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

How to Make an Emergency Preparedness Plan

The reality of living in a time of a global pandemic, such as COVID-19, is slowly starting to sink in for millions of Americans. Without any preventive antibodies, vaccine, or cure, it is extremely scary when the closest thing we can do to protect ourselves is to wash our hands, avoid sick people, and remain socially distant at all times. With society all but shut down, here’s our guide to creating an emergency preparedness plan if you get sick and/or need to quarantine in place for a long period of time.

What and How Much to Stock Up on to Shelter-In-Place

With shelter-in-place mandates in all but a handful of states, it’s important to know what you’ll need for (ideally) several weeks without leaving home. People with diabetes are more susceptible to having severe complications from COVID-19, so even though grocery shopping and going to the pharmacy is permitted under a shelter-in-place order, it’s not necessarily recommended. Even though the food supply-chain will not break down, it’s best to not be running to the grocery store any more often than you absolutely need to, so try and stock up on at least two weeks’ worth of shelf-stable food, water, and toiletries. In a pinch, apps like Instacart and Amazon Fresh offer online grocery orders, so if you’re running low on some staples but don’t want to leave home, these are a great option to have.

Shelf-stable foods:

  • Dried beans
  • Rice
  • Lentils
  • Flour
  • Pasta
  • Canned and frozen vegetables
  • Canned soups
  • Peanut butter
  • Canned and frozen fruits
  • Canned meats and seafoods

In a March interview with NPR, Dr. Peter Jacobson, a University of Michigan professor of health law and policy, advises a stockpile of at least 90 days for medical supplies:

“People should not be caught short of having enough heart medications, diabetic medications, or any potentially life-saving medication that they need on a routine, daily or weekly or monthly basis,” he said.

Sometimes this can be as easy as signing up for your pharmacy’s mail-order option or talking to your pharmacist and asking if they can fill your routine medications for 90 days instead of 30.

Contacts to Have on Hand

Now is an excellent time to gather all of your important phone numbers for doctors and family members should you need to get in contact with them quickly (or if you fall ill and your spouse needs to contact someone quickly). Important numbers to gather and have in a communal space (like pinned up on the refrigerator):

  • Endocrinologist
  • Primary Care Physician (PCP)
  • Your Employer
  • Immediate Family Members
  • Trustworthy Neighbor
  • Local hospital (where your insurance is accepted!)
  • Your Pharmacy/Pharmacist
  • Water Company
  • Power Company
  • Internet Provider
  • Children’s School or Daycare

Have a Plan B If You Need to Evacuate

Have a plan in place if you’ll need to evacuate your home or city. Reach out to your support network of family members or close friends should you need to self-isolate due to COVID-19 exposure, or if you feel your city is becoming unsafe and you need to get away. Make sure you prepare a packing list, have a to-go bag ready, and prepare your home if you need to leave quickly. Conditions can change quickly, so it’s important you know where you can go, how to get there, and what to bring if and when you need to leave.

Important things to pack in a to-go bag:

  • All medications, insulin, and diabetes supplies
  • Cold and flu medicines
  • Low supplies
  • Toiletries and extra towels
  • Clothing/pajamas/exercise clothes and extra socks and shoes
  • First aid kit
  • Copies of important documents, such as prescriptions and ID
  • Chargers for CGM, cell-phone, etc.
  • Vitamins and self-care essentials
  • Books and important mementos

What Do I Do in the Case of…?

It’s a scary time to be quarantined in your home, away from many friends and family. It’s even scarier when you have diabetes. Here are some common conundrums and resources to help you:

  • I Suspect I Have COVID-19: Read up on COVID-19 , and if you suspect you’ve been exposed to the virus, self-isolate immediately and call your physician to describe your symptoms. They will guide you as to what your next steps should be.
  • I Have a Bad Low and I’m Home Alone: If you’re home alone and are battling a bad low, call 911 immediately. If you can access your glucagon, get that while you’re on the phone with an emergency dispatcher. It’s best to know how to inject glucagon before you ever need to know. Learn how to do so here.
  • I’m Sad and Scared During This Time: If you are having trouble managing the emotional toll during this time, check out our top ways to protect your mental health. You can also take advantage of telehealth, and schedule some time with a counselor to talk about your feelings during this hard time.
  • I’m in DKA: If your blood sugar has been persistently high, you have ketones, and you think you may be developing diabetic ketoacidosis (DKA), it’s time to either go to your local emergency department, or call 911 (if you are unable to drive). Be sure to act quickly, as time is of the essence when it comes to extremely high blood glucose levels. Medical professionals will be able to re-hydrate you, better regulate your glucose levels, and monitor you, keeping you safer than you will be at home.

Whether you come down with coronavirus, you are quarantined, or you are self-isolating, you may be unable to venture out to pick up your prescriptions. You may be able to get your medication delivered directly to you. Here’s how:

  • Reach out to big chain drug stores. Both CVS and Walgreens are currently offering free home delivery of prescription drugs.
  • Call your regular pharmacy. Many smaller pharmacies will usually deliver medications for free.
  • Try a mail-order pharmacy. They often offer great discounts (sometimes as much as 90-day supplies for the co-payment of 60 days) as well as free shipping. Find out if your insurance company will cover a mail-order option.
  •  If you need a new prescription, but either can’t get to your doctor’s office, nor can you take advantage of telehealth, consider using HeyDoctor, GoodRx’s telehealth service. HeyDoctor visits cost a flat fee of $20, regardless of your insurance (and even without insurance). They’re currently offering free COVID-19 screening consults.
  • Check out new programs directly from insulin manufacturers. Eli Lilly , Novo Nordisk, and Insulet have recently set up new affordability programs.
  • I Lost My Job: This global pandemic has quickly turned into an economic crisis, with millions of Americans losing their jobs and having their work hours cut, in short order. In the US, losing a job can often mean also losing your health insurance, which is terrifying for someone living with diabetes. Check out our guide to finding affordable health care if you find yourself recently unemployed due to the COVID-19 crisis.

We’re living in extraordinary times, but having an emergency preparedness plan in place can help you manage circumstances in these extreme conditions. What are some ways in which you’ve planned for the worst (but hoped for the best?). What has helped you the most? Share this post and comment below; we love hearing your stories.

Source: diabetesdaily.com

Automated Insulin Delivery: Six Universal Observations and Understandings

This content originally appeared on diaTribe. Republished with permission.

By Laurel Messer

Six universal facts about automated insulin delivery systems, and the things you should keep in mind about this revolutionary technology

Automated insulin delivery (AID) systems are moving towards the forefront of diabetes management. AID systems combine continuous glucose monitors (CGM) with smart algorithms to automatically adjust insulin delivery.

The Tandem Control-IQ system was recently cleared by the FDA, and the Insulet Horizon and Medtronic Advanced Hybrid Closed Loop systems are beginning pivotal trials. These are encouraging developments. As more systems move through the pipeline and eventually into the commercial market, important patterns are emerging in user expectations and user experience. As a diabetes nurse, certified diabetes educator and research investigator, I, along with my team at the Barbara Davis Center, have worked with nearly every AID system in the pipeline, and other systems that will never make it to market. Here are six insights we have gleaned, which seem to be universal (thus far) to all AID systems:

1. You can always beat an AID system with compulsive diabetes management

Many people with diabetes compulsively attend to diabetes care in order to achieve ultra-tight glucose ranges – and are the first to ask about automated systems. What ends up happening is that these “super-users” are invariably frustrated that the system is not yielding the same results that they were able to achieve with their own calculations and management. An important point is that many automated systems are excellent at reducing mental burden for taking care of diabetes, excellent at reducing hypoglycemia, and adequate at improving glucose levels. Humans can beat automated systems if they attend to diabetes care near-constantly. The individuals who will likely be satisfied with AID are those who are comfortable with an A1C in the 7s or above, but they want to reduce the mental load of adjusting settings and micromanaging high glucose levels. The most important question to ask is, “Why do I want to start using an automated system?” If it is to achieve near-perfect glucose levels, the system will likely disappoint. If it is to reduce the burden of “thinking like a pancreas” all the time, it may be a good option. AID will excel at the marathon of diabetes care but may disappoint in the hour-to-hour sprint.

2. Systems work best when you let them work

Using both research and commercial systems, we have seen all the ways to “trick” AID systems—entering phantom carbohydrates, changing set points, performing manual corrections, overriding recommended doses. More often than not, these behaviors lead to glucose instability – reactionary highs and lows from the system destabilizing. All systems will perform best if they are used according to user instructions. This is difficult for the individual who would prefer to micro-adjust settings or desire control over all insulin delivery. Most systems work best when users learn to trust them.

3. Give the system a chance – 2-4 weeks before deciding long term potential

It may benefit us to think about AID like a new significant relationship – it can take some time to “settle.” I mean this both on an interaction level (learning how to respond to alerts, when to intervene, when to let it ride) and on an algorithm level (allowing the system to adjust internal algorithm parameters based on usage). In addition, programmable user settings may need some adjustment in the first few weeks of use, so working with diabetes educators can be helpful for initial set-up and early follow-up.

4. Bolusing is still king

If I could go back in time, I would caution device manufacturers against any whisper of not needing to bolus with AID systems. Bolusing is the singular most important action a person with diabetes can do to optimize insulin delivery on current and near-future automated systems. This will be true until insulin action time gets exponentially faster or artificial intelligence gets better at predicting human behavior, neither of which is on the immediate horizon. In order for people with diabetes to see the best performance on any system (automated or manual), they need to bolus before carbohydrates are consumed. Specific to AID, the timing of the bolus (prior to carb intake) is especially important, as the system will automatically increase insulin delivery after an initial rise of glucose levels, so a late bolus (e.g., after the meal) could lead to insulin stacking and hypoglycemia.

5. Rethinking low treatments

Low glucose levels (hypoglycemia) still happen when using automated systems. What is different with AID is that the system has been trying to prevent the low by reducing/suspending insulin, possibly hours before the low occurs. This means that an individual may need to consume significantly fewer carbs to bring glucose levels back into range – perhaps 5-10 grams of carb at first, reassessing 15-20 minutes later. This can be difficult when wanting to eat everything in sight; however, it can reduce the chance of rebounding into the 200s after over-treating.

6. Infusion sets are still infusion sets

While AID algorithms are revolutionary, the infusion set is not. It is the same plastic or steel cannula that occludes, kinks, or inflames. This hardware limits automated systems and can very quickly lead to hyperglycemia or diabetic ketoacidosis (DKA). It is important for people using AID to recognize signs of infusion set failure – persistent hyperglycemia, boluses that do not bring glucose levels down, ketones, vomiting, etc. Knowing how to treat ketones (via syringe injection of insulin and set change) can prevent a hospital admission or worse.

I love that the diabetes community learns from its members and experiences. Check out our Barbara Davis Center PANTHER (Practical Advanced THERapies for diabetes) website for our team’s latest insights on automated insulin delivery, and tools for people with diabetes, clinicians, and engineers.

Are you considering AID? Feel free to share this article with your healthcare team. For more information about AID systems that are currently available or in the pipeline, click here.

About Laurel

Laurel H. Messer is a nurse scientist and certified diabetes educator at the Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO. She has spent the last 15 years studying how to best utilize new diabetes technologies, and remembers fondly teaching families to wrap up their corded CGM system in a plastic shower bag for bathing. Ok, not that fondly, but look how far we have come! Dr. Messer works with the Barbara Davis Center PANTHER team (Practical Advanced Therapies for diabetes), conducting clinical research trials on promising technologies to make life better for children, adolescents, and adults living with type 1 diabetes. Get in touch at Laurel.Messer@cuanschutz.edu

Source: diabetesdaily.com

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