Toddler Changes His Own Dexcom on TikTok: Advice From His Mom

TikTok has become more than just a place to dance along to the latest trend; it has become a platform for advocacy for many issues, and diabetes has received increased exposure thanks to this social media app. I couldn’t believe my eyes when I saw a TikTok of a very young boy putting on his own Dexcom G6! And he did it with confidence, bravery, and pride. I wanted to share Daxon’s story in the hopes that it inspires others as well. I reached out to his mom who was gladly happy to chat.

Hi Cassie, thank you so much for taking the time to answer my questions! I would love for our community to get to know Daxon a little better! He is such a great role model for other children living with type 1 diabetes (T1D)!

At what age was Daxon diagnosed and what were the symptoms?

Daxon was diagnosed exactly 1 month from his second birthday at 23 months old.

He started to get a bad temper spring of 2019 and we never understood why. He would get so upset so easily and we just thought it was because of terrible twos. In July, he threw up twice one morning for no reason and out of the blue. He started throwing up at nighttime multiple nights in a row and only at night. I took him to his pediatrician, and they told me “it’s probably the stomach bug, it’ll pass” but I told him “but randomly like that? It doesn’t make sense”.

After about two weeks, it stopped until August. He threw up one more time in the morning and then stopped. Once again, we had no idea why. At the end of August he started drinking and peeing excessively. What really gave it away was that he was drenched from head to toe in pee after a 2-hour nap period one day and that was it. I checked his sugar and it was 461 mg/dL (borderline DKA).

How did you as a family adapt to your new normal?

Honestly, we are still trying to adapt. We take it day by day because it is always changing. The one thing about diabetes is that no matter what, it is different each day. Even if you do the same exact thing, sugars will change.

Did you change Daxon’s and/or your family’s diet at all? What are his favorite go-to foods that don’t wreak havoc on his blood sugars? I’m sure lots of moms could use some tips!

I did not completely change his diet, but I do swap stuff out for healthier carbs and a lower glycemic index. He does low-carb bread, cheese, and crackers instead of mac-n-cheese, Go-Gurts, Two Good yogurts instead of the higher-carb ones, chicken meatballs instead of chicken nuggets, Fairlife milk instead of others  (because of his milk allergy, but it is better carb-wise also), keto-friendly cereal because others spike so much that I cannot get it down for hours, keto-friendly bread only because the GI level is so much better. There are some other changes, but the family has not changed any really. He does still eat candy, it is just more in moderation than before.

His go-to foods are pork rinds eggs, a brownie bar called “Good to Go”, keto-friendly ice cream, yellow bell peppers, broccoli, really any vegetable, cheese sticks, pepperoni, lollipop suckers. Any time we are out Chik-fil-A, grilled chicken and fruit are a must. That is all I can think of right now.

Photo credit: Cassie Daniels

At what point did you start using the Omnipod and Dexcom G6? How did Daxon handle that? 

The Dexcom was a month after being diagnosed and he did not handle it well at first. We would have to hold him down to get him to let me put it on. It was a nightmare but once he watched a friend of ours put her’s on and she told him “you have a robot just like me” he got used to it and now it is normal. When his phone tells us it’s time to change it, he’ll tell me “robot needs changed” and he will 100% do it solo now which is amazing.

The Omnipod was a little different. His first endo wouldn’t approve it because they thought he would take it off, so we had to wait but once we switched to a different hospital, they got him on it right away; so, he was about 7 months in when he was able to get the pod. At first, once again — NOT a fan and it was horrible — but once he learned it meant “no more shots” he was perfectly fine with it (sometimes). We will scream — and I mean scream  — the song “Baby Shark” so he will not hear the clicking for the needle and that seems to help also. He is currently working on putting the insulin in his pod so he is super excited about that.

I know I personally prefer shots, but am often intrigued by the control some pumpers get. Do you find using the pump helps make blood sugar management easier?

The pump for us personally is a lot better for different reasons. Omnipod allows such a small dose, so even 1 gram of carbs he would get some insulin, but with shots, we would have to round up or down, which meant [more fluctuations for him]. Also, in the middle of the night, being able to give him insulin without even touching him has been great. I hated waking him up to poke him with a needle. Also, when on the go we can dose from the front seat of the car. However, if he ever decides that he wants to stop the pump and go back to shots I will support him and what he wants 100%.

@cdaniels2015

95% completely solo 💙💙💙💙 He’s get the hang of this soooo quickly 😭🙏💙 #typeonediabadass #BigBoy

♬ Bang! – AJR

I couldn’t believe my eyes when my diabestie, Hillary Emmons,  sent me this TikTok of Daxon changing his own Dexcom! I am so impressed and inspired! At what point did he express interest in doing that?

After about six months of being a type 1, he has always been curious about everything. He has been checking his own sugar with the meter since about 6 months in when needed to be checked. And recently he was really showing interest in the Dexcom and doing it solo. He did half of it one day and then the next change he did it completely on his own, all I did was hold it and help place it. I never asked him to do it because I didn’t think he was ready for that task yet but that day he told me “I do it” and that was it. Now he is showing interest in some of the Omnipod stuff, which is amazing because he feels in control.

I give you credit as a parent for letting him own his management and giving him the confidence to know he can manage his disease! What would you like to tell other parents about how to get children to want to be a part of their daily care?

Make it positive, make it fun, and make it normal. We have the JDRF bear and we practiced on that since being diagnosed. At first, we used it so he could understand more of it. We also got his big brother and all the other family members involved since day one. We check everyone’s sugars, so it is normal for everyone. All the children in our family (our boys and our 3 nieces) have been very curious about it since day one.

I see you are using TikTok as a platform for awareness and this one video alone got over 103,000 likes! Kudos! What would you like people to take away from your videos?

I want people to know the signs of T1D and to normalize it. I hate when I see people hide that they check their sugar or even giving their self insulin. I want to help parents have a voice for their children because doctors sometimes do not listen, and we need to be loud for our children and to follow their gut. I have a lot of people say that he encouraged their children to try putting the Dexcom on solo and I love that it is helping other children also. One of my TikToks potentially saved a child from dying. Her sugar was almost 1000 mg/dL and she was in DKA and doctors were surprised she wasn’t in a coma. Children should not die for people [not being able] to figure out what is wrong!

Does Daxon enjoy making the TikTok videos? I think “injecting” some humor and fun is the best medicine of all! And one you can all do together as a family!

Daxon loves showing people his stuff. He knows it makes him unique and he loves seeing others who are like him. So, when people duet his videos and they show their Dex or pod it’s helpful for him also to see that there are others like him.

Photo credit: Cassie Daniels

What else does Daxon like to do with his free time when he’s not managing his diabetes and TikTok’ing?

Daxon is a typical boy and I mean ALL boy. He rough houses with his brother, loves to color, help with dishes, cooking, loves to read books, play outside, ride his 4-wheeler, and absolutely loves cuddling with me. I think him being a T1D made our bond even stronger.

How does Daxon feel about being a TikTok sensation and knowing that he is helping to inspire many other children just like himself!

I have told him many times that he is helping other children and I don’t think he really understands what it means yet, but he always smiles and says “they have a robot like me” or he’ll go “yay that makes me happy”. I ask him “do you want to make a video?” and normally he’ll tell me “yessss let’s make a video”. I will never make him make TikToks so if he tells me no then I’ll leave it alone.

I ask this in every interview! Do you think they’ll be a cure in Daxon’s lifetime?

100% honestly I do not foresee a cure ever. They make way too much money from insulin (when it should be free, but that’s another story for another time). I wish there would be a cure, but I don’t see it happening.

Daxon

Photo credit: Cassie Daniels

What advice helped you? Can you pass it along to parents of newly diagnosed children?

My advice for parents is:

  1. Take one day at a time because it is an always-changing, never-stopping, headache of a disease.
  2. Do your best and never get down on your child for their blood sugars. That is the one thing I will never do to Daxon, anytime he has “bad” sugars, I never express it to him or show it on my face because it is not his fault, so I don’t want him to feel like he is failing.
  3. Always tell your child they can still do anything they like and never change activities. Just change foods to help [manage sugars during] the activities. For example, we took Daxon and his brother to a trampoline park and I knew his sugar was going to drop. He started at 170 mg/dL and dropped to 50 mg/dL. I was prepared with milk, yogurt, chocolate, and others, so he could still have fun and be a kid.
  4. Try not to have a fight if sugars are not in range, because everything is magnified if high or low. So what I do with Daxon if he is high or low and has a temper tantrum, I ignore it and let him do what he needs to do. Once he calms down, we discuss what happened and I explain I understand he doesn’t feel good but he doesn’t need to act that way.
  5. Treat them like you would any other child because diabetes does NOT define them.

Where do you see going with your advocacy and awareness on social media or elsewhere? Do you have other plans in the future?

I would love to bring more awareness to this disease. I would love for there to be a law that pediatricians must check A1c every year or every other year. They check your iron, and they check lead so why not diabetes? [Some] pediatricians think that younger children cannot get diabetes until at least six years old which is not true. It is ridiculous because a child’s death is avoidable if people were more aware of the signs and doctors tested when they should.

Thanks again Cassie, we really appreciate you taking the time! I look forward to continuing to follow Daxon’s journey and see how many kids he inspires along the way!

Source: diabetesdaily.com

Getting the Most Out of Your Remote Healthcare Visits

This content originally appeared on Integrated Diabetes Services. Republished with permission.

By Gary Scheiner MS, CDCES

A long, long time ago, before the days of coronavirus, there was a little diabetes care practice called Integrated Diabetes Services (we’ll just call it IDS for short). IDS taught people with diabetes all the wonderful things they can do to manage their diabetes. Word got out, and people who lived far from IDS’s local hamlet (better known as Philadelphia) wanted to work with IDS. Even people IN the hamlet wanted to work with IDS but were often too busy to make the trip to the office. So IDS had an idea: “Let’s offer our services via phone and the internet so that everybody who wants to work with us can work with us!” The idea took off, and IDS grew and grew.

And virtual diabetes care was born.

Today, in response to the COVID-19 pandemic, virtual healthcare has become a virtual norm. Often referred to as “telehealth” or “telemedicine,” people with diabetes are connecting with their healthcare providers for everything from medical appointments to self-management education to coaching sessions. Some consults are conducted via phone calls, while others utilize web-based video programs (like Zoom) or simple email or text messages. Regardless of the form, virtual care can be highly effective. But it can also have its limitations. Whether you’ve been receiving virtual healthcare for months or have yet to give it a try, it pays to learn how to use it effectively. Because virtual care will certainly outlive the pandemic.

What Can… and Can’t… Be Accomplished Virtually

Most diabetes care services, including medical treatment and self-management education, can be provided effectively on a remote basis. We have managed to teach our clients everything from advanced carb counting techniques to strength training routines to self-analysis of glucose monitoring data, all while helping them fine-tune their insulin program, on a 100% virtual basis.

Some clinics and private healthcare providers have gone 100% virtual since the pandemic began, while others are using a “hybrid” approach – periodic in-person appointments with virtual care in-between. Depending on the reason you’re seeking care, a hybrid approach makes a lot of sense. While virtual visits are generally more efficient and economical (and in many cases safer) than in-person appointments, there are some things that are challenging to accomplish on a remote basis. From a diabetes standpoint, this includes:

  • Checking the skin for overused injection sites
  • Learning how to use medical devices (especially for the first time)
  • Examining the thyroid gland and lymph nodes
  • Evaluating glucose data (unless you can download and transmit data to your provider)
  • Performing a professional foot exam
  • Listening to the heart rhythm and feeling peripheral pulses
  • Checking for signs of neuropathy and retinopathy
  • Measuring vital signs (unless you have equipment for doing so at home)

The Logistics

Virtual care can be provided in a variety of ways, ranging from a phone call to an email, text message or video conference. Video can add a great deal to the quality of a consultation, as it allows you and your healthcare provider to pick up on body language and other visual cues. It also permits demonstrations (such as how to estimate a 1-cup portion of food), evaluation of your techniques (such as how to insert a pump infusion set), and use of a marker board for demonstrating complex subjects (such as injection site rotation or how certain medications work).

When using video, it is important to have access to high-speed internet. A computer is almost always better than a phone for video appointments, as the screen is larger and has better resolution. If you have the ability to download your diabetes data, do so and share access with your healthcare provider a day or two prior to the appointment. It may also be helpful to share some of your “vital” signs at the time of the appointment – a thermometer, scale, and blood pressure cuff are good to have at home.

In many cases, care provided on a remote/virtual basis is covered by health insurance at the same level as an in-person appointment. This applies to public as well as private health insurance. However, some plans require your provider to perform specific functions during the consultation (such as reviewing glucose data) in order for the appointment to qualify for coverage. Best to check with your healthcare provider when scheduling the appointment to make sure the virtual service will be covered. At our practice (which is 100% private-pay), virtual and in-person services are charged at the same rates.

If security is of the utmost importance to you, virtual care may not be your best option. Although there are web-based programs and apps that meet HIPPA guidelines, there really is no way to guarantee who has access to your information at the other end. My advice is to weigh the many benefits of virtual care against the (minuscule) security risk that virtual care poses.

Optimizing the Virtual Experience

Just like in-person appointments, virtual care can be HIGHLY productive if you do a little bit of preparation.

  • Do yourself and your healthcare provider a favor and download your devices, including meters, pumps, CGMs, and any logging apps you may be using, prior to the appointment. If you don’t know how to download, ask your healthcare provider for instructions, or contact our office… we can set up a virtual consultation and show you how. If you have not downloaded your information before, don’t be intimidated. It is easier than you think. People in their 80s and 90s can do it. Oh, and look over the data yourself before the appointment so that you can have a productive discussion with your healthcare provider.
  • Be prepared with a list of your current medications, including doses and when you take them. Check before the appointment to see if you need refills on any of your medications or supplies. If you take insulin, have all the details available: basal doses (and timing), bolus/mealtime doses (and dosing formulas if you use insulin:carb ratios), correction formulas (for fixing highs/lows), and adjustments for physical activity.
  • Try to get your labwork done prior to virtual appointments. This will give your healthcare provider important information about how your current program is working.
  • To enhance the quality of the virtual meeting, do your best to cut down the background noise (TV off, pets in another room, etc…) and distractions (get someone to watch the kids). Use of a headset may be preferable to using the speakers/microphone on your phone or computer, especially if there is background noise or you have limited hearing.
  • Use a large screen/monitor so that it will be easy to see details and do screen-sharing. And use front lighting rather than rear lighting. When the lights or window are behind you, you may look more like a black shadow than your beautiful self. “Ring” lights are popular for providing front-lighting.
  • Provide some of your own vitals if possible – weight, temperature, blood pressure, current blood sugar. This is important information that your healthcare provider can use to enhance your care.
  • Prepare a list of topics/questions that you want to discuss. Ideally, write them on paper so that you can take notes during the appointment. If there is a great deal of detail covered, ask your healthcare provider to send you an appointment summary by mail or email.
  • Be in a private place that allows you to speak openly and show any body parts that might need to be examined – including your feet and injection/infusion sites.
  • Be a patient patient! Technical issues can sometimes happen. It is perfectly fine to switch to a basic phone call or reschedule for another time.
  • Courtesy. Be on-time for your virtual appointment. If you are delayed, call your healthcare provider’s office to let them know. And if you are not sure how to login or use the video conferencing system, call your provider beforehand for detailed instructions. This will help to avoid delays. Have your calendar handy so that a follow-up can be scheduled right away. Oh, one other thing: Try not to be eating during the appointment… it is distracting and a bit rude. However, treating a low blood sugar is always permissible!

If there is one thing we’ve learned during the pandemic, it’s that virtual care is a win-win for just about everybody. Expect it to grow in use long after the pandemic. In-person care will never go away completely, but for treating/managing a condition like diabetes, virtual care has a lot to offer… especially if you use it wisely.

Note: Gary Scheiner is Owner and Clinical Director of Integrated Diabetes Services, a private practice specializing in advanced education and intensive glucose management for insulin users. Consultations are available in-person and worldwide via phone and internet. For more information, visit Integrated Diabetes.com, email sales@integrateddiabetes.com, or call (877) 735-3648; outside North America, call + 1-610-642-6055.

Source: diabetesdaily.com

Study Compares MiniMed 780G and MiniMed 670G Algorithms

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

A new study in adolescents and young adults with type 1 diabetes directly compared two automated insulin delivery algorithms. Medtronic’s newer Advanced Hybrid Closed Loop (built into the MiniMed 780G system) improved glucose management more than the MiniMed 670G, though both systems showed impressive increases in Time in Range for this population. Ultimately, the 670G gave users over an hour and a half more time in range each day, while the 780G gave wearers over two hours every day in range!

Two Medtronic automated insulin delivery algorithms, the Advanced Hybrid Closed Loop and the MiniMed 670G, were recently compared in a cross-over study, allowing 113 participants to use both algorithms. Results from the study were published in the medical journal The Lancet. Notably, the study tested this technology in adolescents and young adults with type 1 diabetes ­– a group for which diabetes management is notoriously challenging. View our resources for adolescents with diabetes here.

For an introduction to automated insulin delivery (AID), check out our piece on current and coming-soon AID systems in 2021.

What is the MiniMed 670G?

The MiniMed 670G is an AID system that has been available since spring 2017 – it was the first system ever to “close the loop.” The system includes the MiniMed 670G pump, the Guardian Sensor 3 continuous glucose monitor (CGM), and an automated insulin adjustment algorithm. The algorithm adjusts basal insulin delivery every five minutes based on CGM readings, and a target of 120 mg/dl.

What is Advanced Hybrid Closed Loop?

Advanced Hybrid Closed Loop (AHCL) is Medtronic’s next-generation AID algorithm. The AHCL algorithm is used in Medtronic’s MiniMed 780G system, which is currently available in at least twelve countries in Europe. While it is not yet available in the US, Medtronic hopes to launch the 780G in the US this spring. In addition to automatic basal rate adjustments, the AHCL algorithm can also deliver automatic correction boluses and has an adjustable glucose target that goes down to 100 mg/dl. This is big news because many people using closed loop do not want to target the higher 120 mg/dl, even as a safety measure. The 780G algorithm is designed to have fewer alarms and even simpler operation than the MiniMed 670G system.

What was the study?

The newly published FLAIR (Fuzzy Logic Automated Insulin Regulation) study was conducted over six months across seven diabetes centers (four in the US, two in Europe, and one in Israel). The study enrolled 113 adolescents and young adults (ages 14-29) with type 1 diabetes. The study sample is notable, because teens and young adults with type 1 diabetes have the highest average A1C levels of any age group.

At the beginning of the study, participants performed their usual diabetes management routine for two weeks to establish their baseline glucose levels. Half of the group was then randomly assigned to use the MiniMed 670G system, while the other half of the group used the same pump and CGM, but with the new AHCL algorithm. After three months – the halfway point of the study – the two groups “crossed over,” switching to the opposite technology.

What were the results?

Nearly every measure of glucose management favored the AHCL period over the MiniMed 670G:

  • Compared to baseline, participants reduced time spent above 180 mg/dl by 1.2 hours per day when using MiniMed 670G and 1.9 hours per day when using AHCL.
  • Time in Range (TIR, time between 70-180 mg/dl) improved from a baseline of 57% to 63% using Minimed 670G and to 67% using AHCL.
  • Time spent below 70 mg/dl fell 0.2% of the time. While those 28 minutes a day may not be statistically significant – and time in severe hypoglycemia, or below 54 mg/dl, did not increase from baseline when using either algorithm – many people with diabetes would benefit from that additional half hour in range.

The graph below shows the time spent in glucose ranges during baseline, MiniMed 670G, and AHCL periods. For both algorithms, the Time in Range increase from baseline was significant – use of either AID system led to at least 14 hours more each week spent in range. Nevertheless, we also point out, of course, that the group (again, the group that has the most challenges of any age group managing diabetes) still experienced a fair amount of time above 250 mg/dl. This is  another reason for healthcare professionals and people with diabetes to think about the “whole person” when considering diabetes management, and another reason why we always recommend Adam Brown’s Bright Spots and Landmines for ways to improve diabetes management in terms of food, exercise, mindset, and sleep – it includes many strategies for people, especially teens and young adults, to use each day.

AID comparison

Image source: diaTribe

  • The biggest Time in Range improvement came overnight (between midnight to 6am). During this six-hour overnight period, AHCL users spent an average of 4.4 hours in range (74% TIR), compared to 4.2 hours (70% TIR) for 670G, and 3.5 hours (58% TIR) during baseline. While the overnight Time in Range difference between AHCL and 670G may not seem large, it added up to nearly a 22-hour difference over the three-month the AHCL period.
  • With daytime numbers, the average AHCL user spent 63 more hours (about 2.6 days) in range than the average 670G user in each three-month study period.

The graph below shows daytime and nighttime differences in time spent in range (70-180 mg/dl), and the data is included in a table at the end of this article. Better sleep the night before can also make diabetes management more effective during the day.

Comparison

Image source: diaTribe

  • Using MiniMed 670G drove an average A1C improvement from 7.9% to 7.6%, while AHCL use improved A1C from 7.9% to 7.4%.

Both systems showed extremely positive results and were found to be safe for use in young people with type 1 diabetes. The AID algorithms led to dramatic increases in Time in Range in a population that stands to benefit – over the course of a year, adolescents and young adults could spend more than ten additional days in range. The direct comparison between these two AID algorithms is highly informative – we hope to see similar trials in the future.

Comparison

Image source: diaTribe

Source: diabetesdaily.com

CGMs to “Hack” Your Blood Sugar? People with Diabetes Speak Up

It’s becoming more and more common: whether in a coffee shop in Silicon Valley or in a weightlifting gym in Boulder, Colorado, people without diabetes are using continuous glucose monitors (CGMs) to “hack” their blood sugars, lose weight, and hone their diets accordingly. This article will explore the use of CGMs in the non-diabetic population, what the backlash from the diabetes community has been, and what the call to action should be.

CGMs for More Than Just Diabetes Management?

According to one website that promotes the use of CGMs in a non-diabetic population,

“ Wearing a CGM can facilitate the effort for someone who wants to hack their diet, blood sugar control, and overall health. This technology can go beyond a single blood sugar reading that a blood glucose meter provides. A CGM can provide real-time insight on whether blood sugar is trending up or down.”

What may seem like an innocuous accessory for the upper-class elite has many people with diabetes enraged. CGMs are crucial in providing regular, near-constant blood glucose readings to track time spent in range (TIR), identifying patterns in blood sugars, and anticipating both low and high levels.

The Original Purpose of a Continuous Glucose Monitor

For people with diabetes, they are life-saving, and more and more often are being coupled with insulin pumps that will then increase or suspend insulin according to the blood sugar that a CGM reads. It almost entirely eliminates the need for manual finger testing and has proven to help lower HbA1c levels, reduce dangerous low blood sugars, increase time in range, prevent unnecessary emergency room (ER) visits, and save the health care system money and save many lives. It has quickly become a necessity for tight diabetes management in recent years for many people.

For something so seemingly necessary for most people with diabetes, it clearly isn’t seen that way by industry: 16 states, including California (the most populous), do not have Medicaid coverage for continuous glucose monitors at all. And while most private health insurance plans (and even Medicare) now cover CGMs, affording one without health insurance is nearly impossible: the most popular CGM and the one that most commonly connects with insulin pumps, the Dexcom CGM, costs thousands of dollars out of pocket per month without insurance.

So when someone with diabetes, who is already struggling to afford their insulin, goes to the local coffee shop and overhears two dudes from Crossfit comparing their (perfect) blood sugar readings on their respective CGMs over their non-fat decaf lattes, the inequity of the situation can be enough to make your skin crawl.

Clair from Illinois says,

“The general population using CGM devices trivializes them.”

Cate from Nebraska adds,

“It absolutely incenses me [when non-diabetics use CGMs]. There’s a local doctor in my area who treats patients for weight loss and gives everyone a free CGM; meanwhile, it’s an arm and a leg to refill my own.”

Bonnie from Minneapolis says,

“It drives me absolutely bananas.”

We Are All Just Products of the System

Managing diabetes with a continuous glucose monitor is life-changing, but it is expensive, and living with diabetes in America is anything but easy. We have the most expensive insulin prices in the world, health insurance isn’t compulsory or cheap, and even when you do have a job that has health insurance, necessary diabetes technology is sometimes not even covered or affordable under your plan.

Seeing people use technology that we need can be seen as a slap in the face, but we’re directing our anger at the wrong place. The problem with accessibility in the United States is not a supply issue. The problem with accessibility in the United States is that we use health care as a commodity when it is not. We put health care into a capitalist box when it’s something that should be treated as the human right it is. We’ve priced people out of their lives. We treat things like insulin and insulin pumps and continuous glucose monitors as if they’re elastic goods when they’re 100% inelastic. We cannot negotiate our own pricing for insulin. We can’t haggle down the price or walk away. We need the drug or we die.

People without diabetes see products like continuous glucose monitors as the valuable goods they are and are willing to pay for them. No person who uses a CGM recreationally has it covered by their insurance, and it’s important to remember that.

It’s not a zero-sum game where someone’s CGM that’s paid for out of pocket in San Francisco precludes another person on Maine’s Medicaid program from accessing one of their own, but it feels like it does. Instead of taking our anger out on the gym-rat in Colorado who’s paying thousands of dollars out of pocket for their Dexcom each month (which is stupid, but why question their motives?), we should be angry at the government and systems that created this situation to begin with.

If the United States had a single-payer health care system where everyone who lives here had health coverage, we wouldn’t care what people buy on the free market. If all plans (including Medicaid!) covered CGM use for people with diabetes at 100% of the cost, it wouldn’t bother us what anyone else was doing with their blood sugar levels (diabetic or not). It’s a symptom of a system that denies people with diabetes the proper care and regular, reliable access to proper durable medical equipment that makes them covet these devices as much as we do. There’s nothing inherently wrong with people without diabetes using CGMs, but it does sure feel like there should be. 

CGM for non-diabetic population

Photo credit: iStock

Some People Support Wider Use of CGMs

In speaking with others for this story, I found several people who encourage non-diabetics to use CGMs, like Mindy, a registered dietician from Colorado,

“I am pleased that there is adequate supply for people without diabetes who can view the real-time movements and fluctuations of blood glucose. The more understanding there is in groups of non-DMs, maybe we can finally change the direction of people diagnosed with (type 2) in the future.”

Christie, from California, added,

“being mad about someone having a CGM that they bought on the free-market is similar to someone with hypertension being angry over another person having an at-home blood pressure monitor. It just doesn’t compute.”

In a country with nearly 100 million people living with prediabetes, learning to respond to blood sugar trends and figuring out which foods work best for your body can only be a good thing. And although it hasn’t happened yet, the more “mainstream” these devices become, the more affordable they’re bound to become, which would be great for everyone. Additionally, for shy diabetics, CGMs becoming more mainstream can also take away the stigma of having a visible device on your body 24/7. It’s suddenly “cool”.

Benefits for Everyone

Whether or not you have diabetes, a continuous glucose monitor can help with several things:

  • Learning how your body responds to certain foods (grapes versus crackers, for instance)
  • Identifying blood sugar patterns around mealtime and exercise
  • Diagnosing diabetes before the onset of ketoacidosis (DKA) in people at high risk (people who are overweight, obese, live with prediabetes, or who have the antibodies for type 1 diabetes)
  • Improving blood sugar to help maximize energy for a workouts
  • Helping people lose weight by managing their hunger (which is the result of fewer blood sugar fluctuations throughout the day)

In a country where over 70 million adults are obese and another 99 million are overweight, having more data regarding how our bodies respond to the foods we eat is vital. We have a type 2 diabetes epidemic on our hands that is only getting worse, and wider CGM usage may help curb that, but people need to be careful.

Using them as “wellness gimmicks” may bombard those who truly do not understand the relationship between glucose and blood sugars, leaving users overwhelmed with data and confused, while not making any dietary changes at all. In a true market economy, the greater the demand, the more competition will spring up, the more prices will fall (for both people with and without diabetes).

The real issue that people need to focus on is making sure that everyone with diabetes who wants a CGM can get one, but people without diabetes accessing CGMs on the open market will not prevent that from happening. We need to push for greater coverage for CGMs on the private and public health insurance market with our elected officials and make sure that we inch ever closer to the illustrious universal health care system that other industrialized countries enjoy. We need to make sure that everyone with diabetes has access to affordable insulin, pumps, and supplies (including CGMs), with strong grassroots advocacy to equip people with all the tools they need to thrive. If we achieve universal health care maybe someday everyone who truly needs a CGM can get one, but until then, let the Crossfit bro with his Dexcom sensor alone. Although you can let him know that the caffeine in his latte will raise his blood sugar a few points in the meantime.

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

New Tech: College Graduate Invents Glucose-Sensing Earring

Tyra K, a 22-year-old graduate from the University of Huddersfield, surpassed thousands of entries and became a finalist in the 2020 Global Grad Show. Tyra, a  product design graduate, created a discreet earring that can monitor blood glucose levels in real-time.  

I found her story to be quite fascinating along with her reason for creating this device, being that Tyra herself does not live with diabetes. I thought it would be nice to hear from Tyra on how this idea came to life.

Hi Tyra, thank you so much for taking the time to talk to me. I understand you do not live with diabetes. What gave you the inspiration to work on such a project?

Hi, thank you for having me! I was inspired to create a product that helped with type 1 diabetes (T1D) management after an incident that happened with a neighbor of mine. In summer 2019, my neighbor who is a male that lives independently had an unexpected hypoglycemic attack. Fortunately for him, the windows were open, which allowed me and my family members to hear a faint shout for help.

After realizing our neighbor needed assistance, we were able to gain access to his house and immediately called for the ambulance. After my neighbor had received medical assistance and the situation was resolved, it came to light that his hypoglycaemic attack developed thought-out the night, which almost triggered a diabetic coma. Due to this unfortunate circumstance, I was inspired to create a product that can prevent potentially fatal situations and support T1Ds.

What were the first steps you took once you had the idea? I know so many people have ideas but do not know how to execute them.

Once I decided to investigate diabetes management, my initial plan was to conduct and collect as much research as possible. As I am not a person with T1D, nor did I have much knowledge on the subject, [so] it was very important to me to learn as much as possible.

I set up focus groups, interviews, and questionnaires, to pinpoint the main areas of concern. Thanks to the help of the participating parents whose children have type 1 diabetes, I was able to create a focus group. This highlighted the main concerns among children/teenagers, such as the insecurities of managing diabetes in the presence of other people. I thought this was upsetting; no child should be embarrassed to monitor and control their health, especially as it is no fault of their own.

After processing all this information, I decided to create a product that would reduce the stigma of diabetes management and encourage younger type 1s to monitor their condition in a manner that caters to their needs.

I live with type 1 diabetes and wear the Dexcom G6 and find the technology to be life-saving. What makes your Sense Glucose Earring better than the big names like Dexcom and Freestyle Libre?

Products from brands such as Dexcom and Freestyle are revolutionary. The progress in diabetes management over the last 10 years is remarkable as the technology within existing products has helped many diabetics worldwide. Various CGMs seen on the market will cater to different consumer needs. Every consumer is different and will want different things from a product.

The Sense Glucose Earring is different from the leading brands as it focuses on making glucose monitoring discreet, quick and simple. It is designed to look like a piece of wearable tech, similar to wireless earphones, which aims to make monitoring in social situations more appealing and less distressing.

Sense Glucose Earring

Image credit: Tyra Kozlow

I think the earring idea is a fascinating one. How exactly does it measure your blood through your earlobe? Is insertion painful? Do you need finger prick calibrations?

Thank you! I am unable to give the full details on the technology at this stage, as the product is still being developed. However, I can tell you that inserting the device would not be painful, as it will fit into standard lobe piercing, so the only slightly painful part would be getting your ear pierced!

How often will you have to change the sensor? Or is it rechargeable?

The great thing about the Sense earring is that it is rechargeable. The device does not contain any disposable plastic components, the earring can be wiped clean and used as and when required. The life span of the product is yet to be confirmed, but the product is designed to last substantially longer than current invasive sensors.

I understand that once the Sense detects blood sugar levels, it then transmits the information to an app. What features does this app have other than displaying your blood sugar?

The app, like the earring, is still under development, but I hope that it will provide a personal experience for T1Ds, by providing the option for T1Ds share their glucose data with trusted family and friends, which creates a personal support network for the users who require it.

Since the inspiration for this device came from you chairing a focus group of parents who all had the same sentiments of their child not wanting to manage their condition in public due to the stigma, have you reconnected with these families to show them what you have created? What was their reaction? I’d imagine they were touched and humbled by your success!

Yes! I recently spoke to the chairwoman of the support group, who informed me that the group responded positively towards the Sense Glucose Earring and was excited to see how the product progresses in the Global Grad Show.

Sense Glucose Earring

Image credit: Tyra Kozlow

What are the next steps to bring this product to the public?

The next steps are to secure funding and build the right team to get the product on the market.

What enhancements can you see making to this device down the road?

At this moment in time, the focus is getting the earring onto the market, but I hope in the future we can produce variants of the product to further improve the lives of T1Ds.

Since you have already had such great success with such an important device that can help so many, what do you see yourself working on next? In ten years?

Personally, I hope to see the Sense Earring through to market implementation, and I desire to continue developing productions that have a positive impact on people’s lives.

Thanks so much for taking the time to speak with us, Tyra. We look forward to following your journey and wish you continued success!

Source: diabetesdaily.com

New Dexcom Update: Your G7 Questions Answered

Last month, we chatted with Jake Leach, Dexcom’s chief technology officer (CTO) to get the latest scoop on the release timeline and new features of the Dexcom G7 continuous glucose monitor (CGM), a highly-anticipated diabetes technology that will be released in 2021. Many follow-up questions from our readers prompted us to follow-up further.

Without further adieu, here are your questions about the G7 answered:

There is no calibration, correct?

“This is correct.”

What about pharmacy vs. supplier distribution for the G7?

“We continue to focus on making CGM more accessible and easier to obtain for patients. Pharmacy is our preferred distribution channel and we have expanded pharmacy access for Dexcom CGM by nearly 80% since December 2018. This strategy will not change for G7.”

Now that the product is disposable, would this no longer be considered durable medical equipment (DME) and thus covered differently by insurance companies?

“The disposable aspect of the product has no impact on reimbursement.”

Do you anticipate working on integration with all the major pump companies?

“As the first iCGM on the market, and still the only one indicated for use with automated insulin delivery systems, Dexcom G6 is the forerunner in the category of interoperability and are advocates of patient choice in insulin delivery. G7 will be no different. With Insulet’s Omnipod 5 preparing for a first half of 2021 launch, we feel that our leadership in this category will result in us having integrations with the leading tethered pump on the market in Tandem’s Control.IQ, and the leading tubeless pump in Omnipod 5.

We are also very excited about the development progress that Lilly and Novo Nordisk are making in their Bluetooth connected smart pen technology and we continue to believe that the solutions we’re working on with those two teams will enable significant improvements in the user experience and ease the burden of diabetes in the MDI population, which represents the vast majority of intensive insulin users across the world.

Two years ago we stated that we believe that by 2023, 50% of our insulin intensive customer base will be using a connected insulin delivery device in combination with our CGM, and we believe that we are on track to hit that mark. Connected systems are truly the future of diabetes technology and we are working to extend our leadership in the category with these key partners and the tools that we have created to support these integrations, including our Dexcom artificial pancreas algorithm technology.”

Is there any evolution with the readout frequency (to be more frequent than every 5 minutes)?

“Patients and [providers] both tell us there isn’t a need for CGM systems to provide a glucose readout more frequently than every five minutes. This is especially true since Dexcom CGM has an Urgent Low Soon predictive alert that can warn users 20 minutes in advance of a severe hypoglycemic event (55 mg/dL), which helps give them time to take appropriate action before an event occurs.

Will G7 be approved for different wear locations (besides the abdomen)?

“We are conducting pivotal trials with the G7 in multiple wear locations, including abdomen and upper arm.”

Dexcom G7

Image source: Dexcom

In addition, Jake Leach had the following to say, highlighting his enthusiasm for the new developments:

“With G7, we’ve taken all of the great features that we’ve established with G6, features that have resulted in market-leading patient satisfaction scores, and have made them even better. G7 is a real time, factory calibrated continuous glucose monitor with iCGM level performance, a simplified application and start-up process, and a faster sensor warm-up time. We’ve packaged all of this into a fully disposable form-factor that is 60% smaller than our current G6 wearable and introduces significant cost reductions across the manufacturing process. This G7 wearable technology is paired with a brand-new app experience that includes real time glucose information combined with personalized insights designed to further enhance the unique value users get from Dexcom CGM. Take all of these features together and you can understand why we are so excited about G7 as a key driver of the growth story that we’ve laid out today.”

Are you excited to test drive the G7 CGM? Please share your thoughts in the comments!

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

Injection Device Helping a Family Manage New Diabetes Diagnosis During COVID

Injection Port Device Help Family Whose Son Lives with Diabetes

Jennifer, like many others, has worried about her family’s health during the coronavirus pandemic.

In June, she was diagnosed with COVID-19. Shortly after, her 13-year old son Mason started feeling ill. Unsure if he too had contracted the virus, they visited their local emergency room. Soon after, the family was informed that Mason was living with type 1 diabetes. In this post, Jennifer discusses her family’s experience and the ways they are managing Mason’s diabetes during the global pandemic.

Mason came to me and said he didn’t feel right. Upset tummy, sinus issues, and a small headache. We took him to a local emergency room, and sure enough his rapid test was positive for COVID-19. The doctors also said that his sugar was pretty high. They asked if I could watch his levels at home over the next couple of days and if his sugars remained high, then I should call our family doctor. We left the ER on Tuesday evening. By Thursday, I called our doctor because his sugars never went below 200 mg/dL. We were put in touch with an endocrinologist, who advised us to take him to the hospital where he was diagnosed with diabetes. 

As a parent, all fears set in. I was worried that I didn’t know enough about diet and medication. I worried about if my son would ever feel normal again.

I was surprised that Mason was able to start giving his own insulin almost immediately, and he preferred it that way. In the three months since he was diagnosed, I have probably only given 10 shots! 

I was introduced to the i-Port Advance™ injection port through a Facebook page. I posted that we were having issues with him taking too much insulin before meals, and then he was too full to finish what he had dosed for. Several parents came back and suggested we try an injection port! I called my doctor’s office the next day and they were super excited to let him try it.

Almost immediately, Medtronic sent us a box of the i-Port Advance™ injection port to try at no-cost. I could not express my happiness! I was thankful the company was willing to let us try the port before we purchased. As a parent, this was such an amazing feeling and it was one of the first easy experiences we had since Mason was diagnosed! 

Mason fell in love with the injection port, and so did I! When he used the port, it was the first time since he was diagnosed that he didn’t feel like an outcast. Although he is incredibly diligent with what he eats and doesn’t take advantage of his insulin, he is a kid! He wants little treats, he wants to hang out with friends his age, and eat cupcake or have snow cones from time to time. All of which he had stopped because he hated sticking himself all the time and taking shots in front of people. Now, he can take a little extra insulin if he needs to. He can hang out with friends and not feel like an outsider because he can’t eat what they do! I’m also happy because he is building up less scar tissue with 1 stick every 3 days compared to 12-15 injections.

As a parent, I’ve been so happy to watch his outlook change. He knows that he can manage this disease and he isn’t constantly worried with taking another shot! 

Mason’s family enrolled in the 12-day evaluation program offered by Medtronic. To learn more, click below.

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The testimonial above relates an account of an individual’s experience using a Medtronic device. The account is genuine, typical and documented. However, this individual’s experience does not provide any indication, guide, warranty or guarantee as to the response or experience other people may have using the device. The experience other individuals have with the device could be different. Experiences can and do vary. Please talk to your doctor about your condition and the risks and benefits of Medtronic devices.

Safety Information: i-Port Advance injection port

i-Port Advance injection port is indicated for patients who administer or receive multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple injections without the discomfort of additional needle sticks. i-Port Advance injection port may be used on a wide range of patients, including adults and children. For more, please see http://www.medtronicdiabetes.com/important-safety-information.

Source: diabetesdaily.com

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