Tech on the Horizon: Where Will Automated Insulin Delivery (AID) be in 2021?

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

What AID systems are currently available, what can we expect in the next year, and where is AID technology headed?

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As we enter 2021, we’re taking a look at what’s ahead for automated insulin delivery (AID) systems. Because the COVID-19 pandemic delayed many clinical trials and FDA reviews in 2020, several companies are expecting to launch new AID systems in 2021. This list covers many of the most notable upcoming products, but there are likely others on the horizon – if you know of a system you think we should track, please let us know.

Click to jump to a product, organized by expected launch date. You’ll find detailed descriptions and possible launch timelines for each, reflecting US availability.

What is automated insulin delivery (AID)?

Automated insulin delivery has many names – artificial pancreas, hybrid closed loop, bionic pancreas, predictive low-glucose suspend – but all share the same goal: combining continuous glucose monitors (CGMs) with smart algorithms to automatically adjust insulin delivery via an insulin pump. AID systems aim to reduce or eliminate hypoglycemia, improve Time in Range, and reduce hyperglycemia – especially postmeal and overnight.

When thinking about the development of AID technology, it’s often helpful to think in stages.

  • Stage 1: The most basic AID system might shut off the insulin pump whenever the user’s CGM readings drop below a certain number, such as 70 mg/dl, to reduce time spent in hypoglycemia and help prevent severe hypoglycemia.
  • Stage 2: The AID system could predict when glucose is going to go low and automatically reduce or stop insulin delivery to further help prevent hypoglycemia.
  • Stage 3: The AID system may be able to automatically adjust basal insulin delivery depending on whether the user’s glucose is trending up or down, and taking into account other factors, such as insulin on board. This adjustment of basal insulin would aim to increase Time in Range (TIR), and help prevent both high and low glucose levels. At this stage, the user would still have to manually give meal boluses and correction boluses.
  • Stage 4: The AID system will be able to deliver correction boluses when glucose values are high. These small adjustment boluses would be a further step in improving TIR, with less time with hyperglycemia.
  • Stage 5: The systems will be able to detect meals and automatically deliver a system-calculated meal bolus to reduce postmeal high blood glucose levels. With the elimination of manual meal bolusing, the system is considered to be a “fully closed loop” System.

Currently available products are in stages 3-4. By the end of 2021, we may have multiple stage 4 systems available.

Medtronic MiniMed 670G and 770G – already available 

AID

Image source: diaTribe

Now available for people over the age of two.

What is it? Medtronic’s MiniMed 670G has been available since spring 2017 and was the first stage 3 AID system to be cleared by the FDA. Prior to the 670G, Medtronic released stage 1 and stage 2 systems (Medtronic MiniMed 530Gand 630G, respectively). More recently, the MiniMed 770G system was cleared in the US in September 2020. Both the MiniMed 670G and 770G systems use the same insulin adjustment algorithm, which adjusts basal insulin delivery every five minutes based on CGM readings, targeting 120 mg/dl. The target glucose level can be temporarily raised to 150 mg/dl when low blood sugar (is a concern, such as during exercise or sleepovers for children. Both systems come with Medtronic’s Guardian Sensor 3 CGM, which has seven-day wear and requires two fingerstick calibrations per day (although four are recommended). See our article from 2016 for a full breakdown on the MiniMed 670G and from September for more on the 770G.

What’s the difference between the MiniMed 670G and 770G? As mentioned, both the MiniMed 670G and 770G systems use the same insulin adjustment algorithm and the same CGM. However, the newer MiniMed 770G has an improved pump: the 770G pump includes Bluetooth connectivity and can be paired to the MiniMed Mobile smartphone app (available for the iOS and Android) for users to view their CGM and pump information without pulling out their pumps. The app also allows users to share their data with others in real-time. Note: users can only view information but cannot control the pump (e.g., deliver a bolus, adjust basal rates) from the app. Bluetooth connectivity also means the system’s insulin adjustment algorithm can be updated. Medtronic has promised current MiniMed 770G users a free upgrade to the MiniMed 780G when that system becomes available (more below). Finally, the MiniMed 670G is only cleared in the US for people over the age of seven, while the MiniMed 770G is cleared for people over the age of two.

Medtronic management recently shared that algorithms will become an increasingly important part of the diabetes ecosystem, and presumably, a key differentiator for companies – lots of exciting times ahead with AID, that is for certain.

Tandem Control-IQ – already available in US

AID

Image source: diaTribe

Now available for people six years and older.

What is it? The Control-IQ system from Tandem was cleared by the FDA at the end of 2019 and launched to customers in January 2020. It’s precursor – Basal-IQ – was cleared in 2018. The Control-IQ system uses Tandem’s t:slim X2 pump, Dexcom’s G6 CGM which requires no fingerstick calibrations, and the Control-IQ insulin adjustment algorithm. In addition to automatic basal rate adjustments and predictive insulin suspension, the Control-IQ system is the only AID system with automatic correction boluses: when it predicts glucose to be above 180 mg/dL in 30 minutes, the system will deliver 60% of the correction bolus needed to reach a target of 110 mg/dL. Control-IQ targets glucose values between 112.5 and 160 mg/dL, though users can turn on or schedule “Sleep Activity” mode to achieve 112.5-120 mg/dL by the morning. This past summer, Tandem launched the t:connect smartphone app (for iOS and Android), which allows users to check their pump and CGM data on their phones.

What’s next? With the current t:connect smartphone app, users can view information but cannot control the pump (e.g., deliver a bolus, adjust basal rates). Tandem has already submitted an updated app with pump control to the FDA and expects to launch that functionality in 2021. Tandem has also mentioned enhancements to the Control-IQ algorithm that are expected in 2021. While we haven’t heard many specifics, we believe it’s likely that these enhancements will focus on improving glycemic outcomes, personalization, and usability of the system.

Insulet Omnipod 5 – expected early-to-mid-2021 

AID

Image source: diaTribe

FDA submission is likely coming soon (if it hasn’t occurred already), and Insulet aims for a “limited” launch in early-to-mid 2021. Insulet has completed the clinical trial for Omnipod 5 but has not shared the results.

What’s new? Omnipod 5 is Insulet’s AID for its popular Omnipod disposable pumps, also called patch pumps. If you’ve been following the field, you’ll know that Insulet previously called the new system Horizon – same system, new name. Omnipod 5 uses Dexcom’s G6 CGM, and Insulet expects to launch the system with smartphone control capability; users can still opt for a dedicated controller device, since smartphone control will be available for Android users first. Insulet is working on an iPhone version for Omnipod 5, though that will not be available at launch. Insulet is also working with Tidepool (more below) on an iPhone-based AID system. Omnipod 5 will have adjustable targets between 100 to 150 mg/dl. Because the Omnipod pump will store the algorithm and communicate directly with Dexcom G6, the system will work even without the smartphone or pump controller nearby.

Medtronic MiniMed 780G – expected mid-2021

AID

Image source: diaTribe

Pivotal trial completed for 780G and presented at ADA 2020. Medtronic aims to submit the system to the FDA by January 2021 with launch coming around mid-2021 for adults (either ages 14+ or 18+).

What’s new? The MiniMed 780G will be Medtronic’s second AID algorithm and a significant upgrade over the MiniMed 670G and 770G systems. In addition to automatic basal rate adjustments, the MiniMed 780G will include automatic correction boluses and an adjustable glucose target down to 100 mg/dl. The system will also have fewer alarms and simpler operation with the goal of further increasing Time in Range. The MiniMed 770G and MiniMed 780G pumps are identical, meaning MiniMed 780G users will also be able to use the MiniMed Mobile smartphone app for viewing pump data, uploading pump data wirelessly, and updating their pump wirelessly. As the pumps are identical, Medtronic has promised that those who purchase the MiniMed 770G now will be able to wirelessly upgrade to the MiniMed 780G for free when 780G does become available. Finally, the MiniMed 780G will use the same Guardian Sensor 3 CGM as the 670G and 770G, which requires two fingerstick calibrations per day and has a seven-day wear time. As a sidenote, an improved CGM sensor is in development by Medtronic, but isn’t expected to be available when MiniMed 780G launches.

The MiniMed 780G is already available in many countries in Europe, and data from a clinical trial was presented at the ADA 2020 conference. On average, the 157 participants in the study (ages 14-75) saw their Time in Range improve by 1.4 hours per day (69% to 75%) while using the system – that’s particularly notable given the low baseline of the A1C. Speaking of A1C, the A1C improved by 0.5% (7.5% to 7%) after using the system.

Beta Bionics insulin-only iLet – expected mid-to-late-2021

AID

Image source: diaTribe

Pivotal trial underway with completion expected in the first half of 2021. Launch expected mid-to-late-2021, though this is subject to change.

What’s new? Beta Bionics is a Massachusetts-based startup developing an AID pump and algorithm called iLet. iLet will work with Dexcom and Senseonics’ CGMs (and possibly others in the future) and is designed to be especially user-friendly. diaTribe founder Kelly Close participated in an early Beta Bionics trial (2013!) and raved about the system and how easy the pump seems. At set up, users only need to enter body weight (no insulin-to-carb ratio, sensitivity factor, basal rates, etc.), and the system will learn more over time. To bolus, users will use icons to describe meals as containing more, less, or the same amount of carbs as usual (no carb counting). The insulin-only clinical trial for iLet began in the summer of 2020 and is expected to wrap up in the first half of 2021. Beta Bionics aims to launch iLet mid-to-late-2021, though this could be delayed as the FDA continues to prioritize COVID-19-related devices.

What’s next? Beta Bionics’ iLet is unique from the other pumps on this list, because it is designed to work in either insulin-only or insulin-and-glucagon configurations. With glucagon, Beta Bionics believes the system can reduce hypoglycemia while maintaining stable glucose levels and potentially even better-than-average, lower glucose levels due to availability of glucagon. Currently, there are different views on using glucagon in an AID system – in addition to the potential for improved glycemic management, there are uncertainties around glucagon pricing and availability. Regardless, the insulin-and-glucagon version of iLet is still a few years away.

Tidepool Loop – launch timing unclear

AID

Image source: diaTribe

Online observational study completed, and launch timeline depends on FDA progress.

What’s new? Unlike the others in this list, Tidepool is a non-profit and is working on the AID algorithm only; Tidepool does not have its own insulin pump or its own pump and CGM combination (like Medtronic). About two years ago, Tidepool announced plans to submit the do-it-yourself (DIY) Loop app to the FDA to become an officially supported app available on the Apple App Store, compatible with in-warranty, commercially available pumps and CGMs. For now, DIY Loop is a free, publicly available, open-source, non-FDA-approved AID system that works with Dexcom and Medtronic CGMs and old Medtronic and Insulet pumps. Read about Adam Brown’s experience using DIY Loop here. For those who are very interested in the project, there is a great deal to learn from notes that Tidepool shares about its communications with FDA – the latest notes are from a mid-2020 meeting.

Initially, Tidepool plans to launch with Insulet Omnipod and Dexcom G6 compatibility. To set it apart from the DIY-version, Tidepool Loop will have different colors, guardrails around certain settings, and a built-in tutorial for new users. A 12-month, completely virtual study was performed with Loop users and will support Tidepool’s submission of Loop to the FDA. The six-month data was presented at ATTD 2020 showing a Time in Range increase of about 1.4 hours per day (67% to 73%) with Loop. Tidepool also announced in November, 2020 that its human factors study had also been completed – this is another required step of the FDA submission. Much of what Tidepool is doing is unprecedented, so the launch timing is unclear.  In an update on January 8th, Tidepool shared that it has now completed FDA submission of Loop.

Source: diabetesdaily.com

Teenager Builds T1D1 App After Diagnosis with Type 1 Diabetes

T1D1 (which stands for type 1 diabetes from day 1) is an app that was created by a newly diagnosed 13-year-old, Drew M, to help people better manage their condition. Determination coupled with being well-versed in coding led Drew to create this app almost immediately after diagnosis.

I thought it would be nice to hear Drew’s story and how he took his new diagnosis as an opportunity to help others.

Hi Drew, thank you for taking the time to speak with me. I know you were just diagnosed in September of this year. What signs were you showing and what made you see your doctor?

The only reason I went to my doctor was because we noticed I was losing weight while growing. I had lost more than 10 pounds and had grown over an inch over a three month period. I went to my pediatrician and they drew some blood. We left the office and before we even got home, my mom got a call from them and they said, “pack a bag and go to the ER at Children’s National right now!” My blood sugar level was 529 mg/dL and I apparently had large ketones in my urine test.

Drew recovery

Photo credit: Laura Mendelow

I know you were hospitalized, did you get a good education on how to manage this condition?

Yes – I think the diabetes team at Children’s National Hospital was awesome! They had a whole team of people that kept coming in to visit with me. Because of COVID, all group classes were now given one-on-one, so I got a great education.

Although I missed school when I was in the hospital, I still felt like I had math class because there was so much to learn about calculating my numbers and carbs. It felt like a lot to take in, but they did a great job explaining it to me. They taught me how to calculate my insulin doses and count carbs and I practiced on a sponge.

My grandma was diagnosed with type 1 about 10 years ago, when she was 61, so I was pretty familiar with seeing her managing it. That also helped me a lot knowing someone who has T1D so I wasn’t as scared when they told me that I had this disease.

I know you have a passion for coding and had just finished taking a summer course. At what point did it dawn on you that you were fully capable of creating something like this?

We were joking around about it with the nutritionist, Alex, that morning in the hospital. She was showing us some apps to help us out and said it was annoying that there wasn’t one app that did everything. My dad said jokingly, “Don’t worry, Drew will build you one.” When we got home I started looking at different ways to build apps and there are so many platforms now to choose from. I started playing around with it that same day and realized I had enough knowledge of coding that I could actually do it!

The stuff I was doing over the summer was just for fun because my soccer camp and my overnight camp got canceled because of COVID. Basically, I was bored and taught myself how to code using YouTube videos and a few classes that my dad shared with me. I learned how to code video games using Unity, but nothing like this app! I figured I knew enough about how to code that I could figure out how to build an app. It was like a cool challenge to take on.

My dad is a programmer but he had never built an app before either. But I figured if I got stuck, he could help me out. But, he really didn’t know anything about the program I was using, so a few times I got stuck and my dad was like, “I have no idea how to help you with that one, you’ll just have to google it.” So I did.

The platform I was using was limiting, like I couldn’t create a drop-down menu so I would have to learn how to go around the system to create some of the functions I wanted. I just kept teaching myself new things online until I found things that worked.

Drew with his father in the hospital. Photo credit: Laura Mendelow

I know the doctors at the Children’s hospital expressed a desire to create an app that was different than those that already existed. What was their wish list?

Well, they wanted a few things. First, it had to be simple and easy to use. And, it had to be something that a person could use from day one of diagnosis. There are so many apps out there but they may require you to have a CGM or a pump or they’re just too much for someone who is recently diagnosed and too complicated for kids to use. They wanted an easy way to calculate your insulin dose and also log your glucose levels.

People who are newly diagnosed are asked to call in every day after diagnosis for about 2 weeks and report their numbers from the last day (e.g. blood sugar, carb count, insulin taken for every meal, snack and at 2 am). So having a feature where you could email your logs straight to your doctor was a big request as well.

Then, they had more detailed ideas like the option to round to the nearest half or whole number. I didn’t even know some pens have half units and others only have whole units. The doctors knew what people needed, and I knew what I wanted as a person who was newly diagnosed, I just had to figure out how to program it on the app.

Your app has become quite a success! Now available on Android and iPhone, T1D1 has over 9,000 downloads already. What sets your app apart from the rest?

I think people like that the app is simple, yet does everything that they need right from the beginning of being diagnosed and has some cool features (like different settings for different meals) that other apps don’t have. Plus it’s completely free and has no annoying ads or any kind of in-app purchases.

Also, I think they like that it was created by a kid and not a big company, so they know I’m not out to make money or collect their data. I’m new to the T1D community but I can already see that people get annoyed when they see companies using their disease to make money off of them.

How long did it take to create this app and can you tell us a little bit about the beta testing process?

The first version took only about a week, but it was super simple. It was basically just a calculator with a few changeable settings. We then showed it to Dr. Marks and the diabetes team at Children’s and they came up with some suggested features. I would build in the features and then send it back to them for review.

Once we had a few features like a bolus calculator and an insulin log, we then reached out to online diabetes communities to see if anyone would volunteer to help us test the app. My dad reached out to groups on Facebook and Reddit and asked for volunteers. I remember that night, my dad was overwhelmed with how many people wrote back offering their help.

At that time, it was only being tested for Apple and we had about 70 beta testers. After a lot of testing, the app got published in the Apple Store on Halloween. So, that was about a month and a half after I started working on it. Then, a few weeks later we were able to get it published in the Android Google Play store.

I know you have received both national and international attention (Fox News, NPR and the Jerusalem Post to name a few!), how does that make you feel?

Honestly, I was so surprised at how it took off. It makes me feel really good knowing that the app will now reach so many more people. One of my main goals is to make the app accessible to as many people as possible and this publicity really helps me achieve that goal. Anyone who has T1D knows how tough it can be to manage this disease 24/7. Hearing stories about how I’ve really helped others, makes me feel so happy and helps me get through the tough moments. And, these stories keep me motivated to continue working on the app to make it the best I can.

Drew with family. Photo credit: Laura Mendelow

I know you are hoping to keep this app payment-free and ad-free. How can people help support you?

If people want to support the app, they can donate on the “support us” page on the IOS version of T1D1 or through the website T1D1.org. All donations are used to keep the app live and make enhancements. All profits get donated straight to JDRF. Another huge way to support us is to spread the word to their diabetes team and by posting about it on social media!

You are clearly an ambitious young man with a ton of determination! Do you see yourself doing more things with coding and diabetes? What do you think you would like to do when you are all grown up?

This opportunity to make an app really helped me to see the possibilities of being a programmer or developer when I grow up. It’s been really cool to talk with other organizations like Tidepool to learn how they integrate technology into improving people’s lives with diabetes. It’s awesome to think that I can use my coding skills to continue to help others with T1D. I now have a pump and am amazed by the pump technology. Who knows what others will create in the future. I’d love to take part in creating that new technology with them to help make all of our lives easier.

Thank you so much for taking the time to speak to me. You are a perfect example of someone who took an unfortunate situation and took the opportunity to help others.

I wish you much success and look forward to watching you thrive in both your future professional endeavors and managing your type 1 diabetes!

Source: diabetesdaily.com

One Year into DIY Looping

One year ago, I built a DIY hybrid-looping insulin pump, using my Dexcom G6 and Omnipod. For those who aren’t in the know, DIY “looping” is basically “hacking” your insulin pump with a single-board computer, such a Raspberry Pi or Riley Link, to make it communicate with an existing continuous glucose monitor (CGM) to make basal adjustments accordingly.

It’s important to note that this is NOT FDA approved, but the #WeAreNotWaiting community has been sharing information on how to build your own DIY looping insulin pump for years now, and I took the plunge in 2019.

In July I celebrated one full year on my looping system, and wanted to share my thoughts on 365 days of looping.

I Still Have Diabetes

I remember when I first set up my Riley Link and switched on “auto-mode.” I had this magical vision of never counting carbohydrates again, limitless runs without lows, and forgetting what the thirst of a high blood sugar felt like. Then I realized, just as quickly, that I still have diabetes.

Even though my Dexcom continuous glucose monitor (CGM) readings now communicate with my insulin pump and make basal adjustments accordingly, the “hybrid” part means that it doesn’t anticipate, nor account for, any carbohydrates eaten. I also need to tell my pump when I’m about to exercise, and for how long. Since the insulin pump does not operate on artificial intelligence (AI), it cannot anticipate what I’ll do next.

So yes, I still have lows on runs and I still have highs when I eat something that isn’t appropriately accounted for. I still have to count carbohydrates and no, I haven’t forgotten what the Death Valley-like thirst of a 350 mg/dL feels like, although it happens less frequently.

My HbA1c Isn’t That Much Lower

I have always been maniacal about tight diabetes control. My A1cs have hovered in the low 6s for the last 10 or so years. With Loop, I immediately thought that my control would be *perfect* and I would ride out the 4s and 5s into an eternal sunset. NOPE. My latest A1c was 5.9%, which I am rightly ecstatic about, but it’s less than 1% point lower than I was on MDI and a CGM.

The key difference is that my time in range has increased from around 30% to 75%, and the number of lows that I experience has gone down from around 3 per day to 3 per week. It’s easy to have a low HbA1c when you have highs and lots of lows to average it out- it’s much harder (and healthier!) to have a lower HbA1c with few lows. And plus, I just feel healthier. And that has made all the difference.

Dexcom graph by Christine Fallabel

It’s a Mental Vacation

Being a human pancreas 24/7/365 is not easy (why didn’t anyone tell us this at diagnosis?!). In addition to running a household and having a full-time job (and texting everyone back, and maintaining some semblance of a fitness routine, and trying to eat something green at every meal), being an organ all of the time is hard work.

More than anything, a year into looping has given me the mental break I didn’t know I needed. Sure, I still have to count carbohydrates, adjust for exercise, and dose for meals, but hours can go by where I don’t think about diabetes at all, and that never used to happen. My mental distress has gone way down, and I don’t experience diabetes burnout at nearly the frequency I used to. This also helps maintain my motivation to continue to take care of myself and my diabetes.

Dosing Is More Discreet

As I make my way through my 30s, this is less of an issue (if you have a problem with me dosing in public, the problem is you, not my diabetes), but looping has definitely made checking my blood sugar (read: checking my phone) and dosing (also read: checking my phone) way more discreet in public than manually testing my blood sugar and dosing used to be. It’s also more hygienic (I change my insulin pump with plenty of alcohol swabs every 3 days from the comfort of my home), and more convenient. This is perfect when I’m out at a crowded concert, or squeezed into a small table at a restaurant.

It can also cause issues. For instance, if I’m in a public place where cell phones aren’t allowed, sometimes it’s difficult to explain that my iPhone is actually durable medical equipment (DME) that I need to survive. Let’s just say there have been some teachable moments.

Loop app screenshot by Christine Fallabel

I Am Happier

When I was diagnosed with type 1 diabetes in June of 2000, my doctor told me that the cure was just 5 years away. I thought the cure was just around the corner, we all did. And learning that the “cure” is still out of sight, 15 years hence, has been a hard pill to swallow.

I’ve dealt with anxiety and the impending depression of only someone who has a chronic disease with no cause and no cure can experience, but having something like Loop feels like someone is finally on my side, looking out for me, and making things just a little bit easier when the load becomes too heavy of a burden to carry. I can go to sleep and know that my basal will immediately shut off if I start to go low overnight. I can relax if I’m digging into dinner at a friend’s house and I don’t know the exact carb count for a meal, knowing my basal will tick up to cover the difference.

Having a Loop feels a little bit like you have a certified diabetes educator (CDE) and best friend just sitting on your shoulder, making constant adjustments, never judging, and ensuring that you have a better go of it, a little bit of help when you need it. And that help has been life-changing. The cure may never have been 5 years out, but with Loop, I finally feel okay waiting just a little bit longer.

Do you DIY Loop? How has your experience been? Share this post and comment below; we would love to hear from you. Follow the #WeAreNotWaiting hashtag on Twitter to learn more about the DIY movement.

Source: diabetesdaily.com

Best Apps to Manage Blood Sugar

With everyone going high-tech these days, it seems almost intuitive that our blood sugar management would make its way to a screen (remember the days of pen and paper log books?!). Measuring and tracking your blood sugar is easier than ever with the help of apps, right on your smartphone. Here are our top picks […]
Source: diabetesdaily.com

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