Why #insulin4all Advocates Targeted Beyond Type 1

Beyond Type 1, the diabetes nonprofit, found itself in hot water recently after the organization sent a letter stating its apparent opposition to LD673, a proposed bill for an insulin safety net program in Maine. The Maine bill is modeled after Minnesota’s popular Alec Smith Insulin Affordability Act, and guarantees that people with diabetes can access inexpensive insulin in an emergency.

The letter stated that LD673 would “create not only administrative burdens to the Maine government and pharmacies in the state, but also unintended additional out-of-pocket expenses to people living with diabetes.” The organization seemed to argue that its own GetInsulin.org program, a partnership with the major insulin manufacturers, rendered further legislation “duplicative” and unnecessary. 

Some diabetes advocates were outraged at Beyond Type 1’s stance, and accused the nonprofit of favoring the big pharmaceutical companies over people with diabetes.

Late last week, the organization appeared to modify its stance with a new letter, this one explicitly supporting Maine’s new bill. Was it all just a misunderstanding, or did rowdy online activism cause Beyond Type 1 to change its tune?

LD673

Alec Smith, the Minnesota bill’s namesake, died of diabetic ketoacidosis (DKA) in 2017, at the age of 26. At the time, he had recently aged out of his parents’ health insurance plan, and the cost of his insulin had skyrocketed to about $1,300 a month, around half of his total earnings. 

Smith’s mother believes that he died because he could not afford to pay for the insulin that he needed to live. She has become a noted insulin activist, and helped turn his death into a major rallying cry for people protesting the nation’s outrageously high insulin prices.

Minnesota signed the Alec Smith Insulin Affordability Act in April 2020, to widespread acclaim in the diabetes community. 

The new bill in Maine, named An Act To Create the Insulin Safety Net Program, would similarly aim to provide cheap, emergency insulin to those with an urgent need. The emergency insulin would carry a maximum cost of $35 for one month’s supply. The bill also mandates standards for the insulin manufacturers’s otherwise voluntary patient assistance programs (PAPs).

The Letter

In the letter that would cause an uproar, Beyond Type 1 never explicitly stated opposition to the new legislation. Whatever its intentions, however, it’s fair to say that the organization strongly implied its opposition.

The letter argues that state-level legislation such as LD673 is no longer necessary, because nationwide circumstances have changed dramatically since the Alec Smith act was passed in Minnesota:

At the time of its passage, GetInsulin.org did not exist, nor did the urgent need programs offered by the manufacturer. Additional insulin copay, cash pay, and patient assistance programs became available after the Minnesota bill became law that insulin manufacturers’ patient assistance programs (PAPs) are enough to fill the gap in assistance, and that the state statute is not needed. 

While insulin is still disgracefully expensive in most of the US, it is true that there are now more avenues for patients in need than there were only a few years ago. Part of that is due to the success of advocacy efforts, such as the one that coalesced around Alec Smith’s death, that turned insulin affordability into a political hot topic. The Covid-19 pandemic has also shined a spotlight on healthcare inequities, pushing the insulin manufacturers to expand their affordability programs in the last year.

The Beyond Type 1 letter also concentrates heavily on extolling the GetInsulin.org website. GetInsulin.org is essentially a user-friendly portal for the PAPs, aggregating the information from all three major insulin manufacturers in a single space. The website was created in partnership with the big pharmaceutical companies and is at least partly funded by them, facts that raise the suspicions of many people with diabetes, who are often inclined to see Big Pharma as an adversary rather than a partner. 

Are PAPs Really Good Enough?

Patient assistance programs can be valuable and even life-saving resources for people struggling to afford insulin. In some cases, PAPs may even provide more generous support for patients in an emergency than that mandated by the Alec Smith Act and Maine’s proposed law. And because these patient support programs have a reputation for being difficult to access and navigate, there’s no reason to doubt that GetInsulin.org provides a valuable public service.

For insulin affordability advocates, that’s not nearly good enough. The Shot, a weekly digest of insulin affordability news, put the case plainly:

While it’s true that patient assistance programs have become more robust … the programs, like Beyond Type 1’s GetInsulin.org, are voluntarily offered by the companies — often at no cost to them as PAPs are generally tax deductible. The Maine bill, like the Minnesota one that precedes it, locks the companies into providing assistance that patients would otherwise have no guarantee will exist tomorrow.

The PAPs are only reliable as long as the manufacturers don’t dilute them in the future (or disband them entirely). Given that many Americans now feel that insulin is practically a byword for medical exploitation, one can hardly be surprised when people with diabetes regard these programs with suspicion.

The big three – Eli Lilly, Novo Nordisk, and Sanofi – are reliable opponents of government efforts to cap insulin prices. And it would seem that PAPs owe their recent expansion more to the immense public relations pressure that manufacturers have lately had to endure than to any one corporation’s sense of generosity or public service.

Experts do agree that insulin manufacturers do not alone bear the blame for high insulin prices. Manufacturers, pharmacy benefit managers, insurance companies, and pharmacies all benefit from high insulin prices, and our byzantine healthcare market incentivizes all of them to push for price increases. Patients can’t easily vote with their wallets, and are therefore left with little recourse to effect meaningful change.

Insulin affordability continues to be a disaster in the diabetes community. Insulin rationing due to high cost is widespread in the United States, a situation that has probably only gotten worse since the dawn of the pandemic and the economic devastation that has followed. 

The upshot of Beyond Type 1’s argument to the Maine legislative committee was that the PAPs, as accessed through GetInsulin.org, are pretty much good enough. If this wasn’t what the organization intended to communicate with its letter, it made a bad mistake – and on an electric issue.

Online Reaction

Insulin access advocates discovered the letter online, and were outraged. Several accused the organization of corruption and betrayal:

Twitter personality Miss Diabetes illustrated a particularly devastating comic, featuring a caricature of Beyond Type 1 co-founder Nick Jonas:

source: @miss__diabetes

A little context: when Beyond Type 1 was founded in 2015, the organization avowed a principled refusal to accept money from the pharmaceutical industry. Things have changed. Now, according to their website, “Beyond Type 1 partners with pharmaceutical companies, including insulin manufacturers, when the organization finds that doing so furthers mission and impact.” 

This isn’t unusual. Most other prominent diabetes nonprofits also accept Big Pharma money (#insulin4all campaigner T1International is one notable exception). Nevertheless, Beyond Type 1’s position on this issue seemed unusual. The American Diabetes Association, for example, took the opposite stance and penned a letter in support of the bill. 

BT1’s About-Face

Despite the controversy, Beyond Type 1 kept silent for weeks, further disappointing some in the diabetes online community.

In response to a request for comment, a Beyond Type 1 spokesman told Diabetes Daily that the original letter was written not to oppose the legislation but “with the intent of providing information to legislators about existing programs and tools for people with diabetes who are insulin-dependent.” 

Additionally, the spokesman said, “Our team has followed the community response closely, and we know some have interpreted our testimony as one of opposition.”

Soon thereafter, the organization sent a new public letter to Maine’s legislative committee, claiming that it did support LD673, and that it always had:

We’re writing today to clarify and state unambiguously that Beyond Type 1 does support the passage of this legislation. This legislation will help individuals in Maine who may be struggling under urgent or ongoing circumstances to access affordable insulin due to high list prices. Our hope is that people with diabetes who need financial assistance to pay for this life-essential drug may find it through existing programs or potentially those created through Maine’s efforts.

After news of the new letter broke, Hilary Koch, a Maine resident and a Policy Manager for T1International, declared victory on Twitter – but also qualified her celebration with a reminder of how much work needs to be done to achieve universal affordable insulin access.

One can only guess as to the effect that Beyond Type 1’s clarification might have the bill’s chances. Lawmakers may well have already been inclined to support the bill. Just last year, Maine passed more sweeping legislation capping insulin costs for those with state-regulated insurance.

 

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

The Latest on Eylea: A Leading Treatment for Diabetes-Related Retinopathy

This content originally appeared on diaTribe. Republished with permission.

By Kira Wang

New results on Eylea, a treatment for diabetes-related retinopathy, show that the therapy reduces the risk of more serious eye complications when used for prevention.

Key findings were recently published on Eylea, a common therapy in the US used to treat several eye conditions including diabetes-related eye disease. According to Dr. Jennifer Sun (co-chair of the Diabetic Retinopathy Clinical Research Network), 60% of patients may not know they have some form of early-stage diabetes-related retinopathy which may not affect one’s ability to see. The clinical trial was focused on prevention: does early Eylea treatment of diabetes-related retinopathy result in better vision later on? The answer may not yet be clear – while Eylea was found to reduce specific vision-threatening complications, it did not meaningfully improve vision outcomes in the published study.

Eylea is an approved treatment for diabetes-related macular edema and diabetes-related retinopathy, two of the eye complications associated with diabetes. Eylea is an anti-VEGF therapy, meaning that the drug blocks VEGF, a protein that is necessary for new blood vessel growth. The medication is injected into the eye by an ophthalmologist every four to 16 weeks, depending on the severity of the eye disease.

The trial looked at 328 adults with early-stage diabetes-related retinopathy (also called non-proliferative diabetes-related retinopathy) and excellent vision. At the beginning of the study, about half of the eyes received Eylea injections every 16 weeks, and the other half received a placebo injection (which included no medication). The preliminary data were reported through two years. The study will continue for a total of four years.

The researchers were studying two main outcomes in these eyes:

  • Changes in the anatomy of the retina (for evidence of either a more advanced stage of diabetes-related retinopathy, called proliferative diabetes-related retinopathy, or the development of swelling called center-involved diabetes-related macular edema). These can be thought of as structural changes in the eye.
  • A functional difference in participants’ ability to see, known as their visual acuity. See below for key findings after two-years:

The trial found that Eylea led to improved anatomical outcomes and reduced the risk of more serious eye complications:

  • Eylea reduced the risk of developing complications by 68% when compared to the placebo. The probability of developing any complication was 16% in the Eylea group and 44% in the placebo group.
  • Individually, participants taking Eylea were 66% less likely to develop more advanced stages of diabetes-related retinopathy (proliferative diabetes-related retinopathy) and 64% less likely to develop macular edema with vision loss.
  • People receiving placebo injections were five times more likely to need additional treatment (with Eylea) with worsening of the eye disease.
  • There was no difference in the vision quality of either group after two years (excellent vision in 75% of the treatment group and 72% of the placebo group).

The four-year results of the trial will be important in determining whether the higher rate of complications in the placebo group might eventually lead to more vision loss in that group. If this is the case, treating diabetes-retinopathy in its earliest stages with Eylea may present a long-term benefit for vision.

There are several treatment options for diabetes-related eye disease, including oral medications, laser treatments for the eyes, and therapies like Eylea. Increasingly, surgical techniques are being used for less advanced stages of diabetes-related eye disease. Other novel strategies are also being investigated to avoid needing regular injections into the eye.

More information is needed before Eylea can be considered for use as a widespread tool to prevent worsening of diabetes-related retinopathy. Dr. Sun’s bottom line for clinicians and patients? “With regular follow-up and rigorous evaluation, the chances of continuing to have good vision, even with severe non-proliferative diabetic retinopathy and moderate non-proliferative diabetic retinopathy, are excellent. I don’t think this study says that early treatment should be routinely given yet. It is important to hang tight and wait for four-year results.”

The most important action people with diabetes can take is to have an annual dilated eye exam, in addition to managing glucose, blood pressure, and cholesterol levels. If diabetes-related eye disease worsens, there a number of options that can be used to prevent vision loss. To learn more about protecting your eyes and treating eye disease, check out our series: Caring For Your Eyes.

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

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

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