Rush for COVID Vaccine Hinders Diabetes Tech Advancements

Modern science is amazing. The COVID-19 pandemic, which is still shaking the world as we know it, is quickly getting controlled due to fast scientific progress and the vaccine rollout (in the United States, at least).

Having an effective vaccine come to market within a year of the appearance of a novel disease is unheard of; most medicines take decades for adequate approval processes within the Food and Drug Administration (FDA) to be completed. This feat is incredible.

That being said, with all of the rush to get a vaccine to the masses, the FDA pushed the Pfizer, Moderna, and Johnson & Johnson vaccines literally to the front of the approval line, delaying other important medical and technological advancements, including those related to diabetes.

While the vaccine did (and should!) take precedent here, the delays have been tough for people with diabetes in many ways. 

The head of the FDA’s device center, Jeff Shuren, described a “tsunami” of product applications from companies hoping to join the fight against the COVID-19 pandemic.

Those applications include over 1,200 submissions for products like diagnostic tests, ventilators, and digital technology, all of which have slowed their work in other diseases, including diabetes.

Shuren went on to say that review times had begun to increase amid growing backlogs due to the high volume. 

The agency is trying to make as much space as possible to approve COVID-19 related vaccines, medicine, and technology quickly to end the pandemic, which has taken precedence over almost everything else. Experts suspect that the FDA may not be able to meet its own timelines going forward.

In addition, lockdowns and social distancing regulations halted clinical trials and product releases. It’s been a tough year for diabetes tech firms to get much done.

The following products, and their release dates, have been most affected by the pandemic:

Senseonics’ 180-Day Eversense Glucose Monitor

The Eversense continuous glucose monitor (CGM) is a device implanted under the skin that lasts for 90 days. The newest version of their CGM system aims to double its lifespan to 180 days without changing a sensor.

What was supposed to be released in early 2021 now faces delays of up to two months for its application to the FDA while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices. The new release date of the model is scheduled for mid-2021.

The Omnipod 5 (Originally “Horizon”)

Insulet’s Omnipod 5 system, which utilizes CGM data to make automated adjustments to basal insulin throughout the day, will be the company’s first hybrid-closed loop system.

Similar to the T-slim Control IQ system, this insulin pump will provide mobile app control and insulin dosing from a smartphone, eliminating the need to carry their hallmark Personal Diabetes Manager (PDM) around to control the release of insulin.

While significantly delayed due to the COVID-19 pandemic, Insulet said during its Nov. 4, 2020 investor update call that it had recently finished its clinical trial and was finalizing its FDA submission.

They hope to launch their product by June of 2021.

Medtronic 780G

Also known as the Advanced Hybrid-Closed Loop (AHCL) system, this system will improve upon its first iterations of the hybrid-closed loop system, the 670g and 770g. Hoping to seek approval for adults and children as young as two, this system includes:

  • A CGM sensor that will require just one calibration on the first day of wear and no further calibrations after that
  • Automatic correction bolus delivery every 5 minutes, in conjunction with CGM readings, that can automatically bolus for missed meal doses.
  • A lower glucose target range, adjustable between 100-120 mg/dL
  • Different insulin duration times, to adjust for the “tail” of your insulin (eg, Fiasp vs. Humalog)
  • Built-in Bluetooth to share data and provide remote software updates

Due to the pandemic, the approval for this device has been delayed, but Medtronic confirmed that it had submitted its application for review to the FDA in February, 2021.

They hope to have a commercial launch sometime in 2021.

Dexcom G7

The much-anticipated Dexcom G7 continuous glucose monitor (CGM) was also delayed due to the pandemic, but it should be worth the wait. You’ll no longer need to buy separate transmitters; each sensor is a complete and disposable transmitter/sensor integrated system. Some other great features include:

  • No calibrations, much like the G6
  • At the start, wear time will be 10 days, but eventual use will include a 14-15 day feature, also without any calibrations
  • Smaller and thinner: the newest CGM will be 60% smaller than the G6
  • One hour warm-up period

Dexcom CEO Kevin Sayer said that the company eventually plans to have different versions of the G7 for different people.

For example, people with type 2 diabetes who don’t use insulin (or even the general public) might opt for a much simpler interface than people with type 1 diabetes, who will want all of the alarms and settings.

Abbott Freestyle Libre 3

For years, the FreeStyle Libre from Abbott Diabetes was a considered Flash Glucose Monitor (FGM), because it only reported blood sugar levels whenever a user scanned their sensor with a receiver or smartphone.

That will change with the new edition: The Freestyle Libre 3 will function as a real-time CGM, because it won’t require sensor scanning to get a “flash” of blood glucose data. It will instead provide trends and graphs to track blood sugars throughout the day.

The Libre 3 generates real-time blood sugar readings every minute (as opposed to Dexcom’s every 5 minutes), displaying the result on a mobile app on your smartphone. This version also has optional high and low blood sugar alarms, a feature introduced with the Libre 2 in 2020.

Additionally, the sensor is much smaller and thinner (a 70% size reduction), and is kinder to the earth, using 41% less plastic overall.

The Libre 3 received global approval in September 2020. The timeline in the US has been pushed backwards, but with clinical trials now complete, we’ll likely see the Libre 3 applications submitted to the FDA mid-2021.

While the hustle for an effective COVID-19 vaccine has been nothing short of miraculous, people with diabetes don’t want to wait any longer!

Hopefully, with the hastened release of the vaccine, we can see more diabetes technology hit the market in 2021. 

Source: diabetesdaily.com

How to Advocate for Yourself: Making Employer-Sponsored Health Plans Work for Your Diabetes Care

This content originally appeared on diaTribe. Republished with permission.

By Julia Kenney

The therapies, devices, and care that people with diabetes need can be expensive without adequate insurance coverage. For those with employer-sponsored health insurance, there are steps you can take to improve your insurance options and advocate for yourself.

Over 45 percent of Americans have diabetes or prediabetes and roughly half of US adults receive health insurance through their employer. Unfortunately, not all employer-sponsored health plans meet the needs of people with diabetes. According to a study of 65,000 people with type 1 diabetes on employer-sponsored health insurance, the average annual out-of-pocket cost of diabetes care was $2,500. Eight percent of study participants had annual costs well over $5,000. Since diabetes is most prevalent in low- and middle-income households, these costs, in addition to paying for premiums and non-diabetes healthcare, are unaffordable for many people.

If your health insurance does not cover a component of your diabetes healthcare, or if your diabetes care is covered but still unaffordable, you can work with your employer to get better coverage. Here is an overview of the different types of health insurance, who to go to for help, and how to advocate for better diabetes health coverage.

What are the different types of health insurance?

You will have expenses no matter what health insurance you have, but some plans can be more affordable for diabetes care. These are the expenses you will typically encounter with your health insurance plan:

  • Premium – Similar to paying rent, a premium is a fixed amount that you pay every month to keep your health insurance active. It’s common for employers to pay about half of your monthly premium, and sometimes more. In 2019, people with employer-sponsored insurance paid an annual average of $1,242 for health insurance premiums.
  • Deductible – The deductible is the amount you pay out-of-pocket before your insurance provider covers expenses. For example, if you have a $1,000 deductible, your insurance coverage will not kick in until you’ve paid $1,000 in healthcare expenses for that year.
  • Copays – Copays are a fixed amount that you pay for a health service or medication, and your insurance provider covers the rest of the cost. Copays are a helpful way to pay for diabetes care because they are fixed, predictable costs that people can plan for.
  • Coinsurance – Unlike fixed-price copays, coinsurance costs are a percentage of the total price of a health service or medication. These expenses are less predictable because medication prices can fluctuate.

There are three main types of health insurance – health maintenance organizations (HMO), preferred provider organizations (PPO), and high deductible health plans (HDHP). Here is an overview of the different types of health plans and what they might cost:

  • HMO – Health maintenance organizations have high premiums and low deductibles. An HMO plan covers healthcare within a network of hospitals and healthcare professionals. Your providers must be in-network in order to get your diabetes care covered. If your diabetes care professionals are in-network, this is often the most cost-effective healthcare option for people with diabetes.
  • PPO – Preferred provider organizations also have high premiums and low deductibles than HDHPs. PPOs are more flexible than HMOs because you are able to see providers out-of-network and you can see specialists without a referral. Because of this, PPOs typically have higher premiums and out-of-pocket costs than HMO plans.
  • HDHP – High deductible health plans typically have low monthly premiums and high deductibles. In 2020, the IRS defined a HDHP as any plan with a deductible of at least $1,400 for an individual and $2,800 for a family. If you have a high deductible health plan, you can open a health savings account where you set aside money to pay for medical expenses tax-free. These health plans are good for people who don’t anticipate needing regular healthcare; paying for diabetes care can be difficult with this type of plan because you will have high out-of-pocket costs upfront before you meet your deductible.
Advocacy

Image source: iStock Photo

Keeping these different types of health insurance and related expenses in mind, here are some things people with diabetes should think about when reviewing an employer-sponsored health plan:

  • What are my diabetes-related costs? Make a list of your diabetes healthcare costs including medications, devices, supplies, healthcare visits, and lab tests.
  • What are the health insurance costs? Look at the premium, deductible, and whatever cost sharing method (copay or coinsurance) is used for the health plan.
  • Are my medications and devices covered? Refer to your health plan’s Summary of Benefits and Coverage to see what is included in your insurance coverage. If a therapy or device is not covered, you may have to switch to one that is or submit a request to get it covered. Getting a new medication or device covered under your health plan can be a challenging and time-consuming process.
  • Is insulin covered pre-deductible? Some health plans cover insulin before you reach your deductible because it is considered preventive medicine. This can make insulin considerably more affordable, especially for people on high deductible health plans.
  • Are my healthcare professionals in-network? Accessing in-network healthcare is more affordable than out-of-network care. You should choose a health plan where your current providers are in-network or one that has good in-network options.
  • Can I access a flexible spending account (FSA) or health savings account (HSA) to save money? FSAs and HSAs are used to put aside money that is not taxed to help pay for medical expenses. HSAs are paired with high deductible health plans. FSAs can be used for any kind of health insurance and all FSA funds must be used in the same calendar year. Learn more about FSAs and HSAs here.

If I have a problem with my insurance, who do I go to for help?

Your employer’s human resources (HR) department should be able to address many of your insurance-related questions, since it likely helped select the health plan(s) available to you. Your HR department is your first resource for health insurance questions. If you need help selecting an insurance plan, want to see if your diabetes care is covered, need to file a claim, or are having trouble navigating your plan and understanding the costs, the HR department will support you.

For further questions, your HR department can refer you to a representative with the health insurance company or to a third-party administrator. A third-party administrator will help you understand your health plan, file health insurance claims, and navigate the appeals process if your insurance company denies coverage for a diabetes treatment. You can also apply for an exception to get treatments, medications, and devices covered if recommended by your doctor. A third-party administrator will guide you through these steps for getting important diabetes treatments covered.

Advocacy

Image source: iStock Photo

How can I make my employer-sponsored health coverage better for people with diabetes?

People with diabetes typically require expensive medications, devices, and regular visits with healthcare professionals to stay healthy. Robust employer-sponsored health insurance plans should make these expenses affordable and predictable. If you are trying to make permanent changes to your employer-sponsored health plan, your HR department can help you advocate for future health plans that better support diabetes needs. Employers have the power to make changes to their health coverage options every year. Here are some changes you can advocate for:

  • Add insulin and other diabetes care to the preventive medicine list.

In 2019, the IRS ruled that expenses for chronic disease management can be covered before you meet your deductible under a high deductible health plan. HMOs and PPOs also have preventive medicine lists. Diabetes care such as insulin, A1C testing, blood glucose meters, and eye screening – which are all considered preventive medicine – can be added to the preventive medicine list to reduce the copay or coinsurance costs for diabetes care. This saves employees money instead of paying full price before meeting their deductible.

  • Request to get a medication or device covered under your health plan.

If a device or medication you currently use (or want to try) is not covered under your health plan, you can ask for coverage in next year’s health plan. Diabetes devices, such as continuous glucose monitors (CGM) and insulin pumps, can help people with diabetes manage their glucose levels and increase their Time in Range, but are expensive without insurance coverage. Employers can typically negotiate to cover essential diabetes care, so request coverage for your medications and devices. Your diabetes treatment should be determined by your healthcare professional, not by what’s included in your health plan.

  • Share discounts and rebates with employees.

While list prices for diabetes medications may be high, your employer’s pharmacy benefit manager (PBM) can negotiate discounts and rebates on drug prices on behalf of the insurance plan and employer. The list price minus the negotiated discounts is called the net price. Sometimes PBMs and employers will keep the money saved; however, employers can pass discounts on to their employees to lower their out-of-pocket costs.

  • Use copayments for cost sharing instead of unpredictable coinsurance.

Coinsurance costs are unpredictable because they fluctuate as a drug’s net price changes. You can advocate for your employer to choose health plans that use copayments for healthcare cost sharing, instead of coinsurance.

More resources for accessing diabetes healthcare with your employer-sponsored health plan:

Feel free to share this article with your employer or your HR department. All people with diabetes deserve access to affordable, high-quality care. To learn more about health insurance and affording diabetes treatment, visit diaTribe.org/access.

Diabetes Series

Image source: iStock Photo

This article is part of a series on access that was made possible by support from Insulet. The diaTribe Foundation retains strict editorial independence for all content. 

Source: diabetesdaily.com

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

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

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

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

Tackling Carbs with Tech

Many people who live with diabetes avidly avoid eating carbohydrates, as historically speaking, it has been notoriously difficult to cover carbohydrates appropriately with exogenous insulins. But with access to better, faster insulins and the uptick in the use of patient-friendly technology, things are changing, and people’s diets (and their feelings of freedom) have expanded more than ever. Here are the best tech-friendly hacks to tackle the carbohydrate conundrum.

MyNetDiary

This popular app has a searchable database with nearly a million food entries for people to access and look up carbohydrate counts on the go. The company also has a separate Diabetes app that allows users to track blood glucose levels, HbA1c results, and insulin doses, to track their progress over time. If you’re looking to lose weight, MyNetDiary can create a diet plan to meet your needs. You never have to feel restricted when eating meals with family or friends, having all your carbohydrate counting needs right at your fingertips.

Photo credit: GreaterGoods

GreaterGoods Nourish Digital Scale

This food scale is a game changer for those who cook with lots of fresh produce, where carbohydrate counts can vary quite a bit. This scale lets the user view nutrition facts for over 2,000 foods in the scale’s built-in database, and create up to 99 more custom entries. Measure individual ingredients, track full meals, and calculate daily carbohydrate intake much easier with this digital scale.

InPen

This revolutionary device is the only FDA-approved smart pen insulin system that helps prevent users from “stacking” their insulin doses and take the right amount of insulin at the right time. This device works in tandem with a phone app, where users can track insulin on board/active insulin, personalize your doses, sync with continuous glucose monitor (CGM) or glucometer data, and share reports with others. The pen itself is compatible with Humalog, Novolog, and Fiasp, and will even dose in half units. Eating carbohydrates has traditionally been much harder on multiple daily injections, but advancements such as the InPen are making strides to make life much easier for people with diabetes.

Use Alternative Pump Boluses

If you are an insulin pump user, dosing for a high carbohydrate meal can also be difficult, especially if the meal also has a moderate amount of protein and fat (which can delay the absorption of the glucose in the meal). To handle that, try opting for a combination bolus (a.k.a. Combo Bolus or Dual Wave Bolus,  for Animas or Medtronic users, respectively; Omnipod, Tandem t:slim users will use “Extended Bolus”). This is a hybrid delivery mode: a specified portion of the total insulin bolus is delivered upfront, as a normal bolus, while the rest is delivered over a specified period of time as an extended/square wave bolus.

For example, given a 12U dose delivered as a 60/40 combination/square wave bolus over 3 hours: 60% of the total dose (7.2U) will be delivered within seconds of pressing the “deliver” button; the remaining 40% (4.8U) will be delivered equally every few minutes over the next three hours. The result is an initial dose to cover faster-digesting foods, plus an extended amount of insulin action to deal with the slower-digesting foods (which tend to be fattier or have more protein), and to prevent postprandial spikes in blood glucose. Utilizing these settings can be extremely helpful when you’re eating foods like pizza, pasta, Chinese food, Mexican food, or ice cream. Always consult with your diabetes healthcare provider before making any changes to your dosing routine.

Dexcom CLARITY Diabetes Management Software

Photo credit: Dexcom

Dexcom Clarity App

This software can be helpful for patients already using the Dexcom continuous glucose monitoring system, but are wanting to track and change problematic patterns in their blood glucose. This app lets you set target goals for your blood sugars, will track time-in-range, detects patterns of highs and lows and will alert you to them, and will even give the user a predicted HbA1c result. You can also choose to share your data with your health clinic to make changes to your insulin routine or insulin to carbohydrate ratio in real time, and to really find what will work best for you for optimal management.

Living with diabetes is never easy, but thankfully technology has made counting carbohydrates and eating easier than ever before. What apps or tech has helped you to navigate food, eating, and counting carbohydrates? What’s worked best and what hasn’t? Share this post and comment below; we love hearing from our readers!

Source: diabetesdaily.com

Diabetes and Reality TV, with Marcus Lacour from Say I Do

By Alexi Melvin

Netflix’s “Say I Do” is a reality show about surprise dream weddings, but its first episode showcased something we don’t often see in reality TV – type 1 diabetes (T1D). In the episode, Marcus LaCour was given the chance to surprise his wife Tiffany with a magnificent wedding do-over.

Alongside planning and logistics, Marcus also spoke candidly about his life with type 1 diabetes, spurred by a conversation around how wedding catering decisions needed to take into account the food choices he makes to help manage his blood sugar levels. We caught up with Marcus to chat about his experience on the show, how he handled presenting his type 1 diabetes to the world, and where he and his family are now.

Did you ever imagine that you’d be on a TV show on Netflix?

I definitely didn’t expect it. It’s one of those things where you’re like, you know what? If it happens great, if it doesn’t, it’s great too. I don’t think it dawned on me really until we started shooting. Once we started filming, I was like, “Oh, this is it. This is legit.”

When you were talking about your T1D on the show, it came across so well. Is that something you discussed beforehand with the producers? Did you preface anything or was it organic?

It was organic. We literally were just sitting and talking about it. The subject of food came up and early on I told them, “Hey, I’m a type 1 diabetic.” We were just having a conversation of, “Hey, how’s this, how’s that? How did that happen? How were you diagnosed?” Literally, just conversation flowed from there. In my honest opinion, it was one of the most genuine conversations I’ve had with anyone about my condition, just because it was in a room and in the area where there was an open space where I could tell them everything I needed to tell them about the condition.

You touched on how much your wife did for you when you had a situation where you lost your healthcare – the rationing of food and things like that. Did that also include rationing of insulin? Were you having issues with getting supplies?

I was. I was getting samples from my doctor’s office at one point. You know when you’re trying to ration insulin or trying to pick the insulin you can afford, it’s not as effective as what you’re used to. I was getting the regular 70/30 mix insulin pens. I kept bottoming out throughout random times of the day. I was used to taking NovoLog but [at one point, my doctor] didn’t have any NovoLog samples. So I was literally just getting whatever he had.

When [my doctor] did get the NovoLog pens, I was using those thinking, okay, he should have some more samples. Well, there was a time where he didn’t, and that time for about a month maybe, we’ll say three weeks, I was rationing my insulin, because I’m trying to make sure that if I do go high, I have enough to cover the high. If I go low, just [having food] to eat, but more importantly, what you need on a daily basis [to keep your levels stable].

One day, the doc called and said they didn’t have any samples. I was down in my last 10 units. So for about an extra two and a half, almost three weeks, I was rationing 10 units of insulin.

When did that situation start getting better for you?

I ended up getting a loan from my boss because at the time I started a new position and he was like, “I don’t want to see you suffer.” At the time, NovoLog Flex Pens were $250 for the pack. So he gave me a check for $250 and said, “Hey, go get your meds.” So that was how I got through that. Then somehow, by some sort of miracle, after that pack ended, my doctor, all of a sudden, got samples again.

What is your management routine like now?

It’s the Omnipod right now. I’ve got better insurance that covers the pods altogether. It’s still an adjustment for me though, because I’m used to not having a PDM. Before, [when] I was on the injections, it was, wake up, take your long term, and then just carry the Humalog pen on me at all times. Then with the pump, [if] we’re going to work out, I forget to suspend my insulin flow. Or if the site doesn’t take, having to double check and make sure blood sugars aren’t really high. So it’s a couple of different things, but it’s not bad. It’s still an adjustment though.

Do you feel you prefer the MDI or do you feel the pump ultimately is going to be better?

I’m already seeing changes in my numbers, just from average standpoint. On the shots, the lowest my A1C was, or I could get it, with 6.9, 6.8, but now I’m seeing, that even though there are days where I may be high because the pod didn’t take, or I may run low, those days are few and far between, so I’m running normal on a lot more of a regular basis.

Do you use a Continuous Glucose Monitor (CGM)?

I don’t. It looks we have to go four months without a CGM and track those numbers before insurance will approve it.

In terms of your diet, on the show, you talked about how you’re conscious of what foods are going to spike your blood sugar. Is there a specific diet you to stick to? Are there certain foods you prefer or are you getting more flexible with it because of the pump?

I am still a very conscious eater. I prefer to eat clean. Everything has to have a balance. Now I know with the pump, you have that freedom to literally eat whatever you want. But for me, when I was diagnosed, I didn’t have that option. So, it was literally sticking to that diet, sticking to that regimen. Everything has to have a fresh fruit or fresh vegetable, [there] has to be a starch. There has to be a grain and there has to be a protein. That’s the only way that I know.

I came across a comment online that said, “Well, diabetics can eat whatever they want.” It’s very true. But for me, I don’t want to run that risk. I think I’ve always done something whenever I got a new insulin, when I got my Humalog, I wanted to make sure it worked. So I got a peanut butter Twix, took it to cover it, just to see what it would do. When I got my pump, I had a chocolate chip cookie just to make sure it was working. It would work, but overall, my diet is consistent. I prefer to eat clean. It’s just because I know these things aren’t going to have a whole lot of impact on my blood sugar.

I saw on Instagram that your daughter’s been learning more about your T1D management. How’s that going?

It’s going well honestly. Before, when I was taking my shot, it was just, “Hey, Daddy’s got to take his insulin,” or, “Daddy’s got to check his blood sugar.” So she’d always been curious about it. Then one day I had to change my pod. “Are you changing your pod, Daddy?” “Yeah, Daddy’s changing his pod. you want to watch?” “Yeah, I want to watch.” So she came in and got hands on. I always want to make her aware just in case something happens. If my blood sugar goes low and I’m unresponsive, or if I’m too low and I can’t get up to get anything, I want to make sure she’s aware to say, “Oh, Daddy’s not feeling well. Daddy he needs something to eat.” Or, “Something’s going on. Let me tell Mommy.” I always want to make sure she’s aware of what my condition is, not to scare her, but to the point where she can be reactive.

Who did you have as a support system when you were first diagnosed?

My mom was my biggest supporter. I didn’t keep it from my friends, but I felt they wouldn’t be able to understand. They were used to me just being able to get up and do whatever. If we wanted to play football, it was get up and do it without having to worry about anything. They knew I had type 1 diabetes, but they didn’t know the entire scope of what it meant to take care of that condition. So it was my mom. Then over time, my friends started to get a little bit more of an understanding of it. So my friends would ask, “Hey, what’s your blood sugar like? Are you OK?” Or if I was going to the gym to work out with some of my buddies, “Hey, don’t forget your meter.” Or I’d always bring my meter with me and I’d have to check in the middle of work out, see either I’m high or low, or just to figure out where I was at. They would always ask, so they held me accountable in that regard.

Have you been getting a lot of people in the type 1 community reaching out on Instagram or social media?

I’ve gotten that. It’s always refreshing because [they’re] like, “Thank you for representing and letting the world know about your condition.” Well, it’s a part of me. I’d be foolish to hide it, like, “I don’t have a condition.”

Had you been involved in the type 1 community at all before appearing on Say I Do?

Not necessarily. I’ve always wanted to though. I’ve been at this for almost 20 years, it’ll be 20 years in November. When I first got diagnosed, there weren’t a lot of support groups. There weren’t very many places for me to go where I could vent or even if I had high blood sugars or even lows, how to combat that and deal with those. But now times have changed. I would love to be able to get out and talk to people about what our condition is and how to manage it effectively.

What’s next for you and your family?

Honestly, I am not sure. I work for a Children’s Hospital down here, so I recruit for them and it’s just more or less just going with everything at this point, just laying back and enjoying the ride while we have it.

Do you think you’re going to seek out more TV opportunities?

To be honest, I don’t know. This is all new. It’s all new to both of us. If more opportunities come, then yeah. Absolutely. But it really just depends on what comes down the pipes. I think the ultimate goal would be just for us to just enjoy this and see where it takes us.

Source: diabetesdaily.com

Can You Manage Diabetes Well Without Lots of Money?

If you live in a country like the United States, where the majority of health insurance is privatized and there is no strong social safety net, it can feel as though managing a chronic disease like diabetes requires nothing but lots of money. And it does. As of 2017, diabetes cost the United States a staggering $327 billion dollars per year on direct health care costs, and people with diabetes average 2.3x higher health care costs per year than people living without the disease.

Diabetes is also devastatingly expensive personally: the cost of insulin has risen over 1200% in the past few decades, with no change to the chemical formula. In 1996, when Eli Lilly’s Humalog was first released, the price for a vial of insulin was $21. In 2019, that same vial costs around $275. Studies show that 1 in 4 people ration insulin simply due to cost. Diabetes Daily recently conducted a survey study, with almost 2,000 participants, of which an overwhelming 44% reported  struggling to afford their insulin.

So where does this leave patients who don’t have tons of money to spend on insulin and supplies, or who don’t have adequate health insurance coverage for the technology to help prevent complications? Can you manage diabetes well without lots of money? The short answer is yes. The long answer is a bit more complicated.

Best Practices for Managing with Less

If you have insurance coverage, but are unable to afford a continuous glucose monitor (CGM) or insulin pump, it’s advisable to follow best practices for optimal diabetes management. According to the Mayo Clinic, one should test their blood sugar:

  • Upon waking
  • Before meals and snacks
  • Before and after exercise
  • Before bed
  • More often during illness
  • More often when traveling or changing a daily routine
  • More often if on a new medication

One study has even shown that following a lower carbohydrate diet can improve health outcomes, reduce complications, and cut down on medication costs for people living with diabetes.

The study goes on to say that, “…insulin dependent diabetics can expect to half or third their insulin requirements. Less insulin injected results in more predictable blood sugars and less hypoglycemia.” However, no patient should ever feel pressured to follow a low carbohydrate diet solely to control the cost of their medications. There can be more effective ways to manage the cost of medications and supplies.

Photo credit: Adobe Stock

No Matter What You Think, Get Coverage

People with diabetes need health insurance coverage. In the short term, this makes sense, as insulin and things like insulin pumps, continuous glucose monitors, syringes, and test strips are expensive. But it also makes sense long term as well. People with diabetes can face serious complications as they age: diabetes is the leading cause of adult blindness and amputations, and is a leading cause of stroke, kidney failure, heart disease and premature death in its sufferers. Having health insurance helps pay for things like surgery, preventive screenings, doctors’ appointments and follow-up care, and any additional medicine and needs that’s needed.

It may seem cheaper to forego coverage, but don’t. Check to see if you’re eligible for Medicaid in your state. If you are, this comprehensive coverage will help you access affordable medication, doctors’ visits, emergency and preventive care. If Medicaid is not an option, see if you qualify for a tax subsidy on the federal or your state’s health exchange. There, you can find a range of affordable options that will cover your diabetes care and (especially) insulin prescriptions.

Get Help Paying for Insulin

Even if you have health insurance coverage, the cost of your insulin may be prohibitively high. According to the CDC, between 2007 and 2017, the percentage of adults aged 18-64 enrolled in a high deductible health plan rose from 10.6% to 24.5%. These plans have a high dollar amount that consumers must meet before their plan kicks in to help pay for things like prescriptions or hospital stays. Some high deductible health plans have deductibles as high as $10,000. This means that someone with diabetes could potentially pay the full $275 a vial for their insulin, every time they fill their prescription, until they reach their $10,000 deductible. These types of plans are cheaper monthly (have lower premiums), but don’t offer great coverage.

If you need help paying for your insulin, you can get low cost insulin through these assistance programs:

  • Eli Lilly’s $35 Co-Pay Program: Launched in early April in response to the COVID-19 crisis, Eli Lilly is introducing their Lilly Insulin Value Program, which allows anyone with commercial insurance and anyone without insurance to fill their monthly prescriptions of insulin for $35.
  • Novo Nordisk: Novo Nordisk has recently launched a $99 program, where people needing insulin assistance can purchase up to three vials or two packs of FlexPen®/FlexTouch®/Penfill® pens or any combination of insulins from Novo Nordisk Inc. for $99.
  • Sanofi: Launched in 2019, Sanofi’s program allows people living with diabetes in the United States to pay $99 for their Sanofi insulins (with a valid prescription), for up to 10 boxes of pens and/or 10 mL vials per month.
  • Medicare: Medicare recently unveiled a pilot program that would cap the cost of insulin. The Medicare Part D Senior Savings Model would cap insulin co-payments to $35 per month, starting in January 2021. Seniors must sign up for a plan that will qualify under the pilot during the open enrollment period, which is October 15 through December 7.
  • Buy a State-Regulated Health Plan: If you live in Colorado ($100 per prescription per month), Illinois ($100 per 30 day supply), Delaware ($100 per 30 day supply), New York ($100 per 30 day supply), Utah ($30 per 30 day supply), West Virginia ($100 per 30 day supply), Maine ($35 per 30 day supply), New Mexico ($25 per 30 day supply), Virginia ($50 per 30 day supply), Washington ($100 per 30 day supply), or New Hampshire ($30 per 30 day supply) and you buy a state-regulated health plan, you are eligible for a copayment cap on insulin (implementation dates pending, but Colorado was the first bill to be implemented and it went into effect January 1st, 2020).

Check the fine print of any health insurance plans on the federal or your state’s exchange to see if they are eligible for the copayment cap. More states are introducing legislation in 2021, so keep an eye out for a bill proposing some similar changes in your state!

Get Help Paying for Supplies

Several companies have launched affordability programs in response to the COVID-19 pandemic. A few new programs are:

  • Dexcom: Is offering up to two shipments of 90-days of Dexcom G6 Continuous Glucose Monitoring System supplies, with each shipment consisting of one transmitter and three boxes of three sensors for $45 per 90-day supply shipment. For existing customers only, if you qualify.
  • Omnipod: Is offering a six-month supply of products (60 pods) free of charge. The program is focused on current US customers who have lost jobs and health insurance as a result of the pandemic.
  • One Drop: This online subscription package charges the consumer a monthly fee, and you get access to cheaper test strips, online personal health coaching, and a mobile app to track your progress. If your health insurance doesn’t adequately cover test strips, this can be an affordable and effective way to go.
diabetes advocacy

Photo credit: T1International Instagram

Advocate for Change

If you see or are experiencing injustice, you should always try and advocate for change. This means writing letters to your elected officials, calling your members of Congress, petitioning your health insurer, testifying for bills that support better health care coverage, and raising your voice to improve policies that will benefit all people living with diabetes. Get involved in the diabetes online community on Facebook or Twitter. Sign up to become an advocate with T1International. Donate to your favorite diabetes charity who’s working to make things better.

Show up at your state capitol and talk to people about what it’s like to live with diabetes, how expensive it is, and how crucial good coverage and affordable medications really are. You can live a great life with diabetes, but coverage, laws, regulations, and policies can always be better. And things won’t improve until we have everyone at the table, advocating for change.

How are you able to manage well with less to spend? What policies or changes would you like to see in the US healthcare system that would make management easier for you? Share this post and your story, below!

Source: diabetesdaily.com

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