Big Changes! Centers for Medicare & Medicaid Services (CMS) Loosen Requirements for Obtaining a Continuous Glucose Monitor (CGM) During COVID-19

This content originally appeared on diaTribe. Republished with permission.

By Karena Yan and Kelly Close

In-person visits, lab tests, and finger stick documentation are no longer required at present to get a CGM

Editor’s note: This article was updated on May 21, 2020 to reflect that lab testing is still required for an insulin pump and pump supplies.

High blood sugar levels leave the body vulnerable to infections, meaning those individuals with poorly controlled diabetes are at greater risk of contracting COVID-19. To properly monitor and respond to glucose levels and to strengthen the immune system to fight off infections, a continuous glucose monitor (CGM) can be very helpful.

If you are on Medicare, obtaining a CGM through your healthcare professional is a relatively involved process, requiring an in-person clinic visit, lab tests, documentation of frequent finger sticks (four or more times a day), and a lot of paperwork. At present, only those on insulin have an opportunity for approval. However, due to COVID-19 and the increased risks it poses for people with diabetes, the Centers for Medicare & Medicaid Services (CMS) announced that it will not enforce the following criteria for receiving a CGM:

  • In-person clinic visits
  • “Clinical criteria,” including lab tests for C-peptide or auto-antibodies, or demonstration of frequent finger sticks

This means that people with diabetes do not have to go to the doctor’s office or undergo lab tests to receive a CGM. Importantly, these loosened restrictions also reduce the amount of paperwork and bureaucracy for healthcare providers and give them greater flexibility in providing CGMs. Lab testing is still required for insulin pumps and pump supplies.

This increased access to CGMs is a huge win for the many people with diabetes on insulin who would not otherwise be able to get a CGM. Because CGMs provide real-time data for blood sugar levels, users are able to monitor their glucose and proactively adjust their insulin doses. Not only do CGMs help increase time in range, and thus have the opportunity to increase productivity and quality of life, but they can also improve overall diabetes management and can help keep patients out of the hospital.

We hope that in the future, at least those on SFUs will be able to get CGM, as SFUs can prompt hypoglycemia, which is especially dangerous right now, given the importance of staying out of the hospital.

Every person with diabetes can benefit from either a professional CGM used regularly (at least yearly) or a 24/7 CGM. While these new CMS guidelines are temporary in response to COVID-19, we are hoping and advocating for making the changes permanent. With the rise of the Beyond A1C movement and increased awareness of time in range, CGM (24/7 or professional) is an essential tool for people with diabetes to live happy and healthy lives, both during and after COVID-19.

This article is part of a series on time in range maybe possible by support from the Time in Range Coalition. The diaTribe Foundation retains strict editorial independence for all content.

Source: diabetesdaily.com

A Diabetes Educator Walks Us Through a TeleHealth Endo Appointment

With our country slowly heading back to our “new normal,” we will likely have to go back to our regularly scheduled lives, which includes being diligent about keeping up with all our routine doctor visits. It is even more important when living with diabetes to have annual eye appointments, physicals, dental appointments, and of course, our endo and diabetes educator appointments.

Since many are apprehensive about this new set up and wondering how exactly it will work, I thought it would be great to talk to Dawn, a nurse practitioner and certified diabetes educator who works in an endocrinologist office and have her walk us through the process and what we can expect.

Thank you, Dawn, for taking the time to talk to me today! How long have you been living with type 1 diabetes? 

24 years at the end of this month. 

Did living with diabetes play into your decision to become a CDE?

I had a great CDE in 1995 in a rural town which was unheard of. Then in college, I had a great nurse practitioner (NP) that I still look up to as a mentor for my practice. She talked to me like a person. She talked to me without pressure, shame, guilt, accusations and disappointment. She helped me come to terms with my diabetes and I will forever be in debt to her. I want to pass on that experience to other people living with diabetes.

How has your endocrinologist office responded to COVID-19? Have you closed down? How did you prepare for seeing your patients virtually?

We stopped seeing patients in the office at the end of March. We do still need labs so our lab is open but that significantly reduces foot traffic. We are only ordering labs that are necessary and will dictate current decisions. If they are not needed right now, then they can wait. We have two practice locations and staff are staying at one location. This way, if one office is quarantined we still have the other office to ensure patients have medical support.

We transitioned to virtual visits using the telehealth visit option within our EMR (electronic medical record) and we are using doxy.me as well. We are calling patients ahead of time to let them know about the change in the appointment and encouraging them to try to log in and make sure it works prior to their appointment. This would give you the chance to troubleshoot technical issues prior to your appointment.  We have had a few patients who still needed to be seen in person but almost all of our visits can be completed via telehealth.

I know many patients are curious about how an appointment like this will work. Is there anything the patient needs to do prior to the appointment? I know my son has an upcoming telehealth appointment and we had to download a certain app.

I would recommend as listed above making sure your means of communication works. Do a trial run at the location you plan to be at. If you will be at work during the call, make sure it works at work. If you are at home, then make sure it works at home. Will you use a computer or a smartphone? Do you know how to troubleshoot the speakers, video and microphone? Do you have a pump, continuous glucose monitor, or meter to download ahead of time? If you do, then get these downloaded at home prior to your appointment. Do a practice run a week ahead of time so if you need to call for help you have time to do so.

Having blood sugar readings and pump downloads ahead of time has streamlined my practice. I can view them prior to the appointment and focus on key items to make the appointment more productive. We are encouraging all patients to download at home, but we have made the exception for a few (elderly) to come and download at the office.

Can you walk us through what to expect during the appointment?

My wonderful medical assistants (Ariel, Tonya, and Whitney) have been calling patients to go over medications, any new changes to medical history just before the appointment and checking to make sure the telehealth app or doxy.me is working. Hopefully, I have already reviewed blood glucose logs and pump downloads ahead of time. If not, I will encourage the patient to get that for me.

What are some of the drawbacks of a telehealth appointment? I know my endocrinologist usually examines my thyroid, heart, etc. How will the doctor be able to check vitals as well as other routine measures? 

Yes, not being able to physically assess a patient sometimes is tough. However, if I am concerned enough that we need an in-person assessment ASAP, then they likely should have an urgent appointment with their primary care provider. If someone is complaining of an enlarged thyroid, with a keen eye, we can visualize that in most people via video. However, nothing replaces a hands-on assessment. We will see a patient in the office urgently if needed.

Do you find that overall providers have more or less time to spend with their patients this way?

When we have data (CGM/BG/Pump/labs) there is more time for providers to spend having meaningful conversations with patients. This streamlines appointments.

As a medical professional, how are you finding the telehealth appointments? What do you find most challenging?

  • When I have the data prior to an appointment, I love telehealth. I also love that I can go over reports with the patient and educate them on what I am seeing.
  • The most challenging part is obtaining data prior to the appointment. My medical assistant makes 2-3 calls prior to an appointment trying to prepare each patient. If I don’t have data, then essentially we are making an educated guess about what medications need to change.
  • For example, a patient can complain of afternoon hypoglycemia. However, it could be a reduction in basal insulin needs, overcorrection of pre-lunch blood glucose, or a too aggressive carb ratio. If we do not have data (CGM/BG/Pump) information, there is no way to tell for sure. So we ask questions around and around to try to figure out the most likely scenario but if we are wrong, you may have less hypoglycemia but BG will run higher. I know I do not want my provider to essentially guess at what needs to change.
  • Another example is a high A1c and the provider increasing the long-lasting insulin (basal) or basal rates unnecessarily causing low blood sugar in the middle of the night. I see this often when providers are grasping at straws trying to improve blood sugar control. When the real reason may be significant after-meal blood sugar spikes.

For someone who is unfamiliar with Zoom and other related apps, it may present a novel challenge. Have you found patients are having trouble with the new set up? Do you provide explicit directions on how to get set up for the appointment?

Most patients who have reliable internet access and have a smartphone or computer with a camera the platforms we use work beautifully. Doxy.me just requires the patient to click on the link we provide in an email. Click and then wait for me to start the appointment.

What do you think the patients will find the most pleasant about the virtual appointment? And what about the worst aspect?

The best part is that you can sign on from anywhere with cellular service or Wi-Fi. So your time away from work or other commitments is minimal. The worst part is that you are still at work or home and there are often other distractions. For example, if children or a dog are disrupting the appointment, this can be distracting and cause the appointment to take longer. It is also not a good idea to have an appointment while driving.

What can you tell us about privacy compliance? How can patients be sure their information is safe?

When using the Healow app or Doxy.me, the voice and video access is encrypted, keeping the visit private. The actual video does not access the patient chart in any way.

Looking forward, what do you think our medical system will look like after COVID-19? What about in 10 years?

I have no idea. I have learned to never assume anything in medicine because just when we think something will happen, the opposite occurs. I am hoping this opens doors allowing more rural telemedicine. This will provide medical care, especially those with chronic diseases, living in rural areas that travel 1, 2, or sometimes 3 hours for appointments. Historically, telehealth is not covered by insurance and the cost falls onto the patient. This hopefully will allow for proper insurance billing of these appointments to be more cost-effective and convenient.

Thank you so much, Dawn, for taking the time to walk us through what a telehealth appointment will look like. I have had two so far and they both went successfully! Best of luck and thank you for what you do!

Source: diabetesdaily.com

Working with Your Healthcare Team to Achieve Your Time in Range Goals: An Interview with Cleveland Clinic’s Dr. Diana Isaacs

This content originally appeared on diaTribe. Republished with permission.

By Frida Velcani

Dr. Diana Isaacs on improving time in range, making the most of your data, and the barriers facing people with diabetes and their healthcare teams

Dr. Diana Isaacs is a Clinical Pharmacist and Diabetes Care and Education Specialist at the Cleveland Clinic. She works with people with diabetes on a range of issues, including medications, technology, and lifestyle changes. She also educates people every day about the benefits of time in range.

In addition, Dr. Isaacs is the coordinator for the Cleveland Clinic’s continuous glucose monitor (CGM) program. You can find more information on how to choose a CGM here. We continue to think that CGM is of the utmost importance for helping people keep their blood glucose levels in-range, assuming they have access. Dr. Isaacs meets with 200 people every month, through individual appointments, classes, phone follow-ups, and virtual visits. She also works with other healthcare providers, including nurses, nurse practitioners, dietitians, and physicians.

For this article, we spoke with her to better understand her views on the importance of time in range for people with diabetes. Here are her insights on how we can shift away from using A1C and move everyone toward better health.

Dr. Isaacs on Ways to Improve Time in Range, Setting Target Goals, and Celebrating the “Wins” 

We asked Dr. Isaacs to pinpoint the most important things that people can do to improve their time in range. “Work with your diabetes care and education specialist and healthcare team to interpret CGM data, understand patterns, and optimize medication doses,” she said. When reviewing data, it’s important to keep a positive attitude and focus on the successes. Repeat what worked well on the days when your time in range was the highest. Figure out what is causing the lows (which often lead to rebound highs) and work to prevent them.

Dr. Isaacs wants people to know that having high glucose variability is completely normal. Many people have the misconception that they should be spending 100% time in range. In reality, time-in-range goals are different for each individual depending on factors such as medication, age, and type of diabetes. Experts recommend that people with type 1 and type 2 diabetes aim to spend at least 70% of the day within 70 to 180 mg/dl, less than 4% of the day below 70 mg/dl, and less than 25% above 180 mg/dl. However, experts emphasize that even a 5% change in time in range – for example, going from 60% to 65% – is meaningful, as that translates to one more hour per day spent in-range.

“I’ve seen everything from 0% to 100% time in range,” she said. “There are differences when comparing someone who is new to our clinic compared to someone working with us for a year. It’s so individualized, and people have different challenges. The goal is to improve your personal time in range, and any increase in time in range is a win.”

Measuring Time in Range using Blood Glucose Meters, CGM, and Professional CGM

If you are using a blood glucose meter (BGM) or CGM, talk with your healthcare team about your glucose targets. The data will be more meaningful if you are working toward a specific goal.

For BGM users, paired testing can help you see the direct impact of food on your blood glucose – all you have to do is check your glucose before a meal and again two hours after the meal. To check that your basal insulin is working well, check your glucose levels before bed and first thing in the morning.

At the Cleveland Clinic, people are required to attend a two-part shared appointment to get access to professional CGM. The classes are usually two diabetes care and education specialists (pharmacist and dietitian or nurse) and 4-6 people with diabetes.

In part one, you go over glucose targets, time in range, and how to treat high and low blood sugars. In part two, you download the data and review it with your diabetes care and education specialists. You discuss what it means, find patterns, and make medication adjustments as needed. This class is offered five times per month. Dr. Isaacs says that this program has helped many people improve their A1C (an average 0.8% reduction) and diabetes self-management.

How can we make time in range accessible to people with diabetes and their healthcare teams?

Dr. Isaacs believes that everyone should have access to affordable medications, affordable technology, and a great support system. She says, “I’ve seen so much rationing of insulin and medications, especially in the Medicare and uninsured populations.” There are many people that have diabetes and haven’t connected with their healthcare team in years. We need to do a better job to help these people.

According to Dr. Isaacs, the average healthcare professional is not prepared to talk about time in range. A1C has been and continues to be widely used by most healthcare teams. While she is excited about the growing use of CGM, there are “still some hurdles to get all practices up to speed with how to download the devices and interpret the data.”

Her advice is to tackle these barriers from multiple angles:

  • In research, we need to make sure that time in range is an outcome in all clinical trials that measure glycemic management, so that we can directly measure the effect of time in range on clinical outcomes.
  • We need targeted education for busy healthcare professionals, including podcasts, webinars, and continuing education.
  • We need targeted education for people with diabetes who are often the ones bringing information to their healthcare team.
  • In practice, healthcare professionals should discuss time in range with every person with diabetes that is using CGM.
  • People with diabetes using CGM should be encouraged to bring their reports to their healthcare provider and discuss time in range.
  • Instead of only marketing CGM as a convenient way to reduce finger sticks (which is true), the real benefit is that it lets the person with diabetes be the driver, and time in range is their roadmap.

Dr. Isaacs recently spoke on a panel at the ADA post-graduate sessions about the power of time in range and CGM for all people with diabetes. She was joined by diaTribe’s medical advisory board member, Dr. Irl Hirsch, our editor-in-chief, Kelly Close, and Jane Kadohiro as the moderator, who herself has had diabetes for over 50 years. If you or your healthcare provider are interested in learning more about time in range and downloading CGM data, you can make an account and watch the session here!

Source: diabetesdaily.com

How to Avoid the Quarantine 15

As most Americans approach their second full month of quarantine (with widespread shelter-in-place orders in all but a handful of states), with playgrounds, pools, recreational centers and gyms closed, many may be wondering how they can avoid the dreaded, “quarantine 15” that people have been joking about on the internet lately.

If you’ve been consumed with stress-eating and low step counts are haunting your days, take heart: there are some simple ways to get you back on track (and fitting into jeans again soon). Here are our top tips to stay healthy during this time:

Adhere to a Regular Eating Schedule

If you have kids at home that you’re trying to homeschool, pets that need attention, and competing Zoom schedules with your spouse, nothing feels normal. It’s easy to slowly slide from your regular routine of, “quick workout, small breakfast, shower” to drinking coffee and panic reading the news ‘till noon, and then storming the kitchen once mid-afternoon hits. If you can stay on a regular eating schedule for breakfast, lunch, and dinner, by the time evening (and Netflix) time hits, you won’t be starved for calories and make poor choices.

Don’t Treat Every Day Like a Friday Night

If you’re like me, you eat remarkably healthy during the week, but definitely look forward to your Friday night glass of wine, as well as relaxed eating standards during the weekend (I can never say no to a Saturday ice cream outing). Once shelter-in-place orders hit, I started treating every day like a Friday night: wine and nachos one day, a margarita and pizza the next. This wasn’t good for my blood sugars or waistline. Even though these times are not normal, if you can carve out space for little treats only once in a while to retain some sense of normalcy, you’ll feel a lot better in the long run, and your blood sugars will also thank you.

Get Movement Every Day

Gyms may be closed, but no one has canceled nature. One silver lining of this pandemic is that it’s hitting during the most beautiful time of year. Flowers are blooming, and temperatures are mild and warm. This is the perfect time to take a bike ride, go on more jogs, or take a nightly walk after dinner. There are also plenty of online options for yoga, pilates, or cardio classes on YouTube. Take advantage of time saved from no commute, and cultivate a morning exercise routine instead!

Get Creative in the Kitchen

It might be tempting to get pizza every day or order takeout (and hello, it’s way easier!), but try and take advantage of this time at home by getting creative in the kitchen. Remember that Vitamix you got as a wedding gift that’s collecting dust in the basement? Or that juicer you ordered during a cleanse phase that you’ve never really touched? Try and buy one new vegetable a week and create a brand new recipe around that. Or order a recipe book online and work your way through it with your family. Vegetables like garlic scapes, jicama, watermelon radishes, and fiddlehead ferns are just a few delicious vegetables begging to be tried that you may have never even heard of!

Photo credit: Katee Lue (Unsplash)

Find an Outlet for Your Stress

Often times when we go to snack, we’re not *actually* hungry, but bored, tired, or stressed. Try, for a few days, to respond to hunger cues, eating only when you’re hungry and stopping when you’re full. This can be hard, because as people with diabetes, we normally eat in response to a high or low blood sugar, and not to our hunger cues, but try it out. Also, supplement your outlet for stress from eating to a healthy activity like meditation, journaling, or gentle yoga. Other outlets for stress can be listening to a podcast, painting, or dancing in your kitchen. Even if you’re not looking to lose weight, your mental health will thank you. This will also become especially helpful when treating lows; if you have an existing outlet for unwanted stress, you’re less likely to over-treat them, and can prevent the blood sugar rollercoaster.

Have you noticed weight gain since the start of COVID-19, or are you healthier than ever? How has quarantine affected your lifestyle? Share this post and comment below; we love hearing from our readers!

Source: diabetesdaily.com

Why Glucagon Is a Must for Sick Days

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

By Jordan Dakin

Common Knowledge

Becoming sick when you have type 1 diabetes can easily complicate things. When you have the flu or a serious bacterial infection, your blood sugar levels can quickly become harder to manage, as they typically trend higher because of your body’s automatic, hormonal response to being sick. Because of this, you might find yourself needing more insulin than usual and needing to check for ketones more often to prevent diabetic ketoacidosis (DKA). Having a plan for sick day management when you have type 1 diabetes is crucial.

It’s important to be mindful of the possibility of high blood sugar when you’re sick. But it is also important to realize that sick day lows are a definite possibility as well! Especially if you’re taking more insulin than normal to combat highs when sick, you have to be mindful of resulting lows. You also run the risk of encountering a severe low if you are either unable to keep food down or lack an appetite when you’re sick, which are common realities when you have a cold or flu.

Enter Glucagon

Whatever the reason for a low, keeping glucagon handy to combat severe bouts of hypoglycemia on a sick day is definitely a must. Severe hypoglycemia is a dangerous complication of type 1 that can result in seizure, loss of consciousness, or death, and there is peace of mind in having a safety net to prevent any one of those outcomes. Glucagon is the first line treatment for severe hypoglycemia because it is the main counter-regulatory hormone to insulin. Parents and caretakers of those with type 1 can especially benefit by having an immediate safeguard against the dangers realities of a severe low.

The standard of care has been to keep a glucagon emergency kit handy. Historically, these emergency kits came equipped with an injectable form of glucagon, that requires mixing powder and liquid with a syringe by whoever is administering the shot. While this can definitely be an effective form of glucagon, having to mix the shot prior has made the procedure complicated and intimidating for some.

Next Level Options

Luckily for those of us affected by type 1 diabetes (T1D), glucagon has been approved in two new forms over the last year: nasal glucagon and pre-mixed steady state.

Baqsimi is the first and only nasal, non-injectable form of glucagon, offering a slight variation on what most people with diabetes are used to. It is administered like a nasal spray, but does not require inhalation, so even if a patient is unconscious (a frequent cause of severe hypoglycemia), anyone can administer Baqsimi and it will work.

Gvoke is the first liquid stable form of glucagon, meaning though it is an injection, it comes ready to use and requires no mixing on the part of whoever is administering the shot. Gvoke also comes in two forms: a pre-filled syringe (called Gvoke PFS) that is available to patients now and an auto-injector pen (the Gvoke HypoPen) that has yet to become officially available.

Neither Gvoke nor Baqsimi require refrigeration, and both have an impressive shelf life of up to two years if kept at room temperature. Another added benefit of these next generation iterations of glucagon is that these tools can likely prevent an ambulance trip to the hospital, saving time and resources. (Editor’s Note: This is especially important during the current COVID-19 pandemic, as it is not advised to visit hospitals unless absolutely necessary.)

How to Get Glucagon

Lilly currently offers a Baqsimi coupon patients can use to get up to two devices for as little as $25.

Through the end of April 2020, Xeris is offering a Gvoke co-pay card with which some patients can pay as little as $0 with eligible insurance to get their Gvoke PFS. Patients can also opt to request their prescription through the website and have Gvoke PFS delivered by PillPack at no additional cost.

Keeping glucagon handy is the best defense against unexpected lows when you’re not feeling well. Being sick might come with some uncertainties and cause some worry, but you can rest easier knowing you’re prepared and equipped with the necessary tools to take on whatever comes your way.

For step by step instructions on how to use each type of emergency glucagon, click here.

Source: diabetesdaily.com

Diabetes and Divorce: Getting Through the Process

Diabetes can wreak havoc not only on one’s physical health, but on one’s mental and emotional health as well, and oftentimes the toll that diabetes takes will affect the entire family. If you’ve faced or are currently facing a divorce and live with diabetes, you know all too well that it adds a complicated layer that can cause additional stress, heartache, and pain. Here are some ways to protect yourself (and your diabetes!) should divorce come your way:

Court Can Be Ugly

While sometimes divorce can be civil and amicable, going to family court, especially when child custody arrangements are being negotiated or when child support is in the picture, can get ugly. Be prepared for your spouse’s attorney to bring up your diabetes management, and to propose that as a liability against your ability to care for your children. Work with your attorney around this expectation. By providing your attorney your medical records (including HbA1c results), you can defend any argument against you regarding poor diabetes management.

Leaving a Marriage Can Mean Losing Insurance

Leaving any marriage is hard, but this is especially true for people living with diabetes who rely on their spouse’s health insurance, which equals access to insulin, pump supplies, and the ability to see an endocrinologist. Divorce can be a long, brutal process, but knowing that you will lose health insurance gives you time to stock up on supplies, make much-needed appointments, and line up ways to secure health insurance before you have a significant lapse in coverage.

If you were previously unemployed, you may be eligible for Medicaid coverage in your state, or since divorce is a qualifying life event, you can buy a health plan on a state or federal exchange. Check out our resources for securing insurance if you learn that you’ll lose coverage as a result of divorce.

Vulnerabilities Are Laid Bare

As a person with diabetes, we rely heavily on our spouses for everything from helping us take a shot in an unreachable place, to grabbing us a juice for a 3 a.m. low. Losing a spouse means losing part of our support system for managing our diabetes.

If you’re experiencing this sudden loss of support (especially if you struggle with hypo unawareness), try and prepare yourself by getting a continuous glucose monitor (CGM) that can alert you if you go low during the night. Many CGMs now have a “share” option that lets people “follow” your trend lines, and also receive alerts when your blood sugar goes too high or too low. This is an excellent feature for people who live alone and want additional assurance that they’ll be safe when they go to sleep at night.

Additionally, getting a diabetes alert dog can help not only with managing highs and lows, but also with the loneliness that can come with suddenly finding yourself on your own.

Know You’re Not Alone

You may be losing a spouse, but you have a lot to gain in terms of support, if you know where to look. For community encouragement, joining a diabetes support group, volunteering with a diabetes organization, or reaching out to family and friends and letting them know you need some more support around your diabetes can be greatly beneficial. Even becoming more involved in the diabetes online community (on Facebook, Instagram, or Twitter) is an excellent way to stay connected to people from the comfort of your own home.

Go Inward

Divorce is one of the most stressful times in one’s life. Seeking professional counseling can help you return inward, and to start to heal so you can eventually move forward. Counseling can also prepare you to deal with the stressors of moving out, perhaps finding new employment and new health insurance, and dealing with diabetes on your own for the first time in a long time.

Although it can be hard, divorce can also be a truly freeing and necessary step in one’s life, and can lead to beautiful new beginnings. It’s important to take care of yourself and protect your mental health throughout this time. It’s never too early or too late to start (or continue) work with a licensed counselor.

Have you recently gone through the heartbreak of a divorce, while living with diabetes? What aspects of the divorce were the scariest for you, as a person living with diabetes? What tactics and coping strategies helped you the most? Share this post and comment below; we love hearing your stories!

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 Navigate Blood Sugars During a Pandemic

Diabetes management is challenging enough as it is. It takes a daily and consistent effort, around the clock, to check your blood sugar levels, pay close attention to your diet and a multitude of other variables, all while making medication adjustments to stay in your target range. The constant management tasks already take a substantial amount of effort and headspace. It’s no wonder that when a particularly high-stress situation arises, it can make diabetes management especially tricky.

Right now, we are all living through a very stressful time, globally. As the COVID-19 pandemic continues, we are all doing our part in trying to slow the spread of the infection. Between school and university closings, bars and restaurants and stores being shut down, and the constant effort of social distancing, the changes to our daily routines are paramount. Not being able to go to the gym, socialize as we are used to, and the added stresses of childcare, not to mention unemployment concerns, are skyrocketing our stress levels.

We know that stress levels can cause higher than normal blood glucose levels. As a result, many of us may be struggling with our diabetes management more than usual.

Jennifer Smith RD, LD, CDCES, Director of Lifestyle and Nutrition and Registered Dietitian, Certified Diabetes Care and Education Specialist at Integrated Diabetes Services explains:

“Stress comes in all forms and can effect each person a bit differently. Stress at work, from a presentation, a big project for school, studying, a terrifying experience like a car accident, a big game against the top opposing team, a performance in gymnastics, or even a scary movie – these can stimulate the “fight or flight” response in the body. The main hormones that are released in a time of stress are adrenaline and cortisol. The release of these hormones encourages the liver to dump glucose into the blood stream in order to provide a quick supply of energy to “get out of the situation”…our body still responds to stress as if we were running away from a Saber tooth tiger ages ago. This extra glucose can and will raise blood glucose levels. It won’t be the same for each person and different types of stress will cause a different rise in blood glucose, but this is the main reason for the typical rise from stress.”

In these unprecedented times, it is perhaps more than ever important to continue to care for our physical and mental health, and in particular, our diabetes. Optimizing our blood glucose levels can help promote optimal immune system function, which helps us fight off all kinds of infections more effectively. Also, keeping blood glucose levels in range as much as possible can go a long way in helping us to feel our best on a day to day basis, physically and mentally.

Here are some tips for optimizing our diabetes self-care during these high-stress times.

Check Your Basal Insulin Dose

For the many of us who are on a basal/bolus insulin regimen, whether using a pump or multiple daily injections, basal insulin doses (or rates) are the cornerstone of blood glucose management. If the basal insulin dose is too high, we might find ourselves with unexpectedly low blood sugar levels throughout the day or night, while if the dose is too low, we may be constantly chasing higher than desired blood sugar levels.

Jennifer Smith RD, LD, CDCES, explains:

“This the foundation of your diabetes management. Think of it like the foundation of a house – if you build it sturdy and strong then everything placed on top of it will hold stable. If you have a foundation that has holes in it, or it put together with shoddy materials, you are like to have to patch and fix it along with everything you build on top of it or it will all fall apart. Basal insulin is what we use to manage blood glucose without food in the picture. In a body without diabetes there is a fine coordination between insulin released by the pancreas in the fasting state and the livers release of glucose into the blood stream to maintain normal glucose levels. This happens whether or not there is food eaten. Getting the basal rates tested is the baseline of management to ensure that if you skip a meal, or for overnight when you aren’t eating, glucose levels stay stable without falling or rising more than 30mg/dl (1.6mmol). Having this set well will ensure that the bolus insulin you take to cover food or to correct blood glucose when it is too high is working optimally. It may need to be adjusted as you move through life, as hormones for growth, menstruation, stress and illness can change insulin needs. But, if you have your base basal set well, then adjusting for these variables is a bit easier to navigate.”

For most people, stress tends to increase insulin resistance, resulting in higher blood glucose levels. This means that many need more insulin during times of stress to stay in range. However, your response to stress may vary, so it is important to carry out basal testing to determine if your dose is appropriately set.

Photo by iStock

Below, you can find a previously published description of how to determine if your basal insulin doses or rates are working well for you. Once that cornerstone of insulin therapy is properly set, it will be much easier to troubleshoot other areas, like bolus and exercise adjustments. (*Note: always consult with your healthcare provider prior to making any changes to your medication doses).

To determine if the basal insulin dose is set correctly, one can fast for a specific number of hours without bolus (fast-acting) insulin onboard and monitor blood glucose levels to see if they remain steady. Importantly, the test should be performed in the absence of other complicating variables, like exercise, stress, or illness. The test should not be performed if your blood glucose level is low or high.

Many people prefer to perform basal testing in 8-12-hour spurts, so as not to fast for an entire 24 hours. For example, it can be quite easy to check the overnight basal dose by not eating after 6 pm and assessing the blood glucose trend from 10 pm to 6 am (in the absence of food or bolus insulin). To determine the basal dose efficacy for morning or evening hours, one would skip a meal and monitor blood glucose levels to determine whether the basal dose is well-set.

The basal insulin requirement may be very similar throughout the day, or it may vary. In particular, many individuals experience “dawn phenomenon,” whereby hormones stimulate glucose release by the liver in the early morning hours. When using an insulin pump, it is quite easy to adjust the basal insulin rate of delivery to accommodate any variations. For those on insulin injection therapy, it may be worthwhile to split the basal insulin injections into several doses throughout the day, to best match the requirements. These individuals may also benefit from taking a small amount of short-acting insulin upon waking to account for dawn phenomenon.

Accurate basal insulin dosing is the first step to achieve the best blood glucose control possible. Once the optimal doses or rates are determined, one should not need to worry about hyper- or hypoglycemia in the absence of food or other variables (like exercise). This will make it a lot easier to systematically start addressing other variables that affect blood glucose levels.

Reduce Stress

It may be easier said than done, but there are several, proven ways that we can reduce our stress levels. Whether it’s taking ten minutes to meditate every morning, making sure you get your exercise in, or connecting with loved ones through phone or video chats, taking time to care for our physical and emotional health can in itself help us to de-stress. In turn, our blood sugar levels will (hopefully) become more predictable and easier to manage. Check out some of these articles to help you get started:

Mindfulness and Meditation Apps

Staying Active at Home

Taking Care of Your Mental Health

And, as the weather finally improves for many of us, don’t forget about the benefits of time spent in nature. Between the vitamin D exposure and the exercise, you can gain a boost for your immune system and mental state by making it a priority to get outdoors as much as possible.

Create (and Stick to) a Routine

Maintaining some degree of normalcy by having a regular schedule can help us feel more in control and help keep us on track when it comes to our meal planning and exercise goals, which in turn, can have a tremendously positive effect on our diabetes management. A routine can be especially helpful when we find ourselves in a rut or experiencing burnout.

For example, if you’re struggling to check your blood sugar level on a regular basis, you can make a concrete plan of when exactly you will check each day. Next, keep yourself accountable by setting an alarm to do so. Moreover, consider trying out a diabetes management app, to help you stay on track.

If you find that your diet has suffered, try to plan your meals ahead for the week. Focus on nutrient-dense foods and get your family involved. Try out a new vegetable recipe or even a low-carb desert! Similarly, with exercise consider engaging all together at a set time, at least a few times per week.

Make Use of Technology

We are so fortunate to have the advanced technology we have today, diabetes-related and not. If you have found yourself in a rut, not wearing your continuous glucose monitor (CGM), or not utilizing the features on your insulin pump to their fullest extent, this is a great time to lean into the technology that can help us thrive during these difficult times.

Moreover, we can data share with our healthcare providers, providing them with detailed information about what’s working and what’s not. Ask your healthcare providers about telehealth appointments, if you haven’t yet!

Photo credit: geralt (Pixabay)

On another note, just using video conferencing to keep up with family and friends, or even just chatting about diabetes in a forum, is a gift that did not exist even 50 years ago! Making use of the internet to strengthen existing connections and make new ones is critical to our emotional health during these times, and can even help with diabetes management and emotional support.

Lean On Others

If you need help, reach out. If you are having a bad day, reach out to a friend for support. If you’re struggling with your diabetes management, reach out to the online community, as well as your diabetes provider. Don’t underestimate the power of social support, as well as having another pair of eyes to review your data to help you identify where you can make some changes to get back on track.

We may be socially distancing, but we are not alone! Lean into your community and make use of your provider’s expertise, remotely.

Also, be aware of the following mental health hotlines and be sure to share them with anyone who may benefit:

  • National Suicide Prevention Lifeline: 1-800-273-TALK (8255)
  • Crisis Counselor Hotline: Text HOME to 741741 to connect with a counselor

Also, you can visit this website for hotlines that are tailored to more specific mental health issues.

***

How has your diabetes management been affected by the COVID-19 pandemic? What are you doing to stay healthy? Please share your experiences with us in the comments below.

Source: diabetesdaily.com

Another CGM Approved in Europe for Pregnancy: Dexcom G6 Joins Freestyle Libre

This content originally appeared on diaTribe. Republished with permission.

By Divya Gopisetty

In Europe, the Dexcom G6 CGM received approval for pregnant women with diabetes

Dexcom’s G6 continuous glucose monitor (CGMreceived European approval (“CE Mark”) to be used by women with diabetes during pregnancy. This official label is set to launch in spring of 2020 and will apply to women with type 1, type 2, or gestational diabetes. The Dexcom G6 is already approved for people with diabetes over the age of two.

CGM can help provide awareness of blood glucose trends, which is especially important for pregnant women and their babies. The 2019 ADA Standards of Care recommend that pregnant women with gestational, type 1, or type 2 diabetes spend the majority of the day in the tighter blood sugar range of 63-140 mg/dl. CGM can allow people with diabetes to work with their healthcare team to better understand their time in range and improve their diabetes management by reducing hyperglycemia and hypoglycemia.

During pregnancy, insulin (the hormone that helps the body use glucose for energy and lowers blood sugar) may not be able to perform its typical role due to interference from other hormones produced by the developing baby. With gestational diabetes, the body’s insulin can’t keep blood sugar levels in the target range. This leads to higher blood sugar levels that can cause health risks for both the mother and baby.

You can learn more about diabetes during pregnancy here. The late gestational diabetes guru Dr. Lois Jovanovic also shared a few pieces of advice for pregnant women with diabetes. We encourage you to consider these tips as you communicate with your support system and healthcare professional.

Source: diabetesdaily.com

Pregnancy, Delivery, and Postpartum Care During the COVID-19 Pandemic

Almost any pregnancy is full of excitement but can be stressful at times. Add in having diabetes and living through a global pandemic, and it can be quite anxiety-provoking. This article summarizes how recent policy changes due to COVID-19 may be affecting women with diabetes who are currently pregnant or have recently given birth.

A High-Risk Pregnancy

For women with diabetes, pregnancy is automatically classed as a high-risk affair. Although a healthy pregnancy is very possible with any type of diabetes, a lot of emphasis is placed on optimizing glycemic management, and women are closely followed with extra appointments and ultrasound scans throughout the pregnancy, and in particular, during the third trimester.

Telemedicine and In-Person Appointments

For those who are going through pregnancy during the COVID-19 pandemic, certain appointments may be possible to achieve via telemedicine. For example, if you’re working with an endocrinologist to manage your blood sugar levels, odds are, that can be achieved largely through telemedicine (or email). However, certain other checks (like ultrasounds), or if a woman is experiencing concerns or complications, there is no substitute for an in-person healthcare provider or even a hospital visit.

Ask your provider(s) which in-person appointments they expect you to keep and why. Also, keep in mind that there will likely be additional precautions, like waiting in your vehicle, instead of the waiting room, for example.

To curtail the spread of the novel coronavirus, most doctors’ offices and hospitals have now implemented strict policies concerning the number of visitors who are allowed at appointments. Most will find that for all (or almost all) appointments, women will be asked to come to their appointment without any additional visitors.

Of course, these new policies, while important, also can bring up considerable emotional issues. Pregnancy is supposed to be an exciting time, most often shared with loved ones, like your partner and family. Milestone appointments, attended alone, may feel bittersweet.

To help increase support during these times, ask your healthcare providers what their specific policies are and inquire whether it is possible to have your support person or people attend with you virtually. For instance, you may find that your practice will allow your partner to phone in via videochat to virtually experience a milestone ultrasound, and will give them an opportunity to ask any questions that they might have. While not the same as under normal circumstances, this can offer women more emotional support during these exciting (and challenging) times.

Labor and Delivery

One fear that many women are expressing these days (and rightfully so!) is one of having to labor and deliver their babies without a support person. While formal “birth plans” are notorious for falling apart (at least somewhat, as no birth is predictable), this is perhaps the first time in our recent history that women have to worry about not being able to have their emotional support system in place for the big event.

It appears that most hospitals are balancing the need for limiting viral spread with the importance of emotional support for patients during this critical time. Most likely, your hospital will allow one support person to attend your labor and delivery (although this may not be the case everywhere, especially in COVID-19 disease epicenters). However, be prepared that they may not be able to accompany you during the postpartum hospital stay. Ask your hospital ahead of time what the policy is (also for vaginal delivery vs. c-section) so you can be prepared. Also, you may find that (if deemed appropriate) your discharge from the hospital may happen sooner than what is typical.

Diabetes online community member, Shannon M. (who has type 1 diabetes) described to us her challenging experience with delivering her baby boy amid the COVID-19 outbreak:

“I planned on being induced at 39 weeks but was induced the day I hit 38 weeks due to the doctors personal concern about the virus. The hospital was also thinking of starting to allow no help in the delivery room and they wanted to make sure I had someone there with me, as well as to get in and out of the hospital before the virus spread got even worse. My biggest concern the entire time ended up being for the virus rather than health of the baby in general.

While I was in labor, they decided I needed an emergency c-section and took me into another room. I was concerned about going into so many different rooms because that increased my chances of getting the virus rather than being afraid of the c-section itself.

After everything, my baby was taken to NICU for low blood sugars. As I had expected this, I wasn’t too worried, but again, worried about his extended stay in the hospital because of the virus. This also meant I had to visit him daily in the hospital, which concerned me, trying to not get the virus myself and transfer it to him or the rest of my family.

They only let me recover one day in the hospital from the c-section, when it’s usually three days. The social worker admitted to me the cases were getting bad in our hospital and just wanted everyone who didn’t absolutely have to be there, out. Everyone had to wear masks and gloves throughout the hospital. One of my nurses continued to not wear her mask around me and it made me very paranoid.

My baby is still in the NICU. It has now been 13 days and I still have anxiety visiting him. I don’t leave his room to eat or use the restroom unless I absolutely have to. It’s been a horrible experience and cannot wait to get him home. I also live in Essex county NJ, which is the second-worst infected county in the second-most infected state, as we are 20 minutes from NYC.”

Postpartum Care

In addition to possibly leaving the hospital earlier than expected, women are likely going to experience more isolation than they normally would. Importantly, this can affect the rates of postpartum depression, which is of great concern.

Taking time every day for essential self-care and human connection is important for all new moms and is perhaps even more critical during these tough times. Having a support system in place, even if you’re only able to communicate remotely, can help women feel more supported.

Photo credit: smpratt90 (Pixabay)

While many women will probably attend their 6-week postpartum check-up (especially for birth control, like an IUD), this may not be the case for those who don’t have any upcoming procedures, questions or concerns (I actually cancelled my own 6-week postpartum check-up that was supposed to take place mid-March). Be sure to bring up any physical or mental health concerns to your doctor right away. Don’t forget that many issues can be addressed via telemedicine (e.g., mental health appointments), so you can safely stay at home with your baby.

Also, don’t forget to check in with your pediatrician’s office about what their policies are. Most likely, only one parent will be able to attend the child’s well-visit appointments. Some appointments may even be postponed, depending on the specific circumstances.

Jennifer A., who delivered her son at the end of March, describes:

“My son has only had one appointment over a phone chat. It was OK. I prefer to keep him safe but I also want to make sure my son is healthy and growing right and that is hard to tell over a phone.”

Conclusions

Going through pregnancy, labor and delivery, and the postpartum period, while also managing diabetes, is difficult enough but can feel overwhelming during a global virus pandemic. Understanding that the inconvenient policies are there to help protect you and your baby, and getting the mental health and emotional support you need during and after pregnancy is key to keeping the big picture in mind and being able to enjoy this very special time.

Are you currently pregnant or have recently had a baby during this crisis? We’d love to hear about your thoughts and experiences.

Source: diabetesdaily.com

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