#710 Joanne Milo Wants Her Data
Scott Benner
From Joanne:
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Do you like continuous access to your CGM BG data so that your DIY Loop WORKS?! Do you know that we might lose that access with Dexcom G7 and Abbott Libre3 has never allowed access?
I NEED YOU TO ACT ... IT MATTERS!
Please join me in a letter-writing campaign to fill their inbox with our comments and concerns! NOW!
Suggested text:
"I live with insulin-requiring diabetes, an incurable chronic disease requiring continuous monitoring of blood glucose values and administration of insulin. It is imperative that access to my own devices remains possible. The ability to receive glucose values from my continuous glucose monitor and the ability to command my insulin pump to deliver insulin are already permitted and expected of me. In fact, if I don't do these, I will die. So please do not let medical device manufacturers use cybersecurity as a pretense to prevent me from accessing my own devices."
When you put your name (or even if you post anonymously) consider including ‘pwd’ or ‘t1d’ or however you identify yourself as someone with diabetes, I.e. ‘Sally Smith, T1D’ so that they know our community has a voice
You can see the comments that have already been submitted and approved: https://www.regulations.gov/docket/FDA-2021-D-1158/comments.
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DISCLAIMER: This text is the output of AI based transcribing from an audio recording. Although the transcription is largely accurate, in some cases it is incomplete or inaccurate due to inaudible passages or transcription errors and should not be treated as an authoritative record. Nothing that you read here constitutes advice medical or otherwise. Always consult with a healthcare professional before making changes to a healthcare plan.
Scott Benner 0:00
Hey everybody, this is Scott and this is episode 710 of the Juicebox Podcast. This episode was not planned, so I'm squeezing it in on a day where you don't usually get an episode. What you're about to hear is a quick little 30 minute conversation with a lady named Joanne Milo. Now you may know Joanne and you may not. But Joanne founded the Facebook group called loop and learn, as well as being a longtime type one and a longtime type one advocate. Joanne is here to talk about a notice that's been posted by the FDA. And it is open right now for public commenting. Actually, it's open until the seventh of July 2022 at 11:59pm Eastern Daylight Time. That's the last chance you have to make your voice heard. In short, this is about removing CGM from this document so that people living with diabetes don't lose access to their data. Joanne is going to spend a little bit of time explaining why she thinks this is so important. I'm going to tell you at the outset that I believe it's very important that I'm adding my name to the document and giving my reasons. If after listening to this quick conversation, you still need help putting into words why it's important for you. Joanne has written a sample letter that will be in the show notes of your podcast player and at juicebox podcast.com. But I'm quite certain that after the conversation, you'll be able to form your own thoughts and opinions. If you'd like to share those opinions with the FDA. There's also a link in the show notes, a link at juicebox podcast.com. And a link at the private and public Facebook pages where you can do that. There is no time. This needs to be done in the next couple of days. So if you are so moved, please get it completed before the seventh of July 11:59pm Eastern. This will be in my post online but they are Joanne's words. She says we want the FDA to listen to us. If our access to our CGM data is blocked. Innovation dies, I hope you're able to take the next 30 minutes to listen to the conversation that Joanne and I had to really absorb what we're talking about, and hopefully make your voice heard. The call to action here is to get the FDA to not consider CGM as part of this language. Is that Is that correct?
Joanne Milo 2:25
That's correct. They seem to be first of all, can you hear me? Okay, I'm using a headset now. Sounds terrific. Issue is an error clouding it under cybersecurity, that that the CGM companies do not have to release our access to our data, real time on our own devices. And but they can sell it to third parties. They can license it. And it's our data. And they don't have a right to block us. And I have the the laws that say that they can't. It's been enacted. It's it's called the 21st century cures, I think can't do what they're doing. But if they don't hear from us, they can do anything they want.
Scott Benner 3:07
How much of this do you think is just the FDA not knowing what they're doing and just throwing in every device that somebody could think of in a meeting to a pot and saying, Well, this stuff seems like it fits under this heading.
Joanne Milo 3:21
I think there's a tiny bit of that. I think they don't feel very comfortable in what they're doing. But they're also listening to the CGM manufacturers, we've had meetings. We have a small working group, and we've met with the director of diabetes devices with the FDA. We've met with two or three times with Dexcom on Jake leech, and Andy Bello. And we've asked both of them, will you be restricting access to our data of the g7? Dexcom? Just won't answer that. And it would be so easy to say no, we will not block your access. But they don't say that. And the FDA says we're not planning any legislation, which doesn't say they're not going to do this. And to say that it's cybersecurity is really not the issue is our data. It's our diabetes, it's our lives. And if you cut off our access, you also cut off innovation. The DIY community is what pushes development of new products. And if if we don't tell them what we need, and we don't go ahead and say this is what it is. There's very little effort that they're going to make because it just cost them more money on development. We do a lot of the upfront work and they need to listen and appreciate. I have heard Dr. Trang lie say that she does appreciate this community. We just need to make sure the access continues. And while the FDA says they listen to the community We haven't been sitting very much very loud. Right? Now we need to.
Scott Benner 5:05
So let's give people some context, because it's easy to say, if this happens loop won't work anymore. But, you know, I point out all the time. I mean, how many times is looping downloaded? Right? It's, I mean, it's amazing. But what are we talking about 20,000 times something like that?
Joanne Milo 5:24
Yes. In terms of the actual end users, right? Yeah, it's much less than the DIY community. And with more options with commercial systems, it probably will be less over time. But also, when you use a commercial system, you are also giving them access to your data and their partners, you know, the, the terms and conditions that we all just check off. But what that says is they have free rein to use their use the RS, our information, our data with their partners, whoever their partners choose to be, what if their insurance agency, what who do we don't know where it goes? We can't control that. But we can at least say give us our data.
Scott Benner 6:16
Yeah, join. I asked, because I'm trying to put myself in the position of I'm trying to say to myself, let's say I'm at the FDA, and I get 100 or 200, or 500 letters from people after people hear this? And they tell me, No, you can't do this. Here's why. And they give you a good solid reason. How hard is it going to be for me not understanding the world diabetes completely look up and say, Well, how many people have type one diabetes? And what are we getting 500 letters, because that's going to look like nothing. And and that's why I want to have the conversation with you. And while I'm happy to chime in about it. And so let me just say it for anybody that's listening. My daughter has had type one diabetes, and she has to she is 18 in a month. And on our way to college, we have been using a do it yourself algorithm called loop for maybe three years now. In that time, my daughter has suffered minimal, if not any dangerous lows. While her a one C has been better than most people walking around with a functioning pancreas. Her life is easier, it's better, it's healthier, in ways that I could go on for about for an hour in ways that people who don't understand diabetes don't even know exist, it helps her immensely. If you take her access away from that, you are going to raise her agency a point probably, you're going to make sure that her after meal spikes are now 200, not 140, you're going to make sure that she has more lows, you're going to take away flexibility. And I know there are retail systems, and I've used them, and I've seen them, and they are terrific. And for the vast majority of people living with diabetes, they're going to be an amazing improvement. But that doesn't mean just like Joanne said earlier that we shouldn't be pushing the envelope and we shouldn't be changing. And we shouldn't be changing how people work on these things. diabetes innovation in the past and in the recent past has gone so slowly that it was almost non existent. And then a small group of people pushed right with we're not waiting, and then it got faster. And that benefited companies that make CGM products. And now we have these retail systems. On the pod five we have Medtronic version, we have tandems version, and they're absolutely terrific. But there's going to be to Joanne's point, no reason for them to try harder if nobody's pushing them, and they're not going to push each other, and the FDA is not going to push them. And what I'm going to tell you right now that sets loop apart from every retail system I've seen so far is a user defined target blood sugar, and a more aggressive reaction to a rising blood sugar. Those are the two things that in my heart, make loop on another level. You absolutely agree. Yes. Right. So, so really think about what you're, if you're listening from the FDA right now, or from these companies or anything, what you're doing is going to take and raise people's agencies. It just is and I know you're doing a terrific job. But you got to keep doing that job, you got to go back to the FDA and say, hey, look, we made our algorithm we targeted 112 and a half, we need to be able to make this thing a target of 8090 100 We have to let people decide which is really what we're talking about right now is, you know, this thing exists in the world. The companies didn't make it. The the government didn't make it right. People made it people got together. I mean, think of how amazing that is. People got together wrote this algorithm. And it's amazing. Then they made it free. They didn't try to make money off of it. And they they keep it up. They they continue to make it better. It's really one of the more beautiful things I've ever seen in my life. And now we're seeing Hang? Well, we're going to restrict the data that comes from the CGM. And so this loop just won't work anymore. It'll it'll be functionalists. Without that access, and I agree with you. I don't see how this is a cybersecurity issue. And even if it is, I'm using it on my own. It's do it yourself. I've decided I bought a car, I put new wheels on it. That's on me. I put a new muffler on it. That's what I made. It's nobody's fault for didn't do it. I did it. Right. And so if I want to take this risk for my daughter, or if adults want to take this risk for their children, first of all, I'm going to tell you, it ain't much of a risk, because that thing works beautifully. But But if I want to do that, I that's got to be what America is really. i That's my decision. Right? And so, I don't know, but talk more about I'll go on forever. It get me all upset already. Joanne, we're 10 minutes into this. Okay,
Joanne Milo 10:51
well, I know. So it makes the FDA start to manage your own diabetes, or person with diabetes, I don't need their help. I don't want them as a partner in my medical care. There are more studies on the DIY loop systems and open APS than exist on any of the commercial systems. Because we've been studied so much because there was so much suspicion. There's way more data we do well, we are efficient, we create better outcomes, with no downside, no damage, no worse than any other system, because human beings run them. There are laws in place, the 21st Century Cures Act was enacted in 2016. To accelerate medical product development, and bring in new innovations and advances to patients. If you purely rely on commercials, commercial systems, going through the FDA and their process and their trials, what you get approved is four year old technology because it's taken that long for them to bring it to market. DIY is instantaneous, the pushes to updates are constant and immediate. We don't have to wait for the FDA if there's something that needs to be fixed gets fixed immediately. And there's no need to stop that. There's also the individual rights under our HIPAA access to health information, the individual's rights under HIPAA to health information that you cannot have your information restricted, right. So just it was passed in 2020.
Scott Benner 12:30
And it doesn't matter if that means on paper or digitally in the form of of live CGM data.
Joanne Milo 12:35
It's your necessary medical information. I consider my CGM and blood glucose information absolutely essential like a speedometer on a car. I gotta know how fast I'm going have brakes and accelerator?
Scott Benner 12:51
Well, I think you made a point there that I'd like to kind of tack on to, which is four or five years from now, the retail systems are going to work more like Luke does. But you lose a generation of people every time you take away options. So I'm going to tell you, I've interviewed 1000 People who have type one diabetes, and you get stuck wherever you start. So wherever you're diagnosed is the world you live in. And if you diagnose me 10 years ago, I started having outcomes based on the technology that existed then I get diagnosed 20 years ago, I have outcomes based on that. If I get diagnosed today, I have outcomes based on this. This podcast is incredibly popular because people want to take control of their health. And I'm not, you know, I'm not over here saying something crazy. I'm just telling them understand how insulin works. And one of the only ways to understand how insulin works is to watch it in real time the CGM have been they've moved us forward, you know, at a lightspeed type pace. But you're eventually going to get back to where you are now. Like, you're literally you're here already. Like instead of slowing it down and giving, you know, companies time to catch up? Why not just let things go at the pace they are? I think you're exactly right with what you said earlier, there's a small band of dedicated people who are out front blazing a trail, just like we did trying to go to the West Coast, you know, just like we did trying to go to the moon, we're out in front. These people are blazing the way they're taking the risk. They're really, I mean, they're doing you a grand favor.
Joanne Milo 14:28
Well, that's also the struggle we have, because the other mandate that the FDA has been given is to emphasize interoperability. So I can pick any CGM. I can pick any pump. It's my choice in any algorithm. It's our mandate to do interoperability and they, they are not doing that. So it's all this development. And just really, honestly, because you and I both know the folks in the innovation of DIY If we are blocked by the FDA and manufacturers, you know, these people will somehow break into this, it will take a while. And why would you throw more obstacles in our path? Isn't diabetes enough of an obstacle?
Scott Benner 15:15
Yeah, you make a good point, like, look, look at what we're really talking about here, right? Like somebody sat down one day with a CGM and their insulin pump. And they said, these two things are not designed to talk to each other. But I'm gonna make them talk to each other. And then they did. You're talking about brilliant people, these aren't five guys in the backyard trying to turn their lawnmower into a go kart. You know what I mean? And I can use the case of beer at the end for the seat, I believe. But but but these are brilliant people who love somebody who who uses insulin, or they use insulin themselves. They're trying to save their own lives. Right. And so I mean, your points just so valid. If you're the government, and you think there's a real cyber security risk here, if you really think that somebody is going to get it in their mind, to go into my daughter's CGM device and change her readings in a way that's going to hurt her. I mean, what are we talking about? How many times has that happened? Ever? You like who's doing that. But even if it happened once, you're saving 1000s 10s of 1000s of people's health. And, and these people took the risk, they said, I'm going to take this risk, they, whatever happens next is on them, it's about the most American thing I can think of, it's the least American thing I can think of is to step in and tell them, hey, you know what, you want to do better for yourself, you can't, we're gonna stop you. We're gonna save you from yourself. These people don't need to be saved, they've already done it. And they're making it better and better for more and more people.
Joanne Milo 16:51
And they're sharing it, they're making it absolutely open and available. They need to stop treating us people with diabetes as bad guys, we're not bad guys. We're just trying to live better and live through this disease. And the kids, we want the kids to have a better life.
Scott Benner 17:09
It can't be It can't be emphasized enough. That the way that things are, listen, I'm all for things being safe. I don't want anybody taking a drug or using a device that isn't safe. And I understand that slow and steady proves out. It probably is the way things are done. But at this point now, how old is loop? Right? Like it's been going on for a while now. And it's proving that moving at a faster rate is not being done by giving up safety, security or health. It's not like we're leaping forward. It's not like they put out a version of this thing. And 20 people are dead. And they go oh, well, you don't I mean, like it's it's incredibly safe. It's been validated over and over again, I I love my daughter more than anything on this planet. And I without blinking and I put her on this system, because of because of the validation that's gone through. And because of the the community that that comes right out and says, Look, here it is, this is what's happening. This is how it looks when I use this system. It's people being open and being honest, I trust what I'm seeing from people, as much as I would trust anything. You know, I don't understand it. Well, I want to understand Excuse me, what else this inspect it impacts beyond loop. Are there other things that this would stop from happening? Because I'm trying to think how do you get more people to write like, third, like, I don't know, like something like sugar pixel, for example, that little like clock that that gentleman makes that vibrates your bed and wakes you up in
Joanne Milo 18:44
class, it makes an amazing machine that also has variable alarms, because we do tend to get accustomed to the alarms and we don't hear them.
Scott Benner 18:53
That not work. If this happened,
Joanne Milo 18:55
it won't give live stream data. It will not loop file it will not get live stream data nets. Nightscout will not get live stream data if they walk it
Scott Benner 19:05
right now, a company like sugar mate could because they have they're in a business arrangement with Dexcom, for example,
Joanne Milo 19:12
correct right there on by tandem. So I'm sure they're grandfathered in to get to be a partner,
Scott Benner 19:19
right? But I'm not going to be able to call Dexcom up at Scott and say hey, I'd like to be I'd like to be a partner here so I can get my data in real time. So you're gonna have to be, you're gonna have to be part of it, you know, the people that they allow in.
Joanne Milo 19:30
Now, we've asked, we've asked Dexcom to give us a price. How much do I have to pay a year if I pay $25 a year? Can I have access? Can you give me a key? No answer
Scott Benner 19:42
here because that's what I was gonna say is it can't we just my my wife brought this up while we were talking. She's like, why can't they actually my son who doesn't have diabetes overheard the conversation. He goes, Why can't you just like, click a box or sign a waiver and say cool, let me have it anyway. I mean, listen, the easiest thing to do here And I think the best thing to do here is nothing. If if you're going to tell me that something has to happen, then there still has to be a pathway around that. I mean, this is all computers, right? Like there's if it's If This Then That like, so there's got to be a checkbox where you can say, Listen, whatever happens is on me click, I understand. I mean, we run the whole world that way, I signed a mortgage in a PDF document. I'm, I'm pretty sure I can, I can tell people I'm excited to use, you know, an algorithm on my own.
Joanne Milo 20:31
Oh, I've asked some of the the new commercial closed loop systems, could I take a test? And then you let me set my target range? Can I prove to you that I know what I'm doing. And then you let me manage my diabetes a little better with your I'll pay you for your machine. Not yet. Because they say the FDA, the FDA says them, I don't know who it is.
Scott Benner 20:55
But but I've said it to in many, many interviews, I talk about it this way. Say if you look at something called Adobe Elements, it's a, you know, it's a it's a program you get on your computer. There's a tab at the top Beginner, Intermediate. You know, you click you decide like and every tab you click on gives you more functionality. Because if you want listen, if you want to kill loop right now, that's all you have to do is you just have to make the existing algorithms user definable for target. And you have to make them user definable for how aggressively they're going to try to stop a rising blood sugar. It's all I'm sure they all do it.
Joanne Milo 21:37
Absolutely. And the FDA doesn't necessarily think well, how do I qualify people to be capable to do their own settings? And quite honestly, why would I let a lot of the endocrinologist do the settings because that's not what they do. They understand the big disease, but they don't understand the algorithms, they they are happy that then the commercial systems are out because it's not the responsibility anymore. They don't know it, and which is fine. But if we're willing to learn it, let us be,
Scott Benner 22:11
I want to reiterate, because I don't want to be blase about this. I'm gonna by name on the pod five control IQ, the thing that Medtronic has, for the vast majority of people living with diabetes, they are their Mecca, they're the most amazing thing that has ever existed on the planet, there are going to be people who have been walking around with eight 910 1112, a one sees, who are just suddenly and it's going to see magically be having an A one see in the sixes, it's going to save years off their life and health problems that it should not be, it should not be food. This it's an absolutely amazing thing. I think that every one of those companies deserves all the credit that comes along with this.
Joanne Milo 22:52
Those systems are remarkable. And I always tell my groups, diabetes, it's really hard. It is nonstop. It's unrelenting, it's dangerous. And you're 24 hours away from dead is constant. And if you want to kick back and let someone another device take over how wonderful, I'm considering the opening part five, just to really reduce the burden. But then I got a can't get the results. Why can't they let me do the results? That's all I'm asking. Yeah,
Scott Benner 23:25
I could even foresee someone hearing me say that. Or you say that go well, hey, listen, the ADA says sevens the target. So what are you worried about? And to that? I would respond, I would say, well, that's not up to you decide.
Joanne Milo 23:36
That's correct. Right. My body my data? Yeah, that's
Scott Benner 23:40
it. Just listen. For 20 years, this has been on the horizon. You know, data is not something we understood 20 years ago, how important it would be, it gets co opted along the way it keeps happening. It's going to keep happening. Like someone has to say something. I don't know that anybody listening to this, like, Listen, if you're hearing this, and you think I don't even use loop, or I don't know what sugar pixel is, or I don't care, you do care your killer eventually. And we're just asking people to reach out to the FDA, and explain to them that you need access to your data. And it can't be It can't be restricted.
Joanne Milo 24:19
And what I explained to when when the group members just said, Well, I don't use that, oh, I use a share. Why does this affect me? And that doesn't, she's happy. She's doing well. That's wonderful. But we do live in a community. We are a part of this world and we are part of the diabetes community, whether we like it or not. And if we want the next best thing that that goes after Cher, she won't get that if there's no innovation.
Scott Benner 24:45
Yeah, I don't. I would take umbrage with what you said it does impact them. They just don't know how and they can't see the pathway to it. It impacts them because at some point, when my daughter who's had diabetes since she's two is 30, and doesn't have any of the side effects that may come with type one diabetes, even at a seven a one C, people will take notice. And there'll be more and more innovation. And I'm telling you right now, it's every company is going to want, they're going to want people to be able to say, I want my blood sugar to be this, I want it to be this, I want it to be this, they're going to want it to happen safely, which of course should happen. But there's, there's not going to be an end to this. But you can slow it down by removing. By removing reasons why you would go faster with your innovation every time they go back to the FDA, it cost them money, it's not an easy process to go through the FDA, it's not a cheap process, it's not a quick process, nobody's excited to go through an FDA filing, they're just not. But if you put them in a position where they have to, well, then they have to. And if you put them in a position where they don't have to, then you're living in a world where my daughter was diagnosed, and it took four years for a meter to come out. That was slightly better than the meter at replaced. And and still was nowhere near accurate. That's the That's what happens when you block innovation, when you block innovation, that listen. I'm a, I'm an American, I'm a capitalist, I think people should get paid for what they do. I'm with it completely. But when somebody's making $1, and they have to spend 50 cents to make it, they're going to be less happy than if they're making $1 and have to spend 25 cents to make it and etc, etc. So if you if you have diabetes, or you use insulin, I don't care if you know what loop is, I don't care if you understand any of these words, this affects you or it will one day, one day meaning 10 years from now, when an insulin pump company hasn't put any honest effort into making the algorithm you're using better or the CGM you're using better or whatever it is you're using, like you need them to want to work for you. And I think, Joe and generally speaking, I know a lot of these people, and they're wonderful people. And I do think they want that for people. But I just think it's I think it's just it's a human thing. Like, why would I spend 50 cents to make $1 If I could spend 25 cents to make $1?
Joanne Milo 27:12
Absolutely, that's it. And in that that pie slice of most diabetics, or at least 40% of them, just don't want to deal with it, just make it work. Just give me less, I don't want to have to Bolus for foods. They exist there in the world, protect them. I think that's great. They will do better with the devices out there.
Scott Benner 27:37
And that is really everybody. Like it's statistically speaking. That's everyone, like you're really are. It's a weird situation right now. Because you're you're looking at millions of people and saying, I'm going to really focus on these 10,000 Over here, like like we're statistically insignificant.
Joanne Milo 27:58
I am so constantly filled with gratitude. Of these early innovators, they are regular people who just wanted their kids safer or wanted to be safer. And they have worked hard not getting paid, they work. They have a regular job. And then they do this in the evenings or weekends. And it's been an extraordinary effortless don't stop it.
Scott Benner 28:20
Yeah, no, no, I agree. And so if this goes through the way it's written up now and it's attached to it, then you're saying that when we get beyond Dexcom, G six, for example, like in my daughter set up, but that loop will just disappear for her in till someone comes along and puts the effort into hacking it, which I know is that sounds like a dirty word. But but it but what people are really, I mean, listen, I have hard drives on my desk that are connected to things they're not supposed to be connected to, I figured out how to do it, I technically hacked my hard drive to make it work. So if they put this blockade up, those people are going to double down, they're going to figure it out. And that's going to be it. I'd like to make it known so people can send in their letters.
Joanne Milo 29:05
Thank you very much appreciate that. But I included in your post on your on your Facebook group, they can go look at other comments that are made. See what people are saying what why they're saying this is important. It's they're very interesting posts, right?
Scott Benner 29:20
No, I wanted to record with you because I wanted to say why it's important to me. Yes, yeah. And it's it's important for clarity. It's important to me because it it keeps my daughter's a one C in a in a safe range in a in a in a quote unquote normal range. It makes her life easier. It takes away her psychological burdens, it takes away her physical burdens. It makes her life manageable, and not that the other ones won't, but they won't do it at the same level. And that's by design. Nobody can argue with that everybody has gotten together and decided that the target is going to be around 110 and that you know they're not going to be in credibly aggressive when When blood sugar has tried to go up? So you're going to see, you know, spikes? Are they better than people not understanding how to use insulin on their own by 1,000,000%? Like, if if you came to me right now and said, I have diabetes, I don't understand it, what would you do, I'd say go get an Omnipod five right now 100% Do that, I would tell 99% of people who asked me to do that, I would tell them, get a can get a tan, have control IQ, go get the Medtronic, one, go put these algorithms on yourself. They are amazing. This is not to denigrate any of these companies or any of these products, not from my perspective. I
Joanne Milo 30:36
know they're filling an amazing need. And, and they're easy. And that's what it should be for for mostly people that but you just need those extra people saying, let's figure out what else we need to figure out how to do it. That's all
Scott Benner 30:51
Yeah. And to tag on to your point from earlier, there's to make this thing is not it's not easy. It's not like I go on the App Store and touch give me an algorithm and do it yourself algorithm. It's you have to I mean, you have to become an Apple developer, you have to have a fairly expensive computer, you have to read tons of information to figure out how to do it, you have to agree and agree and agree over and over again that you know you're taking this risk on yourself. There's no ambiguity, ambiguity about it. While you're going this, there's no way you could trip and fall and by mistake, end up with a do it yourself algorithm on your insulin pump, as an insulin pump, you just it is not going to happen. You have to willfully make this happen for yourself, you are not saving anybody by blocking them. They these people are making this decision on their own. And even if they're even if they're confused, again, American all you know what I mean. So you get to do each one. So what do they do join, they go to a link, they write a letter, or there's a pre printed letter if they want, how does that work?
Joanne Milo 31:55
I included a suggested letter in the post on Juicebox Podcast, or they just write how they feel and just don't take away my access to my own blood glucose data. It can be that short. So they click on the click the link they go to there's a big box that says comments. Then it asks you whether you want to put your name down or be anonymous. And I think there's one other question, an email address. And I think they're just trying to validate people are real as they go, because they're looking at every single comment that comes in. And then you say Submit. If it's literally two minutes, you can write it up on on your computer, just copy and paste it into comments, then you'd be fine. Okay.
Scott Benner 32:44
So what I'll do is, I'll go I'll take the show notes of this episode. And I'll put your link in there and your, your boilerplate. And people can take a look at that for, you know, for for an example, and I'll have it so you just click on a link and it opens up. Exactly what Joanne's talking about. No, it's my pleasure. And it. It just I mean, at some point. I mean, just common every once in a while joining common sense has got to prevail, doesn't everyone? It just, I mean, how seriously how long has this been going on? Loop? How What's your I don't even know like what's
Joanne Milo 33:24
it started in 2014. I jumped in 2016. I started with Nightscout. In 2014. It's been going it took a leap to easier by 2018. And a lot of the effort in these support groups looping on as one the loop group is another. We're working on documentation to make sure you actually understand what you're doing and how to do it. Well, it's that's our that's our
Scott Benner 33:56
main goal. Right? So for eight years, this has been chugging along, and it's done all the things that it's done for people and it's done all the things it's done for the industry. And you know, and I just leave it alone. I mean, I guess that's my message, just like just leave it alone. Just yeah, it's nothing to do here. You know what they say? Every once in a while the best thing to do is nothing. Here we are. Here, here we are. Alright, is there anything else
Joanne Milo 34:23
you'd like to say? No, just great appreciation, Scott?
Scott Benner 34:27
Oh, of course. It really was my pleasure. If you're still with me, I hope you'll act. I'm going to read to you right now what you're going to find in the shownotes, the podcast player at juicebox podcast.com. And on both of my Facebook pages. These are Joanne's words, and the instructions that you'll need to make your voice heard with the FDA. Comment submissions are closed next Thursday July 7, so do not wait. Instructions. Tap on the link. The link will be there. Fill in the comment box with your message, select option device industry see 0012 Enter your email address where it asks for it. And it will ask you to tell about yourself. You can choose either an individual or anonymous. Then check the box that you have read and understood what you're doing. All you have to do after that is tap the green Submit button. Joanne says it takes fewer than two minutes. If you're having trouble knowing what the right, there will also be a link where you can see comments that have already been submitted and approved. That's it. I'm not telling you what to do. If you do this, I think it's wonderful if you don't, I understand. For me personally, I don't see much that's more important than access to our data, especially when we're making these kinds of huge life altering decisions with it moment by moment. Thank you so much for listening. I'll be back very soon with another episode of The Juicebox Podcast.