Imagine waking up and glancing down at your smart pump. Your blood sugar is a perfect 100 mg (5.5 mmol). You decide to have pancakes for breakfast. You tap “Large Meal” on the screen and start eating. Your sugars rise up to 180 mg (10 mmol) before coasting gently back down towards normal as you go through your morning. As you go out for a run, you marvel that it’s been a month since you had a very low blood sugar.

This is not a fantasy: it is happening today in the Beacon Hill Study of the Bionic Pancreas.

How the Bionic Pancreas Works

Dr. Ed Damiano, one of the fathers of the bionic pancreas and a biomedical engineer by training, shared the remarkable progress of the program over the last 10 years at the Friends For Life Conference in Orlando, Florida. The event, hosted by Children With Diabetes, is the largest gathering for people with type 1 diabetes in the world.

So what is the Bionic Pancreas? Damiano explains: “It’s a pumping system, a sensor, and an algorithm that makes a decision every 5 minutes to dose insulin or glucagon to raise or lower blood sugars.” In today’s incarnation, it’s an iPhone 4S that collects data from a Dexcom G4 continuous glucose sensor and tells two Tandem insulin pumps to dose insulin (to lower blood sugar) or glucagon (to raise it). This is an investigational device. The actual device would be a dual chamber smart pump connected to a continuous glucose sensor.

“This is the bridge that will get us from where we are now to a cure,” Damiano shared. “I hope we all look at this as a transient technology that will one day be swept under the rug. It’s what we have to cling to until the more elegant solution of a biological cure.”

The first edition of the device, built for use in the studies, only cost $93,000 to build, says Damiano. “This is still a kludgy system, but it’s not the final commercially available product.” It will be thrown out when the Dual-Chamber Pump is available.

Many who have used continuous glucose meters in the past – many of which were frequently inaccurate – wonder how this is all possible. Damiano shared data on the latest generation of Dexcom’s G4 continuous glucose sensor and concluded: “We’ve come to the point now where we have accurate enough sensors to do the job. And we have the data to show that.”

The data was truly stunning. For those not using the Bionic Pancreas, they spent 4.6% of their day with low blood sugars. For those on the system, that number dropped to .4% of CGM values. Overnight lows, when the body is in stasis and blood sugars are easier to manage, were dramatically limited.

These numbers are the real deal. Patients are not locked away in a hospital room with every movement measured and controlled. Instead, participants can go anywhere within a three mile radius of the clinic, exercise whenever they want and eat whatever they want. The Bionic Pancreas takes care of all of the blood sugar management.

Although this system is a major improvement over traditional diabetes treatments, there are still issues. For example, there is nothing it can do if you have an issue at the site of the insulin infusion. This can still lead to blood sugars over 400 mg (22 mmol) in a few hours. However, he noted, you could put on a new sensor at 11 pm, go to sleep, and wake up with perfect blood sugars. “Try doing that by taking a major dose of insulin before you fall asleep. That’s going to be a terrible night.”

So why is it called a Bionic Pancreas? It’s a strange word, says Damiano, but accurate: “It’s an externally worn device that emulates biological function through mechanical means. It’s a bio-pancreas. It’s not a pretty thing to look at, but it the best we can do with the technology that is on the table right now. What we have is a really reliable and accurate continuous glucose meter device and a really reliable and accurate pumping system.”

Life on the Bionic Pancreas

Beacon Hill Study participant Kelly Close explained how remarkable the experience was:

So what was it like to have a machine making all these decisions for me? Well… I was never hypoglycemic

I never felt hypoglycemic

I was never worrying about hypoglycemia

I was never recovering from hypoglycemia That’s already enough of a game changer for me. But there was more… If I started veering low, my bionic pancreas figured it out and gave me the perfect amount of glucagon to make sure that hypoglycemia didn’t occur

I always felt safe during the week – at no time did I feel threatened or scared

My glucoses were being watched and stayed perfectly in range overnight, every night. Wow.

I counted zero carbs

I never “corrected”

I never thought about insulin sensitivity and how I couldn’t figure that out

I never thought about insulin to carb ratios

I never bolused

I was a nicer and kinder person the entire week with the bionic pancreas Because the system uses both insulin and glucagon, I got to see mini doses of glucagon in action for the first time. There’s no question about it – glucagon is a cool hormone. It is ten times better than orange juice, glucose tabs, candy, gel, etc. It is SO precise and the power of having just the right amount was really cool. It was magic!

Amazing, right? Below are the blood sugars for someone on the Bionic Pancreas. The green range is normal blood sugars and the blue range is values up to 180 mg (10 mmol). As you can see, this person had the equivalent of a 5.4 A1c with nearly zero hypoglycemia!

Next Steps for the Bionic Pancreas

When Damiano started on this project, he promised his son, David, who has type 1 diabetes, that he would have the project done by the time he goes to college. Damiano says that they are on track to submit this product for approval in 2016 and to get it approved before David goes to college in 2017. This is an ambitious schedule – that’s just 50 months away – but he believes it is possible.

Damiano said there are key areas where he would like to see progress to get this system on the market. First, we need to get glucagon, the hormone that raises blood sugars, to be stable at room temperature. He says that there are a number of small pharmaceutical companies working on this and he hopes that they will get there in the next few years. Second, we need a dual-chambered pump capable of delivering both insulin and glucagon.

On his wish list, he included two items. A continuous glucose meter sensors that don’t need to be calibrated. People often do not calibrate their sensors or use inaccurate blood sugar numbers to calibrate them. This introduces unnecessary inaccuracies into the system. Second, we need faster-acting insulins. Damiano expressed optimism that as the current generation of fast-acting insulin goes off patent in the next few years, smaller, more agile companies will step in and produce faster insulins.

If you are interested in participating in clinical trials for the Bionic Pancreas, follow http://www.bionicpancreas.org. Although the Beacon Hill Study is fully enrolled, they will be enrolling multiple new studies this fall. The FDA has been approving their new study designs in just 30 days, record-breaking time.

To learn more about the development of the technology and to see it in action, check out this video:

Update – July 17, 2013

Thank you to Adam Brown of diaTribe for sharing a number of insights about diabetes technology broadly speaking and the bionic pancreas in particular. He also reminded me that Kelly had in her piece a number of roadblocks to keep expectations in the right range. This is an excellent point. In closing, I’ll share some of the remaining challenges that Kelly Close shared in her diaTribe column:

The fine print: There are a lot of things that have to go well in order for this to be commercially available by 2017. That is the year that Dr. Damiano’s son will go to college and the year that Dr. Damiano hopes to see a commercial system approved by the FDA. Here’s what has to happen: The rest of the current trial has to go well so that the researchers can move onto the next phase – testing the system at diabetes camps this summer (they will be followed by one nurse per four kids).

After that, Drs. Damiano and Russell’s team will test the bionic pancreas in healthcare providers who have diabetes themselves. The two-week study will be more ambitious, as the participants will sleep in their own homes and go to work as they normally would. (This is pretty smart right – they still have healthcare providers around, to ensure safety, but they are themselves!)

If all goes well, the research group plans to conduct pivotal studies, at least one of which will last six-months, that will test the final version of the system in 2015 and 2016.

For these longer-term trials, a new pump will need to be built and approved that can carry both insulin and glucagon. Tandem Diabetes Care is currently working on developing such a pump (see our new now next from diaTribe #50 on this news).

A stabilized liquid glucagon must be developed that can last for a few days in a pump. In this study, the researchers used the current glucagon “kit,” which requires mixing glucagon powder with water. Unfortunately, it had to be replaced every day in the glucagon t:slim pump I was wearing. While this was acceptable in a research setting, it’s not a viable real-world solution because it is too expensive (it’s also a pain, though I would do it in a heartbeat). We believe that this is the biggest obstacle to overcome in the next few years. Fortunately, companies such as Xeris Pharmaceuticals, Biodel, and others are working hard on addressing this problem. The timeline will be tight to make the goal, though I’m optimistic.

Before it can be sold, the FDA has to approve the bionic pancreas – certainly no easy task considering the ongoing three-plus-year delay in approving Medtronic’s MiniMed 530G. Known as the Veo outside the US, this is the most basic version of an automated insulin delivery system – it suspends insulin delivery for up to two hours when the CGM crosses a low threshold and the user does not respond to an alarm. We understand that Dr. Damiano and colleagues’ interactions with the FDA have been quite constructive, so we are hopeful here as well, though it may be a complex journey. Indeed, given last year’s artificial pancreas guidance from the FDA, there does seem to be a clear approval path forward. (For more on that topic, see the learning curve in diaTribe #39.)

Now, given all the fine print, Adam also passed along the following slide from Damiano’s presentation. It shows that the average blood sugar dropped from 151 to 130 when patients were on the Bionic Pancreas while at the same time reducing lows by half.

Read more about A1c, artificial pancreas, bionic pancreas, continuous glucose monitor (CGM), Dexcom, exercise, insulin, insulin pumps, iOS, iPhone, low blood sugar (hypoglycemia), Medtronic, Tandem, U.S. Food & Drug Administration (FDA), Xeris Pharmaceuticals.