Metformin May Reduce Your Risk of Death from COVID-19 Infection

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler

The use of metformin – the most common initial medication for people with type 2 diabetes – was associated with a lower rate of mortality from COVID-19 among people with diabetes in a study in Alabama, confirming five previous studies.

Do you take metformin? It’s the first-line therapy used to lower glucose levels in people with type 2 diabetes. A recent study found that metformin use was associated with a lower rate of COVID-related death among people with type 2 diabetes. Since people with diabetes are at increased risk for severe illness from COVID-19, including hospitalization and death, the relationship between metformin and COVID outcomes in this report may be of interest to many people around the world who take the medication.

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The study looked at the electronic health data from 25,326 people tested for COVID at Birmingham Hospital in Alabama, including healthcare workers, between February and June of 2020. Of those tested, 604 people were positive for COVID-19 – and 239 of those who were positive had diabetes. These results showed that the odds of testing positive for COVID were significantly higher for people, particularly Black people, with certain pre-existing conditions, including diabetes. This does not mean people with diabetes are more likely to get COVID-19, only that people with diabetes were more likely to test positive at this hospital.

Importantly, the study found an association between metformin use and risk of death – the study reported that people who were on metformin before being diagnosed with COVID-19 had a significantly lower chance of dying:

  • People taking metformin had an 11% mortality (or death) rate, compared to 24% for those with type 2 diabetes not on metformin when admitted to the hospital.
  • This benefit of metformin remained even when people with type 2 diabetes and kidney disease or chronic heart failure were excluded from the calculations. This is important because people with kidney or heart disease are often advised against taking metformin. By removing this population, it helps to support the notion that metformin may be involved in this difference.
  • Body weight and A1C were not associated with mortality among people with diabetes taking metformin. This suggests that the association of metformin use with reduced COVID-related deaths was not due to the effects of the medication on weight or glucose management.

The data suggest that being a person with diabetes who takes metformin may provide some level of protection against severe COVID-19 infection among people with diabetes. Other studies have shown similar results, though it is not known whether metformin may itself reduce COVID-related deaths among people with type 2 diabetes. The authors discussed some previously reported effects of metformin beyond lowering glucose levels, such as reducing high levels of inflammation (the body’s natural way of fighting infection), which has been described as a risk factor in severe COVID infection. Severe infection with COVID-19, resulting in hospital admission, can lead to damage to the kidneys and decreased oxygen supply to the body’s tissues – and in these circumstances, serious side effects of metformin can occur.

“Given that COVID leads to higher mortality rates and more complicated hospital courses in people with diabetes, it is important to consider whether specific diabetes medications can provide some relative degree of protection against poor COVID outcomes,” said Dr. Tim Garvey, an endocrinologist at the University of Alabama at Birmingham. “This study adds to growing evidence that people with type 2 diabetes treated with metformin have better outcomes than those not receiving metformin.”

Dr. Garvey also cautioned: “Of course, these case-control studies show associations and do not rise to the level of evidence that might be found by a randomized clinical trial. For example, people with diabetes not treated with the first-line drug, metformin, may have a larger number of diabetes complications or longer duration of disease compared with people not on metformin – which could explain the more severe outcomes. In any event, we advocate for early administration of COVID-19 vaccines and other protective measures for people with diabetes.”

Professor Philip Home, a professor of diabetes medicine at Newcastle University in the UK, agreed, saying, “Multiple studies have now addressed the issue of whether metformin and insulin use are associated with better or worse outcomes in people with diabetes who contract COVID-19. In line with previous literature on other diseases, it was expected that people on metformin would do better, and people on insulin worse, than people with diabetes not using these medications. This is confirmed.”

Home continued: “It is believed to happen because people using metformin are younger and have better kidney function than those not taking the medication, while those on insulin tend to have other medical conditions. The good news is that if you have type 2 diabetes and are taking metformin, you are likely to be fitter than if you have type 2 diabetes and do not take the medication – but there is no evidence that metformin itself will make a difference to your outcome if you do get COVID-19. So, get vaccinated as soon as possible!”

To learn more about metformin, read “Everything You Always Wanted to Know About Metformin, But Were Afraid to Ask.”

Source: diabetesdaily.com

Is COVID-19 Causing a Diabetes Epidemic?

As the COVID-19 pandemic rages on into its second year, researchers have discovered a new, disturbing trend: there has been a statistically significant rise in both type 1 and type 2 diabetes diagnoses observed in patients after an experience of severe COVID-19. Even more disturbing is that nearly 14.4% of people who are hospitalized with COVID-19 go on to have either a type 1 or type 2 diabetes diagnosis, according to a November 2020 study that followed nearly 4,000 patients with severe COVID-19 infections.

It’s too early to tell if these forms of diabetes are permanent or temporary, but the correlation between severe COVID-19 cases and the development of diabetes is strong.

It’s well known that viruses can sometimes trigger diabetes. When someone contracts a virus, the immune system starts mounting a defense to fight it, mostly with T-cells. Sometimes the body will overreact, and start destroying its own pancreatic beta cells, the result being type 1 diabetes.

Scientists believe the same thing may be happening in the case of COVID-19 patients. Traditionally, COVID-19 has been an attack on the lungs, but a host of other issues and complications have come to light from sufferers of “long-haul COVID”: neurological disorders, blood clots, kidney failure, heart damage, and now many believe an epidemic of both type 1 and type 2 diabetes diagnoses may soon be added to the list.

The association between other coronaviruses and the development of diabetes has been made in the past during the SARS outbreak as well.

After the 2003 SARS pandemic, Chinese researchers tracked 39 patients who had developed high blood sugar levels characteristic of a diabetes diagnosis, within days of hospitalization with the disease. For all but six, blood sugar levels had returned to normal by their hospital discharge, and only two still had diabetes after two years.

This isn’t entirely new, either. Doctors in Wuhan, China reported a link between COVID-19 and elevated blood sugar levels back in April 2020. Italian scientists also looked into whether higher blood sugar levels could lead to a diagnosis of diabetes. That study, from May 2020, admitted more research needed to be conducted before a conclusion was reached.

Because COVID-19 is a global pandemic and the link to new diabetes cases has been observed in multiple countries, researchers globally are collecting data points about those patients in a registry called CoviDIAB.

Scientists do not know whether COVID-19 might exacerbate already developing issues or actually cause them; some believe it’s both. Many people who have had COVID-19 and have gone on to develop type 2 diabetes already have existing risk factors, such as obesity and a family history of the disease. Perhaps the increased medical attention sought out by people suffering from COVID-19 has detected the disease early, when a diagnosis was inevitable later on down the line anyway. Some medical experts believe that more people are getting medical attention than ever before, being closely monitored by experts in the field, and are unveiling underlying issues that may have been there all along.

Another theory is that elevated blood sugar levels also are common among those taking dexamethasone, a steroid that is a common treatment for COVID-19. Steroid-induced diabetes is rare, but not unheard of, and may trigger diabetes in people who have no known health risks for the disease.

“Researchers are working like crazy to see if COVID attacks the beta cells of the pancreas, which makes insulin,” pediatrician Dr. Dyan Hes said. “Some studies feel that they do, but other studies have been repeatedly saying it is not attracted to the beta-cell.”

How exactly the two conditions are connected isn’t quite clear yet, but a prominent theory is that the COVID-19 virus destroys or alters insulin-producing beta cells in the pancreas possibly by binding to ACE2 receptors, according to a short letter published in the New England Journal of Medicine.

Whatever the association is, researchers from the journal of Diabetes, Obesity, and Metabolism say a direct effect of COVID-19 on the development of diabetes, “should be considered.”

Francesco Rubino, a diabetes surgery professor at King’s College London, is convinced there is a connection between the two conditions and has been tracking and studying the phenomenon since early last year. “We really need to dig deeper, but it sounds like we do have a real problem with COVID and diabetes.”

Additionally, Rubino thinks the type of diabetes being developed as a result of COVID-19 may be a hybrid form, something of a cross between type 1 and type 2. His findings show that the symptoms in these patients have some characteristics of each form of diabetes, which he finds concerning.

Researchers are also now seeing a rise in type 2 diabetes diagnoses in children who have had asymptomatic COVID-19, which is even more troubling, as many schools are back in session, many public places do not require masks on children, and the tipping point of a diabetes epidemic may rest solely on the shoulders of our youngest, most vulnerable citizens.

This can also complicate a few things for people: firstly, that neither the Pfizer-BioNtech nor the Moderna COVID-19 vaccines are approved for children, and secondly, that type 1 diabetes is not being prioritized on the Centers for Disease Control and Prevention’s list for vaccine dissemination. States are able to follow their guidance or dismiss it out of hand, but federally, there is no coordination to prioritize the population.

With nearly 10% (34 million people) of the United States already affected by diabetes, and another 100 million living with prediabetes, the tidal wave of COVID-19 cases could very well send our country into catastrophe fighting two disasters at once: both uncontrolled community spread of COVID-19 along with a (COVID-triggered) explosion of new diabetes diagnoses, especially in children. This would not only send our country into panic mode but could also completely overwhelm our already fragile health care system that everyone is so heavily relying on.

Scientists are rushing to find the exact connection between severe COVID-19 cases and new diagnoses of diabetes, but between diabetes being a major risk factor for death in COVID-19 cases (nearly 40% of COVID-19 deaths have been in patients with diabetes), along with the increased risk of developing diabetes from a severe bout of COVID-19, one thing is for sure: we need to find the connection and fast and get the diabetes community and those at risk for diabetes vaccinated as quickly as possible. We don’t have time to waste.

 

Source: diabetesdaily.com

Survey Reveals the Heavy Burden of the Pandemic on People with Diabetes

The COVID-19 pandemic has now been ongoing for over a year, and even with the light finally visible at the end of the tunnel, it is undoubtable that it will have lasting effects, for years to come.

Late in 2020, we partnered with the American Diabetes Association (ADA) to conduct a survey-based analysis to assess the effects of the COVID-19 pandemic on Americans living with diabetes.

Approximately 2,600 responses were collected from the Thrivable online patient panel. People from all 50 states shared their experiences during the pandemic, describing the impacts on access to healthcare, food, outlook on receiving a COVID-19 vaccine, and more.

Key Findings: Reduced Health Care and Food Access

  • About 4 of 10 Americans with diabetes delayed seeking routine medical care, with more than 50% stating the fear of COVID-19 exposure was the primary reason.
  • About 1 in 5 Americans with diabetes have foregone or delayed getting an insulin pump or continuous glucose monitor (CGM).
  • More than 1 in 4 stated their access to healthy food was reduced, with about 1 in 5 relying on food assistance programs.
  • Almost half who receive assistance report that the food they receive negatively affects their diabetes management.
  • About 1 in 5 people who receive nutritional assistance report not having enough food to eat.

Moreover, about 1 in 5 Americans with diabetes have reported having to choose between buying food vs. affording their diabetes supplies.

The effects of the COVID-19 pandemic are widespread and span across multiple facets of people’s lives. For people with diabetes, many of whom are already struggling to afford their healthcare expenses, the financial effects of the pandemic may be particularly grim.

Perspectives on the COVID-19 Vaccine

When asked about their comfort level of receiving a COVID-19 vaccine as soon as it is made available to them, people with diabetes reported being more likely to want to receive it right away as compared to data collected from the general population.

Less than half as many people with diabetes stated that they would never want to get the vaccine as compared to data on the general population (10% vs. 21%, respectively).

It is perhaps not surprising that people with diabetes feel more strongly about receiving a COVID-19 vaccine than the general population. Currently, the Centers for Disease Control and Prevention (CDC) state that people with type 2 diabetes  “are at increased risk  of severe illness” from COVID-19, while people with type 1 diabetesmight be at an increased risk for severe illness.”

Other Insights: Barriers to Clinical Trials Participation

In addition to exploring the financial burden of the pandemic and assessing readiness to receive a COVID-19 vaccine, we also gathered information regarding previous participation or willingness to participate in a clinical trial. As per the recent press release,

“People with diabetes have participated infrequently in clinical drug trials in the past (only 11% report having done so), but the majority – 60% – say they are likely or very likely to participate in such a study in the future. Yet nearly a quarter of those who responded to the survey said they didn’t know how to participate in a drug trial if they wanted to do so.”

Check out the full press release from the ADA as well as the more data below:

New Data Alert: COVID-19 Brings Crisis of Access for Millions Living with Diabetes

Effects of the COVID-19 Pandemic on People with Diabetes

Methodology and Panel Demographics

These figures are based on Thrivable’s survey of more than 2,500 people with diabetes nationally, between December 7th and December 14th, 2020

  • A multiple-choice survey was distributed online to people with diabetes (U.S. residents) who signed up for the Thrivable Insights panel.
  • Participants were not compensated for their responses.
  • Data was analyzed using Qualtrics and Excel.
  • Details on panel breakdown include:
    • N = 2,595
    • o 47% with type 1 diabetes, 53% type 2
    • o 69% female, 31% male
    • o All 50 U.S. states are represented

Source: diabetesdaily.com

COVID-19 Vaccine: Experience and Thoughts from the Diabetes Community

We are almost one year into the COVID-19 pandemic and while it is still causing devastation, there is light at the end of the tunnel thanks to two companies, Pfizer and Moderna, now offering a vaccine.

It varies by state but healthcare workers and people over 75 years (over 65 in some states) are the first in line. After that, people with high-risk, pre-existing conditions will be next. See here to find out your exact eligibility per state.

Many people have mixed feelings about the vaccine. Some are certain they will get it, not only because they don’t believe the vaccine is at all harmful but because they want life to go back to normal as soon as possible, while also protecting their health. Others are reluctant, possibly questioning the novelty and quick turnaround of the vaccine and wondering if there may be unforeseen side effects.

We thought it would be nice to hear from people like ourselves, who also live with diabetes, and see how they feel about getting vaccinated. We also spoke to some people who have already received the vaccine and heard about their experiences with side effects.

We asked our own Diabetes Daily forum members and the diabetes online community and here is what they had to say:

My wife with type 2 diabetes also suffers from COPD, bronchitis, and asthma. Accordingly, she would have a problem surviving COVID, so we have both registered with the NJ Covid Registry and will take the vaccine as soon as it becomes available. ~ Don1942

As I see it, two of these vaccines (Pfizer and Moderna) use a completely new and untested approach called mRNA. They were tested for only a short term on young, healthy adults. Animal, medium, and long-term testing were bypassed entirely. No testing on those with various health issues, and no testing for drug interactions. They only claim to reduce the number of symptoms. Zero claims are made about keeping you from getting or transmitting the virus. Last statement verified by Fauci saying anti-social distancing, lockdowns, and masking will still apply once you have had the vaccine. Then there are the 3+% of those who are vaccinated who suffer worse side effects than the symptoms the drug is supposed to reduce, keeping in mind that in the age groups tested only 1% would ever show any symptoms at all.

Finally the manufacturers take zero fiscal responsibility for bad outcomes. If they don’t believe their drugs are safe, why should I? ~ BobCan2

I have a nephew that has a doctorate in biochemistry (currently working on gene therapy). Said “I would take any of the vaccines in a second.” His wife also an MD has had the Moderna vaccine. I have a niece that is working on her doctorate in microbiology who has had the vaccine. So yes, I will take it. ~ 1986

I’m a no. Given my recent extended exposure, I’m not concerned. I’ll gladly wait for herd immunity. ~ HaoleBoy

I am a surgeon. I got the first dose of the Moderna vaccine. Just a sore arm. I have reviewed all of the science presented to the FDA and have no concerns. Glad to have access! ~ Dr. Carrie D.

So I voted yes… I’ve stated before that I used to be in the vaccine industry and I trust the science and the process. It’s not new technology being used. ~ Jughed

I’m getting the Moderna vaccine on Monday. I am a special education teacher in WI and we are the first group identified in the school district. Blessing! ~ Melissa R.

I think most people of my age remember friends getting polio, and I also remember giving my father chickenpox, which made him very, very ill; so having seen the miracles these vaccines did for quality of life, and preventing unnecessary deaths, I know I am very much pro-vaccination. My name will go down for a vaccine when it finally arrives here, hopefully, next month. I’m eligible for priority vaccination because of my age and a couple of chronic conditions.

I am 81 years old and a type 1 diabetic for 75 years. I am very high risk if I have the COVID virus. I am scheduled for the vaccine on Wed, Jan 21. My only hesitance is that the vaccine is being given in the gym complex at the local high school. I will probably encounter several individuals in the parking lot, while entering the building, inside the building, etc. In some states, people are receiving the vaccine without getting out of their cars. I wish it was done that way here where I live. ~ Richard `57

I am getting mine next weekend. I am 100% behind the science and haven’t given it a negative thought. Bring it on! ~ Susan K.

I’ll have it as soon as it’s offered. I am just recovering from COVID and it is awful. Sugars were terrible. I never want it again if I can help it. ~ Michelle R.

I will not be getting one. Mostly because I can’t help but think childhood vaccines play a major role in type 1 diabetes in the first place as vaccines are designed to trigger the immune system. ~ Fabian B.

I plan on getting the J&J one once it’s approved. I’m uncomfortable with the speed of the first two on the market, despite all I know everyone is saying. I feel better about the slow poke even if it’s irrational. ~ Caroline L.

Nope, nope and nope again. ~Kristin R.

I won’t be giving it to my son or myself. ~ Julie P.

I plan on getting one. In Nebraska, people living with diabetes are now eligible. ~ Wendy G.

My daughter is type 1 but it is not approved for children yet but she will not receive one and will remain not vaccinated as she always has been. ~ Stefanie R.

Here is what the people who have already received the vaccine had to say:

I had both doses. I’m 10 days out and still feel very run down. I was COVID-tested yesterday because it felt like a mild case but was negative. I received the vaccine 2 weeks ago and no side effects. Type 1 for 55 years. ~ Cindi H.

Tolerated both injections. Side effects were mild, with some deep muscle soreness, at least for me. I did note some insulin resistance post injections. ~ Chris A.

I got my first dose a couple of weeks ago and will get my next one in two weeks. I just had a sore arm and a little fatigued the next day. By the third day, I felt pretty normal. I didn’t notice any changes to my insulin sensitivity or blood sugar levels. ~ Karissa G.

I received both doses. My only issues were headache, fatigue, and chills.

COVID vaccine update #2: 24 hours later, I don’t feel horrible, but definitely off. Some body aches, headache and overall sluggishness. I went to bed at about 8:30 and “slept” till 10:30. (with my saul dog interruptions and the baby kicking my bladder, etc.)” ~ Nicole M.

I had mine because I work for the National Health Service and I had no side effects at all. ~ Kate B.

I was nauseous after my first dose for about 12 hours. I took a Zofran and was fine. ~ Jamie B.

I did have side effects (pain, mild fever) but I won’t hesitate to go for the second shot.

I have completed the series and just had a sore arm for a couple of days each time.

No side effects beyond a sore arm. I like the peace of mind and I did extensive research before getting it to fully understand what I was getting into. ~ Sarah R.

My 82-year old identical twin sisters each received the first dose. One got the Pfizer and the other the Moderna. No adverse reactions thus far. The one that got the Pfizer has allergies so was a bit concerned but had no reaction. ~ Auburn75

It should be mandatory that vaccines like this are taken. It’s not a conspiracy theory. There aren’t robots in the vaccine. This whole virus story isn’t a hoax, and this hasn’t been started because some people are simply trying to make some money. The sheer lunacy I’ve seen out there is beyond description. Some people think the world is flat. I’ve gotten both doses and have had zero side effects. ~ Sheralyn B.

I received my first vaccine on Jan 8 with minimal side effects being a sore arm and mild low blood sugars. On Jan 27 I received my second vaccine. Initially only had a sore arm and headache but after 36 hours, developed mild fever of 99.7, body aches, headache, continued low blood sugars, and a grape side swollen lymph node in my armpit, the arm I received my vaccine in. Fever and swollen lymph node improved with Tylenol and Ibuprofen! ~ Carlie W.

Will you be getting the vaccine once it is available to you? Have you had one or both doses and experienced side effects? Share and comment below!

Source: diabetesdaily.com

New Therapy to Treat Type 1 Diabetes Rolls Out Clinical Trial

Type 1 diabetes is an autoimmune condition whereby the person’s own immune system attacks the pancreatic cells that produce insulin. Insulin signals for glucose uptake into cells, a carefully regulated and important process, that when disrupted, can lead to an array of health complications, and without treatment, results in death. Many advances in the care of type 1 diabetes have been made in the last century; however, there is no cure for the condition, and patients rely on frequent blood glucose monitoring and insulin injection or infusion therapy to survive.

We have been closely following the work of Dr. Bart Roep and his colleagues at the City of Hope over the last several years. We first spoke to him at the 79th American Diabetes Association (ADA) Scientific Sessions in 2019.

“Dr. Roep has dedicated his professional life to trying to cure type 1 diabetes. Over an almost 30-year career, he has earned numerous prestigious awards and is perhaps most well-known for his work discovering how T-cells recognize specific antigens on beta cells in the context of type 1 diabetes pathogenesis. Currently, he is Chan Soon-Shiong Shapiro Distinguished Chair in Diabetes and the founding chair of the Department of Diabetes Immunology within City of Hope’s Diabetes & Metabolism Research Institute. Dr. Roep is also the director of the Wanek Family Project for Type 1 Diabetes.”

The immune system coordinates defenses against pathogens (like viruses and bacteria) via intricate cross-talk between different immune cells in the body. It is also able to recognize the host (self-tolerance) and under normal circumstances, should not attempt to destroy the person’s own cells (with the exception of special circumstances, like cancerous cells, for instance).

Photo by iStock

For the treatment of autoimmune conditions, like type 1 diabetes, much research is ongoing in an effort to “re-write” some of the “programming” and cellular cross-talk thought to be responsible for autoimmune attack. The “inverse vaccine” for the treatment of type 1 diabetes attempts to do just that in the following process:

  1. Immune cells are taken from patients and “re-educated” in the test tube to improve self- tolerance
  2. These cells are injected back into the patient, in hopes that they will not longer drive autoimmune attack, but rather “educate” the immune system to tolerate the person’s own beta cells

Last year, we reported that the initial safety and tolerability studies appeared promising.

Now, additional clinical trials are poised to begin:

“The vaccine is made using one’s own immune cells (dendritic cells) and a beta cell protein. The vaccine may teach the immune system to stop attacking the beta cells, which may help the beta cells recover and make enough insulin to control blood sugar levels. The vaccine may also help reduce future type 1 diabetes related complications.”

It is a very exciting time for type 1 diabetes as we move from just treating the symptoms to actually trying to stop the disease,” Roep remarked in a recent press release.

What are your thoughts on this research? Would you participate in the trial?

Source: diabetesdaily.com

Has President Biden Just Canceled Affordable Insulin?

President Biden, a long-time champion of both expanded access to healthcare and affordable prescription drugs, just froze a move made by the Trump administration late in his term aimed at reducing the cost of insulin. This has some advocates fearing that Biden essentially “canceled” affordable insulin in his first week in office. So, what’s going on?

In fact, President Biden did indeed freeze a plan that was promoted by the Trump administration to lower the cost of insulin. But it’s not what you think.

Last week, the Biden administration announced a regulatory freeze pending review on all new regulations and Executive Orders (EOs) signed by President Trump during the final days of his term, including new regulations that had not yet gone into effect. The freeze will last 60 days until the Biden team can review them more thoroughly.

President Trump had signed an EO last year claiming to make insulin more affordable, that would force community health centers, including Federally Qualified Health Centers (FQHCs) to pass along 340B Program federal discounts on insulin to patients who qualify under the program. The rule was finalized in December 2020.

This would have essentially made insulin-free for low-income patients who qualify, instead of between $1-5 dollars per vial that they have traditionally paid at these health centers for their insulin. The rule was supposed to go into effect on January 22 but has now been delayed until March 22nd.

President Trump claimed that the rule change would make insulin more affordable for the 28 million Americans who frequent FQHCs for their health care, but a Health and Human Services statement admitted that “the economic impact is expected to be minimal” because the majority of patients who get insulin from these 340B participating health centers already get discounted insulin. In some cases, patients receive a 30-day supply of insulin for just $7, according to the report published in the Federal Register.

There is some speculation that enacting President Trump’s Executive Order would cause some Federally Qualified Health Centers to go out of business, which would be truly detrimental to the populations they serve during a pandemic, and the Biden administration just wants time to review all EOs and assess their potential consequences before taking further action.

In short, the 60-day regulatory freeze is not causing the price of insulin to increase, and it is not preventing action in the future to make sure that insulin is available and affordable for all Americans who need it. Additionally, there is no evidence that the Executive Order would have actually lowered insulin costs in a substantial way for the majority of people who require the hormone to live.

While President Trump’s Executive Order may have caused a media firestorm last year, it in no way paved the way for more affordable insulin for the 7.4 million Americans who rely on daily insulin injections to live, and President Biden freezing Trump’s EO in no way raises the cost of insulin, either.

Only time will tell what steps will be taken at the federal level to assure more affordable insulin for all Americans who need it to survive. Time is of the essence, and we’re running out of it.

What steps do you think the new Biden administration needs to take to address the rising cost of insulin in the United States? Share your ideas below!

Source: diabetesdaily.com

COVID-19 Vaccine for People with Diabetes: What’s Going On?

The COVID-19 vaccine is here, and like most things dealing with the pandemic, the rollout of both the Pfizer-BioNtech and the Moderna vaccines has been a nightmare. The Trump administration’s Centers for Disease Control and Prevention (CDC) Advisory Committee for Immunization Practices (ACIP) released loose guidelines for states to follow in determining how to disseminate the vaccine but has largely left most of the decisions up to the states. Most people don’t yet know when they’ll receive the vaccine, and on the whole, most states are still in phase 1a, disseminating shots to frontline healthcare workers and those living in long-term care facilities.

In their initial recommendations, people with type 1 diabetes would receive the vaccine further down on the priority list, along with healthy individuals under 65 years old. People with type 2 diabetes are classified as, “at increased risk for severe COVID-19–associated illness”, and are thus to be given priority access in phase 1c, along with people who suffer from other conditions, such as cancer, heart failure, sickle cell disease, chronic obstructive pulmonary disease (COPD), and smoking. Type 1 diabetes is classified as, “might be at increased risk for severe COVID-19-associated illness”, to be given access in phase 2, with other conditions such as being overweight (BMI >25), and suffering from neurologic conditions.

This would put people with type 1 diabetes in the general population rollout, months after not only people with type 2 diabetes have gotten their shots, but behind many other chronic conditions, too. This is a harsh slap in the face for a community that could face so many negative consequences should they contract the virus (not to mention people with diabetes make up 40% of all COVID-19 deaths).

But recent data has come out that people with type 1 diabetes suffer from mortality from COVID-19 at similar rates as people with type 2 diabetes, and a study conducted by Vanderbilt University said people with either type 1 or type 2 diabetes who have COVID-19 have three to four times higher risk of severe complications and hospitalization as compared to people without diabetes.

Several more studies show that having type 1 diabetes is potentially even more dangerous if you contract COVID-19  than having type 2: A Lancet Diabetes & Endocrinology study published last year looked at medical records from the National Health Service in England to conclude that the risk of dying from Covid-19 was almost three times higher for people with type 1 diabetes and almost twice as high for type 2 than for those without diabetes.

In Scotland, another Lancet study said being admitted to an ICU or dying was more than twice as likely for type 1 diabetes patients and nearly 1.5 times more likely for type 2 diabetes patients than for people without diabetes.

People with type 1 diabetes have been told that they live with a disability the entire time they’ve lived with this incurable illness. We’ve sat on the sidelines while going low, been discriminated against in the school and workplace, shut out from certain industries and employers, and know the unique and awful feeling of our skin tightening from a hyperglycemic event after our pump failed for the umpteenth time in our sleep. We require special accommodations, a militant watch on our medication, exercise, insulin, and food intake, and are never offered a break, a day off, or even a hint of affordable insulin.

We live in the unique situation of a dual-reality: having a chronic condition, yet feeling its invisibility every day. We’re never quite “sick enough”; we never “look” diabetic; sometimes, we feel like we don’t even “deserve” the meager accommodations that we get (always pre-board flights, because you’re allowed to!). We live every day with the knowledge that our life expectancy is likely shorter, our days are harder, and especially during this pandemic, many of us have lived in fear of a serious complication should we contract COVID-19 and the bleak consequences we could face. Many of us have stayed home, shut-in, and waited this out, while watching some of our able-bodied peers continue to ignore public health protocols and guidelines.

The end result of the CDC’s recommendations burns and is tangible: states, including Iowa, Illinois, and Virginia, are prioritizing dissemination of the vaccination to people living with type 2 diabetes before people living with type 1 diabetes. Simply put: we’ve been told to stay in, shut up, and wait it out for the vaccine, due to our fragile health condition, and now that the vaccine is here, our disability is yet again being ignored.

Yes, type 2 diabetes is being prioritized and that is right, good, and important, but type 1 diabetes needs to be prioritized, too. They’re not mutually exclusive. Currently, the United Kingdom is not differentiating between type 1 and type 2 diabetes; they are prioritizing people who have either type. Other countries are following suit.

On Tuesday, the Trump administration reversed course, adopting part of president-elect Joe Biden’s distribution plan, advising states to prioritize everyone over the age of 65 and any person with a chronic condition to get the vaccine as soon as possible; states have yet to officially adopt these plans on a wide scale.

Recently, several letters were sent from various diabetes advocacy organizations to the CDC urging them to reconsider their guidelines. Organizations such as T1International, Mutual Aid Diabetes, The American Diabetes Association, JDRF, Beyond Type 1, Children with Diabetes, The diaTribe Foundation, DiabetesSisters, and T1D Exchange have lent their voices to make the needs of the 1.6 million people living with type 1 diabetes in America known.

The bottom line is that we need to curb the tide of this pandemic. Almost 400,000 Americans are dead, with a holiday-related surge in cases, hospitalizations, and death on the way. We need to get shots into as many arms as quickly as possible and stop telling some of our most vulnerable populations that, yet again, they aren’t sick enough to qualify, and that they can wait. We can’t.

Source: diabetesdaily.com

New Dexcom Update: Your G7 Questions Answered

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

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

There is no calibration, correct?

“This is correct.”

What about pharmacy vs. supplier distribution for the G7?

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

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

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

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

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

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

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

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

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

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

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

Dexcom G7

Image source: Dexcom

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

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

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

Source: diabetesdaily.com

Great News: Trials Show Some Diabetes Drugs Can Actually Protect Your Kidneys

This content originally appeared on diaTribe. Republished with permission.

By Matthew Garza, Eliza Skoler, and Rhea Teng

More people with diabetes are taking drugs like Jardiance and Farxiga, originally developed to lower glucose in people with type 2 diabetes, because the latest data confirms that these drugs can protect your kidneys. A therapy still under investigation, finerenone, has been developed to protect the kidneys of people with and without diabetes

Recent research is showing that certain drugs can benefit your kidneys if you have type 2 diabetes. Diabetes is the leading cause of chronic kidney disease (CKD), and many people don’t receive adequate treatment for this condition, so advancements in therapy to treat and prevent kidney disease are important for the 800 million people worldwide who live with chronic kidney disease. We bring you some of the newest findings on finerenone, Jardiance, and Farxiga – three medications that have been shown to protect the kidneys in people with decreased kidney function, including those with diabetes and CKD.

Note: The latest results on Jardiance and Farxiga confirm earlier findings on two other SGLT-2 inhibitors – Invokana and Steglatro – which clearly show the kidney and heart benefits of this class of medication. As a result, SGLT-2 inhibitors are recommended for treating kidney disease in many people with diabetes. SGLT-2 inhibitors were a focus of the recent American Society of Nephrology’s virtual kidney conference. As research has shown an increased number of benefits of these medications – in terms of glucose levels, weight loss, hypoglycemia reduction, and heart and kidney health – new guidelines have rapidly developed (since 2013) for the use of these drugs in people with type 2 diabetes. And, in the case of Farxiga, SGLT-2s can also protect the kidneys in people without diabetes.

Finerenone

Finerenone is currently being tested to treat CKD in people with type 2 diabetes – it’s a new type of drug (called a non-steroidal MR antagonist) that interferes with the receptors that cause kidney cells to retain, or hold onto, excess salt and water. In the FIDELIO-DKD trial, almost 6,000 people with type 2 diabetes and kidney disease received either finerenone or placebo (a “nothing” pill) and were enrolled in the study for over two and a half years. The results from the trial demonstrated the benefits of finerenone:

  • Finerenone significantly reduced the risk of severe kidney outcomes by 18% over two and a half years.
  • Finerenone reduced the risk of severe heart outcomes by 14%, compared to the placebo.

The FIDELIO-DKD trial showed this medication to be helpful for people with type 2 diabetes. Given these positive results, finerenone has been submitted to the FDA and the European Medicines Agency for approval as a CKD treatment option for people with type 2 diabetes.

Jardiance

New findings from the EMPEROR-Reduced trial showed that Jardiance, an SGLT-2 inhibitor, improved heart and kidney outcomes in adults with heart failure with reduced ejection fraction (HFrEF, or a reduced ability to pump blood out of the heart), regardless of whether they had chronic kidney disease at the start of the trial. Of the 3,730 people enrolled in the trial – with or without type 2 diabetes – participants taking Jardiance showed:

  • A 22% reduced risk for severe heart outcomes among people with CKD, and a 28% reduced risk in those without CKD.
  • A 47% reduced risk for severe kidney outcomes in those with CKD, and a 54% reduced risk in those without CKD.

The variation in risk reduction was determined to be due to chance, rather than a difference in health outcomes between people with and without CKD. These results show that even though CKD increases a person’s risk for heart issues, Jardiance lowered that risk to the level of people without CKD.

Farxiga

New analysis of the DAPA-CKD trial found that Farxiga, another SGLT-2 inhibitor, protects the kidneys regardless of the cause of kidney disease, in people with or without type 2 diabetes. This builds on the positive results presented earlier this year on Farxiga’s ability to treat people with heart disease and CKD.

Why is this important?

More than 800 million people around the world live with chronic kidney disease, including 45 million people in the US (almost 14% of the US population). The need for effective medications that work for everyone, including those with or without diabetes, is high. Treatment with SGLT-2 inhibitors – or non-steroidal MR antagonists – could be key to helping these people.

Organizations like the American Diabetes Association and the European Association for the Study of Diabetes now recommend that people with type 2 diabetes and kidney issues be treated with SGLT-2 inhibitors or GLP-1 agonist medications. If you have diabetes or kidney disease, talk with your healthcare team about which of these treatment options may be helpful for you.

It’s important to catch kidney disease early so that it can be treated. If you have diabetes, ask your healthcare team to test your kidney function every year. To learn more about preventing kidney disease, view diaTribe’s helpful infographic. You can also read about UACR and eGFR, the two lab tests that are commonly used to evaluate kidney health.

Source: diabetesdaily.com

Dexcom’s Chief Technology Officer Reveals Updates on the G7

We are almost through to the end of this year and we are all looking forward to new diabetes technologies coming out in 2021! Continuous glucose monitoring (CGM) technology is an incredibly useful tool that can improve diabetes management, and the release of Dexcom’s new CGM, the G7 is certainly one to look out for. For me, the sheer difference in size alone (the G7 will be about the size of a quarter, certainly an improvement over the G6!) is something to get excited about. Moreover, the company has completely redesigned the product, which will now be completely disposable, as opposed to previous iterations that included a reusable transmitter.

I recently talked to Dexcom’s Chief Technology Officer, Jake Leach to get the most recent scoop on what’s to come with the release of the highly anticipated new product.

When Will the G7 be Released?

Due to the COVID-19 pandemic, the start of clinical trials was delayed. Leach explained that the company used that time to integrate in even more technology with the G7. Clinical studies needed to get FDA approval for the G7 are currently in the process of getting started. Although they could not disclose specific details on timing, Dexcom confirmed that will see the product come to market in 2021. A broader launch is expected to come in 2022.

What About the Accuracy?

Dexcom has taken a lot of technologies of the G6 and made improvements on them. It will need to meet stringent accuracy requirements to be approved by the FDA. It is expected that the product will perform well and offer improvements over existing technologies.

What About the Wear Time?

Currently, the Dexcom G6 is approved for 10-day wear. However, many users try to circumnavigate this. Dexcom’s CTO had this to say about advancements for the G7:

“The platform is designed to extend the wear beyond 10 days, so the electronics, etc. are compatible with that. We are striving for a very high level of reliability for both the sensor and the adhesive patch. [So far, early studies have shown that] the right time frame for our customers is 10 days with this product, but we do intend to continue working to expand both the sensor and adhesive performance to go beyond 10 days. We feel that our customers deserve a sensor that is highly reliable for the full wear duration, and so 10 days is where we’re at with G7.

What About the Cost?

“We know that for CGM to be accessed by many many people, we need to continue to remove cost from the general system. So, G7 is designed to be highly manufacturable in very large volumes. We have our first G7 line up and running. We are using a fully automated assembly line. The product is not only highly reliable but also lower cost to manufacture. Providing users with the product that is disposable, there were hurdles that we had to overcome in engineering, to be able to provide a product where you are throwing away more components, but we are able to do that at a cost-point equal to or lower than G6.”

What About the Sensor Insertion?

The sensor insertion will be fully automated. Dexcom stated that the product will be even easier to apply than the G6, and that the applicator will be much smaller than the G6, reducing the environmental footprint.

“We specifically designed it to be as small as possible [but still large enough to ensure a comfortable insertion process]. Definitely smaller than G6…”

What About the Adhesive?

In the diabetes online community, I have recently been hearing more reports of adhesive-related allergic skin reactions, and speculations that perhaps there was a change in the adhesive formula being used. Here is what Dexcom had to say about that:

“Some very small number of users do have issues with irritation, and there is a number of different ways that can be addressed. It’s a balance between the adhesive properties of making the sensor stay on for the full duration and there are so trade-offs with irritation. We are very focused on minimizing irritation. We have made improvements to the patch where many users are seeing their sensors last longer, but we have seen a small number of irritation complaints and we are focused on [for both the G6 and the G7] always making improvements. We are focused on investigating what possibly could be causing these irritant properties. The G7 does have a different adhesive than G6 and we are looking to ensure that [causes] very little, if any, irritation.

What About New Integration with Other Systems?

“The way that we’ve designed our system is so that it can integrate with many different types of systems.”

In addition to integration with the Tandem’s Control IQ and Insulet’s OmniPod system, integration has also been developed for Companion Medical’s InPen as well as over 25 commercially-available apps. Leach also highlighted that as of now, the Dexcom CGM is the only product that has been approved for use with hybrid closed-loop insulin delivery systems.

What About New Predictive Modeling Algorithms?

Recently, Dexcom has partnered with the University of Virginia to conduct research on a variety of automated insulin delivery models and algorithms. Dexcom has also partnered with the European company Ypsomed to further develop CGM integration for automated insulin delivery systems. In addition, Dexcom is working to investigate the use of CGM data, in general, to provide users with key insights on blood glucose trends and potential therapy optimizations.

“Our general approach is to provide many options to our users. We know diabetes is a personal disease and everyone has different opportunities to connect with different devices, and what they feel fits into their lifestyle. We try to support as many options as possible so we do that through the pump integration, as well as the digital ecosystem of the app partners.”

What About the Data Display and Device Compatibility?

“It will be compatible with both Android and iOS. One thing we are doing with the G7 app is we are integrating more insights into the app. So, G6 does a great job of showing glucose information, trends, as well as the ‘urgent low soon’ alert. G7 is taking that even farther and starting to integrate in a lot more of the some of the functionality from Clarity, some of those insights you get will be built into the G7.”

Dexcom is also working to enhance some features of their apps for data sharing with support people and clinicians. In addition, a receiver will still be a part of the new system, for those users who want an alternative to using their smartphone for data display.

Staying Ahead of the Competition

The CGM market is growing rapidly, with more and more companies coming out with competitive products. We asked Dexcom where they view themselves and what their advantages are over other systems.

“We feel that G7 is going to be a whole new level of comfort and convenience in the CGM ecosystem and the integration that we can build on with both insulin pump partners and the digital ecosystem of  apps… is a significant differentiator between [us] and some of the other competitors. We’ve been providing real-time CGM data since day 1, and we want to continue to expand and improve and provide users with new tools that enable them to take control of diabetes.

Moreover, the use of CGM technology is also expanding in the clinical setting, and Dexcom is a big player there.

“With COVID, we got approval for emergency authorization use for Dexcom CGM in the hospital. During the pandemic, since the beginning, hospitals have been acquiring the G6 from us and using the device in the hospital setting. It has performed very well. It also limited the need for interaction between healthcare providers and the patients [with COVID].”

We thank Jake Leach for taking the time to provide us with the most updated information. Sounds pretty great to us, and we look forward to learning even more and updating our readers as more details come to light!

Do you use a Dexcom CGM? What are your thoughts on the advances in CGM tech? Please share your thoughts in the comments.

Source: diabetesdaily.com

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