So whoa! Much woe.
Posts tagged ‘dexcom’
During my visit to Clara Barton Camp yesterday, I heard the same sentiment over and over again from the kids wearing the bionic pancreas: “It works.”
“It was weird not to touch the buttons when it beeped,” Addy said, an 11 year old camper at Clara Barton Camp who has been living with type 1 diabetes since she was two. “I’d reach down to look at it or touch it when it beeped but then I’d have to remember not to touch anything.”
“A big change from needing to check every beep and look at the devices all the time, right? So when did you feel like you were used to wearing it?” I asked her.
“Yesterday. Yesterday, it beeped and I didn’t reach down. I just said, ‘Whatever.’”
“You trusted it?”
“Yes. I trusted it. It works. If you check it, it’s perfect. My blood sugars are perfect.”
Addy has been wearing the bionic pancreas since Sunday, part of the Bionic Pancreas study taking place at The Barton Center (and also the Joslin Camp) this summer. She’s one of thirteen campers at Barton taking part in the study, ages ranging from six to 11 years old, six girls suited up with the bionic pancreas last week and seven this week. “My blood sugars have been perfect – I haven’t been low at all and I haven’t been high, except for one 203 mg/dL.”
If a week without blood sugar excursions sounds like an impossible dream, take heart. Take pancreas, too, because this technology actually exists and is currently attached to seven girls in Massachusetts. And not “seven girls stuck in a hospital bed under strict activity guidelines,” but seven girls who are running amuck at camp, swimming, dancing, singing in the dining hall, and burping at picnic tables outside of the cabins. The bionic pancreas has been highlighted in the New York Times, NPR, chronicled extensively over at diaTribe, and has also been the subject of a frequently-downloaded-and-rabidly-shared New England Journal of Medicine article.
The system has a few moving parts: two t:slim insulin pumps with the Bluetooth switched on for communicating with the phone (one filled with insulin and one filled with glucagon), a Dexcom CGM, and an iPhone. An in-depth look at how the technology works together can be found in the NEJM paper, but the basic gist is that the Dexcom monitors blood sugars and sends that data to the iPhone, which is running an algorithm that doses insulin, glucagon, or refrains from dosing anything at all. Lows can be corrected by glucagon, highs by insulin. Meals aren’t carb counted, but instead the algorithm “learns” what a big meal, small meal, or snack is based on minimal input from the PWD.
“It’s beautiful,” I said to Ed Damiano, one of the principal investigators on the project, after seeing some of the blood sugar outcomes from previous studies.
“It’s still a little clunky,” he replied. “I want to see one device, one infusion set. But this? It works.”
Currently, the camp study at Barton has girls on the full bionic pancreas system for five days, and then five days on their own insulin pump, but with the CGM blinded to the user and still uploading to the cloud. Bionic pancreas campers are required to check their blood sugar at least seven times per day. Due to camp safety protocols, the study team can’t let low blood sugars “ride” and assume that the bionic pancreas will step in with glucagon in time, so success on some levels isn’t judged by minimal time below 70 mg/dL but instead the reliable metric becomes how many times did the study team need to intervene for a low blood sugar.
This summer, there are a few new features on the bionic pancreas. One is “microburst glucagon,” which is most useful for when people are disconnecting the system for swimming or similar, in efforts to provide a safety net for low blood sugars while doing that kind of activity. There is also an option for temporary targets, which allows people to adjust their target thresholds. “Normally, we aim for 100 mg/dL, but if we can adjust the threshold and show a change in the A1C based on that adjustment, we’re able to titrate A1C levels using the bionic pancreas,” said Ed.
Some challenges still exist with the system. The bulky devices, for one, are their own challenge, but as the project moves forward, the diabetes community rallies to support current needs. “Donna from Tallygear came up and made these ‘GO BIONIC!” belts in a matter of 48 hours.” Ed said, smiling. “We didn’t ask her to do that. She offered, and we are so grateful because the kids love them.”
The kids sing the praises of this device. Ally, diagnosed in 2009 at the age of five, wore the bionic pancreas the week before Addy suited up. “It really works. When I saw the video online, I thought it was made up. I thought the girl in the video was lucky, and that her numbers were just perfect that day. And then I wore it [the bionic pancreas] and I was like, ‘Wait … it really does work!’”
Addy chimed in, her bionic pancreas belt visible over her shirt: “Ally wore this last week and now I’m wearing it. She said to me, ‘If you don’t want to wear it, can I wear it for you?’”
Ally nodded. “I did say that.”
“Does the weight of the device bug you?” I asked Ally.
“No. It’s a little heavier but I don’t care. Even with all the pumps on and the phone, I could still do a back-handspring in the grass.”
The study at Barton concludes this week and then moves over to the nearby boys’ camp. But after this study finishes, there is still work to be done. The amazing bionic pancreas team has come so far and the 2016 pivotal study is in sight, but needs community support to get there.
This is where the Bionic Challenge comes in.
According to the website call-to-action: “The Bionic Challenge asks each family to raise $5,000 in 60 days (by September 1, 2014). If each family in attendance here today can turn to their friends and relatives and obtain 50 $100 donations (that means finding only about one donation per day for the next seven weeks), we can resume our development effort in September and keep on schedule for our final pivotal study in 2016. If we cannot resume in September, it could jeopardize our ability to secure a recently announced time-limited $20MM NIH funding opportunity, which is due in about nine months (April 15, 2015) and could support all of the clinical costs of our pivotal study.”
tl;dr: the project needs the support of the diabetes community because, without it, the goal of a 2016 pivotal study may be delayed. If you can donate, please do. If you can’t, please consider sharing this information with someone who can. The more people who know how to help, the better.
After being promised a “cure in five years” back in 1986, the idea of the bionic pancreas being delayed because of money makes me feel insane. I could understand a delay if the technology wasn’t up to snuff, but to delay due to funding is unreasonable. I saw kids playing outside yesterday afternoon, running around and laughing and having fun and the burden of diabetes seemed only as heavy as the belt around their waist, which with time and technology becomes smaller and lighter.
“I look at diabetes as management and maintenance,” said Ed, as we sat in the Barton Center bionic pancreas command center, where the study team was hard at work monitoring the campers blood sugars from the cloud. “The maintenance part is the changing of an infusion set, the changing of a sensor, the checking of blood sugars. The management part, to me, is the emotional part of diabetes. The fact that you are so often told that you’re ‘wrong’ because you’re trying to thread the needle. This device doesn’t take away from the maintenance part because it still requires that you wear something, do something, change something. But it does make the management part smaller. So much smaller.”
I don’t know if a biological cure will be seen in my lifetime. I was diagnosed with type 1 diabetes in 1986 and have been living well, but not without frustration, as a host to this disease for almost 28 years. My perception of what a “cure” is has changed as I’ve grown older, and my hope for something that takes this disease away fades with time. But seeing the bionic pancreas at work, around the waists of children not much older than my own, and watching the worries of diabetes lifted from their minds and the minds of their families, I feel renewed hope. More hope than I’ve felt in a long, long time because this is real. I held it in my hand. It filled me back up.
Because it works.
You can follow the progress of the bionic pancreas on the Bionic Pancreas website and “like” their Facebook page for more updates. Links to articles featuring the bionic pancreas are here , and this video shows you how, and why, the bionic pancreas works:
Waiting, when it comes to diabetes, frustrates the hell out of me. According to the “cure in five years!” mantra that rang out constantly when I was diagnosed in 1986, I’ve been waiting for a cure for almost 30 years. Currently, I wait (impatiently) for the Animas Vibe to become available to US patients. I wait for the Dexcom Share application to become available. I wait for doctors to call me in for appointments and on the phone with mail order pharmacies and on and on … lots of waiting.
I hate waiting.
But people aren’t waiting anymore. There’s a whole movement in the diabetes community embracing that very concept. And today (and tomorrow) I’ll be taking an in-depth look at how amazing people in this community are taking their diabetes data into their own hands. We are not waiting, indeed!
Today, John Costik, one of the founding members of the CGM in the Cloud Facebook group, an engineer, and diabetes dad to Evan, talks with me about the #wearenotwaiting movement and how he was inspired to make CGM data bend to his needs. (This is a long post, but his perspectives are awesome.)
Kerri: What is your connection to diabetes? And can you tell me about the CGM in the Cloud group, with some background on the We Are Not Waiting movement?
John Costik: When Evan was diagnosed, it felt like the floor to the lives we knew had vanished. The grief, anxiety and denial were all very real, and once we had our hospital training and sent on our way, the reality of it all sank in. Type one management is hard! But my wife, Laura and I are both engineers; we saw, almost immediately, that processes can be improved, data can be collected and analyzed. If we could make life (even just a little) more like life without T1D, we had to try. After researching pumps and CGMs around Christmas of that year, we decided we wanted to start on the [Dexcom] G4 as soon as possible. The DOC was very helpful – your first and second impressions posts, along with other reviews, made it pretty clear that this was an amazing device.
We danced with the insurance company, fortunately not for too long, and we had Evan’s CGM in hand in late February of 2013. I decided to start tweeting about it – it was a very real shift to a more optimistic attitude in all of us.
— John Costik (@jcostik) February 23, 2013
I was hooked, and the anxious father in me never wanted those numbers and trends to be more than a glance a way. Less than a week after getting the G4, using files provided with Dexcom Studio (libraries), we had a windows laptop pulling the data and sending to a simple Google doc for Laura and me to pull up throughout the day. I built a simple trend and number app for our iPhones that pulled this data – sitting in a dock at work, Evan’s BGs were a glance away.
— John Costik (@jcostik) April 2, 2013
I also wanted to cover the “gaps” in data – recess, walks around the ponds at daycare; arguably the riskiest times for a low to creep up on Evan. I then began to look into using a cellphone to read the G4, and send the data to a cloud service that any number of devices could pull from. I took family medical leave starting in April 2013: Evan’s honeymoon was ending, pump therapy was beginning, and Kindergarten prep wasn’t going to be as simple as we’d expected (plus, Laura and I were exhausted). I set aside a few weeks in May to see if I could make the cellphone chat with the G4. Fortunately, I didn’t let my technical shortcomings keep me from trying, and I figured it out pretty quickly. An Android app that can read G4 data became a thing!
— John Costik (@jcostik) May 13, 2013
— John Costik (@jcostik) May 14, 2013
This led up to an email from the wonderful Lane Desborough. We got talking, I shared my simple Windows uploader with him, and he began working on “Nightscout” – a glance-able BG chart that could be viewed throughout a home. After several months of testing, improving the Android app to work more reliably, I shared the code – Lane continued to develop Nightscout, with assistance from Ross Naylor – I leveraged the chart code in our own “Care Portal” and grabbed a Pebble watch to play with.
— John Costik (@jcostik) July 16, 2013
We continued to work on our apps and tools, more folks on twitter began to notice – and it became very clear that people really wanted this tool. It was life changing for us, and other parent’s immediately saw the value, the hope for a less complex, safer, healthier life it can bring. Freedom!
The “CGM in the Cloud” facebook group started from these early twitter interactions and helping just a few other d-parents looking for a better way. We have wonderful tools, but they can do more! Jason Calabrese, Jason Adams, and Toby Canning deserve the credit for scaling this system.
Jason Adams started the group, because he knew that we were not the only ones tired of waiting.
A simple tweet that started something bigger:
— Jason Calabrese (@jasoncalabrese) August 18, 2013
#wearenotwaiting was coined by Howard Look, d-parent and CEO of non-profit start-up Tidepool. It was the call to arms for the first “d-data exchange” hosted by Tidepool and DiabetesMine, just prior to their Innovation Summit in November 2013.
— Tidepool.org (@Tidepool_org) November 21, 2013
As a movement, it is all about doing more & not waiting for:
- Anyone else to step up and change the standard of diabetes care.
- To cut through the old proprietary systems of big medical.
- To take ownership of our data.
- To use the combined data (BGs, Nutrition, Insulin, and Biometrics) to unravel the unique mystery that
- everyone’s T1d is.
- To go out on a date with a spouse, without T1d’s shadow tagging along.
- So many things!!
— John Costik (@jcostik) May 14, 2014
Kerri: What kinds of discussions have you seen taking place in the group?
JC: Wonderful Testimonials! I can’t express how amazing it is to see so many people “taking back” from T1D. Parents out on dates, children riding bikes, going on sleepovers – these events were either put off or filled with anxiety and fear over the constant “???” Removing the mystery makes it possible. It makes averting dangerous lows possible… To see others experience what we experienced, it is still overwhelming.
HELP! And lots of it freely given… New folks learn, and teach others, the combined learning of hundreds, now (potentially) 1,500+ people. How do you pack this setup together? How does your child carry it? What phone works best? What cables do I need? How do I compile the code? I see the full spectrum of technical prowess in the group members, but no one should ever (and I hope hasn’t) feel that there are any questions off limits. I know, as I’m typing this, that there are at least 20 conversations going on covering how to install the pebble watch to the best Nintendo 3DS case to stuff this setup into. The future! Don’t like ???’s We can see through them – Want less lag in your CGM data? That’s coming.
— John Costik (@jcostik) June 21, 2014
The discussions in the group also point out the very real shortcomings of a DIY system – all of a sudden, instead of just worrying about a sensor problem or being out of range – you have cell service drops, weak wifi, bad cables, phone battery life, all these new points of failure… but we work through them, because not one or all of those new concerns can topple the improvement in life the “CGM in the Cloud” brings.
Kerri: How is this group moving current diabetes technology into tomorrow’s tech space?
JC: CGM in the Cloud gives us a look at the future of connected devices – a space that consumer products are starting to fill, but medical devices lag. It’s understandable: regulatory delays, walled-off device ecosystems that, by design, keep you tied to a single device maker, and device hardware focus (not the integration or software) induce this lag (among many other things). CGM in the Cloud bridges this gulf in time – simply knowing how to “talk” to a device and get the same data we see on a receiver screen, that’s all we need to get started. The remaining technology is there to be bolted on and consume the available data, to display it in such a way that unobtrusively integrates it back into our lives. What works for me may not work for someone else, but that’s fine – there’s no limit to what or how we use or access the data.
Light bulbs that can turn themselves on, change color, audio systems that can wake up the neighborhood, an app that can call someone when conditions merit. Standards, and organizations like Tidepool will make this fly – I would much rather read a standards document than decode byte arrays. I would love a single platform or application that lets me talk to all of my medical devices – not three separate and poorly designed apps that I hate so much I never use anyway…
Publishing protocols and using standards will benefit device makers – I wonder how many new G4 Platinum systems have been sold because CGM in the Cloud exists? I know people that were on the fence between Enlite & G4 – and CGM in the Cloud was the deciding factor (I know people that have switched out right – Insulin suspend or Remote monitoring … remote monitoring was a bigger benefit to them)
Kerri: Is this group only for Dexcom G4 users? Or is someone dabbling in Medtronic/Abbot space?
JC: I “hacked” the G4 because it is the best CGM product for us, available to us – d-parents, PWDs – anyone that uses a medical device to keep them alive & well should be able to use device that suits them best. The company name on the device should be irrelevant – I have zero brand loyalty when it comes to CGM, BGM, and pumps – I will use the best product available, and that’s it.
If the Enlite is the best product for someone, and they want to use the CGM in the Cloud tools, they can – we just need to know how to get the data from a 530g to the cloud, preferably wirelessly, and the rest is ready to go. I actually think Medtronic would be doing themselves a favor by letting us know how to read the data in this way. As I mentioned, I know people that have switched or picked the G4 because they can see the data virtually anywhere in the world.
I hope these companies understand that something as “simple” as internet accessible, real-time CGM data makes a big difference for a lot of people.
Kerri: Do you fear the FDA? The CGM companies? Anything? (Or is part of the movement to also #techwithoutfear?)
JC: I don’t fear the FDA or CGM companies … anymore. My biggest concern, and why it took nearly a year to make the code open source & available on github, is the fear of litigation from individuals. Covering those bases was extremely important. Doing all this work to make our (my family) lives better, only to risk financial ruin would’ve been, well, awful. Licensing, disclaimers, LLC’s – they can cover you pretty well, but it’s the larger CGM in the Cloud community that offers the most help. The programs that CGM in the Clouds use are part of an open source repository owned, not by me or anyone else, but to the group – it’s open to any and all contributors. Ben West has taken on curating the group code, and that code is as much yours as it is mine.
The FDA is coming around – the group will “pre-submit” to the FDA at some point, and if their new guidance is any indication, we could eventually see a “CGM Uploader” app in the “Google Play” store.
In fact, I have several apps and tools that remain private, and these regulatory changes would make sharing them a no-brainer.
Dexcom has been largely silent, but always aware of what we’re up to – I see very little reason to be afraid of them. Every interaction with them has been great. I hope they like what they see!
Kerri: I’ve downloaded the “CGM in the Cloud” high level set up. How easy is it for members to get one another suited up and running on a remote device?
JC: Pretty easy! From phone advice to actual setup help (Rajat Gupta is amazing, I think he’s helped over 60-70 people get it set up), it’s all there, and Facebook group posting style can make it challenging to find an answer – so a new post is always okay.
Laurie Schwartz, Jason Adams, and Jason Calabrese are the group admins, and they’ve done a great job guiding users and staying very current on the posts with their very sage advice. As much as any of us that wrote the original code may have done, they’re the ones that carry it up and on to a level I never would have thought possible. [Editor's note: Look for more from Laurie tomorrow!]
Kerri: John, why is this tech important to you?
JC: It makes life better, it gave Evan a school year with but a single BG below 60. ￼It gives Evan non-diabetic A1c’s – with pizza and cake still on the menu! And hypo and hyper a mere 1% for over a year. (Caveat: Evan eats anything and everything, which allows very good timing and 100% pre-bolus capabilities – solving for specific foods by collecting the data, analyzing and improving the bolus strategies)
It lets Laura and I go on dates, and actually pay attention to something other than diabetes! Evan and Sarah can play for hours outside, without mommy and daddy hovering or interrupting constantly. As I’ve said before, it takes back some of what type 1 took from us that day in August.
Technology is only as good as the good it does for people. If it doesn’t make life better, easier – skip it,find something that does. For us, and our use, it goes beyond merely seeing BGs all the time. The increased awareness, even at its most passive, helps us understand diabetes a little better, and it gives a CWD or PWD a team of people that understand it as well. Our school nurse is amazing, and she used a custom site (which will end up in the open source repositories this summer) to view his BGs, log treatments, and view those treatments on the same Chart. Her own intuition about Evan’s diabetes was key to a virtually hypo-free year.
— John Costik (@jcostik) April 28, 2014
I hope the shared awareness continues to lighten the burden for Evan, and helps prevent burnout as the ￼tasks ramp up. I told him, if we haven’t cured it, I will always be happy to mind his diabetes if he needs a break from it – whether 13 or 53. Technology like this enables me to do just that, without actually impeding or limiting Evan’s ability to enjoy life.
Kerri: And lastly, how can the greater DOC support this movement?
JC: Share use cases – how would you make it better, how could it make your life better? YMDV, and no system will meet all needs all the time, but we can try – the beauty of a crowd-sourced tools like this -someone else probably wants what you want, and if you’re alone, there’s still someone more than willing to help make it happen for you.
The DOC can spread the word, and help build the community. Together we can show the device makers what products we really want – if a group of 1,500 can get some attention – the stronger our voice, the better. It’s hard to find better motivated people than the DOC – what we do to keep ourselves, a child, a spouse, a friend, (and so on) happy and healthy comes from a place of great love. I suspect our best ideas, our biggest innovations come from the heart, and not a desire to make money.