“A Roomba ate my pancreas!” It sounds like the plot of a weird sci-fi comedy. But in Dana Lewis’s life, this is just a normal day.
Lewis is one of the first people in America to create her own mechanical pancreas in an attempt to better manage her type 1 diabetes. (Her robotic vacuum cleaner keeps slurping up and choking on the system’s many cables.)
Type 1 diabetes is, at its simplest, a broken pancreas. Sometimes called juvenile diabetes, the autoimmune disease disables the pancreas from producing insulin, a key component for controlling blood sugar. People with Type 1 diabetes often have to use glucose monitors and insulin pumps to allow their bodies to function.
For years, the Holy Grail of diabetes management has been the so-called artificial pancreas, a system that can measure blood glucose levels and automatically give the appropriate insulin dosage. And while a handful of companies are close to getting the technology to market, tech-savvy patients have grown impatient.
Dana Lewis and her husband Scott Leibrand devised a system to “hack” the usual methods of diabetes management, which they found tiresome for a normal, active person trying to live their life. Their Open Artificial Pancreas System (OpenAPS) rigged Dana’s glucose monitor and insulin pump to automatically understand shifts in blood sugar and adjust insulin rates accordingly.
An early version of the couple’s system caught the attention of the Food and Drug Administration – the government agency that regulates medical devices. The FDA strongly encouraged Scott and Dana to keep their invention to themselves and not distribute do-it-yourself pancreases or the code running them.
But last year the couple decided that OpenAPS was working so well for Dana, that they had a moral obligation to share it with the type 1 diabetes community. In February of 2015 they open-sourced the documents for the artificial pancreas and now, nearly 50 people have been built their own versions.
In this episode of Only Human, we look at how Dana and Scott hacked together one of the first artificial pancreas systems and the complicated ethical questions that come with sharing the technology.
Have you ever hacked your own medical advice? Tell us in the comments below.
Mysterious DreamArtist: MokhovAlbum: Revel Revival
IntegrateArtist: Christopher NormanAlbum: Process
Mary Harris: I’m Mary Harris, this is Only Human and today I am joined by Kenny Malone. Hey, Kenny.
Kenny Malone: Hey Mary.
MH: You got a story for me?
KM: Yeah, let’s just, let’s launch into it. And I’ll start by introducing you to this woman.
KM: Okay, Doris, can you hear me?
DL: Yes, I can.
KM: Alright. Small victory.
MH: Who is this?
KM: This is Doris Lewis, she’s a mom from Huntsville, Alabama.
And Doris made a deal with her daughter Dana when she went away to college: Every morning...Doris was going to be in touch.
DL: It was just part of my routine like brushing my teeth, it was that I was gonna text her or call her every morning just to make sure that she was okay.
MH: She sounds kinda like a helicopter.
KM: Well, in this case, “Okay” she means conscious and alive.
MH: Oh, why?
KM: Dana had been diagnosed with Type 1 Diabetes when she was 14 years old.
MH: Ok, I always get Type 1 and Type 2 confused.
KM: Yeah, so Type 2 Diabetes is way more prevalent. Type 2 often associated with obesity and diet.
Type 1 diabetes usually happens at a younger age. And while both types have to do with the body’s ability to control blood sugar, type 1 can be a lot scarier.
MH: Why’s that?
KM: You could slip into a coma or die within a matter of hours, if your blood sugar drops too low. And so for Doris nighttime was the scariest for this reason.
Her daughter Dana had this alarm that was supposed to go off when her glucose levels dropped too much, but the problem was the alarm didn’t always wake her up. Either she had gotten used to it or it wasn’t loud enough. But either way, the problem could spiral very quickly if she didn’t wake up.
DL: When your blood sugar drops super low, your brain just doesn’t work right. And I mean even though she should take a glucose tab you’re just not able to.
So one morning, Doris calls to check-in on Dana and Dana dose not pick up.
DL: The first one it was like no big deal, maybe, you know, maybe she’s still in the shower. By the third or fourth call it was probably 10:30, 10:45 I’m getting a little anxious.
KM: She starts sending texts.
DL: Call me.
KM: And emails.
DL: I’m worried about you.
KM: After an hour Doris calls her husband to talk about an emergency plan. They’re two hours away in Hunstville. Could they call someone to open the door or call the police?
DL: I at that point was in a total panic. I’d make multiple calls like back-to-back-to-back hoping that the phone ringing, the phone ringing the phone ringing would jar her awake.
KM: And then… all of sudden.
Dana Lewis: Hey mom.
KM: Dana picks up the phone. Totally fine.
DL: Oh gosh I’m late or something.
DL: Of course I burst into tears and of course that made her upset that I was upset. And that was quite terrifying for us. Her dad and I still talk about that.
KM:The charger for Dana’s old flip-phone hadn’t plugged in all the way and the phone died. It was a total fluke, completely unrelated to her alarm or her diabetes.
MH: But totally related to being a college student.
KM: Perhaps, yes.
DL: That’s something else that goes along with diabetes. Sometimes your blood sugar goes low or high or this weird situation that wasn’t diabetes related but they thought it was. And just that guilt for me as a person with diabetes of: I have to make sure my phone was charged. That one time I’ve ever not charged my phone and that happens. I just feel horrible even to this day knowing how much that upset and worried them.
MH: Dana had spent her life with diabetes relying on this loose network of devices and people to keep her healthy. Today on Only Human we have the story of how Dana Lewis hacked together her own system and became part of a quiet revolution of patients who don’t want to wait for a medical device company to figure out what they need.
Our reporter Kenny Malone has got it from here.
Dana Lewis is the grown-up version of your annoyingly talented kid sister. She’s 27. Wears her hair in a ponytail, is tall and confident and kind. Reads books faster than you. Ran a full marathon and scuba dives. Maybe you only ran a half marathon, snorkel a little bit.
After college Dana landed a great job in healthcare communication, moved to Seattle and found an apartment with a view of the Space Needle.
As Dana and I walked into that apartment she immediately noticed something was wrong.
KM: Wait, what happened?
DL: So he’s lost.
KM: The Roomba robotic vacuum cleaner, which apparently is a “he” has gone missing.
DL: I don’t know where he went.
KM: He’s not charging by kitchen. He isn’t vacuuming the living room.
KM: He’s right there.
DL: Is he?
KM: Roomba appears to have run out of batteries under the bed.
DL: Okay, that’s not too bad. Usually he completely eats something.
KM: Wait, like what?
DL: Roomba has, at two different occasions from here and over there eaten pancreases…
KM: The Roomba has developed a taste for pancreas.
At its most basic, Type 1 diabetes is a broken pancreas. This is the organ that’s supposed to release enzymes and hormones to help us digest food and control the level of sugar in our blood.
What Dana has built is an artificial pancreas. And it looks a little bit like a cartoon time bomb with lots of wires and occasionally the Roomba slurps up one of those and chokes. But this device is the diabetic Holy Grail and Dana built it herself.
To understand why it’s so important and how it came about you have to understand how dealing with diabetes used to rule Dana’s life.
DL: It’s 7 o’clock at night, it’s raining outside so it’s dark but well lit inside.
KM: It’s April 2013. A Saturday evening. Dana’s about to walk into a first date, which is nerve wracking for anybody.
She’s meeting this guy from OkCupid… who is a “high percentage” match and the restaurant is called “Purple.”
DL: It’s a restaurant and a wine bar so it’s got this staircase that winds all the way up so it’s kind of cool interior decor. I was wearing a skirt and a sweater and I had it clipped to my waistband.
KM: “It” being her insulin pump. Dana’s thinking about “it” before she’s even on the date.
DL: I had it probably under the sweater so he wouldn't have seen it when I walked in.
KM: She sees the OkCupid guy at table in the front. His name is Scott.
Dana sits down, they hit off. Turns out neither has been dating much. As predicted, they have tons in common… Dana’s mind is on the date and how great it’s going and then the food comes.
DL: I remember I was eating a salad that had fruit and chicken and some kind of sugary dressing.
KM: Dana’s Type 1 Diabetes means Dana has to make up for everything her pancreas would do naturally.
So food is a challenge.
Food creates glucose which insulin is supposed to process. Dana’s pancreas does not make insulin. So she needs to give herself insulin, but also figure out how much to give herself. And that depends on how much food she’s eating, how much exercise she plans to do, all kinds of things. To do that, she usually looks at one device tapped into her skin and watching her blood sugar, do a bunch of mental math, and then push a button on another machine: the insulin pump.
So back to the restaurant. Dana is looking at this salad, the date is going great and on the outside she is trying to maintain charming first-date banter.
DL: Our families, our work, what we do in our spare time.
KM: But inside her head; it’s like multivariable calculus.
DL: How many carbs is this? What if I get distracted with the date? What if I eat the whole salad? Date’s kind of going well what if I eat part of the salad how long is it going to last? Am I going to walk home? Walking home uphill--keep that in mind. It’s a lot. Food is such a social experience it’s so important to us culturally. It’s a big part of everything we do, including dates, that sometimes that type of stuff is stressful.
KM: Not to mention that she’s also thinking: This guy I’m really into, should I disclose a to him our first date a chronic illness and how would he react?
DL: I could either press the buttons on my pump under the table or I could pull out my pump and make sure he saw it and see what he said.
KM: She pulls up the pump - it’s a palm-sized black thing with buttons and a screen.
DL: And at that point I was feeling comfortable enough with him that, this was the first time I’d ever done it, but I actually pulled my pump out high enough of the table so he could see me blousing giving myself insulin on the pump.
KM: And her date, Scott, looks at this.
Scott Leibrand: And the first question was the obvious one, which was: Why are you carrying a pager!?
KM: This is Scott.
SL: And she very quickly told me that…
DL: No, that’s my insulin pump.
SL: So my curiosity is okay how does that work.
DL: But it was really reassuring that he was able to just accept that information, kind of process it along with everything else he learned about me, and just move on. But that was a big deal for me to pull out my pump, make it visible, and make it something we talked about that early on.
KM: That first date lasted five hours.
SL: We always get told when we’re doing presentations that we need to slow down, speak more clearly and enunciate.
KM: Scott and Dana are a high-achieving couple with a low tolerance for inefficiency.
SL: Cause I talk like this, at about double speed.
KM: Well I’m gonna encourage a little bit of that, or I’ll just slow you down half speed.
KM: Leibrand just turned 36. He used to work at Twitter, works at a Seattle startup now.
Early on in their relationship, the two started targeting problems with Dana’s diabetes devices. They bring over this old cracked iPad.
SL: Casualty of the Roomba accident.
KM: Problem one: Dana sleeping through her low-glucose alarm. The reason her mom had to call every day when Dana went to college.
Scott and Dana found a way to pull readings from Dana’s blood sugar monitor and send them to this iPad, which has a very effective alarm.
SL: Let’s see which one is the really loud one.
KM: Yep, that’s pretty obnoxious.
DL: And that’s the one we used to wake me up and I still associate with the waking up sound.
KM: That’s a bad sound, that’s a bad feeling.
DL: No it’s bad, but it’s good.
KM: Next, they tackled all that mental calculus Dana had to do secretly on their first date and programmed a computer to do it.
Dana would get these digital alerts that warned her: Hey, you should probably press your insulin pump once because of that meal you had. Or, by the way, your blood sugar’s going to be low soon, probably should eat a few carbs.
They called this the DIYPS --Do It Yourself Pancreas System.
SL: Tell him about the bear hug.
DL: So when we first built DIYPS there was a combination of me walking from one of my old office campuses to another having just eaten lunch. So my insulin went into faster effect than I’d expected. And I got a DIYPS alarm it said the recommendation was something like 34 carbs and one bear hug. And I clicked on the web link and it was just this panda picture of two pandas giving each other a hug.
SL: I think I programmed that after she’d mentioned something like I just need a hug when I’m this low. She’d something about like in the moment that that’s what she really needed. And I’m like, well, I can’t exactly program a hug but I can do something that might make her smile.
KM: You two are insufferably adorable.
DL: We hear that a lot.
KM: Dana estimates that she has to make around 300 decisions a day related to her diabetes. That means, on average, the disease demands her attention every five minutes.
And so their final hack was what’s called “closing the loop.” Creating an automated, artificial pancreas that can run without Dana checking any glucose levels, doing any mental math or pressing any buttons.
And they had the perfect the deadline. The kind of thing Dana would not want to be distracted from.
Reverend: Your love has been pretty evident for each other ever since you had those first dates.
KM: Their wedding.
Reverend: You remember, the first date that lasted five hours, the second one that lasted six hours and that third date that lasted seven hours on which you literally closed down the restaurant.
KM: You’d never know watching this video and I guess that’s sort of the point. But Dana is strapped into a system that is like a Rube Goldberg pancreas.
When Dana’s blood sugar shifts, her continuous glucose monitor picks up the change, that information is pumped up to their complicated algorithm which spits out a dosing recommendation that gets fed down the line and ever-so-slightly tweaks the settings on Dana’s insulin pump.
Instead of Dana making hundreds of decisions that day, the artificial pancreas could make thousands and never has to stop watching.
DL: So my blood sugar was perfectly in range all day. I didn’t have to worry about diabetes and we were able to just focus on the wedding and getting married and celebrating with our families.
Reverend: For richer, for poorer.
DL: For richer, for poorer.
Reverend: In sickness and in health.
DL: In sickness and in health.
KM: I feel like most people are like -- yeah, sickness and health, but you guys…
SC: Yeah, we got that.
Reverend: So, by the power vested in me by the State of Alabama. I now pronounce you wife and husband.
KM: A few years ago, Scott and Dana were invited to a conference in San Francisco to show off the DIY Pancreas System.
DL: We’re upstairs from the conference room, so it’s kind of an L shaped room, we’re kind of at the edge of where the tables are. There’s cocktail tables, people having beverages. Wandering around being social and you just kind of see them make a beeline for us.
KM: Them, are representatives from the Food and Drug Administration. Word had apparently gotten out about Dana and Scott’s project.
DL: I think I remember them introducing themselves to make sure we knew who they were and saying so, like, tell us what this thing is and how it works.
KM: But Dana says it felt a little like being called into the principal’s office. She didn’t think she had done anything wrong. It hadn’t occurred to Scott and her that the device may be a problem for regulators, or the medical industry. So, she showed the FDA guys how DIYPS worked and when she finished.
DL: And they said, well, did you know that this type of thing would be a Class III medical device? Because you are making dosing recommendations off of a CGM.
KM: CGM. Continuous Glucose Monitor.
DL: And the CGM is not FDA approved for dosing insulin.
In other words, this invention of yours should get federal approval before you share it.
DL: I think it was something like: We do not recommend sharing this code online. It would be seen as distributing a Class III medical device.
DL: We kind of walked away from that saying, wow. The ramifications just gradually sinking in. I think because we were so excited about talking to so many people it didn’t really hit it until we talked through it of, this would be the impact if we did try to distribute and the FDA didn’t understand what we were doing. All these negative horrible things could happen.
KM: Dana imagined lawsuits, U.S. Marshals kicking down her door. She and Scott decided not to share the Do It Yourself Pancreas. At least for the time being.
We’ll be right back after the break.
MH: This is Only Human and today we’re telling you about this tech-savvy couple from Seattle -- Scott Leibrand and Dana Lewis who hacked their diabetes devices to make an artificial pancreas.
They had gotten some attention from the FDA, who didn’t necessarily threaten them, but strongly recommended they not share their work.
Kenny Malone is back with me for this second part of the story.
KM: Yeah, before we launch into this, Mary, I want to explain a little more in depth the theory behind Dana and Scott’s artificial pancreas.
MH: Alright, I’m ready for it.
KM: So join me in our imaginary car of artificial pancreas.
MH: I’m ready. Let’s drive.
KM: So imagine you’re driving.
KM: You’re on the open road. No cars anywhere. You’re gonna go 45 miles an hour.
MH: Seems really slow for me.
KM: Ok how fast do you want to go?
MH: 70, maybe 80.
KM: Okay, well let’s say 70. You’re going to go exactly 70, you don’t have cruise control. How do you maintain a speed of 70 miles an hour?
MH: Oh by constantly looking at the speedometer, and looking around and looking at the speedometer.
KM: Speedometer, road, speedometer, road.
KM: What if you’re only allowed to look at the speedometer every 10 minutes?
MH: Oh, then I’m definitely going to speed.
KM: You look at the speedometer. You’re going 85! What do you do?
MH: Yeah you take your foot off the gas.
KM: Ok, so you don’t look for 10 more minutes. Now you look at the speedometer again, you’re going 55.
MH: Yeah I’m definitely putting my foot back on the gas.
KM: You look up, you look down, you’re going 85 again. You’re bouncing in and out and in and out. You’re struggling to maintain 70 miles per hour.
So essentially you have two options. You can look at the speedometer all the time and maintain a speed or you can look up and down very slowly and bounce around all the time. That is sort of life with diabetes. You could look at your glucose monitor all the time, make tiny adjustments all day long. Or you could live your life every once in a while and bounce in and out of your target glucose range.
MH: Is that healthy?
KM: Well, it makes you feel bad and it’s risky. So what Dana and Scott did is essentially institute cruise control. A device that watches her levels all the time and makes tiny little adjustments so she can live her life.
MH: That’s awesome.
KM: So remember, the FDA had told Dana and Scott not to share their code or hand out DIY Pancreases. But that didn’t mean they couldn’t keep using their own or talk about it, including on social media.
And it was going really well for Dana. She was logging all of this progress online. Tweeting pictures left and right.
Maybe a stable blood sugar graph. Maybe numbers from a night where her glucose alarm never needed to go off. And one day she tweets something.
DL: Just one of those, what I thought was a pretty typical picture showing: Here’s what the loop is doing, here’s what my blood sugars did.
KM: It was the response she got from someone on Twitter that caught Dana off guard.
DL: Nobody else can access this, why you talking about it. Kind of indicating, why are you taunting why are you doing this, this is not accessible to everybody.
KM: Which Dana says, was certainly not her intent. She wanted to show other people with diabetes what’s possible. But this was a wakeup call.
DL: Kind of reminded me how fortunate I am that I not only have access to insulin, I have access to these devices and I have the time and energy and resources to hack on them and have built this system. So I am very very fortunate. And I want to be aware of the sensitivities of people being frustrated about not having these systems and having to wait potentially years.
KM: There is no artificial pancreas system available to the public yet. One of the bigger manufacturers told me they were hoping to submit their version of this product for pre-market approval by June and they would not speculate with me when the actual product would be available.
But there is a general impatience within the diabetic community that this device isn’t out yet. Meanwhile, it’s going very well for Dana, and she’s starting to feel guilty.
There’s a statistic that looks at percentage of time someone with type 1 diabetes spends within their target glucose levels. Before all this device hacking, Dana was at around 50%. With the closed loop she is regularly above 90%.
Eventually Dana and Scott reached a pivotal moment: The FDA had told them not to distribute their work, but keeping the system and code to themselves, they thought, that had its own cost.
DL: What’s been guiding us is kind of our moral compass of what is the right thing to do. And what is the safest thing to do for people. This knowledge is important, it needs to be shared, but when is code safer to be distributed versus not distributed. We do believe that it is absolutely safer for somebody to build the system and run it versus the standard of care of just letting the pump use the preprogrammed insulin rates if you go low overnight.
KM: And so in February of 2015, they started the process of making their system open source and posted the first documents associated with OpenAPS, the Open Artificial Pancreas System.
KM: Dana and Scott say they’ve had conversations with the FDA and they don’t have a green light to do this but they also don’t necessarily feel like their door is going to get kicked down. The FDA declined an interview for this story but wrote, in an email:
We understand that living with diabetes can be very difficult and the desire to develop tools to make people with diabetes lives easier. We also understand that individuals may be modifying medical devices to address these issues, but want to caution that doing so could lead to harm if the device fails, and we find it concerning when people modify devices used on other people.”
But I was still curious about the FDA’s role in all this so I talked to Jeremy Greene, a medical historian at Johns Hopkins who’s written a bit about device hacking.
Jeremy Greene: I think it’s difficult. And I can’t speak here for the FDA of course.
KM: Jeremy says, hacking medical devices is as old as medicine. The difference is that we’re in a “black box” era where devices are so complicated that you need to know coding and electronics to fully understand how a device even works.
And so, from the FDA’s perspective, if you change the code at all or even open up the device up.
JG: This thing, this complex arrangement of parts that has been carefully vetted over a long and exhaustive process by the FDA to be safe and to be effective at doing what it does, is no longer a coherent thing that the FDA can validate those claims for.
KM: But another reason I wanted to talk Jeremy is that he’s a medical historian but also a practicing physician.
JG: This is the problem, if someone walked into my clinic with an artificial pancreas that they had produced, on the one hand I would be so fascinated. Clear out my schedule and just learn from them what they had done. And on the other hand, my duty as a physician is to make sure that my patients really understand the relevant risks and benefits of the medical decisions that they’re making.
Woman at Meetup: Flatline at 140, you can’t really complain about that. Well, you can If you’re Dana.
KM: It’s a Thursday night. Dana and seven other people are hanging out in her building’s common room. It’s mostly twenty or thirty-somethings, drinking diet soda, looking down a lot to check in on their blood sugar levels.
Dana hosts these meetings regularly to help people with diabetes get up and running on the system. Sometimes it sounds like I’ve stumbled into a foreign language club.
DL: You can see just the slight change of basal, the dotted line difference there, so it’s obviously doing some kind of basal different. But this is bad overnight.
KM: Dana often says she doesn’t want someone to quote “trip and have a pancreas,” in other words she and Scott have made this thing tricky to build because if something stops working there’s no customer support line. That person needs to know how the thing works.
The barrier to entry is a very conscious choice about how to share this safely.
Elliot Stewart: Yeah, I mean the way I think about it is you guys built the LEGO blocks and I’m trying to make the picture on the box but I don’t really have a manual to do it.
KM: This is Elliott Steward. He is a not a computer programmer -- at all. But he saw Dana give a talk, got obsessed with the idea and was actually one of the earliest people up and running with OpenAPS.
ES: And that’s, I think the best way to describe it. Is like, they’ve made all these pieces and they fit perfectly but you have to, for someone who doesn’t know anything, you have to look at the picture and then kinda like put them together and trial and error and that didn’t work. And then get help and ask a lot of questions.
Meetup member: Or you sit there and look at it, I have no idea what’s going on.
DL: Phone a friend option.
KM: One of the more recent people to build an artificial pancreas is a computer programmer named Matt Pressnall who’s here. But he didn’t build the system for himself.
MP: So this is my daughter Ella.
KM: Ella is 10.
KM: Hey Ella.
PM: Why don’t you introduce yourself.
Ella Pressnall: I’m Ella… it’s spelled E-L-L-A, I was diagnosed when I was eight.
KM: Matt says they were waking up usually 2 or 3 times a night to help Ella with blood sugar issues. And so he was excited that the system existed, but cautious about trusting his daughter’s life to someone else’s code.
So he ran the thing through the gauntlet by feeding Ella trouble foods like pizza.
MP: What else did I give you, uncovered, to make you spike?
EP: Cookie and caramel and yummy things like that.
MP: So yeah, to be able to test her I would give her sugar, uncovered, to watch her blood sugar spike and then the very first time the artificial pancreas came in and said: Hey, we need to give her more insulin. Was I happy, I forget.
EP: Yeah, you were definitely very happy.
MP: What did I do, do you remember?
EP: I think you jumped for joy at least five times.
KM: I know that people build their own cars and boats and planes all of which could kill you if you mess it up.
But for some reason, saying: I’m working on a building a hotrod sounds a lot less dangerous than: I’m working on building a pancreas system.
Maybe it’s because there is a paternal nature to medicine. There is usually an authority in the room, signing off on everything.
And it’s disorienting to be in a room full of people who feel comfortable enough with their own bodies and their disease to build and test a system that is not “officially” sanctioned.
I probably ask Dana and Scott a dozen different ways how they end up on this side of things. Feeling comfortable with all of this.
KM: Is there any concern to either of you that someone could be hurt by a system that you guys created?
DL: Yes, and my fear is similar but it’s more around people who don’t understand their diabetes. They don’t understand how a pump works. I feel like the people who are most successful with this type of system are people who have a deep understanding of their diabetes, their bodies and the pumps. But the average person who doesn’t really understand the difference between basal and bolus and what is a temporary basal rate, they may not be a good user of this pump until they do some learning. But that’s not something we can screen for. People self-opt in to doing this.
SL: There’s people. Everyone is concerned about adverse events from medical devices. But diabetes is one big long series of adverse events. And to the extent that we can reduce the frequency and severity of those, we’re making things better. And so we are very confident both from a design perspective and from a years of experience perspective that there’s really not anything that you can do with this system that’s going to make things worse, it’s only going to make things better. And the question is how much better?
MH: Kenny this all just feels risky to me still. As someone who flunked a lot of math tests because I didn’t carry the 3.
KM: Well, I passed a lot of math tests and let me tell you it still feels that way to me.
MH: Well, I’ll have you hack my pancreas.
KM: I think this gets to something really fundamental about where we are with medical technology now. Things are so advanced that you have to kind of trust the system. Whether it’s trusting that the FDA has regulated this properly and you’ve been handed a safe device or, like what Scott and Dana are doing, building a device that you are forced to understand every single component of before you use it.
I came to terms with the idea that I as an outsider am never going to fully comprehend the rationale behind this. Number one, because I haven't spent any of my life with Type 1 Diabetes. People with Type 1 Diabetes tend to know their bodies better than most of us and so they’re more comfortable watching their bodies react, watching the system react and being able to tell whether it’s working. But number two, if you don’t have the time and the resources and wherewithal to master the tools it takes to put this thing together then it’s not for you. It’s probably not going to work for you but also you can’t do it.
MH: Which gets to the whole issue of privilege here. Which is, they have the time and the resources, but there are a lot of people out there with diabetes who could benefit from what they’re doing.
KM: Yeah yeah, and Dana said in the story that she occasionally is reminded that they are in a very privileged position to be able to do this. So what they’re hoping is that for people who can’t hack together their own pancreas, that at least having these things out in the wild will motivate manufacturers and regulators to maybe move things along a little more quickly.
MH: But it sounds like they’ll be having Meetups like this for a while to come.
KM: That is an interesting point. Because while Dana has had some conversations with the FDA that have made her feel like, “Eh, you know what, we’re probably OK, they’re not going to shut us down or kick our door in or anything.” She did say they at one point made this one comment she wasn’t sure how to take.
DL: I don’t remember if this was a one on one conversation or if it was at a conference, but they mentioned something about, “well it kind of depends on the numbers.” And we’re like, what is the magical number? Is it 40, is it 50, is it 100, is it 1000? At one point are so many people using it that they decide that we have to actually step in and do something specific and make a guidance or a ruling or have a formal communication about this because it is so widespread. I don’t know what that point is going to be but that’s kind of like the one gray area where they said you know it kind of depends on the number of people.
KM: So, when Dana started she didn’t really expect there to be more than half a dozen people when I talked to her the number was up to 38. Today she just texted me, and this is April 8th, 38 has now gone up to 49. So we’ve been trying to track down these people and trying to interview them. And no one we’ve talked to reported any adverse effects, but we’re having trouble keeping up because there are so many people now. And here are just a few of them.
ES: I started looping on August 25th, 2015
SH: The beginning of November of last year.
SM: Last, July?
CH: August 18th, 2015, somewhere just before midnight.
SK: I think I closed the loop. Let me look at the calendar.
LM: No, I don’t remember.
SK: Sunday, January 3rd.
AC: Back in November last year.
JM: January 29th, 2016
EP: January 18th, 2016. And I remember that night my dad just stayed up the whole night and then in the morning he was really excited to show everyone the graphs and it looked really cool.
SK: I woke up one morning and was like how do I feel today, what’s my day going to be like instead of what’s my blood sugar and how can I correct that. And I was like that’s amazing that I’ve had that feeling for two weeks.
ES: I remember just thinking that, wow there’s a really small set of people who have closed loops and I’m one of them.
AC: People say it’s really complicated and a lot of people are jealous of it, some people are jealous over it. And I say, if you want one, you can’t buy them, you have to make them.
MH: That was Elliot Stewart, Saraj Joward, Sam Mazaheri, Chris Hannemann, Sara Krugman, Luke Males, Andrew Calabrese, James Matheson, and Ella Pressnall.
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