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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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Diabetes Connections with Stacey Simms Type 1 Diabetes
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Now displaying: February, 2022
Feb 25, 2022

It’s “In the News…” Got a few minutes? Get caught up! Top stories this week include: a look at Vitamin D in newly diagnosed kids with type 1, new study about bariatric surgery, type 2 and COVID, endos are the top specialty adopting telehealth and a look at a new movie about type 1 - find out why it also has backing from the Star Trek community!

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Join us LIVE every Wednesday at 4:30pm EST

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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Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

OMNIPOD

DEXCOM

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days. If you’re new we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast.
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Looking to get organized? Diabetes supplies can really add up and all that pump and CGM stuff or even shots and wipes and strips can clutter everything up. I’ve got a great new guide to help you out. It’ll get you started and keep you organized. That’s totally free and it’s over on the podcast homepage.
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A new study adds to the idea that Vitamin D might help with type 1 diabetes in kids. These researchers look at young people ages 10-21 and found that a supplement of Vitamin D2 may improve insulin sensitivity and slow the increase of A1C for those newly diagnosed. This was over the course of a year. Very small study, fewer than 40 kids and teens, and all of them diagnosed for three months or less. A lot more to learn here.. but the study is in the Journal of the Endocrine Society.
https://www.healio.com/news/endocrinology/20220221/vitamin-d2-supplement-may-slow-progression-of-newonset-type-1-diabetes-in-children
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This is more business news.. but something to keep an eye on.. RosVivo has signed with Eli Lilly for commercial development. Rosvivo has a drug said to be a game changer to treat diabetes and obesity. Lilly will now review and move it forward. The drug is said to restore the function of beta cells that secrete insulin, the cause of diabetes, and at the same time lowering insulin resistance. Animal studies only but we’re keeping an eye on this one.
https://finance.yahoo.com/news/rosvivo-therapeutics-inc-signed-material-125200372.html
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Provention Bio has resubmitted the Biologics License Application (BLA) for teplizumab. This is the drug that shows a delay of clinical type 1 diabetes for three years. The FDA said “no” last year.. but it did so in a way that left the door open, so Provention has done what’s been asked and is now resubmitting. The CEO says quote - “We continue to proceed with a sense of urgency, recognizing that significant unmet need exists for patients and their caregivers.”
https://www.empr.com/home/news/drugs-in-the-pipeline/provention-bio-resubmits-bla-for-teplizumab-to-delay-type-1-diabetes/
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The link between high blood pressure and diabetes seems to come down to a small protein cell. An international team shows this glucagon like peptide called GLP-1 pairs up the body’s control of blood sugar and blood pressure. Doctors have known for a long time that high blood pressure and diabetes go together, but this is the first time the reason for that has been found in the body. GLP-1 is released from the wall of the gut after eating. It also stimulates a small sensory organ in the neck. These researchers say GLP-1 is just the start for more study.
https://scitechdaily.com/long-standing-enigma-finally-cracked-link-discovered-between-high-blood-pressure-and-diabetes/
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More support for bariatric surgery as a treatment for type 2 diabetes. A study found that adults with obesity who had weight loss surgery and achieved “substantial weight loss” before contracting COVID reduced their risk for severe infection by 60% compared to those who didn’t have surgery. The study was conducted by researchers at the Cleveland Clinic. Previous studies have found that in obese patients with type 2, bariatric surgery sends it into remission more than 75% percent of cases.
https://blogs.bcm.edu/2022/02/21/bariatric-surgery-helps-with-diabetes-leads-to-better-covid-outcomes-study-finds/
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Throughout the COVID 19 pandemic, endocrinologists have had the highest rates of… telehealth adoption. This study released by Doximity – we’ve spoken to them on the show – looked at telehealth claims from January 2020 to June of 2021. As expected, younger physicians used telehealth more than their older counterparts. And they say the research shows that telehealth can successfully help manage diabetes – and that it even lowers A1C in people with type 2. They don’t say why.. but I’d think it’s because it’s easier to get a visit in remotely. Interestingly they also did a top five for metro areas with the highest telehealth adoption. They were: Boston, Baltimore, Charlotte, Philly and San Francisco.
https://mhealthintelligence.com/news/telehealth-adoption-highest-among-diabetes-gi-care-providers
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The World Health Organization is looking for people living with diabetes for an international focus group. They say they hope to foster solidarity and policy action between people living with diabetes, while acknowledging and highlighting differences in treatment and management needs between different types of diabetes. The focus group will be held March 9 and 10 live and online. We’ve linked up the survey you need to fill out to be considered.
https://extranet.who.int/dataformv3/index.php/257838?lang=en
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An ambitious project to make a movie about type 1 diabetes in a dystopian world is moving along via kickstarter. Noah Averbach-Katz is an actor and writer and has lived with type 1 for more than 20 years. He says too often a disabled person is reduced to a plot point - a problem that gives the abled hero an opportunity to save the day. He wants to tell a story that captures the fears, trials, and experiences of a Type 1 diabetic. The Star Trek community is rallying behind this – Averback Katz and his wife Mary Wiseman are both part of the Star Trek Discovery series. The kickstarter goes until March 24th.
https://www.kickstarter.com/projects/noahak/type-1
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As we hinted last week, Omnipod has a fun crossover with Nintendo. The very popular Switch game, Animal Crossing now has a new diabetes-themed designed by Insulet. It’s known as Omnipod Bay, you add it to the game with a special code. Omnipod Bay features booths from selected diabetes charities as well outfits, diabetes supply bags and diabetes-themed areas and activities. I asked – no little podcast headphone as of this time! The game add-on comes just two weeks after Insulet’s Omnipod 5, was cleared by the FDA.
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Our long format episode this week is with the Lauren Bongiorno, a diabetes health coach who is a terrific example of why it’s not a great idea to aim for perfect with diabetes. She shares how her A1C was basically perfect during college but that she… was miserable. And next week.. all about Eversense, the 6 month CGM.
Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Feb 22, 2022

Lauren Bongiorno was diagnosed with type 1 as a child and growing up, she showed every sign of success. She was a division one athlete, playing soccer in college and achieved the lowest A1C her endo had seen in a college student.. but while her care team celebrated that 5.7, she was miserable.

Lauren shares how she took control and got that happiness back. She’s now a Diabetes Coach at her company, Risely. We talk about some common pitfalls, the pressure to be perfect and what coaching really means.
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!
-----

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

OMNIPOD

DEXCOM

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Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921 Where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, Lauren Bongiorno was diagnosed with type one as a child and growing up she showed every sign of success. She was a division one athlete playing soccer in college and achieved the lowest A1C her endo had ever seen in a college kid. But while her care team celebrated, she was miserable.

Lauren Bongiorno 0:41
And I was sitting there and it was like literally an out of body experience because I'm watching like the doctor, high five, my mom and my five each other and I was like, I'm not happy, I'm not happy.

Stacey Simms 0:52
Lauren shares how she took control and got that happiness back. She's now a diabetes coach. We talk about some common pitfalls, the pressure to be perfect and what coaching really means. 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. As I'm taping the intro to this episode. I am like you sifting through some FDA approvals these seem to be coming in fast and furious now or at least as fast and furious as the FDA does anything. But after a very long logjam, you know, this is all stopped up by COVID. It really seems like things are moving along. So to that end, this episode will not focus on tandems mobile bolus, which was just approved, you know, bolus by phone or the ever since CGM 180 day where approval. Those were the two biggies over the last week. And I am going to focus on them in upcoming episodes ever since should actually be next week. And Tandem a couple of weeks after that. As always, if you'd like to get your questions asked please join us in the Facebook group Diabetes Connections, the group if you're not on Facebook, no problem. Shoot me an email Stacey at diabetes connections.com. I have my own set of questions. But I always want to hear from you. And your questions are always fantastic. So please send them in.
But there is a lot more to diabetes than technology. You all know that. And I wanted to share Lauren Bongiorno’s story, because I think this really resonates for parents of kids with type one. And for adults with diabetes, nobody's harder on us than we are on ourselves, right and the pursuit of perfection. It's just gonna mess you up. I'll let Lauren share her story. But just for background, She is the CEO and head coach at a company she founded called Risely that's a bit of a play on how in diabetes arise isn't a good thing. You know, an arrow up on your CGM, a higher A1C , their website says type 1 diabetes has given rise a bad reputation. But we think it's time we reclaim it. I think that's really clever. And I think this is the first time I've spoken with a health coach on the show. So we talk about what exactly that is, and why somebody would choose to work with a coach along with a medical provider. Here's my talk with Lauren Bongiorno.

Lauren, thanks for spending some time with me and my listeners. I'm so excited to talk to you.

Lauren Bongiorno 3:33
Oh, thank you so much for having me on. Stacey. I'm so looking forward to this conversation. Yeah, I

Stacey Simms 3:38
feel like I've we've connected and I've seen you, you know, all over social media. So I'm, I'm really excited to kind of hear more of your story and share your experiences. Because just the little bit that I know, I feel like you're kind of the embodiment of why perfect doesn't always work out with diabetes, if I could say that.

Lauren Bongiorno 3:56
Yeah, I think you can say that. And it's so interesting, because I think that if there's one thread of my entire life that I can really look at, it's this striving for perfection, and then getting too close to perfect and realizing, Oh, wait, this is not what I wanted. So definitely applies to diabetes, for sure.

Stacey Simms 4:17
Well, let's back up and explain what we're talking about here. Let's start closer to the beginning. You were diagnosed at age seven. Do you remember any of that?

Lauren Bongiorno 4:24
Yeah, I definitely remember it. I remember it was the day after Halloween. I remember my mom being on the phone with my dad in the kitchen and I had just had a tantrum and I think she was trying to figure out if it was a seven year old tantrum or if it was a something's wrong tantrum. And I had been losing a lot of weight and when you're seven years old, and I was really like skinny as a child and you lose, you know, 20 pounds, there's definitely some signs that something else may be going on and I was drinking so much water and I remember hearing my mom, you know, talk to my dad and have them deciding To take you to the doctor, so I went to my regular pediatricians office, and I was sitting there. And the distinct memory I have is of my mom and the doctor on the other side of the door and my mom hysterical crying. And if you know, my mom, she's like the strongest woman, she is a like, so independent, so strong. And I don't think that was the first time I ever heard her cry, or at least I remember her ever crying. So I was like, Oh, something is wrong. And then I ended up in the hospital, stay there for a few days. And when you're a kid, and you have everybody around you crying and saying, it's going to be okay, and you're so strong. And you also at the same time, don't really understand what that means. It sets you up for an interesting and interesting path and an interesting life. And definitely now looking back a lot of things that I think I didn't realize was going on in my mindset, and in my own personal development and relationship with diabetes.

Stacey Simms 5:53
And so fast forward to a story that you tell on your website, which is when you were in college, and kind of realized that this was not sustainable. But I'm curious between seven and 19. Were you that model diabetes kid?

Lauren Bongiorno 6:05
Yeah, that's actually the phase I don't talk about as much. And it's interesting, because I think it's the phase that most people and most of our clients that rise they relate to. And so that stage from seven to 18 really was, it was me just being in a very reactionary mode with my diabetes. So it was like, Oh, your blood sugar is high. Shoot, let's correct it and get it down. Oh, shoot, it's low. Alright, let's drink some juice really fast. So you can get back on the soccer field. And it was very kind of ping pong lead. And I never fully felt like I had the energy or the mood that I think that I could have in hindsight now, because I didn't realize like how much that Ping Pong was impacting me. And I also really didn't care. Like for me what was most important and for my parents, and what they instilled in me was a, you're gonna do anything you want in life, diabetes isn't going to stop you. And B, as long as when you go to the doctor, your a one C is in a good place, then you're good and you're in you're healthy. And my a one C was never crazy. It was always in the high sixes, low sevens. And that was before CGM. Right? I was diagnosed 21 years ago. And so there was no really concept of time and range being more important than a one C and and things like that. I think that during that time, it was a lot of because I didn't want diabetes to stop me. I took that as don't slow down to pay attention to your diabetes, it was very much do the bare minimal to keep your numbers not from being crazy, but just in a healthy range or healthy to your doctor standards or to your parents standards. And that time of ping pong up and down. When I eventually got to college, I realized that wait a second, I'm playing I was recruited to play division one soccer in college, it was the first time that I really started to connect my mind and my body and my numbers. And really realizing that I was not taught a lot about my whole body like this whole body approach of food and nutrition and glycemic index and eating for energy and eating for better blood sugars and exercise for specifically insulin sensitivity and what happens with weight training. And we're working out you know, two times a day when you're playing soccer in college. And those exercises are impacting my blood sugars in different ways than I had seen in the past. And I was trying to compete with a lot of other players for spots. And now my blood sugar's 300. And now I have a disadvantage. And I didn't like that because I was a very competitive person. And I took this as an opportunity to become more independent and tuned in to my diabetes and crafted in a way that would make me feel successful and would make me feel in control. And as an effect of that, what I did was I became obsessed, I became obsessed with my numbers obsessed with the food that I was putting in my body, obsessed with exercising, like over exercising all of this to the point where I actually lost my menstrual cycle for four years because my body fat percentage was so low, and it wasn't like I wasn't eating it wasn't like I was suffering from an eating disorder. In that sense. It was literally just a disorder of almost like perfection, in the name of wanting to control my diabetes in my numbers so badly. And when you start to see the results of that you're like, Okay, I'm doing this right. And that is a story I tell a lot and a lot of people know is I came home from college I think I was a sophomore junior in college. I had my endocrinologist checkup and you know, when you're a teenager your parents still come to the endocrinologist with you sometimes the doctor and so I remember sitting on the chair and my mom next to me and the doctor coming in who is my pediatrician kind of doctor from my dad. The doctor from a from childhood. And she was like her hands were in the air. And she was like Lauren, I have never seen a college student with a 5.7 a one. See, this is A1C you've ever had this is incredible. How did you do it? She like calls the nurse and the nurse comes in. She's like, can you talk to my other patient like in the UK, this other girl in the other room who's in who's in college and her agency is in great. And I was sitting there and it was like, literally an out of body experience. Because I'm watching like the doctor, high five, my mom and my five each other. And I was like, I'm not happy. I'm not happy. And you often think that your blood sugar's being perfect, or your agency being perfect. That is the sign of happiness, it's a sign of hell, that's a sign of perfection. I know you've made it. And I would never ever want to put my body through what it went through and go back to that place. And it was really because of my mindset. It was my mindset, it had nothing to do with a 5.7 a one C because my last day one C most recently was a 5.6.

Totally different plays, I eat pizza, I have doughnuts, I have, you know, I want to have a fabulous relationship with exercise and with food. So it's all about the intention behind what you're doing. And that's what I realize most in that moment.

Stacey Simms 11:21
I have so many questions, Lauren. How did you get them from I mean, you're still very young at 19. I'm thinking my daughter is 20. My son is almost 17 at 19. How did you get from I have this great agency. And I'm not happy to now. And I'm sure it was a journey I'm sure didn't happen overnight to I have a great agency. And I'm happy with I mean even pizza and I'm exercising the way I want to.

Right back to Lauren, but first Diabetes Connections is brought to you by Dexcom. It's really hard to remember what things were like for us before we started using the Dexcom. I mean, I haven't forgotten at what I mean is it is so different. Now, when it was a toddler, we were doing something like 10 finger sticks a day. Even when he got older, we still did at least six to eight every day and you know more when he wasn't feeling well or when something was off. But with each iteration of Dexcom, we've done fewer and fewer sticks. The Dexcom G six eliminates finger sticks for calibration and diabetes treatment decisions. I think all the time about Betty's little worn out fingertips. And it makes me so glad that Dexcom has helped us come so far, his fingertips are now healthy and smooth, which I never thought would happen when he was in preschool. If your glucose alerts and readings from the G six do not match 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. Now back to Lauren. She's talking about how she found her way to being more kind to her body and to herself.

Lauren Bongiorno 12:58
I would say that it was definitely a culmination of a few different things. The first thing was the real that moment really was a defining moment for me. But it also just opened up more ways of thinking about my life. And my just understanding of myself. I had started doing yoga around that time in college and Yoga does this incredible thing of giving you space to really watch your body and watch your patterns and watch your thoughts without judgment that's like at the root of the philosophy of yoga, or at least one of them. And what I realized was I wasn't happy with myself and with my identity, that diabetes was something that my whole life I kind of pushed away and it was always in the background, but I never fully accepted it. And if you don't accept the body that you're in, in my experience, you try to overcompensate in other areas. So you try to overcompensate in being perfect with food being perfect with exercise being perfect with your blood sugars. And ultimately, I had this like moment at the doctor's office where I just looked it's almost like a flashback in a movie where I looked back in my time so far in college and I'm like everybody is going out and having fun and I'm like saying no to going out to dinner with friends so I can make my organic broccoli and fish or whatever it was because I was didn't want to be tempted by having bread or pasta at this like restaurant they were going to or I would you know not want to stay out late or even like drinking college I didn't drink a lot like barely drank in college because I wanted to go to a 6am yoga class next day because I know that that really benefited my mind and my body in the way that I thought it needed to. And I just realized that I didn't want to live a life that a wasn't sustainable and be I wasn't happy. Like I think that it's important to understand your core values and I think my values were shifting away from perfection and approval of others or approval. Have my doctor my family and like more of being a little bit of a renegade and being like, well what do I want my life to look like? What do I want my relationship to food look like what I want my relationship to just everything that I do look like and what came out of that was this realization that what I was doing didn't match up and so what I was doing it wasn't sustainable if I wanted to lead a healthy and happy life and so I wanted to find a way of how could I have a healthy diabetes you know journey with my blood sugar's and not have complications later on in life and not have be in that phase in my life where I was from seven to 18, where I was just paying palming all over the place and not being aware of my blood sugar's not having predictability and those types of things. And how could I also not be on the other end of the spectrum where I was super restrictive, obsessive over health, there had to be a happy medium, there had to be a better way. And I had tried so many different diets at that point, high carb, low fat keto, high fat, low carb, like don't eat bread, don't eat process, this so many packaged food, but I realized that it was just exhausting. It was exhausting to try to apply it an outer rulebook to my life, and I wanted to start looking at my inner knowledge and creating that rulebook for myself.

Stacey Simms 16:17
Let's talk a little bit about coaching. Can you explain a little bit about what coaching is because I'm, as a parent of a kid with type one we have only ever, like, seen the endocrinologist. And then I've relied on our educator, and, frankly, the diabetes online community. What's a coach,

Lauren Bongiorno 16:34
of course, so a coach really is somebody who is helping you with accountability is helping support you in getting to the vision that you have for yourself, and is there to reflect back patterns and observations and help you with behavior change. So for example, a lot of parents of kids that we work with in our programs, they're coming because they realize, okay, we see our endocrinologist or a doctor a few times a year, and there's so much time in between that we want to be able to understand how to get our child's numbers better overnight, or in the morning time or when they're going to play sports. And we know that it's really about like the day to day things and not so much the let's go to the doctor and just depend on on them to tell us everything, we want to essentially take ownership over this and understand what's happening with their hormones with their insulin sensitivity with their, you know, time of the month, if they're females who are going through that phase that can be really challenging or just growth spurts in general, with nutrition and all this knowledge. So I really Riselywe focus on a behavior change, be published research, and then see our client data that we've had since 2015. And it's a lot of of work of a combination of mindset, and the blood sugars and the emotional impact that diabetes has on you. So you can think of it as a supplement to your endocrinologist, your CDE. And you're an a therapist or a mental health provider. If you have that.

Stacey Simms 18:05
I get a little nervous when people who don't have a medical degree are helping but at the same time, I understand that. Like I said, I got most of our information from the community right when I started a Dexcom on my son at age nine. I didn't call the Endo. I mean, I literally put it on Twitter, and was like, I don't understand this. Can you help me? What am I looking for? So I'm kind of speaking out of both sides of my mouth, Lauren. But I guess the Frank question is, talk to me about helping people with type one as a coach, when you are not a diabetes educator when you know you do not have a medical degree?

Lauren Bongiorno 18:39
Hmm, I absolutely love this question. All the coaches on our team are nationally board certified health coaches with that at the root health coaching is about helping you get unstuck by helping you develop the tools and the strategies to become aware of your blocks and your patterns so that you can move toward that vision that you have for yourself or for your child. A lot of times people know what they should be doing. Right? They know, when you slow down you take time what's happening with your blood sugar's what we're doing is we provide a space for you that is a dedicated space and dedicated time to slow down and hold you accountable for looking at your Dexcom clarity and looking through the patterns of your blood sugar. Your child's blood sugar's for the past two weeks and saying, Oh, wow, we didn't even realize that at 8am Every morning or 7am when they get on the school bus that their blood sugar is is really spiking and we're rushing, right, we're rushing to get out at the door. So we're not giving them a pre bolus. We're not doing drinking water in the morning or we're having, you know, just a waffle instead of maybe adding a little bit of protein in that and let's get curious what would happen if you did X, Y and Z Right? Or putting them in the driver's seat most of the time and saying what do you think would change the outcomes for these numbers? Like what are the things things that you've noticed have worked for you that you want to be doing more. It's identifying the gaps in your knowledge, giving them the accountability and the relatability, to somebody living with diabetes, as all our coaches do that they need, and helping them with the implementation and creating sustainable change. We've coached over 350 clients over the past six years now. And if you look at all that client data, it speaks, and it says something. And what it says is that there is a need for coaching, because diabetes is a condition where it is impacting you 24/7. And depending on seeing your doctor, which the health care system in America specifically is very much a top down model approach, where you're sitting there and you're waiting to receive, receive your next move, receive what your basal changes receive what you should do next, it doesn't set you up for success, the education that diagnosis doesn't set you up for success, the touch base with your doctor doesn't set you up for independence. And we have a choice to either follow that or to create a new system and create a new way. And that's essentially what we're doing.

Stacey Simms 21:09
So let me ask you some specific questions. If I could like kind of pick your coaching brain here. This time of year, without diabetes, many of us are thinking about changing what we eat. I'm going to diet this year, I'm going to lose that weight I gained I'm going to and it never works. Because I think we all know that that kind of FAD dieting or that short term stuff doesn't work, but we do it anyway. Can you speak a little bit? Because you've been successful with this, you know, you mentioned you wouldn't go out to eat with your friends, because you had to eat a certain way at home? How do you get there? How do you create those changes that really do make a long term difference,

Lauren Bongiorno 21:45
I think that we have to stop thinking that there's this next one thing, this next diet, this next outer rule book or whatnot, that is going to be the solution to all of our problems with our methodology and coaching specifically, and in my own personal life, what has made the biggest difference is really holistically looking at the areas of your life that impact your health, from your relationships to your self worth and your self love to your with diabetes, it's nutrition and relationship with food. It's stress management, it's your sleep, it's your hormones and your understanding of all of that it's a holistic approach, and a holistic approach. It can't happen overnight. And so diets and things like that with food, if you've tried to do it in the past, and you've gotten through, like, you know, up to Wednesday, and then you're like, shoot falling down. More is like, Alright, we're gonna go over like on Monday, which like we've all been there, it's so fascinating that we keep going back to doing that same thing instead of realizing, wow, that doesn't work, right. And so what I like to say is, don't set a goal that has anything to do with a metric, whether it's weight, or even with a one C and like, specifically, set the vision that you have for yourself. And if you set the vision that you have for yourself, like how do they feel? How do they what do they look like? What how are they operating from day to day? What are they thinking like, who are they at their core, then you start making decisions on a day to day basis that support that vision and there's less pressure and when there's less pressure of like, oh, shoot my a one C or my you know, blood sugar isn't better than it was yesterday, when I woke up or the weight, the scale is a second today than it was yesterday, there's more chance of actually lasting longer, because you're not going to feel as defeated. So if you want to feel somebody who is energized, and who is, you know, really fitting good in their clothes, or just confident set that as your vision of yourself, and then on a day to day basis focus on doing things that support that vision.

Stacey Simms 23:54
Let me ask you if I could, and this will be for people who live with type one, you know, adults, young adults, older adults, but not parents yet, like we'll get to them later. Can you give us some advice, perhaps or a couple of tips to have, you know, like more confidence with type one. And as you said, like not necessarily how to get your agency down or more time in range, but just like some good stuff for this year.

Lauren Bongiorno 24:14
Yeah, I love that. So I would say the first thing is to lean into your diabetes. So many of us often think that the diabetes part is the shadow part of us and it's the part that we have to hide and we have to push away and if that is your underlying belief that I can't be loved if people know that I have diabetes, or if I'm showing my insulin pump or I won't be accepted onto the soccer team or football team or whatever it is. If that is your like subconscious root belief, then you're going to operate from that place and you're not going to want to be checking your blood sugar in public you're going to wait until after you're done eating with your friends or drinking to the bathroom and give yourself you know a shot or give yourself your insulin and setting yourself up for you know higher blood triggers all night long. So there are so many benefits of just leaning in. And coming from a place of me for years hiding my pump, not letting people know that I had diabetes and not telling my now fiance until three months in that I had diabetes, it is so freeing, and such a relief when you can just show up as your full self. And it has benefits of obviously your mindset, and how confident you are and of your numbers as well. So I say I would think that that's the first tip I would have because it's a more of a mindset, emotional tip that will take you so far. And then on a number standpoint, I would say to focus on 1/4 of the day. Diabetes is like a Rubik's cube where there's 1000 different is that there's at any one given time, I described it recently as being interviewed for an article and they were asking me to describe but a day in the life of diabetes. And I essentially said it's like a seesaw with 50 Different factors piling up on either side at any given time, and you trying to find the centerpiece, right. So there are so many different factors. And the idea is is to not get overwhelmed by all those factors. Because if you're overwhelmed, you're going to be paralyzed, and you're not going to do anything, and you're not going to want to move forward and you're going to feel defeated. So try to look at 1/4, the day that maybe it's your most out of range section, whether it's overnight, morning, afternoon or evening, and just commit to working on that. Just commit to maybe pre bolusing at dinner time or commit to actually putting your CGM alarm on or on a different ringtone. So you wake up in the middle of the night, if it's high, since that's like the longest amount of time you want, you want to be arranged essentially, for your overall health, choose that 1/4 of the day, and then once you nail that, then move on to the next piece. But diabetes is always this thing that it's continuous learning, and you want to be able to have the energy to sustain until there is a cure. And we don't have to lower your agency five points, or three points, or even two points in the next 30 days or 90 days we can work rather on building the habits that support that a one C.

Stacey Simms 27:13
What is your advice to parents of kids with type one in the new year? Like what should we be thinking? How can we help our kids like grow up? This is a big challenge. Happy, Healthy, independent, not too worried about diabetes, but worried about

Lauren Bongiorno 27:26
oh my gosh, yes. And we were talking about this off air. See where it's interesting, because we've coached so many people who are in their 20s 30s 40s 50s and beyond who have had diabetes since they were kids. And we've seen a lot of their challenges that they're coming to us with today that a lot of it is rooted in their childhood and how their maybe parents kind of or their their caregivers or their doctors spoke about diabetes to them or how they were trained to relate to their diabetes. And so when we see the parents of T Wendy kids in our group coaching program, or in our one on one programs, we're watching and we're we're seeing how they're relating to their child's diabetes and what their child is how they're related to their diabetes, and we're able to help shape them in a better direction, so that they're not ending up where the kid is, you know, 30 years old coming back to us being like my, you know, my mom, did you when I was coaching with you guys when I was younger, and I've been and I feel like I need to come back. Right? Like it's, it's helping them now. And still, those things that we wish as coaches and the older people in our programs wish that they had when they were children. So I think there's a few different messages that I would share. One is your goal as a parent is not to help your child avoid suffering, and avoid all the highs and all the lows and all those things all the time, your goal and your job is to be there for them in a way where they feel like they can talk to you, they can come to you. And you could observe maybe what you're seeing in their blood sugars or in their behavior in a teammate kind of way. So kids are going through so much with their hormones and with development, and especially in their preteen and teenage years just fitting in, in general. And then when you add diabetes on top of it, it's there's this extra layer that just comes with it. And so one of my least favorite things is when you hear a parent or a doctor say off that child, they're just being so non compliant, right? They're just they're not testing their sugar, they're not doing this, they're they're just not being responsible. We have to put stricter rules on them or we can't let them go out or we can't do that. That isn't going to help. Right what they you really need to do is to help them get to the root of why they're feeling that way and why they're behaving that way. So one thing that I we work a lot with on with parents is on helping them understand what their child's goals are, which for a lot of them it's to have the cupcake at school with their friends or to be able to go out and have a sleepover with their friends and not have their mom call them 26 times, right? Which I always joke about, because I'm like, now there's Dexcom share, when I was a child trying to have a sleepover, my mom didn't even have Dexcom to like, look at, I'm pretty sure she sat in the car outside the person's house for like, the whole entire night. It's valid, right and those in the kids and what they want, it's this balance between wanting to keep your kids safe, and also wanting them to just be a kid. So I think that a lot of the time, it's about you as a parent wanting to protect them by not burdening them. And just by taking away you know, all of the jobs that they're doing with their diabetes or their task or making it simple with like carb counting for them, we're only putting quote unquote, healthy food or low glycemic foods on their plate. But that might not actually be what's going to help them for the long run. So really, I think for any parent listening, this, to me is one of the hardest jobs, you guys are all heroes, I can't imagine I look at my mom now and my dad, and I'm like, Thank you, like, I had no idea what you were really going through. And that that job that you that extra job you had when I was diagnosed, and you're doing great. And I think that you can do quote unquote, all the perfect parenting in the world and your child, there's going to still have, they're still going to have challenges later on. So the goal is really to set them up with to be independent, to care about how they feel, to care about their numbers, but also to not be limited by their diabetes and and to find that balance.

Stacey Simms 31:32
I'm just curious. Did you ever go back to your endocrinologist who was like, Yes, this is amazing, like the high fiving. Doctor like does that doctor know about it this way?

Lauren Bongiorno 31:43
So the funniest thing about it is I adored that doctor, I love her. She we follow each other on Facebook. Sometimes when I do local, I speak at local JDRF event. She's there love her. And I think that she's probably seen me talk about it a little bit on social media for sure. We've never like address it specifically. But I don't it's not about her. That wasn't her fault. She was celebrating me like I think a parent would celebrate a child to achieve who had an agency like that. And I think the bigger issue is really the lack of emphasis on mindset. And on mental the mental and emotional impact diabetes has on children and teenagers and adults for that matter with diabetes.

Stacey Simms 32:27
Hey, I'm just curious. And I always ask guests this, you don't have to answer. What kind of tech do you wear? What are your diabetes devices if you don't mind sharing?

Lauren Bongiorno 32:34
Yeah, so I wear an omni pod and the Dexcom G six, I was on charts for my first two years living with diabetes. And then I went to a Medtronic wired pump for about, I would say, 14 years. And then the last six years, I'm not sure if this math, somebody can add this math, drag, but it should all equals 21, less five or six years I've been on an omni pod. And I just love, love love that it doesn't have a wire. And that's that works for me personally,

Stacey Simms 33:02
before I let you go. It talked to me a little bit about your partnership with a couple of nonprofits. You know, I know that you would rightly want to make more of a difference than just with coaching. So who are you working with? What are these about?

Lauren Bongiorno 33:16
Yes, so we are here to help create the short term change for individuals impacted by type 1 diabetes and families and the long term change with diabetes care. So our approach is community based it's collaboration, it's how can we all take our the best of our missions and lift each other up. And so ways in which we collaborate with the community. Number one, we have Kyler Keres, which is a nonprofit organization that provides grants for continuous glucose monitors and insulin pumps for children and young adults living with type one diabetes. And Kyle banks is the founder, he actually played Mufasa on Broadway in The Lion King. And he is an incredible human being we actually found out recently when we were together that we have the same diabetes anniversary November 1, so that was fireworks were going off. Because we already love each other so much, but we're thrilled to partner with them. Because we just have, I think, because I was diagnosed as a kid and so many people on our team are also diagnosis kids, we have a special space place in our heart for young adults and children who don't have access to those things. And there's a direct correlation between your household income and your agency and your diabetes control. And so we really want to be able to give back in that way and to help support those people. And then secondary to that we have our together to one D Impact Fund which partnerships that we you know, work with in the community. They're able to donate to that fun to help give coaching scholarships to people who face significant barriers to health care to our coaching programs. And all the people who come through our programs through the scholarship They're carefully selected and you know, have an in depth review process, but it really allows us to be able to impact the community on that intimate level.

Stacey Simms 35:05
It's so interesting to hear, like how much I noticed didn't happen overnight, but like how much you are doing, when you look back at that 19 year old with that amazing a one C, but that not so amazing life? What do you think you've come so far?

Lauren Bongiorno 35:21
You know, in a way, I feel like I had so many years of struggling with my diabetes, that it was a blessing in a way it was such a blessing because it brought me here and we've impacted so many people's lives with diabetes. And you know, women who weren't able to have babies, they've had miscarriages after miscarriage because you know, maybe it's related to diabetes. And then finally bring a healthy baby baby into this role because their agency is down or to the parent who their child is diagnosed. And they feel like there is no possible way and they don't understand how they can, you know, go to a soccer game and not completely tanked their blood sugar's and then they're able to and they feel that their child has that sense of freedom back and confidence that all these little things, it's really, it's why we do what we do. We are there's so much passion behind what we do so much intention, so much integrity, and so much, so much hope that what we're doing can continue to be a ripple effect and impact people on an even larger level than we're doing now. And that's what keeps us going every single day. So I think 19 year old me or even seven year old niece who is standing in front of my gym class, my mom recently found a video I was sending for my gym class after getting diagnosed, doing a fundraiser at my school with my little pigtails and limited t shirt on it was so cute. And that girl was I feel like meant to do this all along. And it doesn't mean that there's not challenges, it doesn't mean that there's not Robox but it means that that those things are just there to push me to keep going and push me to realize how worth it this is.

Stacey Simms 37:00
That's great. Oh my gosh. I love that. Lauren, thank you so much for joining me.

Lauren Bongiorno 37:04
Thank you so much for having me, Stacy.

Stacey Simms 37:11
You're listening to Diabetes Connections with Stacey Simms.
More information about Lauren and coaching and Risely and you can read her story. And she's been on some national media, she's got great videos, all of that is linked up at diabetes connections.com. As we do every week, every episode has its own page.
If you head on over there and click on episodes, you will find them all. There's also a very robust search. And I say that because we are up to this is episode 455. So if there's a topic that you're interested in, we have likely covered it. Obviously, we haven't covered everything. And please send me your suggestions. But if you just type it into the search box, it really is. I'm really thrilled with my web folks, I'm stuttering around because I had nothing to do with it. But I asked them to make me a great search. And they did. And you could also search by topic by date, whatever suits your needs. So please check that out.
We have some great shows coming up. Boy, there's so much going on these days every Wednesday I do in the News Live and that's on social media. And then I turn that into a podcast episode. That's every Friday five or six minutes of just headlines and in the news stuff for the diabetes community. Next week, you should be hearing from ever since I'm working on that episode right now we're going to talk about their longer where and you know, a lot of you already have commented in the Facebook group about you know, worries about this device. And who was it for? I gotta tell you, Benny is super eager for this because of wrestling and his sports. Think about a CGM that you can't knock off, right. So I'm not here to endorse them. But I am here to say let's talk to them and find out more about this option. We're also going to talk about Tandem and waiting because while they just got FDA approval, they have an earnings call later this month that I want to wait until after that because some interesting things may come out. So we'll be speaking to them. And that episode will probably air in early March.
But in between those two, I have an interview with the folks at Pixar and I have a great story about why there is diabetes technology featured in turning red. This is the newest Pixar movie debuting on Disney plus in March. And so look for that episode, probably right before the movie comes out. We've taped it, I have to hold it sometimes these things are embargoed, and this was one of those cases. So really excited to bring that to you. 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 soon Until then be kind to yourself.

Benny 39:43
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Feb 18, 2022

It's "In the News..." Got a few minutes? Get caught up!

Top stories this week include two big FDA approvals! Tandem's Mobile Bolus and Eversense 180 day sensor both get the okay, we're looking at earlier detection of T1D in kids, there's a new discovery around a protein that might help T2D, info about Spare a Rose and Omnipod drops a hint about a crossover with a popular Nintendo game.

Join us LIVE every Wednesday at 4:30pm EST

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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Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

OMNIPOD

DEXCOM

FB LIVE:
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days. If you’re new we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast.
XX
Looking to get organized? Diabetes supplies can really add up and all that pump and CGM stuff or even shots and wipes and strips can clutter everything up. I’ve got a great new guide to help you out. It’ll get you started and keep you organized. That’s totally free and it’s over on the podcast homepage.
XX
Our top story this week – big movement from the US FDA, two approvals we’ve been waiting for. The first, Tandem Mobile bolus – what I’ve been calling bolus by phone. As expected, company says when released, this will be no additional cost for in-warranty customers through a remote software update. Limited launch in the spring, followed by expanded launch this summer. It’s compatible with both iOS and Android, although limited to just a couple of models right now. This is a very important step not just for customer convenicen but as Tandem moves forward with it’s new hardware line including Mobi will need an external device for full control.
https://www.tandemdiabetes.com/landing-pages/remote-bolus
XX
The second FDA approval came through for The Eversense E3 continuous glucose monitor. This 180-day implantable sensor will be available later in 2022. If you’re not familiar, you have the sensor, inserted under the skin of the upper arm (and removed) every six months by a trained healthcare provider. There is a rechargeable transmitter which vibrates on the body for highs and lows.. and a mobile app. The sensor requires two calibrations per day for the first 21 days of wear. After that it requires one calibration. Lots of questions here and I’m talking to these folks for an upcoming episode.. look for that in about two weeks.
https://diatribe.org/180-day-implantable-cgm-eversense-e3-approved-fda
XX
Saw an interesting post from Omnipod this week on IG.. All about Pat Podder® - the caption says she “is a long-time member of the Pod Squad who loves a good DIY project, going swimming, and to explore new places.” Take a look at this animation, along with the hashtag they used.. Animal Crossing.. are we about to see a gaming crossover? Insulet says an announcement is coming Thursday of this week, so if you’re listening to the podcast it may have already happened.. I’ll follow up.
https://www.instagram.com/p/CaA_5rEsyMH/
XX
Big push in Germany to get doctors to screen very young kids for type 1. This group conducted the world’s largest population based screening for type 1 diabetes in children so far. Since 2015, any child aged 2–5 years in Bavaria, Germany, could have their blood tested for islet autoantibodies. These show early stage type 1 diabetes years before high blood sugars and other symptoms. More than 90-thousand kids have been tested and point 31 percent (.31%) have been diagnosed. Next up is to take a deep dive into the potential cost savings and increased quality of life compared to what happens without these early screenings.
https://medicalxpress.com/news/2022-02-early-diabetes-children.html
XX
It’s a mouse study.. but good potential here for a drug to treat type 2 diabetes. It works by amplifying a protein that has a positive effect on insulin. The protein is called Swell-1 and it’s vital for normal insulin secretion from pancreatic cells. And, SWELL-1 activity seems to be significantly disrupted in people with type 2. Fixing that seems to restore both insulin sensitivity and insulin secretion. And it does this without lowering blood glucose when that’s not needed. Long way to go but promising..
https://newatlas.com/medical/new-drug-target-diabetes-metabolic-disease-swell1/
XX
The Spare a Rose campaign was back – focusing on Valentine's Day but continuing through February. The idea here is that instead of buying a dozen roses.. you buy 11 and donate the value of that last flower to help someone with diabetes. Since starting in 2013 Spare a Rose has raised almost 400-thousand dollars.. most of that has gone to Life for A Child. Now, these donations are going to the Insulin For Life Global organization. It provides insulin, supplies, education, and advocacy to children and adults. With that the name has changed from Spare a Rose, save a child to Spare a Rose save a life.
https://sparearose.org/
XX
More type 1 at the Olympics! Last week we told you about Snow Boarder Kamilla Kozuback who was diagnosed at age 13. Czech skeleton athlete Anna Fernstädtová came in 7th a couple of days ago. A MONTH ago she was in the hospital, newly diagnosed with diabetes. She wrote on Instagram: “7th place at the Olympic Games. Not the runs I wanted, not the result I wanted. But these are happy tears. Not even a month ago I was in hospital, without knowing what would happen. But we made it happen. Thank you everyone who got me here And to everyone who is also dealing with type 1 diabetes: everything is possible! You got this!!”
https://www.facebook.com/annafernstaedt
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Our long format episode this week is with the folks at Sigi pump.. a new tubeless rechargeable pump that got breakthrough device designation last fall.
Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

 

Feb 15, 2022

Last fall, Sigi pump received Breakthrough Device Designation from the US FDA. Although it's still a long way from being released, Sigi is very intriguing; it uses some of the best parts of existing pump systems.

Pim Von Wesel is Co-CEO of AMF Medical, the company that makes the Sigi Pump. We’ll talk about what makes this system unique, which partners they're eying for collaboration and the timeline for submitting to the FDA really looks like.

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!
-----

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

DEXCOM

Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921, where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, it's called Sigi pump. And last fall it received breakthrough device designation from the US FDA, there's still a long way to go before this tubeless rechargeable pump could be on the market. And company leaders say that's okay by them.

Pim van Wesel 0:37
We're biding our time to make it short is excellent in every respect, technically, from a usability point of view, of course, which has a huge focus to us lowering therapy burden, and also just being able to produce it in sufficient quantities.

Stacey Simms 0:51
Pim van Wesel is Co-CEO of AMF Medical, the company that makes the Sigi pump, we'll talk about what makes this system unique, which partners they're eyeing for collaboration, and what the timeline for submitting to the FDA really looks like,
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show, always so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. Before we jump in, I want to give a big shout out to the amazing people in our Facebook group. If you're not there, it's Diabetes Connections, the group and I just want to single them out, because I think that it is the smartest diabetes Facebook group that's out there. I know I'm a little biased. But you know, it's not the kind of group that's going to tell you how to eat or how to dose or you must do this, or how dare you do that. As you know, if you listen to the show, that's not our deal at all. And I just want to take a moment because I've been asking the folks in there many of whom have lived with diabetes for 50, 60 years, many of whom work for technology companies, many of whom have been blogging about diabetes for many, many years. And I've been bringing them questions that have come up in my local group, things like cannula length, making a difference, some questions I had about summer camps for this year. And they all also have fabulous conversations. So I know we're all if you're on Facebook, you're in a ton of groups already. I do think that it's a really good one. If you'd like to hear from people who have lived with this condition for a long time who are very knowledgeable and frankly, very opinionated, which I like a lot. I do run a very tight ship. I do this in my local group as well as this one, you're not going to get away with any nonsense. Any weird stuff, a snake oil. Yeah, we will have none of them. But it's a great group. And I just was given them a shout out because they've been very, very helpful, especially lately.
Okay. Sigi pump caught my attention when it received that breakthrough designation that I mentioned. And to be clear, that means the FDA will try to speed it through the process. It does not mean it's approved for that it's guaranteed approval. And Sigi by the way is S-i-g-i. I did share some photos of it in the Facebook group. And my guest is Pim van Wesel , the CO CEO of AMF medical, that is the Swiss company behind Sigi pump. They are very early on here. Clinical trials have not yet started, but they do plan that when they get through the process to launch in the US first while it looks a bit like an omnipod, but the pod part is reusable. You recharge it as needed, and they give you two so you don't have to stop pumping while you're recharging. One of them. The only disposable part is the infusion set, although they call it something else, the part that connects to the body. Lots more information about Sigi in my interview with Pim van Wesel

Pim thanks for joining me. I am excited to find out more about this product in this company. Thanks for coming on the show.

Pim van Wesel 3:54
Thanks for having me. Stacey. Very excited to share what we have.

Stacey Simms 3:57
Yeah, I have so many questions for you. But let me just start by asking, just tell you a little bit about the company that makes Sigi what is A M F medical? What do you all do?

Pim van Wesel 4:08
Well, AMF medical was really spun out as a standalone company in 2021. But the history of the company goes back to 2014 when the founders hit upon a technology which they initially started using in some high end components for laboratory equipment. But a number of the founders had a history from a previous startup in insulin delivery. It didn't work so well then. But when they analyze this particular technology, they said, Wait a minute, we can probably make a insulin pump with this technology that would work that would not destroy insulin and being a large, fragile hormone. And they started a project in 2015. Over time, the project got big enough that they decided what we decided I joined since then to make it a separate company just because the investment story is very big. Different for insulin technology versus, you know, high end led components. So, company started in 2014, on off separately in 2021. Around the time we kind of came out of stealth. And, you know, I joined a little over a year ago, basically to help build a business after the founders started with a technology hired a great r&d leader pair who turn it into a product and then meet to help make it a business.

Stacey Simms 5:27
Or you mentioned coming out of stealth mode. The first time I heard about this was when the US FDA gave what they call breakthrough device designation. What does that mean? And why is that important?

Pim van Wesel 5:40
Well, it's important to us because we feel we have a few capabilities, particularly around usability and lowering the therapy burden that we wanted to test with the FDA, if it deserves to some recognition. Practically, it means that that puts us a little bit earlier and faster into the approval process. But we have an ongoing conversation with the FDA that started with a pre submission conversation there. And we decided to that we would try for this designation to get some recognition for some of the capabilities that we have, they picked up on a number of them, which got everybody very excited. You know, in a way, it's, you know, recognition that we're addressing unmet patient's needs.

Stacey Simms 6:18
Okay, so I got a little bit ahead of myself there by starting by asking about the FDA, let's just back up and talk about what the product is. Tell me about the Sigi pump. What makes this different,

Pim van Wesel 6:28
it is a patch pump, we have designed it for interoperability with multiple systems, so multiple third party glucose monitors and multiple algorithms. And I think one of the novelties that we'd like to bring is just tremendous ease of use. So we use standard prefilled insulin cartridges, I think that's in a nutshell, the product, it is a semi reusable product, the pump itself is reusable, you would have to as a user, with a dedicated charger, and whenever you need to switch it out. Because your cartridge is empty, you take your second pump, pump, pump into cartridge, use a new sterile cap to close it and then put it back onto your pad. The pad is a or tray, but we call it a pad is basically placed on your skin. And you can clip your palm on and off as needed.

Stacey Simms 7:17
I'm going to describe this probably pretty poorly. But in my mind's eye using existing technology, this seems to me like you use sort of a pump infusion set. So you would insert the tray the base as you called it onto the skin. And then that's temporary, right, you would take that off every couple of days like you do right now. But the patch pump is more like a more durable pump like a Medtronic or a Tandem, but you physically clip it flat, it connects to that infusion, well, I'm calling an infusion set. And is that close to accurate?

Pim van Wesel 7:52
That is I think that is a very good description with the one caveat that we have the ambition for the pads to last a little bit longer than a couple of days. Which basically means that once the pad is on the skin, let's just say for a moment that it lasts a week, as you run out of insulin you your take your pump off, you put in a new cartridge, and you clip your pump back on as long as the pad lasts, or what you could imagine somebody who has a very high use in need of insulin, they might for instance less in people that are in type two, not that that's our primary focus. But if they were to go through 160 units in less than two days, they wouldn't have to change the insertion of the pad or to disposable if you will. So that's the idea. Absolutely.

Stacey Simms 8:38
Got it. We're going to talk about more features, and you know a lot more about what the system is about. But before we go any further is what we're talking about in existence yet. In other words, is somebody wearing this? Is this in clinical trials? Where are you in the process?

Pim van Wesel 8:53
So we have functioning prototypes? We have not, and we've tested the usability of those we published something at ATDD last year. And we'll we'll have some more information at ATDD coming up in March sort of product exists. But formally speaking, we have not done the first human yet and as planned for later this year towards the end of 2022.

Stacey Simms 9:16
Got it? Well, the next question I know my listeners are going to have is can they take part in that are those are those first people in Europe or in the United States?

Pim van Wesel 9:24
There? I'll be very honest W in Europe. And that is primarily just to you know, we're startups. So we're trying to keep it manageable and coordination effort. So to do this in the US is probably a little bit beyond what we can can do at the moment. But clearly, I mean, just to answer the following question. Our intent is to first go in marketing United States and that's why we have these conversations with the FDA.

Stacey Simms 9:48
Got it. Got it. Well, we have lots of listeners in Europe too. So we'll put all the information out is as you're able to send to us. Alright, so let's talk a little bit more about the product itself, or the system itself, I should say the public Um, you mentioned you know, refilling insulin, this is prefilled pump cartridges as designed, right? This is not, you don't have to draw it out and fill it correct.

Pim van Wesel 10:09
There's no, if the term here fiddling to fill it, you basically take it out of the, you know, insulin caps in the refrigerator, and you pop it in straightaway you you don't have to wait 20 minutes for it to warm up, the system is compensating for that. So there's no air bubbles. And these cartridges, they already exist, they're already on the market. They're just being used today, with, you know, the Tethered pumps, or, you know, the pumps you were in a belt or in a pocket. So, you you mentioned the Medtronic pumps. Actually, there's other products out there that use this exact same existing cartridge. And I think you've spoken about some of these pumps in other podcasts.

Stacey Simms 10:46
Yeah, it's interesting. You know, we're so US centric sometimes that I certainly tend to forget, I believe what, Ypsomed uses the cartridges?

Pim van Wesel 10:54
Yes, Ypsomed uses that cartridge here in Europe And they have their agreement with Lily in United States. And there's a Roche product as well that uses this. But to our knowledge, this is the only patch pump that's designed around this cartridge. And it's actually a big part of why the pump has the size that it has, we couldn't make it much smaller and, and still fit the cartridge in

Stacey Simms 11:16
tiny a little bit more about the pump design itself. As I'm reading through, it looks like it is controlled from a phone or controlled by a separate controller. Are there any buttons on the pump itself,

Pim van Wesel 11:27
there are no buttons on the pump itself. And it is operated via your own smartphone. That's definitely the ID that we're working towards. We don't think people need another personal device manager in their pocket. So keep it simple.

Stacey Simms 11:40
And now I've talked about system a few times. Let's talk about that. So Bluetooth unable to go to a smartphone to go to an AI Controller talk about that a little bit.

Pim van Wesel 11:49
It is in no technical parlance. It's it's designed in the discussions with FDA RS ultimate controller enabled pumps. So nice pump, and it has everything that you could, you know design to so we're not trying to backwards integrate an algorithm and interoperability with third party CGM is designed to be able to do that. And when we say designed to be able to do that it has the communication capabilities with Bluetooth, it has the processing power to have an algorithm on board, and it has the battery life to deal with it as well. It's a rechargeable battery, of course, all of that is designed to be able to communicate and to calculate in, you know, work with dosing algorithms, if you will, that would be onboard. There's some systems that have the dosing algorithm on a personal device manager or in the future on the phone. We can accommodate that as well. We think that there's some advantages to having the algorithm actually embedded on the pump. And we've designed it to be able to do that.

Stacey Simms 12:46
I may have missed this point. You're not creating an algorithm for the pump?

Pim van Wesel 12:52
No, I think when we initially I think the ambitions were for the company were quite large. But if we really look at the core competencies, the core capabilities that his team has is around fluidics management and is around miniaturization. So over time, we also realized that, you know, we should better stick to what we do well, and is just make an excellent pump a truly excellent pump. Otherwise, we don't think we have any right to be on the market. And we have this open ID, you know, collaborating with, as far as we're concerned with any algorithm that's approved with any CGM, that is that is available. So we really have an open protocol or an open system mindset there. I think that's a little bit. You know, if we read the documentation, what the what the FDA is doing with the creation of these new product categories, such as ace pump, an IC, GM and I control, or we read a little bit with the JDRF has as a position statement around your artificial pancreas. We're fully subscribed to that philosophy, because we're open. Yeah,

Stacey Simms 13:59
it's really interesting, because ideally, and we've been talking with this for a couple of years now ideally, right, you'd get your pump, you get your CGM, you'd be able to pick and choose and then say, Okay, I want this algorithm I you know, I want my, I mean, I'll put the blue sky thing I want to Sigi I want my libre, and I want to use the control IQ. Correct? Is that something you think is a real possibility here?

Right back to Pim in just a moment, but first Diabetes Connections is brought to you by Dexcom. And we've been using the Dexcom system since Benny was nine years old. We started with them back in December of 2013. 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 wear and the applicator is so easy. I have not done one insertion since we got it. Benny does them all himself. He's a busy kid, and no way he can just take a quick glance at his blood glucose numbers to make better treatment decisions. is reassuring. Of course, we still love the alerts and alarms and that we can set them how we want it for glucose alerts and readings and the G six 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.
Now back to Pim talking about interoperability and whether the system will work with other algorithms and devices.

Pim van Wesel 15:27
Well, we're definitely building our product for that to work, and depends a lot, of course, on the collaboration that that you can put in place with some of his companies. And being a startup, you know, a number of these collaborations are actually, you know, very enthusiastic, and other ones are a little bit more and wait and see, because we're still startup at this point in time. And I understand some of the bigger CGM companies, they might say like, well, let's wait and see if these guys actually gonna make it to market before we spend an awful lot of time co developing with them. But a number of areas septic, and we have good conversation. So will it work with all depends? You know, I don't think it's so much a technical question as a question of, you know, is there the will to make it happen. But we're very encouraged by some of the collaborations that that have been put in place, still early days, but we plan to do our first human and fairly soon thereafter have a what we call a hybrid loop trial with with a select number of patients.

Stacey Simms 16:26
Not to belabor the point here, it would be too early to ask you which CGM you would work with because you're, you're still

Pim van Wesel 16:33
Well, let me turned the question around. Which CGM? Would you first like to see on our pump?

Stacey Simms 16:39
I would. But I first like to say, good question here in the US, right, we only have a Dexcom and Libre, and Medtronic, I'd left them out of that, because they're so proprietary, you know, they only work within their system. So you know, if you ask me, I'm going to say Dexcom? Because that's what we use. But I would also say, I mean, I'll speak out of both sides of my mouth, everybody.

Unknown Speaker 17:03
So

Stacey Simms 17:07
in the works, probably two of which will come to market?

Pim van Wesel 17:09
Well, yeah, it's interesting that you mentioned that, Stacy, because the other day, with, you know, we basically had an inventory of the number of CGM projects out there. And I think it was getting to about close to 40. If you kind of all add them up, and we don't have 40 agreements in place, we have some agreements in place, and when I can talk about it, because there's confidentiality there, but you probably won't be disappointed with some of the names that we're talking about. But to your earlier point, you know, there's different form factors, right. Some people are very comfortable with having, you know, every six months or every 12 months, a minor intervention, not to have, you know, not as a wearable other people are actually, you know, preferring a wearable. And I think we want to accommodate that, as you said, different form factors, different dosing algorithms. So that that's our philosophy. And we're sticking to that for an hour and see how much of that we can make happen. But clearly, when we make our selection the same way these big companies do it, right. They say, I'm not going to work with this startup, well, how much do I believe they actually going to exist five years from now? Those same considerations apply to us as well? Yes, we have some conversation with early startups. But if you want to be successful, we'll probably have to partner with one or two of the bigger ones first, just being very pragmatic. And that's what we're doing.

Stacey Simms 18:28
And I left out one apologies to ever since the folks at Sensionics , who I'm sure you're very well familiar with, but I did not mention them as the US CGM company are available here. And they certainly are. I'm always gonna say work with everybody. It's so interesting to think about how it's changed in the last Gosh, even the last five

Pim van Wesel 18:45
years now. Right. But that's despite debts. It's going so fast. We think there's really just only only one really successful patch pump on the market. And we think we have something to offer in that space where we're at. And we're focused on that.

Stacey Simms 19:00
Is it waterproof? Yep. The fast answer. That's easy.

Pim van Wesel 19:05
No, I think, do the way we think about hedge pumps and look, and I've worked at some of the larger companies that have projects or had projects or have projects in the works on it. There have been so many attempts, I think, and there have been so many bridges burned in that space that are we get a lot of pressure from investors and from, you know, people that pick up with us on the websites to go fast and our philosophy and less our product is excellent. We don't have the right to be on the market. And we're biding our time to make sure it's excellent in every respect, technically, from a usability point of view, of course, which has a huge focus to us lowering therapy burden, and also just being able to produce it in sufficient quantities. It's a high hurdle. We don't want to come out unless we're absolutely excellent. And I'll tell you the story what what I discussed with our r&d people. I said look, we'll go to market when we are confident that we can Then pick a handful of influencers in diabetes technology world, and we'll give them flutter for three months. And we say, do what you want, write whatever you want. If we're totally comfortable doing that, then we're ready to go to market.

Stacey Simms 20:13
I had a question from a couple of listeners. And you've answered this a little bit about the differences between Sigi and the Omni pod, which is, you know, pretty much the closest to something like that, that we already have right here. And you've mentioned things that it's, you know, it's smaller, it's lighter, it is rechargeable, so you're not throwing the pump itself away. Are there other differences you'd like to point out?

Pim van Wesel 20:34
Well, I think the other one you pointed out as well, and that we we put a lot of effort in is the fact that it uses a prefilled cartridge, then this is designed upfront for interoperability, and we'll think we'll be very open. But I think you hit on most of them. Plus, of course, the fact that we use this prefilled cartridge, which we think is also looking at, you know, the feedback that we're getting on the website. There's there's an encouraging number of Omnipod users who've picked up on our website and are sending us comments. So we'll keep working at it. From that perspective.

Stacey Simms 21:05
I'm curious, we I've been talking a lot in the last couple of weeks on the show about infusion sets. You know, we had the folks from convatec on talking about the different types that they're looking to make you already mentioned, hopefully longer. Where can you talk a little bit about that part of this system, I know you can't, you know, there's a lot of proprietary and I'm sure information you can't share. But just in terms of he would seems to be that it would be a different type of insertion, just because it to me and it could be wrong, it seems like it might be have to be bigger, I'll let you talk about it.

Pim van Wesel 21:33
Let's talk about the insertion is designed to be very fast and fast in this respect often means, you know, limited, limited pain, right? If you do it very quickly. That's number one, or insertion is intended to be very quiet, particularly with very young patients in mind, this should not be a scary experience. So that's the insertion the cannula itself, we have a number of ideas around it to make it 470. Where and of course, because the pump, and isn't just the the setup itself, but the pump itself is very, very lightweight, we aim to make it you know, very wearable from that perspective, as well. We are doing a number of tests around you, we've done some testing or the wearability, and we've made some changes to the adhesive. And that's, you know, continues to be a big focus, just trying to work with the best adhesive companies out there. And in terms of the cannula, we are doing some tests around making sure that that you know, we don't have clogging and that we actually can get to seven days without, you know, too much inconvenience. Putting for sale is a pretty high hurdle there for seven day use and need to see if we can get there that's still already work. But I do wonder what are the thing I will say compared to some other pumps is we have no tubing at all right? So the the fluid path, if you will, from the cartridge to the skin of the user is actually very, very short. And that of course has the advantage as well, which other patch pumps have as well, not all of them, but some for sure is that it has very little incident wastage involved, of course, we really aim to completely empty the cartridge.

Stacey Simms 23:12
Are you making the infusion set or the connector? Are you all making that yourselves?

Pim van Wesel 23:17
Yeah, we make everything ourselves except the insulin cartridges which are available, but we are doing everything ourselves. We have from our micro fluidics technology background, we have a lot of information on what works. And we've done extensive insulin compatibility testing with insulins that we believe will be available in this cartridge just so we have the data, which is very encouraging that, you know, it lasts and that doesn't create any you know, material interaction issues. For instance,

Stacey Simms 23:45
I mentioned at the beginning of our chat here that you are relatively new to the company. And you also talked about you're already getting input, I'm sure criticism, comments from the diabetes community from the website. What were you doing before this? And what has it been like to move into the diabetes space where well are very, very passionate?

Pim van Wesel 24:06
Absolutely. It's, I've been with the company formally for about a year, I've, you know, been helping the management team, the executive team and the board a little bit before that. I have a longer experience in diabetes. I worked for about five years in diabetes with Medtronic and Europe. So this is not my my first rodeo. It is a very engaged community and very passionate and very vocal. I've also worked in incontinence and I can tell you that the people who have incontinence problems are a lot less vocal than people living with diabetes for sure. And people stay around right. It's been very encouraging to to reconnect with some of the experts, the clinical experts I had the privilege of working with in the past and they're still around and you're still advising and they're still happy to have a discussion and give very solid input. So quite a bit of experience with diabetes been in medical technology for since 2003. if you will, so coming up to almost 20 years, but I must say that working in diabetes is in the diabetes technology field is particularly gratifying you, you're actually much closer to what's happening than in many other areas of medical technology. So it's been good. It's been good to be back. Absolutely.

Stacey Simms 25:17
That's great. Yeah. And then the past few years, as well, there's been this push from the pump is, you know, this clunky medical device to realizing that people, you know, it's such a part of the day to day life of someone with diabetes, and our phones look great, Why can't our pumps look great. And I'm assuming that that is part of the design here to this is kind of silly to ask, but I did get this question. And I like silly. Is there any planning here to make it different colors to have any designs on it, things like that,

Pim van Wesel 25:48
let me Well, a couple of things. Colors is not the high priority, we have a project extension matrix and colors is actually on there. We think it's a fairly low efforts, we're just questioning in terms of user benefits, if there's not other things we need to focus on first.

Stacey Simms 26:06
And also getting it to market probably is the top priority,

Pim van Wesel 26:08
for sure. But you know, when you talk to two people in the diabetes investment community, they want to see some ideas of what else you can think about for the future. And we have a number of ideas in this. But particularly for young, young users and pediatric patients, for instance, we know these things are important to my, in my former life, I've spent a lot of time coming up with cool stickers that worked on a pump, if you will. But we were already worked very hard on the design. If I show you one day, the first prototypes, they looked very different and quite a bit bigger. And we're very fortunate to work with an excellent design company around some of these four factors, things, I didn't fully appreciate that necessarily when I started. But for instance, the applicator has gone through numerous separations, iterations to allow for single hand application at all different body parts so that the angle still works. And one of our investors, you know, said, Oh, I get it. And I'm not sure if this analogy resonates in the United States. I think it does. But one of the investors said, Wait a minute, you're like the Nespresso, of insulin therapy. And I don't know, if you, you know, if you made an espresso in the old fashioned way, you had to get the amount of coffee, right, you had to get the pressure, right, you had to get the temperature, right. It's quite involved, right, and espresso comes around, and kind of makes it, you know, standard and repeatable and very, very easy to use, come and take a little bit further, it's so happens that the design company that we've worked with, on route a form factor, not that technology run the form factor, actually happens to be the same company that designs the Nespresso machines. They liked our project very much. And I wouldn't say they're doing it for free, but I think we're getting a better rate. And then this person is,

Stacey Simms 27:55
you know, a friend of mine makes a t shirt that says I run on coffee and insulin will have to send them one of

Pim van Wesel 28:00
those. Absolutely. And I'll share it with my espresso friends as well.

Stacey Simms 28:05
Hey, I meant to ask you earlier, and this is a question I got from a listener, you have mentioned, you know, we've talked several times about the prefilled insulin cartridges, do you anticipate a certain type of insulin? Will it work with most of the types that are out right now,

Pim van Wesel 28:19
we have tested it for insulin compatibility with for insulins today, we've tested it with Nova rapid, we've tested with fierce, we've tested with Lumia F, and we've tested with Humalog. And we think that we that we cover a very significant portion of the US market, because there are some, you know, various there is a sell Fill option as well for this product, although that's probably not the benefit that we you know, we we kind of put forward that much but we're very interested in working with with multiple intell insolence, particularly if they could be available in in prefilled insulin cartridges. And we have some ideas are as well, particularly for for type two, to work with higher concentrated insolence. And we have some discussions around well, could the pump identify which type of insulin you're actually putting in your pump? You don't want to confuse you 200 or higher. Right? Right, you 100 Of course, the further discussion around that. And this may be a little bit too far ahead. And you know is well wait a minute, you have different types of insulins, our future algorithms going to take different types of insulin rapid, ultra rapid and to take take into account in their calculations. And how could we ccommodate that the some of the discussions we're having with insulin manufacturers around Okay, would you pump be able to tell which insulin type you have actually just loaded your pump with snakes. Interesting.

Stacey Simms 29:50
Yeah. Yeah. It's very interesting to think about that. My goodness. I was just thinking like, could you use Humalog, Novolog? The four you mentioned, I guess Apidra would be the only one I would have a question about but it just doesn't sound like you've tested it.

Pim van Wesel 30:00
You know, we've not tested it yet. And there's no other reason than that. We know that the insolence I just mentioned, they might be available in the cartridge form factor, or Nofal. Rapids. And, and fill us with, that's public information that they're available in pump cart. And we've all learned about the lily project with Ypsomed, and we kind of figure that they will use a similar cartridge, we don't think that it's going to be very different form factor wise. So that's why we focused on those four,

Stacey Simms 30:33
we've already started looking probably further ahead than we should with something like this. But you mentioned the next time there may be more information will be in in March, and then more trials on people starting later this year. Do I have that correct. Anything else that you want to add that's happening in the near future?

Pim van Wesel 30:50
Will will hopefully well, one feature that we haven't discussed and which we are exploring very actively, and we announced this last HDD is that we have very fast Ultra very fast occlusion detection. And we have now independent data, which will hopefully see published at attd, about comparison to comparative data, how fast our occlusion detection is, and we're exploring what are some of the benefits of that, of course, we tried to balance it against alarm fatigue, of course, we don't want everything to become, you know, an alarm and basically drives people crazy. But we think there's some real benefits to having very faster collision detection, particularly if you go to very young patients. And I think we're seeing more and more people with diabetes getting diagnosed earlier and earlier. And here in Europe, at least, they almost instantaneously go on a pump. And then we think we want to accommodate that. So that's going to be some clinical work we need to do, how do we how do we position the ability to, you know, very, very quickly, we're talking minutes, not hours, right? If you have a very low basal rate, you might not see an alarm in days. And we're actually minutes in that respect and that support very encouraging that we, we still need to think about. So maybe that's one feature we haven't talked about, and we're gonna do some clinical work around.

Stacey Simms 32:09
Interesting. Well, thank you so much for joining me. I look forward to learning more. I appreciate you starting the conversation. Tell your folks when they send those pumps for people to try. Certainly espresso machine. We all love espresso, they can handle that. Very good.

Pim van Wesel 32:23
I like the idea. Well, I wanted to thank you Stacey for the opportunity. And we're always available to answer questions.

Stacey Simms 32:29
Fabulous. We'll talk soon. Thank you so much.
You're listening to Diabetes Connections with Stacey Simms.
Lots more information about Sigi at diabetes connections.com. Every episode has its own homepage with a transcription and more information. If you go there, and the transcription isn't there. And it's an episode after January of 2020. It's coming. It just may take a couple of days to get it posted. But I promise it's there. And we are working our way backwards through the other episodes since we started the show in June of 2015.
I did want to add one thing I forgot to ask during the interview and I asked it later, why the heck is it named Sigi. I emailed them after the interview. And they told me that they came up with the name through an internal naming competition. The chairman of the co founder proposed it kind of a little tongue in cheek was tribute to one of his fellow co founders, an older gentleman, he is 84 years old now. And he was at the origin of what they call the system's core a microfluidic pumping technology idea. His name is Siegfried Strassler and Sigi is his nickname. They said everybody liked it. Also, because I love this it evokes a certain friendly, reliable swiftness. And so it was voted. So that's why it's called Sigi. I love names, I just love to find out why these things are called what they are. I mean, sometimes it's just a number like Omnipod. Five is the next one, Dash was number four and back from there, they're keeping it simple. I liked horizon. I like with control IQ. I hope that they keep names like that. So we don't have to just remember numbers, it makes it easier and it gives a little bit more personality. So thanks for the definition of Sigi and congratulation to Mr. Sigi Sigfrid strassler. Although I guess if it's his nickname, I would not call him Mr. Sigi. I'm calling him Mr. Sigi.
Anyway, we will keep you posted on how the Sigi system moves through the pipeline. And of course, I'm following closely on technology and hoping that we're getting more approvals and more movement for the US FDA for stuff that's already in front of them and that is in the pipeline.
What's coming up. I will say that if you are interested in sending your child to diabetes camp, jump on that most of the camps have opened registration, they usually do that in mid February or by mid February. So chances are if you've got a local camp near you or you want to send your kid to a camp that's not local. Go ahead, look that up. I actually thought I remember when Betty was diagnosed because campus such a big part of our lives as the kids got older, I was thinking, Okay, we're going to do like a diabetes camp tour. I'm going to send him for a week to the local one, I'm going to send three weeks to that one, because that goes for three weeks. I'll send him for two weeks to that, like, I was just gonna trick them around the country. But then of course, he said, No, he was going to go to the regular camp where his sister went, and that was the end of that. And I don't know if I've mentioned here before, I think I have, but he's gone for eight weeks this summer to be a CIT. I'm so excited about that. But eight weeks, man, no share, no follow up. I don't have WiFi at this camp. He'll be fine. We're going to talk about how he wants to do it. I mean, he's 17 years old at this point, so I'm really excited for him.
Okay, we have lots coming up. Please join me for in the news we do that live on social media on Wednesdays, and that it becomes an audio only podcast on Fridays. 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 soon. Until then be kind to yourself.

Unknown Speaker 36:01
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

 

Feb 11, 2022

Every week “In the News…” brings you the top stories and headlines around the diabetes community. Top stories this week: A new treatment is being studied to help prevent hypos, cannabis use may decrease women's risk of type 2, examining Veterans Affairs claims for T1D & Agent Orange, better prevention for T2D and heart disease and which athlete at the Winter Olympics was diagnosed with type 1 as a teen?
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DEXCOM

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days. If you’re new we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast.
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Looking to get organized? Check out my new guide with top tips to clear your diabetes clutter. Everything from how to start to where to donate and how to keep it from taking over your house. Head over to the home page to get organized.
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Our top story.. moving forward to find a daily therapy to slow or prevent low blood glucose in people with type 1. This is from diabetes-focused life sciences company Zucara Therapeutics. They’re calling the drug ZT-01 and in theory it could restore the body's ability to release glucagon. Long way to go here, but reducing hypoglycemia is obviously a great outcome due to the many risks lows can create. Zucara will now move ahead with it’s proof-of-concept clinical trial in people with T1D. The company expects to publish the findings from that study closer to this summer.
https://www.biospace.com/article/zucara-reveals-hopeful-preclinical-data-in-type-1-diabetes-/

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Part of the 2021 National Defense Authorization Act means a close look at type 1 in the VA. It mandates a report on disability compensation claims submitted by Vietnam War veterans who have Type 1 and were exposed to an herbicide agent during their service. The VA recognizes that Vietnam veterans' Type 2 diabetes can be related to Agent Orange. But it requires veterans with type 1 to provide evidence. There are some challenges here: The VA's claims decision data only goes back to 2003 and they track Type 1 and Type 2 with the same diagnostic code, they don’t distinguish between the two conditions. In 2020, diabetes represented roughly 6.5 percent of all service-related conditions for which Vietnam War era veterans received compensation.
gao.gov/products/gao-22-105143
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New study of gestational diabetes shows it recurs for nearly half of women who’ve had it before. These doctors say little is known about the risk factors for recurrent gestational diabetes. Part of the problem is that they just changed criteria for diagnosing it. In this study about 8-percent of women had a history of gestational diabetes. Of those, almost 50-percent had it recur and just over 7-percent developed type 1 or type 2 between those pregnancies.
https://www.healio.com/news/endocrinology/20220208/risk-factors-differ-for-first-time-recurrent-gestational-diabetes
XX
What’s the link between weed and a lower risk of type 2? First.. this study only showed such a link in women NOT in men and only in heavy users. In this study that means using cannabis at least four time in the previous month. No differences in the prevalence of type 2 in men who were light or heavy cannabis users versus nonusers. These findings come from a large 5 year study that ended in 2018 and in which people self-reported their use. These researchers say the gender difference was also seen in animal models. Expect more study on this one.
https://www.medscape.com/viewarticle/968186
XX
More good outcomes with SGLT2 inhibitors and GLP-1 receptor agonists. These drugs are a mouthful but new research links them with lower chances of potentially fatal heart problems in people with type 2 without established heart disease. They compared these newer meds to the risks in people using more traditional therapies, such as metformin. The researchers showed the odds of developing heart failure was 51 percent lower for people using SGLT2 inhibitors, 18 percent lower for GLP-1 users and 57 percent lower for people using both drugs. The newer drugs are prescribed less and these researchers say we need to look at why when the newer ones show better outcomes.
https://medicalxpress.com/news/2022-02-diabetes-drugs-thousands.html
XX
Some tough numbers about depression and diabetes. In the US.. about 30-percent of people with either type 1 or type 2 have depressive symptoms and 11-percent show signs of major depressive disorder. This lines up with studies from other countries as well, so it’s not just about healthcare. There’s some info in this study about how insulin resistance may go hand in hand with depression.. Women with diabetes seem to be at a heightened risk. Emerging research suggests treatment of depression with antidepressants may decrease the risk of developing diabetes-related complications, although other research suggests there may be complications related to their use.
These conflicting findings highlight the need for further research.
https://www.endocrinologyadvisor.com/home/topics/diabetes/diabetes-and-depression-and-distress-and-psychological-and-clinical-and-social-causes-insulin-and-glycemia-and-antidepressants/
XX
Our friends at DiabetesMine have a good write up about the very attractive and ever elusive state of non-invasive blood glucose monitoring.. One that caught my eye was Scanbo. This technology uses a 60-second noninvasive finger measurement instead of a traditional blood drop required to measure glucose. The company has developed a prototype. You just put your fingers on the flat white sensors and the system uses a set of algorithms to analyze and offer insight on glucose values. Like most of these we’ve reported on.. they present at consumer shows, not medical conferences and no clinical trials. And.. this is my editorial.. what a weird photo. It looks like you have to put both hands on the machine and with the chipped purple nail polish this looks like no thought was put into it.
https://www.healthline.com/diabetesmine/non-invasive-diabetes-technology
XX
At least one athlete in these Winter Olympics lives with type 1… Kamilla Kozuback was diagnosed at age 13.. and her first question was whether she’d ever be able to snowboard again. That was only four years ago! At the time she told JDRF Canada – quote, “I want to be in the next Olympics. I’m going to keep working hard, and training all I can” She’s competing in Beijing this week.
https://www.instagram.com/kamillakozuback/?hl=en
https://www.jdrf.ca/finding-strength-in-adversity-newly-diagnosed-teen-competes-in-2020-youth-olympics/
XX
The documentary “Pay or Die” gets some Hollywood star power behind hit. Susan Silverman signs on as an executive producer. We had directors Scott Ruderman and Rachel Dyer on the show last year to talk about what they describe as a look at the health care crisis in America, told through the personal stories of those with Type 1 diabetes who, because of soaring insulin costs, are living on the edge of survival.
Silverman says, “I believe Rachael and Scott might just shame our shameless government enough to move the needle,” “I’m grateful for the chance to help get eyes on this crucial documentary.”
https://www.hollywoodreporter.com/movies/movie-news/sarah-silverman-diabetes-insulin-documentary-1235084792/
XX
Our long format episode this week is Molly Schreiber who lives with type 1 and rheumatoid arthritis. Medication for the latter made the decision to get a COVID vaccine complicated and she shares her story. Next week we’re talking with the people at SIGI pump.. a new tubeless rechargeable pump that got breakthrough device designation last fall.
Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Feb 8, 2022

People with diabetes were encouraged to get a COVID vaccine early on when the shots were released. But what happens when you live with type 1 and another condition where the vaccine recommendation is more complicated?

Molly Schreiber lives with T1D and rheumatoid arthritis. Her doctors told her to absolutely NOT get a COVID vaccine due to treatment she was taking for the second condition. She was able to eventually get vaccinated then, despite taking precautions, she and her entire family got the Omicron variant. They’re fine now and Molly has a lot of good info to share. She also has several family members with type 1 and has a lot to say about how we care for older people with T1D.

Molly works at the Community Manager for Savvy Coop.

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

Type 1 Diabetes with Other Autoimmune Diseases 

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Episode Transcription Below (or coming soon!)

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DEXCOM

Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921, where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, people with diabetes were encouraged to get a COVID vaccine early on, when they were released. But what happens when you live with type one and another condition where the vaccine recommendation is… complicated?
Molly Schreiber 0:35
And I messaged my rheumatologist and I said great news. My hospital has the vaccine in I can get an appointment. You know, I was super excited. And she called my cell phone immediately and says You could not get that vaccine and it was a gut punch. What do you mean, I can't get this vaccine,

Stacey Simms 0:52
Molly Schreiber lives with type one and rheumatoid arthritis, she was able to eventually get vaccinated, then despite taking precautions, she and her entire family off the omicron variant, they're fine. And she has a lot of good information to share. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show, always so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. And one of those people had a really bad low last night, as most of you know. And if you are new, I will explain my son, Benny was diagnosed with type one right before he turned two, he is now 17. We use the control IQ system with Tandem and Dexcom. And I gotta tell you, it has been a while since that urgent low has gone off on my Dexcom app. And I really don't remember the last time he had an urgent low that he didn't treat pretty quickly. You know, he very rarely asks for my help. We are at the point now where I have turned off all of the Dexcom alerts except that urgent low.
But in the middle of the night, it was like one o'clock in the morning it went off. And I don't know, you know, usually I would have waited and just said maybe he's got it. He always had stuff in his room. But it was It wasn't in 55 It was 42. So I said, you know, I'm gonna just go check on him. And they brought up a juice box like I have done a bajillion times, you know, when he was little, it's so funny. I gotta say, you know, the juice box used to seem like a big deal, a big amount, I should say. But it looks so tiny. He’s now like six feet tall, but I brought it upstairs.
And it was immediately clear that this was a real low. This wasn't a compression low. He wasn't leaning on the Dexcom. He was disoriented, he was sweaty, he was super hungry. So he drank the juice box, I got him some crackers. And then I sat with him for a little bit. And he started to kind of come back to himself. But he was so hungry. And you know what this is like, I don't know about you. But he was sometimes I really try if I'm with him, which isn't the case all the time anymore. I tried to say you know, you've had you've had your 15 or 20 carbs or you know, when he was little you had your four to eight carbs. And let's just sit because you know, you're going to be okay. Now, you know, you're not going to be hungry in 15 to 20 minutes. But man, that urge to eat. I mean, I know his brain is screaming at him. So I was like, you know, forget this. I went downstairs and I got him some more food. I figured I can always give him more insulin for it and who knows. He just really still felt bad. So we overtreated which, again, we haven't done it a long time totally overtreated. And, you know, he finally felt better and was able to go back to bed. But you know, my adrenaline is like, through the roof. I finally did get back to bed. But I'm sure that he felt much worse than I did. I oh my gosh, it's been a long, long time. I'm sure many of you were asking, Well, what happened? The truth is I don't know what happened. I didn't ask him in the moment. I mean, he's 42 he's not gonna have a coherent answer. I don't really care. I just wanted to treat the low and then go back to sleep.
I’ll ask him tonight at dinner but I gotta tell you at this point, 15 years in the answer he has diabetes is good enough for me. My guess is he ate something and gave too much insulin. Or I know we put a new site on. Maybe that was like a super absorbent site. You know, sometimes that happens, you just hit that sweet spot. And it's just the insulin flows somehow a lot better in that place. If it was really interesting or unusual, I will report back but I only bring it up because it has been a long time. Since I've had to treat a low like that in the middle of the night. It made me remember all those times, you know, not just before control IQ but before Dexcom when that would have been you know a finger stick every five minutes while we were waiting for him to come up and you know, very different times. I hope we all get a better night's sleep tonight. And like I said, if it's anything really interesting or if there's a follow up here, I will let you know.
Alright, this week's guest is somebody I've known for a long time through the diabetes online community. She certainly remembers a different type of technology. We did get to meet in person at a healthy voices conference in Chicago nearly six years ago. We talked about that at the very end of the interview. That was so cool. Hold that conference was freezing. But man, I would love to go back to more in person stuff even if it's freezing. Molly Schreiber was diagnosed with type 1 diabetes as a child in 1989. Her father, grandfather and a cousin all lived with type one as well. In 2018, she was also diagnosed with rheumatoid arthritis. I follow Molly on social media, she's been very open about her struggle, not just with these conditions, but with how difficult COVID has been for her. You know, with autoimmune stuff, you want to be more careful. But her art a diagnosis rheumatoid arthritis diagnosis made getting the vaccine a tough decision. And then when her entire family did catch COVID During this omicron search, it made that more difficult to Molly has been a longtime blogger in the diabetes community. And I'll link up some of what she has written. She is currently the community director for savvy cooperative, and she explains more about that as we talk. I do want to say, you know, Molly really is an incredibly positive person, but she's not a Pollyanna. She keeps it real. And it was great to catch up.
Molly, welcome to the show. Thanks for coming on.

Molly Schreiber 6:08
Thanks for having me.
Stacey Simms 6:09
All right. Before we jump in, or talk about anything, I have to ask, how are you? How are you feeling as your family

Molly Schreiber 6:14
were okay, we all, you know, had the pleasure of having COVID Funnily enough, we pulled my daughter from college because it was getting pretty intense down there and gave her COVID When she got home, so really failed there. But no, we're all doing a lot better. It's been almost three weeks now. So

Stacey Simms 6:31
yeah, I'm glad. And um, you know, there's an awful lot to talk about leading up to that diagnosis, but I'm glad everybody's doing okay. Scary stuff. Yeah, this is usually where I asked people to tell us their diagnosis story. And I'd like to start there with one additional question if I could, because you don't live with just and I put that in quotes with just diabetes. Right?

Molly Schreiber 6:50
Right. I was diagnosed with type one diabetes, when I was a kid, when I was back in 1989, I'll date myself, and I knew a lot about the disease. So my father had type one or had type one and his father and then my paternal cousin. So type 1 diabetes was very much in my life, you know, needles were around testing. At that point, testing blood was not as common as urine. But um, you know, it wasn't a shock, I should say, a lifestyle change. We were already kind of living that. But fast forward to about 10 years ago, I was diagnosed with rheumatoid arthritis, which, yeah, the just living with both is definitely a challenge. They don't, you know, unfortunately, autoimmune diseases can come, you know, in pairs or in groups, you tend to be a collector, but they don't necessarily get treated, or even you have similar symptoms to each other diabetes and RA,

Stacey Simms 7:51
would you mind and Pardon my ignorance? Would you mind talking about RA for a moment what that is?

Molly Schreiber 7:56
Yeah, so the easy way to sort of translate it to the diabetes community is instead of attacking I slit cells, my immune system is attacking my joints, and specifically the synovial membrane, which is sort of that lubricating fluid that's in your joints is not immune disease, as well. So comes from the same family. As you know, and most of your listeners, we don't really know why yet, it happened to me very, I would say suddenly, and I had sort of just an elbow pain thought I grabbed a bag, wrong, you know, off of an airplane on on a weekend trip and just thought, I've asked to push that bag too hard or done something and within a month, I couldn't straighten that elbow. So my arm was bad. And I got to have the fun experience of doctors telling me I was favoring it or had tennis elbow or all sorts of fun things. But within a few weeks, I couldn't walk downstairs and I was sitting because my feet and my knees and just did not then did not work. And I quickly went to the doctor and just said something's really wrong. And unlike type one where you get a blood test, and you know, if your blood sugar is a certain number, there's a pretty good chance you know that you're going to be diagnosed with diabetes with RA, there is a blood test. Lucky for me, I tested positive but plenty of your listeners if they have RA they not not everyone test positive. So you could go down a very long treatment of trying to figure out what's wrong. What is the treatment? Is there treatment? There is there's a couple different treatments, so definitely medication. So you would start with what are called disease modifiers and the most common one that people might know of is called methotrexate, it can be used all these drugs can be used for cancer, but these are used in the RA and similar disease spaces in much smaller doses. So yes, you may if you look them up, see them referred to as chemo that they are just given in lesser doses. So we have those drugs. Most of the time. They don't do enough and you need something that's called a biologic and There are quite a few options. To be honest, this was the hardest part for me. All right, is that I went from living with type one, you know, basically my whole life and there's one treatment, right? There's insulin, everybody takes it. You know, we might have the rare person. I'm sure everyone's heard of someone that was maybe allergic but you take it it works. Does it work perfectly? No real? No, that doesn't always work the same. But everybody takes it. But with a biologic. And with other treatments with these arthritis, autoimmune conditions, it's a gamble. You know, what commercial? Did you see that maybe you want to try that one is a literal question from your doctor. Wow, it is a true gamble of what's going to work. They don't know yet. Why some jobs work and some don't for people and what works for me, if you were to be diagnosed with RA, it might not work for you. It's just a complete gamble. And they don't last forever. So some people have had success for a long time. Others have tried multiple drugs because they lose efficacy. We'd like to say that the drug failed the patient. Patients like us are tend to sort of internalize it and say, Oh, I failed that one. But no, we're gonna say that the drug failed that

Stacey Simms 11:11
I'm pausing here, I'm just gonna kind of stuttering because I'm trying to figure out how to ask this. What I'm trying to say is, with type 1 diabetes, and RA, you're mentioning insulin, you're talking about biologics and other medication, any dangerous interactions, anything that you specifically have had to look out for.

Molly Schreiber 11:24
Yeah, so a couple different things. So one of the initial treatments for rheumatoid arthritis, and it can be a treatment that a lot of patients stay on are steroids. And so plenty, you know, if you have diabetes, and you've ever, you know, had even a horrible bronchitis or pneumonia, or maybe you've had to get a steroid injection, you know, that horrible boost, your blood sugar is going to take them after you have started either that steroid pack or you've had that injection, well, a lot of patients are on a long term dose of steroids. For me, that's simply not an option. And I say that for myself, because, to me, the the struggle of managing my blood sugar as well on them. And also just the feeling of being on them is not worth the side effect of the you know, I'm not getting enough bang for my buck, you know, with with a steroid, so it's not worth the added stress. That's not to say you can't manage steroids, you know, our pumps and our different basal rates and everything, do great things. And I even have a steroid profile in my pump. If for when things get bad, yes, I will go on them. I'm not going to be too prideful. But steroids are first line of defense, they make you feel better quick, they get you back to life, you know, and for me, there's that added habit of blood sugars. But then there's also that little piece of how we're susceptible to getting sick, you know, where our cold takes a little longer for us to recover from, you know, and when you're on these additional medications, you want to keep your blood sugar in check, because when it's not, you're feeling worse, and you're more susceptible to those complications. So there's just that added caveat, you know that you want to stay as healthy as possible, but you're on these drugs that are really, they're calming down your immune system, so it stops attacking you. But in that same breath, they're also not preventing you from getting sick.

Stacey Simms 13:17
I'm going to come back to your family's experience with type one as you listen, I don't want you to think that I'm going to skim over that we're definitely going to revisit that. But keeping our conversation about ra here with COVID. You are one of the first people I remember seeing on social media in my circle, certainly that was talking about issues with either being able to take the vaccine or wondering about being able to take a COVID vaccine. Is that because of the biologic or the medications or is because of the RA condition itself?

Molly Schreiber 13:48
Yeah, so it's a little bit more on the medication side, but a lot of patients again, are on a ton of different biologics. And so at the time when vaccines first came out late in December of 2020, as their confer hospital then and with that came with being eligible to get a vaccine early, which is great. Sounds wonderful, right? I was super excited that I was in a drug club or Texan or Texans are really strong line of defense. With Ra. It's used a lot with non Hodgkins lymphoma as well. It's pretty in terms of the drugs you could be on. It's a pretty heavy hitter, but when I went on it three years ago, I needed it. My disease was in a space that needed it and it worked. I just had an infusion. So vertex in isn't infused by logic. Some people get it once a year, the earliest you can get it is every four months to talk to infusions every four months and repeat. So I was on that schedule, and I'd had an infusion in October, and I messaged my rheumatologist and I said great news. My Hospital has the vaccine in I can get an appointment. Yeah, super excited. And she called my cell phone immediately and says You could not get that vaccine and it It was like a gut punch. What do you mean, I can't get this vaccine. And she said, look, the ACR, the American College of Rheumatology, you know, like a lot of us even still, to this day, we don't know everything, still trying to figure it all out right in terms of COVID. But they know that you need to at least be as far away from that biologic infusion injection as possible for the vaccine have a chance to work. And since I had just had it, I wouldn't be due for my next one until March or April. And she said, We got to try to get you to March or April. And there is a little bit of history behind this. So a lot of patients that have been on vertex in the flu vaccine, for example, doesn't work in one dose, sometimes it's recommended that they get two doses to be able to have an immune response. So they at that time, were kind of basing it on that. And so I waited. And it was incredibly frustrating. I'm pretty sure that's probably what you saw on my social channels, was that here's this thing that we've all been waiting for, with the promise of it, getting back to our lives, but also the promise for, you know, auto immunocompromised patients like myself to feel a little bit more safe, you know, we could get this vaccine and finally feel safe. And I just couldn't get it. And so I had to wait. And the only other thing that came with waiting as I went back into our sort of statewide system of trying to get an appointment, which I think everyone probably still have stories, I'm getting an appointment or getting a test and had to wait and get my initial vaccine. I got that in April, when I was earliest I can get an appointment.

Stacey Simms 16:40
I feel like I may have missed something. I'm sure you said it. Did you have to go off your medication and in order to get the shot to get the vaccine?

Molly Schreiber 16:47
Yeah, so with the toxin and retexe intakes, obviously, everything varies, but the the longer you can have it out of your body, the better. So your body can start, you know, kind of revamping and not being so suppressed. And so with vertex and they wanted me to try to wait six months, I sort of made my own compromise of April, it would have been nice. And with that came a discussion with my rheumatologist. And she frankly told me that she wasn't keeping any of her patients on this drug until COVID was sorted. And this was again a past discussion now, right? Right now it's as we know, we're not going to stay on this drug because of how unprotected you can be against these viruses that are popping up. And she and I agreed that since I still had some other options on the table, that I would try something else. And retexe in its place, obviously, if she had patients that truly, you know, it was the difference between walking and not or, you know, work and not she was not going to take the drug away from them. But we had to have a frank discussion and with our eye, again, back to what I said earlier to gamble when you take a medication, so it was another Okay, Let's gamble and see what this next one might do. While I was on one that was working.

Stacey Simms 18:10
And then after all of that, like many who were vaccinated and boosted buzz, you know, being very careful. Masking up. You got film Kron virus got you got omachron. So I hate to say like, what's your reaction? Because I think we would all have the same reaction. But you went through so much.

Right back to Molly in a moment, but first Diabetes Connections is brought to you by Dexcom. And I get a lot of questions about Dexcom coverage for people on Medicare. And why not, it's not just that you stopped needing a CGM, the minute you turn 65. The good news is that the Dexcom G six continuous glucose monitoring system is covered for Medicare for patients who meet the coverage criteria. If you have either type one or type two diabetes and intensively managed insulin you may be covered. To find out more about what that means. And if you qualify, check out dexcom.com/g six dash Medicare and I will link that up for this episode. You don't need to write it down. It will be in the show notes at the homepage at diabetes connections.com You're going to want to talk to your doctor and you may even be able to get your Dexcom supplies at the pharmacy saving time and money learn more again it's dexcom.com/g six dash Medicare. Now back to Molly talking about her family's experience with COVID.

Molly Schreiber 19:37
So I'd had my two doses that are that had the Pfizer vaccine I had an April and May and then I actually got a third dose that they're not calling it a booster but a third dose and August because it wasn't that six months but they offered it to patients that were immunocompromised this is I know there's so much has come out from the FDA and the CDC this probably was a blip But that

Stacey Simms 20:02
now remember, right? Yes,

Molly Schreiber 20:04
it was a blip and but it was a big blip for me. And so I went and got a third dose all along. I had participated in a research study through Johns Hopkins, which I know a lot of patients have done in, they were just trying to see efficacy in the vaccine with patients with different kinds of autoimmune conditions or health conditions. And so they tested your antibodies before and after each of your vaccine doses. So with my first two, I didn't have any antibodies. I got my third dose so quickly, because I was so excited that happens hadn't been ready with their lab slips yet. So my rheumatologist tested me in November, and showed that I still didn't have antibodies. And I found that out the week before Thanksgiving, and she said, you know, you really need to just stay in your bubble. And I'm like, I've been in this bubble for a long time. But like I mentioned, I have a family. You know, my husband works at the airport, my son works, my daughter goes to college. But luckily, everyone, like you said, We're maths, they're all vaccinated and boosted. Everybody was good. We daughter's college was getting a rise in cases, and they switched exams to online. So my husband ran down and grabbed her right, the week and a half before Christmas. And then that Saturday before Christmas, we all thought a little off. And knowing that there are monoclonal antibodies that I could maybe get, if I were to get COVID, I've been instructed multiple times by all of my doctors, you know, you get these if you get COVID, call us, we took a test, my husband was positive, I was positive, my daughter and my son, and I didn't see it coming, like I said, grabbed my daughter and brought her home and gave her COVID. Right. At school, I really missed the mark as a parent on that one. But it's not a cold, it's not a bad cold. It's not what I guess a lot of people are sharing, at least it wasn't for my family. And I know that I mentioned that I didn't have any antibodies, but my family dead, they're healthy. They're my daughter's 18, perfectly healthy, and had the 102 Fever, the vomiting, the cough, the body aches like you couldn't imagine. And I the sounds so awful to say but they actually understand a little bit of what our eye fatigue is now, because it was so intense with with COVID that I just said, you know, when you felt like you didn't have that extra oomph to pull on. That's what it's like. So I did get a little taste of that. But now, you know, we're about three weeks out doing so much better. But I'd be lying if I didn't say it was a little scary, you know, at times, especially with where our health system is right now.

Stacey Simms 22:43
I'm so glad everyone is doing better. I know so little about Ra. So forgive me if this is a dumb question. Are there lingering issues or concerns that now you have to think about in terms of what medication you're able to take or anything like that, because of having COVID?

Molly Schreiber 22:57
There are so with my rheumatologist, we've been kind of you know, going back and forth. I'm incredibly thankful for portals because I could send messages whenever I had energy, it was great. She said that there's a couple things to be concerned about. She said that they've seen that a lot of patients with autoimmune conditions tend to shed the virus longer so that I'm going to say 10 days I know now it's five days, whatever it is, right? When you listen to this podcast, whatever amount of days it is that they're saying you need to quarantine for, they're saying that they're finding that patients like myself can shed it longer. So that is a concern for you know, if I were to say, Hey, I'm good and you know, go to the party I haven't gone to in many years, that's a concern for the public that the other thing is because I could still be shutting it. They're not sure when to start my biologic backup. And so basically, we're kind of going week to week my rheumatologist just wants to make sure I have zero symptoms, just not even a cough or runny nose. Nothing that could you know, taking something to oppress and suppress my immune system, you know, could trigger and so there's there's that but really, it's just the twofold wanting to keep others safe of them still shedding, you know the virus longer because like I said, we missed Christmas and my mom, you know, was like, well, when can I come up? And I'm like, I don't know. I just don't know and I'm never gonna put her at risk. So I think there's still as awful as it is so many unknowns right now.

Stacey Simms 24:34
How Okay, nosey question you don't have to answer How were your blood sugars? Was it difficult to manage? Did you do okay during all of this,

Molly Schreiber 24:41
so that is how I knew it was coming honestly, I think a lot of patients would probably identified that they could tell Oh, I should have known I was gonna I was getting sick, my blood sugar's are higher but my family got very sick that weekend. And on that Sunday, kind of boasting that the one with no in bodies just had a runny nose, you know? feeling great. And that night, my blood sugar started going up. And for me, you know, I'm home, I work from home. Like a lot of people, I kind of have a routine, you know, if I eat or drink, you know, that boring stuff that you can do with diabetes for a long time. And so my blood sugars are pretty good. Of course, there's random days for you're like, What in the world is happening, but this was consistent. This was, you know, I'm not eating something. And I'm just high, you know, it is just higher than normal. And the next morning that Monday, I woke up with 102 fever and felt awful. I actually used I mentioned earlier that I had a steroid personal profile in my pump for when I do get infusions, they come with that infuse steroids, and it has a higher basal rate and a little bit more of a carb ratio in there. And I put that on when I was sick. And so that helps with keeping my blood sugar's under control when I just wasn't feeling well enough to even deal with my pump. Honestly, I was very grateful that I already had that setup. Might be a little too aggressive. I'm not sure. But it was nice, because I don't think I would have had the energy to think through a whole new basil program.

Stacey Simms 26:13
Yeah, definitely. I totally understand that. And it's funny, as soon as you said, you look back at those blood sugars. Oh, yeah, I should have seen it coming. I mean, Vinnie said diabetes for 15 years. I can't tell you how many times we still say oh, yeah, three days?

Molly Schreiber 26:26
Oh, I still do. I've had it for over 30. And I'll be like, should I know that was coming? I've only been through this a million times. Right? Oh, it's always after during you're like, why am i Hi? She makes no sense. And then the next day or like,

Stacey Simms 26:42
you know? So, as you said, You've lived with type one for 30 years, you were diagnosed in a family that was familiar, but at a time you said 1989? Where I'm guessing, you know, my recollection, home meters are just being introduced that sort of thing. Tell me a little bit about your Dad's experience with type one, if you don't mind.

Molly Schreiber 27:01
Yeah, my dad. So my dad was diagnosed in the late 1950s. And so my dad was in the time of boiling needles of no blood sugar testing at all, a lot of guessing. He would say just living his life as a teenager without thinking much about diabetes. He got there serious about his diabetes a little bit later. But because he had sort of grown up in this non technology way of managing type one. He thought it was great that I eventually got meters, pumps and everything. But they weren't for him. CGM weren't for him, nothing was for him, he would see the value for me that it was never. But it's funny when I see that funny, but I look at kids now. You know, I remember. And it's still a fear, but it was a strong, you know, fear of my, my own children getting tightwad, you know, I just, you know, you don't want anyone to experience anything that they don't have to. And so looking back, you know, I didn't have a meter at school, because we had a home meter that sat in the bathroom, you know, I had a snack every day, you had to eat your snack at the same time. And I that was my like, big cool thing about having type one in elementary school, but I look back and you almost have a moment of going, how did I survive all that, like, I didn't have this thing beeping on May 24/7, to tell me what my blood sugar was doing. And I went to gym class and I, you know, I, I survived. And so I a lot of that, I'll look back on you know, when technology fails, or you know, a server's down and all this, I just think back to the fact that I would go to school all day, without a meter with a pack of graham crackers, you know. And I'm still here, and I'm okay. And my dad, on the other hand, my dad, he learned sort of a way that I think a lot of people with type one, including myself, you can kind of slip into where you're very regulated, you know, dinner has to be at 630 because your body has to eat it. You know, and our pumps and everything and our short acting insulin have really given us flexibility, but my father was very regimented, because that was how he survived. You know, that was the insulin they had that was knowing how much food to have in his body at certain times. And so even my husband jokes that family dinner time is 630 because when he came into my family, that's what my father did. That's when he had to take insulin.

Stacey Simms 29:34
Did you say your grandfather had type one? Yeah. So

Molly Schreiber 29:37
my, my grandfather, my dad's father had type one as well. He passed away, right? Shortly before I was diagnosed with type one due to complications, but you know, it's so varied. I don't really even know. At that point. He never would have even experienced a glucose meter.

Stacey Simms 29:56
He diagnosed you know, the date or the year.

Molly Schreiber 29:59
So my dad was born in 48, January of 48. And I believe his father was mid 20s, when he was born so early, a long time ago, and so my dad got it. They used to tell him that diabetes always skipped a generation and a sex. Have you heard that I'm sure you have. And so my cousin who's female has it as well. And that really fed into my dad's thinking of that my dad was the oddball that if he hadn't gotten it, it would have fit the, you know, the mold would have followed the program, you know, but he really blamed himself that I got type one, he really, you know, for a long time, it was really hard for him, but he's also the one who knew to test my blood sugar. You know, my mom took me to the doctor 10 times, and I poison ivy that gave me type one of all the things I got poison ivy, and then just stopped eating and got out, went to the bathroom a million times, and my dad got frustrated and tested my blood sugar. So he didn't see it that way that he had saved me, he thought that he gave it to me. So it's a heavy emotional burden.

Stacey Simms 31:14
It's really hard. Yeah, such an emotional experience. And that's, you know, it's so difficult you think about the tools that that generation didn't have, and how they they did the best they could,

Molly Schreiber 31:22
yeah, so my dad, he, you know, had a bad low when he was living on his own. And this was back in 2015. And he fell and hit his head. And, you know, my father had had a onesies bill of five. And when I say that he lived a very regimented life, he did because that fear of, you know, what could happen if you didn't manage your diabetes was very prevalent, you know, for him growing up. And you know, he had laser eye surgery at Hopkins, when they were still testing on monkeys, like he had a very real fear of losing a limb and more, you know, really suffering. And so he managed himself extremely tightly. And that came with a lot of lows, you know, and we'll all say that your agency is only reflective, you know, of the broad range, you know, it doesn't show the 30s, you know, that you had, and even growing up, he had bad lows, I have many recollections of ambulances coming to the house. And so he had a bad low has had and was admitted to a nursing home, because he just wasn't 100% Ready to care for himself. So just rehab sort of the the problem is, and kind of mentioned this with technology. So we have the tech, right, we have glucose meters in every office everywhere. But even the nursing home staff didn't understand what type one was. So he would tell them, I need my insulin transferred from the hospital without any insulin, she would say, you know, be put down as non compliant. One of our favorite words, right, because he wouldn't eat because he knew his blood sugar was high, but they wouldn't test it, they wouldn't give him insulin, they thought he was just like a type two. And if he wasn't going to eat, he didn't need any insulin. And they would reference him and he said, it doesn't matter what type I am, I need insulin. To the point that, you know, he, no matter how much education we tried to provide, no matter how much he tried to provide, on his end, there was even one night he called an ambulance from his nursing home bed for insulin, because he needed insulin. And the true story is he ended up in DKA from this, and he passed away from it simply because nursing home staff and I'm not generalizing, I personally have not been in a nursing home, but I can only go by his his information of what's happened and others have shared, they simply didn't understand that insulin, you know, is, is air and water for us, you know, we need it, we cannot live without it, and ended up in DKA and didn't come back. And that all stemmed from lack of understanding diabetes, which has been around forever. I just mentioned my great career, my grandfather, it's been around a long time. And so it's really important to me and I, I've talked with a lot of fellow diabetics who are, you know, and early 40s. And we've talked and it's a real fear. And that kind of comes into COVID. You know, what if you end up in the hospital, and can't manage your own disease? And so I think that that's a real fear, even today, you know, if you get COVID, if God forbid, you know, need to be on a ventilator or just are unable to care for yourself what happened?

Stacey Simms 34:36
No, it's absolutely terrifying. And I know that sharing that story is not something that you do lightly. You know, it really is amazing to see these concerns. I don't know how well they're being addressed. All we can do is keep talking about them, and keep educating. So thanks for bringing that up. I do appreciate it.

Molly Schreiber 34:54
Yeah, I don't have the answer. Like you said that. I think we'll figure something out of everyone just shares and

Stacey Simms 35:00
Before I let you go, I do want to ask you about your job because you're, you know, we've been talking what we basically talked about for the last few minutes is patient advocacy. And that is something that you are you're doing in your job day to day with savvy, tell me a little bit about what this organization is and what you're doing.

Molly Schreiber 35:15
Yeah. So savvy, cooperative, founded by two patients to Jen is in the juvenile arthritis space. And Ronnie are other co owners, the cystic fibrosis space and like myself, like probably a lot of people you know, and even you to have had the pleasure of being at, you know, the different tables, you know, pharma tables, companies that are trying to make products better for, you know, all types of different health conditions. And eventually, like myself, Ronnie, and Jen found themselves looking around the table and you see the same faces. And I've met some great friends that way. But are, you know, are all the white women at the table really representing the patient voice of rheumatoid arthritis? You know, and we're being asked questions like, well, what does someone do you know, when they can't afford rent or medication, I am privileged enough to not know what that feels like. And a lot of people are in So Jen, and Ronnie just said, What can we do. And so they started this Co Op. And what that means by a co op is a co op is owned by its members. So we're literally a patient owned organization. And what we do is, quite simply, what I just said, is try to bring every voice to the table, try to have, you know, if a product is created for the HIV community within the HIV community to be at that table, creating that project, you know, and that product and medication and treatment. And so that's just like a very nutshell of what we do.
But we basically have people come to us, and they want to know more about a health condition, or they have an ideal treatment, or medication or an app, or a variety of things. And they asked us to find the people and maybe do the research and do the interviews, and at the end products and ideas and medications or treatments are being co created with the patient, rather than the patient at home seeing a commercial and going well, if they'd asked me, I would have told him that doesn't work. benefits, both the company and the patient. And thing I like to share that's a great example of what we do is a lot of people have heard of Amazon, I'm going to go ahead and assume and maybe even Alexa, and they did a study with us where they wanted to improve Alexa so that people would voice impairments, like stutters and different things could communicate better with her. And now they have a patch that anybody can get add into their Alexa. And it lets more people use that technologies here. And so that is just a small example. But I think it's a great one, you know, showing how something that they took to actual patients and had patients use and give feedback now benefits the greater world and all patients. And so that's what we do, I realize I give a very, you know, nutshell, I work in communities and the community director, which means I get to talk with patients and partners organizations all day, which is a great fit for me because as a patient, which is gathered by now, I really wouldn't want any patient to not feel like they're part of the community, and that they're alone in their journey or that their voice isn't important. So if you know one person hears this, and it's like I've already in diabetes, which I'll reference the great Rick Phillips did for me years ago, made me feel like I wasn't the only person that had those conditions. And if that happens because of this will Stacy, you've done a huge job. I haven't been here.

Stacey Simms 38:57
I hope that happens. It's really as we've learned over the years, right? How just knowing that there's somebody else out there going through the same stuff makes a huge difference. Just one more checking if I could with your family. You mentioned you picked up your daughter, you know you wanted to keep from having coverage came home Scott COVID. How's everybody doing now?

Molly Schreiber 39:14
Everyone's doing okay, much, much better. But it's not lost on me that anyone can get this again at any time. So we're staying in a safe and our masked bubble for now.

Stacey Simms 39:25
Gosh, well, thank you so much for joining me it's so much fun to talk to you. I just you know I have to mention I remember when we first met I don't know why this just popped into my head maybe it's cuz I was I just miss traveling so much. Did we meet in Chicago

Molly Schreiber 39:37
at healthy freshmen airport? We I was

Stacey Simms 39:41
Yeah, I was wearing that blanket thing that I wear like really heavy winter coat anymore. Yeah, we met in the airport in Chicago. Geez.

Molly Schreiber 39:50
Yeah, that's where we met and I it was one of those great moments where you're like, I know you but now I actually know you you know like, it's like my honor. Lying knowledge and then by in person, which is the best because you really know people then

Stacey Simms 40:04
isn't that the time when there was this thing going around the internet, the kids probably call it a meme. But there's this thing going round where it was like, the only really good thing about the internet sometimes is when you meet someone in PR person that you know from online, it turns that first meeting from a handshake to a hug.

Molly Schreiber 40:20
Yes. That's what it is. Yeah. And I do now right now, I picture us waiting for our car together. years ago, too many years ago, because we've been traveling so long.

Stacey Simms 40:34
Oh, my gosh. All right. Well, here's to travel in the future. At some point, Molly, we will grab that cape blanket thing out of my deep recesses of my closet and we'll we'll meet again.

Molly Schreiber 40:45
Yes, we well.

Stacey Simms 40:51
You're listening to Diabetes Connections with Stacey Simms. I will link up more information about a lot of what Molly talked about there, including information about savvy cooperative, yes, that is the group that I have linked to in some emails. And in the Facebook group, a bunch of you have signed up to take part in their research studies. So if you're interested in that, be on the lookout, when it's relevant to our group, I will definitely share that with you. And sometimes there are opportunities to get paid, which is always nice.
It was fun to think about travel again, by talking to Molly and I have some things tentatively on the calendar, you know, you're always afraid now to you know, we got to make plans. But who knows. So I'm excited. In March, I should be going to Syracuse, I have an event at Syracuse University. This is an annual or at least it was before COVID and annual alumni event that I always have a lot of fun in. I'm trying to set up some kind of diabetes event as well, maybe for moms, maybe for families. So I'll keep you posted on that. I am talking to some local diabetes people in the Syracuse, Central New York area, and hopefully we can work something out.
Then at the beginning of April, friends for life Indianapolis is on registration is open. I still haven't pulled the trigger on that I haven't committed to going yet. But I'm pretty sure I'm going to maybe you can help me make up my mind. I think I'm going to be there. But regardless of me go if you're in that area, this is a great regional conference. And the hotel has like these train car rooms. It's a train station that's now a hotel. Definitely check that out. And looking down the road. There's gonna be some local events here in the Charlotte area in April and May and then it'll be friends for life in Orlando in July. So I'm hoping that there will be more in person events as the year goes on. Cross your fingers and hope we stay safe. Man, I'm not sure that it's I'm ready to say anything about a return to normalcy, but it would be a lot of fun to just see some people again and make those connections that you can make them online but there is just you know, as you know, something so different about him person, and I missed that. I miss that a lot.
Alright, thank you, as always to my editor John Bukenas from audio editing solutions. Thank you for listening. Wednesday, it is in the news. Don't forget I do this every week. We are live on social media and then it becomes a podcast episode that'll be out on Friday, just five or six minutes of news in our community. And next week's interview. Have you heard about the Sigi pump? This is a brand new insulin pump. It looks like it's going to be a competitor to Omnipod. There's some really cool features. It's not here yet, but I'm talking to this company about why they are trying to bring it to the US as soon as next year. We'll see what happens with the FDA and everything else but man this pump is really cool. And I can't wait to tell you more about it. Alright, that is all I am Stacey Simms. I'll see you back here soon. Until then. Be kind to yourself.

Benny 43:44
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Feb 4, 2022

Every week “In the News…” brings you the top stories and headlines around the diabetes community. This week: Omnipod 5 is approved, T1D families win a NYC field trip lawsuit, the first drug to delay type 1 DX gets a second chance and getting glucagon without a prescription
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Join us LIVE every Wednesday at 4:30pm EST on Facebook and 4:45pm on Instagram

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

Join the Diabetes Connections Facebook Group!

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Episode Transcription Below (or coming soon!)

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DEXCOM

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days. If you’re new we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast.
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Looking to get organized? Check out my new guide with top tips to clear your diabetes clutter. Everything from how to start to where to donate and how to keep it from taking over your house. Head over to the home page to get organized.
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Our top story.. Omnipod 5 is approved. The US FDA has okayed the system more than a year after it was submitted – held up like a lot of other diabetes tech due to COVID. This is a hybrid closed loop which means you still to give insulin for meals but it will work hard to keep you in range. It’s the first system approved with phone control and with a bit of A-I.. the system uses what it learns about you to improve dosing. I spoke to the company’s medical director for the podcast this week and I recommend you listen to that episode for tons of detail on how the system works, what makes it different from what’s already on the market and details about insurance, Medicare and a lot more.
XX
Medtronic is sending out a letter this week to everyone who received one of its new or replacement insulin pumps within the last six months to remind them to make sure they have saved their basal insulin rates on their devices. This is considered an “urgent medical device correction” notice and was prompted by a series of injuries recently due to the use of pumps that had not been properly programmed.. they came out of the box with no basal rates which is normal.. and for whatever reason, users didn’t know to enter them. Moving forward, Medtronic will look into making their pump menus more user-friendly and updating the educational materials that come with the box to be more clear. It’s a good reminder that whatever pump you use, keep track of the programming – we take photos of my son’s pump settings with his phone and back the photos up periodically.
https://diatribe.org/medtronic-issues-urgent-basal-insulin-reminder-pump-users?utm_source=facebook&utm_medium=organic&fbclid=IwAR0Gsn8KugMTcuzvFKXL7xfZeUgSeHJ9BZzqi7lL38bpuG1qyFrp59i3ooE
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Big ruling in favor of kids with diabetes and other disabilities.. federal court has found that New Yrok City’s Department of Education routinely denies students with diabetes access to field trips and bus transportation. Three sets of parents of T1D kids and the American Diabetes Association sued the district after no care was provided for students on field trips and that the policy of “we’ll call 911” was insufficient for bus riders. The court has ordered the district to train bus drivers and attendants in the use of glucagon and will hire nurses to help on field trips. Many states don’t mandate nurses on fields trips, just trained staff, but NYC does and that made it very difficult for them to follow their own rules. Worth noting, these parents did not seek monetary damages, but filed the suit with the hope of policy change.

https://www.diabetes.org/newsroom/press-releases/2022/federal-court-rules-children-with-diabetes-in-nyc-denied-equal-access-to-field-trips-bus-transportation
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For the second year in a row, in 2021 - more than 100,000 Americans died from diabetes. The story, as reported, is that now Congress should overhaul diabetes care and prevention, promoting consumption of healthier foods, ensuring paid maternity leave, put taxes on sugary drinks and expand access to affordable housing, among other areas. But – and this is just my opinion – they could also tackle the price of insulin and other diabetes medications and supplies. That’s mentioned in this report, but well down the list and isn’t what most of the headlines have picked up on. About 37 million Americans, or 11% of the population, have diabetes, and one in three Americans will develop it in their lifetime if current trends continue, according to the commission.
https://www.reuters.com/world/us/exclusive-us-diabetes-deaths-top-100000-second-straight-year-federal-panel-urges-2022-01-31/
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Another chance for teplizumab. The FDA says Provention Bio can resubmit its application for this therapy to delay type 1 diabetes. The drug has been on hold since the agency questioned whether the planned commercial product was comparable to the product used in clinical trials. The resubmission should be ready to go “in the first quarter," the company said. Teplizumab was granted a breakthrough-therapy designation by the FDA but was rejected last year.
https://www.fiercebiotech.com/biotech/provention-s-med-for-delaying-diabetes-granted-go-ahead-for-fda-resubmission
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Michigan’s attorney general is taking a close look at Eli Lilly, accusing the drugmaker of charging excessive prices for insulin. She’s asked a judge to authorize a probe under the state consumer protection law, including the use of subpoenas to get records and to interview company officials. Michigan supreme court rulings have prevented this kind of investigation before.. the attorney general says those decisions were wrongly decided and “have served to end many consumer cases, and have prevented countless others from ever beginning.”
https://www.usnews.com/news/best-states/michigan/articles/2022-01-26/michigan-ag-seeks-to-probe-eli-lilly-for-high-insulin-prices
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North Carolina law goes into effect this week that allows pharmacists to dispense emergency glucagon without a prescription. There’s not a lot of detail on this – I’ve reached out to local pharmacists and they didn’t know about it. My question is.. which glucagon do they mean? The old red box one or the newer Baqsimi or Gvoke Hypopen? My guess is that whichever, the no prescription may mean paying completely out of pocket.. but I’ll find out. Interestingly this was part of a bill that also makes birth control available in NC without a prescription which I’d think would be bigger news.
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A couple of weeks ago, Dr. Heather Walker was a guest on the podcast.. she is the author of (Un)doing Diabetes: Representation, Disability, Culture… and that book is now available for purchase! As we explained during the episode.. this book explores popular media representations of diabetes.. everything from TV, movies, theater, fiction, fanfiction, fashion and more. It’s meant for academia but you can get it on Amazon.. and I’ll link it up.
https://www.amazon.com/doing-Diabetes-Representation-Disability-Palgrave-ebook/dp/B09QYGLB3S/ref=sr_1_2?crid=Y4JJCSJ18KAQ&keywords=%28un%29doing+diabetes&qid=1643724695&s=digital-text&sprefix=undoing+diabetes%2Cdigital-text%2C72&sr=1-2
XX
As I mentioned, our long format episode this week is with the folks at Insulet, makers of the omnipod. When that device was approved it bumped out the episode I had scheduled so next week we’re talking about what it’s like when type 1 is just one of the auto immune conditions you live with.. and the other one makes it very difficult to get a COVID vaccine.
Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

 

Feb 1, 2022

The US FDA has approved Insulet’s Omnipod 5 Automated Insulin Delivery System. This system was submitted more than a year ago but has been delayed due to COVID 19. Stacey talks to Dr. Trang Ly, Senior Vice President & Medical Director at Insulet Corporation who explains what makes this system different from the other AID systems on the market, what phone control means, what the roll out will look like, insurance issues, Medicare and more.

Omnipod 5 FAQs from Insulet 

DiabetesMine's write up of Omnipod 5

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

 

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

Join the Diabetes Connections Facebook Group!

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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 (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

DEXCOM

Learn more about Dexcom help for veterans here 

Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921 Where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, the US FDA approves Insulet’s Omnipod 5 automated insulin delivery system. This was submitted more than a year ago but has been delayed due to COVID 19. Let's hope this approval signals at least the beginning of the end of that logjam at the FDA.
Welcome to another week of the show. I am always so glad to have you here I am your host, Stacey Simms, and we aim to educate and inspire about diabetes with a focus on people who use insulin. If you are new to the show, my son was diagnosed with type one right before he turned two back in 2006. He is now 17. My husband lives with type two diabetes. I do not have any kind of diabetes. I have background in broadcasting. And that is how you get the podcast. And for this episode, I am so excited to speak to Dr. Trang Ly, Senior Vice President and medical director at Insulet Corporation. Insulet, of course, makers of the Omnipod. I asked for questions within our Facebook group. It's Diabetes Connections, the group and boy to do come through. But because Dr. Ly is part of the medical side of Insulet, I'm sure you understand there are some questions she just can't answer she it's not her realm of expertise. But I promise we will follow up in the weeks and months to come. And I will do a deep dive into what is such a huge story for our community. I am always so excited to see more choice for people with diabetes and automated insulin delivery is a game changer.
Let's go through the basics. Because while many of you just want to get to “when can I get this in my hands. And I've used this product for years. And it's basic forms, I just want to get the loop..” Let me just take a quick second and set the table because there are a lot of people new to pumping and to pods. And I just want to be absolutely clear. And this is going to be very simplistic Dr. Ly we'll get into many more details. But the pod is what sits on the body. That's what holds the insulin and infuses the insulin into the body. There are no buttons, there's no display, there is a separate handheld controller. This could be a phone, we will talk about that. And that is how you control the pod when it comes to giving insulin for meals, you still must give insulin for meals with this system. With Omnipod 5, you also have the Dexcom G6 that is the continuous glucose monitor. The pod and the CGM work together, it very simplistically gives you more or less insulin to try to keep you in range.
There are similar systems on the market already. The Medtronic 670 was the first like this in the United States. Now they have their 770 G system. Tandem has the control IQ system. For the record. That is what my son has used since January of 2020. And Omnipod system is a little different on these systems all have differences from one another. But as you'll hear the Omnipod system is the first in the US that will actually learn from you. And we'll talk about what that means Omnipod 5 is going to launch through the pharmacy channel just like previous products and will still have no contract. And they are offering what they're calling a limited market release. So this is not going to be available tomorrow to most people Insulet has a Frequently Asked Questions section on their website that I got to say it is one of the most robust I have ever seen in my 15 years of diabetes. So please go there. If you don't hear your question answered by Dr. Ly. I'm going to link it up at diabetes connections.com There will be a link in the show notes.
And as I said, we're going to be covering this a lot more this year. And make sure you tune in every week I do a short newscast episode. We do that every Wednesday live at 430 on Facebook and YouTube. And then I turn that into an audio podcast which comes out on Friday. Those are five or six minutes long, and I'm sure we're gonna have Omnipod updates there. Okay, usual disclaimer, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Dr. Trang Ly, welcome back. And congratulations.

Dr. Trang Ly 4:28
Thank you, Stacey. I'm super excited to be here with you.

Stacey Simms 4:31
I feel like we should have a confetti cannon that started this episode.

Dr. Trang Ly 4:36
Just Oh, it's been incredible few days.

Stacey Simms 4:39
I'd like to talk a little bit later, perhaps about more of your personal feelings. You've been involved in this for so long. And when we spoke in August, you were really generous about sharing some more of your experiences, but I know everyone who's listening wants to get into the nuts and bolts. So let's start by just jumping right in. Tell me what was approved by the US FDA. Let's talk about what Omnipod five is.

Dr. Trang Ly 5:02
Yeah, so Omnipod five is our tubeless automated insulin delivery system that we've been working on for quite some time, and that the whole entire community is excited about. I'll talk about it in terms of the components of the system. So we have the tubeless pod that many people will know and love today. And that essentially stays the same that has added features. So it has the smart adjust technology, which is our algorithm inside the pod, and that delivers insulin every five minutes and can increase decrease or pause insulin delivery based upon the CGM value, so the sensor glucose value, so we are connected to a very important part of the system, which is the Dexcom G6 sensor, great sensor accurate. And that is connected wirelessly to the pod, the person wears the pod and the CGM. And they can have on body closed loop control. Another key component is our controller device. So every person who is prescribed Omnipod 5 will have access to our Insulet provided controller, which is basically the remote controller for the system. And on that is our Omnipod 5 app, where they're able to control their pod and do all their settings for the algorithm. And what is really quite unique about what got cleared and announced on Friday is that patients will also have the option to control their pods from compatible smartphones. And so that is really quite a unique advancement in technology in diabetes, for automated insulin delivery systems. You don't have to use the smartphone to control the pods, but that optionality is there for compatible smartphones. So that would in certain cases, replace the need to carry the Insulet provided controller?

Stacey Simms 7:13
Yeah, we'll definitely talk about the smartphone aspect. As you said, this is a first in many ways. So I want to talk about that in more detail a little bit later on. And another component of the system then is the Dexcom G6.

Dr. Trang Ly 7:25
That's right. And I think what is unique about this is that you'll be able to control the G6 from the G6 app. So all of that start stop sensor, all the calibration, all of that, and the Dexcom follow all that functionality that people are familiar with today stays the same in the Omnipod 5 system.

Stacey Simms 7:49
Okay, we know I needed to clear that up. Because you started off by saying you control it from the G6 app, do you control it from the Omnipod 5 app?

Dr. Trang Ly 7:56
No, you actually control it from the G6. Yeah, that is slightly different to other systems that are on the market, the G6 sensor is stopped and stopped through the G6 app. And then you have the functionality of the Dexcom follow with our system with Omnipod. Five, when you set it up, you enter in the transmitter ID for the Dexcom. And what that allows the Omnipod 5 system to do is connect to that transmitter and display that information front and center of the Omnipod 5 system.

Stacey Simms 8:37
You know, it's funny, I'm sure as we're talking, we're gonna get into a lot of the weeds here because they went straight into the weeds. And I know that we'll talk a lot more as this year goes on. And there's more and more people use the system. But I do want to kind of try to stick to some of the nuts and bolts. Yeah, I'll catch myself here. It's definitely it's not you, it's me as we're going through this. Let's talk about how the system tries to keep people in range, because one of the things that many in my audience are watching very closely are the customizable targets. So you can take Omnipod 5 and customize your glucose target from 110 to 150. Is that still the case that that's what was approved?

Dr. Trang Ly 9:14
Yes, that's correct. That was what was approved. So you can set up see during the day, you want to be at 120. And then overnight, you want to be 110, you can set up a profile that would reflect that, you know, if you're someone who is new to AI, D and you generally tend to run a little bit higher, you don't want to be at 110 straightaway and you want to you know, run at 130. For a while you can set that profile, you can set that 24 hour profile with glucose targets. And that is a unique feature of our system. And that's what was tested in our clinical trials and we're really pleased to be able to offer this level of customization for our patients.

Stacey Simms 9:57
Tell me a little bit more about smart adjust, my listeners And I almost hesitate to ask this. But my listeners are incredibly in tuned to their devices. They have already taken so many of these devices and tried to customize them as much as possible. Many people are trying to adjust their glucose many times an hour. I wonder sometimes about the the adjustment, and no, no pun intended with smart adjust. But the adjustment of people who you kind of need to leave these systems alone, I guess is what I'm trying to get at Have you already come up against that? Or is there any advice you tell people to kind of like ease into the system like this when they're used to making a ton of adjustments themselves?

Dr. Trang Ly 10:34
Yeah, I do think there is some adjustment that needs to be made when adapting to an automated insulin delivery system. But I think a lot of your listeners will be fairly familiar with this type of technology. And really, it is the ability for the system to react to the CGM that's coming in and dynamically adjust insulin every five minutes. I mean, that is what is really the value here in within our system. So smart adjust is our algorithm. And the feature that is really going to set Omnipod 5, apart from the other systems out there. And it is what we tested in our clinical trials, which, as I mentioned, you on our last poll, you know really had extraordinary results in terms of timing range, a one seat reduction, and then that hyperglycemia profile, which was very low hypoglycemia. So I'm really proud of the system that we have built, it is something that we, you know, made improved upon, over the years through our clinical trials. And it was really developed from learning from our patients and all of the of the participants who took part in in our trial. So it really is a real love letter to the community who have advocated so hard for this level of innovation.

Stacey Simms 12:00
One of the very unique things about Omnipod 5 is that in reading about it, you always say it learns the user, right? It kind of changes as it goes in, it adapts which is brand new, this is not something that any of the other automated systems on the market commercial systems do. Can you explain what that means? Yes.

Dr. Trang Ly 12:18
What about design philosophies going into this is simplicity for the user. We know diabetes is an incredibly burdensome condition. And it was important for us that we did not, you know, through delivering automated insulin that we didn't make life even more challenging for people and requiring more attention. We really wanted to create more headspace for people to forget about their diabetes and do other things. Omnipod 5 is a real advance on that front. What we talk about in terms of learning and adapting is that our system initially takes the basal rates that are entered by the system as a starting point for the automatic controller, and then the algorithm as more information comes in, which includes the CGM values, and then the total insulin that is delivered by the system. Based upon that information, the algorithm will augment how much insulin the patient needs at baseline, and then with hyperglycemia, and hypoglycemia as well. Perhaps the most stark example of this was when we had a adult patient who came in who had relatively high A1C, starting point, so probably was not getting as much insulin as she needed. And so had a starting insulin program of around 27 units a day. And then over time, it was about two weeks where the insulin delivered by the system actually ramped up to close to 70 units a day. And that's just in basal insulin

Stacey Simms 14:03
from 27 to 70. Seven Zero. That's correct. Wow.

Dr. Trang Ly 14:07
Yeah. And so that that's a fairly extreme example. But what it shows is the capability of the system to take in new information and make adjustments along the way. And the whole point of that is really to reduce the work that people and parents have to make in terms of, you know, tweaking those basal rates, because, you know, we want to add a system that would reduce that type of burden for these. We're doing as much as we can for our users in this first system. But there will still be the ability for, for users to augment the insulin to carb ratio and correction factor. That all works exactly the same. So if your insulin sensitivity changes over time, you may need to make those adjustments, but the ability for the algorithm to adjust that baseline insulin delivery that day Damage Control does adapt based on new information coming in over time.

Stacey Simms 15:04
I said, Wow. And I want to be very clear on why I am. So I want to stand remember the confetti cannon, I said at the beginning, I want to fire it again. I, I fought I mean, I can only speak to my personal experience. I'm not a health care provider, I'm not an endocrinologist. But I talk to so many parents who feel like their kids aren't doing what they're supposed to be doing, quote, unquote. And then the doctor says, Oh, my gosh, you have to double the basal rates. And suddenly, it's working again, because things can change so much. And we don't know exactly. I can just think of my family as an example, when Benny was a tween to teenager, his basal rate doubled within two years, and then doubled again. And he was getting these incredible amounts of insulin. And when I would tell my friends, a few of them would say like, I could never do that, that sounds so dangerous. I can't believe how much he's getting. And I mean, I've shared he was getting 80 units of basal a day of just basal. And he's back down. It's not it's not even close to that anymore. But he needed it. And I just feel like, gosh, I was gonna ask you to give an example. And I'm so glad you gave that one. Because to know that the system can learn that much and safely give that big of a change is remarkable. I'm curious, did you have any changes in the other direction, like people who were really worried about people who were really experiencing? hyperglycemia?

Dr. Trang Ly 16:23
Yeah, Stacey, going down is easy. Going up is hard. It's, you know, and I'll tell you, it takes some courage to do these types of things. And people are scared, and I will share that I was scared in making, you know, some of these decisions. But, you know, I have learned so much from patients, I've taken care of teenage boys, like your soul, you know, who, who need more than 100 units a day who fluctuate between 70 and 120 units a day in a week. And that's what we need to be doing is helping people like that, you know, who who really struggle and have different insulin sensitive Rudy's on a daily basis and different requirements who are at risk of both hyperglycemia and hypo. And honestly, I carry that with me every day, you know, all those learnings and say, you know, we have to create products that can, you know, address this, because this is what we're trying to help here

Stacey Simms 17:39
right back to Dr. Ly, in just a moment, but first Diabetes Connections is brought to you by Dexcom. If you're a veteran, the Dexcom G6 continuous glucose monitoring system is now available at Veterans Affairs, VA pharmacies in the United States, qualified veterans with type one and type two diabetes may be covered. Picking your Dexcom supplies up at the pharmacy may save you a lot of time to connect with your doctor for more information. Dexcom even has a discussion guide you can bring with you get that guide and find out more about eligibility. Here's the link, I'm going to put this in the show notes, it'll be easy to find it's dexcom.com backslash veterans. But if you don't want to write that down again, it'll be in our show notes at diabetes connections.com. And now back to our conversation with Dr. Trang Ly.

This next question may not make sense with the system. But you tell me, I wanted to know about the percentage of correction bolus that Omnipod 5 gives. And you know, my frame of reference is the Tandem control IQ which my son has used, which the system adjusts basal, if you get close to 160, it gives you a partial bolus if you get close to 180. Is there anything like that going on here?

Dr. Trang Ly 18:51
Yeah, for sure. And what I'd say is that rather than having that modular approach that the other system has, you know, als really has that dynamic insulin delivery every five minutes. And it's pretty straightforward. Basically, whatever target you said, the system is always driving towards that target. So, you know, you can be 110 all day and do that. And, you know, when we did our clinical study, the adult and adolescent population, so this is the 14 and older age group, the target that they used most frequently was the 110 target. And in those patients during the time that they were using that lowest target of 110, they were able to achieve 76% time in range, really great to be able to do that. And so I would say it's basically that straightforward. Whatever target you set the insulin, we're going to adjust insulin to try and get you there as quickly and as safely as possible.

Stacey Simms 19:55
If I'm hearing correctly, though, maybe with this system, we don't think about it as Adjusting basal giving a bolus. It's more, there's an algorithm in here. And it's proprietary. But there's an algorithm in here, and it's just giving insulin as needed. Is that what I'm hearing?

Dr. Trang Ly 20:11
That's right. It is a hybrid closed loop systems that people are still expected to bolus for meals. Right. So that's really important for people to do. And you know, to in order to really get good glucose control, it's important that people premium bolus and work with their healthcare providers to really optimize that insulin to carb ratio and correction factor that yes, our pancreas don't think in terms of basal and correction, those are concepts that we made up, you know, as I tell my team insulin is insulin, you know, it's basal correction, whatever, it's really, you know, how much insulin on board there is, what the trajectory is, and you just make the adjustment accordingly. So, yeah, I don't really separate it

Stacey Simms 20:57
out. new way of thinking really interesting. Again, I'm going to get us off topic here. But I am thinking of the people who've never pumped before and jumping into a system like this, and how much different that must be.

Dr. Trang Ly 21:08
Yeah, we always think about those patients, because we think pump therapy is just a much better therapy in terms of the physiology of insulin delivery, and it's just a much safer, and modality there. So, you know, actually, in our clinical trial, we had about 15% of our users who were on multiple daily injections. So they came in, and we put them straight on Omnipod 5, so they didn't have to first use a pump, or first use the CGM, they just came straight in, we put them on Omnipod, five, and they did really, really well. And we've presented that data at various conferences. So they really did, ultimately, just as well as the people who had previously been pumpers, it is very simple and easy to use. And that really, the simplicity of our system is what makes it so great. And it really reduces that burden of you know, having to pull out pens and syringes when you're out and about and, and be able to discreetly deliver insulin from a phone device. I think, really, that is what sets our system apart from other systems is it's the simplicity and ease of use.

Stacey Simms 22:23
I'm gonna give you a couple of specific questions from our listeners, if you can't answer that. We understand. And I actually have worked in a bunch of questions already. As you listen, I'm getting to as many as I can. But one came up that I thought was interesting, which was, is the system robust enough to defeat a 350 blood sugar on its own, you know, I think everybody's been there. They forget to bolus they're eating a big meal, they realize it too late. And then with these automated systems, you have to be very careful about how much you correct. And then there's a second part of this question, which is, if I do want to give an additional shot for any reason, will the system keep track of something like that?

Dr. Trang Ly 22:58
I guess it depends on why your 350 in the first place. So if it's from food and underestimation of carbs, or you forgot to bolus then I will tell you that by the time you are 350, the algorithm has already known that and it has already delivered a bunch of insulin to bring you down, it will bring you down and it will generally do that in two to three hours and get you within range below 180. Within that time. And we know that because the development of Omnipod 5, we specifically gave people these large meals and didn't bolus for them and watch the algorithm and see what it would do. And, and part of the reason why that's so important is because we know this happens to people all the time, and we want to safely bring them down, but not cause rebound hypoglycemia, because that is not good. And people will not trust the system and will stop using it. So that is exactly the type of testing that we do. So I would say that it is very robust and is very specifically targeted for that in terms of the question of if you give a shot not through the pump, then no, the system would not know about that. But what it will detect is, you know, a falling blood glucose level, and it will be able to suspend insulin delivery very quickly. And depending on the rate of change of glucose, it could suspend, you know, even if it's in the two hundreds, it could suspend very quickly. And as far as I'm aware, actually, none of the commercial systems are able to import that information. So you would have to do that very cautiously because the system isn't aware of that external insulin.

Stacey Simms 24:51
It's an interesting question. You know, we've we've done that, you know, sometimes there will be a bad infusion set or things will happen. I mean, obviously the pod it's a little different and you'll want to give them Manual injection. I understand what you're saying. And I think it was, it was a good question, but it's practically speaking, we're not gonna be able to do every circumstance.

Dr. Trang Ly 25:07
That's right. Yeah. Unless we had like this really special insulin detector.

Stacey Simms 25:16
Why don't we have that yet? Special insulin detector get on that?

Dr. Trang Ly 25:21
Well, you know, well, technically, it's very hard to do insulin assays. So, yeah, anyway.

Stacey Simms 25:28
I guess, you know, in layman's terms, what I what I think of a lot is, okay, if my son needs to give an injection, can he just put in Okay, pump. I gave myself this much. Because with the older non smart pumps, or before there were any hyper close loops, you really could do that. You could kind of fake a dose.

Dr. Trang Ly 25:44
Yeah, you can't with our system. Yeah. Yeah.

Stacey Simms 25:50
I don't think you can do that with any of the automated systems. Now, another quick question, before we move on to smartphone, can you extend a bolus, this was something that came up, can you still do that, or if you can't do you even need to, you can

Dr. Trang Ly 26:02
if you're in manual mode. So manual mode is basically on the pod Dash. And that is when you set it up with the settings that, you know, you discuss with your healthcare provider, and they preset basals and bolus settings. So if you're running that mode, or if you happen to, you know, not have a CGM and you don't want to run an automated mode, then you will have that functionality to have extended bolus. And there are a number of reasons. But we actually looked at this in a clinical trial that we did specifically looking at high fat meals and using extended bolus with our algorithm versus just letting the algorithm work. And what the results showed was that with high fat meals, the algorithm was better in terms of figuring out how much insulin you needed, then a person trying to figure out okay, how much do I give up for and how much do I extend? And because of that data, we decided not to include the extended bolus with our algorithm. side. So in automated mode, extended bolus does not work.

Stacey Simms 27:17
Great. And, and you lead me then into the next point, which is, can you expLyn the manual mode? This is not something that the system decides you're in, right? This is the user saying, okay, I'd like to be in manual mode or no, I'm going to be in auto mode. In other words, you can't get kicked out like on the Medtronic system.

Dr. Trang Ly 27:31
Exactly. So the manual mode, as I mentioned, is all the preset settings that are programmed into the system. And then automated mode is when you have a CGM connected to it. And as long as you have CGM transmitter ID entered you are and you know, your targets set up, you can off you go. And so the setup of the system is very similar to Omnipod dash, except there is an additional step where you enter in the transmitter ID so that the pod knows which CGM to search for. And then once that value comes in, and in fact, you don't actually have to wait for that value to come in, you can just start automated mode, and then the system will use the information that it has to augment insulin delivery. Got it?

Stacey Simms 28:25
Let's talk about the phone. Because I think this is incredibly significant. It's a first for the FDA, it's just going to open the door in my opinion to so much other technology. Yes, right. Now, as you and I were talking, there's only two smartphone models that works with that's gonna change. But let's go down and talk about these features. This is full control allowed from a smartphone, right?

Dr. Trang Ly 28:44
Yeah, I was so excited about this feature. I mean, see, it's the number one feature that our patients ask for over ad over automated insulin delivery, which kind of really blows my mind. I will I

Stacey Simms 28:57
was, you know, I've shared with you, I was gonna say I'm actually a little bit more excited about this. And I, I kind of ended high because automated control is so is so incredible. But phone control is also I mean, my son is he cannot wait for this. It's just, we don't even again, we don't use your system. But yeah, wait, it's just such a great thing. So before I start getting all crazy, let's go through some of the features full control from the phone.

Dr. Trang Ly 29:21
Yeah, and I want to say that, you know, as a pediatric endocrinologist, I totally under appreciated the how our patients valued having phone control, and being able to control their devices from their phone. And it wasn't really until I saw the data that where everybody might have this is their number one request that I was like, huh, we better start listening to patients. Because in my mind, you know, if people aren't using their devices, they're not getting any benefit from automated insulin delivery. So it's really important that we address all the pain points. For our patients, I am really proud of the team for getting this through and getting this clear, it is just so meaningful for our patients, I think it's really important to clarify that if we don't have the phones that we currently have available, it doesn't mean you can't use a ID, that you can't use Omnipod 5, you know, our system will always come with an Insulet provided controller, and you know, you can use it as a separate device. But you know, very, very quickly, we're going to have many phones available where you can download an app, it's as simple as that it, it works on your phone, just like any other app, you open it up, and you input your settings, just like you would setting up a brand new controller, and then you start and stop your pods and manage everything just from your phone, and then you're getting rid of that controller device, you know, you're carrying fewer devices. That's what it is. And you know, in future, we will have iOS and Apple devices in future. We haven't set a timing for that. But you know, all of that is in the works. Because, you know, we care a lot about reducing the friction for people to use and access Apple devices. So I'm very excited about it. All right,

Stacey Simms 31:21
I know you can't give me a timeline. But you said very quickly is very quickly this year for Android and next year for Omnipod is very quickly quarter two for Android and end of this year for kind of get any timeline for

Dr. Trang Ly 31:34
I know, I can't provide any timelines. But you know, the team's working on it. And you know, I get to see the prototypes, and I get to test things out. So it's super fun for me, but I am sorry, I can't provide any time timeline

Stacey Simms 31:47
updates. You know, one of the big questions that came up Omnipod, five is going to come out with limited release. What does that actually mean? And how do you decide who gets it first? And who gets it next? Is it geography? Is it when people signed up? How does it work?

Dr. Trang Ly 32:01
I know everyone is super excited about Omnipod. Five, and especially us as a company, I think it's really best practice before we do anything big in life to start small and make sure that you know everything, all systems are working. And you know, we are doing a lot of innovation actually, not just with the product, but also the way we serve patients in terms of our onboarding platform, our self guided training, ordering, product support all of that. So it's quite a large undertaking for our company. So what we're doing here is making sure that everything goes well and, and is smooth for our users before we embark on the full launch. So right now, just in the next few days, we'll be rolling out our limited market release. And then once we have all the information we need, and all the data to make sure that we can handle all the demand that comes in will be then announcing our full locker release. And we expect that to be in terms of timely, just shortly after the limited. Release is complete.

Stacey Simms 33:10
Okay, but I have to ask a follow up on that. But to be clear, then it's a limited release for the people you've decided we'll get it. Yes. And then it goes to everybody. So it's not going to be a rolling limited release? No, it's a so then my next question is the first question. How did you decide the limited release? Who are these people,

Dr. Trang Ly 33:29
we haven't provided details about that. And part of it is really to make sure that we have, as I mentioned, you know, really assessed our full systems and making sure that, you know, we can address the demand that will be coming in. So I think what people what our patients really need to know is, you know, how did they get on products? That's certainly the number one question that I'm getting is, how do I go on Omnipod? Five? And how do I prescribe it? So you know, for that, I would say that today, you know, getting on Omnipod dash is the fastest way to get Omnipod 5, because for those users, that means that they are most likely have access through the pharmacy channel. And then we expect that our Omnipod 5 coverage will be very similar to our Omnipod dash coverage. So if you're already on the dash, it's expected that you know once Omnipod 5 is available and there is insurance coverage which you know, we're ramping and growing every day then that transition should be very very smooth. And also you know in terms of devices you know, if you're already on and only Pradesh and you're on a G6 you can go through our self guided training and so you know already being familiar with our system and devices that makes it a lot easier in terms of training and transition but also it in enables you to get onto our interest list for Omnipod. Five. And what we'll be doing once it's fully available is really going through that list in in order of people's names on it to make sure that they have coverage and getting them Omnipod. Five as quickly as possible. We're really committed to our current dash users. I mean, all of our new pod users were fully committed to

Stacey Simms 35:23
do people need a new prescription to move from Dash to Omnipod 5?

Dr. Trang Ly 35:27
yes, it's a different product, it's an entirely different product. So yes, they will need a new prescription. Okay,

Stacey Simms 35:33
because that was one of the interesting things with when Tandem rolled out control IQ. Sometimes as you listen, you know, you got to get in touch with your endocrinologist once once it starts rolling out. Right. That's one piece of the puzzle we have to make sure to include, um, you mentioned Dexcom, questions came up Dexcom G7, knock on wood could be approved in the United States this year? What will that change over look like when it goes from G6 to G7 for Omnipod 5?

Dr. Trang Ly 35:57
Yeah, so were working on next in terms of integration of the physical integration with G seven. We're working on that and future sensors. So we haven't announced any timing in terms of when Omnipod 5 would be available with G seven. That is something that we're working on. Even if G seven gets cleared this year. We certainly haven't announced any thing in terms of Omnipod 5 compatibility with that, at this point in time

Stacey Simms 36:29
about Medicare, it is the Medicare coverage expected to be seamless, and supplies seamless for that population. Yeah,

Dr. Trang Ly 36:36
so in that population, you know, we have fairly good coverage for that. And again, growing and as well, and Omnipod dash is available through the pharmacy channel. And as I mentioned, we have great coverage. And already today with Omnipod. Five, we actually have more covered lives right now than we had even just, you know, a few months after Dash was launched. So the team has, you know, our team has made extraordinary progress on that front to ensure that you know, when we're at for release, our patients can get access to that as quickly as possible.

Stacey Simms 37:19
And I should ask the clinical trials where ages six to 70, while the lower limit is something that you have talked to your endocrinologist about people over the age of 70 can still use this device, right?

Dr. Trang Ly 37:30
correct way, clade full six and over no problems for our 70 plus population.

Stacey Simms 37:36
Excellent. What about the rest of the world? The question was, has it been submitted for CE marking Europe, my friends in Australia, your friends in Australia are like what's going on?

Dr. Trang Ly 37:45
I know I I'm like really behind in my emails. Because everyone in Australia wants it, it's gonna come, we have to get it cleared. And you know, our first hurdle was getting across the line in the US. So you know, I'm just super, super excited to get it. And it means we have a great product and you know, our clinical trials prove it. And in time, it will get to all of those places.

Stacey Simms 38:16
I know have kept you longer. I have two more quick questions for you. The second last here is will Omnipod and Dexcom work together on the customer service side now that you are linked as a system? Will customers be able to work with both? If you're not familiar, as you listen with Tandem? Sometimes you call Dexcom? Sometimes you call Tandem. When you have issues. The Tandem can send you replacement sensors, things like that. It's not it's not a seamless partnership. They want help with everything. But I'm curious if Omnipod and Dexcom will start working together in that way.

Dr. Trang Ly 38:47
Yeah, we have. We've been working together for years, in fact, to get this right, because we care a lot about customer service and taking care of our patients. So the teams have been working together very, very closely to make sure that there is warm transfer between both companies for our patients. And that means you know, whatever we can address we address and whatever Dexcom addresses they'll be addressing. Yeah, so as you point out, it is different to some other models that are out there, in that these are really two separate devices. And that means that we're not handling Insulet is not handling any of the sensor orders. But we're just really focusing on on the pod. And I think what that allows us to do is you know, allows each company to do what we're really good at and not like try and figure out how to be dispensers of sensors, that allows us to really scale and move quickly in this space. And again, it's a different type of way to serve customers. But at the end of the day, we don't want to be wasting our time. It's time over these things because they got better things to

Stacey Simms 40:03
do. I meant to ask when we talked about the phone control, and the phone display is a follow feature going to be part of Omnipod 5? So caregivers, spouses can look, yes, we

Dr. Trang Ly 40:13
already have that today with Omnipod View app with the Omnipod dash. So, you know, that's really great and really great, especially for our pediatric population. So that capability already exists today. And we will be providing that later in the year.

Stacey Simms 40:30
And then before I let you go, you and I've talked several times during this interview, and when we last spoke about how you have worked with patients for a very long time, you've seen the burden that diabetes puts on people and how systems like this can start to alleviate some of that. I can't imagine that you've had that much time to reflect it just got approved last week. But you know, how are you feeling about this going forward? It's a combination of so many people's work over the last several years. I mean, I guess what I'm saying is, take a second take a victory lap.

Dr. Trang Ly 41:02
Yeah. See, it's been a pretty emotional week for me to be able to bring this to fruition, I think I really carry the spirit of many of my patients, you know, those types of interactions just never leave you. And just a lot of gratitude this week for what we'll be able to do for a lot of families. I love

Stacey Simms 41:28
it. I'd love to have you come back on or maybe when the system has been out for a while we can talk to some folks who've been using it and and kind of dig a little bit more into how it's helping. But thank you so much for being so accessible for answering so many of my questions and congratulations, I it's I know it's been a long time coming. And I'm so excited for my friends who use Omnipod to have this new choice. Thank you so much.

Thanks, Stacey.
You're listening to Diabetes Connections with Stacey Simms.
More information about this I know you probably still have questions, go to diabetes connections.com for a couple of links, including that frequently asked questions section, it really is very robust, and can answer a lot of what Dr. Ly was unable to get to. It's so exciting. Boy, I know. You know, we're not Podder's, we have not used the Omnipod. But oh my gosh, I know the community has been waiting so long for this. I'm so thrilled for more people to get an automated insulin delivery system, it has made a huge difference with my son. And I can't wait to hear what you all think I know some of you. And some of the people in our Facebook group were in the clinical trials. I don't know how much you all can talk about that. But if you want to post about it, if you'd like to tell me more, you can shoot me an email Stacey at diabetes connections.com. I'm just so excited.
Two quick things before I let you go. First, at the top of the show, I briefly mentioned Club 1921. This is our brand new project, it is still in beta. And it is where anyone with any type of diabetes can find events anywhere in the United States. If you have diabetes, or you love someone who does, you are already a member of club in 1921. If you go to the website, club 1920 one.com, you will find that it's very easy to sign up for free. And we will send you the events you're interested in, you never have to come back to the website, you just click a couple of boxes, tell us what you're interested in. And we will send you the events. If you'd like to list events, you can also sign up and this is for everything from big conferences, to educational events at hospitals, to you know, a Hangout moms at a playground, going for coffee, whatever you want for the diabetes community, any type of diabetes, any type of event anywhere in the United States. As I said, we're still in beta, I'd love for you to sign up and let me know what you think. And if you haven't already guessed why Club 1921 I'm sure most of you have guessed that is the year that Banting. And best and the rest of their team are credited with the discovery of insulin.
The second thing I want to address is it's a little selfish, but I want to share the Omnipod story, this kind of breaking news. This kind of stuff is why I started the podcast. Many of you have heard the story before. But if you are new, I started the podcast in 2015. Because there were and there still are a lot of really good diabetes podcasts out there. But most of them were people telling their personal stories. And that's great. And they were mostly adults. And you know, as a parent of a young child at the time with type one I could relate but it wasn't exactly for me. But more to the point. There was nobody doing diabetes news and that's my background. I was a local TV reporter and Radio News host for my entire career for 25 years plus, and I had just left a career in morning radio because I was so tired to get up at three o'clock in the morning. That's I'm sure you can imagine I did that for 13 years. And I was trying to figure out what to do next. And I realized that There was no one covering diabetes news. And it's not just saying, Oh Omnipod 5 is approved. It's asking the questions that you just heard. I mean, I guess it kind of sounds kind of braggy to talk about this. But to be frank, as the parent of a child with type one, and as the spouse of somebody with type two, I want to know this information. I want to hear it from these companies, I want to ask follow up questions, I want to call them on it, when we have questions that they aren't answering, or we have issues that they're not addressing, whether that's a technology company, or more to the point the insulin companies and things like that.
So if you're new, I hope you go back, we have a great search box on diabetes connections.com. It's in the upper right hand corner. And there's if you click on the episode page, you can get there's more than 400 episodes, you can go through the archive, but I urge you to search for what you like whether it's technology or issues, that sort of thing. And you can really see these products, we started talking about them five or six years ago, and follow them through development, see how things have changed to me. It's so interesting. And there are very few places to get our questions answered. Your a lot of these folks will go on the financial channels and talk about the company. And I'm thrilled, as you probably know, Omnipod stock went up, I don't own Omnipod stock or Insulet stock, but it went up last week. Hurray, that's fantastic. But I care less about that than I do about knowing what they mean by you know, the system learns you, right. So thanks for giving me the opportunity to just kind of share why I find this stuff. So exciting. This is why I started the show. And I hope you enjoy listening.
if you have questions, if there's issues you want to hear more about, please let me know you can always reach me through diabetes connections.com or on social media. And boy, what do you think is next has this loosened up the logjam at the FDA are we gonna see other issues that have been waiting? We've got bullets by phone from Tandem. We've got stuff from Medtronic that's out there waiting, we got tide pool loop. Oh my gosh, I hope 2022 proves as exciting as it has started out. Please join me every Wednesday for in the news. I do that live on Facebook, YouTube, LinkedIn, and at 445 on Instagram. And then we turn that into a regular podcast episode that comes out on Fridays. That's just five or six minutes of the top news headlines in our community every week. And then on Tuesdays, I do these longer format interviews. They usually go up at four o'clock in the morning Eastern time. This was a little different if you're listening as it is first released because I did the interview with Dr. Ly today. It did it at one o'clock this afternoon. And then we turned it around and got it out as quickly as possible.
Thank you as always, speaking of those kinds of audio heroics, 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 soon until then, be kind to yourself.

Benny 47:49
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

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