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

Mandy Marquardt: Redefining Diabetes Through Racing

Mandy Marquardt is a Track Cyclist for the USA Cycling National Team and Team Novo Nordisk, the world’s first all-diabetes professional cycling team. Their mission is to inspire, educate and empower everyone affected by diabetes. Mandy has been part of the team since 2010 and believes what the team does really makes a difference to the people in our community – racing and inspiring everyone around the world affected by diabetes is something that brings her great joy.

Thank you so much Mandy for taking the time to answer our questions! We know you are an inspiration to many and would love to share your story!

At what age were you diagnosed with type 1 diabetes?

I was diagnosed with type 1 diabetes at the age of 16 while racing and living in Mannheim, Germany with my father.

What were your symptoms?

I surprisingly didn’t have any symptoms that I was aware of and the diagnosis was a shock. There were signs now that I look back at what I thought were some odd incidents. For example, I would take forever to warm up and felt this overwhelming feeling of exhaustion and tiredness frequently. I thought it could have been from the stress of school and training hard.

Along with my type 1 diagnosis, I shortly after found out I have hypothyroidism too, so having that all discovered and learning to get it under control was such a good feeling.

Being diagnosed as a child is hard, how did you handle your diagnosis? Were you quiet about it or were you vocal and welcomed the opportunity to educate?

When I was first diagnosed, I didn’t know anyone else living with type 1 diabetes. While hospitalized for two weeks, a doctor told me I would never be able to compete at a high level again in the sport of cycling. I was heartbroken, but my parents were my biggest supporters, and helped me get back on the bike. I always knew it was my happy place. I started riding again, and just training for fun and told myself, we’ll see what happens.

Joining Team Novo Nordisk in 2010, racing amongst other athletes with type 1 diabetes and learning how to talk about my diagnosis gave me hope.

At what point in your life did you get active with fitness and more specifically, cycling?

I was born in Mannheim, Germany and moved to South Florida at the age of 6. My parents got me involved with the local swim team and I started playing tennis. I picked up running and was interested in competing in triathlons. In 2002 at the age of 10, my dad came across The Brian Piccolo Velodrome, which was a short drive from our home and was a safe place to learn to ride competitively. A year later, my parents and I drove to Texas to compete in the 2003 U.S. Junior Women’s 10-12 Road National Championships and I won two gold medals in the criterium and time trial and a silver in the road race – I was hooked.

I continued to race both the road and track discipline for years. My success on the track has currently led to 18 U.S. National titles and 3 American National Records (records all with type 1 diabetes).

Photo credit: Team Novo Nordisk

At what point did you decide to do it professionally?

After I graduated from the Pennsylvania State University – Penn State Lehigh Valley commonwealth campus in the Spring of 2014, I was invited to a USA Cycling camp that fall.

Afterwards I was invited to go represent the United States at my first UCI Track World Cup in Guadalajara, Mexico. I was so terrified to compete at that level, but now, six years later, I’m right up there with the world’s best, ranked 12th in UCI World Sprint ranking and one step closer to hopefully competing at my first Olympic Games. It’s been a slow and steady process, but if diabetes has taught me anything, it is consistency, patience and resilience.

In June of 2020, I was honored that USA Cycling named me as a member of the Long Team for Women’s Track Cycling. The final selection will be made next year, since the Tokyo Games have been rescheduled for July 23-August 8, 2021.

Did type 1 diabetes ever come in the way of your training or races?

Oh absolutely. It can be a challenge at times and the race doesn’t pause for me. Training and racing at this level, I’ve conditioned and adapted my body to handle the stress and workload, but occasionally the body will do what it wants. Of course, sometimes, it’s still frustrating when my blood sugars aren’t cooperating, like [when]  training and competing at altitude, going through different periods of my training cycle, juggling time zones and everything life throws at me.

I work closely with a sports psychologist and my team’s diabetes educator. Through a lot of trial and error, I’ve found what routine and nutritional habits work best for me and I’m still always learning and improving.

What do you use to help you manage your diabetes? Do you use a pump or do you prefer injections? Do you use a continuous glucose monitor (CGM) to help you monitor your blood sugar levels?

I use a continuous glucose monitor and take injections. It’s helpful to have real-time data around training, racing and traveling to better my diabetes management and performance – getting the most out of my training and recovery. Plus, I want to live a long healthy life, without complications!

Photo credit: Team Novo Nordisk

Photo credit: Team Novo Nordisk

What do you recommend to other athletes when it comes to managing your blood sugars during this type of activity?

Whether competing at a high level or just going out to exercise, always be prepared. I love my snacks! My favorites are the Honey Stinger waffles, performance chews, and protein snack bars! It’s important to be mindful about nutrition and fueling, and incorporating more protein, and eating consistently through the day. Most importantly, be patient and seek resources. My team, Team Novo Nordisk has many great resources and tips on their website too!

I know you are very active within the community, what are some of the things you’ve been up to lately?

I love my cycling career, but I think it’s important to have a balance between my personal and professional life. I recently partnered with Mammoth Creameries, a yummy keto-friendly ice cream founded by Tim Krauss, who is living with type 1 diabetes – it’s a pretty sweet partnership!

I also recently launched my logo and merchandise. The diabetes community has always been inspiring and supportive. I feel that my logo really puts my journey and the connection with the diabetes community in perspective. The blue circle is the global symbol for diabetes – that we are all connected in a special way and my initials subtly share a story that we are all greater than our highs and lows. For my merchandise highlighted with my logo, I wanted to create a wide range of awesome and high quality clothing and products that people can feel inspired and connected with.

Where do you see yourself both personally and professionally in 5-10 years?

Well, currently training hard in hopes of being selected for my first Olympic Team! I’d like to aim for the 2024 Olympic Games in Paris. So, in 5-10 years, I’d love to hopefully be a 2-time Olympian. Personally, I’d like to continue my education and earn my Masters Degree. I have an undergraduate degree in Business Management and Marketing from The Pennsylvania State University – Penn State Lehigh Valley (’14) commonwealth campus. I want to continue to prove to myself what I’m capable of as an athlete and what is possible with diabetes.

What would you say to the children out there, living with type 1 diabetes, who aspire to do great things when it comes to sports and fitness?

Go for it! Never limit yourself and your own capabilities. Use your platform to create awareness and inspire and connect with others affected by diabetes. The Founder and CEO of Team Novo Nordisk, who is also living and racing with diabetes says, “Diabetes only chooses the champions.”

Mandy, thank you for taking the time to answer our questions! We will continue to follow your journey and can’t wait to see more great things from you! We wish you all the best!

Source: diabetesdaily.com

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

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

What Is It?

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

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

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

What Does It Do?

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

1. Insulin delivery information

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

InPen Screenshot 1

Screenshot from Companion Medical

2. Built-in calculator

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

InPen Screenshot 2

Screenshot from Companion Medical

3. Reminders

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

InPen Screenshot 3

Photo credit: Companion Medical

4. Reports

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

Screenshot from Companion Medical

5. Temperature alerts

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

6. Syncing to Dexcom

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

Screenshot from Companion Medical

How Can I Get the InPen?

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

Conclusion

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

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

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

Source: diabetesdaily.com

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

FDA Approves Lyumjev – A New Rapid-Acting Mealtime Insulin

This content originally appeared on diaTribe. Republished with permission.

By Frida Velcani

Lyumjev reduces blood glucose spikes and can be taken at the beginning of a meal, or even 20 minutes into the meal; available through Lilly’s insulin affordability program

A new rapid-acting mealtime insulin has been approved by the FDA to reduce high blood sugar after meals and keep blood glucose levels in-range. The insulin is rapid-acting, meaning that it is absorbed into the bloodstream and the body more quickly. This approval provides another important mealtime insulin option for adults with type 1 or type 2 diabetes. Lilly’s Lyumjev was approved in Japan and Europe in March 2020, and the company is working to make Lyumjev available to people in the United States as quickly as possible.

Lyumjev will be offered at the same price as Humalog. Lilly will also offer Lyumjev through its newly launched Insulin Value Program, which makes the therapy available at $35 per month for people who are uninsured or have commercial insurance. The $35 cap applies regardless of the number of insulin doses required.

This approval was granted based on the results from the 2019 phase 3 PRONTO-T1D and PRONTO-T2D trials. The data showed that, compared to Humalog, Lyumjev reduced blood glucose spikes (hyperglycemia) one hour and two hours after a meal in people with type 1 and type 2 diabetes. The drug did not affect A1C reduction. In people with type 1 diabetes, Lyumjev reduced hypoglycemia four hours after meals, whereas in people with type 2 diabetes, the insulin slightly increased hypoglycemia both one to two hours and two to four hours after a meal.

Lyumjev can be taken at the beginning of a meal or 20 minutes after starting it. This flexibility is due to the faster onset and offset of the insulin. That said, it is still strongly recommended that whenever possible, people should take Lyumjev before the start of the meal.  Lyumjev by Lilly joins Fiasp by Novo Nordisk as the two faster acting insulins available giving people with diabetes more flexibility in mealtime insulin dosing.

Source: diabetesdaily.com

$35 Insulin on Medicare Pilot: Is This the Beginning of Affordable Insulin for All?

On Tuesday, President Trump held a press conference announcing a new pilot program for seniors on Medicare that would cap the monthly co-payments of insulin to $35. The announcement was attended by senior executives of two main insulin manufacturers, Eli Lilly and Novo Nordisk, and staff from the American Diabetes Association, as well as the Surgeon General, Jerome Adams.

In typical Trump style, midway through his announcement, he proclaimed, “I don’t use insulin. Should I be? Huh? I never thought about it, but I know a lot of people are very badly affected.” While this comment has created a wave of groans and eye-rolls throughout the diabetes online community, the core of his message is more important: seniors in America will now be more able to comfortably afford their insulin.

For everyone on earth, insulin is a necessary hormone to live. People without diabetes produce insulin endogenously, whereas people with diabetes must take insulin exogenously. Without adequate access to affordable insulin, people with diabetes face serious complications, such as kidney failure, blindness, amputations, and premature death. Unfortunately, the rising costs of insulin over the past few decades have become a major barrier to appropriate management of diabetes. American seniors are some of the hardest hit by the rising costs, who are partially-retired or out of the workforce completely, often trying to survive on smaller, fixed-incomes.

Trump remarked, “Today I’m proud to announce that we have reached a breakthrough agreement to dramatically slash the out-of-pocket cost of insulin. You know what’s happened to insulin over the years, right? Through the roof.”

The pilot program will take effect starting in 2021, and would be part of the enhanced Medicare Part D Senior Savings Model, to which over 1,750 standalone Medicare Part D and Medicare Advantage plans have applied to participate in, according to the Centers for Medicare and Medicaid Services (CMS).

s$35 Insulin on Medicare Pilot

Photo credit: Adobe Stock

This is a welcome respite from the high cost of insulin for American seniors on Medicare, who, despite being covered by health insurance, sometimes have to pay hundreds if not thousands of dollars for their monthly insulin prescriptions.

Despite the multitude of executive orders and policy decisions the Administration has made to chip away the Affordable Care Act, this enhancement of American’s largest healthcare social safety net was met with applause from seniors all across America, many of whom have cooled their support of the President since the beginning of the COVID-19 pandemic and our nation’s response to it. This is an excellent first step to ensuring that our aging Americans can afford the insulin they need to take care of themselves.

It is estimated that Medicare beneficiaries (generally Americans over the age of 65) who use insulin and join a plan participating in this pilot could see average savings of $446, or 66% for their insulin every year. The pilot is funded in part by insulin manufacturers who will pay $250 million in discounts over the five years of the pilot. There has been a positive response from Medicare Part D plans nationwide, and CMS predicts coverage in the pilot will be available in all 50 states, D.C., and Puerto Rico. Medicare beneficiaries will be able to enroll in a pilot-participating plan during traditional Medicare open enrollment, which is October 15th-December 7th, 2020, for Part D coverage that begins on January 1, 2021.

1 in 3 Medicare beneficiaries has diabetes, and over 3.3 million Medicare beneficiaries use one or more types of insulin, so this change isn’t insignificant. Out-of-pocket spending on insulin by seniors in Medicare Part D quadrupled between 2007 and 2016, from $236 million to $968 million, putting a harsh burden on millions.

Seema Verma, administrator of the Centers for Medicare and Medicaid Services said, “We think that this creates a foundation and a platform to fix some of the problems that we have in the Part D plan (of Medicare). It’s time for that program to be updated.”

While this is a great first step, the pilot is only slated to last for five years, and it will only apply to the Medicare population- generally, people living with diabetes who are 65 and older. This begs the bigger question: how do we afford our insulin before we are eligible for Medicare? How can we ever hope to make it to that point, if insulin is unaffordable every step of the way? Men with type 1 diabetes have an average life expectancy of 66 years, compared with 77 years among men without it. Women with type 1 diabetes have an average life expectancy of 68 years, compared with 81 years for those without diabetes. Realistically, this may not even help people who have diabetes for very long.

We can only hope that this initiative creates enough momentum for the federal government to start capping the actual price of insulin, for the other 7 million Americans who rely on it every day to survive.

Source: diabetesdaily.com

What to Do If You Need Insulin Right Now

This content originally appeared on Beyond Type 1. Republished with permission.

By Lala Jackson

What to Do If You Have No Insulin at All

Go to the emergency room. Under US law (The Emergency Medical Treatment and Active Labor Act), the emergency room cannot turn you down in a life-threatening emergency if you do not have insurance or the ability to pay.

If Emergency Room staff is telling you they cannot treat you, stay put. Be clear that you are in a life-threatening emergency because you have type 1 diabetes (T1D) but do not have insulin. Do not leave. Please note that urgent care centers are not required to abide by the same laws.

Once you are stabilized and before you leave the hospital, hospital staff is required to meet with you to make sure you understand that you are leaving the hospital of your own accord. At this time, let the hospital staff person know about any financial situation you are in. Some hospitals are aligned with charities that can help you pay. Other hospitals offer payment plans based on your situation. No matter your financial situation, know that your life is the most important thing.

What to Do If You Have Some Insulin, But Are About to Run Out

Utilize Kevin’s Law

If you have an existing prescription at your pharmacy, but have not been able to get ahold of your healthcare provider to renew the prescription, you may be able to take advantage of Kevin’s Law. Kevin’s Law was named for a man with T1D who passed away after not being able to access his insulin prescription over the New Year’s holiday. Under the law, pharmacists are able to provide an emergency refill of insulin in certain states, without the authorization of a physician to renew the prescription. Rules around the law vary from state to state and not all states have the law in place. Kevin’s Law only applies to those who have an existing prescription and, depending on where you live, your insurance may or may not cover the refill. Learn more about Kevin’s Law, including whether or not your state has it, here. Please note, your pharmacist may not know the law by name, or know that the law exists. If you are in a state with Kevin’s Law and working with a pharmacist who is unaware, stay put and ask to speak to someone else in the pharmacy.

Ask Your Physician for Samples

While this is not a long-term access option, your care provider may be able to provide you with a few vials/pens for free, and bringing your HCP into the access conversation means that they can help direct you to other options that might be available to you, like local community health centers with insulin available.

Utilize Patient Assistance Programs – Standard out of Pocket Cost $0

  • If you take Lilly insulin (Humalog, Basaglar) call the Lilly Diabetes Solutions Call Center Helpline at 1-833-808-1234
    for personalized assistance. You may be eligible for free insulin through LillyCares.
  • If you take Novo Nordisk insulin (Fiasp, NovoLog, NovoRapid, Levemir, Tresiba) and demonstrate immediate need or risk of rationing, you can receive a free, one-time, immediate supply of up to three vials or two packs of pens by calling 844-NOVO4ME (844-668-6463) or by visiting NovoCare.com
  • If you take Sanofi insulin (Admelog, Lantus, Toujeo): the Patient Connection Program provides Sanofi insulins to those who qualify, which is limited to those with no private insurance and who do not qualify for federal insurance programs and who are at or below 250% of the federal poverty level – with a few exceptions.

Utilize CoPay Cards – Standard out of Pocket Cost $35 – $99 per Month

Copay cards that reduce the out-of-pocket cost you pay at the pharmacy exist for most types of insulin. Some copay cards can be emailed to you within 24 hours. Currently, copay programs exist for:

  • Lilly, capping copays at $35 per month for those with no insurance or with commercial insurance
  • Novo Nordisk, capping copays at $99 for those with no insurance or with commercial insurance
  • Sanofi, capping copays at $99 for those without prescription medication insurance
  • Mannkind, capping copays at $15 for some of those with commercial insurance

Unfortunately, copay cards are typically not available for those insured through Medicaid or Medicare. Use the tool from the Partnership for Prescription Assistance to search in one place for discount programs and copay cards you qualify for here. Please be aware that you will need to search by brand name (i.e. Humalog, Novolog), not just “insulin.”

Get R & NPH Human Insulins – Standard out of Pocket Cost $25-$40 per Vial

R (Regular) and N (NPH) human insulins are available over-the-counter in 49 states and cost much less ($25-$40 per vial at Walmart) than analog insulins such Novolog, Humalog, Lantus, or Basaglar. They also work differently than analog insulins – they start working and peak at different times – but in an emergency situation can be a resource. Speak with the pharmacist or your healthcare provider if possible before changing your regimen and keep a very close eye on your blood sugar levels while using R & N insulin.

Research Available Biosimilar (Generic) Insulins

The biosimilar insulin market is changing rapidly as the FDA adopts new regulatory pathways to more efficiently approve interchangeable insulins that may be available for a lower price. Ask your healthcare provider for the most up-to-date options for you. A few options available are:

  • A generic version of Humalog — Insulin Lispro — is available at pharmacies in the U.S. for $137.35 per vial and $265.20 for a package of five KwikPens (50% the price of Humalog.) If you have a prescription for Humalog, you do not need an additional prescription for Lispro; your pharmacist will be able to substitute the cheaper option. Insulin Lispro is not currently covered by insurance.
  • Authorized generic versions of NovoLog and NovoLog Mix at 50% list price are stocked at the wholesaler level. People can order them at the pharmacy and they’ll be available for pick up in 1-3 business days

If you have enough insulin to last you a few days, but need to figure out where to get a more reliable, consistent supply, visit our Get Insulin page to find further resources.

Source: diabetesdaily.com

Charlie Kimball and His Driving Force to Success

The COVID-19 outbreak presents unique challenges for those of us living with diabetes.  Charlie Kimball, a professional IndyCar driver and father of two and lives with type 1 diabetes. His sport (and job!) is now on hold, and he is home trying to manage his diabetes, eat healthily and stay fit, all the while adjusting to life as a family of four. Charlie and his wife just had a baby in March, amidst the COVID-19 pandemic. I thought it would be nice to talk to Charlie about how he is managing despite what is going on in the world.

Charlie, congrats on your new baby! And thank you for taking the time to talk to me!

How long have you been living with type 1 diabetes?

It’s hard to believe that I’ve been living with type 1 diabetes for 17 years. At age 22, my diagnosis felt devastating and I stopped racing mid-season, unsure of how I could possibly continue to pursue a career as a professional racecar driver.

Each year on October 16, when I celebrate my “diaversary” (that is, the anniversary of my diabetes diagnosis), I reflect on the support I’ve received from the diabetes community. They, along with my wife, my healthcare team and my IndyCar family, all play a role in how I navigate and manage my diabetes.

Did your diagnosis play into your choice of becoming a professional race car driver?

Although I was actively pursuing a career as a professional racecar driver before my diagnosis, I believe racing with diabetes empowers me to be an even better driver. Physically, I have become even more in tune with my body and more connected with my team since my diagnosis. I’ve also found it really rewarding to represent people living with diabetes as part of the Novo Nordisk Race with Insulin program to reinforce the idea that diabetes doesn’t have to stop you from following your dreams.

Charlie Kimball, A.J. Foyt Enterprises Chevrolet

What challenges did you face in this profession due to your type 1 diabetes?

At the time of my diagnosis, it was mid-season while I was racing in Europe and I took some time off to figure out blood sugar testing, insulin management, and how to get back on the track. Thanks to my amazing support system, I was back in a race car three months later and claimed a podium finish in my first race back.

When I decided to move back to the US and race in IndyLights (the feeder system to IndyCar), my endocrinologist, Dr. Anne Peters, met and worked with the IndyCar medical staff to create a plan to get me back behind the wheel.

With the recent news of the first person living with diabetes to be certified by the FAA for a First Class Medical, how great does it feel to know you are the first licensed driver in the history of IndyCar racing?

I first raced in go karts at nine years old and I come from a motorsports family. When I was first diagnosed, a friend helped me to put everything into perspective by pointing out that, while I’d need to manage my diabetes for the rest of my life, it was important – and possible – to get back behind the wheel. I’m really proud of my role as the first licensed driver with diabetes in the history of IndyCar racing, and I’ve never shied away from talking about living with type 1 diabetes. Now, I’m glad to see other drivers out there who are also living with diabetes on the track!

I know from my travels that there are incredible people with diabetes doing inspiring things all over the world. It never ceases to amaze me when I see people with diabetes following their dreams -– whether they are making history in their profession or they are simply accomplishing goals that they may not have considered possible, like running a half marathon

Photo credit: Charlie Kimball

When you heard the virus was picking up speed, what were your first thoughts? Fears? How did you prepare for staying at home?

We recently welcomed my son in March, so we were impacted by some of the same considerations new parents are facing during this time. But, when I held my baby boy for the first time, it was hard to think about anything else other than the love I had for my new family of four.

There have been a lot of changes over the last few weeks and while I’d love to be racing right now, this has been a good time to connect with my family, and an opportunity to plan for future races with both my healthcare and race teams.

Even though I am home, I am still committed to staying active, eating healthy and paying close attention to my blood sugar. Also, right now, a crucial part of my management plan, is making sure that I have enough medication at home and keeping track of when I need to reorder. Having a supply of insulin on hand is not a luxury. It’s a necessity, especially at this time. My partners at Novo Nordisk are working very hard to ensure patients still have access to their medicine. If anyone is having problems affording their medicine during this time, please visit NovoCare.com for information on how Novo Nordisk can help

I’m sure racing comes with a lot of stress and adrenaline. How do you recommend people handle unpredictable blood sugars due to the stress during this time?

Yes, you’re right, racing does come with a lot of stress and adrenaline. I manage that through careful planning every race weekend to ensure that my blood sugar remains in range. But everyone has their own stress and we all handle it differently. The everyday realities of work, family, and life inevitably create that, and I encourage everyone to just have a plan in place for all different situations.

As for our current situation, I’ve found that I’m handling it like everyone else, by washing my hands often and practicing social distancing. It’s been important for me to stay in constant contact with my healthcare team, so they can help me to adjust my diabetes management routine appropriately.

I keep a close eye on my continuous glucose monitoring (CGM) and that allows me to make small adjustments throughout the day if needed. I also take time to exercise, laugh with my wife and children, and connect with people who matter to me – albeit virtually these days. This all helps reduce that stress.

Charlie Kimball, A.J. Foyt Enterprises Chevrolet

How do you plan ahead for a race so that your blood sugars won’t get in the way?

I work very closely with my healthcare team on my plan for each race. We track everything from my workouts that week to my meal before I get on the track. Using this data to make a plan comes naturally to me – it’s the same way I approach driving a race car. On the track, my race engineers, strategists, and I utilize around 50-70 sensors that feed into the central brain of my car. They are calibrated so that I can monitor every detail during a race – think g-force, speed, throttle, RPM, tire pressure – and, importantly, my blood sugar levels. My blood sugar levels from my CGM are tracked and displayed on a custom screen that sits on my steering wheel and is relayed back to my team in the pit lane so that we can make adjustments as needed.

With IndyCar racing on hold, what are you doing to stay active and healthy? Both mind and body?

I’ve partnered with my team to develop a modified workout routine while I’m at home. While I’m not racing, it’s still so important for me to stay in shape so I can do my best when I’m back on the track. Beyond staying active, I’m focused on eating nutrient-rich foods, tracking my blood sugar levels, and taking my medication.

Technology has always been an important part of my diabetes management. With it, I’m able to monitor calories, carbs, hydration, and of course, my blood sugar. Lately, while I’m at home, using my CGM has been a helpful way to watch my blood sugar in real time throughout the day. For me, keeping a close eye on my numbers and taking a mindful, disciplined approach to my diabetes management has been the key to my success during this time.

I am also using this time to connect with my family as we adjust to life as a family of four. I’m especially grateful for my wife and mid-morning naps for keeping the Kimball household happy and healthy during this time!

Thank you so much for taking the time to talk to me, Charlie. Congrats on your success as an IndyCar driver and as well as on becoming a family of four!

Source: diabetesdaily.com

Rybelsus, the First GLP-1 Pill, Approved for Type 2 Diabetes in Europe

This content originally appeared on diaTribe. Republished with permission.

By Frida Velcani

Rybelsus, a GLP-1 agonist pill already approved in the US, received positive feedback from the European Medicines Agency (EMA) in January and was just approved on Saturday!

In exciting news for the type 2 diabetes community, the first GLP-1 agonist pill for type 2 diabetes has not only been recommended for approval in Europe, it has just been approved by the European Medicines Agency (EMA)! Rybelsus (formerly known as oral semaglutide in clinical trials) is a pill version of Ozempic, a GLP-1 agonist injection for type 2 diabetes. Rybelsus was approved in the US in September 2019, and was met with incredible enthusiasm from the diabetes community, particularly due to its availability and accessibility in the US. For a Rybelsus savings card, text READY to 21848, or go to saveonr.com.

Rybelsus, a once-daily pill, can be taken alone or in combination with other treatments for type 2 diabetes. Currently, GLP-1 agonists in Europe are available only as injections (which, depending on the medication, are taken twice-daily, once-daily, or once-weekly). This approval provides more options for people interested in starting GLP-1 treatment. The EMA approval was great news for giving people more options – the once-weekly injections have also been widely embraced.

The EMA added data to the Rybelsus label confirming that it lowers blood glucose and improves heart health – although it doesn’t say “primary prevention,” the label indicates that heart attacks are prevented in people with and without established heart disease. Clinical trials show that both Rybelsus and Ozempic reduce the risk of heart attack, stroke, and heart-related death. This is important because people with type 2 diabetes are at substantially higher risk of heart disease than those without diabetes. Click here to learn more about the benefits of Rybelsus.

Novo Nordisk has not released information about pricing for Rybelsus in Europe. Our hope is that everyone who can benefit from a GLP-1 agonist will be able to access it as early as possible.

There are more social safety nets in the EU than in the US, and many parts of the EU are more focused on prevention and preparedness than the US, so we have high hopes for accessibility in the EU. The European Society of Cardiology recommends that those with type 2 diabetes begin taking GLP-1 or SGLT-2 medications directly after diagnosis. This is good news for people with type 2 diabetes, as the recommendation should enable greater awareness among healthcare professionals. It will also help the field get less caught up in what has previously been called “clinical inertia.”

If you have type 2 and would like to learn more about a pill that has the benefits of GLP-1 – heart disease prevention, weight loss, lower A1C, and less hypoglycemia (and many experts associate also associate improved time in range with GLP-1) – chat with your doctor or a member of your healthcare team. If you like the idea of a pill, mention Rybelsus, or if you like the idea of a once-weekly injection, mention BydureonOzempic, or Trulicity.

Source: diabetesdaily.com

How to Make an Emergency Preparedness Plan

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

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

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

Shelf-stable foods:

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

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

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

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

Contacts to Have on Hand

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

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

Have a Plan B If You Need to Evacuate

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

Important things to pack in a to-go bag:

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

What Do I Do in the Case of…?

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

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

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

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

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

Source: diabetesdaily.com

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