In our continuing coverage of all things closed loop, today we're excited to share the experiences of a long-time type 1 in the Boston area who's recently had the chance to try out the much-discussed Bionic Pancreas system -- our friend and fellow diabetes advocate Bernard Farrell.
The Bionic Pancreas is of course being developed by Dr. Ed Damiano and Dr. Steven Russell from Boston University. We've written about their work before, and it's been making huge strides in the past couple years (something I'm personally very excited about).
At the recent American Diabetes Association's Scientific Sessions, Damiano reported that his team expects to do some more key trials soon that include testing how their system functions using insulin only, without glucagon -- which has been included until now. That will provide important insight before they head into the pivotal trial phase, in hopes of introducing a commercial product by 2018.
We shall see, but in the meantime it's encouraging to hear how fellow D-peeps are using this next-gen tech during trial runs.
Without further ado, let's hear from Bernard about how it went...
A Guest Post by Bernard Farrell
I’ve had type 1 diabetes for over 40 years. In that time, I’ve had a chance to use three significant pieces of technology that are diabetes life-changers for me: blood glucose meters, insulin pumps and continuous glucose monitors (CGMs).
Now, the next-generation system that's in development is the Artificial Pancreas, and it brings together -- or closes the loop -- between all three of those life-changing devices.
Recently I had a chance to participate in a trial to support the closed loop research being done by Dr. Ed Damiano and his team at Boston University. They call it the Bionic Pancreas. Based on using a prototype device to improve my blood glucose (BG) control and improve the quality of my life, I plan to get one of these as soon as they’re on the market.
I'm not the first to go through this trial, of course. You may have already read about previous trials for this research, the Beacon Hill Study in 2013 where folks had a chance to live with the Bionic Pancreas while they roamed around the Beacon Hill area in Boston. If that sounds restrictive it wasn’t; reading some of the postings afterwards makes it clear that although the equipment was prototypes, the results were astounding. Last year, some kids at the Clara Barton diabetes camp also had a chance to wear the BP and see the amazing results. It’s clear to me the BP team is using real-world situations to push the boundaries on this technology and produce great results.
Despite my pump and CGM, managing my BG control is still a huge amount of work. I have too many days when I can’t tame my rollercoaster blood sugars or can’t get my BG levels into any kind of reasonable range. So when offered a place in this latest trial, I didn’t hesitate.
This trial investigated whether using automated glucagon delivery can better control BG levels. The setup was that participants were each given a Tandem t:slim insulin pump for glucagon or placebo delivery; a Dexcom CGM for BG monitoring; and another device referred to as the Bionic Pancreas.
File photo of Bionic Pancreas system; not what Bernard used, as he had a double-blinded device where he couldn't see the actual data.
The BP itself is a large, heavy, case that holds both an iPhone and a Dexcom receiver. (I think the extra weight is due to a battery that powers the combination.) Both the pump and Dexcom had Bluetooth connections to the iPhone. The iPhone took the Dexcom reading (every 5 minutes) and decided whether some glucagon was needed. It also transmitted all the information to the cloud, so the team knew if there were any issues with connections.
The BP Dexcom readings were hidden from me, but I continued to wear my own Dexcom setup and used that as usual to decide on insulin dosing. The glucagon pump was also essentially disabled for me; the only thing I could do was enable or disable Bluetooth. Here's what the glucagon-pump screen looked like:
This was a double-blind study. That means neither the researchers nor myself knew whether I was getting glucagon or a placebo on a given day. Currently a liquid solution of glucagon is only stable for about 27 hours, so I had to change out the extra pump set around the same time every day. This was the only difficult part of the study. We were given a daily supply of the liquid to use; it was contained inside black cylinders so we didn’t know whether we were filling the pump with glucagon or the placebo. These cylinders made it hard to get the liquid out. This daily routine was truly the hardest part of the trial. There was also a daily survey at the end of each 24 hours that asked questions about any nausea I felt, how many lows I experienced, and if I thought I was using a placebo or glucagon and why.
The study folks were careful about setting expectations and making sure we all understood how everything worked and how to deal with any error messages. For the two-week duration of the study there was always someone on call. I was called a total of three times because the BP had lost the connection to the pump and needed to be reconnected.
OK, enough about the nuts and bolts. How did it work in real life?
First of all, I knew there were several days when I was getting real glucagon. I never experienced any nausea, the doses delivered are much smaller than you’d get from a glucagon injection. But this was a pleasant surprise.
How could I tell when there was glucagon? My Dexcom graph gave it away. Below, you can see my BG dropping really fast from a big high -- magically when it gets to a certain number.
I did catch the Tandem pump dosing too because it sometimes buzzed. So I could ‘see’ how many units it was giving me though I couldn’t tell whether it was glucagon or placebo. Glucagon concentration peaks within about 20 minutes and tails off very quickly, in about 90 minutes. So I did notice times when I was given several ‘glucagon’ boluses over a few hours. Around 120 mg/dL it changes direction and levels out. Then it starts to drop later and is pulled up again. By the time I went to sleep around midnight, I didn’t worry too much about further drops because of the results from 3:30 pm onwards.
In the Beacon Hill Study, participants could notify the Bionic Pancreas that they were eating a meal. For this study, we couldn’t do that, which is one of the things I find amazing. The BP didn’t know whether I was exercising, eating, or had taken an insulin bolus. But it did a great job at maintaining my BG levels within a fairly tight range.
What were the downsides? It was a challenge to wear two Dexcom sensors. And changing the glucagon site every day was an effort and hard to remember. I ended up setting a reminder because I’d forget and get to it a few hours late. Several times the two sets of tubing were tangled and wearing two pumps was a challenge to my waistline. But…
This is a prototype setup. In 2013, JDRF announced it was working with Tandem on a dual-chamber infusion pump. Glucagon stability is difficult but several companies (Calibrium and Xeris) and research projects seem to be working on this issue and hopefully this will be solved before long. Ideally a solution will allow a single site that delivers both insulin and glucagon in the same cannula, but if two cannulas are needed and can be provided in a single insertable unit that should work for many folks.
My sincere hope is that this research moves quickly into product development. I don’t know whether the research already completed, including this trial, will count as Phase I and Phase II trials for the FDA. But the practical experience gained in running the research and gathering results should enable the BP team to effectively complete all needed FDA trials.
What I see as the biggest challenge is cost and insurance coverage. Pumps and CGMs are now covered for type 1 diabetes by many insurance companies, but this technical development will cost more initially and insurance providers may hold back on reimbursement until it’s been proven.
Dr. Ed Damiano started work on this project after his son David was diagnosed with type 1 diabetes as an infant. Damiano wanted to make living with diabetes much easier and he’s hoping to get the BP on the market before David leaves for college -- that’s in about two years' time.
Given all he’s accomplished in the last 14 years, my money is on the success of this project. And unlike ‘the cure’ (whatever that may be) this should be in our hands before 10 years are up.
Thanks for sharing, Bernard. Sounds exciting, even with the double-blinded aspect. Needless to say, we look forward to seeing how the research moves forward!