Don’t Be Deceived: How Food Labels Mislead

People with diabetes have to be very conscientious about the foods they eat. This can sometimes be tricky in the world of 24/7 advertisements, fast-food billboards and commercials, and temptation around every corner.

Marketers and food conglomerates will try anything to appeal to an audience, even people with very specific nutritional needs, including people with diabetes.

The following food labels may be true, but they’re definitely deceiving. Next time you’re shopping or placing your takeaway order, be wary.

Gluten-Free

The explosion of gluten-free foods on the market has been a godsend for people living with Celiac disease. And because Celiac tends to affect people living with type 1 diabetes at higher rates, this is especially applicable to this population. There are, however, many misconceptions around gluten-free food.

Something being gluten-free doesn’t automatically make it “healthier” or even lower-carbohydrate. It simply means that the food was prepared without wheat proteins, a group of seed storage proteins found in certain cereal grains.

Prepackaged gluten-free foods can sometimes even have higher carbohydrate counts than foods containing gluten.

For example, Domino’s gluten-free pizza crust clocks in at 75 carbs (for a small pizza), whereas their crunchy thin crust pizza (for a small pizza) is only 67 carbs. If you’re Celiac, that’s great, but if you think going gluten-free will mean you’re automatically a low-carbohydrate eater, guess again.

Additionally, Domino’s gluten-free pizza dough contains the following ingredients: water, modified rice starch, rice flour, brown rice flour, potato starch, olive oil, potato flour, evaporated cane sugar, fresh yeast, honey, avicel (a “fat replacer”), salt, calcium propionate. These ingredients are not exactly the healthiest nor the cleanest.

No Sugar Added

A few years ago, the Food & Drug Administration (FDA) overhauled their food label protocol by adding more nuance to the “sugar” category. Now foods will be broken down into two categories:

  1. Total sugars
  2. Added sugars

There is no Daily (recommended) Value on food labels for total sugars because no official recommendation has been made for the total amount to eat in a day.

The Daily (recommended) Value for added sugars is 50 grams per day based on a 2,000 calorie daily diet.

This can be helpful for people with diabetes when they’re trying to decide what and how much to eat. It also distinguishes natural sugars, like those naturally found in fruit, milk, and vegetables, from added sugars, like the sugar, dextrose, or glucose added to popular children’s breakfast cereals, baked goods, and other sweets.

It’s healthier to choose a banana rather than two bowls of Cap’n Crunch, even if they have the same number of total sugar. But don’t be fooled! Just because something doesn’t have any added sugar doesn’t mean that it has no sugar (or no carbohydrates), and it definitely does not make it a low-carbohydrate food.

Fortified

If a food label says it’s been fortified or enriched, it simply means that nutrients have been artificially added to the product. For example, Vitamin D is often added to orange juice and milk, B Vitamins and Iron are often added to refined bread and granolas, and puddings, ice cream, and other children’s snacks are often fortified with Calcium.

But this doesn’t make any of these products inherently healthy. Be careful to read food labels and (especially) ingredient lists closely to make sure the “fortified” food you’re buying is worth it. You can always take a supplement of the Vitamin or Mineral you’re aiming to get, without the junk food accompanying it.

Organic

The organic food trend has hit the United States by storm, and as of February 2021, organic foods make up over 4% of overall food sales in the country. “Organic food” can be a few things:

According to the United States Department of Agriculture (USDA), “produce can be called organic if it’s certified to have grown on soil that had no prohibited substances applied for three years prior to harvest. Prohibited substances include most synthetic fertilizers and pesticides.”

“As for organic meat, regulations require that animals are raised in living conditions accommodating their natural behaviors (like the ability to graze on pasture), fed 100% organic feed and forage, and not administered antibiotics or hormones.”

Organic may mean more natural, but it doesn’t necessarily mean a food is healthier. Some organic products may still be high in sugar, salt, fat or calories. For example, organic sugar is still sugar. An organic cookie might taste self-righteously good, but it’s still a cookie (and you’ll definitely still need to bolus for it).

Natural

One of the most misleading food claims is stating that something is “natural”. This is because there is no official guideline or definition from the FDA for what “natural” actually is, although the agency loosely has considered the term “natural” to mean that nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be in that food (like artificial food coloring).

The FDA also did not consider whether the term “natural” should describe any nutritional or other health benefits.

“Natural” simply means that at one point, the manufacturer or food-processing plant worked with a natural source like soybeans, corn, or rice, all of which can be heavily processed and turned into unhealthy versions of themselves (most notably, types of digestible sugars!).

Some “natural” yet not the healthiest foods include:

  • Natural fruit juices
  • All-natural ice-cream
  • Natural dried fruits
  • Natural potato chips

Be careful not to correlate the word “natural” with “healthy,” especially if you have diabetes.

The Bottom Line

The easiest way to avoid being misled by food labels is to avoid processed foods altogether, and to enjoy whole foods (that have no ingredient lists!) instead. If you choose to eat packaged foods, have a keen eye for the ingredient list, know how to properly read the nutritional label, and be wary of deceiving food labels and trendy terms. Bon appétit!

Source: diabetesdaily.com

Rush for COVID Vaccine Hinders Diabetes Tech Advancements

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

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

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

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

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

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

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

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

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

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

Senseonics’ 180-Day Eversense Glucose Monitor

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

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

The Omnipod 5 (Originally “Horizon”)

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

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

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

They hope to launch their product by June of 2021.

Medtronic 780G

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

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

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

They hope to have a commercial launch sometime in 2021.

Dexcom G7

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

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

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

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

Abbott Freestyle Libre 3

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

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

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

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

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

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

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

Source: diabetesdaily.com

The PROTECT Study

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

By Makaila Heifner

Let’s face it, there are a lot of research studies out there, and we mean… a lot. But one you should definitely know about is The PROTECT Study. Especially if you or a loved one was recently diagnosed with type 1 diabetes (T1D).

The PROTECT Study aims to understand how the investigational medicine, teplizumab, works in children and young adults who have recently been diagnosed with T1D, as well as assessing if there are any side effects while taking the medication. This treatment is still being evaluated in clinical studies and has not been approved by the FDA for treating T1D. In previous studies of high-risk individuals, teplizumab was shown to delay the onset of T1D an average of nearly 3 years (35 months).

Who Is Eligible for the Study?

This study will include 300 children and adolescents in clinics across the United States, Canada, and Europe that meet the following criteria:

  1. Age 8-17 years old
  2. Diagnosed with T1D in the previous 6 weeks
  3. Positive for 1 of 5 T1D autoantibodies (test to be done as part of the study) 4. Ability to produce a minimum amount of your own insulin (test to be done as part of the study)
  4. Otherwise generally healthy, with no other significant medical conditions, recent or history of infections, or taking medicines that might interfere with teplizumab

If you meet all the criteria, the next step is to visit a study clinic, where the study team will:

  • Discuss the study in more detail and explain what participation would mean for you or your child.
  • Talk through the potential benefits and risks of being involved in the study.
  • Ask questions and carry out medical tests to determine whether you or your child are right for the study and the study is right for you or your child.

If you and/or your child are interested in potentially participating in the PROTECT study, click here to find a study clinic near you.

Before the study begins, you/and your child must agree to and sign an Informed Consent Form which explains the study in detail, any potential risks or benefits of participation, as well as your rights and responsibilities as a participant of the study.

All study-related treatment and care will be provided to eligible patients without charge; however, patients will not receive any compensation for their participation in the study. Patients who decide to participate are able to withdraw from the study at any time for any reason.

Participants do not have to change their primary doctors as the study provides short-term study-related care only. Patients are encouraged to tell their regular doctors about taking part in a clinical research study. Some medicines are prohibited to take while part of the study so a patient’s doctor may want to contact the study physician to request additional information.

How Does It Work?

If you/or your child are selected to be part of this study, you/your child will be placed in one of two groups, either the teplizumab group or the placebo group (meaning you/your child will receive no treatment). Deciding who will be placed in each group is chosen at random by a computerized system, and neither you/your child nor the study doctor will know which treatment group you/your child was placed in. This is done so that results from the different groups can be handled the same way.

Over the duration of the study, you/your child will receive 2 courses of study medicine given by intravenous (IV) infusion. The IV infusion usually lasts about 30 minutes and will be given daily over 12 days on 2 separate occasions, 6 months apart.

The study will last just over a year and a half (the study reports the study will last up to 84 weeks) and require 36 study clinic visits, including the initial screening, treatment courses, and observation periods.

During visits to the study clinic, you/your child will be asked several questions and perform a series of study-related medical tests. These tests are done in order to understand how the treatment is affecting you/your child and how well the body is responding to the medication.

Identifiable information (for instance, name or address) will not be accessible to anyone who is not directly part of this study; additionally, The Sponsor (the company carrying out the study) will not have access to any personal information that is submitted through the study’s website.

Why?

The treatment works by interfering with the cells that destroy the insulin-producing beta cells in the pancreas. If the treatment successfully interferes with these cells (T cells) patients who are taking teplizumab may be able to continue producing their own insulin and reduce their need for insulin injections, have better control over their blood glucose, and experience fewer complications from T1D.

Visit theprotectstudy.com to learn more about PROTECT.

Source: diabetesdaily.com

Tell the FDA What Delaying Type 1 Diabetes Would Have Meant to You

Imagine a treatment that could delay the progression of type 1 diabetes for years. How much would an extra year (or three or four) of good health have been worth for you or your loved one?

It could become a reality soon. This month, the United States FDA will evaluate what would be the first-ever approved treatment to delay Type 1 diabetes.

And you can help make it come true. In late May, the FDA’s advisory committee will review comments on the matter, including those from the general public. Just a single compelling letter from a person touched by diabetes could make a big difference.

We believe that it would be amazing to have an FDA-approved type 1 diabetes prevention treatment, and we hope that you’ll consider writing a letter of your own. We’ll provide instructions on how to do so at the bottom of this article. But first, a quick review of the proposed treatment and its potential:

Teplizumab

The novel drug is named Teplizumab. It’s been developed by ProventionBio, a biopharmaceutical company wholly dedicated to the prevention of autoimmune diseases.

When given to patients known to carry the antibodies that cause type 1 diabetes, Teplizumab delays the onset of symptoms by an average of nearly three years. And the effect may be even more potent than that. ProventionBio’s most important trial is still ongoing, and even after eight years some participants still appear to be benefiting from the treatment, which was given just once, in a single 2-week course.

Teplizumab was created decades ago, initially as an immunosuppressant, but researchers soon learned that it was especially effective at suppressing the specific T-cells known to attack the pancreatic Beta cells. Apparently, it can suppress that autoimmune attack for quite a long time.

How Teplizumab Might Change Diabetes Care

As of today, there is no validated way to slow type 1 diabetes,. Even if you have utilized antibody testing and know that a family member has an extremely high likelihood of developing type 1 diabetes, there’s little to do but keep watch for the symptoms of hyperglycemia.

But if Teplizumab gets approved, doctors would have a tool to help delay the onset of the disease for the first time.

And as Dr. Jeremy Pettus has explained, antibody screening would likely move into the mainstream. Even if Teplizumab were not indicated, antibody testing could also give many families valuable time to prepare for the progression of type 1 diabetes, months or years to learn about the condition and what to expect. That change could significantly reduce the frequency with which type 1 diabetes is diagnosed in the emergency room, only after the patient has experienced diabetic ketoacidosis (DKA).

How to Tell the FDA Your Story

It couldn’t be easier.

Here is the link to provide a comment for the FDA advisory committee that will rule on Tepluzimab’s application.

  • Write Your Comment
    • You can simply begin typing directly into the form, or you can attach a file.
  • Select a Comment Category
    • From the drop-down menu, select “Individual Consumer.”
  • Provide an Email Address. (Or Don’t).
    • A box allows you to provide an email address to receive confirmation that your comment has been received.
  • Provide Contact Information. (Or Don’t).
    • Decide whether you wish to provide your contact information, or you can file your comment anonymously. Your name will be made public, but none of your other information.

How to Write an Effective Comment

The FDA panel invites commentary from non-experts for a reason: they really want to hear the opinions of regular people. A good letter won’t just vanish into a slush pile.

This treatment is uncharted territory for the FDA, so the real-life experiences of people with diabetes and their caretakers might be especially relevant. While doctors and advocates will attest to the quantifiable medical benefit of delaying type 1, the experts on the advisory committee may not necessarily be able to imagine what those extra years could really mean for patients and their families.

Subjects that may be worth exploring in your comment:

  • The burdens and demands of living with type 1 diabetes, and the difficulty of a life totally reliant on insulin
  • The impact of what a two or three year delay in insulin dependence would mean to patients and families, including:
    • More time to live a normal life
    • More time for a patient and family to learn about the disease, prepare for it, safely manage it
    • Better long-term health, fewer complications
    • Lighter impact on families
  • How increased screening for type 1 diabetes antibodies will improve the standard of care and patient outcomes
  • How important those extra years of insulin-free life might be

Comments do not have to be long to be persuasive, but they should demonstrate a good understanding of the issues.

The government website also has a list of criteria to follow: click “Commenter’s Checklist” above the commenting form to pull up a pop-up window. It’s worth reading through.

For reference, you can look at comments that have already been posted here.

Deadline

Comments posted by the end of May 13 will be provided to committee members before the actual hearing, and will likely have the greatest opportunity to make an impact.

If you’ve missed the May 13 deadline, comments posted by the end of May 26 will still be taken into consideration.

 

Source: diabetesdaily.com

Review: RxSugar’s Zero-Carb Sugar and Syrups

It isn’t easy to find a natural sugar substitute that tastes good, keeps your blood sugars in check and doesn’t upset your stomach. I was pleasantly surprised to find RxSugar tasted great and was kind to both my blood sugars and my digestive system. I received RxSugar products free of charge, and all opinions are my own.

What Is RxSugar?

RxSugar is the first natural plant-based sugar that contains allulose and has been clinically proven to help support weight management and body fat reduction. It has 90% fewer calories than traditional table sugar, contains zero net carbs, and scores a zero on the glycemic index.

How Is RxSugar Different From Other Sugar Substitutes?

RxSugar, per the FDA, does not have to be listed on the Nutrition Facts label as a sugar or added sugar since it is not metabolized by the body like traditional sugar. Therefore, it does not significantly impact blood glucose levels.

Allulose is the only natural crystal alternative sugar that is patented non-GMO Certified and Tested, Keto Approved, FODMAP Friendly, Kosher, and Halal. It’s also naturally Vegan, Gluten-free, Grain-free, Soy-free, and Cholesterol-free.

How Does It Taste?

I was pleasantly surprised by the taste of RxSugar. It is about 70% as sweet as regular sugar, and I didn’t find it overpowering at all.

First, I tried their easy individual stick sugar packs in my coffee and found no weird aftertaste and no effects on my blood sugar or stomach. Next, I tried their sugar, which comes in an easy-to-use 1-pound canister, for some of my low-carb baking. I found it tasted great, with none of the cooling effect that some other sugar substitutes are known to have. And last but certainly not least, the syrups were the best sugar substitute that I have tried to date. For one breakfast, I sneakily replaced my daughter’s regular maple syrup with RxSugar’s pancake syrup, and she had no idea. She even asked for seconds! It is great knowing that my kids, who don’t eat as low-carb as me, can still enjoy their waffles and pancakes without so much added sugar. And for me, I enjoy making my own protein waffles and love that I can use this syrup liberally!

Where Can I Purchase It and How Much Does It Cost?

RxSugar products are now available nationwide in over 3,000 retailers, including Vitamin Shoppe; you can also order through their website. They offer granulated RxSugar in 1 pound canister or as a 30-pack of individual sticks (coming soon in a variety pack). The business also offers RxSugar in a liquid form, in addition to the pancake syrups, in both maple and chocolate flavors.

All of their products are $12.99, and the website offers free shipping on all orders over $40.

My Review

I thoroughly enjoyed all of the RxSugar products and will definitely be making them a staple in my house. The substitute sugar is great to have on hand for my coffee and baking, allowing me to enjoy delicious sweetness without worrying about my blood sugars. Additionally, the syrup has quickly become a family favorite, and I will be purchasing it for a long time to come. I can give RxSugar products my highest recommendation.

Source: diabetesdaily.com

Diabetes + COVID Vaccines: What You Need to Know

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

By Lala Jackson

COVID-19 vaccines are here. If you have diabetes and/or other underlying health concerns, you may have questions about timing, safety, and what to expect.

It’s important to remember that having well-controlled diabetes alone does not seem to put anyone more at risk for contracting the novel coronavirus, but other factors like older age, high-exposure employment, consistently elevated blood glucose levels, or other non-diabetes related health factors like obesity and hypertension may increase your risk of infection.

We also know that diabetes care itself is made far more complicated after contracting COVID-19 and protecting anyone with diabetes from getting COVID-19 is our ultimate goal. That’s why we encourage everyone with diabetes to get vaccinated as soon as possible.

Immediate side effects from the vaccines are similar to many people’s experience with the flu shot – soreness at the injection site, general muscle aches, some nausea, and tiredness. Some – but not all – people with diabetes are experiencing slightly elevated blood glucose levels. These side effects are typical, indicate the immune system is learning how to fight the virus, and go away within 24 to 48 hours.

Once you are able to get your vaccine, keep practicing safety measures. A vaccine protects you from severe outcomes from COVID-19, but it may still be possible to spread the virus to others. Keep wearing a mask and keep social distancing to help keep us safe until we’re all safe.

Want a deeper dive? Here’s everything you may want to know:

What Vaccines Are These?

In November 2020, Pfizer and BioNTech announced positive results from the conclusion of their COVID-19 vaccine clinical trials, quickly followed by Moderna. In February 2021, Johnson & Johnson’s announced the same.

Each has now been approved for use in multiple countries across the globe, with a few other vaccines rolling out on a country by country basis. Worldwide, more than 60 other vaccines are in various stages of clinical trials.

Each vaccine went through the standard three phases of clinical trials – Phase 1, where it is administered to a small number of people to show initial safety, Phase 2 to hundreds of people split into groups by things like age, ethnicity, and background to show how different types of people react to the vaccine, then Phase 3, in which it is given to tens of thousands of people, tested against a placebo. Because of the speed needed for development, both vaccines were approved to go through animal clinical trials at the same time as human Phase 1 clinical trials.

To be approved, the FDA requires the vaccine work in at least half of those who receive it. Early analysis from the National Institutes of Health independent data review board (DSMB) saw that 94-95% of those who received the Pfizer/BioNTech and Moderna vaccines in the trials became immune to the coronavirus. Johnson & Johnson’s vaccine showed 66% effectiveness against the virusMost importantly, all three vaccines provide significant protection against severe outcomes from the virus.

The Pfizer/BioNTech and Moderna vaccines are mRNA vaccines, a type of immunization that does not use the real virus in the vaccine, but instead employs a piece of genetic material to create antibodies against the novel coronavirus. Each of the mRNA vaccines requires two doses, given three to four weeks apart. The Johnson & Johnson vaccine is slightly different, which makes it easier to store and only requires one dose.

Other vaccines – different types of immunizations made by multiple companies – are currently in clinical trials with results expected early (and throughout) 2021. More than 50 vaccines are currently going through human clinical trials; in any trial where participants exhibit worrisome symptoms, the trial is paused and cannot proceed until any issues are corrected.

  1. More than 60 vaccines are under development worldwide. In the US, the three currently being distributed are from Pfizer/BioNTech, Moderna, and Johnson & Johnson, with some others being rolled out in certain countries.
  2. All three vaccines approved for emergency use in the US provide protection against severe complications or death from COVID-19. Each vaccine has a slightly different rate of protection against getting the virus at all, but each guarantees protection against the worst outcomes of the disease.
  3. The Moderna vaccine trials had a slightly more diverse participant group but both leading vaccine trials included participants from across races and ethnicities, age ranges, health conditions including type 1 and type 2 diabetes, etc. No specific populations experienced any major issues with the vaccines.

Do COVID Vaccines and Diabetes Mix Well?

People with diabetes in each of the vaccine’s trials have not reported major side effects (read this T1Ds experience in the Moderna COVID-19 vaccine trial). Overall, some clinical trial participants have reported mild side effects of the vaccines, much like how some people experience injection-site soreness, mild lethargy, a low-grade fever after other vaccines. These mild reactions some people experience after vaccines are typical and not cause for alarm – they are a result of the immune system going into action as purposely triggered by the vaccine, creating the ability to fight against the actual virus were a person to be exposed to it.

In the UK, two healthcare workers who received the Pfizer/BioNTech vaccine during initial general population rollout experienced severe allergic reactions for which they administered adrenaline autoinjectors. Both individuals had a history of severe anaphylactoid reactions for which they carry adrenaline autoinjectors anyway, so if you are a person who does tend to experience severe allergic reactions, it is recommended that you not receive the Pfizer/BioNTech vaccine at this time. Other vaccines may be better indicated for your use. If you do not have a history of severe allergic reactions, there is no reason to expect you will experience one from a vaccine.

Because of the mild symptoms experienced by some, it is important to stay vigilant about blood sugar levels for the first 24 to 48 hours after receiving the vaccine. The symptoms may impact your BG, so check your levels frequently, stay hydrated, and be familiar with your sick day routine. The mild symptoms you may experience after the vaccine are significantly safer and more easily managed than potentially getting COVID-19 itself.

As we currently understand, you are not more at risk to catch the novel coronavirus if you have diabetes, but if you do catch the virus, you may be more at risk for more severe complications from COVID-19, particularly if you have been experiencing consistently elevated blood sugar levels.

If you have specific concerns or worries, make sure you speak to a healthcare provider you trust (or keep tuning into Beyond Type 1 coverage of COVID-19 to hear from the healthcare providers we trust, like Dr. Anne Peters).

Read this T1Ds experience in the Moderna COVID-19 vaccine trial

Great, When Can I Get Mine?

While the vaccines rollout in the US started as a bit of a logistical mess, the process is finally starting to get more clear! As of March 31, the CDC classified all people with diabetes as part of priority vaccination groups, updating their previous guidance that only included type 2 diabetes. And as of April 19, the Biden administration has announced that all people aged 16 and above in the US are eligible for the COVID-19 vaccines.

The COVID vaccine rollout is being handled on a state by state basis, which has made finding vaccination appointments a bit tricky. Additionally, many states are falling short in equity – many vaccine appointments are only available online, and some states have limited and hard-to-get-to vaccine locations. If you’re trying to find a vaccine appointment, here are some recommendations:

  • VaccineFinder.org is a medical-professional vetted place to find a convenient vaccination appointment.
  • You can also look up your state health department’s guidelines. Each state generally has a special COVID-19 page where they then list out COVID-19 vaccine eligibility guidelines and locations. Many states have started working with local drug stores and pharmacies; if so, they are often linked to from the state health department website.
  • If it is unclear or you are unsatisfied with what you’ve found, go ahead and reach out to your healthcare provider. Particularly if you have a healthcare provider like an endocrinologist who helps you take care of your diabetes, they may have some insider information on how their hospital or practice is planning to distribute the vaccine. Remember to be kind and patient – healthcare providers are carrying an immense amount and they may not have an answer for you immediately.

What About Kids With Type 1 Diabetes (T1D)?

The Pfizer/BioNTech vaccine is currently approved for ages 16+; they also just requested clearance from the FDA to expand eligibility to ages 12 – 15. Initial COVID-19 vaccine trials were focused on the adult population – both because adults seem more susceptible to severe outcomes from COVID-19, and because trials for those under the age of 18 require a stricter review and approval process.

Starting in 2021 and beyond, more trials are including children so that they may be safely vaccinated against COVID-19 as well. Important to note is that children do not seem to be likely to contract coronavirus or have severe outcomes from the disease. However, as we’ve seen throughout the pandemic, disparities are abundant. Native Hawaiian, Pacific Islander, American Indian, Alaskan Natives, and Hispanic children have experienced significantly higher rates of infection than their peers. Non-Hispanic Black children with T1D who contract COVID-19 are four times more likely to also experience DKA.

So while generally children are less likely to contract the coronavirus, it is important to remain vigilant and continue practicing measures to protect everyone – like wearing a mask and social distancing – to keep everyone safe until we’re all safe.

Still Have Concerns?

Individuals have expressed some hesitation to personal vaccination for COVID-19. This is an understandable feeling – vaccines do not typically make it through development and approval this quickly.

Here’s what we know:

  1. The speed with which the vaccines were developed was unprecedented. However, the clinical trials these vaccines had to go through were strict and the reporting of their safety and efficacy had to be unequivocally proven and replicated. Three phases of clinical trials, including a Phase 3 with tens of thousands of participants, had to prove safety and effectiveness of the vaccines. Phase 3 of the clinical trials were also double-blind, meaning neither the trial participants nor the company that created the vaccine knew if participants were receiving the vaccine or a placebo. Data was reviewed by the National Institutes of Health independent data review board, and final approval for the vaccines must be provided by the FDA’s Vaccines and Related Biological Products Advisory Committee, composed of scientists who have no ties to the companies by which the vaccines were produced.
  2. The Moderna COVID-19 vaccine trial focused on creating a diverse trial participant group, knowing that this is vital to ensuring the vaccine works as intended across populations. 37% of the trial’s participants were from communities of color, which is similar to the US population. The Pfizer and BioNTech trial had less representation, and many of the ongoing trials are not reporting diversity numbers at all. It is vital that each and every trial not only focus on recruiting diverse – across age, race, ethnicity, health background, and more – trial participants to prove safety and effectiveness, but also proactively communicate the effects of their vaccines across groups.
  3. Black, Native (including Pacific Islander), and Latinx communities have been hit hardest by COVID-19 because of systemic and medical racism, with Black Americans dying from COVID-19 at twice the rate of white Americans. Ensuring equitable distribution of the COVID-19 vaccines is vital to work against the deep impact of systemic and medical racism, but this must be coupled with understanding distrust due to violent medical racism throughout the US’s history.
  4. We don’t know for sure what percentage of the population needs to be vaccinated in order to achieve herd immunity, but we do know that the more people who are immune to carrying or spreading the virus, the better. Those who are willing and able to take the vaccine are helping to protect everyone in their community.
  5. If, after doing research from reputable, science-based sources (we recommend science communicators like Jessica Malaty Rivera for easy-to-digest and accurate information), you are still not comfortable taking the vaccine as it becomes available to you, continue to practice safe health measures to protect yourself and others from the novel coronavirus. Until the majority of the population is vaccinated, we cannot rely on herd immunity. We must keep those most vulnerable among us safe until we’re all safe, practicing simple actions like wearing a mask and social distancing to do so.

2020 has been hard; at many times, scary and filled with grief. Working toward getting our communities safe and healthy is important for a multitude of reasons, and will take a united effort. Ensuring you have a plan for when you will get vaccinated once you can is vital to keep yourself and those most vulnerable among us safe until we’re all safe.

Source: diabetesdaily.com

Will Insulin in a Pill Soon Become a Reality?

Since insulin was first discovered and isolated for therapeutic use nearly 100 years ago, most everyone with insulin-dependent diabetes has had to rely on exogenous insulin, given in the form of injections, whether via an insulin pump or multiple daily shots every single day of their lives (inhalable insulin was approved by the FDA in 2014, but its use is not widespread).

While research and development have come a long way in that time, the reality for millions (and over 7 million people in the United States alone) has been thousands upon thousands of invasive injections, oftentimes causing scarring, bruising, and pain. However, that may be about to change.

Researchers from the New York University in Abu Dhabi have successfully developed a pill using nanomaterial layers that disseminate insulin in rats safely without being destroyed by their stomach acids. This could be life-changing for the millions of people around the world who rely on insulin to live.

“Imagine being able to take insulin in a pill instead of injecting it a couple of times a day,” said first author Farah Benyettou, a research scientist in the Trabolsi Research Group at the New York University in Abu Dhabi. “The insulin was loaded in a system that protects it from the acidic environment of the stomach. Once in the body, the system can sense the blood sugar level and can release the loaded insulin on demand.”

A pill form of insulin has the potential to radically change the daily management of diabetes for the better: It would make treatment easier for children and people with a fear of needles, safer for both patients and clinicians in hospital and clinic settings, more effective, and patient-friendly.

Nearly 30% of people with diabetes rely on insulin injections, and while it might not be for everyone, this revolutionary advancement would be the first of its kind in the world.

Other attempts at orally administering insulin have been made in the past but faced roadblocks in the gastrointestinal tract, where stomach acids and bile quickly destroy insulin and any effectiveness it has.

This is different from common type 2 diabetes drugs like Metformin that aren’t insulin but simply improve the efficacy of insulin that their body already makes.

The research team in Abu Dhabi thinks it has solved the problem of the insulin-destroying stomach bile issue by encapsulating insulin within nCOF nanoparticles in a capsule that is resistant to such acids but responsive to sugar, reacting quickly when it senses blood glucose in the body is rising but survives the dangerous journey down the G.I. tract to reach the bloodstream.

This new advancement also has the potential to reduce or eliminate low blood sugars, as the release of insulin shuts off as soon as it senses blood sugars have fallen. This creates a helpful feedback loop and prevents an overdose of insulin, which for many, is an almost a daily occurrence on injections, where people are constantly walking a balance beam to prevent both high and low blood sugars in a world of stress, meals, exercise, and normal everyday living.

While this is all excellent news, it’s important to remember that the study’s success was only observed in rats, and human bodies are very different. The team will next test different nanomaterials to see what may be appropriate for human trials, and potentially, widespread market availability.

“Our revolutionary technology developed at NYUAD will dramatically improve the well-being of diabetic patients worldwide in a very simple and straightforward way,” says senior author Ali Trabolsi, an associate professor of chemistry at the New York University in Abu Dhabi.

While taking a daily insulin pill may is far from a functional cure, managing diabetes could become easier than ever, especially if the threat of low blood sugars is greatly reduced or eliminated.

The team hopes that diabetes management can soon be a lot less stressful, painful, and dangerous for the millions of people around the world who currently rely on insulin.

Source: diabetesdaily.com

FDA Approves New Glucagon Option From Zealand Pharma

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

By Lala Jackson

On March 22, 2021, Zealand Pharma announced the FDA approval of Zegalogue in an autoinjector and prefilled syringe. The approval will add two more easy-to-use glucagon options, joining Eli Lilly’s nasal glucagon Baqsimi and Xeris Pharmaceuticals’ GVOKE HypoPen and prefilled syringe.

Slated to be commercially available in the US in June 2021 for ages six and older, Zegalogue’s approval follows three clinical trials in adults and children with insulin-dependent diabetes. Following use of Zegalogue in response to severe hypoglycemia, patients showed recovery (an increase in blood glucose of ≥ 20 mg/dL) within 10-15 minutes.

Dasiglucagon is a peptide analog (i.e. a human-created drug designed to mimic the actual hormone) version of glucagon, a naturally occurring hormone that triggers the body to release glucose reserves from the liver to raise blood sugar. In the body of a person with diabetes, this process has to be manually managed. However, partly because easy-to-use glucagon options are fairly new to the market, many people with insulin-dependent diabetes don’t typically carry or know when to use glucagon.

FDA guidance for Zegalogue and other forms of glucagon indicate usage in response to any severe hypoglycemic event, defined as a severe low blood sugar during which the person experiencing the low becomes unable to easily help themselves. A person with diabetes does not need to be experiencing seizures or unconsciousness before dosing glucagon, and it is safer to dose glucagon before either occurs.

For all forms of glucagon, possible side effects after dosing are nausea, vomiting, and headache, with a small number of people also experiencing diarrhea or injection site pain.

Source: diabetesdaily.com

What You Should Know About COVID-19 Vaccines and Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler and Dr. Francine Kaufman

Last updated: March 22, 2021

COVID-19 vaccines have been authorized for use in the United States and in many parts of the world. We’re here to answer questions for people with diabetes. Are the vaccines safe? How do the vaccines work and does it matter which one I get? What are the side effects, and how will the vaccine affect my blood sugar? What can I do after I am vaccinated?

Now that three COVID-19 vaccines have been authorized for use in the United States, and ten more around the world, many questions are circulating about the vaccines, their safety, and when to get vaccinated. While timing may differ by state and even between sites, people with type 2 diabetes or obesity will be eligible for early vaccination in the US in the coming months, though this may not be the case for millions of others – including those with type 1 diabetes and loved ones who are not currently recommended by CDC to receive the vaccine early. As states begin to distribute the vaccines, we’re here to answer your questions about COVID vaccination in the US; we’ll update this article as more information becomes available.

Click to jump down to a group of questions:

Why get the vaccine?
Why should I get the COVID vaccine?
How does the COVID-19 vaccine work?
How do mRNA vaccines work?​
How do viral vector vaccines work?

Vaccine Safety
Is the vaccine safe for people with diabetes?
Does it matter which vaccine you get?
Which vaccine is best for people with diabetes?​
What are the side effects? Can the vaccine be dangerous?
How will the vaccine affect my blood sugar levels?
Do diabetes medications affect the vaccine?
Should I get vaccinated if I have diabetes and other health conditions?
What is the AstraZeneca vaccine?

Getting the Vaccine
When will people with diabetes get the vaccine?
How will I know when it’s my turn to get the vaccine?
How much does the vaccine cost?
What should I expect at my vaccine appointment?
I had COVID-19 – should I still get vaccinated?
If I have symptoms of COVID-19 now should I get the vaccine?

After Receiving the Vaccine
What happens after I get the vaccine – can I still infect people with COVID?
Can I see people now that I am vaccinated?
Is one dose of the COVID vaccine effective?
Does the vaccine protect against the new variant of COVID?
Can I get COVID from the vaccine?
Are other vaccines coming?
When can I stop wearing a mask?

Why get the vaccine?

Why should I get the COVID vaccine?

The vaccine has the ability to protect you, your loved ones, and your community. It will help your body’s immune system fight off a COVID-19 infection – this means that if you are exposed to COVID, your body can protect you and significantly reduce your chances of getting sick or experiencing severe complications from the virus. Two of the vaccines that are currently authorized in the US (from Pfizer-BioNTech and Moderna) are almost 95% effective at preventing symptoms of COVID in adults who have been exposed, and the third vaccine (Johnson & Johnson) is 85% effective at preventing severe COVID infection. In other words, if you are vaccinated with any of the three and then come into contact with someone who has COVID, you probably won’t get sick.

To stop the global spread of COVID-19, the majority of people around the world will have to become immune to the virus. The COVID vaccine – like the many vaccines that protect us from small pox, measles, the flu, and other illnesses – will play a major role in improving the health and wellbeing of people across the globe.

How does the COVID-19 vaccine work?

There are currently three vaccines that have received emergency use authorization in the US: the Pfizer-BioNTechModerna, and Johnson & Johnson vaccines. The Pfizer-BioNTech and Moderna vaccines are similar – both use messenger RNA (mRNA) to target the “spike proteins” on COVID-19 virus molecules. The Johnson & Johnson vaccine is a viral vector vaccine that also targets the spike proteins.

How do COVID mRNA vaccines work?

mRNA contains genetic instructions (like a blueprint) for making specific proteins in cells. The mRNA in COVID vaccines was developed by scientists to trigger human cells to make harmless COVID spike proteins, and after the proteins are built the vaccine mRNA is destroyed. The body’s immune system then recognizes these foreign proteins and builds antibodies against them. This means that if you are later infected with COVID-19, you’ll have antibodies that recognize the spikes on the viral molecule and can destroy it. To learn more about this process view this detailed, interactive piece from the New York Times.

mRNA vaccines are not “live” vaccines – the live virus is not injected into a person’s body. This means that you cannot get COVID from the vaccine. Similarly, the vaccine will not alter your own genes.

How do COVID viral vector vaccines work?

Similar to an mRNA vaccine, a viral vector vaccine causes the body’s cells to make harmless COVID-19 spike proteins so that it can learn to recognize the foreign proteins and build antibodies against them. Later, if you are infected with COVID-19, your body will have antibodies ready to fight off the virus.

Instead of using mRNA, a viral vector vaccine contains the DNA for a different, harmless virus. In the case of the Johnson & Johnson vaccine, it’s an adenovirus – the type of virus that normally causes a cold or a flu – that has been engineered so that it does not make you sick. Once you get the injection and the virus is inside your body, its DNA can be read by your cellular machinery to produce spike proteins. As your immune system works to fight these foreign proteins, it will learn to protect you from COVID-19. To learn more about this process view a detailed, interactive piece from the New York Times.

Vaccine Safety

Is the vaccine safe for people with diabetes?

All three currently authorized vaccines – Pfizer-BioNTechModerna, and Johnson & Johnson – appear to be safe and effective for adults with diabetes. Rigorous clinical trials tested the safety of these vaccines in adults of all ages, races, and ethnicities, as well as chronic health conditions.

  • The Pfizer-BioNtech trial included 3,150 people with diabetes (8.4% of trial participants).
  • The Moderna trial included 2,858 people with type 1, type 2, and gestational diabetes (9.4% of trial participants).
  • The Johnson & Johnson trial included 3,389 people with type 1 and type 2 diabetes (7.7% of trial participants).
  • In terms of racial and ethnic diversity, the trials each included more than 20% Hispanic or Latino participants, almost 10% African American participants, and almost 5% Asian participants.

These vaccines were advanced quickly thanks to the immense resources provided for COVID vaccine development – even with a speedy process, the vaccine manufacturers had to follow the typical safety steps and thorough checks. Read more from the CDC about how the vaccines work, potential side effects, and details from the human clinical trials.

Does it matter which vaccine you get?

No – all three of the vaccines will protect you and those around you. However, there are some differences between the vaccines that may be important to people with diabetes.

Clinical trials found both mRNA vaccines to be extremely effective in adults – with almost 95% efficacy overall, only one in 20 people that receives the vaccine would get sick from COVID. Among the trial participants with diabetes, the Pfizer-BioNtech was 95% effective and the Moderna vaccine was 100% effective, while the Johnson & Johnson vaccine was 53% effective. Participants were only followed for a few months, so we don’t yet know the long-term effectiveness of these vaccines. As more vaccines are administered there will be more data collected, and hopefully children will be enrolled in clinical trials soon.

What does it mean for these vaccines to be “effective?” If a vaccine is 50% effective it successfully protects half of the people who receive it from getting infected by COVID-19 if they are exposed. If a vaccine is 75% effective, it protects three out of four people from COVID-19 infection. More importantly, all three vaccines are highly effective at preventing severe COVID-19 infection. All three clinical trials found that in people who did get infected after vaccination, the infection was much milder – among people who had received one of the three authorized vaccines, there were almost no deaths or hospitalizations resulting from COVID-19. To learn more about how the three vaccines compare, watch this video.

During early vaccine distribution, you likely won’t have any choice in which vaccine is available to you because there will be a limited supply and the goal is to vaccinate people as quickly as possible. Both mRNA vaccines require two shots, meaning that they are not considered fully effective until you have received both doses, and your immune system has developed protection against the virus (after the second shot). You should receive two shots of the same vaccine (either Pfizer-BioNtech or Moderna). The Johnson & Johnson vaccine only requires one shot.

Which vaccine is best for people with diabetes?Which vaccine is best for people with diabetes?

Due to the distinct design of each clinical trial, it can be hard to directly compare the three vaccines that are currently authorized in the US. However, based on trial data and information from the vaccine manufacturers, here’s the best information we have on how the vaccines compare.

Vaccine data table

Image source: diaTribe

The data show that no matter which of the currently authorized vaccines you get, getting a COVID-19 vaccine is safe and important for people with diabetes. All three vaccines are highly protective against severe COVID illness and death. Click here to watch an in-depth video explaining how the vaccines compare.

What are the side effects? Can the vaccine be dangerous?

When you receive a vaccine for a particular virus, your immune system builds protection against it. Because your body is creating antibodies and learning how to fight the virus or bacteria targeted by the vaccine, you may experience normal side effects for a day or two – this is similar to getting a flu shot, and people with diabetes should monitor their blood sugar levels and have a sick day management plan ready.

According to the CDC, these are the common side effects of the COVID vaccines – they are similar for people with and without diabetes:

  • Pain, swelling, or redness in the vaccinated arm
  • Fever
  • Chills
  • Fatigue
  • Headache
  • Nausea
  • Muscle pain

These side effects are a result of your immune system preparing to combat a future viral infection – they do not mean that you have gotten sick from the vaccine itself. If your side effects don’t go away, contact your healthcare team.

Severe allergic reactions to the COVID vaccine are rare – you can learn more from the CDC here. If you have ever had an allergic reaction to any vaccine, ask your healthcare professional if you should get the COVID vaccine. If you experience a severe allergic reaction to the first dose of the COVID vaccine, do not get the second dose.

How will the vaccine affect my blood sugar levels?

Because the vaccine can cause symptoms of illness that can lead to high glucose levels, it’s important to carefully monitor your blood sugar levels for 48 hours after you receive your vaccination. Stay hydrated, and make sure to have your sick day plan ready in case you feel ill. So far, people with diabetes seem to be experiencing few side effects and minimal effect on blood sugar levels.

Do diabetes medications affect the vaccine?

At this time there is no information available on drug interactions between the authorized COVID vaccines and other medications – this has not yet been studied. However, it is not anticipated that the vaccine itself would interact with insulin or other standard diabetes medications. Note: it may be helpful to avoid injecting insulin or placing a glucose sensor or pump infusion set in your vaccine injection site for several days after vaccination.

Should I get vaccinated if I have diabetes and other health conditions?

People with complications of diabetes (including heart disease and kidney disease) are at much higher risk of severe illness from COVID-19. If you have other health conditions in addition to diabetes, getting the vaccine is especially important.

What is the AstraZeneca vaccine?

New results from the US clinical trial of the AstraZeneca viral vector vaccine show that the vaccine was 79% effective at preventing symptoms of COVID-19 infection, and fully prevented severe illness and hospitalization in more than 32,000 participants. The two-dose AstraZeneca vaccine is currently authorized in Europe and in other countries, but has not yet been authorized for use in the US. The latest clinical trial results show the vaccine to be both safe and effective.

In early March, several countries briefly paused giving people the AstraZeneca COVID vaccine due to concerns about possible rare side effects, including severe blood clots. However, since the data does not show that the vaccine increases the risk of blood clots, the World Health Organization determined that it is safe and that the benefits of the vaccine outweigh any risks. We look forward to updating this article if the AstraZeneca vaccine receives FDA authorized in the US.

Getting the Vaccine

When will people with diabetes get the vaccine?

In most places across the US, people with type 2 diabetes and obesity will be prioritized in the third group of early vaccination (Phase 1c) – this has already begun in some parts of the country. Type 1 diabetes is not currently considered a high-risk medical condition for this phase. Some diabetes experts believe that if you have type 1 diabetes and any evidence of kidney damageheart disease, or obesity with high insulin doses, it’s a good idea to seek vaccination as soon as possible because you may be at high risk for severe illness if you are infected with COVID-19. To learn about the CDC’s recommended stages of vaccination and where you fall in the vaccine line, read Dr. Francine Kaufman’s “When Can I Get the COVID Vaccine if I Have Diabetes?

How will I know when it’s my turn to get the vaccine?

The distribution of vaccines is the responsibility of each state, and states have different plans for vaccinating people. Most states will use networks within hospitals, healthcare offices, and pharmacies to distribute vaccines to residents. Depending on where you live, you may be asked to get on a vaccine waiting list. Click here to see the state by state report from the Kaiser Family Foundation, including who is currently eligible for vaccination in your state. To learn more about your place in the vaccination line, read Dr. Kaufman’s “When Can I Get the COVID Vaccine if I Have Diabetes?” If you have type 2 diabetes or obesity (a body mass index above 30 – check here), contact your healthcare office to ask when and how you can get vaccinated.

How much does the vaccine cost?

You will not have to pay for the COVID vaccine in the US; it will be given to all US residents for free. That said, some vaccination providers may charge an administration fee for delivering the injection. Ask your healthcare office if there will be any costs associated with your vaccination.

What should I expect at my vaccine appointment?

When you get your COVID vaccine, you’ll receive a paper card that says which vaccine you received, and when and where you received it. You’ll also get a fact sheet (paper or electronic) with more information about the vaccine, its benefits, and its side effects. After you get your injection, you’ll be asked to stay on-site for a short period of time so that healthcare professionals can monitor your body’s reaction.

I had COVID-19 – should I still get vaccinated?

Yes – though you can wait up to 90 days after initial onset of your COVID-19 infection. Researchers don’t know how long immunity against the virus can last after natural infection, though evidence suggests that you’re not likely to get sick with COVID again for the first 90 days. You should still get vaccinated for longer-term protection, and the CDC says that you can wait 90 days after the infection before getting your vaccine.

If I have symptoms of COVID-19 now, should I get the vaccine?

If you recently tested positive for COVID-19, are currently experiencing symptoms, or were exposed to someone with COVID, please stay away from other people.

  • If you test positive for COVID, wait until you’ve recovered (as early as 14 days from infection) and up to 90 days before getting the vaccine.
  • If you are experiencing symptoms of COVID, self-isolate and get tested.
  • If you were exposed to someone with COVID, quarantine for 14 days and monitor yourself for symptoms. Get a COVID test. If you do not get sick and your test is negative, get vaccinated once your quarantine period is over.

After Receiving the Vaccine

What happens after I get the vaccine – can I still infect people with COVID?

Once you have received both doses of the vaccine, it should protect you from getting sick with COVID. However, researchers don’t know whether you may be able to carry the virus (without symptoms) and pass it on to others. That’s why it’s still important to maintain safety measures even after receiving the vaccine: wear a face mask that fits you well if you’re in public, avoid contact with people not in your household, social distance from others, wash your hands, and monitor your health. Continuing to follow these measures will help you protect others and your community.

Can I see people now that I am vaccinated?

Two weeks after your final vaccine dose (one dose for Johnson & Johnson, two doses for Pfizer-BioNTech or Moderna) you are considered to be fully vaccinated and protected against severe COVID-19 infection. According to new CDC guidelines, people who are fully vaccinated:

  • Can gather indoors with others who are fully vaccinated, with no need to wear a mask.
  • Do not need to quarantine, stay away from others, or get tested if exposed to someone with COVID – unless you begin to show symptoms of illness.

The CDC also says that people who are fully vaccinated can “visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing.” However, people with diabetes have a higher risk of getting severely ill from COVID-19 (though there’s no greater chance of being infected). For this reason, even if you are vaccinated, please continue to be cautious.

Is one dose of the COVID vaccine effective?

For the Johnson and Johnson vaccine, yes.

For the Pfizer-BioNTech and Moderna vaccines, not entirely. Results from the clinical trials (Pfizer-BioNTechModerna) show that one dose of the vaccine can offer some protection, but two doses of both authorized vaccines are required for full efficacy.

Does the vaccine protect against the new variant of COVID?

Probably, but not certainly. Researchers are still studying the newest variants of COVID-19 to determine how effective current vaccines are at protecting against them. So far, much of the virus structure is unchanged in the variants and the currently-authorized vaccines seem to produce antibodies that recognize variants of COVID-19. Other strains of COVID will likely develop with time (similarly to the flu), and the vaccines can then be tweaked to match the changed threat. Click here to learn more about COVID variants, how they work, and what you can do to protect yourself.

Can I get COVID from the vaccine?

No. The vaccines do not contain the live virus, so they cannot infect you with COVID-19. Side effects that appear after you receive the vaccine occur because your immune system is activating and building antibodies – they are not signs of infection.

After vaccination it takes time for your body to develop full immunity to the virus, so it is still possible to get infected with COVID in the days before or after your vaccination. This does not mean the vaccine did not work; rather, it means that your immune system did not have enough time to build full immunity from the vaccine before coming into contact with the virus.

Are other vaccines coming?

To date, 13 vaccines have been approved for full or limited use around the world. Seventy-eight vaccines are currently in different stages of human clinical trials: 55 are in the early stages and 23 are in the final stages of testing. Hopefully, some of these vaccines will be found to effectively protect against COVID, opening up more vaccination options for people around the world. To track global vaccine development, view the New York Times Coronavirus Vaccine Tracker.

When can I stop wearing a mask?

Even after you get the vaccine you should still wear a face mask whenever you are in public places. Masks will continue helping to shield you from the virus and new variants of COVID (since no vaccine is perfect), and will reduce your chances of spreading COVID-19 to people around you (if you are carrying the virus and don’t have symptoms). As more people get vaccinated, the number of people carrying the virus in your community will decrease, bringing the risk of infection down. Public health authorities will make announcements about this, which may vary from place to place and even with the season.

If you are fully vaccinated, you can begin spending time with others who are fully vaccinated without wearing face masks.

While we await further information and research on COVID vaccines, protect yourself and those around you. For more information, read “Staying Safe – And Staying Well – During a Pandemic Winter” and “COVID Variants, Double Masks, Diabetes, Oh My!

Editor’s note: This article was first published on January 8, 2021, and last updated on March 22.

Dr. Francine Kaufman is Chief Medical Officer at Senseonics, a diabetes device company and Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine, University of Southern California.

Source: diabetesdaily.com

What if a Pump Could Deliver Both Insulin and Glucagon?

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

By Lala Jackson

Diabetes technology like insulin pumps and continuous glucose monitors (CGMs) have created less burdensome care routines for people living with diabetes who are able to get them. For some, this tech has also led to lower A1c, more time in range, and fewer hypoglycemic events. As we work to get better access to diabetes technology and medications for all who need them, we’re also looking forward to what’s next in diabetes tech – dual hormone artificial pancreas systems that keep blood sugar levels in a healthy range using both insulin and glucagon delivery.

Existing artificial pancreas (AP) systems, also known as hybrid closed loop systems, integrate insulin-only pumps and CGMs using a programmed algorithm that allows the insulin pump to “make decisions” in insulin dosing based on the blood sugar number provided by the CGM. In the current systems, the insulin pump can dose insulin in response to high blood sugars, but has no way to directly address a predicted low blood sugar other than lowering or stopping insulin delivery, or suggesting external actions (such as eating carbs) be taken. Even with this limitation, current AP systems are shown to significantly improve daily time in range, a key measure for safety and quality of life in those living with diabetes. But what if we could more closely mimic a fully functioning pancreas?

Enter, the Dual Hormone Artificial Pancreas

Also known as the bihormonal artificial pancreas (BHAP), several companies have been working on these systems over the last decade, but the last few years show promise toward a streamlined, effective, easy-to-use BHAP.

In late 2019, the FDA granted breakthrough device designation to the iLet™ pump system, made by Beta Bionics. Breakthrough device designations create an accelerated regulatory review process for a product or therapy that “has potential to address unmet medical needs.” Essentially, it shows priority for a solution that is believed able to create a large impact on people’s lives, beyond anything currently available.

Beta Bionics’ intentions for their iLet systems are ambitious – they aim to provide their system in insulin-only, glucagon-only, or bihormonal with both insulin and glucagon. Additionally, their algorithm is unique, in that the wearer must only enter their body weight, “with no need to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

The iLet system was granted breakthrough designation with the use of insulin analogs that are currently approved for usage in an insulin pump, alongside Zealand Pharma’s dasiglucagon, recently approved by the FDA for use in an autoinjector and prefilled syringe. Dasiglucagon, a glucagon analog (i.e. a synthetic lab made version of the naturally occurring hormone), is stable as a liquid, versus old formats of glucagon in which a powder and liquid had to be mixed immediately before use.

Beta Bionics’ insulin-only AP system is currently in Phase 3 clinical trials, with its BHAP system slated to be one to two years behind, having completed a Phase 2 at-home use trial in 2019. Phase 3 trials of the BHAP system are expected in 2021.

Other insulin and glucagon BHAP systems are also in development, with additional companies looking into a dual-hormone format pump using insulin and pramlintide (commercial brand name Symlin), aimed at better mimicking natural absorption rates of food, leading to better time in range.

The Bottom Line

As we get closer to diabetes technology that more closely mimics a fully functioning pancreas, affordable access to both life-improving diabetes technologies and life-sustaining insulin remains key. Robust diabetes technology has the power to greatly improve quality of life, particularly when coupled with affordable, equitable healthcare.

Source: diabetesdaily.com

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