The final results: Bionic Pancreas vs. Louise

Last Friday was the official end of the UNC bionic pancreas trial. Just like arm 1, we all collected at the UNC Diabetes center on Friday and got our work ups done on each of us. Around 6pm we turned all our items in, and the Boston team started crunching numbers and making fancy graphs of all the data. They had agreed to meet with each of us for a 15 minute session to go over our control on the bionic pancreas and how it compared to our normal control.

I had a pretty good 11 days of control for my normal care, probably due to all the training for the 10-mile race I ran yesterday. Running definitely does great things for my blood sugars! I wasn’t sure what to expect going into my personal meeting, but one of the trial coordinators hinted to me that they were super excited to meet me because I was an “exceptional” participant. I went into the room (which seemed to just be buzzing with energy – probably due to a large number of very smart doctors and engineers finishing up a very high profile clinical trial!) and we all introduced ourselves. I got to meet Ed Damiano, who developed the bionic pancreas and brought this entire project to fruition for his son who has type 1 diabetes, and Firas El-Khatib, who is another major investigator on this project who handled all the data in an incredibly short amount of time on Friday and made some easy-to-understand graphs to show us how our control compared between the arms.

So, how did my control compare? They first showed me my graphs, and told me that admittedly they thought they were looking at my bionic pancreas results – not my own care! They said my level of personal control was remarkably steady and that my day time and night time averages were wonderful. They actually called me wonder woman! I was very surprised by this – sure, I work VERY hard to keep my blood sugar control as in-range as possible, but no one has ever told me that it is that good. I was surprised they considered me one of “the most unique” participants in this trial of more than 90 people, because even though my HbA1C is in the mid 6% range, many diabetics are able to achieve that so I was confused why they felt I was so special. They said it’s because most diabetics who can get their HbA1C down to that level also experience many more hypoglycemic (low blood sugar) events as a trade off. They said in my 11 days on my own care, I NEVER got below 60 mg/dL at night, and had only a couple day time episodes in that range, which they felt was remarkable for a diabetic who has such a low HbA1C. But, I reminded them that to keep myself from going below 60 at night (or during the day), it takes me setting my CGM alarm to go off when I drop below 80, so I can wake up, test, eat something if I have to, etc. This results in me waking up 2-3 times every single night and constantly paying attention to where I am during the day. This is the type of life I have to live to achieve “wonder woman” status in their books! And, like I’ve said before, I didn’t always have this level of control, and there are certainly diabetics out there who work harder than me and have more out-of-range blood sugars, as well as diabetics who probably put in less effort than me and have better control. It’s a personal decision how much effort I want to put into my own care, but since I choose to put a lot of effort into this aspect of my life, I have to say it was one of the most rewarding things I’ve ever experienced to have this team of researchers basically tell me that I couldn’t be doing a better job on my own!

But, all in all, the bionic pancreas did do just a hair better than my own control – a few mg/dL lower during the day and night averages, which the team was quite proud of!  =) Something else interesting is that on the pancreas I got an average of 31 units of insulin a day. On my own care I take between about 27 and 32 units per day, so they really weren’t too far off, which makes me feel more confident about my own basal rates and carb bolus ratios.

So what’s all the hype about the bionic pancreas, if my own control is “just a hair behind?” Well, for 11 days I didn’t have to wake up in the middle of the night to get a nice “flat line” of blood sugars all night long. I didn’t have to do exact carb counting all day long for every food that I eat. Sure, the bionic pancreas has some functions that need to be tweaked (like for exercise) but that will be improved on future models. It’s just unbelievable that the bionic pancreas can take over something that I probably, on average, put at least 1-2 hours of thought into every single day of my life. That’s over 400 hours of stress and inconvenience a year (10 work weeks of time!) I’d get back for my life. The pancreas would give me back my energy that I lose from almost never having a full night’s sleep. Even if my control is almost as good as the bionic pancreas, the value of that energy and time is immeasurable, and I look forward to the day, which might be only a few years away, that I will have the option to hand my control over to the bionic pancreas and regain those hours of my life.

It sounds like the next round of trials will start towards the end of 2016, and will be 3-12 months in length, and will test a “finalized” version of the pancreas – it’ll all be in a single, dual-chambered pump, the pump will have one tube with two channels in it to deliver the insulin and glucagon, and the glucagon will be a more stable form that will last 2-3 days like insulin. That’s a long trial, so I’m not 100% sure I’d be willing to commit to that but we’ll see where I am when they start recruiting and what’s going on in my life, and maybe I’d consider it. Getting to work with such awesome people on this trial truly was a treat, so that would certainly be incentive to participate again!

The data from this trial will be published towards the end of this year, and at that time I will get my full workup of my personal results which will be exciting (we can’t see it now since it is all unpublished data). It was such a cool experience to participate in this trial – frustrating and a little confusing at times, but overall very exciting and interesting, so I feel so lucky that I got to be a part of it. Thank you to my blog readers for following my experience to the end! As I said in an earlier post, if this work excites and inspires you, you can support it by donating to the Bionic Pancreas team (http://sites.bu.edu/bionicpancreas/donate/), or visiting their website to read more about the project and the next phase of development.

Thanks again for all of your support!

– Louise

Trial Arm 2

Today will begin my second 11-day portion of this trial – I’ll carry around the “brick” with me which has the CGM in it to record my blood sugars, but I can’t see the screen. I will not wear the bionic pancreas pumps, but instead I’ll do my normal care and they’ll compare it to my control on the bionic pancreas a few weeks ago. I normally wear an omnipod pump and a CGM, so I’ll get to use my normal devices, with the extra brick devices tracking my results.

This week has gotten much better with the lows that were plaguing me when I first went off the bionic pancreas – the study team thinks it was a combination of all the running I’ve been doing (I have a race coming up!) and the fact that my glycogen stores may have been low in my liver from the combination of exercise and 11 days worth of getting glucagon on the pancreas, which causes my glycogen stores to be released into my body. So I ate a few higher carb meals to replenish my glycogen stores, and adjusted my basal rates a bit to accommodate the extra exercise and things have been much smoother since last Sunday.

In unrelated news, I have a funny coincident to share with you. Only Dexcom CGM users might find this funny…so let me preface this story with that =) As CGM users know, the little grey transmitter that snaps into our CGM sensor and reports our glucose values to the receiver has a 6 month warranty, meaning our insurance will chip in for a new one every 6 months. This still leaves me with a ~$130 bill, so it’s not cheap to get a new one even with insurance coverage. The battery should last between 6-11 months, but that 6 month warranty starts when you order it, so naturally I wanted to use my current one until it ran out of batteries before ordering a new one, to maximize my 6 month warranty on the next one. I am almost at the 12 month mark (April 14th 2014 is when I started using the last one!) and I hadn’t gotten the “low battery” warning, but I figured it had to be coming soon so I finally broke down and ordered a new transmitter last week. It arrived on Friday afternoon, and guess what?? I got the low battery warning Friday night – the same exact day! I must have some good diabetes karma for that to have happened!

So, arm 2 starts today. I’m not looking forward to another 11 days carrying around the brick, the study blood sugar tester, and the study phone, but this is an important part of the trial, to show whether our normal control performs as well as the bionic pancreas. I predict that my control won’t be too far off – I think I do a better job with meals (generally speaking), and the pancreas definitely does a better job overnight (which is about a third of each day, so that can make a huge impact on my overall control!), so we’ll see.

Back to Reality

Last Friday afternoon, I had to give my pancreas back. All the study participants gathered in a conference room at the UNC diabetes center, and we got to chat and hang out while the study coordinators took us one by one to draw some blood and do a brief work up on us. Half of us had been on the bionic pancreas, and the other half had been on normal care. We’ll all return to the study center in a week to flip flop – so my second arm in this trial will be my normal care, but I will still be monitored by the study team so they can compare my control to when I wore the bionic pancreas.

The room was filled with mixed feelings – I think all of us that had worn the pancreas for the last 11 days were both excited and sad to give it back. Of course we all disliked having to carry so much gear around, and having to do the daily infusion set changes. Some people were really happy with the control they achieved on the bionic pancreas, and some of us felt there was room for improvement. Before the trial I was so excited to have something take away the “stress” out of making dosing decisions, but in the end, I found it was stressful to see the bionic pancreas making decisions I felt were not ideal decisions (like dosing huge amounts of insulin for a small breakfast, and then having to give me lots of glucagon to catch up in an hour). I unexpectedly found it was a huge relief to have my control over my diabetes handed back to me. I think the next model of the bionic pancreas will have better options for exercise and more input for telling it about future activities that might impact its dosing decisions. With all the running I do, I think this will be a huge improvement over the current model, at least for me, so I look forward to the next prototype.

I happened to be coasting in the high 200’s all afternoon Friday before going off the pancreas, so it kept dosing me with insulin to try to bring me back down. I started coming down just as we were taking off the system, so the study coordinators warned me that I had a lot of insulin still acting in me. They said that I should be careful going back on my own regimen because my pump wouldn’t be aware of that insulin, so to be cautious when dosing for the next few hours. Well, that was an understatement. Not only was I low through Friday evening, but the past 2 nights I have had debilitating low blood sugars all night long, and often during the day. I was below 50 mg/dL for long periods of time Friday overnight, and during the night I ate 15 glucose tablets!

And then Saturday night, I woke up low 3 times. For one of these I had to wake Nik up because I was afraid I might pass out – I had woken up to my CGM alarming and displaying LOW (meaning I was so low it wouldn’t display a number) and my meter confirmed I was only 30 mg/dL. That is one of the lowest lows I’ve ever had and it took a LONG time (and 6+ glucose tablets) to go away. No one likes the feeling of a low blood sugar, and this one was just awful. Nik held my hand through it and kept squeezing it every few minutes, waiting to see if I squeezed back each time to confirm I was still conscious. About 10 minutes later I had come up to 42 mg/dL, and then finally about 20 minutes later I felt alright enough to go back to sleep. Then a couple hours later, I woke up again with my CGM alarming that I was in the 70’s, so it was time for another snack. And then I woke up low this morning too. I don’t know why I’m so sensitive to my normal insulin regimen since being on the bionic pancreas – I even had my basal rates set at -25% of my normal rate all night last night, and those lows still happened which is very unusual for me. I’ll have to check in with the study staff on Monday and see if they have any speculation as to why this is happening an how to adjust to it.

So, to wrap up this post, my trial arm with the bionic pancreas is officially over. At 6:05pm on the 27th we were allowed to disconnect from our bionic pancreas brick and our 2 pumps, and we were instructed to put our old pump back on. By 6:19pm I was back to reality, and heading out the door of the study office.

So, bye for now bionic pancreas, but maybe we’ll meet again! They’re hoping to have the system approved by 2017 – the guy that has made this entire project a reality has a son with type 1 diabetes who will go to college that year, and he wants his son to have the bionic pancreas ready to go to keep him safe away from home. So, maybe I’ll get to hang out with you in another clinical trial in 2016. Maybe you’ll be there in the future to walk down the aisle with me. Maybe you’ll be by my side the moment that I welcome my first baby into the world. I don’t know what the future will bring, but I have a feeling this isn’t goodbye forever!

Sushi Success and My Bionic Belly

Well, its coming down to the last few days of the trial – I have to give my organ back on Friday afternoon! I feel like overall I’m getting ready to give it back – between the daily set changes (sometimes 2 a day) and the ton of stuff I’ve had clipped to my waistband, and the nagging worrying that comes with a small phone taking over the job I’ve taken responsibility of for 13 years, I’m not going to miss it.

I decided that I was going to reward myself for some of the frustrations I’ve had with the bionic pancreas by going out for a splurge meal last night. I had sushi and fried calamari at a restaurant the week before I started on the trial, and that night I was coasting near 300 mg/dL for HOURS afterwards and had a very hard time bringing that blood sugar down with my normal pump. A perfect meal to splurge on! We went out for this exact meal again last night. The proud side of me that wanted to prove that I’m not that bad at managing my blood sugars on my own was deviously thinking “Take that, bionic pancreas! I’m sure I’ll be 300 after this meal just like when I take care of myself!”

Well, it didn’t happen. Two huge sushi rolls and a plate of fried calamari with a sugary plum sauce later (probably 80+ carbs!), and I think the HIGHEST I got was about 159. Literally – that small peak on the left side of the CGM screen below was my “big peak” after a gluttonous amount of rice. And then I gently came back down to about 110-120 and stayed there for hours. In my moment of doubt, my bionic pancreas did its job perfectly!

I’m trying to figure out why the bionic pancreas seems to perform best when I eat meals that I consider NOT typical – it seems to do just alright for my “typical size” meals, but it does an excellent job for meals that I called “larger than typical”. I can’t see exactly how much insulin it doses for these larger meals, but it’s probably a pretty hefty dose – in the double digits (10+ units I’m guessing). I think that when I’m on my normal care, when a large meal is presented to me, I’m stingy with my dose. My doses are calculated by how many carbs I’m eating – for example, at dinner I should take 1 unit for every 10 grams of carbs. If I go out for sushi (~75g carbs probably) my insulin pump would suggest a dose of 7.5 units (which is a lot for me!). Then I fall into the trap of thinking to myself “Whoa…that seems like a lot. Let’s just cut that back a few units…I ran a few days ago, maybe I’ll still be sensitive from that exercise…” So I’ll dose maybe 5.5 units, and then I usually end up high. I clearly have a fear of “over dosing,” so I’m always on the cautious side.

For a typical meal, this isn’t too big a deal since I’m not eating that many carbs so if I dose a bit too lightly, the impact isn’t huge. So most days, I don’t notice my stingy-ness with meal time insulin. But for a large meal, being stingy with my insulin can keep me high (and I mean high high – like 300) for hours afterwards. I don’t know why I’m so afraid of over dosing. I am (thankfully) still very sensitive to feeling a low blood sugar, plus I use a CGM regularly so I can see when I’m trending low. I think my fear of overdosing stems back to weight – insulin, in theory, makes you gain weight, and if you give too much insulin and then have to eat even more to treat a low after a meal, that just seems like a double whammy to me. But I also need to realize I hate having high blood sugars after a meal, so I have to get over my fear of large doses of insulin.

When I go in on Friday to return my pancreas, I’m curious if they’ll give me reports of how much insulin it dosed me at each typical or larger than typical meal, and it may help me get over my fear of large doses, because clearly they work well with the bionic pancreas when I have a larger than typical meal! However, it’s also possible the pancreas doesn’t worry as much about overdosing, since it also has glucagon that it  can dose me if I start to go low, and that is a luxury I don’t have on my normal care.

Anyway, I have a few funny pics from last night when I was getting ready for bed (please disregard my PJ’s and bedtime hair). Somehow all my bionic pancreas things have ended up on my stomach in the last day, so here’s a picture of my bionic belly:

The 2 pumps and my CGM sensor on one side, the bionic pancreas brick in the pink band, and the two pump infusion sets on the other side with lots of tangled tubing in between! Its amazing it doesn’t bother me to sleep with all this gear on me!

My Pancreas Has a Case of the Mondays

I’m happy to say that my weekend with the bionic pancreas was great! My blood sugar numbers behaved nicely, and despite some of the ups and downs with meals during the week, I did pretty well on Saturday and Sunday. I think this is ironic, because all week long I worked hard to eat very “typical meals” spaced at least 4 hours apart, as recommended by the study team, to really give my bionic pancreas time to learn my body. This weekend my parents were in town, and we ate very a-typically (weird times of day because it was the weekend, as well as some restaurant meals), and my pancreas did better with the a-typical sized meals than it had done with my typical sized meals all week long! Go figure.

I did a 7 mile run early Saturday morning, and woke up around 5:30am to raise my target blood sugar on my bionic pancreas in preparation for the run at 8:30. I tend to be less sensitive to insulin in the morning, and this coupled with the increase in my target value worked out very well for the run. I only ate 2 glucose tablets about halfway through, and I finished feeling great right around 80 mg/dL. Success!

So far, I haven’t had any major system glitches, and I should’ve known this was too good to be true. I had changed my CGM sensor last night on schedule, and everything went pretty smoothly – that was until around 4:30am this morning. I got a phone call from the study staff at that time, and they saw that my CGM wasn’t working properly – instead of just displaying a blood sugar value, it had the dreaded “???” in the upper right hand corner. We did some troubleshooting, and the error symbol wouldn’t go away so I had to wake up Nik and do a whole new sensor insertion. That wasn’t too bad on its own, but CGM sensors take 2 hours to boot up, and in that time, the bionic pancreas has no values to work off of. So I had to manually test my blood sugar (fingersticks) and enter in a value every 15-30 minutes between 5am and 8am. I also happened to be trending low during this whole window of time, so I entered more finger stick values than usual to keep it dosing me with glucagon. Finally 7:45am rolled around, and the boot-up session ended, and I entered my CGM calibration values in, and it just wouldn’t pair with the bionic pancreas for some reason. I had to reboot my pancreas a couple times, and FINALLY around 8:25am it seemed happy.

So, its been a long morning. The new CGM sensor is working all right – the beginning of a new sensor session can be a little erratic as far as reporting blood sugar values go, so this whole morning has been a bunch of “bumpy” trendlines followed by erratic glucagon/insulin dosing by the responding pancreas. I’m keeping my fingers crossed it straightens out this afternoon, since I’m planning to run again in the early evening!

Infusion Sets and Five Day Update

I’m glad to say that things seem to be trending towards much steadier blood sugars, 5 days into this trial. I ran again Thursday night, and that went much better. I still hit blood sugars in the 60’s by the end of 3 miles, but I didn’t feel bad and the glucagon seemed to kick in much faster so I only ate one glucose tablet.

My bionic pancreas is still trying to figure out breakfast – for the past 4 days, I’ve told it I’m eating a “typical” breakfast for me, which is a banana, and it continues to give me a huge dose of insulin, always followed by several large doses of glucagon since I start to drop low. The pancreas should learn that my “typical” breakfast is quite small, so it should learn not to dose as much insulin for it, but maybe it needs a few more days to figure this out. Its keeping my “average” blood sugar around 120, but with peaks up to the 220’s (after meals) and lows in the 60’s. When I control my diabetes on my own, this isn’t too far off from what I’m able to achieve (my averages might be closer to the 130’s, but similar peaks). But of course, controlling it on my own means constant monitoring, use of my own CGM every day, always adjusting, eating for lows, So its pretty impressive the pancreas can do my job as good (if not better) than I can with only 5 days of learning about my body. And I think it will continue to improve over the next 6 days.

There’s lots of people reading my blog (thanks! It feels so great to know people care about this!), including a lot of people who are parents of young kids with type 1, or people who are curious to learn more about type 1 diabetes. One of the most common questions I get from people is “so what actually goes IN your body with an insulin pump?” Also, an annoying comment I often get when I tell someone about diabetes is “Oh my gosh, I COULD NEVER take shots every day!!”  Well, guess what – if your life depended on taking shots every day to stay alive, you’d suck it up and deal with them! And you’d get used to it, as much as a human can get used to poking themselves with needles, and you’d even be thankful for needles because they keep you alive and feeling good!

So, naturally, people are curious about the needle aspect of managing diabetes, and what type of needle an insulin pump infusion set uses, so I’ll write about needles and infusion sets today. As I said, I have to change my glucagon infusion set every 24 hours on the bionic pancreas, and my insulin infusion set every 48 hours, so I’m getting lots of practice with infusion sets =) With my normal care, I use an Omnipod insulin pump, which still uses an infusion set but it is all automatic and contained under the pod, so the pod inserts the needle/cannula automatically and you can’t really see it (one of the good aspects of the Omnipod for me, since I still get squeamish about inserting infusion sets even after so long!). I showed you what infusion sets look like on my skin, and the little blue part can disconnect the tubing while leaving the infusion set in my skin for shower time.

Changing an infusion set is a million times better when my wonderful boyfriend gets me pretty flowers to keep on my desk where I do my set changes =)

So, this is a new infusion set inserter package (this version is the “Inset 90, 9mm”). The 90 means it goes in at a 90 degree angle (they have a 30 degree version too), and it comes in 9 or 6 mm lengths, depending on your skin type, how much fat, etc.

I fill up the reservoir in the pump and then I attach the tubing that is wound inside the package” and the pump has a function to prime (or fill) the tubing so that it has no air in it.

Next, I alcohol swab my skin to clean it. These infusion sets can go in any fatty area (they used to say wherever you can pinch an inch!), so I typically wear them on my outer thigh, upper butt, love handle area, stomach, or outer arm. Its important to rotate sites so that scar tissue doesn’t build up. Here’s a picture of the cannula. For insertion, there is a needle inside the plastic cannula to help pierce the skin, and then the needle is removed leaving the plastic cannula behind in the skin:

That little infusion set pod has a built in plastic launcher spring that cocks back and locks into position:

And then you place it on your site, and depress the sides of the pod and it deploys into your skin. Then you pull back the pod and the needle part pulls out, and the infusion set is in place (sorry for the awkward angle of these pics…the site is on my stomach!)

Then the cannula needs to be primed (filled) as well to displace the air where the needle was.

This is what the infusion set cannula looks like when I pull it out before doing a set change, so that’s what’s actually under my skin for the time I wear that infusion set:

So do these hurt? It depends – many times I don’t even feel them go in, and once in a while (like this morning) I have to sit a few minutes waiting for the sharp pain to dissipate. Even if it hurts going in, usually my nerves stop feeling it after a few minutes. Rarely, its uncomfortable enough that I take it out and start over. Also, there’s the possibility that you can hit a capillary and get some visible blood in the top of the infusion set, or you can see some blood when you remove the set, which isn’t ideal. But more often than not, the insertion isn’t that bad, and during my normal care it only happens every 3 -3.5 days so I deal with it.

For shots, which I occasionally use if my pump is acting up and I want a quick dose, the needles I use are 31G 5/16″ needles. That’s SHORT (only about a quarter inch) and that’s THIN – definitely an improvement over the insulin syringes of decades past that had to be boiled and sharpened with sharpening stones! We’ve come a long way, thankfully! Here’s a pic of my syringes, with a bobby pin for reference:

I was admittedly terrible with the needles when I was first diagnosed (at that time I used a needle that was about twice as long as the one above, and not as thin since the technology wasn’t as advanced back then and a 1/2″, 29G was as thin as they came). My mom had to do my injections for months (meaning driving to high school if I needed a shot at lunch, following my athletic team bus after school if we had a match at another school to make sure she was there to dose me, always being available to come over if I was at a friend’s house and I needed a dose. Finally I got up the courage to do it myself one night for dinner (it must’ve taken 2 hrs for me to ACTUALLY get the needle in me (which of course wasn’t that bad), with much complaining, and since then I’ve mostly taken care of things myself.

So for those of you who aren’t diabetics that already use this stuff, I hope I was able to demystify diabetes injection/infusion devices, and show you that they’re not as scary as you might have thought! You could even show your favorite person with type 1 diabetes that you’re supportive, and ask if they’ll give you a pretend injection to see what it’s like!

Wearing My External Organ

It’s day 3, and this bionic pancreas is definitely still getting to know my body. I’ve noticed that it learned a little from Monday in that it is giving a bit less insulin, and subsequently a little less glucagon so I haven’t had as many nausea episodes. However, I went for a 3 mile run last night and I think this has thrown it for a loop today. Running usually makes me more sensitive to insulin (aka more low blood sugars) for at least the next 24 hours, so the bionic pancreas had to haphazardly adjust to this overnight last night and during the day today.

I had a pretty strong low during my run, since glucagon takes some time to kick in, and strenuous exercise can make my blood sugar drop faster than the glucagon can act. So I had to eat some glucose tablets (fast acting sugar) to bring my blood sugar back up. I also had a low this morning after breakfast that I had to eat some sugar for since the glucagon didn’t kick in fast enough. So, my bionic pancreas has some learning to do, but its only day 3 so I’m keeping the faith! It will learn over time that I still need less insulin than what it is giving, which will keep me from going low so often and needing a glucagon dose or a sugary snack. And also, I think the next prototype they’re working on will have a function to help prevent lows during or after exercise more effectively. This model doesn’t really have a function for that built in, so the study staff warned me to be careful about exercising and bring sugar with me, so I was more than prepared for that low.

I showed you the many things I need to carry on my person for the bionic pancreas, so I thought I’d put a few funny pictures in today to show you how I’ve integrated it (or attempted to, anyways!) into my outfits. I’m in job search mode right now since I’ll be graduating in several months, and of course I have a ton of networking events to go to in the next week that I need to look “professional” for. I went to a networking thing Monday night, and here was my get up for that:

Not too bad, I’d say. That pink running belt has been a lifesaver for carrying everything, so I’m glad I have that!

At that networking event, I was helping with the registration table. I was taking advantage of my time near an outlet to charge my pancreas (this thing drains batteries like crazy!) and I noticed a lady walk in with an insulin pump.  I’ll often say to Nik, “That person we just passed – DID YOU SEE THEIR PUMP?? THEY HAVE DIABETES LIKE ME!” But he will totally not have noticed anything unusual about the person. Clearly I’m just too observant of other people’s waistbands! That being said, I don’t think I’m alone here – any diabetics reading this, don’t you agree that we have the uncanny ability to spot a diabetic from a million miles away if they’re wearing an insulin pump, or are carrying a tester case? And I definitely perk up if I ever pass a lone test strip on the ground that isn’t mine – I know there’s another diabetic about! We know there’s many other diabetics out there…and when have a diabetes encounter “in the wild,” its just exciting to feel that instant camaraderie, and instant respect for a total stranger that knows more about a particular aspect of my life than my own parents and friends and boyfriend can ever understand.

Anyway, I digress. So this very nice lady with the insulin pump walks up, and she instantly recognizes my bionic pancreas brick plopped on the table charging. She had seen pictures of it from previous trials, and it is pretty distinctive looking (since it is WAY bigger/thicker than any 2015 cell phone, and has “Boston University” written on it.) She was so excited about it, and we agreed to meet up after the event so I can show her all the parts, and tell her how it’s working. She was incredibly supportive, and really curious to know how it was working, and I have to say it is just so cool that the diabetes community is like that. So many type 1 diabetics are eager to participate in or contribute towards research, and we all want to know how current research is going. The discoveries being worked on in the diabetes research world are things we’ve been told about since we were diagnosed. When I was diagnosed, doctors said there would be a cure in 5 years. Five years later they said the same thing. Ten years later they said the same thing. A cure always seems to be 5 years away – and I think diabetics just get excited to see actual clinical trials going on for things like the bionic pancreas that are truly less than 5 years away, and that will make our lives easier. So meeting this kind lady “in the wild” was a fun and encouraging “diabetes encounter” for me!

So back to outfits! For my run yesterday, I spent quite a while figuring out how I’d carry everything with me in a comfortable manner. Here’s what I ended up with – I’m standing in my lab, getting ready to head out for my run:

My friend carried the blood sugar tester bag for me, but I managed to keep everything else on me, with no major issues. And I didn’t get too many glaring stares from passer bys about my pointy-looking abdominal area. Success!

I’m still hoping the pancreas keeps learning more about my body in the next few days because I’m still having lots of ups and downs. It is pretty cool not having to worry about calculating doses or (for the most part) dealing with lows, so I’m still enjoying the trial.

Louise

First Impressions

Hello all!

Yesterday was an overwhelming day, so I didn’t get a chance to update you all yet (but yes, I’m alive!). I got to the UNC diabetes center at 8am, and the other 4 participants who were wearing the bionic pancreas for this arm of the trial were there. Over the next few hours, we got our continuous glucose monitor (CGM) sensors inserted and booted up (this takes 2 hrs for them to “warm up”). We got an initial work up done with weight, BP, a blood draw, etc. And finally, we got the two bionic pancreas insulin pumps filled up with glucagon and insulin, got the infusion sets inserted on our body, and got the system started!

I was nervous going into this. I’m not sure why – past trials have shown the system works amazingly, so I think I was just nervous because I didn’t know how I would react emotionally to having this system doing my job that I normally work so hard at for the next 11 days.

I happened to be trending towards a low blood sugar right as I started up my bionic pancreas, and sure enough the first thing it did was give me a boost of glucagon (the hormone that raises blood sugar). We were all leaving the center as this was happening since we were done putting the system on and getting it started, so I sat in my car for a few minutes before driving home and I watched the screen. I saw my blood sugar go from the 60’s (low) back into the 90’s (perfect!). For the first time in 13 years, I didn’t have to eat for a low blood sugar. I thought about this and let it sink in, and unexpectedly, I started crying. I didn’t think it would hit me that hard, but it was just so unbelievable to have the choice not to eat if I didn’t want to. Diabetes often takes that freedom away from me, and while I deal with it just fine on a daily basis, it was really amazing to see, right off the bat, that my bionic pancreas was taking care of business =)

Alright, I know you all probably want to see what this bionic pancreas looks like, so I’ll show a lot of pictures today, and in the next posts I’ll get into more nitty gritty details of what I have to do each day to keep this complex system happy!

So these are some pictures of “the brick” which is a 90’s cell phone-sized unit that holds the bionic pancreas iPhone with the algorithm as well as the Dexcom CGM on the flip side that measures my sugar level every 5 minutes.

I’m covering the study labels so I’m not identifying myself for “anonymity” of the study.

Here’s a picture of the two insulin pumps side by side, and I have the brick jammed inside that pink belly band, and this is me on the way to work after getting everything booted up! The brick talks to the two pumps by bluetooth, but the range is only 3 feet so I have to keep it in very close proximity to the pumps every minute of every day or I get a disgruntled phone call from the 24/7 study staff telling me I need to move it closer. I also have to carry a study iPhone (in addition to the brick’s iPhone and my personal phone) that the staff can reach me on, and a special accurate blood sugar meter, so there’s quite a bit of hardware that comes with this trial!

    

At the center yesterday morning, each participant got thousands of dollars of supplies (insulin, glucagon, infusion sets, CGM sensors, a blood sugar tester and test strips for calibrating the CGM every 12 hours, reservoirs for the insulin/glucagon pumps, a million power cords for charging the system, etc etc etc. They gave us 2 large bags to tote it all home in to last us the 11 days. I spread it all out on my bed (which is a queen size bed, mind you) for dramatic effect:

 

And in the picture above you can see the two pumps have tubing that connects to the infusion sites. Here’s a pic of my infusion sites and how they make us label them very well with stickers and writing to make sure we don’t switch the glucagon tube with the insulin tube (that would be disastrous!). I unclick the tubing when I go to shower, so it is critical they get put back on the right infusion set afterwards.

The glucagon reservoir in the glucagon pump as well as the infusion set in my skin needs to be changed every 24 hours because glucagon isn’t very stable once it’s in solution. So I had my first change last night, and then I’ll change it every evening for the 11 days. The insulin pump gets changed every 48 hours, so my next change will be Wednesday morning for that. They want us to change them at totally different times of the day, as an extra precaution for not mixing up the tubing/what goes into each pump.

Glucagon is normally used for reviving a diabetic that has become unconcsious from a low blood sugar. For this study, we use the same red emergency kits (shown on the left), but the pumps deliver it in very small doses unlike the large dose that would be given if someone was passed out. The glucagon comes as a dry pellet in a vial with a syringe of saline.

The saline is shot into the vial with the pellet, and it dissolves. We use 2 kits for every glugacon refill, so here are my lovely mixed up vials. They bubble a lot, so I need to let them sit for 5 minutes before using them to fill up the glucagon pump reservoir.

I use this syringe to fill the reservoir after I draw up the dissolved glucagon from the 2 vials:

And then I insert a new reservoir into the glucagon pump, and it gets it all ready:

Then I need to fill all the tubing with glucagon before I put the new infusion set in my skin, being very careful to get out any bubbles. I’ll repeat a very similar process for the insulin refill.

So what do I think so far??

I’ve noticed the bionic pancreas dosed A LOT of insulin and A LOT of glucagon the first 24 hours, but this is probably because it’s still figuring out my body, and eventually it will reduce the insulin doses until it is closer to what I need so that it doesn’t have to give as much glucagon to keep me from going low. I did notice a few episodes of bad nausea after glucagon doses, which is also expected since glucagon causes nausea. The bionic pancreas is still learning about how to dose me for meals, so it didn’t do a stellar job yesterday of keeping me in range after meals, but that will get better with time. Overnight, I stayed very steady between about 85-115 all night, and aside from a wave of nausea that hit me between 4-5am (again, probably from a glucacon dose) I had a lovely night with the system. I didn’t notice myself rolling over on the many devices that were strapped to my PJs, I didn’t get any phone calls which means the bluetooth connectivity worked well all night long, and my tubing was relatively untangled when I woke up this morning, so I’d call that a success! I wish I could show y’all my glucose trends from overnight but the study staff doesn’t want us sharing actual data since it will be published after the studies are complete. But it was basically a flat line =)

I’m curious to see if it does better with dosing my meals today and tomorrow. I’m also going for a short run tonight with my two dedicated running pals that have gratefully offered to help me carry my extra phone, blood sugar meter, and emergency sugar supplies, and I’ll have to find a way to strap the two pumps and the brick to my body to keep everything within 3 feet of each other during the run. I’m interested to see how it works with exercise, it’ll be an adventure!

Alright, I think that’s enough for my first update! Thanks for sharing my journey with me!

What is the Bionic Pancreas?

For this post, I’m going to write about my sugar control over the years, and introduce you to what the bionic pancreas is and why it is supposedly better than current care regimens.

In high school and college I admittedly didn’t have great control over my blood sugars. My HbA1C (which is a test that can give an “average” of how my blood sugars have been over the past 2-3 months) was always in the 8-9% range (which is an average blood sugar of well over 200 mg/dL). A non-diabetic HbA1C is < 5.5%. My parents are amazing people, and although my diagnosis was probably one of the hardest things that have ever happened to either of them, they dealt with it perfectly. They gave me independence when I needed it, and help when I needed it. They resisted criticizing me when I’d snack without dosing, and worked tirelessly with our insurance company and my high school to make sure I always had the supplies I needed. When my control would slip, they would nudge me to work harder and step up to the challenge. Even after living with diabetes for so long, I can’t imagine what it is like to have a child with this disease, and although I hope I never have to live through that, if I dealt with it with half as much poise as they did with me, my kid would be in good shape! So thanks, Mom and Dad, I owe so much to you! Here’s a pic of my parents from over Christmas, with my dad rocking his “winter” beard:

My HbA1C started dropping into a healthier range in grad school, when I started running long distance, and more importantly, I met my amazing boyfriend, Nik. Here’s Nik:

Nik listens unconditionally when I need someone to complain to about diabetes, he laughs it off when we wake up in the morning and there’s bits of food mushed into the bed from me having to eat something overnight, he helps me take injections and he inserts my CGM sensors that have scary inserter device needles, he’s honest when my breath smells funny because of a high blood sugar, and many other things. My parents love me so much and have always wanted me to be as healthy as possible for myself. But Nik made me care more about my future and my health because I want to be healthy to be around for him. So, in addition to loving Nik for being an amazing boyfriend the past four years, I also love him for making my diabetes management a team effort. Since the first few months we started dating, my HbA1Cs have been steadily in the high 6%- low 7% range.

So what’s the bionic pancreas, and why is it better than how I manage my diabetes now? The risk now is that human error and life’s unpredictability is unavoidable. Error like that apple was larger than I thought and I assumed it only had 15g carbs when in reality, it had 20g carbs, so my blood sugar went high because I didn’t dose enough. Or, unpredictability like I calculated a dose for a meal expecting to nap on the couch afterwards but instead I had to run to the store to get something and that unexpected activity made me go low. High or low blood sugars like this make me look back and wish I could’ve dosed differently at the time. There’s always guilt that comes with making unpredictable dosing errors like that. In all honesty, most days with type 1 diabetes, you think you did a good job calculating a dose for a meal, and for some entirely unknown reason, the dose didn’t do at all what you expected it to. Insulin is an amazing, lifesaving drug, but it is different than taking a pill, where you take it, it works, and that’s it. Sometimes insulin has a mind of its own! I’m proud of myself for working so hard to manage my blood sugars, but knowing I could maybe do better if I tried harder, or kept a stricter schedule, or ate almost the same thing every day, will always leave me with some inescapable guilt.

The bionic pancreas has 2 insulin pumps – one that has insulin, and one that has a hormone called glucagon. Insulin lowers blood sugar, and glucagon raises blood sugar when it gets too low. The bionic pancreas also uses a continuous glucose monitor (CGM, the same one I use now – the Dexcom G4 platinum) to measure blood glucose every 5 minutes. Then that information goes to an iPhone that is programmed with an algorithm that automatically doses the insulin and glucagon pumps throughout the day to try and keep my blood sugar value in a target range. The only user input is I can tell the iPhone if I’m about to eat a small, typical, or large meal to give the insulin dose a head start. Insulin takes a bit of time to start working, so by the time my CGM would detect my blood sugars rising after a meal and the insulin pump would kick on, I’d end up with a pretty big sugar spike before the insulin could catch up. The bionic pancreas can prevent overnight highs or lows that often wake me up on my current regimen. I can go for a run without having to eat a snack beforehand to prevent a low blood sugar. It’s exciting to think of all the things I can do for 11 days without having to think of diabetes first!

I’m excited to not have any of these 40 mg/dL and dropping episodes:

Or any of these stubborn unexplainable high-for-hours-and-drain-all-your-energy-even-though-you’re-taking-tons-of-insulin blood sugar episodes:

I’m admittedly a little nervous I’ll find myself bored during my 11 days on the bionic pancreas system. I spend so much time thinking about blood sugars, I could feel like a bored empty nester when my control is out of my hands – as if the child that is my diabetes will have moved out to make a place for itself in the world, but 11 days later it’ll come running home crying and park itself on my sofa (pancreas) forever. It’ll also be so nice to get a break from the guilt of miscalculated doses. For 11 whole days if I have an out of range blood sugar, it won’t be my fault – I don’t even care if that off blood sugar makes me feel bad – not having that guilt that my own dosing decision made that blood sugar out of range will feel AMAZING! In the past, I haven’t been super-enthusiastic about the bionic pancreas because I want a real CURE for diabetes, not a treatment that requires all these external medical devices, but now that I get to participate in this trial I’m pretty darn excited about it! I’m excited that if it gives me more steady blood sugars throughout the day I’ll have more energy and feel better.

I’ll wrap up by thanking the people who have made this UNC trial possible. I spent 3 hours with the training team at UNC diabetes care this afternoon (some of whom were down here visiting from the Boston Unversity group). They’re a fantastic group of dedicated researchers and nurses, and I’m looking forward to working with them on the trial. I’m also so thankful for the whole team of researchers at Boston University who have been working on making the bionic pancreas a reality for years and years, and also to JDRF and other wonderful agencies for funding this research. The bionic pancreas website is here (http://sites.bu.edu/bionicpancreas/), and if you feel passionate about this work you can donate on their site, or donate money to the Juvenile Diabetes Research Foundation (JDRF) that funds many type 1 diabetes research projects.

Thanks for reading again – hopefully by my next post, I’ll be bionic!

Louise

Hello! I’m Louise and I have type 1 diabetes

Hello everyone! Welcome to my new blog that will be a place for me to write about my experiences with the Bionic Pancreas trial held at UNC Diabetes in Chapel Hill, NC! The trial starts on March 16, 2015 and lasts for 11 days, so I’ll take these entries before the trial starts to introduce myself, tell the story of my diagnosis, and how I’ve managed my type 1 diabetes over the years. I’ll also give some details about what the bionic pancreas is. So here goes my diagnosis story:

My name is Louise and I was diagnosed with type 1 diabetes at age 14. I’m 27 now, and I just celebrated by 13^th anniversary with diabetes (affectionately known as a “dia-versary”). It’s been a long time, but I can still remember the day I was diagnosed like it was yesterday.

I had been experiencing extreme thirst and very frequent urination for a week or two before my diagnosis, and my mom had ordered some blood work for me to be tested. I had a swim meet the night before I was diagnosed, and I distinctly remember sitting by the side of the pool wishing more than anything that I could dive in and drink all the water in there. The next day, December 13, 2001, I got sent to the high school main office in the middle of school day, and I knew walking over there I must have diabetes. I had a young neighbor who had been diagnosed with diabetes a short while before me, and although I didn’t know all the details of her care at the time, I knew that everything in her life had changed and she had to have needles every day. I walked into the office, and my mom was there crying. The rest of the day was a blur, with lots of finger pricks and tears. I think my blood sugar was 389 mg/dL upon getting admitted to the hospital (normal range is around 80-100, but I’m thankful I was only that high because many type 1 diabetics are diagnosed at closer to 1000 mg/dL or higher). I was so hungry, but I couldn’t eat because the hospital still hadn’t given me my first dose of insulin. I was dreading my first injection, but finally the nurse came in, and all of a sudden the injection was over. The needle wasn’t that bad, and I remember thinking, “Ok, I can do this.” I was in the hospital for 4 days, learning everything there was to know about type 1 diabetes and how my life was going to be forever different.

There are a lot of misconceptions about type 1 diabetes. I didn’t get this disease from eating too much sugar as a kid. In fact, if any of you know my mom, she raised my brother and I on very healthy diets, and both of us were skinny as a rail and very active growing up. Type 1 diabetes is caused by an autoimmune attack of the islet cells in the pancreas, which are the cells that release insulin into the body to lower blood sugar. It’s thought that a combination of genetics and environmental exposures cause type 1 diabetes, but it isn’t known for sure. Type 1 diabetes is often diagnosed in young people (which is why it used to be called Juvenile Diabetes), but more and more middle aged and older individuals are being diagnosed. There is currently no cure for type 1 diabetes, so it isn’t a disease I will ever “grow out” of.  Type 2 diabetes is very different from type 1 diabetes, but it is still called “diabetes” because the end result is the same: unregulated blood sugars. Type 2 diabetes is not an autoimmune disease, and it is caused by a body losing sensitivity to the insulin it produces, which can be (but isn’t always) caused by poor diet or lack of exercise. Therefore, some type 2 diabetics are able to regain control of their blood sugars by improving their diet and exercising. Good diet and exercise certainly help me manage my type 1 diabetes, but I will always have to take insulin.

In the early days, I used fast acting humalog insulin and intermediate acting NPH insulin, I had to eat at exact times throughout the day, and I had to eat an exact number of carbohydrates at each meal – very restrictive! After a couple years I moved to a different insulin regimen that allowed me to eat whatever (within reason) and whenever I wanted, with the trade off of taking an injection of short acting insulin every single time I ate, in addition to one more injection of long acting insulin at bedtime. Finally, I caved into getting an insulin pump, which is a device that has a plastic cannula that goes into my skin that delivers insulin continuously, 24/7. I was sick of taking 5-6 injections a day, and although I was very against having an external medical device constantly on my body to remind me of my diabetes, I decided a pump would help better control my blood sugars. I started on an Animas insulin pump, and about two and a half years ago, I switched to the Omnipod insulin pump which sits directly on my skin in a little pod, and is controlled by a remote control (called a PDM) that also serves as my blood sugar tester. Here’s a picture of my PDM:

Then, almost a year ago I added a continuous glucose monitor (CGM) to my arsenal of diabetes management tools, and this has a small needle under my skin and a receiver that allows me to see my approximate blood sugar value every 5 minutes, which lets me know if my blood sugar is trending up or down or staying steady – very important information if I’m about to go to sleep, or go for a long run. Here’s a picture of my belly with my omnipod pump (on the right) and my CGM sensor (on the left). These things move around on my body every few days from arms to thighs, to upper butt, to belly, and moving them often reduces the risk of infection as well as the development of scar tissue.

And here’s a picture of my CGM receiver, with the red/white dots indicating where my blood sugars have been for the past 3 hours, an actual reading, and a small sidways arrow indicating I’m staying steady at the moment:

I want to wrap up my first post by saying that I’m not writing about my challenges with diabetes to make any of you pity me. I love my life, and I’ll never let diabetes change that. I feel lucky that I happened to be diagnosed with a disease that has really good treatment options that can keep me alive and healthy, even if it takes time and effort out of my day to day life. There are so many terrible diseases out there, and while each comes with a different set of challenges, I don’t ever feel like I got the short end of the stick because I have diabetes. While I’m not seeking pity from family and friends, it definitely does feel good to know that you all respect how hard I have to work to stay healthy, so I always appreciate the amazing support you give me. I think that I am a resilient, passionate, attentive, intelligent, scientific, and loving person, and I’m confident I’d be a very different person today, not better or worse, just different, if I didn’t have diabetes.

Next time I’ll write about how my blood sugar control has been over the last 13 years, and I’ll write about what affects my blood sugar control, what the bionic pancreas is, and why it is supposed to improve my control.

Thanks for reading! I’m looking forward to sharing my trial experiences with you!

Louise