• Steve Mann

Heck, it's the Tech: The 2021 Guide to Diabetes Devices from a Type-1 Diabetic

What is intriguing to me after reading a series of articles on diabetes technology is the repetitive nature of the content, I mean plagiarizing from one another. And, their perspectives are those of a journalist turning out words because they are paid to do so, not as of a diabetic whose perspective is likely yours.


So as a diabetes coach, here is my view of 2021 and technology for the diabetes community.


Insulin Pumps


Virtually all pump providers are focused on advancing their hybrid closed-loop pumps (managing meal boluses is still our responsibility) to make them less hybrid and more closed-loop. Insulet, for example, is updating its algorithm to better adapt to meal times, and Medtronic's 780G system is designed to adapt to any complications that can arise from users inputting inaccurate information. Medtronic is also looking at technology that can track hand movements to identify when people take bites - an intriguing approach to identifying when diabetics are eating.


I think a better way to do this would be to listen for “chews”. :)


insulet omnipod 5

Insulet Omnipod 5

Omnipod 5 (formerly Horizon)

Having been in the Horizon pivotal trial, I have a unique perspective on this device. Frankly, I like and will continue to use it. Now renamed the Omnipod 5 (don’t know why - I liked the brand differentiation.)


After so many years of using tube pumps, I became a Podder. I just couldn't stand tethered anymore. So the fact that there is a hybrid closed loop system with pods is fantastic. It connects the Pod to a CGM and uses an algorithm to make automatic insulin dosing adjustments.


What I love about the Omnipod 5:

  1. The Personal Diabetes Manager, the brain of previous Omnipod configurations, is being replaced by a Samsung Galaxy G8 with an app... the Omnipod 5.

  2. The user interface is clean and incredibly intuitive. No real training is required, but of course you will (and should) get it anyway.

  3. You can switch quickly and easily between automated and manual mode. Sometimes I want to take control when I am in a situation that NO hybrid system could handle, including super fast highs to lows or lows to highs.

  4. The initial target of 110 is fine for me at the moment, although I like to target 90-100.

  5. Few lows - if you get many lows, look at the Omnipod 5. The Algo is not only excellent at this, but also has a nice hypo-protection function, where you can set a 150 target for as many hours as you want. I use it for both pre- and post-workout exercises, and during those times when I have to do SWAG bolusing.

  6. Did you know that Pods are not considered durable medical equipment, as are their competitors? It makes it easy to get them.

Improvements I would like for the Omnipod 5:

  1. In manual mode, you can run an extended bolus that you can't do in automated mode... that's something I'd get a kick out of.

  2. I tend to put my CGM (Dexcom G6) in line with the Pod's placement. The Pod -- CGM connectivity is better.

  3. Although I like the interface, the placement of buttons could be better. Many times, I have reached a confirmation of an action, only to be asked if I want to cancel it. This needs to be changed.

  4. I am a bold diabetic (management wise) and do significant work to keep my BGs where I think they should be. All closed-loop systems must be a bit more conservative, so I have had to get used to it or trick it into being more aggressive.

Omnipod 5 is based on the Omnipod DASH platform launched in 2019 and uses the same pods and mobile app. I understand they are targeting July for FDA approval - which is first available to connect with the Dexcom CGM and later Abbott's FreeStyle Libre.



Tandem t:sport mini-pump


Tandem will launch t:sport, which has a form factor like an Omnipod. It competes with Omnipod in terms of form factor and lack of screen. It differs from Pods in it still has the t: lock connector "pigtail" insulin tubing that connects to the infusion set for insulin delivery. I hope the design will make it easier to get out of bed at night without dragging the pump tail behind you... oh well.





Tandem’s t:slim (top) and prototype of new t:sport mini-pump



As the pandemic delayed the clinical trial and FDA submission, it looks as if the launch will be at either the end of 2021 or early 2022. I am interested in t: sport - not only for the form factor, but also because I am a fan of Tandem's insulin delivery algorithm - it is flexible and is a bit more aggressive than the Pod algo. You can also do extended bolusing when in automated mode.


By the way, I am a huge fan of Sugarmate for accessing, analyzing and sharing my data. It is customizable to view the data most important to you and can be used with or without a pump.



I also love the fact that I can check my data on virtually every device, including my Mac, AND Sugarmate is also an Amazon Alexa skill.

“Alexa? Ask Sugarmate what my reading is.”



Tandem purchased Sugarmate last year. It's no cost... again, if you want to customize the data you use every day, you can download it here.



Medtronic 780G


Medtronic, the Grandfather of insulin pumps (actually MiniMed), expands on the foundation of its first two iterations: the 670G and 770G. I tested the 670G at one point. I found the system's design not to my liking. Frankly, I thought the whole pump was upside down (another post).



Medtronic 780G


Features of the Medtronic 780G

  1. Works with Medtronic's next-generation Zeus CGM sensor, which requires only one calibration on the first day of wear, and no other finger sticks beyond that (this sensor is also 7-day wear, as with its current model) - I don't like the fact that you're locked in to the Medtronic sensor.

  2. Has an adjustable glucose target between 100 and 120 mg/dL.

  3. Offers different insulin duration times, unlike other commercial closed loop systems, but I do not believe this dramatically changes the functionality or effectiveness of the system.

  4. Built in Bluetooth for data sharing and remote monitoring, as well as remote software updates, users will not have to buy a whole new device every time new features are launched (currently only Tandem t: slim X2 offers this remote updating capability).


Tidepool Loop


As a former Looper, this is exciting. Loop is a driver of # wearenotwaiting movement and offers the ability to build an iPhone app to offer automated insulin delivery functionality to both Pods and a subset of Medtronic pumps.



Tidepool Loop


Tidepool has established a relationship with some original Loop developers to build the first FDA-approved automated insulin dosing app, which brings together both DIY work and the FDA-regulated commercial side.


Based on the open source code, this Tidepool Loop mobile app works with the Dexcom CGM and Omnipod pump. It will initially be available on iOS.

Tidepool filed with the FDA on Dec. 17, 2020, and is seeking regulatory approval some time this year. Note Tidepool constantly updates its progress on the org blog, so you can keep tabs there. If you have not used Tidepool for uploading, sharing and analyzing your data, you should give it a whirl.


CGMs


Dexcom G7

This latest model of the Dexcom CGM will bring significant form factor changes: a combined sensor and transmitter design.


Dexcom G7



Dexcom plans to submit the G7 to FDA approval as soon as possible this year and plans for a limited launch at the end of the year. They’ve also released the first images of the new G7, which are stylish!

Here are the details:

  • Fully disposable: Unlike previous Dexcom CGM models, the G7 will be fully disposable. There will no longer be a separate transmitter with a three-month battery life. Instead, the sensor and transmitter are integrated, and once the sensor is done, you will dispose of the entire combined device.

  • Wear time: While it starts at 10-day wear, like the current G6 version, the G7 is designed to eventually support longer wear for up to 14 to 15 days. No finger stick calibrations will be required.

  • Thinner: Dexcom says the G7 will be the thinnest generation of its CGM sensors, 60 percent smaller.

  • Decision support: Dexcom has talked a lot about the desire to integrate software features, including dosing assistance, information, and prompts, that help users make better health decisions based on their CGM readings. Given Dexcom's acquisition of TypeZero Technologies in 2018, they appear on the road to providing a smart algorithm for this type of user support. This should also help the company expand CGM use for more people with type 2 diabetes, as well as for users without diabetes.

In recent investor updates, Dexcom CEO Kevin Sayer explained the company plans to eventually have different versions of the G7 for different groups of users. For example, non-insulin-using type 2s or general health consumers may prefer a much simpler interface than insulin-using type 1s, who have experience with CGM technology and want all the bells and whistles.


Abbott FreeStyle Libre 3


FreeStyle Libre 3


The FreeStyle Libre from Abbott Diabetes is known as a Flash Glucose Monitoring (FGM) because the system offers a “flash” point-in-time glucose reading when the sensor is scanned with a handheld receiver or app. The Libre 3 is a true CGM, as it no longer requires sensor scans to perform real-time glucose readings.


Libre 3's fully disposable sensor is also smaller and thinner than previous versions. Per Abbott, it is a 70 percent size reduction, which uses 41 percent less plastic.


WaveForm Cascade CGM



WaveForm Cascade CGM


WaveForm's Cascade CGM is a 15-day CGM sensor with a rechargeable square transmitter that communicates via Bluetooth to both Android and iOS mobile apps.

  • The sensor and transmitter are worn on the body in a single compact form, about the size of a nickel.

  • This system uses a proprietary enzyme-based electrochemical sensor virtually pain-free to insert and measure glucose levels via interstitial fluid like other CGMs.

  • The sensor transmits glucose data wirelessly through its small, rechargeable transmitter to a smartphone app, which provides up-to-date feedback on glucose levels.

It's not as efficient as the latest CGM competitors, but on the same level as most first-gen iterations. A clinical trial began in May 2020 and is expected to be completed in mid-2021. WaveForm plans a 2021 FDA submission and is expected to launch in the United States by the end of the year.

Connected Insulin Pens


There are now countless smart insulin pens with data connectivity on the horizon.


Bigfoot Unity

Bigfoot Biomedical, a closed-loop technology startup, spun out of the #WeAreNotWaiting DIY movement. Their first product will be a system built around a proprietary connected insulin pen, rather than a pump.


The system connects the smart insulin pen with the FreeStyle Libre to automatically calculate and adjust insulin dosing. Bigfoot will eventually move forward with its pump version known as Bigfoot Autonomy, using the base design of the Asante Snap insulin pump Bigfoot acquired after its collapse.


The Autonomy-based pump is expected to launch in 2022 or 2023.


Lilly connected pen

Eli Lilly plans to launch a new smart pen system with Welldoc technology in the second half of 2021. This is a pre-filled, disposable insulin pen designed to form the foundation of the company's new pen-based solutions.


Novo smart insulin pen

Novo Nordisk has been expected to release new smart pens for several years. Their NovoPen 6 and kid-friendly Echo Plus models received European approval and were expected to launch in Europe in 2020, but now all appears happening in 2021.


New glucagon rescue pen





HypoPal glucagon rescue pen


The HypoPal Rescue Pen was designed by Zealand Pharma and expected to clear the FDA in the first quarter and launch later in the year. In May 2020, the biotech company submitted its new drug application for this new stable liquid formation called dasiglucagon to regulators. But I have to say that I am more partial to the relatively new Nasal Glucagon distributed by Lilly.


There is a lot on the horizon to help diabetics, their coaches and doctors control their diabetes.


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