The Artificial Pancreas is Coming - Bi-Hormonal Pumps Explained

Added: 2026-05-31

[00:00:00]An artificial pancreas, a device that prevents people with diabetes [music] from having high and low blood sugars, has been a goal for decades. Many of companies have built automated insulin delivery systems and algorithms to help curb the burden of diabetes, but most of these are insulin pumps and they're only using the insulin hormone. That is only solving half of the diabetes management puzzle. These pumps aren't foolproof systems.

[00:00:27]>> [music] >> If you give yourself too much insulin, you have a low blood sugar. If you don't give yourself enough insulin, then you have a high blood sugar and you could be stuck there like I am. As you can see, I have very high blood sugar right now.

[00:00:38]But one technology aims to solve many of these problems, [music] the bihormonal pump or also known as a dual hormone pump, which many see as a potential artificial pancreas. This system would bring another key hormone, glucagon, [music] in to save the day. Glucagon is released in the pancreas in response to low blood sugar. It tells the liver to make stored glucose usable, then releases it to help raise blood sugar among other functions. A system that uses not just insulin to help lower blood sugar levels, but also adds glucagon to help rise glucose levels, could be [music] the other half we're missing of diabetes management. Welcome to the show. I'm Justin and I have type 1 diabetes and on here I talk all things diabetes tech, news, and research. We've got a podcast on Mondays where I talk to industry leaders and those building the tech themselves and we've got videos like this on Fridays where I review the tech and I talk about the industry, where it's going. So, if you find today's video interesting and you want to learn more about diabetes tech, make sure you are subscribed. Today, I am unpacking the history behind the dual hormone pump and all the problems we have and ultimately, how the bihormonal pump could fix things. First, there's BetaBionics. These are the makers of the islet insulin pump, which was actually inspired by the dual hormone pump. Uh they've been working on it the 2000s.

[00:01:58]I'll also get into Insulet, who has been working on a separate device already being used by 100 people. Keep in mind that anything you hear on this show is not medical advice and is for educational purposes only. Always consult with your healthcare team before making changes to your treatment. All right, let's get into it.

[00:02:14]What if I told you that the first insulin pump ever was bihormonal? It had two hormones, glucose and insulin, and it was the size of a military backpack.

[00:02:25]The system was developed by Dr. Arnold Kadish in 1963.

[00:02:29]It was a fully closed-loop system. It measured glucose levels every 15 seconds through an IV and administered insulin and glucose through separate intravenous syringe pumps to keep the level steady.

[00:02:42]Insulin brought levels down and glucagon brought levels up. I saw the device in person at MiniMed headquarters, where an executive showed me around their whole museum of diabetes technology, and he explained to me how this bihormonal pump worked.

[00:02:57]>> This is actually the first insulin pump that we're aware of. It's completely mechanically driven for all intents and purposes. It was basically a pneumatic system. And so, what it would have is a reservoirs that were holding pressure and then valves that would open and then that would essentially infuse insulin into the body. Pretty tricky setup to deal with because each one of these valves had like a different flow rate, a different basal rate, so to speak.

[00:03:20]And so, you know, you would turn them on and off in order to make sure that that, you know, all kind of balanced out.

[00:03:25]>> I dig even more into that pump and the whole evolution of diabetes tech if you want to check out that video. I'll throw it down in the show notes. The pump never became available for consumers, but it paved the way for pump developments for decades to come. So, we would go from that to more insulin pumps that were pretty big in size, then they got smaller and smaller to wearable sizes. There was the blue brick, then they got even smaller. MiniMed had super small ones that I saw on display at that same location. And so, since the 1970s, we've had these insulin pumps. But then eventually later, they started working with continuous glucose monitors where CGMs would send glucose readings to the pump and they would automate insulin delivery. And that's what we have today.

[00:04:05]We have AID systems. These systems introduced algorithm that would regulate the insulin based on glucose readings and it would predict what glucose is going to be in the future. We call our pumps today hybrid closed-loop systems.

[00:04:19]That's because we've got the CGM, the pump, and the human who's still part of the loop. If I'm going to exercise, if I'm going to eat, those are decisions that my system needs to know. Otherwise, I could have a low or a high because injectable rapid-acting insulin can take around 15 minutes to even start working.

[00:04:38]So, if I don't log my food ahead of time, my pump doesn't know and the insulin is too late. And not only does it take that long to start working, but it takes an hour to 2 hours to peak. So, the responsibility falls on us to try and time insulin injections or boluses.

[00:04:55]If you work out, you become more insulin sensitive. Your system needs to know that so that it takes back the insulin it's going to give you ahead of time before your workout. Otherwise, the insulin you gave yourself an hour ago will be hitting you during that workout.

[00:05:08]While I am so grateful for the technology we have today, because it only uses insulin, they can only be so powerful. You can only give yourself so much insulin before potentially going low. Or, if you don't give yourself enough insulin, then you go high. So, we need more aggressive insulin therapy ideally. Now, let's talk about these hormones. First, you've got insulin.

[00:05:30]Now, people with diabetes use insulin to lower their blood sugar, either with insulin pumps, shots, or pens. Now, with glucagon, people with type 1 and type 2 diabetes, their glucagon is still being produced in their system, but glucagon release isn't always adequately stopped when our sugar is high and isn't always adequately increased when our sugar is low and that is our safety cushion. If we don't have enough glucagon release, then we will go too low and we could pass out, which is why we sometimes need to intervene with glucose snacks. We have our low snacks with us and we need to eat those in order to not have a low.

[00:06:07]Now, in event of hypoglycemic emergencies, people with diabetes sometimes need to use emergency glucagon such as Baqsimi which which gets puffed up your nose or there's Gvoke HypoPen, which is a a shot. Both of these raise blood sugar from dangerous lows and these are typically only taken when carbs cannot be eaten or someone is unresponsive. Diabetes is a roller coaster, but bihormonal pumps aim to significantly or outrightly remove lows from the equation and help with glucose management. There are a lot of pros to bihormonal pumps. There's the big one, which is quality of life, a more hands-off diabetes approach where your system is giving you glucagon when you need a little boost, insulin when you need to be brought down. Of course, we could still have tech failures, you can't really remove that from it, but it's kind of doing its thing. It could also remove the need for announcing carbs. If there's a safety cushion of glucagon, you can be more aggressive with insulin, which means that you can be later with carb counts or you your system doesn't even have to know you ate until later. Then you also potentially don't have to make adjustments for workouts.

[00:07:14]Even if insulin's on board, if your system gives you enough glucagon to keep you in range during that workout, you'll never have needed to touch your system.

[00:07:22]And then of course, there's the possibility of having a tighter glucose range and a lower glucose range. The cons are you may need to wear multiple CGMs, there may be multiple infusion sites because you're taking two hormones. Then there are lots of tubes.

[00:07:38]Right now, none of the systems that are currently being worked on are tubeless and scar tissue. By wearing more devices over your body over time, it can cause more scar tissue, which could ultimately mean that the absorption gets worse over time. So, just things that we should be cognizant of. One of the hardest things here is a glucagon development. So, insulin has always been easy to pump, but glucagon is tricky. Glucagon stability is affected by temperature, molecular structure, and its environment in solution or solid form. It can easily degrade because of these physical and chemical instabilities. So, glucagon is difficult to use. However, new stable forms of glucagon have been developed, which last longer and could be used in a pump. But, there are still challenges and because of glucagon's intricacies, that means that these systems could require more maintenance than the insulin pumps of today.

[00:08:27]Today's episode is sponsored by Sweet Dreams. This is probably the coolest app I found for diabetes management. Those are my live glucose readings on my home screen. With Sweet Dreams, you can display real-time glucose readings right on your iPhone lock screen and Apple Watch for Freestyle Libre, Dexcom, MiniMed, and other integrations currently in early access like Eversense, Medtrum, and Twist. First, you'll want to download Sweet Dreams on the Apple App Store. There's a link in the video description. Once you're subscribed, you'll have access to all the functionalities, including live activity. Once you activate it, readings will show up on the iPhone lock screen.

[00:09:04]You can customize the style to a graph that shows the last five readings, a large view of your current reading, or a compact view. I love this feature because I can discreetly slide my phone out of my pocket, check my levels, and put it back in without anyone noticing.

[00:09:20]A live activity reading also activates on your Apple Watch. There are widgets for the watch face, too. I like this one that shows a graph right in the middle of the screen. There's so much more you can do in this app from a standby mode screen to Apple CarPlay integration, and they're constantly updating the app. Let me know what you think of this app in the comments and you can download Sweet Dreams with that link down in the show notes. All right, back to the episode.

[00:09:44]Now, let's get into the two companies that are currently working on this technology in trials and limited releases. One of those is Beta Bionics.

[00:09:52]You may know them as the producer of the iLet Bionic pancreas. Beta Bionics has been working on its own dual hormone pump for nearly 20 years. The founder, Ed Damiano, was inspired to build a dual hormone pump after his son's diagnosis in 2000. He came on my podcast and he explained that the company's vision has always been to create a true bionic pancreas. One that handles highs and lows automatically. Human trials with the initial algorithms started in 2008 with the participants in hospital beds hooked up to laptops. In 2013, they began outpatient home use studies using two tandem pumps, one administering insulin and the other glucagon, a Dexcom G4, and an iPhone. All of this started before Beta Bionics was formally founded in 2015. Around 2014, they started building the first iLet device. After years of trials and developments, the fourth generation was brought to the FDA and commercialized as an insulin pump only in 2020. The dual hormone pump that Beta Bionics is working on looks exactly the same. Early renderings of the device show two tubes and two infusion sets.

[00:10:58]There are two chambers on the device itself. In fact, the first iLet had two chambers, one for glucagon in it, but they eventually changed that design to the iLet that we have today, which now only has an insulin chamber. On my podcast, Ed explains that the insulin and glucagon would need to be changed at different rates. The goal's to have glucagon change about every 3 days, and depending on use, insulin cartridges would last about a week. In 2024, Beta Bionics partnered with Xeris BioPharma, they're the makers of the Gvoke HypoPen, to develop a stable pumpable glucagon formulation for long-term use. The partnership addresses the core chemical barrier that has held back dual hormone pump designs. The Gvoke HypoPen uses a glucagon that has been stabilized. The companies are working together on a formulation that can be used in a pump at a higher concentration, dialing in on biocompatibility testing. Now, the vision for the future of this dual hormone pump would be to have a single site, but a dual cannula infusion set that could deliver both insulin and glucagon through one location. So, it would basically be one tube, but then it would be like two tubes connected that would then go to the same infusion site.

[00:12:09]They found that they can place infusion points within about a 1 cm of each other. So, pretty good. The next steps for this device will be a small clinical trial with the drug in the pump before pivotal trials. Pivotal trials will take much longer as the FDA requires a larger study for bihormonal pumps, since they're introducing a new drug. This would be a first of its kind. While the dual hormone version is still in the works, we've got that Beta Bionics iLet out today, insulin only. If you want to learn more about the iLet pump, I had a user come on and talk about the algorithm. It's pretty interesting. You don't have to necessarily carb count.

[00:12:43]You put in like how big your meal is, and apparently that is kind of the goal for the bihormonal pump as well. You would still carb announce, but you just wouldn't put in numbers. Uh you also only have to put in your weight, which is the only setting you need to start using that pump. So, if you want to learn more about that, I'll throw my interview with the user down the show notes, as well as the podcast episode with Ed Damiano, where he gets even deeper into the dual hormone pump.

[00:13:06]Inreda also came on the podcast, so I'll throw that down in the show notes if you want an even deeper dive into this. The company is based out of the Netherlands, and they are pushing this technology further. We had the CEO and the founder of Inreda on the show. He uses the device himself. He shared how the device was developed from the beginning stages all the way to today's current model. It started as the size of a mini refrigerator with multiple computers and today is about the size of two MiniMed 780Gs. Yeah, it's still pretty big, but it has come a long way. Its system is called the Inreda AP. AP is for artificial pancreas. We love it. This device is not commercially available yet, but it is being tested in real-world pilot programs in the Netherlands. There's the AP5 model. It consists of two computers, so it has a main system and a control system. There are two chambers, one for insulin and one for glucagon. It delivers both insulin and glucagon using two infusion sets, one for each hormone and two CGMs for safety and redundancy. So, if one doesn't work, if one's warming up, it can still send readings and you can still get the hormone sent over. On this system, calibrations are required every 24 hours and if only one sensor is working, it will require it every 11 hours. Sensors are measuring glucose levels every second and those values are wirelessly transmitted to the device.

[00:14:31]The onboard algorithm is continuously learning a user's insulin sensitivity and automatically adjusting insulin and glucagon delivery based on glucose trends and activity. Now, with this system comes a lot of maintenance. So, for insulin, it depends on usage, but that could last about every five to six days and need to be replaced. The infusion set for that needs to be replaced every three days. Glucagon, the cartridge of glucagon needs to be replaced every two to three days and the infusion set every one to two days. Now, that sounded like a lot to me. So, when I spoke to the CEO on the podcast, I asked about that. I said, "That's a lot." And he said that altogether, if you add up all the time spent doing it, it's 20 minutes. But, if you think about all the time, you know, needing to be spent throughout all these moments needing to switch it out, that is a lot.

[00:15:18]I'd be curious if if if you had a system that that completely controlled your diabetes or like took out a lot of the equations, but you still had a lot more maintenance to it. You had to like constantly be tinkering with it. Would that be worth the trade-off for you? Let me know down in the show notes. Very curious to hear what you have to think.

[00:15:34]What about for me? If it meant I had a system that constantly regulated me without having to make the decisions, if it was guaranteed then may you know what? Maybe yes. If it was guaranteed to be taking control of me during food and exercise that actually does sound like a really good trade-off.

[00:15:50]Insulet has developed a carrying case.

[00:15:52]It's a hip little bag. Uh it's got a belt strap and you can uh put it in that so you're you're set. The AP5 is kind of the initial device. It's just for these trials. It's not waterproof. They're also developing a next-generation device, the AP6, which is expected to be about 50% smaller and it is much sleeker. This is intended to be a more widespread consumer use and this one is waterproof. It's designed to be more user-friendly and for those who are visually impaired. Insulet's studies with the AP5 have shown promising results so far. After 1 year of use, people experienced average time in range increased to 80% hypoglycemia rates dropped dramatically, only about 3 to 4% in low range overall. 97% of the users meeting therapy goals of more than 70% time in range and less than 4% below range. Insulet is hoping to release this commercially in the Netherlands in late 2026 or early 2027. I mean, that would be this year. I don't know if that's still the plan. Uh I'm very curious. I will reach out to them and find out. So, will dual hormone pumps reach people living with diabetes anytime soon?

[00:17:04]I don't know. I mean, it sounds like Insulet is close. It sounds like Beta Bionics has a lot more time to go. I'm curious to hear your thoughts down in the comments as to how do you think that these would perform as is today or with a little more time and development if they got smaller, less intrusive, worked out the kinks of these things? Do you find promise in all of this? Regulatory reviews will take time here, especially since these systems count as a combination drug-device product, and these have never been on the market before. But, this technology could change the game, and I don't think it's a concept of what if, but more about when. For those of you who are ready to take the leap, you can find out more information on how to sign up for trials or preliminary use on both the Inreda and Beta Bionics islet websites.

[00:17:54]If you try it, let us know. If you've been in part of these studies, let us know. We've covered so much more on this channel from the future of insulin pumps, reviews of the Tandem Mobi, uh DIY Loop, Omnipod 5, Libre 3 Plus, all the CGMs, all the pumps. So, if you want to learn more about all this stuff, make sure you subscribe, but also check out the other videos on our channel, and give this video a like if you enjoyed it. Also, be sure to subscribe to our newsletter on there. We're always putting out the latest information in diabetes tech. Thank you all for watching. I'm Justin, and I will tech you later.