“Our Trials are Totally Different.” The Denise Faustman Interview

There’s no question that Dr. Denise Faustman does things differently.

Dr. Faustman’s research has won her avid fans and raised millions from donors, but it has also provoked significant pushback from major diabetes organizations. Dr. Faustman wears that repudiation like a badge of honor, proof that her work is disruptive and important.

A Maverick Approach

Dr. Faustman takes an unconventional approach. Her work, which is focused on the underlying immune response responsible for type 1 diabetes, has led her to a very old and inexpensive drug, a tuberculosis vaccine used widely in the developing world. It’s a treatment that may have been hiding in plain sight for generations.

Dr. Faustman’s immune intervention trials also concentrate on adults with long-standing type 1 diabetes. By contrast, virtually all of her peers have targetted patients with new-onset diabetes, or even patients that have yet to develop diabetes. This approach is generally considered more likely to succeed, because the targets of the interventions have not yet entirely lost their ability to secrete insulin. But in Dr. Faustman’s telling, it hasn’t accomplished much yet:

“Over the last 30 years, immune intervention trials in type 1 diabetes haven’t had very good outcomes. The important diabetes advances have been different versions of insulin and new forms of blood testing, but the immune intervention trials have been a very sad point. Nothing’s worked very well, no new treatments have been approved.”

“Our trials are totally different. They’re all in people that have had diabetes for decades.”

Dr. Faustman told me that a who’s who of diabetes experts has told that her approach is crazy, a response that has clearly tickled her contrarian side.

“We thought the need is to treat the people that actually have the disease. It sounds like a no-brainer, but keep in mind that nobody else is doing it!”

The decision to study patients with long-established diabetes, which was originally made well over a decade ago, was inspired in part by financial constraints: “we could not afford to do new-onset diabetic trials.” And focusing on an incredibly inexpensive generic drug meant that Dr. Faustman had no way of interesting large pharmaceutical companies and their very large R&D budgets.

“It’s a terrible drug to make money off of.”

BCG

The drug is BCG, the Bacillus Calmette–Guérin vaccine, which was first used a century ago in order to protect patients from tuberculosis. It is considered extremely safe, and is still administered to millions of infants annually, most prominently in the developing world.

BCG first piqued Dr. Faustman’s interest because it was “the only drug in animal models that has worked in established diabetic mice.” Exactly why it worked, though, still requires some unraveling. The results of her Phase I trial – results that were both celebrated and questioned – showed that patients receiving the vaccine experienced impressive improvements in glucose control without restoring insulin production or insulin sensitivity.

Most immune intervention drug trials involve the suppression of immune cells that are harming the body – in the case of type 1 diabetes, the T-cells that attack the pancreatic Beta cells. But the BCG vaccine works the opposite way, not by depleting the immune system, but by putting something else back in.

“BCG adds to the microbiome. It’s actually the tuberculosis organism, inactivated. So you’re putting back in, effectively, tuberculosis. When you revaccinate with this vaccine, the reason it takes a little while is that it gets to your bone marrow and actually resets your stem cells in your bone marrow.”

Why would you want tuberculosis in your bone marrow? Dr. Faustman referred to the hygiene hypothesis, the idea that many autoimmune and allergic diseases are caused at least in part by our excessively sanitary modern world. Myobacterium tuberculosis may have co-evolved with humans for thousands of years, and its absence may therefore trigger immune system dysfunction.

“The absence of this organism has allowed these rogue immune systems to take off and create all these autoimmune diseases. We’re just reestablishing this synergistic relationship to get immune tolerance.”

Because of its many possible effects, BCG has lately become “fashionable” in the research community, Dr. Faustman told me. The old vaccine is being evaluated as a treatment for other serious autoimmune diseases, and it has also been theorized to provide protection against the novel coronavirus that causes COVID-19.

But how does all that help with your blood sugar levels? Dr. Faustman believes that when BCG vaccine “retrains” the immune system, it also causes the immune system itself to begin utilizing large amounts of glucose in the bloodstream.

“What really happens is that their white blood cells now become the regulator of sugar, and have restored sugar transport. So there are underlying defects in type 1 diabetes in the use of the lymphoid system as a sugar regulator, and BCG restores that.”

The Effect

“It’s definitely a game-changer. Our hope, based on the early results, is that it will lower your A1c 10-15%, stably. You can use less insulin, and have better blood sugar control.”

It is, however, a slow process:

“It takes a number of years to have its metabolic and immune effects. We know we need to follow these patients for 3-5 years to get the maximal effect. But it’s got good durability. It’s quite permanent.”

The nine patients that originally received the BCG vaccine for the Phase I trial are still checking in with Dr. Faustman’s lab every six months, and she says that they continue to enjoy dramatic improvements in glucose management.

“Everyone wants to know if we have any [trial participants] off insulin. We have one person off insulin. Normally when he’s on a fairly low dose of insulin his A1c is in the normal range. When he goes off insulin, he no longer goes into DKA, but he goes up to around 7.2%.

“Is it gonna last twenty years? Thirty years? We don’t know yet.”

Sample Size

One of the chief concerns that other experts have raised with Dr. Faustman’s work is the tiny sample used in her Phase I trial: a mere nine patients received the BCG vaccine.

Dr. Faustman is completely unphased by this criticism, arguing that the statistical significance of her results speaks for itself.

“A p-value of .05 is as statistically significant in a sample of 10 as it is in a sample of 200,000. The only difference is, in the sample of 10, everybody responded, and the magnitude of the response was large.

“If you have to design big trials, you have small effects and unresponsive groups. And that’s what you’re seeing in the [rest of the] diabetes community.”

The criticism of her work by major diabetes authorities, particularly ADA and JDRF, doesn’t seem to have phased her, although she admits that it has slowed down the pace of her trials. She quoted one of her most significant boosters, the late Lee Iococca, a rockstar among American executives as the CEO of Chrysler during the 1980s. Iacocca told her, “I love it when they’re shooting the cannons at me. It means I’ve got something good.”

Dr. Faustman continued: “If they didn’t think it was competitive, it wouldn’t matter to them. The fact that they shot their cannons, to issue statements that were not truthful, it shows that it mattered to them a lot, that it was threatening to them.” She believes that the criticism set forth by the ADA and JDRF in a remarkable joint letter was not only misguided but dishonest.

Don’t Do It Yourself

Referring to the BCG vaccine’s long history of safety, Dr. Faustman suggested that there was little downside to her proposed intervention.

I felt an uncomfortable comparison to some of the pandemic era’s health controversies, in particular to the arguments advanced by many in favor of poorly investigated COVID-19 treatments such as hydroxychloroquine and ivermectin. I asked her what she would say to readers that are ready to go get the BCG vaccine themselves, before it’s been evaluated by the FDA. It’s a question she deals with constantly.

About once a month, Dr. Faustman gets a call from a physician, asking confidentially where one might acquire BCG of the correct strain. Sometimes it’s pharmacies attempting to fulfill a prescription, sometimes it’s the patients (or parents) themselves.

“Everyone’s trying to do it in the closet because it’s a safe drug, right? People try to do it all the time. But you should really wait until we get the right strain and the dosing. What we try to say is that if you get vaccinated with the wrong strain of BCG, we’re not sure, when we give you the right strain, that it’s gonna work.”

The BCG vaccine may be easy to come by in countries where it is used frequently, but there’s no telling what strain you’d get and what the effects would be.

For patients that are very eager about BCG, Dr. Faustman recommends registering for one of her clinical trials.

Timeline to Treatment

There’s already a phase II trial underway, which will test the BCG vaccine in adults with long-standing type 1 diabetes. This expands the study size from 9 to over 200; Dr. Faustman expects that good results in a much larger cohort will finally resolve the criticism and controversy that has dogged her for years.

Meanwhile, her lab is beginning its first trial of children with type 1 diabetes.

In an ideal world, she told me, the phase II trial for adults would be followed by phase III, an even larger study which she would then present to the FDA for evaluation. In a best-case scenario, the approved drug could be administered to regular patients in “five to eight years.”

“We’re moving as fast as we can.”

Source: diabetesdaily.com

We Asked an Immunologist Your Questions About COVID-19 Vaccine Safety

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

By Lala Jackson

August 2021 is starting to feel like March 2020 – the COVID-19 delta and other emerging variants are more dangerous than the original virus, but what does that mean? Cases are rising rapidly, are we safe? Do we need to wear masks or not? Vaccines work, but do they for everyone?

To get some clarity, we spoke with Bernard Khor, MD, PhD, of the Benaroya Research Institute at Virginia Mason in Seattle, Washington. Dr. Khor’s laboratory is trying to find new ways to treat autoimmune diseases, specifically for people living with Down Syndrome as they are more likely to develop autoimmune diseases like type 1 diabetes. Because he spends so much time researching immune responses, we published his interview on whether type 1 diabetes means a person is immunocompromised and wanted to talk with him more about COVID-19 vaccine safety for people with type 1 diabetes.

Beyond Type 1: Are people with type 1 diabetes more likely to get COVID-19?

Dr. Khor: People who have autoimmune diseases aren’t necessarily immunocompromised; instead we can think of it as having a dysregulated immune system. That’s what causes the immune system to attack its own body. It does not necessarily mean that they don’t respond appropriately against infections.

What we do know is that, if they catch it, people with type 1 diabetes are more susceptible to worse outcomes from COVID. If it were my child or loved one living with type 1 diabetes, I would do everything I could to mitigate that risk.

What about the delta variant? How did we get here?

The delta variant and other variants we’re seeing start to develop are worse for everyone. These mutations happen because the virus has had time to persist and improve itself. If we were able to completely contain it, if everyone got the vaccines right now, we could stop this pattern by giving it nowhere to hide. But if the coronavirus is hiding in 30 to 40 percent of the population, it will come back and come back worse again and again. It’s just a matter of time.

That’s the thing about a virus – it’s not a one time threat. It’s an ongoing, adaptable threat. It’s a virus that mutates. It’s trying to survive. It can change and adapt to circumstances. There’s another variant coming out from Peru that’s getting more powerful – it’s affecting younger people, it’s leading to more rapid hospitalization, it’s a worse disease.

I cannot overstate how much COVID-19 needs to be respected. The writing on the wall was very clear from the beginning. We have seen outbreaks of diseases before and we have seen pandemics before. They are all agents that need to be respected immensely.

Other forms of coronavirus – SARS, MERS – were incredibly bad. In both cases we basically escaped worse outcomes because we got lucky; transmission rates of those viruses weren’t as high as COVID. Now we have COVID. We started off unlucky, and if we don’t respect it, it will get worse. It can cause death, it can cause disability, it can cause horrible outcomes. We’ve seen nursing homes decimated, it’s devastating.

We as scientists can make the best thing we possibly can, but it doesn’t matter if no one uses it. I see this as our generation’s World War event. We’re lucky that many of us are inside, that we have Netflix and ways to work from home. But the societal impact is every bit as serious.

Are people with type 1 diabetes more likely to have a particularly bad reaction to the vaccine?

All the data points to no. You’ll rarely hear a scientist say never—1 in millions is not never—but all the studies to date say no, and we can have confidence in that because there’s been a lot of post-marketing assessment of these vaccines. We have a lot of people who have taken the vaccines already worldwide to see how it’s working.

And that’s what we look at—the remarkably low rate of adverse reactions that are reported and tracked, versus the highly measurable rates of severe illness or death, or of long-term disability from long haul COVID.

What about the fear that vaccines in general can lead to new or more autoimmune issues? Can you explain the risk?

It’s a terrible thing to come down or have your child come down with a severe life-long illness. Type 1 diabetes is so diabolically difficult, and it’ll be different for different people. It’s a slog. So of course we want to know why it happens. Especially when you’re trying to find that important of an answer, our minds are programmed to look for patterns, but when you look from a single case, you’re only able to make the pattern from the single situation. Huge studies have uniformly debunked the idea that vaccinations commonly cause autoimmune issues.

That’s the benefit of our system – it’s very transparent. When there are adverse effects, we know about them. There are rare occurrences that have been seen; an example was a batch of flu vaccines in the 1970s, where several people came down with a rare autoimmune disorder called Guillain-Barré syndrome (GBS). Even in that instance, the risk of getting GBS was ten times less than the risk of death from flu. The cost benefit ratio is not even close.

Editor’s Note: There have been 100 reports of GBS among people who received the Johnson & Johnson vaccine, from approximately 12.5 million doses administered. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder. Whenever health issues like these do arise from vaccines, the FDA requires revisions to the information provided to vaccine recipients and healthcare providers so that they know about potential risks. No similar pattern has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines.

How can we trust vaccines that only have emergency use authorization (EUA) And are not fully approved?

Editor’s Note: Since this interview was published on August 10, 2021, the FDA has granted the Pfizer and BioNTech COVID-19 vaccine full approval for ages 16 and up, with the EUA still in effect for ages 12-15 and booster doses for immunocompromised individuals. 

I think it’s incredible that we have a vaccine ready as quickly as we did – that has been due to immense collaborative work from the entire global scientific community. That work happened because of the immense threat and impact of COVID-19.

In this case, scientists worked hard, building upon decades of existing research to make this thing work. In a sense, we also got lucky. We are so fortunate that these vaccines work as well as they do. We built this nice big shiny thing, now we have to walk on in. Because scientists can build the best possible solution and it means nothing if people don’t use it.

Lack of full approval—which we know is coming soon—is due to the fact that the FDA has a rigid and bureaucratic approval process. It’s not wrong. But it makes it very slow even once the medicine and science has been proven, as is the case with the COVID-19 vaccines we offer in the US.

But no corners have been cut—the data has been reviewed, the process has been transparent. Everyone understands the need for post-marketing surveillance, ongoing data from the vaccines as they are administered. No expense has been spared for that.

How do we know that people who take the COVID-19 vaccine won’t face health issues from it in twenty years?

I cannot think of a scientific mechanism to be worried about that. I do know that COVID is here and is a very real risk, right now. We fear the unknown; the fear of the known has become hard to remind people of. After more than a year, we’ve gotten used to the bear that’s in the house. We can get worried about how we’re dealing with the bear, or we can go ahead and get the bear out of the house.

We heard discussion a few weeks ago about the psychology of choosing to take the COVID-19 vaccine; that to humans, it’s scarier to face making a choice and something bad happening, like taking the vaccine and getting sick from it, and less scary if something bad happens to you passively, like getting COVID-19 when you are going about your daily life trying to be careful. It feels like less responsibility. What are your thoughts on this?

Choosing not to do something is as much a choice as doing something. It’s about the risk of not doing it, not taking the vaccine.

You can always be nervous about some infinitesimal risk of doing something, but there’s a true risk of not doing something in this particular case. And the risk is not just what might happen to you if you get COVID, it’s the risk of all the people you might pass COVID to, including grandparents and children.

Because it’s not a question of if you will be exposed to COVID-19, it’s a question of when.

Source: diabetesdaily.com

FDA Propels Insulin Affordability with Semglee

This content originally appeared on diaTribe. Republished with permission.

By Karena Yan, Joseph Bell, and Arvind Sommi

Semglee may provide a cheaper alternative to Lantus (insulin glargine) – it costs $148 for five pre-filled insulin pens.

Semglee, which was approved last year as a new basal insulin for adults and children with type 1 diabetes and adults with type 2 diabetes, has now been designated by the FDA as an “interchangeable biosimilar” insulin to Lantus (insulin glargine). This designation allows pharmacists to substitute the much cheaper Semglee for Lantus without having to consult the prescribing healthcare professional – providing a potentially more affordable alternative to drugs such as Lantus.

Semglee is available by prescription in either a pen or a vial – it costs $147.98 for five 3 mL pre-filled pens or $98.65 for one 10 mL vial, which is a 65% discount from the list price of Lantus. The actual out-of-pocket costs can differ dramatically since the list price does not consider discounts or rebates available with a variety of insulin brands.

For people who are uninsured or underinsured, or don’t qualify for patient assistance programs, Semglee represents a far more affordable option for people who take basal insulin. While biosimilars are usually not as inexpensive as “generic” versions of drugs, because biosimilars are more expensive to manufacture, they may provide cheaper alternatives to brand name drugs. Further, because Semglee has been deemed functionally equivalent to Lantus, it should provide an important and practical option for basal insulin users who are concerned about insulin costs. Semglee was previously approved as a biosimilar in 45 countries, including Australia, Japan, South Korea, and several European nations.

But what exactly is a biosimilar drug?

Drugs can either be a chemical compound or a biologic compound. When a company makes a brand new drug, they can get a patent that prevents competing companies from copying their drug for a certain amount of time. Once the patent expires, other companies can try to create their own version of the original drug. If the drug is a chemical compound, then it is relatively easy to copy – this is called a generic drug. If the drug is a biologic compound, like insulin, then it is more complex and harder to create an identical copy. However, competing companies can attempt to make an almost identical biologic drug that has the same effects as the original company’s drug – this is called a biosimilar drug. Additionally, if a biosimilar drug is designated as “interchangeable” with the original drug (Lantus), then (depending on your state’s laws) your pharmacist may be able to provide you with a cheaper biosimilar (Semglee) without having to get permission from the prescriber because the two drugs exhibit the same effects on the body.

Two biosimilar insulins are currently approved in the US: Basaglar, a basal insulin similar to glargine (Lantus) which was approved in 2016, and Admelog, a rapid-acting insulin lispro approved in 2018. The recent FDA approval is significant because Semglee is now the first interchangeable biosimilar insulin product.

Mylan is offering a co-pay discount card and a patient assistance program to help people afford Semglee. The co-pay card is available to people with commercial health insurance – you may be able to receive up to $75 off each 30-day prescription. Learn more here. People without prescription insurance coverage, you may be able to get Semglee for free. You can access the patient assistance program by calling Mylan customer service at (800)796-9526.

Source: diabetesdaily.com

Islet Cell Transplants: How the USA Fell Behind the Rest of the World

The United States has fallen behind other countries in the effort to make pancreatic islet cell transplants available for patients with type 1 diabetes. As the technique grows in popularity through much of the developed world, in America innovation has come to a standstill.

Islet transplantation is an advanced treatment for type 1 diabetes. Briefly, doctors take a donor’s islets of Langerhans (the clusters of cells in the pancreas that contain the insulin-producing beta cells) and inject them into patients with diabetes, typically into the liver. When successful, patients can discontinue insulin use altogether, or greatly reduce it. Some transplant recipients have remained free of insulin therapy for many years following the procedure, with only minor side effects, although most patients require some insulin therapy at five years post-transplant.

Islet cells are harvested from the pancreas of a deceased organ donor, and immunosuppressive drugs are required to prevent rejection by the recipient’s immune system. These donor cells are scarce, and while there are many ongoing attempts to find other sources of usable islet cells (such as the use of pluripotent stem cells or even genetically engineered pigs), the procedure is not expected to become a mainstream treatment in the foreseeable future. But for patients with a dire need—for example, those with extreme glucose management challenges, hypoglycemia unawareness, or advanced kidney disease—islet transplantation can be a lifesaver.

Unfortunately, in the United States, the procedure has been “effectively halted,” according to an official report on the American Diabetes Association’s recent Scientific Sessions conference. While the technique was largely investigated and defined by scientists working in the US, it has never become available to the general public, and there is little hope that it will become available any time soon. Meanwhile, some medical centers in Canada, Australia, Europe, and Asia are now performing the technique routinely.

Dr. Camillio Ricordi, a leading researcher on the treatment with the University of Miami, blamed the issue on “outdated regulation” from the FDA. Because of a quirk in the National Organ Transplant Act of 1983, subparts of organs (such as the islets of Langerhans) don’t count as organs and are not covered by the network of rules and programs governing organ transplantation. Instead, transplanted islet cells are regulated as if they were drugs. Treating the cells as pharmaceuticals subjects them to standards for precision and consistency that they cannot meet.

Phase 3 trials have already proved that islet cell transplantation can deliver impressive results, and do so safely. And yet, America’s leading experts have agreed that it is all but impossible for a research institution to apply for and secure full approval for the technique.

Around the world, other medical authorities have taken a more practical stance. This has also allowed insurers to pay for the procedure, just as they would any other organ transplant. Most of the countries that lead the world in islet transplantations have robust social healthcare systems.

But islet transplantation is still considered purely experimental in the United States, and today can only be performed under the auspices of an official clinical trial. While the ADA and other advocates have pushed for change, so far, the regulation still stands in the way.

As islet transplantation becomes more available across the globe, the treatment is going nowhere fast in the USA.

 

Source: diabetesdaily.com

Tackling Type 1 Diabetes – Where Are We on Technology and Research?

This content originally appeared on diaTribe. Republished with permission.

By Andrew Briskin

Andrew Briskin joined the diaTribe Foundation in 2021 after graduating from the University of Pennsylvania with a degree in Health and Societies. Briskin is an Editor for diaTribe Learn.

At the Milken Institute 2021 Future of Health Summit, leading experts in type 1 diabetes research and innovation discussed the path toward a cure, the latest in glucose monitoring technology, and the importance of screening for type 1 diabetes.

A group of leading experts in type 1 diabetes research and innovation took part in the panel discussion, “Tackling Type 1 Diabetes: Where the Science is Heading” at the Milken Institute 2021 Future of Health Summit last month. They exchanged insights on the advantages of continuous glucose monitoring, automated insulin delivery (AID), Time in Range for better diabetes management, as well as tantalizing new possibilities for curing type 1 diabetes.

The discussion from June 22nd was moderated by diaTribe Founder Kelly Close and included:

  • Aaron Kowalski, Ph.D. – CEO, JDRF International
  • Shideh Majidi, M.D. – Assistant Professor, Pediatric Endocrinology, Barbara Davis Center for Diabetes
  • Felicia Pagliuca, Ph.D.  – Vice President and Disease Area Executive, Type 1 Diabetes, Vertex Pharmaceuticals
  • David A. Pearce, Ph.D. – President of Innovation, Research and World Clinic, Sanford Research

The panelists began by discussing how continuous glucose monitors (CGM) now provide people with type 1 diabetes even more information and the power to manage their glucose levels. CGM data provides people with crucial metrics such as Time in Range (TIR), which corresponds to the percent of time someone spends within their target glucose range – usually 70 to 180 mg/dL. This target glucose range may vary though, for example, if you are pregnant. You can learn more about the helpful metrics that CGM provides here. Alongside A1C, TIR allows more insight into your day-to-day diabetes management by showing fluctuations in glucose levels caused by factors like meals, exercise, illness, and more.

However, CGM is not perfect or widely accessible yet. The panelists touched on this issue of access to CGM and the existing disparities in care across race and type of insurance. Dr. Majidi emphasized that in populations with access to this technology, CGM use has increased from 20% to over 80% of patients over the last five years. However, some studies have shown that providers tend to prescribe technology only to certain patients due to unconscious biases about which patients may be able to handle using advanced technology.

Advocating for early and consistent training for healthcare providers on addressing these biases, as well as provider and patient education on CGM and other technologies for glucose management, Dr. Majidi said, “we need to look at these unconscious biases to start providing everyone with the opportunity to use and learn about new technology.”

The panel then explored the advantage of AID hybrid closed-loop systems. These systems combine a CGM, insulin pump, and an algorithm that allows the CGM and insulin pump to talk to each other. Dr. Kowalski said he was especially encouraged by the advancements in AID systems, emphasizing that it not only decreases the number of highs and lows, but it also removes much of the burden of diabetes management from patients and their families.

AID systems especially benefit families with children who have diabetes, reducing concerns from parents about the safety of their children during the night or at other times when the risk of hypoglycemia is high. The panelists said they were hopeful that these new innovations are bringing us closer to developing a fully closed-loop artificial pancreas, which could automatically respond to changes in glucose in real time without the need for a person to deliver manual boluses or calibrations.

Echoing their advice on how to address disparities in CGM use, the panelists noted the importance of education for healthcare providers to combat disparities in prescribing AID to ensure equal opportunity for all to achieve better health outcomes.

The discussion then shifted to the latest research towards a cure for type 1 diabetes, focusing on beta cell replacement therapies. Because type 1 diabetes occurs as a result of the body’s immune system attacking and destroying its own pancreatic beta cells (the cells that make insulin), scientists have been researching how to replenish the beta cell population from stem cells. Scientists believe that stem cells, not yet fully differentiated or mature cells, could potentially be directed to become functioning beta cells.

Dr. Pagliuca shared updates from her work at Vertex, studying stem cell-derived beta cell transplants in type 1 patients with impaired awareness of hypoglycemia. This initial study relies on systemic immunosuppressive drugs (these are drugs that “turn off” the body’s immune system so it won’t attack the implanted cells) to protect the implanted beta cells. The hope is that future studies will seek to use a different method called encapsulation, which protects beta cells from the immune system with a physical barrier, avoiding the need for immunosuppressant medications.

So far, with the successful conversion of stem cells into mature beta cells accomplished in controlled lab settings, the science has developed to the point of testing stem cell-derived beta cells in clinical trials, with Vertex first clinical trial now enrolling patients. This initiative will encompass the entire type 1 community, with Dr. Pagliuca stressing that “transitioning these breakthroughs into the clinical phase will require participation from all stakeholders, patients, researchers, and healthcare providers.”

Considering the latest research into the immunobiology of type 1 diabetes, the panelists advocated for significant increases in screening for type 1 across the general population.

Dr. Pearce advised that testing for the presence of specific autoantibodies (small molecules in the body that are the cause of the immune system attacking a person’s own beta cells) in the general population is essential for implementing prevention programs, given that the presence of at least two of these autoantibodies is a very predictive measure to assess the risk of developing type 1 diabetes.

According to him, the predictive power of these screenings make it is possible to classify an individual as having type 1 diabetes years in advance of any symptoms, even while they still have normal glycemic control. In this way, type 1 diabetes can be classified into 3 stages – stage 1 is when someone has two or more diabetes-associated autoantibodies, but normal glycemia and no symptoms. Stage 2 is when you have the autoantibodies, have begun to develop glucose intolerance or abnormal glycemia, but still no symptoms. Stage 3 is when symptoms begin and you are diagnosed with type 1 diabetes. Classifying diabetes in this way and identifying those in the early stages could increase patient involvement in clinical trials, and help connect individuals to new drugs such as teplizumab (not yet approved by the FDA), that aim to delay the onset of symptomatic type 1 diabetes or prevent it altogether.

Drs. Pearce and Kowalski agreed, recommending a screening strategy involving primary care providers and screening children during the toddler years. On the importance of this screening process for involvement in clinical trials, Dr. Kowalski noted, “Diabetes is a global problem. The voice of the patient is hugely important on new devices and therapies, and clinical trial pathways are delayed when there isn’t equal participation in the trials.”

You can watch the panel discussion and hear insights from the four incredible experts here.

Source: diabetesdaily.com

Should We Be Screening Every Single Child for Type 1 Diabetes Risk?

If Type 1 diabetes struck you or a family member, it may well have seemed completely random, unpredictable, and unpreventable.

It’s less random than it might seem—with a drop of blood, doctors can roughly estimate the risk of developing the condition, even in a newborn baby. And while the condition cannot yet be prevented, education and awareness can make its onset significantly less damaging, possibly resulting in lifelong health gains.

Screening for type 1 diabetes risk could become a routine element of childhood checkups, applied to all children. Should it be?

How Screening Works

There are, generally speaking, two ways of screening for type 1 diabetes risk.

The first, autoantibody screening, tests the blood for the immune proteins that cause type 1 diabetes when they attack the pancreas’ Beta cells. Autoantibodies emerge unpredictably, and are best assessed in early childhood, when the risk of disease onset is at its highest.

The second, genetic screening, tests a patient’s DNA for variations that are associated with type 1 diabetes. Genetic screening can be accomplished immediately after birth.

Screening of either sort rarely gives a definitive answer as to the likelihood that any one person will or will not develop type 1 diabetes—it places a patient in a bracket of higher or lower risk. One exception is when a blood test finds multiple autoantibodies present in one person, which can be said to indicate very early (subclinical) type 1 diabetes. In these cases, it may be years before the symptoms become noticeable.

Much of the data linking antibody presence with risk factors comes from the long-running Trialnet Pathway to Prevention study. TrialNet has been celebrated in the diabetes community for providing simple and free screening to so many. Click the link, and you can contribute to the body of knowledge by getting yourself (or a family member) screened.

Genetic and autoantibody screening can be used separately, but the most accurate projections use the two (along with any family history of diabetes) in concert.

The Benefits of Screening

Type 1 diabetes isn’t, so far as we know, preventable. So why screen for it at all?

Perhaps the single largest benefit to type 1 diabetes screening is the reduced incidence of diabetic ketoacidosis (DKA). When doctors, patients, parents, and caregivers are all aware that one patient has an increased risk, they’ll be more likely to identify hyperglycemia early, before it progresses to a critical state.

Avoiding DKA, a dangerous and incredibly painful condition, is just the start of it: studies have also shown that patients that got an early warning of the risk of type 1 diabetes also go on to have reduced A1c, fewer diabetes symptoms, and increased residual beta cell functioning. The earlier you catch the progression of type 1 diabetes, the healthier you’re likely to be in the coming years and perhaps even decades.

While researchers can’t always prove a causal relationship, mounting evidence appears to show that the severity of hyperglycemia at diagnosis can have a lasting and possibly even lifelong effect. In our recent article on diabetes and the brain, for instance, we learned that children that experience severe DKA at diagnosis have measurably worse cognitive impairment compared to children that did not have DKA. This effect lasts for years, and may be permanent.

And then there’s the game-changing drug teplizumab, which appears to delay the progression of symptomatic diabetes for years when given to patients that already have two or more antibodies. Those delays can be hugely valuable to families, meaning both enhanced health and emotional well-being. An expert panel recently voted to recommend that the FDA approve the drug. If teplizumab proves to be as effective as hoped, it would significantly strengthen the case for large-scale type 1 diabetes risk screening.

Teplizumab may just be the start, as doctors are working on other novel approaches to delaying (or preventing) type 1 diabetes. At the moment, for example, trials are underway to see if infants with a genetic predisposition to the condition will be less likely to develop the disease if given the probiotic B. infantis or insulin powder. Who knows what other therapies the future could bring?

Experiments with Universal Screening

At the recent American Diabetes Association Scientific Sessions, Germany’s Dr. Anette-Gabriele Ziegler discussed the results of two different experiments in universal diabetes screening. In these studies, all children within a certain area were tested for type 1 diabetes antibodies, regardless of family history.

The first, named the Fr1da study, tested children aged 2-5 during their regular check-ups in Bavaria, Germany. Only 0.29% of these Bavarian children got the bad news that they had the antibodies indicating subclinical type 1 diabetes.

While this was a very thin slice of the population, that knowledge still made a big difference. 81 tested Bavarian children went on to develop full-blown type 1 diabetes within the next three years; of those 81, only three developed DKA, an astoundingly low 3.7%. This was an immense improvement over the status quo – elsewhere in Germany, about 45% of newly diagnosed children developed DKA. And even that 3.7% seems somewhat inflated – of the three kids that suffered DKA, two of them belonged to families that declined diabetes education after receiving the positive test results.

In short, testing about 140,000 kids saved about 36 (and counting) from DKA and from whatever other long-term health deficits that acute hyperglycemia might have caused in the future. It also significantly reduced stress in the parents of newly diagnosed children.

A similar effort in Colorado, named ASK, delivered similar results. While only 0.52% of the participants were found to have subclinical type 1 diabetes, only 6% of them developed DKA, a vast improvement over usual rates.

Dr. Ziegler said, “We would like to screen everybody.”

The Downside of Screening Too Many

So why not start screening every child now? It costs money. Insurance companies will need to be convinced that it’s worth paying for.

The cost of screening may be significant, and the cost of follow-up education can be even higher.

Even if we can screen all children for type 1 diabetes, it’s not at all clear how many families should receive diabetes education, as Dr. Richard Oram of the UK’s University of Exeter expressed in a presentation at the conference.

Suppose, for example, that we had a universal genetic testing program – every newborn child in the country gets his or her drop of blood analyzed. At what level of genetic risk do you begin to apply education and intervention?

If you draw the line at the infants in the top 10% highest risk, you’ll identify nearly 80% of the kids that are going to develop type 1 in the coming years … but that’s only 2.4% of the kids selected for extra attention, meaning it’s likely a waste of time for the remaining 97.6%. On the other hand, if you only choose to educate the tiny minority of kids with the highest risks, you’ll waste less time, but ultimately only identify less than 10% of the children that will go on to develop type 1.

Public health experts are not ready to just brush aside all that education delivered to families that don’t really need it. And it’s not just a question of wasted time or money – as noted by Dr. Laura Smith, a clinical psychologist at USF, studies have shown that these screening programs can result in clinically significant levels of stress or anxiety for kids and caregivers alike. Parents will also often attempt to change their kids’ diets or increase their monitoring of their kids’ health, perhaps unnecessarily.

Profit and Loss

In reality, it will likely be the insurance companies that decide where to draw the line. The most important question, sad as it sounds, is whether or not testing children for type 1 diabetes risk is cost-effective.

Early research into this question tended to say that no, broad screening efforts are not economically worthwhile. A 2015 study concluded that screening would have to cost $1 or less in order to be viable (it’s a lot higher)—anything more would cost too much to justify the health improvements.

That study, however, looked only at the impact of reduced incidence of DKA, and not at the other benefits for patients. The University of Colorado’s Dr. R. Brett McQueen argued to the Scientific Sessions audience that this early study fell short of the mark, because screening is likely to offer many benefits beyond just DKA avoidance.

Dr. McQueen presented his own study, which assumed that screening would result in lifelong health improvements for patients with new-onset type 1 diabetes, such as improved A1c. While McQueen’s work confirmed that DKA avoidance alone was not enough to justify the high cost of most screening programs, those other benefits may tip the scales. Even an extremely modest improvement in glycemic control can make a big difference over the years, leading to many fewer diabetic complications and expensive interventions. And that’s before we even consider teplizumab, the potentially groundbreaking therapy that can delay onset for years.

The cost of screening is certainly substantial – Colorado’s ASK screening program ended up spending about $4,700 per case detected, a number that could be even higher when implemented elsewhere. But DKA and diabetes complications—think retinopathy and kidney disease—are pretty expensive too.

This type of math requires some guesswork. McQueen stated that if we want a rigorous accounting of how cost-effective early screening is likely to be, we’ll need about 30 years of follow-up data. Of course, we don’t have the luxury to sit back and wait for generations—“we need to make these decisions now.”

Conclusion

Today there is virtually no screening for type 1 diabetes risk factors in mainstream medical practice. There are many children (millions worldwide) that are at an enhanced risk of developing type 1 diabetes, and would stand to benefit from diabetes awareness and education.

Screening (and follow-up education) can have a significant positive effect. Risk screening has been shown to dramatically reduce the incidence of DKA, and is likely to improve diabetes management and reduce stress and anxiety. And the recent development of teplizumab, a drug that can delay the onset of the disease, may make early screening even more efficacious.

The most accurate screening would combine genetic testing at birth with antibody testing in early childhood, either once at age 3-4, or twice, at ages 2-3, and again at 5-7. But even a single test, either of genetics or autoantibodies, can provide significant predictive value.

Screening for type 1 diabetes risk could become a routine element of childhood checkups—if doctors and insurers can be convinced that it’s worth the effort, time, and money.

Source: diabetesdaily.com

Teplizumab: Can We Delay the Onset of Type 1?

This content originally appeared on diaTribe. Republished with permission.

By Dr. Francine Kaufman

Provention Bio’s new injectable drug was recommended by an FDA committee for approval on May 25, 2021. Studies show that teplizumab can delay, for people at risk for type 1, the onset of the condition for two years or more. Learn what happened at the FDA meeting and what might come next.

Rarely does one get to witness the potential for an entirely new therapeutic or preventive drug to come onto the medical horizon. But that is the threshold we have now reached with the possible approval by the U.S. Federal Drug Administration (FDA) of the first drug that attempts to delay the onset of type 1 diabetes (T1D) ­– teplizumab.

Some questions remain to be seen: whether there is enough data, whether the data is sufficiently compelling, and whether the risk-to-benefit ratio is favorable enough for the FDA to grant teplizumab’s approval. To address these issues, the FDA convened an Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC) on May 27, 2021.

What is teplizumab?

Teplizumab is a drug (specifically, an anti-CD3 monoclonal antibody) that binds to cells in the immune system called T-cells (these are the body’s infection-fighting cells). Scientists hope that teplizumab will change the types of T-cells in a person’s body so that autoimmunity – or the destruction of body tissue by ones’ own immune system – is decreased. This would reduce the self-destruction of the insulin-producing cells of the pancreas, called beta-cells, that leads to T1D.

What’s next for teplizumab?

The FDA now has to determine if teplizumab can truly help beta-cells survive. This will show the “effectiveness” or “efficacy” of the drug. The FDA also must determine if teplizumab is safe or if there are too many side effects (the “safety” of the drug).

How did we get here?

The drug manufacturer, Provention Bio Inc., applied to the FDA to approve teplizumab as a way to delay the onset of T1D in high-risk individuals. Even before Provention Bio’s TN-10 clinical trial, other studies were conducted with different forms of this type of medication.

Macrogenics (the previous company to own teplizumab) evaluated whether anti-CD3 could be used at the onset of T1D to preserve some of the insulin producing beta-cells.  If people with T1D could still make some insulin on their own, in addition to the insulin they needed to take, diabetes management could be made easier, with less hyperglycemia, lower A1C levels, and less risk of diabetes complications. However, the data did not show sufficiently strong outcomes needed for the FDA to approve anti-CD3 for new-onset diabetes. Perhaps it was simply too late in the diabetes process for this type of drug to make a significant difference. So, the focus turned to prevention – and to “delaying” the onset of T1D.

The TN-10 trial compared teplizumab to a placebo in 79 people with type 1 diabetes ranging in age from eight to 49 years. Teplizumab was given by intravenous infusion (IV) for 30 minutes over 14 days. To assure that study participants and research staff did not know who received teplizumab or the placebo, the placebo was given through IV in the same manner.

After two years, 43% of those given teplizumab developed clinical diabetes compared to 72%  of participants in the placebo group. The health outcomes between the treatment and placebo groups were significant and in favor of teplizumab, but the number of people in the trial was small (only 79 people). Similarly, TN-10 showed teplizumab to be safe, but it is hard to be sure about both the short- and long-term safety profile of the drug. Provention Bio is asking the FDA to allow teplizumab to be approved for children and adults who are at risk for (but do not yet have) diabetes. Because of this, understanding the safety and effectiveness of the drug is even more important.

What happened at the FDA meeting?

The EMDAC panel was asked to analyze the data and provide a recommendation on teplizumab, but the final decision, as always, rests with FDA. The panel was composed of 17 highly regarded endocrinologists, rheumatologists, cardiologists, biostatisticians and mathematical statisticians, a consumer representative, and a patient representative. All panelists agreed that teplizumab showed benefit to the participants of the TN-10 study by delaying the onset of diabetes by two years. However, there was concern about some of the data from prior studies on teplizumab which did not reveal a significant effect on glucose management in people with new-onset T1D.

The panel focused on safety concerns, mainly in terms of long-term risks. The data from TN-10 and the five previous studies in those with newly diagnosed T1D showed higher rates of diabetic ketoacidosis, viral infections, and cytokine release syndrome (which causes flu-like symptoms) in the anti-CD3 groups than in the placebo groups. There were also three total deaths in the treatment groups and none in the placebo groups. The EMDAC panel agreed that long-term surveillance studies would be required to better understand how safe this treatment is, if approved by the FDA.

Although five previous studies were submitted as evidence about teplizumab, the manufacturing and the rate at which the drug was cleared from the blood stream are not the same as what has been seen with the teplizumab under FDA review. This brings up the concern that the prior studies don’t truly support the present submission. The panel also agreed that if the FDA approved teplizumab, it could only be indicated for use in people with the same characteristics as those evaluated in TN-10 – people over the age of eight, with a family history of T1D, and similar glucose profiles. Since about 80% of people who develop T1D have no affected relative, the target population for the drug would be smaller than the actual number of people it could help, at least to begin with, though this could be reconsidered once more safety data is available.

Of the 17 EMDAC panel members, 10 voted in favor and seven voted against recommending FDA approval of teplizumab for the delay of T1D.

What does this mean in the diabetes community?

During the Open Public Hearing that helped influence the EMDAC’s decision, diabetes community leaders and organizations provided input, shared perspectives, and advocated for approval. The experts talked compellingly about the benefit of a two-year delay in diabetes diagnosis and what that would mean with regards to health. Several endocrinologists described the burdens of managing diabetes despite improvements in medications and technology, and the unmet needs that are still present in type 1 treatment regimens. The speakers included:

  • JDRF CEO Dr. Aaron Kowalski
  • Dr. Mark Atkinson (University of Florida)
  • Dr. Louis Phillipson (University of Chicago)
  • Dr. Jeff Hitchcock (Children with Diabetes)
  • Dr. Jeremy Pettus (University of California San Diego)
  • Dr. Jennifer Sherr (Yale University)
  • Dr. Korey Hood (Stanford University)
  • diaTribe founder Kelly Close (Close Concerns) and Jackie Tait (dQ&A), who detailed input from a survey by dQ&A on 1,078 people with T1D.

These speakers were supported by 187 letters posted to the FDA, as well as a dQ&A survey of 1,078 adults with T1D. Survey participants reflected upon how a two-year delay before needing to start insulin would have affected their life with diabetes.

Now it is in the hands of the FDA. If approved, teplizumab would become the first disease-modifying, preventive drug for T1D, and it could have the potential to change the paradigm of how the condition is managed. Stay tuned as we aim to keep you updated on this drug’s journey through the FDA approval process.

Source: diabetesdaily.com

Don’t Be Deceived: How Food Labels Mislead

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

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

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

Gluten-Free

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

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

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

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

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

No Sugar Added

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

  1. Total sugars
  2. Added sugars

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

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

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

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

Fortified

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

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

Organic

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

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

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

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

Natural

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

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

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

Some “natural” yet not the healthiest foods include:

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

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

The Bottom Line

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

Source: diabetesdaily.com

Rush for COVID Vaccine Hinders Diabetes Tech Advancements

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

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

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

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

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

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

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

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

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

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

Senseonics’ 180-Day Eversense Glucose Monitor

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

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

The Omnipod 5 (Originally “Horizon”)

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

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

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

They hope to launch their product by June of 2021.

Medtronic 780G

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

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

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

They hope to have a commercial launch sometime in 2021.

Dexcom G7

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

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

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

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

Abbott Freestyle Libre 3

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

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

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

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

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

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

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

Source: diabetesdaily.com

The PROTECT Study

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

By Makaila Heifner

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

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

Who Is Eligible for the Study?

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

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

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

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

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

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

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

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

How Does It Work?

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

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

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

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

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

Why?

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

Visit theprotectstudy.com to learn more about PROTECT.

Source: diabetesdaily.com

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