Upcoming Apple and Android Watches to Include Glucose Monitors

In 2015, when Apple first launched its smartphone “watch”, or “smartwatch” people all over the world flocked to the new device, but it clearly became evident that the most popular feature (besides telling time), was health and fitness tracking. Suddenly, literally within arm’s reach, users had the ability to not only track their steps and mileage but to track floors climbed, standing time, moving time, heartbeats per minute (HBM), electrocardiogram monitoring, and even check for atrial fibrillation (AFib), among other things.

Apple CEO, Tim Cook, had initially suggested that they would be cautious in adding medical tracking to the watch, as approval from the Food and Drug Administration (FDA) could slow innovation.

“We don’t want to put the watch through the FDA process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it, maybe an app, maybe something else,” Cook said.

But customer demand for health tracking proved unmatched, and the company decided to change its mind, slowly adding more and more health tracking capabilities with every new version of the watch.

It should come as no surprise that according to a report out of South Korea, the newest Apple Watch, the Series 7 as well as the newest Samsung Galaxy Watch 4 (both of which are slated to launch later this year) will feature continuous glucose monitoring, developed in partnership with MIT, as people with and without diabetes alike are finding a constant watch on their blood sugars to be extremely beneficial to one’s health.

Both watches promise a “no-blood sampling method” to detect blood glucose levels using an optical sensor, and the feature will be advertised to those with and without diabetes. Unlike popular continuous glucose monitoring devices like the Freestyle Libre or Dexcom, these watches will rely on non-invasive detection of blood glucose levels, which can be achieved via infrared sensors.

Since this technology would be truly groundbreaking, it would be all but impossible to launch without FDA approval, which means that both watches would have to face several clinical trials before being available for public consumption. Clinical trials take a lot of time and money and can mean delays in a launch, especially if the glucose-sensing technology is non-invasive (which has not been seen yet, especially for people with diabetes who rely on this technology to successfully manage their diabetes).

There are many doubters, including the CEO of Valencell, an optical heart rate sensor company, who stated in 2017 that non-invasive blood glucose tracking “would never happen”.

“It is completely impossible to have a truly non-invasive glucose monitor,” Valencell CEO Steven LeBoeuf said.

Additionally, unleashing this kind of technology for mass-consumption could have unintended consequences: Will high demand for the product raise or lower the price? Will people with diabetes be priced out of their lifesaving durable medical equipment? Will blood sugar monitoring become the newest “it” thing? Will companies like Abbott and Dexcom go out of business? Will test strips eventually be a thing of the past? Will health insurance companies be mandated to cover smartwatches eventually? Will smartwatches eventually loop with insulin pumps for automatic insulin delivery? Will this be a good thing or a bad thing for the diabetes community? Is it even possible to have reliable blood glucose readings without invasive technology, interstitial fluid, or blood samples?

Can two of the leading technology companies prove all of the doubters wrong? Can people with (and without!) diabetes finally be able to track their blood sugars without invasive tactics, and achieve better control, all through a smartwatch? Can Tim Cook and Samsung CEO Ki-Nam Kim prove everyone wrong? A lot seems to be in store for the latter half of 2021, so we will just have to wait and see!

Do you monitor your blood sugars from a smartwatch? How would having your smartwatch double as a continuous glucose monitor (CGM) help you? Do you see any negatives to such a device? Share this post and comment below; we love hearing from our readers!

Source: diabetesdaily.com

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?

Want more information just like this?

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

Want to Try Continuous Glucose Monitoring?

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler and Albert Cai

The Hello Dexcom 10-day sample kit includes a Dexcom G6 continuous glucose monitor, instructions for set up, and guidance for getting the most out of your glucose data. Ask your healthcare team to order the device for you in the US or Canada.

Have you heard about continuous glucose monitoring (CGM) for people with diabetes, but aren’t sure if it’s right for you? Dexcom’s new CGM sample program, Hello Dexcom, allows people with diabetes who take insulin to try out the Dexcom G6 CGM for 10 days in the US or Canada. Through Hello Dexcom, healthcare professionals can provide people with a free one-time sample of the technology, along with full instructions for set up and information on using and understanding their glucose data. All packaged in one small box, the program is designed so that people can start using the technology and interpreting their glucose levels on their own and from their home.

Continuous glucose monitors measure the body’s glucose (or sugar) levels in real-time by sensing the glucose present in tissue fluid under the skin. The Dexcom G6 CGM measures glucose levels every five minutes – this means that you can get 288 glucose readings a day without fingerstick blood sugar checks.

Dexcom G6

Image source: diaTribe

We got a sample in the mail and checked it out for you. Here’s what the Hello Dexcom kit includes:

  • A G6 CGM sensor, transmitter, and applicator
  • Easy-to-follow instructions on how to insert the sensor
  • Simple instructions for downloading the Dexcom G6 and Dexcom Clarity apps
  • An online portal with support and Frequently Asked Questions
  • A digital “10-day journey of empowerment” to teach you about the features of the G6 and to help you interpret CGM data. The 10-day course involves:
    • logging events and becoming familiar with the G6 and Clarity apps
    • adjusting alert settings
    • learning from meals
    • reviewing data through Dexcom Clarity
  • A printed guide to using your G6, with information alarms, treatment decisions, troubleshooting, and more
  • Note: the kit does not include a separate sensor reader, so only people with a smartphone (Apple or Android) can use this program.
Dexcom G6

Image source: diaTribe

Eliza got to try out the new product – here’s what she thought: All in all, I opened the box, read the instructions, and activated the online portal in less than ten minutes. The step-by-step set up instructions were straightforward and included illustrations, and I felt quite comfortable going through the process on my own. After I downloaded the Dexcom G6 app and made a Dexcom account, there were videos to help me insert the sensor and activate the transmitter.

If you’re curious about CGM, ask your healthcare professional if you can get Hello Dexcom – you can send our article their way. Healthcare professionals can learn more about the program and order Hello Dexcom sample kits here. To learn more about CGM – how it works, its benefits and considerations, what the data means, and stories from user – check out this CGM pocket guide.

For more try-before-you-buy diabetes technology, learn about the free Omnipod DASH insulin pump trial.

Source: diabetesdaily.com

Dexcom’s Chief Technology Officer Reveals Updates on the G7

We are almost through to the end of this year and we are all looking forward to new diabetes technologies coming out in 2021! Continuous glucose monitoring (CGM) technology is an incredibly useful tool that can improve diabetes management, and the release of Dexcom’s new CGM, the G7 is certainly one to look out for. For me, the sheer difference in size alone (the G7 will be about the size of a quarter, certainly an improvement over the G6!) is something to get excited about. Moreover, the company has completely redesigned the product, which will now be completely disposable, as opposed to previous iterations that included a reusable transmitter.

I recently talked to Dexcom’s Chief Technology Officer, Jake Leach to get the most recent scoop on what’s to come with the release of the highly anticipated new product.

When Will the G7 be Released?

Due to the COVID-19 pandemic, the start of clinical trials was delayed. Leach explained that the company used that time to integrate in even more technology with the G7. Clinical studies needed to get FDA approval for the G7 are currently in the process of getting started. Although they could not disclose specific details on timing, Dexcom confirmed that will see the product come to market in 2021. A broader launch is expected to come in 2022.

What About the Accuracy?

Dexcom has taken a lot of technologies of the G6 and made improvements on them. It will need to meet stringent accuracy requirements to be approved by the FDA. It is expected that the product will perform well and offer improvements over existing technologies.

What About the Wear Time?

Currently, the Dexcom G6 is approved for 10-day wear. However, many users try to circumnavigate this. Dexcom’s CTO had this to say about advancements for the G7:

“The platform is designed to extend the wear beyond 10 days, so the electronics, etc. are compatible with that. We are striving for a very high level of reliability for both the sensor and the adhesive patch. [So far, early studies have shown that] the right time frame for our customers is 10 days with this product, but we do intend to continue working to expand both the sensor and adhesive performance to go beyond 10 days. We feel that our customers deserve a sensor that is highly reliable for the full wear duration, and so 10 days is where we’re at with G7.

What About the Cost?

“We know that for CGM to be accessed by many many people, we need to continue to remove cost from the general system. So, G7 is designed to be highly manufacturable in very large volumes. We have our first G7 line up and running. We are using a fully automated assembly line. The product is not only highly reliable but also lower cost to manufacture. Providing users with the product that is disposable, there were hurdles that we had to overcome in engineering, to be able to provide a product where you are throwing away more components, but we are able to do that at a cost-point equal to or lower than G6.”

What About the Sensor Insertion?

The sensor insertion will be fully automated. Dexcom stated that the product will be even easier to apply than the G6, and that the applicator will be much smaller than the G6, reducing the environmental footprint.

“We specifically designed it to be as small as possible [but still large enough to ensure a comfortable insertion process]. Definitely smaller than G6…”

What About the Adhesive?

In the diabetes online community, I have recently been hearing more reports of adhesive-related allergic skin reactions, and speculations that perhaps there was a change in the adhesive formula being used. Here is what Dexcom had to say about that:

“Some very small number of users do have issues with irritation, and there is a number of different ways that can be addressed. It’s a balance between the adhesive properties of making the sensor stay on for the full duration and there are so trade-offs with irritation. We are very focused on minimizing irritation. We have made improvements to the patch where many users are seeing their sensors last longer, but we have seen a small number of irritation complaints and we are focused on [for both the G6 and the G7] always making improvements. We are focused on investigating what possibly could be causing these irritant properties. The G7 does have a different adhesive than G6 and we are looking to ensure that [causes] very little, if any, irritation.

What About New Integration with Other Systems?

“The way that we’ve designed our system is so that it can integrate with many different types of systems.”

In addition to integration with the Tandem’s Control IQ and Insulet’s OmniPod system, integration has also been developed for Companion Medical’s InPen as well as over 25 commercially-available apps. Leach also highlighted that as of now, the Dexcom CGM is the only product that has been approved for use with hybrid closed-loop insulin delivery systems.

What About New Predictive Modeling Algorithms?

Recently, Dexcom has partnered with the University of Virginia to conduct research on a variety of automated insulin delivery models and algorithms. Dexcom has also partnered with the European company Ypsomed to further develop CGM integration for automated insulin delivery systems. In addition, Dexcom is working to investigate the use of CGM data, in general, to provide users with key insights on blood glucose trends and potential therapy optimizations.

“Our general approach is to provide many options to our users. We know diabetes is a personal disease and everyone has different opportunities to connect with different devices, and what they feel fits into their lifestyle. We try to support as many options as possible so we do that through the pump integration, as well as the digital ecosystem of the app partners.”

What About the Data Display and Device Compatibility?

“It will be compatible with both Android and iOS. One thing we are doing with the G7 app is we are integrating more insights into the app. So, G6 does a great job of showing glucose information, trends, as well as the ‘urgent low soon’ alert. G7 is taking that even farther and starting to integrate in a lot more of the some of the functionality from Clarity, some of those insights you get will be built into the G7.”

Dexcom is also working to enhance some features of their apps for data sharing with support people and clinicians. In addition, a receiver will still be a part of the new system, for those users who want an alternative to using their smartphone for data display.

Staying Ahead of the Competition

The CGM market is growing rapidly, with more and more companies coming out with competitive products. We asked Dexcom where they view themselves and what their advantages are over other systems.

“We feel that G7 is going to be a whole new level of comfort and convenience in the CGM ecosystem and the integration that we can build on with both insulin pump partners and the digital ecosystem of  apps… is a significant differentiator between [us] and some of the other competitors. We’ve been providing real-time CGM data since day 1, and we want to continue to expand and improve and provide users with new tools that enable them to take control of diabetes.

Moreover, the use of CGM technology is also expanding in the clinical setting, and Dexcom is a big player there.

“With COVID, we got approval for emergency authorization use for Dexcom CGM in the hospital. During the pandemic, since the beginning, hospitals have been acquiring the G6 from us and using the device in the hospital setting. It has performed very well. It also limited the need for interaction between healthcare providers and the patients [with COVID].”

We thank Jake Leach for taking the time to provide us with the most updated information. Sounds pretty great to us, and we look forward to learning even more and updating our readers as more details come to light!

Do you use a Dexcom CGM? What are your thoughts on the advances in CGM tech? Please share your thoughts in the comments.

Source: diabetesdaily.com

FreeStyle Libre 3 Cleared in Europe – Smaller, Thinner, and No More Scanning!

This content originally appeared on diaTribe. Republished with permission.

By Matthew Garza and Katie Mahoney

The FreeStyle Libre 3 has been cleared in Europe for anyone ages four and older. The new continuous glucose monitor is as small as two stacked US pennies, provides real-time readings directly to the mobile app via Bluetooth, and has the same low list price

Abbott announced that the new FreeStyle Libre 3 has been cleared in Europe – see 40-second video here. This third-generation continuous glucose monitor (CGM) has many of the same features that make the FreeStyle Libre 2 so popular, including optional alarms, 14-day wear, and high accuracy. The FreeStyle Libre 3 also adds several new features:

  • Real-time, minute-by-minute readings are sent directly to the FreeStyle Libre 3 app via Bluetooth – moving this CGM from “on-demand” to “always-on,” so there is no need to scan the sensor every eight hours.
  • It is 70% smaller than previous models, making it the “smallest and thinnest” CGM sensor yet – it’s said to be about the size of two stacked pennies. Importantly, this new model will reduce the amount of plastic and carbon paper used, improving the production of the device significantly from an environmental perspective.
  • It is cleared for people with diabetes as young as four years old.
  • It is cleared for use in gestational diabetes and pregnant women with type 1 diabetes. We suggest that everyone who is pregnant and has type 1 diabetes try to get CGM, and that everyone else who is pregnant be tested for gestational diabetes as early on as possible.
  • It is cleared as an iCGM, meaning it can be used for automated insulin delivery (AID) development in Europe.
  • The new FreeStyle Libre 3 app, available for both iOS and Android devices, will contain many of the same features as the FreeStyle Libre 2 app (Libre View) including the all-important time in range graphs and ambulatory glucose profile (AGP). You can learn all about the AGP here.

Currently the FreeStyle Libre 3 is cleared for upper-arm wear, though we imagine people may try to use it “off-label” on their abdomen or other spots. There is no separate reader for collecting and monitoring sensor data, so people will use smartphones with the FreeStyle Libre 3 app in order to connect to the sensor.

The FreeStyle Libre 3 will be available at the same price as previous versions of the CGM ($109 for a one-month’s supply, without insurance); Abbott will continue to offer the FreeStyle Libre 2 at the same price for people who prefer the to scan their CGM. The FreeStyle Libre 3 is expected to launch in the coming months in Europe, and though we don’t yet know where it will first launch, we expect it may be Germany, like Abbott’s other CGM launches. In the US, Abbott has not announced any potential timeline for FDA submission or clearance. With the recent Libre Sense clearance in Europe, there is lots happening with this brand – stay tuned for more. Readers in European countries, we’d love to hear your early thoughts once you try the FreeStyle Libre 3!

Source: diabetesdaily.com

REVIEW: Companion Medical’s InPen, A Smart Delivery System

Companion Medical’s smart insulin delivery, the InPen, is a reusable injector pen plus user-friendly mobile device which allows individuals to improve their diabetes management. I choose multiple daily injections (MDI) over a pump for various reasons, but I cannot deny that a pump allows for more precise calculations. With InPen, people on multiple daily injections can achieve the same accuracy plus so much more!

What Is It?

The InPen is a reusable injector pen that not only helps you calculate your doses but also keeps a log of insulin data for up to a year. The InPen connects, via Bluetooth, to the smartphone app, and keeps track of all your insulin deliveries.

InPen is now approved for all ages (7 and over, or under the supervision of an adult), who are insulin-dependent. The pen can deliver between .5 units to 30 units of insulin, dialed in half-unit increments. The pen is compatible with the Lily Humalog, Novo Nordisk Novolog and Fiasp U-100 3.0 ml insulin cartridges.

InPen is compatible with all Apple iOS devices that support iOS 10 or greater. It is also compatible with Android (more info about compatibility here).

What Does It Do?

I made sure to use this pen for about a month before writing my review. I am in awe of how easy this pen makes my management. Up to now, to be quite frank, I am guilty of a lot of “WAGS” (wild a** guesses) and then winding up too high or too low. I also really never kept tabs on when my last insulin dose was, so would find myself stacking quite often. Thanks to InPen, a lot of this carelessness has been eliminated. Here are all the amazing things it can do:

1. Insulin delivery information

The InPen connects to the app via Bluetooth which allows the app to store your insulin delivery information and shows you how much insulin you have taken and how much you have on board. There have been so many times when I would correct a high, not realizing I still had insulin on board, which led to episodes of hypoglycemia. As you can see here, your information appears in real time from your lock screen.

InPen Screenshot 1

Screenshot from Companion Medical

2. Built-in calculator

The InPen has a built-in calculator to help you get the most accurate dose possible. Your physician enters your settings, and it will give a recommendation on how much to dose. It takes into account your previous insulin delivery, your current blood sugar and the number of carbs you are eating. Since I have been using this feature, my blood sugars have improved greatly.

InPen Screenshot 2

Screenshot from Companion Medical

3. Reminders

It also has a reminder to take your long-lasting insulin. There have been so many times when I can’t remember if I took my Tresiba. I know this is a common problem for people on daily injections. This takes the burden off of the individual and has proven to be one of my favorite features.

InPen Screenshot 3

Photo credit: Companion Medical

4. Reports

The InPen generates reports that you can share with your healthcare team. These comprehensive reports will allow for easier decisions regarding changes to your diabetes management.

Screenshot from Companion Medical

5. Temperature alerts

The InPen comes complete with temperature alerts! It will notify you anytime your pen is in temperatures too hot or too cold which could make your insulin ineffective. This will come in handy during my next vacation or even if I leave my bag in the car for too long.

6. Syncing to Dexcom

InPen can sync up to the Dexcom continuous glucose monitor, via the Health app. This allows you to see your continuous glucose monitor graph on your logbook and reporting feature of the app.

Screenshot from Companion Medical

How Can I Get the InPen?

Many commercial insurance companies cover InPen, you can fill out this form and a representative will contact you about your copay. They also have a copay assistance program.  Commercially insured InPen customers will not have to pay more than $35 dollars a year which is a small price for better control.

Conclusion

I think InPen is a game-changer for anyone on multiple daily injections. With all of the capabilities the InPen offers, I can achieve better blood sugar numbers. I feel more in control of my diabetes because now I am confident that I am administering the right doses. I am also avoiding stacking insulin, which means fewer blood sugar roller coasters, and now I also have reminders to take my long-lasting insulin.

InPen can also help empower children to make better choices and manage their own diabetes. You can even sync two different pens if a child wanted to leave one pen at school and one at home.

Using InPen has helped me take back some control of my diabetes. It allows me to feel more in control and allows me to spend less time thinking about my condition. I can’t imagine going back to MDI without InPen in my toolbox and highly recommend this to anyone else who prefers injections over the pump.

Source: diabetesdaily.com

COVID-19: Apps to Stay Active at Home

Within just a few days, the world as we know it has changed. We are all now understanding the reality of this disease, COVID-19,  and are being forced to social distance and stay home whenever possible. Some of us have taken work to our living rooms, homeschooling our children, making 3 meals a day for an entire family, all while trying not to panic that either you or your loved one falls under the high-risk category.

We mustn’t forget about self-care. It is important for us to be in a good place mentally, emotionally and physically for ourselves and anyone else who may need us. It is also proven that staying active boosts our immune system, which we all need more than ever.

With so many workouts available online, there is no shortage of things to do from your own home or yard. Depending on what you like, here is a variety of ways to stay active while being stuck at home.

Back to the Basics

Calisthenics is probably the most underrated form of exercise. And it is great to do at home since no equipment is required. Also, anything cardio-related will strengthen your heart and your immune system! Try to do a routine of a certain amount of rounds and repetitions of moves like burpees, sit-ups, push-ups, lunges, squats. One of my favorite free apps for calisthenics is Madbarz. This will be sure to get your heart pumping and leave you feeling energized!

Take It Online

It is really wonderful how people are coming together during this time. Many gyms, fitness companies, and coaches are providing their clients and the public with free workouts. Here are a few to check out and this is a great time to try something new!

  • BeachBody – They are offering a two-week trial to new members.
  • Nike Training Club – This app is offering free workouts designed by trainers. It is available on both iOS and Android.
  • Tone It Up – This fitness program for women is offering a free month for new users.
  • Skyting – This yoga television is allowing new members one week free. Perfect time to try a different form of exercise, yes I’m talking to you powerlifters!
  • Barre3 – This full-body workout will help you work on your cardio, build strength and leave you feeling refreshed and empowered. They are offering two weeks free.
  • Comptrain – If you love CrossFit like me, this website is for you! They offer free workouts daily that are challenging and sure to humble us all!

Get Moving

Oftentimes, people think exercise has to be at a gym or running in a park but that is not the case! Doing a good thorough cleaning of your house (which we could all use right now), doing loads of laundry or cleaning out your closet is sure to burn some calories! Track your steps and calories burned on a device like Fitbit.

Dance Party

If you have children who enjoy Tik Tok, Just Dance, and other interactive dance games and apps, this is the time to get onboard! You can bond with your children while getting in a sweat.

No matter what you do to stay active, it is vital for both our bodies and minds. Getting fresh air, vitamin D and keeping our bodies moving is key not only for our physical but our mental health as well. The fact that it boosts our immune systems, too, is a great perk!

What will you do to stay active during these uncertain times? Share and comment below,  let’s all help each other!

Source: diabetesdaily.com

Shadow’s Edge: Video Game Designed to Help Kids Cope With Chronic Disease

Being a kid is hard enough as it is. Add in having a chronic disease and it can make those very special years potentially very isolating ones. Shadow’s Edge is a virtual reality game that allows children to process and express their feelings about their disease — or whatever else they may be going through. This mobile game can help change the experience of a serious diagnosis, or challenging times, by combining art therapy and cognitive behavior therapy and giving children a safe place to not feel so alone.

Action video games can help reduce depression in teens and Shadow’s Edge hopes to help bring positivity and community to those who need it most. Founder and philanthropist, Sherri Sabrato Brisson, is a brain cancer survivor who initially co-wrote a book, “Digging Deep: A Journal for Young People Facing Health Challenges ” with Rose Ofner, to help kids process their chronic disease or serious illness and it had great success. She then met Rosemary Lokhorst, who is now the game producer because of how much she loved the concept and that is how Shadow’s Edge was born.

Shadow’s Edge is a free and completely donation funded, virtual city that has just been overtaken by a storm, much like our lives after being hit with a diagnosis of some kind. The storm removes all the color from the city, much like our disease has the potential to take away some of our happiness…if we let it. The object of the game is to bring back the color to the city through writing and art, which helps empower the player to take on whatever it is they are going through.

Shadow's Edge

Photo credit: Shadow’s Edge

So far, Shadow’s Edge has worked with many organizations and university clinics in the US, Brazil and in Europe, focusing on kids and teens with cancer, and has received very good feedback, especially from doctors. Currently, they are running a complex research study nearby the Lurie Children’s Hospital in Chicago, with more than 100 kids testing Shadow’s Edge. So far, the results have been fantastic, and the game is helping these children build up the resilience to tackle the challenges they are facing.

I was able to chat with Sherri to find out more about Shadow’s Edge and their plans for the future.

Sheri, the journey you went through with brain cancer must have been so traumatic. Did writing your first book, Digging Deep: A Journal for Young People Facing Health Challenges, prove to be therapeutic? What about creating this game?

As a survivor, I can tell you, I know how difficult it was for me to even know how I was feeling at the time, let alone be able to express these feelings.

On my 25th anniversary of survivorship from brain cancer, I envisioned a world where every young patient has real-time access to the tools he or she needs to build emotional resilience through their experience.

I started by co-authoring Digging Deep: A Journal for Young People Facing Health Challenges, with Rose Offner, MA. I donated 35,000 journals to hospitals across the country, but it still wasn’t enough. So, we decided to meet young people right where they are—on their phones, playing games.

Seeing the success of your book shows that there is a need for resources and tools for people who have serious illnesses or a chronic condition. How do you think Shadow’s Edge can help fill that gap for our children?

Just like the physical journal, Shadow’s Edge helps teens build their emotional endurance to tackle the challenges they face through the power of their personal narrative. There are very few resources directed at teens today. Our aim is to meet them where they are – on their phones, playing games. So this time, teens are engaged through their medium—their phones or tablets—to express themselves through writing and now, covering a city in graffiti! Through gameplay, teen players realize they needn’t stay in their confined world—they have the power to reshape their world into whatever they choose. Through their expression, they can create beauty where there was once dilapidation: There can be light; There can be color; There can be hope. And, there can be a community.

“When starting to play Shadow’s Edge, a teen may not even know how they feel or what is troubling them. As they continue through their journey, they often discover they are at a different place emotionally in the end—there may be a sense of resolution, a greater understanding, a place of peace”.

I know for me personally, when I was diagnosed with type one diabetes, finding community changed everything for me. I was so much better off mentally and emotionally and had a much better outlook on my future. How does playing this video game help children connect with others? 

Yes – connection is key to build resilience and to feel better! Teens asked us for a space that is theirs only, where they can express things for themselves, as they are not always clear or ready to connect. Interestingly, this working with oneself helps to reach out. Additionally, the game has an in-game sharing space (once you reach the new level, Disillusionment). There you receive a means to see other players’ art and provide messages of support and where you can publish your graffitis. The community aspect is one that we are focusing on to expand – it is the key ask of players to build on.

I could see how the concept can be applicable to many different obstacles a child could be facing, what other areas are you focusing on and what do you hope to accomplish?

We are expanding the content so that teens facing a variety of difficult situations can benefit from it – these can be changes in the family like a divorce or death of a family member, bullying, anxiety, stress, depression, identity questions.

Shadow’s Edge has the potential to help so many children going through hardships. Where do you see Shadow’s Edge going from here?

We are working on expanding the community aspect of the game. We want to create a community around self-expression where teens facing all kinds of challenging situations can share, collaborate to create art, find psychoeducational content and just connect with each other.

As a brain cancer survivor, what message would you like to share with people facing a health battle of some kind? 

Your challenge does not define who you are, you define this. When you are ready, take an active role in opening up–every time you tell your story you tell it a little differently, this make you integrate it and see new perspectives. Practicing this also supports you to understand you are stronger than you think, getting comfortable with your story and owning it as a part of you, but not all of you.

Shadow’s Edge is available on both IOS and Android, and available in 6 languages.

They also have a special website dedicated to helping parents and healthcare professionals who are helping a young person with illnesses, see more information at www.diggingdeep.org.

Source: diabetesdaily.com

Search

+