News! A short weekly newscast full of the top diabetes stories and headlines of the past week. I’m Stacey Simms & whether you’re joining me live on Facebook or watching or listening after, I’m here to get you up to speed quickly
XX
In the News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff”
In The News this week..
XX
A potential once-weekly basal insulin is moving ahead in studies. These two trials looked at the safety and efficacy of a modified version of insulin called insulin icodec.
Every participant – and they all had type 2 - was also taking an oral glucose-reducing medication that was not insulin, such as metformin.
An extensive phase 3 program is underway –this includes people with type 1… it also will include people new to insulin and those who’ve already used it. Weekly Insulin Icodec could potentially take the place of daily basal injections.
Weekly basal insulin: https://www.medicalnewstoday.com/articles/once-a-week-insulin-treatment-may-be-a-novel-way-to-treat-diabetes#Toward-a-less-burdensome-injectable
XX
Roche today announced the launch of the mySugr Pump Control, which lets you work your insulin pump directly via a smartphone.
The first pump to be controlled with the mySugr app is the Accu-Chek Insight. This is only available in Austria right now, where mySugr is based, and on select Android phones. It will launch in more European countries soon.
All the U-S pump makers are working toward bolus by smart phone but no approval yet. Interestingly, Roche calls the mySugr Pump Control an important building block within their integrated Personalized Diabetes Management or iPDM. If that sounds familiar, it sort of leads us into this next story..
Roche & MySugr launch bolus by phone: https://www.prnewswire.com/news-releases/roche-launches-mysugr-pump-control-within-the-mysugr-app-to-simplify-insulin-pump-therapy-via-smartphone-301294085.html
XX
Pump lawsuit in the UK. Insulet is suing Roche Diabetes Care claiming that Roche is selling tubeless insulin pumps three years before Insulet’s patent expires.
The suit was filed last year but the trial just began in the U.K. High Court.
Insulet claims that Roche has been infringing the patent on its Omnipod insulin pump by marketing their Accu-Chek Solo pump since mid-2018.
Insulet has asked the court for an injunction to stop Roche from marketing these products. It is also asking for unspecified damages.
https://www.drugdeliverybusiness.com/insulet-sues-roche-over-diabetes-tech-patent/
XX
Is there a relationship between marital status and diabetes risk? These researchers say yes.
Biggest finding? Men who are divorced/separated have increased risk for diabetes, and women who are widowed are at increased risk
The usual assumptions here about men eating healthier while they’re married and women perhaps over-eating after the death of a spouse due to stress and because they’re not taking care of anyone anymore. .
However, food doesn’t seem to actually be part of this study. So I think you have to be careful about that conclusion.. these researchers do say the big take away here is that other studies don’t differentiate between non-married or divorce… and widowed, which they say makes a big difference.
https://www.dovepress.com/diabetes-mellitus-and-marital-status-evidence-from-the-national-longit-peer-reviewed-fulltext-article-IJGM

XX
New study from the American Diabetes Association and dQ&A, finds that growing numbers of people with diabetes have not only been forced to put off needed medical care since the outbreak of COVID-19, but that alarming numbers are struggling to manage their blood glucose levels.
Key survey results found:
Nearly 1 in 5 Americans with diabetes have skipped doctor's appointments since the start of the pandemic, mostly due to fear of contracting the virus;
1 in 4 people report having trouble controlling their blood glucose levels
1 in 10 say they have developed new health complications like high blood pressure, heart problems, peripheral artery disease, and eye disorders since last March.
ADA COVID & Diabetes study: https://www.johnsoncitypress.com/covid-fears-kept-one-in-five-people-with-diabetes-away-from-the-doctor-during-pandemic/article_ffcb98a9-55df-58ad-a010-c7acd12070bb.html
XX
A saliva test for glucose levels? That’s coming up but
but first.. quick break – want to tell you about one of our great sponsors who helps make Diabetes Connections possible.
● Inside the Breakthrough is a podcast that mixes historical wisdom with modern insight – it’s a science show that’s also entertaining. I love it. The latest episode talks about when a belief thought to be settled science turns out to be wrong. And to illustrate that point they talk about the horse poop crisis of New York City. Really. Listen to Inside the Breakthrough wherever you listen to podcasts..
XX
Back to the news..
A South Korean company is seeking the approval of both the US and Korean Food and Drug Administration for the commercial rollout of its saliva-based glucose monitoring device after completing its first clinical trial in December.
The device called D-SaLife, uses something called a microcurrent control technology to determine the glucose level present in a saliva sample. They say they will move to clinical trials in the US – that first one was in in Seoul – but no date so far.
D-SaLife is not the only saliva-based glucose test in the works. There’s an Australian company that’s testing a disposable strip.
Glucose saliva test: https://www.mobihealthnews.com/news/apac/south-korean-chipmaker-bats-us-fda-approval-its-non-invasive-glucose-monitoring-device
XX
And finally, this one caught my attention because the headline says Gnome Man begins 380 mile walk to type 1 diabetes camp.
Turns out Richard Humphreys runs the Gnome Countryside Nature Trail in Pennsylvania. But he is 78, has lived with type 1 for 64 years and really is walking 380 miles to raise money for Camp Ho Mita Koda – the world’s oldest operating summer camp for children with Type 1 diabetes in Newbury Township, Ohio. Good luck Richard and wow. Thank you.
Gnome man walks to D-camp: https://lancasteronline.com/news/local/watch-kirkwoods-gnome-man-begins-380-mile-walk-to-type-1-diabetes-camp-in-ohio/article_8a5bc632-b669-11eb-a02a-f7a41b012ed6.html
XX
That’s Diabetes Connections – In the News. If you like it, share it. And feel free to send me your news tips. Stacey @ diabetes dash connections dot com.
Please join me wherever you get podcasts for our next episode -Tuesday – we’re talking to one of the founders of Bigfoot Biomedical about their new FDA approval and also what it means for other products in their pipeline.
Thanks and I’ll see you then!

May 18, 2021

It's getting hot out there and it's vital we keep insulin at the right temperature. However, that's something health care providers say isn’t always front of mind. Stacey talks to Diana Isaacs, a Clinical Pharmacy Specialist and a CDE at the Cleveland Clinic. We’ll get the real deal about insulin temperature and suggest some ways to keep your supply safe.

In Tell Me Something Good… glamorous inspiration and a grateful mom – plus babies! And a big anniversary.

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

Check out VIVI-CAP www.tempramed.com - use promo code DIACON21 to save 10% off your purchase! (promo code valid through 8/31/2021)

 

EPISODE TEXT HERE...

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!
-----

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Episode Transcription below

 

 

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  0:20

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:26

This week, it's getting hot out there a conversation about keeping your insulin at the right temperature. It's something healthcare providers say isn't always front of mind when we're troubleshooting tough diabetes days.

 

Diana Isaacs  0:39

Why are the blood sugars out of range this day? Why was it in range this day? And why? What's the difference? And this is really one of those pieces to the puzzle. And I think we spend so much of our time worried about other pieces like food that sometimes this really goes neglected.

 

Stacey Simms  0:55

Diana Isaac's is a Clinical Pharmacy specialist and a CDE at the Cleveland Clinic, we'll get the real deal about insulin temperature and suggest some ways to keep your supply safe

in Tell me something good, glamorous inspiration, a grateful mom and babies plus a big anniversary.

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 always so glad to have you here. We aim to educate and inspire about diabetes with a focus on people who use insulin. You know, My son was diagnosed 14 years ago, just before he turned to 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. I live in the southeast us in North Carolina. So it has been warming up for quite a while here. But pretty much all over the United States. We are seeing the warmer weather hot summer is coming. Shout out to our listeners in Australia and elsewhere in the world where summer is not coming please save this episode for a few months. But in addition to the advice here, I've got a thread going in the Diabetes Connections Facebook group about what to use not only to keep insulin cool, but to keep diabetes gear holding tight in the summertime CGM and pump sites as you know, tend to slide off in the wetness sweat. So please check that out. Lots of good suggestions. And as I mentioned, in my book, the world's worst diabetes mom, we really like stay put medical to hold stuff on. But I'll tell you in a pinch Benny will just slap a big waterproof bandaid over his Dexcom I really like the clear tegaderm stuff, but I mean he doesn't care yelled us anything and you can find that in a CVS. So if you're off to the beach and you don't have anything, it really comes in handy. Most of the rest of the stuff that's being suggested in that Facebook group thread has to be special ordered either Amazon or the website from the company that makes it

okay quick housekeeping note, you will hear my guest mention a product called VIVI cap in this interview and I have a promo code for you if you want to buy it you'll get a discount if you use the code, but I'm not being paid by VIVI cap. Although we are talking about doing something together in the near future. My guest is not a paid consultant for VIVI cap. She really likes the product and they know that and they helped coordinate this interview that said this conversation is about a lot more than one product. So whatever you use, keeping insulin at the right temperature is really important that promo code for VIVI cap is DIACON21, which gets you 10% off the product@temperment.com I'm pretty sure you're not listening with a pen. So I will put that in the show notes and on the episode homepage at Diabetes connections.com.

My guest this week is Diana Isaacs, she is a Clinical Pharmacy specialist and the remote monitoring program coordinator at the Cleveland Clinic Diabetes Center. She was the 2020 at CES Diabetes Care and Education Specialist of the year and a Cleveland Clinic. She does have a pretty unique CGM training program. And you'll hear about that during the interview as well.

But first Diabetes Connections is brought to you by Dario health. And we first noticed Daario 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 Daario offers even more now, the Daario 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 complete view of your data. The plan is tailored for you with coaching when and how you need it and personalized reports based on your activity. Find out more go to my daario.com forward slash diabetes dash connections. Diana Isaac's welcome. Thanks so much for joining me. I'm really interested to talk more about this. Thanks for being here.

 

Diana Isaacs  4:46

Great. Thank you so much for having me.

 

Stacey Simms  4:48

Or it is getting hot. I know that not everybody lives like I do in the south where it's been hot for a while. But let's start by talking about what you tell your patients.

 

Diana Isaacs  4:58

Yeah, so many people don't really The storage and the storage of insulin is so important. It's actually very fragile. And if it's not stored correctly, it actually most commonly it loses its potency. So it ends up you know that 10 units of insulin that you inject doesn't work like 10 units to work like seven units, like six units, you just don't know exactly, it's just will not be as potent.

 

Stacey Simms  5:18

When we're talking about storage of insulin. I know if I leave it in my hot car, and it gets to be, you know, above 110 degrees, it's going to lose its potency, but day to day, just kind of throwing it in the bag or having it with you, how do you need to store it,

 

Diana Isaacs  5:33

it's recommended any unused insulin pens or vials or cartridges should actually stay in the refrigerator, once it's been opened, then typically, it's good at room temperature for either 28 days, or some of the newer insulins are good up to 56 days, when it goes above that room temperature, that's when you really can't guarantee the potency anymore, and that's when it can break down and it is not going to be as effective. And in terms of Well, what's the danger of that? Well, a you really have no idea how much you're giving yourself. Because like suddenly, you know, what you usually give yourself isn't going to work as effectively. And you know, the real risk or the big risk would be a complication like diabetes ketoacidosis, where you're just not getting enough insulin and that could be you know, a life threatening complication,

 

Stacey Simms  6:23

what is considered room temperature

 

Diana Isaacs  6:25

78.8 degrees, it should be it should not go over 78.8 degrees Fahrenheit or 26 degrees Celsius,

 

Stacey Simms  6:32

you mentioned that the newer insolence can be out of the fridge for 56 days which insolence.

 

Diana Isaacs  6:37

So specifically, the ultra long acting like tresiba, insulin degludec, and then toujeo, which is insulin collaging. You 300 those lasts a little bit longer at room temperature.

 

Stacey Simms  6:49

Do you have any idea why I know those are made up a little differently from like, you know, Lantus or levemir.

 

Diana Isaacs  6:54

Yeah, the you know, they're just, they're made a little bit differently, which allows them to act longer in the body. And that's how they were studied to show that the potency, you know, still really maintains a fact at that point. And I mean, it's good also, because there's larger pens that holds more units. And so you know, that way a person, if they needed it for 56 days could have that the reality is a lot of people with the doses that they're on, you know, will go through a pen, you know, much faster than been 28 days. All right,

 

Stacey Simms  7:26

we're gonna do some True Confessions here, because I gotta tell you, we have kept insulin a lot longer than 20 days. And we have, and again, I'm not a diabetes educator, and endocrinologist. So you know, I'm just telling you what we have done as you listen, not just for you. But for example, Benny had a vial of insulin, my son that he took in and out of the fridge at school for almost an entire year, it was like a backup. So he would use it if he needed it. And when he was in elementary school, he used like, drops of insulin. It's not like now and he's a teenager. So we would put it in the fridge at the beginning of the school year, and then he would like take it out, use it, put it back in, take it out music, put it back in. Now, I know that's not advised. But it does work. So I mean, how delicate really is insulin, if we can get away with doing something like that.

 

Diana Isaacs  8:08

So Oh, man, you're burning my ears as a pharmacist? Oh, I hear that. But yeah, I mean, we know that that is reality that people are doing that. I think, you know, as long as it has maintained its room temperature, or refrigeration, probably a lot of insulins have at least close to the near potency for longer. It's just it really can't be guaranteed beyond that point. Because how it studied, I think, where things become different, or when it's exposed to too much heat, like we know for a fact that when it's exposed to high temperatures, or direct sunlight, it mean it loses its potency almost immediately. And if you've ever had you know, the insulin just sitting in the sun and then try to inject it, I I'm willing to bet it would be different. It wouldn't it would not work as well.

 

Stacey Simms  8:53

Right? And I think with that example that I gave, it never got below the refrigerator temperature because it was out and in so quickly. But I give that example because I know people who once they take it to the fridge, they think that's it. And it's just it was probably out for less than three minutes.

 

Diana Isaacs  9:08

Yeah. So I mean, that's interesting, right? So it's still you use it, but right, it wasn't out as much. So obviously, it's not ideal. We can't confirm how you know that it's so potent, but it sounds like in your case it was I have seen a lot of situations though, where people use insulin for example, longer in their pumps, like usually we say to change it out, you know, every three days and an insulin pump and people go five days, seven days and a lot of people notice as they go further out from those three days that it seems like they are needing more insulin that it is losing some of its potency.

 

Stacey Simms  9:39

I will say one of the only times we had an I refer to it very scientifically, skunky insulin. The only time we had skunky insulin was we had come home from summer camp and had unpacked the car but we had not seen like one of the bags kind of worked its way into the corner. And of course that was the bag that had two vials of insulin and two or three days later in our house. Summer car. We this was years and years ago, we used it anyway, of course, it did nothing. It was like sailing, or it was really bad. So that was a realization like, oh, it really does get terrible.

 

Unknown Speaker  10:12

Yeah. All that precious insulin law. I know. I know,

 

Stacey Simms  10:17

well, once we know, it's been 14 and a half years, so it happens, it happens. What do you advise patients then to do I mean, obviously, we can change out pump insulin more often. But as you said, Nobody wants to waste precious insulin like that. What are the tips that you give people to keep their insulin cool in the summertime, whether it's in a pump in a vial, that kind of

 

Diana Isaacs  10:42

thing? Yeah, so I'm a really big fan of something called the Vivi cap. And this is actually can go over like, it can replace the cap of an insulin pen, and you put it on there, and it guarantees that it stays at room temperature, even if it's exposed to, you know, a really hot car, really extreme temperatures, that is something that I've really been recommending for my patients, because it's just, it's a simple tool. And that way, you don't have to stress about like trying to, you know, I see a lot of people trying to get ice packs and things and that, that's risky, because you could accidentally freeze your insulin. So some a tool like the vivie cap, I find is really, really helpful,

 

Stacey Simms  11:20

you want to take us through a little bit of what it does.

 

Diana Isaacs  11:23

Sure, basically, it replaces the cap. So essentially, you know, like, let's say you have a novolog pen, right that you're using for your meal time injection. So you would go ahead and you would take off the cap. And instead, you would go ahead and you would put this Vivi cap directly on it, and you would replace that. And then you honestly, you can just throw it in your purse, in your bag, or whatever. And when you want to be sure that the insulin, you know, let's say you were in extreme temperatures, it was in your 100 degree car, and you're not sure if this insulin is going to be effective or not, there's a button at the top of it, and you go ahead and you press it. And if that button becomes green, then you know that that insulin was stored properly, it is a safe temperature, and it is safe to be able to use it if the D button would turn red, that would tell you Oh, there was an issue, the insulin is not safe. Now the good news is the way it actually you know, through a thermal cooling mechanism is actually getting rid of the heat where the insulin is. And so it's saying, you know, keeping it at room temperature. And why this is important also is because a lot of other things out there will make insulin really cold or accidentally freeze it or just make a cold. And really once it's out, and once it's open, it should say every temperature and so this really ensures that it will happen.

 

Stacey Simms  12:52

That's interesting. So the V cap doesn't necessarily keep it cold. It keeps it like it doesn't keep it refrigerated.

 

Diana Isaacs  12:59

Right, it's keeping it at room temperature. So it's really meant for the pen that you're using you're actively using. You can throw this cap on you can put it on your long acting and your mealtime insulin, and you can go on a trip, you can go wherever do whatever and it will stay at room temperature.

 

Stacey Simms  13:17

Here's a dumb question. We don't use pens very often. So I'm curious, do all pins have the same caps would this fit on pretty much any insulin pen

 

RIGHT BACK TO DIANA in just a moment but first Diabetes Connections is brought to you by Gvoke Hypopen and 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 connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke glucagon comm slash risk.

Now back to Diana answering my question about what type of insulin pen fits in the VIVI cap?

 

Diana Isaacs  14:25

No, that's a really good question. So they actually make different ones for different types of pens. So for example, if you're using like the novalogic products like novolog, and for siba are similar. There's a V cap for those. If you're using like human log products, they have a different Vivi cap. And so yeah, depending on the type of insulin that you're using, you would just go ahead and get the vivie cap that goes corresponding to the one that you need.

 

Stacey Simms  14:49

It's amazing that until now, I mean we're seeing a few more products address this, but it seems like you know insulin has been around for a long time and you know until recently cuz I've seen a few products like this until recently, the freo is the only thing I can think of that was really out there affordable, you know, easy to use, do you think people are just kind of catching on to the fact that this is really important?

 

Diana Isaacs  15:11

Well, I think this is just like a really neglected area. Like I spend a lot of my time like analyzing glucose levels, looking at CGM, and in blood sugars and all that kind of stuff. You know, often you're trying to figure out the puzzle. Why are the blood sugars out of range this day? Why was it in range this day? And why? What's the difference? And this is really one of those pieces to the puzzle. And I think we spend so much of our time worried about other pieces like food that sometimes this really goes neglected. And as it's summer, you know, summer is approaching is really a good opportunity to remind everyone that this is a really important for insulin. I mean, this is so so important and will affect it, if it's not stored properly.

 

Stacey Simms  15:52

It just sounds like common sense. But I'm curious, have there been studies of this? Do we have any idea how many people are having issues with insulin that's not stored properly, or using insulin that has, you know, been out of the fridge for too long? Is there any information on that?

 

Diana Isaacs  16:08

Well, I don't know, if we have, you know, we certainly don't have like randomized control trial data on that. I mean, how would you do it? Right? I can tell you anecdotally, I think it's just difficult to capture. Because you could ask people I mean, oh, with any person will say that they've had their insulin at high temperatures at some point. I mean, if you, you know, are a human being that goes outside, you know, it's likely that your, you know, your insulin was exposed to higher than room temperature. It's just a matter of how long and I think in the summer, it's really easy for it to, you know, when you meant for it to just be a couple of minutes, that ends up being hours. And then before you know it, you just don't know. And I think also it's difficult to classify, because there's so many reasons that blood sugars can go higher. And so in the moment, it might be hard for someone to be like, Oh, wait, oh, yeah, I was, you know, I left my insulin in the car for three hours. That's why my blood sugar is so high versus they might be thinking, Oh, was it the food I ate? Or am I under stress? So I think sometimes it's just difficult for people to make that connection that it really was the insulin that made their sugars higher,

 

Stacey Simms  17:11

because I'm kind of picturing people listening to this episode of had diabetes for a long time going, I don't need that. It's been fine. Right? And I'm kind of one of those people that I'm like, Oh, it's fine. I can't imagine this really happening all the time. But you're exactly right. How would we know?

 

Diana Isaacs  17:26

Yeah, I would just encourage people to reflect on it. I mean, it likely has happened. If you had diabetes long enough, it's probably happened at some point in your life where your insulin hasn't been stored perfectly, right. I am a really big fan of patient choice, and people knowing what's out there. So if you've come up with a perfect solution, or your insulin is always at home, and you never go out great. You don't need something like the Vivi cat. But you know, if you're out you're traveling or going on a trip, I think it's good to know what options exist out there.

 

Stacey Simms  17:54

I'm curious too. And this is kind of separate from vicap. My son is using insulin pumps since he was two years old. And he we live in the south, as I've mentioned, and it's always hot, the summer is ridiculous. But he has the insulin next to his body. His body is pretty warm all the time. Is there any Are there any issues with that three days in the pump? Do you see people having more issues in the summertime? And do you ever recommend, you know, changing the insulin at more often because of temperature?

 

Diana Isaacs  18:20

I do. Yeah. A lot of people have issues is especially in the summer. I'm like I've seen people with like Omni pod. And it's just like boiling in the sun. And it goes bad very quickly. So yeah, I am a fan of encouraging people to change more often, like every two days instead of every three days if they notice that it's wearing off sooner. So I think like a lot of people should consider that in the summer if they noticed that third day there. boluses are just not having the same effects on their blood sugar's.

 

Stacey Simms  18:46

We've also found that winter to summer, we always have to change basil rates. And that's probably because of activity, but it's also because of heat. And I know that that affects people differently. How do you advise your patients to look at the weather and how it affects their bodies?

 

Diana Isaacs  19:01

That's a good question. I mean, everyone is affected a little bit differently. I really like Adam brown from diatribe. And he talks about 42 factors that affect glucose levels. And actually a sunburn is one of the things that could affect levels, it could increase glucose. So I think, you know, weather can affect it any kind of stressor on the body can absolutely affect glucose levels, but it is very individualized. For many people, the weather won't be a huge deal. But for some they may be more sensitive. And I think the best thing is to really reflect on it to review data with a diabetes educator or diabetes care and education specialist and really try to determine what are the patterns and who knows, yeah, it could be whether it does create a pattern for someone that if you know that it's helpful, because then you can kind of preemptively prepare for it and give yourself more or less insulin as needed.

 

Stacey Simms  19:52

Can we talk about sunburn for a minute, because every year in the parenting groups, somebody comes in and says it's their first time can the sunburn I raise my kids blood sugar, and everybody kind of says yes, yes. Why is that? Is it just trauma to the body? Is it like being ill?

 

Diana Isaacs  20:07

Yeah, I think it's like anytime there's a stressor on the body that can affect it. So yeah, if it's causing stress, you know, sunburns can be pretty painful. And we know pain can increase glucose, so it's likely related to those factors.

 

Stacey Simms  20:21

I don't wanna change the subject too much, but I'm reading your bio. You know, in researching for this episode, he talks about how you run a CGM shared medical appointment program. Can you tell us what that is?

 

Diana Isaacs  20:33

Yeah, so I am a big advocate of CGM of continuous glucose monitoring. And in our program, we often introduce people to CGM for the first time. And so with our shared medical appointments, we have usually four to six people with diabetes, and we have a meeting. And then we also have a dietician, and it's a two part shared appointment. And the first part, we get everyone together we place the CGM, and we have a discussion about what are the glucose targets and what kind of things affect glucose levels. We also review how to treat high and low glucose levels. And then everyone comes back after seven days and we download the devices and we we actually show everybody's data on a big screen and we go through it together. It's really interesting because a lot of people there, you know, there's similar things like the overtreating Alo or learning you know how oatmeal affects your blood sugar's you know, like, there's a lot of similarities that kind of it's nice to have that group environment. Yeah, that's

 

Stacey Simms  21:30

I've so many questions, but my first one would be, you'll have to, you'll have to come back on and just talk CGM with us. I'm curious, how do you manage or handle when people are looking at everybody's CGM numbers? And some must feel like, Oh, that's bad? Or I didn't do that very well. You know, do you talk about that part as well, and kind of managing the data mentally.

 

Diana Isaacs  21:51

So my rule is data numbers are data, and they cannot be good or bad. So it's simply being in target or out of target. But it's not a judgment, there's no such thing as good or bad numbers. And I'm really careful about this. I mean, even you know, when someone is 100%, in range, and has an agency of 6%, I try really hard not to say, Oh, that's so good. Like, you know, do jumping jacks, because, you know, I don't want someone then to have a higher agency and to be less than range and then not want to come back for their appointment because they think I'm only be happy when it's, you know, in range. So it's really an important point to not be judgmental with with data.

 

Stacey Simms  22:27

Oh, all right. You're gonna have to come back on and talk to us more about that. I think that's,

 

Unknown Speaker  22:31

I'd love to Alright, good. Good. Good.

 

Stacey Simms  22:32

All right, back to the summer, though. So since you work with a lot of people with with CGM, do you find that there are ways for people to keep their gear better on in the summer? Do you have any advice for that? Because diabetes technology can be kind of slippy in the summer?

 

Diana Isaacs  22:45

Yeah, no, it can be. So I'm a big fan of skin tack and of overlay patches, like sin patch, and stuff for keeping on CGM sensors and sites for the pump. I think technique with everything is really important. Making sure the skin is clean and dry. You know, placing it right after a person has recently showered or bathed just to have the most success with it digging and staying on. But I think absolutely using products like skin tack mass assault, for people that sweat, it's just it's like kind of a must to have those extra, those things can really help.

 

Stacey Simms  23:17

Yeah, we found or at least just anecdotally, everybody's skin is so different that you know, overlays vary brand to brand. So unfortunately, you kind of have to keep trying until you see what works for you. And one of the nice things we did locally when we could meet up and we're going to start meeting up again, which I'm very excited about is I always tell people, like let's bring samples, right? Because you get like a 20 pack of sim patch, and I get a 20 pack of stay put medical patches and you know, people just bring different brands, and then we can kind of trade because I used four or five different brands on my son before we found what worked. So if you're listening and you have a local group, and you're meeting up again, that's just something you can try cuz it's so frustrating.

 

Diana Isaacs  23:55

Yeah. And sometimes like, right, you put something on over it, and then you know, it starts peeling off after a couple of days, you have to put another thing over it. So yeah, I agree trial and error. You know, we

 

Stacey Simms  24:05

spoke a lot about the temperature extremes with insulin on the warm end, we touched on freezing, but let's talk about that again. What's the danger of insulin freezing? I mean, we know it doesn't work well. But is there anything to say about that in terms of why? Or you know, is it just that you mean, obviously, if it's frozen, you can't put it in a syringe, but it does completely lose its potency? Right?

 

Diana Isaacs  24:26

Well, I don't know if it completely loses its potency, but it very much does. But also, I mean, particles may form to which could make it definitely more difficult injecting and then I mean, I guess it could cause pain with injection as well. So I mean, it's just another reminder to like anything, you should really always visually inspect the insulin as well. And most insolence should be clear. So checking for that is really important as well.

 

Stacey Simms  24:54

Yeah, that's the the hotel refrigerator syndrome. So many times the fridge In the hotel is not set to the correct temperature. So you put your vial of insulin and it freezes. I've heard that so many times. It's just terrible.

 

Diana Isaacs  25:07

Yeah, I mean, it's really, it's really a problem. And so yeah, I mean, that's a really good point, when you're traveling, it's often really hard to rely on the hotel refrigerator, which is often is not set correctly for temperature is the right temperature,

 

Stacey Simms  25:21

what we usually do is, if we're staying for more than one night, is we'll put something you know, water, we'll put whatever in that fridge and kind of see how it does in a couple of hours, to see if we trust the insulin. But that's only helpful if you're going to be there for a couple of days, and you have a way to keep your extra insulin, you know, at a cool temperature, because so much of what we're talking about is not even so much for the the insulin you're using at that moment, although you want to keep it at room temperature, exactly. But you know, we don't have to keep it refrigerated. But when you're traveling with extra insulin, that's really a problem.

 

Diana Isaacs  25:52

I just would encourage people to think about it and just be just plan. I mean, just have a plan for the summer, whatever that plan is. And just be aware that I think some of the traditional methods that people use, like using like a lunch bag and putting an ice pack in it can, you know, you don't really know that temperature that's going to be in there. So there is an option available that you can be assured it's going to stay at room temperature. And it's just it's really simple. And it doesn't take up all this extra space and everything. I think that's the key. It's just it's a super simple thing. And so I would just encourage people to kind of check it out and go to the website and learn more about it.

 

Stacey Simms  26:34

It's interesting too, because insulins not alone, I mean, so many medications are temperature sensitive, as newer insulins come out, do you think that the temperature sensitivity will ever be factored out of insulin? Or it's just it's just part of the component?

 

Diana Isaacs  26:51

It's a really good question. Because I I'm sure you know, there's research in this area to see can insulin be more stable, or it's not? I think the problem is, it's just it's a large peptide. And, like due to its nature, it's just really hard to get it to be stable for a long period of time. I mean, it's one of the reasons why we don't have oral insulin, at least not yet. Like we don't have it in pill form. It's just really, really unstable. I think it's going to be challenging. Maybe one day we'll have that. But it's definitely going to be a challenge to

 

Stacey Simms  27:19

have that. You mentioned the newer insolence, like the longer acting like to CBOE and toujeo. Is that considered an advancement? Or is it just different, it's not going to apply to the shorter acting?

 

Diana Isaacs  27:30

Well, I think it is an advancement, in that we have an insulin that they were able to alter to work longer in the body, which I think ultimately really helped to stabilize blood sugars. And when you think about like, where we progressed, we started off with NPH, which you know, only works like half a day. And then we got longer act insulins like lantis and lab Amir, and then now we have these, like ultra long ones, like TJ Oh, and receba. And there's actually a weekly insulin that's in development that hopefully will, you know, see in the near future. So I think we're definitely making advancements and insulin, which is really exciting. Although the other area where we need to make advancements, which is a whole other episode is the affordability of insulin as well. But there are definitely advancements that are are being made. So yes, maybe with the storage, those will be things that will get better. But I don't see it completely resolving, you know, anytime soon.

 

Stacey Simms  28:23

How do pharmacies Sue with this? I mean, as far as I know, we've never had a problem getting our insulin from the pharmacy at the right temperature, of course, then I have to bring it home. And we do a lot with mail order as well and knock on wood. It's always been delivered, I think at the right temperature. Is there a problem from that perspective as well, like in the supply chain,

 

Diana Isaacs  28:43

know, the supply chain is heavily regulated? So I mean, they are monitoring refrigerators constantly. And they have certain standards, there's inspection so you can feel really good about the supply chain. It's really once it gets to the person that it's not regulated. But yeah, in the pharmacy, it is very, very maintained to a tee to those temperature and they're like specialized refrigerators is not just your it's definitely not your hotel refrigerator that for storing Insulet

 

Stacey Simms  29:12

Yeah, it's good. That's good. That is good. Before I let you go, I'm just curious. I we have been lucky enough to see my son's endocrinologist in person for the last couple of visits when we did a lot of telehealth. Are you seeing people back in the office? I mean, how are you all doing through all this?

 

Diana Isaacs  29:29

I never stopped seeing people in the office. So I've been here through the whole pandemic, I've actually come to work every day. Now. A lot of our visits have been virtual out of convenience for people but we are open and people could come here you know, whenever they want. And some For some it's preferred because as much as we've made advances in technology, we you know, we've got some patients who really have challenges downloading their data at home and stuff and it's, it's good to have them in the clinic. So yeah, our doors are open and but I will Say telehealth has flourished. And for a lot of people, it just makes so much more sense. Like today this morning, you know, we trained a person on their new pump. And rather than like me having to have her come in next week, I can just do a virtual and just look at her data that way and make adjustments. That's kind of where we're at with it.

 

Stacey Simms  30:15

I would imagine your patients have been very happy to walk in and see you during this past year. Like it's very be very reassuring. I was surprised how when we were able to see my son's endocrinologist again. I'm kind of happy we were.

 

Diana Isaacs  30:29

Yeah, I think it's nice. And I mean, I feel especially now with like the vaccine now that we've all been vaccinated, I feel very, you know, I feel great. It was definitely a little stressful. Like, I'll tell you back in December, we were doing our CGM shared medical appointment. And I had a class of four people and I, you know, you see people starting to like, move their masks down, and you're like, Oh, my gosh, is this safe, like at this stage, because we're doing a class and that was right, when the numbers were really increasing? So we did, we did pause them for a few months till the numbers came down. But But yeah, I think overall, you know, it's good. It has been reassuring. And you know, it's care doesn't stop, like some people are getting new insulin pumps. And yes, while you can get, you could do virtual training. And for many people, we do like some people really want that hands on time, when that was their first time starting upon, they want to come in and see it.

 

Stacey Simms  31:17

I can't imagine the people who were diagnosed this past year or had children diagnosed and were more isolated than normal. It's isolating enough to have diabetes. And I just can't imagine. So thanks for doing that. And, you know, keeping in touch with everybody, I mean, I'm not your patient. You don't really know me, but I want to say thank you.

 

Diana Isaacs  31:34

Oh, you're welcome. I mean, I love doing it. I love working with people with diabetes. It's so rewarding. And it's like, I just, yeah, I just feel like I feel very optimistic. With all the new technology and the advances being made. I just feel like, yeah, there's so much opportunity to help people.

 

Stacey Simms  31:50

Well, thank you so much for spending so much time with me. And we'll have you back on to talk more about CGM and the shared medical stuff. I think that sounds great. Thank you so much.

 

Unknown Speaker  31:57

Oh, you're very welcome. Yeah, thanks for the opportunity.

 

Unknown Speaker  32:05

You're listening to Diabetes Connections with Stacey Simms

 

Stacey Simms  32:11

I’ve  got more information about the temperature at which insulin is supposed to stay. We touched on that. But if you'd like to learn more, and there's some more studies that really delve into this, I'll put that at Diabetes connections.com. Every episode has its own homepage there. If you're listening on an app for podcasts, there are always show notes, but some of them don't show these things very well, you can always come back to the main page, and I'll put it there with a transcript as well.

And the promo code for VIVI Cap is DIACON21, like Diabetes Connections, di a co n di a con 21, which gets you 10% off the product. Alright, tell me something good. Coming up help prom photos provided some unexpected inspiration.

But first Diabetes Connections is brought to you by Dexcom. So I was watching a movie with my husband the other night, and I got a Dexcom alert and he was upstairs in his room. And you know, for some reason, that took me back to the days when we basically had blood sugar checks on a timer, we would check doing a finger stick the same time every day at home and at school and you know, whatever extra we needed to. But it's amazing to think about how much our diabetes management has changed with share and follow. I didn't have to stop the movie to get up and check him. I knew what was going on, I could decide whether to just text him or go upstairs and help him out. Using the share and follow apps have really helped us talk less about diabetes, which I never thought would happen with a teenager. Trust me, he loves that part too. That's what's so great about the Dexcom system. I think for the caregiver or the spouse or the friend, you can help the person with diabetes manage in the way that works for your individual situation. Internet connectivity is required to access Dexcom follow separate follow up required, go to Diabetes connections.com and click on the Dexcom logo.

 

Tell me something good this week, I don't know about you. I'm in a lot of moms groups. And I have seen a bajillion prom photos over the last month and it's really nice. But one of the things that happened that I didn't expect is that it provided diabetes inspiration to families, especially families with younger kids, I don't have permission to share her name. So I'm just gonna tell you the story here. But this woman posted that she was looking at all the pictures of the beautiful girls and their dresses and their Dexcom and their pumps and their Omni pods showing. And you know, she was excited to see that. But her little girl who's totally into the princess phase right now she's six or seven years old, loved seeing the photos of all these grown up girls with diabetes. And it really provided an easier way to get her little girl to feel better about the gear that she is wearing. And I just thought that after all these years was still kind of unexpected. Now let's be honest, not everybody wants to show their gear all the time. And that's okay too. And honestly, I highly doubt that these girls are going to the prom thinking. I'm gonna have my mom posted. On Instagram or Facebook and that's going to inspire somebody else. Right? But man did it ever. So thanks to all of you who did that, who posted the photos? What a cool thing

I have to wish a happy wedding anniversary to Janice and Bill Grigsby they celebrated 50 years married in April. And Janice was cute. I was asking for good news in the Diabetes Connections group and she wrote that may not be what you were looking for, since it doesn't have to do with diabetes. But you know, Janice, we're all together because of diabetes. Janice and Bill's daughter marked 20 years with type one late last year, so I think that counts so congratulations on that amazing milestone. It doesn't all have to be diversities. 50 years married. That is fantastic.

And a big congrats to Alison nim Lowe's, who had a baby last week, little Stellan joins Big Brother Henrik is still in it was a little impatient came into the world a little bit early. So he'll be staying at the hospital for a while. And they helped to bring him home by the end of May. But everybody's doing well. Alison is somebody I've known for years. She's been on the show before I will link up that episode. She's on social media as the diabetic therapist Of course, we talked about therapy and mental health in that episode, but congratulations all around really exciting stuff. If you have something good to share, please let me know Stacy at Diabetes, Connections comm or pop into our Facebook group and share when I asked on a regular basis. Just tell me something good.

Before I let you go, quick reminder that on Wednesdays in May, I am doing in the news, a live diabetes newscast every Wednesday at 4:30pm. Eastern time. I hope you can join me for that. I'm also turning it around to then putting it out on different social platforms. And on this podcast. That episode right usually has been coming up Thursdays or Fridays. And it looks like we may continue this because people are really liking it. I definitely need to know how you feel about it though. So you can email me comment on the post itself. It's a little bit of different work than the podcast to be honest with you. Not necessarily more work, but I do have to brush my hair and put some lipstick on to go live on Facebook. That's just how I am if I continue this, maybe you'll see me eventually in the ponytail and opaque but I'm having a lot of fun doing it. And I think it's a need. We don't really have a diabetes newscast anywhere. So I may continue. I will be deciding probably between this weekend next week's episode, and I'll definitely let you know.

Thanks 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 just a couple of days. Until then be kind to yourself.

 

Benny  37:42

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

May 13, 2021

The only weekly diabetes newscast! We're covering the top stories of the past week including:

--
Big insulin recall from from Novo
FDA approval for Bigfoot's Unity system
Lilly inks a new agreement
T1D athletes speak up about the COVID vaccine
--

These are planned for the month of May - Stacey shares live on Facebook every Wednesday. If you like it, we'll keep it going! Full transcript and news/source links below.

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!

Episode transcript and links below:

Click here for iPhone      Click here for Android

 

Hi, I’m Stacey Simms, the host of Diabetes Connections, a weekly podcast providing info & inspiration with a focus on people who use insulin. This is “In the news..” a new, short newscast full of the top diabetes news of the past week.

The goal here is to get you up to speed – quickly – with good info.

XX

And let’s not forget.. Diabetes Connections In the News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff”

Let’s jump in!

In The News…

XX

Novo Nordisk is voluntarily recalling nearly 15-hundred product samples because they were stored at the wrong temperature. This recall is only for product samples – NOT for the insulin you get at pharmacies or mail-order services. But it does cover Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy (ZUL-ti-fye like multiply). We’ll have a link in the show notes with all the info, batch and lot numbers to look for.

Side note we just got Tresiba samples for the first time from my son’s endo. So good timing there!.

You should receive a notice from your doctor if you have any of this insulin, but there’s a phone number to call and a way to report to the FDA as well. Again, link in the comments here on FB and in the show notes if you’re listening to the podcast.

Insulin sample recall: https://www.prnewswire.com/news-releases/novo-nordisk-issues-voluntary-nationwide-recall-of-levemir-tresiba-fiasp-novolog-and-xultophy-product-samples-due-to-improper-storage-temperature-conditions-301286839.html

XX

Bigfoot Biomedical gets FDA approval for it’s Unity Diabetes Management System. This is a connected pen system – where the insulin pens, both long and short acting, take data from a Libre 2 continuous glucose monitor and give insulin dosing instructions.

You’ll get current glucose numbers as well as any recommended correction doses. The system also provides reminders for the long acting pen and provides low  notifications.

The unity system was cleared for people 12 and older with Type 1 or Type 2 diabetes.

Bigfoot was founded in 2014 to create a commercial version of an existing DIY hybrid closed loop pump system. That is still in the works, under the Autonomy label. We’re working on talking to Bigfoot in the next week or so to catch up.

Bigfoot Unity FDA approved https://www.mobihealthnews.com/news/fda-greenlights-bigfoot-biomedicals-insulin-recommending-diabetes-management-system

 

https://www.ajmc.com/view/diabetes-in-the-news-pregnancy-and-diabetes-dementia-risk-pediatric-ketoacidosis

 

https://www.bizjournals.com/triad/news/2021/04/22/vtv-wins-fda-designation-for-diabetes-therapy.html

XX

After nearly a century, BD is spinning off its diabetes care business.

The split is expected to be completed in the first half of 2022, after which the segment will become a completely separate, publicly traded company, tentatively dubbed "NewCo."

BD spins off: https://www.fiercebiotech.com/medtech/bd-to-spin-off-diabetes-care-business-into-newco-a-standalone-public-company

XX

New deal for Eli Lilly and four diabetes management companies – integrating the not yet released Tempo Pen and Tempo Smart Button products.

The companies that signed with Lilly here are Dexcom, Glooko, myDiabby Healthcare and Roche’s MySugr. myDiabby is French and I’m sure I’ve pronounced it wrong.

These agreements are all about integrating with software platforms and allow for the collection and sharing of personal health data.

Lilly agreement with 4 diabetes companies: https://www.mobihealthnews.com/news/focused-diabetes-eli-lilly-inks-integration-deals-roche-dexcom-glooko-and-more

XX

Tandem’s latest earning call in just a moment but first.. quick break – want to tell you about one of our great sponsors who helps make Diabetes Connections possible.

  • Inside the Breakthrough explores the idea of a “Eureka” moment. It’s historical wisdom mixed with modern insight – a little bit history show, little bit science show. The latest episode tells the story of Dr. Banting and the discovery of insulin. Every week is a different story – they’ve talked about snake oil and leaded gasoline & crime – but this week has info about the discovery of insulin that I’d never heard.. Banting had to sell his car to get money to buy dogfood. And of course, there’s scientific info as well. Listen to Inside the Breakthrough wherever you listen to podcasts..

XX

Back to the news.. Tandem diabetes had it’s first quarter earnings call last week. Several highlights:

They have submitted a couple of new features to the FDA and are waiting on approval. First, still waiting for an update to the Control IQ algorithm to allow for more personalization

Second is the mobile bolus or what I call bolus by phone. They got some response from the FDA in March but this, like many projects, is delayed because of COVID. Tandem CEO John Sheridan says, “we're no longer planning for our Q2 clearance, but we will be working to bring this highly sought after feature to market as quickly as possible.”

It’s still expected before the end of this year.

T-sport also pushed back, Sheridan wouldn’t give a specific date on that but when pressed, said probably a commercial release in summer 2022.

For parents of young children, Tandem has started a study of CIQ with toddlers as young as two.

 

Tandem earnings call transcript: https://www.fool.com/earnings/call-transcripts/2021/05/06/tandem-diabetes-care-inc-tndm-q1-2021-earnings-cal/

XX

Max domi (DOE-mee like show me) shot https://twitter.com/BaileyAJohnson_/status/1391812883361714179

Finally, Some prominent athletes with type 1 are speaking up about urging people to get the COVID 19 vaccines. Indy driver Charlie Kimball did a PSA for the Indiana Dept of Health – I’ll link up that video..  and NHL player Max Domi (Doe-mee like show me) spoke out at a media avail. This quote was tweeted out by reporter Bailey Johnson. Domi says: in part, "I will never forget the feeling I got after having the vaccine. Just the sense of relief and freedom... as soon as I got it, it was like the world was lifted off my shoulders.

 

Once I did that, my game took off, I felt better about myself and was just enjoying life a lot more. Diabetes or not, it freed me up a lot and I'm thankful I had the opportunity to get it when I did."

That’s Diabetes Connections – In the News. I’m going to do this for about a month and see what the response is. So far I’ve been thrilled to hear from a lot of you who like it. If you like it, share it. And feel free to send me your news tips. Stacey @ diabetes dash connections dot com.

Please join me wherever you get podcasts for our next episode -Tuesday – we’re talking about the importance of keeping insulin at the right temp during the hot weather.. not related to that Novo recall I told you about today, but definitely timely,

Thanks and I’ll see you then!

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.

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!

Episode transcription below

Click here for iPhone      Click here for Android

 

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 connections.com 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

Stacy.

 

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 dario.com 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 connections.com 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

May 6, 2021

New information about kids with type 1 and COVID, a possible link between pollution and type 2, a look at Dexcom's latest earnings call and a lot more.

We're trying something new for the next few weeks! Join Stacey live every Wednesday on Facebook for the top diabetes news and headlines or listen back via the podcast or on other social outlets.

Full transcription and links/sources below.

Watch the replay on our Facebook page or YouTube Channel

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

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

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Podcast intro: Hi all! This episode is very different. Instead of a classic episode, I wanted to try something new. What you’re about to hear first aired live on our FB page. Join me every Wednesday this month at 4:30pm eastern for DC the news!

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Hi, I’m Stacey Simms, the host of what’s usually a weekly podcast providing info & inspiration for people with diabetes with a focus on people who use insulin. I’m trying something new. A short newscast full of the top diabetes news of the past week. And that’s all types of diabetes. We’ll debut here on FB Live and then share on other outlets, including the podcast.

The goal here is to get you up to speed – quickly – with good info.

And let’s not forget.. Diabetes Connections The News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff”

Now..  let’s start!

In The News…

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The majority of children with type 1 who tested positive for COVID.. did just fine. According to the very first report about this, from Barbara Davis Center, 77% of children with type 1 who had COVID were cared for at home, without complications.

The children who were hospitalized were all diagnosed with diabetic ketoacidosis and the greatest risk for adverse outcomes was an A1C over 9. Fewer than 2% of all these cases required any respiratory support, and no deaths were recorded.

Kids with T1D and covid fared well: https://www.medscape.com/viewarticle/950277

XX

Another study about kids and covid.. The incidence of severe diabetic ketoacidosis among children presenting with new-onset type 1 diabetes doubled during the pandemic period compared with 2019, according to data published in Pediatric Diabetes.

This research comes clinics in Canada from March to August 2020 and compared to the same period in 2019. The number of children diagnosed with T1D was similar but the frequency of DKA went from 45% to 68%.

What they called severe DKA went from 13% to 27%.

Speculation here is that fear of COVID kept people out of the doctor’s office until it was absolutely necessary, but these researchers say more education is needed around DKA even after the COVID pandemic ends.

More severe DKA in kids during covid: https://www.healio.com/news/endocrinology/20210422/severe-dka-at-type-1-diabetes-diagnosis-doubles-during-pandemic

XX

Hat tip to chris Wilson for this..

Dexcom had it’s first quarter earnings call last week. Still expecting G7 to launch in Europe ahead of the US, with US launch towards the end of the year. We’ll find out more details about the G7 at ATTD conference this summer. That’s the advanced technologies and treatments for diabetes conference.

Chief Operating Officer Quentin Blackford also reports that quote, “we rolled out an update to the G6 algorithm in the first quarter. We believe this update will drive further reductions to times in which data is temporarily unavailable And I've seen excellent results from the initial launch of this updated algorithm in Canada in 2020.”

I’ve talked to Dexcom a few times about how they can make changes to the transmitters and sensors that don’t require regulatory approval – no announcement they just roll them out. Looks like this was one of these.

https://www.fool.com/earnings/call-transcripts/2021/04/29/dexcom-inc-dxcm-q1-2021-earnings-call-transcript/

XX

Looking at type 2.. A new study suggests that people exposed long-term to certain air pollutants may have a higher risk of diabetes. This was part of the ongoing Jackson Heart Study which looks at African American patients in Mississippi.

The study included more than 5000 people ages 21 to 94 in the Tri-County Jackson area.. where traffic is the major source of ambient air pollution.

Levels of diabetes and of pollution exposure were assessed 1 and 3 years prior to visits 1 and 2. They reported a diabetes prevalence of 21.8% at visit 1 and 33.2.% at visit 2. Furthermore, 12.5% of those without diabetes at visit 1 developed it by the second visit.

Theses researchers say the results provide some evidence that the exposure is linked to diabetes. Apparently there are very few studies of environmental pollution risk factors in communities of color – these researchers say more follow up is needed.

Air pollutants and type 2 diabetes: https://www.hcplive.com/view/air-pollutants-associated-diabetes-prevalence

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Quick note about gestational diabetes. Turns out few women who meet the criteria for early gestational diabetes screening receive it. This study was only done at one location, but the authors say it’s indicative of a greater problem.

Only 12% of women who met the American College of Obstetricians and Gynecologists’ criteria for early gestational diabetes screening actually received it at a New York hospital. It’s recommended that all pregnant women be screened for gestational diabetes (GDM) at 24 to 28 weeks.

Nearly one-fifth of the women who met the criteria for early screening but were not screened were ultimately diagnosed with gestational diabetes further along in their pregnancy.

https://www.healio.com/news/primary-care/20210501/few-women-who-meet-criteria-for-early-gestational-diabetes-screening-receive-it

XX

Quick break – want to tell you about one of our great sponsors who helps make Diabetes Connections possible.

  • Inside the Breakthrough explores the idea of a “Eureka” moment. It’s historical wisdom mixed with modern insight – a little bit history show, little bit science show. The latest episode tells the story of Dr. Banting and the discovery of insulin. Every week is a different story – they’ve talked about snake oil and leaded gasoline & crime – but this week has info about the discovery of insulin that I’d never heard.. Banting had to sell his car to get money to buy dogfood. And of course, there’s scientific info as well. Listen to Inside the Breakthrough wherever you listen to podcasts..

XX

Back to the news.. one of the pioneers of diabetes technology passed away this week. Helen Murray Free co-developed the dip-and-read diabetes test, a paper strip that detected glucose in urine.

She died on Saturday at the age of 98.  Before the invention of the dip-and-read test in 1956, technicians added chemicals to urine and then heated the mixture over a Bunsen burner. The test was inconvenient, and, because it could not distinguish glucose from other sugars, results were not very precise.

Ms. Free and her husband figured out how get strips of filter paper to turn blue when glucose was present. The test made it easier for clinicians to diagnose diabetes and cleared the way for home test kits, which enabled patients to monitor glucose on their own.

https://www.nytimes.com/2021/05/03/science/helen-murray-free-dead.html

And finally, big book launch this week – Chris Ruden is out with The Upper Hand: Leveraging limitations to turn adversity into advantage.

Chris is one of our favorite guests – he’s been on the podcast a couple of times. Chris was born with 2 fingers on his left hand and a shorter left arm. He was diagnosed with type 1 at age 19. He’s a champion power lifter – he’s been on the Titan Games and got a big hug from The Rock – and he’s out with a new book. Again it’s called The Upper Hand.. Congrats Chris!

XX

That’s our first Diabetes Connections – The News. I’m going to do this for about a month and see what the response is. If you like it, share it. And feel free to send me your news tips. Stacey @ diabetes dash connections dot com.

Please join me wherever you get podcasts for our next episode -Tuesday – we’re talking to the folks from Zealand Pharmacy about the newest shelf ready emergency glucagon -Zegalogue

Thanks and I’ll see you then!

May 4, 2021

It's hard to imagine having a child diagnosed with type 1 diabetes during the COVID pandemic. Most of us rely on community support and in-person meet ups and events to help support and guide us during that first year. But when you're diagnosed during a time of isolation and social distancing, what do you do?

Andrew & Emily Hollis join Stacey this week to share their story. Their toddler, Addison, was diagnosed a year ago, a time when only one parent could enter the hospital with her, due to COVID restrictions. The Hollis family connected with others online and even created a line of 3D printed items to help diabetes technology stick better on the body.

Deck my Diabetes website

Andrew testing Deck My Diabetes gear (video mentioned in the episode)

In Tell Me Something Good we're looking ahead to in person events

Chris Ruden's new book "The Upper Hand"

Stacey will speak at Camp Nejeda's Thrive & Survive event 

looking ahead to in person events and a new book to give you the upper hand.

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

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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 auto injector for very low blood sugar and by Dexcom help make knowledge your superpower with the Dexcom G6  continuous glucose monitoring system.

 

Announcer  0:24

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:29

This week, having a child diagnosed with type one during the pandemic happened to the Hollis family. Addy was just three years old. But her parents couldn't bring her to the hospital together because of COVID restrictions.

 

Andrew Hollis  0:43

We both walk into the ER, and there's the guard at the door and he's like only one adult. And I'm like, this is my kid. I need to be here. This is my daughter. But I also knew that my daughter needed her mom, and I want it to be there for my wife as well. And I know I've tried to put up a little bit of a fight and he's like no one adult,

 

Stacey Simms  0:59

Andrew and Emily Hollis join me to talk about their daughter's diagnosis, finding their way with diabetes during the last year in isolation and their product deck my diabetes. Oh, and chickens in Tell me something good. Looking ahead to in person events and a new book that'll help give you the upper hand. 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. We aim to educate and inspire about diabetes with a focus on people who use insulin. I'm host Stacey Simms, and my son Benny  was diagnosed more than 14 years ago, right before he turned two my husband lives with type two diabetes. I don't have diabetes, I have a background in broadcasting. And that's how you get this podcast. If you're a longtime listener, you know, I tell a lot of stories about how lucky we were when Benny was first diagnosed, we had a lot of positive experiences that can help set the tone. And you know, we already knew some families touched by type one. And we met a lot more in that first year in at person events. It's really hard for me to imagine having to do those first months that first year on social media alone. There was no social media at all back in 2006. So you know, it wouldn't have been an option then anyway.

But that is what happened to the Hollis family. Addy is now four. She was three when she was diagnosed back in May. I know a lot of families have had kids diagnosed during the pandemic, we have added quite a few to our local group. And I so admire their strength in dealing with all of this without family or friends who can help in person. Look, the truth is you don't have a choice parents of kids with diabetes. Or if you're an adult living with type one, you just have to jump in and get it done. And the Hollis family did that. But they also found a way to fill a need helping keep gear sticking better with their product with Deck my diabetes. We'll talk about all of that coming up. As always, there is a transcript at Diabetes connections.com and I would really appreciate it if you have a moment to share the podcast if you haven't done that in a while. And you know new people with type one you think they'd enjoyed this episode are some of them are tech focused episodes, please share the podcast that is really the best way to help more people find it. Reviews are nice, but word of mouth from you is a lot better.

Alright, 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 why I love partnering with people who take the load off on things like ordering supplies, so I can really 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. Dario’s published Studies demonstrate high impact clinical results. Find out more go to mydario.com forward slash Diabetes Connections.

Andrew and Emily, thank you so much for coming on the show. Welcome. I'm glad to have you here.

 

Andre & Emily Hollis: 4:21

Thank you for having me.

 

Stacey Simms  4:22

Yeah, we've got a lot to talk about today. I guess we're going to talk about chickens too, at some point. Andrew, I'll start with you. Your daughter was diagnosed just in the last year. Tell us the story.

 

Andrew Hollis  4:35

Sure. So leading up to diagnosis. My wife Emily, she actually noticed some things in in our daughter and it's got to be the mom thing. You know, she was saying, hey, she's eating a lot. she's drinking a lot and I always chalked it up to she's growing. I mean, there's no history, family history on either side for type one. So we really didn't cross that bridge until maybe three or four weeks into it. And she said, Hey, I did some research on Google. And she might have diabetes, and I was in total denial. And it wasn't until in May, I was at work, my wife sent me a photo of my daughter. And you could just tell she was dehydrated circles around her eyes, white skin, super tired complaining about her legs hurting. And when I got that photo, I immediately called her and said, pack her up. I'm headed home, we're going to the doctors, see if they can get us in today. And our pediatrician got us in almost immediately. It was a Sunday, so it was kind of an off day for them. And we showed up there, they checked her blood sugar and said, go directly to the hospital, do not pass go do not collect $200 go home. My daughter didn't even have shoes on. We were barefoot. We were not prepared. We just rushed directly to the hospital.

 

Stacey Simms  5:48

Emily, let me ask you, What had you noticed? I mean, it sounds like all of the signs were there. And like most of us, you know, it takes a while until you really let all that sink in and go to the doctor.

 

Emily Hollis  6:00

You know, I'd call family members and said, you know, something's not right. She's not acting right. She doesn't want to walk in a chicken coop in the morning to let him out. He says carry me. You know, it was just, I knew something was wrong. But I was a little bit of denial as well. Like, I don't want it to be diabetes. And with no family history, I kept telling myself well, you know, maybe she's just studying a flu bug or something. You know, we had COVID going around, and we had been quarantined since beginning of March. And here it is May. And I'm like, it's probably nothing, but we're gonna take her in anyways. And then when they finally told me it was just like the whole world just, you know, came crashing down.

 

Stacey Simms  6:33

Yeah. Did they test her for COVID? At any point? No, they

 

Emily Hollis  6:36

did not. Because she never ran a fever. She never had like, any congestion or anything like that. It was just strictly the, you know, let's go potty every five seconds and, you know, drink 30 gallons of water, it seemed like and let you know, it was just non stop. And I was, you know, to the point of frustration I felt bad for but then it's like, after we got the diagnosis, I was like, you know, I probably should have taken her in sooner. Even though the doctors assured me that we got her in there just in the nick of time.

 

Stacey Simms  7:04

I think we all feel like we should have gotten our kids in there sooner. I have friends who are nurse, right? You know, I have friends who have type one themselves. And that denial is a very, very strong thing. And we just we don't want to think that it can happen to us. So then you're in the hospital. Did you do the basic training there? You know, three days was she at a danger pretty quickly, Andrew.

 

Andrew Hollis  7:24

So we get to the hospital in what was interesting is being in COVID, lockdown, we both walk into the ER, and there's a guard at the door. And he's like only one adult. And I'm like, this is my kid, I need to be here. This is my daughter. But I also knew that my daughter needed her mom. And I wanted to be there for my wife as well. And I know I've tried to put up a little bit of a fight and he's like, no one, one adult. So my wife went in through the ER entrance. And when they finally got settled in a room she called me and I've been sitting in the parking lot now for almost two hours just worrying my head off just not sure what's going on. And calling friends and family and just about in tears. You know, I'm just telling them, pray, pray hard, because I don't know what's going on with Addy. But we're at the ER, she ended up calling me and said, Hey, they're saying one adult. But bill let us trade off one time per day. The plan at that point was basically to have her spend the nights with my daughter. And then I would give her the reprieve time during the day to go home and sleep and get a shower. We didn't have any clothes with us at the time. So I ran home and started packing an overnight bag and had to hand deliver that to the guard at the front. And then he walked it up to the room for her. It was really interesting to have to take that answer of No, you cannot enter and just have to wonder what's happening. Fortunately, with technology, we're able to FaceTime we were able to talk. And we had a fantastic nursing staff there who actually bent the rules a little bit and said, If you happen to be passing each other in the room, and it takes an hour or two. Oh, that's okay.

 

Stacey Simms  8:50

That's fantastic. I thought that I was thinking more about COVID after you got home and not being able to be part of an in person diabetes community, but holy cow, you know, to be able to live together.

 

Andrew Hollis  9:02

Yeah, it was very difficult. Like I said, when we were passing in the room, that's when the nurses took the opportunity to do training with us. Yeah. And so that worked out really well. We actually ended up several days there. I think she was in the hospital for almost four days, when they were doing the training, we kind of stretched that time to be almost three to four hours together. And we would go home, get a shower, get a couple hours of sleep and come back after dinner and then take over for the night shift.

 

Stacey Simms  9:28

Emily, What do you remember about that time? I mean, learning about diabetes is so overwhelming. I have like some bits and pieces but the whole thing still seems like a blur.

 

Emily Hollis  9:37

Yeah, I agree. It was long. It was very long. You know just in and out and then you know at night it's like this when I it kind of reminded me a little bit of when I was in the hospital having episodes like you're trying to sleep, they're out poking and prodding you every seems like every five minutes. You're like, you know, this child's gone through enough. Leave her alone for an hour. So you don't really get any rest just like I said like labor and delivery. You don't get anywhere. I've been in hospital. And that was very stressful. You would cry for a dad, he couldn't come up there. And then it I mean, overwhelming. It's just very, it was very overwhelming. Yeah, it's a ton of information. They want you to read all these books and all these pamphlets, and you have gotten zero sleep, you're dealing with a child that, you know, does wants mom and doesn't understand what's going on. Why am I getting poked in the fingers? And why am I getting poked in the toes, and I'm trying to sleep and it was very hard, you know, looking back now, she doesn't really remember a whole lot of that today, which is kind of a good thing. I kind of find that as an answer prayer, because she doesn't remember that traumatic time that she had.

 

Stacey Simms  10:38

Andrew, do you could speak a little bit to about the the overwhelming amount of information, I'd love to hear your take on that.

 

Andrew Hollis  10:43

Because I was on the day shift, you know, washing machine, my daughter during the day, I got a lot of interaction with the nurses that were more than just, hey, let me check her blood sugar and make sure she's okay and fix the IV. And there was a lot of conversation, when they presented us with a book and said, Hey, you start reading this, this is good information. And between, you know, the things going on in the hospital, there's no way you can get enough reading and I tried to sit down and read through a chapter and just the medical terminology that's dropped down you having no history for diabetes, and you're learning about aka and you're learning about how to manage blood sugars and how to check blood sugars and what insulin does and how insulin works and how your pancreas is supposed to function. And how a diabetic pancreas maybe doesn't function all the way or at all, and you start getting all of this information piled on you. And then they're like, hey, in two days, you're going home, and you've got to do this and you become almost panicked because you're like, how am I going to manage and I'm sure every diabetic parents been there how am I going to manage this I've had three days crash course on how to be this kid's pancreas and I was not designed to be a pancreas. Definitely was overwhelming and scary. Very scary.

 

Stacey Simms  11:50

Emily take me through when you went home. What was that like?

 

Right back to Emily and Andrew but first Diabetes Connections is brought to you by Gvoke Hypopen and you know, low blood sugar feels horrible, you get shaky get sweaty, even feel like you're gonna pass out there are a lot of symptoms that can be different for everyone. I am so glad we have a different option to treat very low blood sugar gvoke hypo pen, it's the first auto injector to treat very low blood sugar Gvoke Hypopen is pre mixed and ready to go with no visible needle before Gvoke, People needed to go through a lot of steps to get glucagon treatments ready to be used. And this made emergency situations even more challenging and stressful. This is so much better. I'm grateful we have it on hand, find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit gvoke glucagon.com slash risk.

Now back to Emily. And I was asking her about going home from the hospital.

 

Emily Hollis  12:58

Well, we actually got to go home the day before my birthday. So that was I was like Addy can't tell the nurses I have to be home for about a birthday. I'm like, Okay, well, we can probably work that out. So we got home. And at that time, she was not on a Dexcom or a pump or anything. She was dealing with a lot of highs more than lows at this point. We're still trying to get her out of the two hundreds and move at home to hospitals. So it was a lot of finger poking and crying and screaming and I don't want a shout out and it was very hard. Nobody likes poking their kids, you know, you have to hold them down. And it's just, it's a lot of a lot of stress. But you try to stay calm and just reassure them that it's for their good you're doing this to help them until they got the Dexcom I didn't get any sleep because you're just constantly worrying about their sugar. Okay, is she gonna wake up is she gonna pass out?

 

Andrew Hollis  13:47

Probably a week and a half after diagnosis. We were driving down the road and daddy goes, there's a sale out there. Okay, we'll put our mask on. We're Let's go, you know, COVID we nobody really knew a whole lot about it. So it will keep social distancing. But we'll check out this garage sale. It turns out that couple had raised a daughter with type one. And unfortunately, they gave us their horror story about her going into seizures in the middle of the night. And that's how they induce you below and we're like a week and a half into it.

 

Unknown Speaker  14:15

Oh my god,

 

Unknown Speaker  14:16

it made us panic. That did not help us understand and feel better.

 

Stacey Simms  14:21

Oh, you know, I say all the time. We were the luckiest people ever. Because it's the stories that you hear in those first weeks that set the tone. And oh my god, how scary is that?

 

Emily Hollis  14:33

Yeah, my daughter is sitting there listening to the story as she's holding the course. Yeah, like she's looking there and her sugar is going up because he's getting you know she's getting anxiety over this. Yeah, like we gotta go we got somewhere to be

 

Stacey Simms  14:46

your home. you're figuring things out. I always tell people the first two weeks of us being home was the worst and then after two weeks ago immediately really almost got better that quickly. He was okay with. He was always okay with finger sticks, but he got okay with the shots like it. really got better quickly, although it's, you know, it's still scary and, and stressful? Did it work out more quickly than you had expected? Or was it more difficult for those first few months?

 

Andrew Hollis  15:09

I think we both found out that children are very resilient. And Addy definitely picked up on things very quickly and understood. You know, after about a week, she kind of understood, okay, this is going to happen. And the finger pokes got a little bit easier. She was always worried about the hospital lancets they were using adult, they were using the adult land sets, which are massive on those little fingers. There's no real estate there and a three year old, the one that we ended up getting from the pharmacy worked a lot better was a lot smaller, wasn't nearly as deep. And so she kind of gave into that really quick. But being on MDI with the shots, the injections, we kind of took turns, giving it until there was a day that I actually hit one of the nerves in her leg. And she jumped through the roof. And I think it traumatized me more than traumatized her. I mean, I I walked away knowing that I just hurt my daughter. And that's not something you want to do. And ever since then she's been like, Dad, you can do it, but only if mom's not around, because mom does it better. Right? So, so I think, you know, she gave into things definitely we get in a routine and and since we started this journey, we've made friends with a lot of people through social media, that has also just began their journey. And some of them that have only been a week or two weeks when we finally get to talk to them. And we try to encourage them and let them know, you will get in a routine and you will develop new daily routine very quickly. And it will become second nature. Before you know it, it won't be this big, scary thing looming anymore. You'll know, okay, we're going to eat, we're going to check your blood sugar, and we're going to give you your your insulin, and then you can go eat, and everything's gonna be okay. And we're going to go on throughout our day, and it's becomes the new normal, and it happens so fast. Literally, within three weeks of being home in the hospital, we were already very comfortable and starting to teach our friends and family. If something were to happen, we're not around, this is what you need to do. Emily,

 

Stacey Simms  17:01

I've looked at your perspective, I know you don't have a different one. But to me going through COVID isolation with a child with type one newly diagnosed, I see this in my local group too, it's going to be very difficult, because one of the things that really sustained me was beating up with families that had been doing this for a long time, like meeting in person. It sounds like you were able to form at least an online community or talk to other people. What does happen? Like,

 

Emily Hollis  17:26

yeah, I mean, I am a people person. So it was it was very difficult. I mean, very difficult. But I mean, if it wasn't for social media, I think it would have been a whole different story. You know, I've met, I can't even count, you know how many families I've met have parents that are going through the same thing. And I'm just very thankful for the social media groups that I've made friendships with other families that we've been able to help and, you know, we sent care packages, and you know, different things like that adding mixed pictures for different people. And, you know, she really enjoys knowing that there's other people out there like her and she's not the only one.

 

Stacey Simms  18:01

Alright, so let's talk about Dec my diabetes. It's amazing to me, I spent the first year of my son's diagnosis, basically, with my head down going, what the heck, how am I going to do this? You know, I'm trying to be a mom, and I'm trying to work and I'm trying to, you know, I have two kids. And I've talked to a couple of people in the last year who said, My child is really diagnosed, and I'm going to create this new thing that's going to help all these other people into how did you get this idea? How did this come about?

 

Andrew Hollis  18:25

Well, prior to diagnosis, I had bought a 3d printer kind of as a hobby. And my brother started a small business, he allowed me to make some items for him. And he was actually my first customer who paid off my machine. So that was really nice. But what ended up happening after we were on Dexcom, we noticed that we needed an overlay patch with an active child and the first patches we tried, they just stuck to her skin so well, that getting them off at the end of a cycle. It was a screaming fit, it would take us 1520 minutes just to get the overlay off before we can even start on the Dexcom itself. In one of the sites in the forums that I'm part of for 3d print communities, somebody had created a very similar feel to what we now offer. And so we printed one and tried it and it worked out really well. Emily posted it on one of the diabetic Facebook pages and people were like, Hey, we're waiting on ours. It's taken forever shippings backed up because of COVID. Can you make one? So we made a few and realize, man, people actually need these and they can't get them maybe we can fill a gap. So I contacted the owner of that particular file and said hey, you know, you've released it under copyright law, and I need your permission in order to formally sell these. I'm asking for permission and after some discussion, the fly ultimately came back and he said make your own. So we did and we we created what I believe is a better mousetrap. It fits better it's contoured to fit the Dexcom and that was the first product right was our G6  shield. What we've noticed is that the market there are people that are making similar things but they are awfully expensive. Have, we were able to cut some of our competitors prices almost in half. Because we don't need to make a million dollars, we really want to help people, we need to cover our costs and our shipping. So that's where it started. And from there kind of spooled because we had requests for Omni pod covers that are similar design. People want to deliver a cover that's a similar design to that. And actually, we just finished designing and we'll be releasing this week, sometime and I port cover that will help children with I ports help keep them in place. Because let's face it, diabetic equipment is very expensive. We can't afford to be knocking them off or having them fall off early.

 

Stacey Simms  20:36

Yeah, and I should just mention, if you don't know as you listen, when an eye port is, I wish I had found this earlier because my son did we did shots. We did MDI for the first six months. And I port is, I believe, a Medtronic product. And it's not always covered by insurance. I did a lot of research. Andrea, Emily, when I published my book, this is one of the things I mentioned in it. It's basically a pump site, it goes in the same way as a pump and said, you know, the needle goes in the needle comes out, the calculus stays below, it's a little teeny sticker, but then you put shots through it, instead of feeling the shot go in basically, it makes it so much easier. It's a little bit more precise, I think I'm giving a review of someone who has never used it just from what I've heard. But that's a really interesting bit to make this technology for. And Andrew, tell me a little bit about what it does, because you mentioned this the stickiness of some of the other overlays. This stays on, but it's not super sticky.

 

Andrew Hollis  21:27

Correct. Our covers are designed to meet three main goals. The first goal is to provide a shield between an overlay patch and the device itself with the intent of being able to change an overlay patch without risking removing the device on accident. So if you're mid cycle, and you need to change that patch, because it's just starting to look ratty or falling off, it will allow you to remove the patch without accidentally peeling up the adhesive of the device you're wearing. So that's the first thing that we wanted to accomplish with it. The second thing is to help provide bump protection. I cannot tell you the number of people that bump their device on a doorway or when they're putting their shirt on and they rip it off. There are our devices have sidewalls that cover the Dexcom the lever a the Omni pod, they're contoured to help deflect some of that impact and help things glands off of them. In fact, I just released not too long ago, a promo video showing all three of those devices on an arm where I'm smashing it against the doorframe as hard as I can actually bruised my arm trying to get it to knock off and they don't come off.

 

Stacey Simms  22:32

I am laughing because I watched that video. And I wanted to ask you if you hurt yourself, because and I'll link it up. You have to see it. He's just boom, boom, boom, boom into the door jamb.

 

Unknown Speaker  22:44

That's gonna be painful. Yeah, I'm

 

Emily Hollis  22:46

gonna add in there apart. The Addison was yelling from the end of the house, she said, makes her death. Okay, you did? They're banging his arm on something.

 

Unknown Speaker  22:55

Yeah, yeah. That's great.

 

Andrew Hollis  22:58

Really. Yeah, they do work. The third thing that our covers do, and this is really what our mission is. If you look at our logo, it says deck my diabetes deck out and show off. We wanted there to be something fun and colorful that you can add to your medical device that makes you feel comfortable about showing people my daughter was afraid of going out in public with her Dexcom she did not want to go to our family get together, she did not want to have a birthday party. She did not want people to see it because she thought she was different. And we tried to explain to her you're different, but it's not. It's a good different. You have something this thing here saves your life. And helps you understand what your diabetic track is. Being a three year old, she just didn't get it. So we put that cover on. She was suddenly like, wait, I could pick a cover. And I get to pick a patch, I get to accessorize. And she was all about putting it on. And then once she had those the patch on and the cover on, she was showing everybody look at this, look at my Dexcom Look at my cover, my dad made it for me it's purple or pink or whatever color she wears that week. And so those are the three main goals that we have for our products to help you change the overlay patches if you need to, to protect your device and to be comfortable wearing it to be able to assess arise and show off what you have the technology we have that ultimately makes life a lot easier.

 

Stacey Simms  24:18

As you look ahead. You are coming up on one year of your your diversity. The Addison Emily, let me ask you, what would you say to yourself a year ago, you know, how do you think you're doing?

 

Emily Hollis  24:31

Actually it's gone by very fast. And if you were to ask me, you know the dailies, the hospital, can you do this? No. You know, it's like, No, I can't do this. Why are you sending me home already? But I mean, it's just part of our life. It's just a normal everyday thing. Now,

 

Andrew Hollis  24:46

you know, if I if I could talk to myself a year ago, I would have said keep calm guys got this. Hang on. Life will become normal again soon. You know, it's hard to express how far we've come and feeling more comfortable with Dealing with this disease and understanding more about it. I did not know when she was diagnosed that I was going to have to wear so many hats. And now I'm partially her pancreas. I'm a data analyzer to help Emily make decisions based on trending data what we need to do with insulin. I'm a dietician now, right? I have to look at every label. If you're not diabetic or not family of a diabetic, you don't understand that you're looking at every label trying to understand what's in it, what's the carb count? What's this gonna do to her blood sugar, and then you realize it becomes normal. I probably look like a crazy guy in the grocery store picking stuff up now. But every, every time I'm looking at the label and reading it, and I'm calculating in my head, what's this going to do? Is this worth having to bump that extra insulin or maybe fight that high? But I would tell myself, it will be normal. Soon, it will become the new norm. Just hang in there.

 

Stacey Simms  25:47

Who wants to tell me about the chickens? 2022 chickens.

 

Emily Hollis  25:52

Yeah, we have 22 chickens. I always throw around a farm. My grandparents had a farm growing up. I'm an animal lover, Addison. You know, she take any animal and if she could, is on the hunt for a unicorn, so if anybody ever sees one of those, she really wants a pet unicorn. One day, she said there might be one that shows up, but we'll see how that works. Anyways, yeah, I mean, we do it as a hobby. It's, you know, it's fun to watch. We, you know, have the eggs that sell the friends and family. And this is something that I don't know, it's relaxing. I know that kind of sounds weird. But I find it relaxing to watch the chickens and go out there and seeing them. And right now we have 10 baby chicks that we just actually took out to the coop yesterday. They're about six weeks old. So we're all introduced them in a couple weeks to the old hens.

 

Stacey Simms  26:40

Do you get eggs from them? I mean, I assume?

 

Emily Hollis  26:42

Yeah, we do we get the eggs from them. It's nothing like farm fresh eggs. If you've never tried them, you'll never buy wheat. Or again,

 

Andrew Hollis  26:49

we like to say that if you own chickens, you'll understand chicken math. So we started with, I think six chickens, and rapidly that grew to 10. And then we realized we needed a bigger coop. So I searched around and found an old shed and converted it into a coop and we needed a bigger run. And then we had 20. And since then we've rotated out some of the older chickens that aren't laying anymore and brought in these new chicks. But she's Emily's already said she wants more and like, we just don't have this space. And I can't build another coop overnight. So we'll have to table that for a little bit. All right,

 

Stacey Simms  27:21

I you will know that I am definitely not a farm type person. Does anybody eat the chickens themselves? Or is this just eggs pets? For me a horrible person for asking this?

 

Andrew Hollis  27:31

No, there are, there are definitely people who will eat a laying chicken after they've stopped laying or slowed down to a point where there there's virtually no egg production. We don't mainly because we see our chickens as pets. The other thing to think about is the older an older animal get, the tougher the meat will be so a four or five year old chicken is not necessarily something like the rotisserie chicken to pick up from the grocery store. So part of our journey in creating our business is we've developed a lot of really good partnerships, and a lot of good friendships, right. So when you're in the business, you're looking at other things, and you're getting feedback from other people. And one of the other businesses that's out there actually has become really good friends of ours. And they're based out of Texas. They're called the sugar patch. And they provide overlay patches that they manufacture out of their home, the owner, she is a type one diabetic. And we have actually just recently partnered with them to be able to sell some of their patches through our site. So you can come and get a cover and a patch that fits without actually having to do any trim or anything else. But there are other partnerships that we are in talks with right now with other diabetic families that have started businesses because of their child's diagnosis or their diagnosis. We are trying to leverage some of the larger community to be able to help each other, advertise for each other or being able to put in a little Facebook post for each other. Because to me, it makes more sense to support a diabetic family than maybe to support a larger conglomerate that just produces for the money. Yeah.

 

Stacey Simms  29:07

Well, Andrew, Emily, thank you so much for joining me. It was great to hear your story. Again. I can't imagine having a child diagnosed during the last year where you couldn't, you know, see people in person, but it sounds like you've really found a community and I'm so glad for that. But thank you so much for joining me. I appreciate it.

 

Andrew Hollis  29:24

Well, thank you so much for having us on. We had a fun time.

 

Emily Hollis  29:26

Thank you so much.

 

Announcer  29:33

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  29:38

I will link up information about deck my diabetes. And of course that video that we've mentioned, where Andrew is slamming his arm into the door jamb to show you the strength of the product there. I'll link that up as well. If you've listened for a long time, you know that chickens just kind of seem to come up. I always have dumb questions about chickens. That's not my life experience. I'm not going to ever be a person Some who has chickens in my backyard, just a different way of living. That's all.

Okay, tell me something good is coming up. But first Diabetes Connections is brought to you by Dexcom. And we have been using the Dexcom system since Benny was nine years old. We started with Dexcom back in December 2013. And the system just keeps getting better. The Dexcom G6 is FDA permitted for no finger sticks for calibration and diabetes treatment decisions, you can share with up to 10 people from your smart device. The G6 has 10 day sensor where the applicator so easy, I haven't done one insertion. Since we got it Benny does them all himself, which is a big change from the previous versions. He's a busy kid, knowing he can just take a quick glance at his blood glucose numbers to make better treatment decisions is really reassuring. Of course, we still love the alerts and alarms, and that we can set them how we want if your glucose orders 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 connections.com and click on the Dexcom logo.

 

It's time for Tell me something good. And I want to give a big congratulations to Chris Rutan. Many of you are very familiar with Chris. He lives with type one. He was born with a much shorter left arm and only two fingers on his left hand. He has shared on this show that he hid his disability for years and years and never wanted to take his hand out of his pocket even. But he is now a motivational speaker. He is just a champion in our community. He was on the Titan games. And he's been all over the place. He was just profiled recently in men's health. And today, his book comes out. It's being released today on Amazon and everywhere. And it is called the upper hand leveraging limitations to turn adversity into advantage. I love a good book title. And that really is fantastic. So congratulations to Chris, I will link up to the book. I haven't read it yet, at least not as of this taping, I will probably circle back with him and have him on the show again, because he's just always a fantastic guest. And he's just a fantastic person.

He also has the best sense of humor, as you can tell by his book title. But at friends for life a couple of years ago, it was either 2018 or 2019. He was taking pictures with kids. He has a really cool looking prosthetic arm. And he would take it off and he would take the hand off and he would pose in crazy positions and put like have you hold it I'll have to link these pictures up or put them in the Facebook group. It's funnier for the kids. I look like such a ding dong. But it's amazing how he goes out of his way to make you comfortable. And he suddenly hero in our community. He's a hero in places like the lucky Finn project, which is a nonprofit organization that helps raise awareness and celebrates people born with limb differences. And you know why lucky Finn, if you've seen Finding Nemo, you know, Nemo has a lucky fin one is smaller than the other. And that doesn't really stop him from what he wants to do. It's a great organization. And I've only learned about it because of Chris. Congrats again, Chris, the book is the upper hand. And I'm sure you'll be hearing a lot about it.

In other Tell me something good news, friends for life is going to be in person in July, the largest family diabetes conference in the country is back it is going to be different, of course, because even though we're getting back to normal, we're certainly not there yet. And for people with diabetes, CDC and others have different guidelines. But there is a lot of information now at children with diabetes calm, I will link that up in the show notes as well, as you're listening, a lot of the kids groups are likely full because they really had to cut down on attendance, there is a lot of new health and safety requirements and information. But if you're at all interested, definitely check it out my understanding and I'm not part of children with diabetes, the organization that runs this or friends for life, although I'm a big fan, and I go every year, and I've spoken quite a bit. My understanding is that as we get closer, if the requirements change, if Disney's guidelines change, they may be able to open it up to more people. And as a personal aside, I think this is going to be the experience of a lot of these programs. And our local diabetes camp is planning to open with half capacity but has a waiting list because they're hoping as they get closer, the restrictions will start to be lifted. So who knows. But let's be optimistic. And if you've got an in person event happening, let me know this summer this fall. I mean, we're gonna be seeing so many more things open up. Oh my gosh, I know it's gonna take a while and we want to be cautious, but I'm getting really excited. So that's my Tell me something good. I am planning to go back to friends for life this year. I don't know about what the speaker situation is yet. I may have it sorted by the time this episode airs. But as of this taping, My plan is to be one of the vendors again, I absolutely love being part of the conference. And I think that's where I'm gonna start talking about book number two. So I will keep you posted. But that's the goal right now I have a good idea but I need your help for the world's worst diabetes mom Park. To do or whatever we're going to call it. If you haven't told me something good story or an in person event, you know, all that's all the same right now to me, please let me know Stacy at Diabetes connections.com or post on social media, join the Facebook group. And we will let everybody know about your good news.

 

Hey, before I let you go couple of events to tell you about still virtual but lots of fun, survive and thrive boot camp is happening. This is for adults with type one. And this is a camp Nejeda or the program of Camp Nejeda. We are not there in person yet, which is a fantastic diabetes program in New Jersey, which just as a coincidence, my cousin who lives with type one, he went to this diabetes camp growing up Saturday, June 5, bunch of sessions about living with type one, learning about the latest and greatest in technology and mental health. I'm doing a session on advocacy. And it's not really on traditional advocacy. It's more about sharing your story sharing your voice. Why yet all there are it's a crowded field. Right? Everybody's got a story. There's five bajillion influencers now, but why your story is still really important. And I want to talk to you about sharing it and getting the word out and that kind of thing, what media looks for to we're going to talk about that how to share your story to the media, traditional and not so traditional. So I hope you can join me for that I will link it up.

Also, if you're a podcast person, if you're interested in podcasting, I will be speaking at pod fest a master class, the second week of May, I am doing a whole session about ethics in podcasting. And I'm so excited. I have been pitching this for years and somebody finally took me up on it. So we're gonna be talking about ethics. It's gonna be so fun for me. I'm excited about it. I have a free promo code if you would like to join masterclass, and this is again, a virtual podcasting conference. It's not about diabetes, just let me know and I will DM you the promo code. Okay, I think we're good. thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I appreciate each and every one of you. It is we're having about six years of the show. And I still am just so excited to produce the show and bring it to you every week. So thank you for being here. I'm Stacey Simms. I'll see you back here in a couple of days. Until then, be kind to yourself.

 

Benny  37:22

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

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