“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The decision to study patients with long-established diabetes, which was originally made well over a decade ago, was inspired in part by financial constraints: “we could not afford to do new-onset diabetic trials.”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

Danger Ahead: One-Upmanship in the Type 1 Diabetes Community

We type 1s face danger at every curve: the yummy meal laden with carbs, the pump that suddenly malfunctions, the low that plunges to scary territory, the high that won’t come down, the infusion set that bleeds upon insertion, the CGM that needs constant calibration…the list goes on.

But there is perhaps a larger danger lurking out there, one that can have a devastating effect on our attitude if we let it. It is called one-upsmanship. What do we mean by that?

When speaking with fellow people with diabetes, how often do you hear some of the following lines?

  • I have no problem with control. I have an A1c of 5.1.
  • I’m in range 99% of the time.
  • My pump is great. It keeps my average sugar at 95.
  • I rarely, if ever, go low.
  • My numbers could not be better.
  • My endo tells me I’m doing perfectly.
  • I never go above 150.
  • If I’m at 200, I bring it down in minutes.
  • I have no problem saying no to sugar.
  • Managing diabetes is no big deal.

My reaction to such comments is: Really? I wonder what planet these folks live on. Are they being truthful?  If so, why are my numbers so different? What are they doing that I’m not?

Am I the only type 1 who is not doing that well? Why can’t I be like them?

People with diabetes who brag or boast to others about their ability to handle diabetes are basically sending the message that they can manage better than you. They are putting themselves above you and playing a vicious game of one-upsmanship.

In our constant, ongoing battle with diabetes, our toughest job is to remain optimistic. When we hear others boast of great control, we tend to think less of ourselves. We lose confidence.

Without a strong belief in ourselves and our ability to stay in the diabetes fight, we can get discouraged. Not only do we feel depressed, but worse, we are tempted to say, “The heck with it.” Why should I eat so carefully if I can’t get results like my friend’s?

Some argue that it is human nature to promote ourselves over others or simply want others to know how good we are. Facebook, one might argue, is often a look-at-me activity, where people describe all the wonderful things in their lives. Multi millions around the globe participate in Facebook just to show the world their daily achievements.

How does this make others feel? If, for instance, someone on Facebook shows pictures of a delightful vacation to Paris, France, some readers might say to themselves, “Wish I had that kind of money.” Or: “Wish I had free time.” Or: Wish I had friends to go with.”

The same holds true with diabetes. When others flaunt their abilities to deal with the disease, we can easily start to feel incompetent.

Here’s some advice: Avoid those who would continuously boast about their victories over diabetes. Most of the stories simply are not true. Those that are don’t do us much good.

We need to choose our diabetes support circle as carefully as we choose insulin pumps and carbs at meals. We need to stay positive in the daily struggle and associate with those who provide us honest emotional support.

Source: diabetesdaily.com

How to Explain Insulin Price Insanity in Just One Image. Or Several Images.

Insulin prices in the United States are insane. This isn’t exactly news—if you have insulin-treated diabetes, you surely already know it. And even those without a connection to diabetes should recognize that insulin affordability is one of the most talked-about healthcare topics in politics. It’s also the rare issue that finds widespread agreement across the political spectrum, at least with regard to the existence of the problem, if not the solution.

What’s less well-understood is exactly why insulin prices are so outrageously high. This one image may help you understand:

source: Drug Channels

Oh, what’s that? It didn’t explain everything?

Maybe one image wasn’t enough. Try this one. It’s a bit simpler:

Source: diabetespac.org

If you’re confused, well, that’s the point. It’s a total mess! But don’t worry, we’ll walk you through it.

These two images were bravely prepared by Dr. Adam Fein of Drug Channels and the Diabetes Patient Advocacy Coalition (DPAC), an influential nonprofit diabetes advocacy group. There are many other versions of this chart, and none of them is easy to understand.

The “insulin-payment journey” is a bizarre and complex path that is poorly understood by outsiders. A recent congressional investigation took two years to conclude, and relied on an immense volume of internal documents to tease out what the heck is going on.

The relationships are messy, but a couple of things are clear:

  • The amount of money that you fork over the pharmacy counter has essentially nothing to do with supply and demand.
  • The higher the price, the more everyone benefits. Everyone except for you.

The images above identify the many different players shoving their fingers into the pie. Here’s a look at who some of these different forces are, and how they conspire to push your insulin costs into the stratosphere.

The Drug Company

It’s probably safe to say that most people in the diabetes community tend to blame high insulin prices on the greed of the insulin manufacturers.

Just three companies—Lilly, Novo Nordisk, and Sanofi, each a multinational pharmaceutical giant—make 90% of the world’s insulin and 100% of the insulin approved for sale in the United States. It sure seems like the Big Three have locked down the market and can charge whatever the heck they want. Patients, especially those with type 1 diabetes, have little or no ability to shop around or reduce their reliance on the life-giving medication, and get stuck paying the price whatever it is.

Make no mistake—the insulin manufacturers have plenty to answer for. The Big Three engage in a variety of hijinks, such as “evergreening” patents and paying off (or suing) would-be makers of affordable biosimilars, to help keep their iron grip on the insulin market. The insulin makers tend to raise prices almost in lockstep. This image from Business Insider should cause outrage:

source: Business Insider

But it turns out that insulin manufacturers are by no means the only organizations pushing prices up. If you look at the first two images, you’ll see multiple other participants in the insulin-payment journey—insurance companies, pharmacies, pharmacy benefit managers and drug wholesalers—all of whom profit when insulin prices increase.

In a nutshell, everyone makes more money when prices go up, and patients have hardly anything that they can do about it.

The Pharmacy Benefit Manager

If there’s a second major villain in this story, it’s the pharmacy benefit managers (PBMs), perhaps the one source pushing insulin prices up even more forcefully than the insulin manufacturers.

The PBMs is a middleman that negotiates deals between the big pharmaceutical companies, health insurance companies, and pharmacies. And because PBMs determine which medications insurers will cover—deciding whether millions of patients will use this insulin or that one—they wield immense power. There’s another Big Three here: CVS Caremark, Express Scripts, and OptumRx combine to dominate the market.

PBMs like high prices because they take a cut out of every transaction, through administrative fees and insulin rebate programs. The higher the price, the higher the rebate, so PBMs are strongly motivated to choose higher-priced medications. The result is that insulin makers find themselves competing with each other to raise prices in order to offer higher rebates to PBMs. PBMs aggressively encourage this competition.

The size of rebates has increased “exponentially” in the last decade. For more detail on this ridiculous situation, check out this summary from Beyond Type 2.

The Insurer and the Wholesaler

Insurance companies also share some of the PBM’s bounty, as the PBM’s usually pass through a percentage of those big rebates. In theory, some of this value should get trickle down to individual patients in the form of reduced insurance premiums. In reality, it is still patients with chronic conditions like diabetes that bear the brunt of the system, especially those that can only afford to choose high-deductible plans.

There’s something similar going on with drug wholesalers, middlemen that purchase insulin directly from manufacturers and then sell it to pharmacies and other medical facilities.

Believe it or not, there’s yet another Big Three here—in 2018, just three businesses held over 95% of the American drug wholesale market—again facilitating the use of monopolistic practices. These powerful drug wholesalers can bully their suppliers and customers; the Senate report mentioned above reports that they use “aggressive disruption techniques” to secure favorable deals and boost their profits.

The Consumer

There’s a reason you come last: the consumer is an afterthought in this system. When insulin manufacturers set the list prices of their medications, they think an awful lot about how that price will impact their relationships with PBMs and drug wholesalers, and insurance companies, and somewhat less about the number that eventually hits the patient. After all, you have virtually no ability to “vote with your wallet”. Whether you had to pay $30 or $300, the manufacturer long ago made its profit.

Bottom Line

There’s a lot of blame to go around. Insulin prices are determined by a closed system of warped incentives, full of greedy middlemen that hike up the price with no discernible benefit to patients. It’s a vicious cycle in which higher prices make more money for everyone except the patient.

The inefficiencies and absurdities that drive up insulin prices are at work in many other ways throughout our byzantine healthcare system. Insulin is particularly plagued by these problems because there are no generic insulins available and because demand is inelastic.

You can help advocate for change, big or small. New laws in several states have capped insulin prices, and many similar grassroots efforts are underway throughout the nation. You can also advocate for yourself, your loved ones, and even your employees on a smaller scale: check out DPAC’s Affordable Insulin Project, which connects people with diabetes to patient assistance programs, and helps those with employer-sponsored insurance get the most out of their plans.

 

Source: diabetesdaily.com

Athlete & YouTube Sensation: Elijah

Tandem Diabetes Care Pump

This content originally appeared on Tandem Diabetes Care’s blog. Republished with permission.

Elijah is 11 years old and doesn’t let diabetes slow him down — not while pounding the pavement running cross country, and not while playing basketball, football, baseball, or his favorite, golf.

Having spent most of his life with type 1 diabetes, Elijah is a pro at overcoming challenges and adapting. He started on an Animas pump at four years old, then later switched to a tubeless pump. With support from his family, all of this change was manageable.

What Inspired Elijah to Try a Tandem Diabetes Care Pump?

One day, Shawn, a family friend and Tandem Diabetes Care team member who met Elijah the day he was diagnosed ten and a half years ago, proposed the idea of switching to a Tandem pump, but Elijah was reluctant. Elijah liked his current pump. Plus, he still had lingering worries from when his dog grabbed on to his tubing when he was four years old.

“Elijah did not want to switch,” explained mom, Molly. “And we understood, change is hard. He does a great job, but things were not going in a direction we felt good about… he was doing well, considering diabetes is a tough disease, but he had three consecutive A1c results, each higher than the one before it.”

Elijah wasn’t satisfied either. “My first experience wearing and using a pump was great, but I was always going really high and low. My blood sugars were not controlled well,” he explains. It also made some of his favorite activities more challenging, “My blood sugar, especially during baseball, would go low.”

The innovative Control-IQ® technology available for the t:slim X2™ pump piqued his parents’ interest. Around this time, they also moved in next door to Shawn. This created an opportunity for Elijah to get the feel of a Tandem pump, without an infusion site. He wore one around as a test drive of sorts.

Known by his family as a “numbers guy,” Elijah was really interested in the tech and advancement, and his parents reminded him that his body awareness had improved since he was four. They were optimistic the tubing would be less of a challenge, and it was a perk that the t:slim X2 pump offers a variety of infusion set choices.

It didn’t take long before he told his parents, “OK. Let’s do it.”

In October 2020, Elijah officially made the leap. He adjusted with help from some “diabesties” (friends in the diabetes community) and essential mentor, Shawn. By November, he was enjoying his newfound freedom.

“Everyone needs a Shawn,” exclaims Molly. Having that person, whether it be a diabetes educator or Tandem representative, can be an essential part in bridging the gap in “pump 101.”

Tandem Diabetes Care Pump

What Does the Family Love Most About the t:slim x2 Pump?

Elijah’s pump has settings for activities like Exercise and Sleep that can adjust basal rates and deliver automatic correction boluses, and it’s helping him focus more on his sports. “Putting my pump on the Exercise setting makes a big difference.” Whether he’s up to bat or sinking a hole in one, his blood glucose levels are on his mind a little less often these days.

“I sleep all night now,” says Molly, who loves the Sleep feature. “I can’t remember sleeping through the night before.”

These days, Elijah can go to bed at 200 mg/dl and wake up in the morning at 90 mg/dl–now that he wakes up with better numbers, it sets the tone for the rest of the day. After-breakfast spikes are also less likely. Molly describes the switch to Tandem like many often do, “It’s been a game changer.”

After trying a couple different infusion sets, Elijah has found his favorite, the TruSteel, which is rigid and is inserted manually. “He likes it because he controls it going in,” explains Molly. Elijah found that the automatic insertion of this tubeless pump would cause him anxiety each time it was changed. He counted every click in anticipation and was bothered when the timing differed from insertion to insertion.

“I was a little scared of tubing at first, but I don’t even notice it anymore,” says this active guy.

After a few months of use, it was time to see the endocrinologist. Starting at a 7.6 A1c in October, Elijah had achieved an impressive 6.8 by January. While they wish they would have made the switch to the t:slim X2 pump sooner, Molly wanted to wait until her son felt he was ready.

“As a parent, it changes the diabetes game 100%.” Molly goes on to say she knows that highs and lows are still possible, but are far less extreme with Control-IQ technology. When asked who, in her opinion, is a good candidate for a Tandem pump, she replied, “Anybody with type 1—if I was diagnosed tomorrow I’d go on one.”

Tandem Diabetes Care Pump

What Is Elijah Working on Now?

As for Elijah, his focus is on other things. He is hard at work on his own YouTube channel, Diabetic Dude, which features feel-good content and messages about diabetes awareness. “I mainly started to show people what type 1 diabetes is. It’s a serious disease, but I want to show people I can still do everything normal. I’ve started making more fun and hilarious videos.” He hopes his channel becomes lucrative, so he can donate proceeds to JDRF, a nonprofit 501c organization that funds type 1 diabetes research.

“I feel like he has more freedom, I feel like he can be a kid,” Molly says, excitedly explaining how nice it is that he can just have a popsicle at a friend’s house if he wants one. Elijah and his family have only good things to say about other diabetes devices, but Tandem has brought them to that next level of diabetes achievement. They leave us with this insight about Tandem, “The tech is just better. “

We thank Molly and Elijah for sharing their story and wish Elijah a very happy 1-year anniversary of Diabetic Dude! Check out his channel and be sure to subscribe!

Tandem Diabetes Care Pump


 

Responsible Use of Control-IQ Technology

Even with advanced systems such as the t:slim X2 insulin pump with Control-IQ technology, you are still responsible for actively managing your diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce glucose variability, but it requires your accurate input of information, such as meals and periods of sleep or exercise. Control-IQ technology will not function as intended unless you use all system components, including your CGM, infusion sets and pump cartridges, as instructed. Importantly, the system cannot adjust your insulin dosing if the pump is not receiving CGM readings. Since there are situations and emergencies that the system may not be capable of identifying or addressing, always pay attention to your symptoms and treat according to your healthcare provider’s recommendations.

From time to time, we may pass along suggestions, tips, or information about other Tandem insulin pump user experiences or approaches to the management of diabetes. Please note, however, individual symptoms, situations, circumstances, and results may vary. Please consult your physician or qualified healthcare provider regarding your condition and appropriate medical treatment. Please read the Important Safety Information before using a Tandem Diabetes Care product.

Source: diabetesdaily.com

How Insulin Rebates Work

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

By Lala Jackson

A major contributor to high insulin list prices that is often misunderstood – because it is designed to be complex and opaque – is the Pharmacy Benefit Manager (PBM) and rebate system. Rebates are a percentage of the list price of a medication, given by a drug manufacturer to a Pharmacy Benefit Manager (PBM), in order to be listed on the health insurance plan formulary or placed in a pharmacy.

Essentially, rebates function a bit like a “broker’s fee” of sorts and can account for 30-70% of the cost a person has to pay at the counter for insulin if they don’t have insurance, or if they are paying the full cost of insulin until they hit their insurance deductible. The PBM takes a portion of the rebate as their own profit, then gives the remainder to their client, which can be the federal government (Medicare), an employer’s health plan, or a standalone health insurer.

Insulin manufacturers choose to participate in this system that drives list prices up because it benefits their business – by giving PBMs a large cut of their profits, their products get placed on insurance formularies more often, leading to more sales. This system creates up to 70% of the current list price of insulin in the US, and it doesn’t have to be this way.

Rebates – They Don’t Mean What They Sound Like

The math is infuriating, but here’s the heavily-simplified basics of how rebates work – if you made a product for $5 and wanted to sell it, you may set the price at $10, to create a $5 profit. With that $5 profit, you can invest back in your company to create better products, pay yourself – whatever you want to do with your $5.

But let’s say you want your product to be in more places and available to more people. You might hire a middle person to place your product in new stores across the country, and they’ll charge a fee, which is reasonable.

When you begin, their fee is $1. So that you can keep your $5 profit, you raise your price to $11. Still reasonable. But over time, your middle person makes themselves indispensable and knows it. You’re making way more money because of how many products you’re able to sell, so you’re not about to drop your middle person.

And oh oops – you also signed a contract with your middle person to ensure you’ll always get your product placed in these nation-wide stores, so you’re locked in. And part of that contract was a promise that you won’t lower your price, since that would impact your middle-person’s profit.

And oh oops – your middle person also has contracts with your competitors, and the contracts signed with those competitors make it so that if your competitor gives the middle person a little bit more of their profits, your middle person won’t sell your product in certain stores for a year. You can fix this by raising your own price to give the middle person more profits, so you can kick your competitor out of a store the next year.

So now, your product costs $50. It’s the same product – you’ve never improved it. Your customers are receiving no more value than when the product costs just $10. Over time, you wanted to make more money from it, so your profit is now $10.

It’s still $5 to make your product.

You get $10 profit, doubled from your original earnings.

And your middle person? They’re making $35, 70% of the list price, off a product they don’t make or even touch.

But you’re definitely not going to get rid of your middle person, because they’re the reason you’re able to sell so many products and make the money that you do.

For a regular product like a water bottle, no worries, your customer will just go somewhere else.

But what if your product was water, and your customer needed it to survive?

The Role of Pharmacy Benefit Managers (PBMS)

PBMs are third-party intermediaries who negotiate prices and drug placements on insurance formularies between pharmaceutical companies and insurance companies. Sometimes they are standalone companies, other times they are attached to national pharmacies or insurance companies.

For their negotiating services, they take a share of the profits from prescriptions. This share is known as ‘rebates.’ They also profit from “administrative fees” for each unit of drug sold, which can be up to 5% of the list price.

Speculated about for some time but difficult to prove because of private contracts (fully legal through the US system, which is notoriously bad at regulating drug pricing) is the sheer amount of cash being collected by PBMs. Originally created to help get needed drugs to patients more efficiently, PBMs have unfortunately become a key agitator to high out-of-pocket drug costs.

From a January 2021 Senate Finance Committee report, we now definitively know that “…drug manufacturers increased insulin WAC [wholesale cost], in part to give them room to offer larger rebates to PBM and health insurers, all in the hopes that their product would receive preferred formulary placement. This pricing strategy translated into higher sales volumes and revenue for manufacturers.”

The big legislative stumbling block we now face is just how reliant on PBMs the US healthcare system has become. In a more simple system, a pharmaceutical manufacturer could provide their medications to a pharmacy for direct disbursement to patients who require them. But in a system with a shaky foundation to start with and many players in the space, across private and public entities, the water gets significantly muddied.

To keep PBMs happy, ensuring they negotiate the placement of each manufacturer’s insulin on insurance formularies, rebates for insulins have increased exponentially, particularly since 2013.

In July 2013, Sanofi offered rebates between 2% and 4% for preferred placement on a formulary. The same product in 2018 provided a 56% rebate. That’s more than half of the out-of-pocket cost of insulin being handed to companies that don’t make the insulin.

This is one example, but every single insulin manufacturer does this. As the report states, “What is clear is that the money that flows through PBMs is nothing short of enormous. As discussed throughout this report, rebates have grown at a rapid pace in the insulin market in recent years, which is not true in all therapeutic markets.”

The Bigger the PBM, the Greater the Power

The three largest PBMs – CVS Caremark, Express Scripts, and Optum Rx – wield significant power in the market commanding large rebates. Lilly documents show that they offered a 22% rebate to a small PBM, but offered Optum Rx a 68% rebate for the same products in order to get placement in Medicare’s Part D prescription plan. As noted in the report, this robust ability to negotiate has led to “…some PBMs securing rebates as high as 70% in recent years.”

Manufacturer contracts with PBMs, previously confidential but exposed by the Senate Finance Committee report, are written in percentages. This means that it is to the PBMs’ benefit to encourage list price increases, making their portion of payout larger.

PBMs actively encourage manufacturers to raise the list price so that they may receive more money, and use threats of removing insulins from insurance formularies as leverage. The bundling of multiple products (increasing one product’s rebate amount to get other products included) is also a tactic used in PBM and manufacturer negotiations, especially in exclusivity contracts.

“As Eli Lilly explained to its investors in 2019, failing to secure formulary placement can “lead to reduced usage of the drug for the relevant patient population due to coverage restrictions such as prior authorization in formulary exclusions, or due to reimbursement limitations which result in higher consumer out-of-pocket cost, such as non-preferred co-pay tiers, increased co-insurance levels, and higher deductibles.”

The Bottom Line

The US healthcare system is deeply broken, and insulin pricing is one of the clearest examples that an unregulated drug pricing system motivated by profit will always put cash flow over patient lives. PBMs and the rebate system exacerbate the problem, but every participant within the system is at blame. Each entity has chosen profit over people.

Significant rebate reform and an overhaul or removal of the PBM system could slash the list price of insulin by up to 70% and would impact not just insulin, but many medications and devices that are subject to the rebate system. Robust federal healthcare reform could create a system where drug prices could be negotiated on a federal level, and current proposals like rolling back prices to more reasonable levels could be a step.

A deeply broken system requires layered solutions. Without a full overhaul, we risk fixing the insulin pricing issue with a bandaid, while driving up prices and limiting access to other life sustaining medications and life changing technology.

Substantial healthcare policy change takes the voice of many, and individual advocates make a resounding and impactful difference. If you are looking to get involved with diabetes access advocacy, start here. Reach out and get to know your state’s congressional representatives in the House and Senate. Make sure they know your personal experience and how issues of healthcare, drug pricing, and access impact you.

Source: diabetesdaily.com

5 Top Tips to Manage Diabetes in this New Normal

5 Top Tips to Manage Diabetes in this New Normal

During this unprecedented time of COVID-19, it is especially important for the millions of people managing their diabetes to be conscious of the ongoing climate and how it may impact their daily routine.

In this “new normal,” diabetes tracking and management can look different from person to person. From incorporating healthy habits daily to maintaining a consistent wellness routine, the tips below can help people living with diabetes and their caregivers better navigate through this time.

1. Find ways to stay active and energized.

Identify exercises that can be performed at or close to home that you enjoy. Staying active, combined with eating a healthy diet, is a simple way to help ensure that you’re still taking care of yourself on an everyday basis.

When implementing new healthy habits, don’t forget that keeping up with mental health is just as important as physical exercise. Find hobbies that keep you engaged and motivated while at home, whether that’s reading a book, trying yoga for the first time, or baking a new healthy recipe.

5 Top Tips to Manage Diabetes in this New Normal

2. Stay connected with your healthcare providers.

Telehealth solutions, such as video, online chat and email, provide direct access to doctors and healthcare professionals from the safety of your own home. By connecting

virtually, you can get the medical advice you need, while minimizing your potential for exposure to COVID-19 and other illnesses. Continuing to stay regularly connected can help ensure that you are on the treatment program that works best for you.

3. Be prepared.

With so much recent change to our everyday lives, it’s important to stay a few steps ahead, including with the management of diabetes medications and care. Ensure you have an ample supply of medication on hand and keep track of when you will need to re-order it. The CDC recommends keeping at least a 30-day supply of diabetes medicines available, including insulin.1

4. Keep data at your fingertips.

With today’s resources, tracking insulin doses and various other diabetes data has never been easier. Use continuous glucose monitoring (CGM) and smartphone connectivity to monitor data trends and help keep your blood sugar in the target range. This data can also be useful when discussing your diabetes management plan with your healthcare provider.

Technology can also be used to monitor other components of your day-to-day health, beyond diabetes metrics alone. Specifically, tracking calories, carbohydrates, and hydration are all key for keeping diabetes management on track.

5. Lean on your support system.

When navigating the uncertain road ahead, it’s important to have a solid support system of family and friends. Make sure to stay connected – whether it is via phone call or virtually – with the people in your life who are supportive in your diabetes care.

People with diabetes are particularly vulnerable to COVID-19 and the need to consistently and optimally manage diabetes is now more important than ever.2 In fact, type 2 diabetes is a key risk factor for COVID-19 and its progression, and type 1 or gestational diabetes might increase your risk of severe illness from COVID-19.1 For more information, download this helpful ‘Diabetes and COVID-19’ fact sheet.

5 Top Tips to Manage Diabetes in this New Normal

Be sure to stay connected with your healthcare team and your emotional support system to identify what medications, treatment approaches, and daily care routines will best help you manage your diabetes during this time. Click here to learn more about how you can stay on track with a diabetes care plan.

References

1. Centers for Disease Control and Prevention. Coronavirus Disease 2019: People with Certain Medical Conditions. Available at: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Accessed August 2020.
2. Zhu, L. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metabolism. Available at: https://www.cell.com/cell-metabolism/pdf/S1550-4131(20)30238-2.pdf. Accessed August 2020.

© 2020 Novo Nordisk        All rights reserved.       US20TSM00348       November 2020

Source: diabetesdaily.com

How Telemedicine Improves Diabetes Care

How Telemedicine Improves Diabetes Care

By Heather Nelson

Rapid advances in telehealth have provided doctors a level of convenience (1) that lends itself to well-rounded patient care. In this article, we will highlight some benefits of telemedicine relating to diabetes management.

Rise of Diabetes Distance Care

Telemedicine is the use of technology in delivering medical care to patients from a distance (2). Once considered necessary for rural or underserved communities, telemedicine has transformed over the past 50 years into a vibrant, integrated service utilized by hospitals and physicians around the globe (3).

Diabetes telemedicine has combined the wonders of technology and the necessity of recurring specialty care to enable providers to be more proactive. One effect of telemedicine on the management of diabetes is that providers are able to help their patients see improved HbA1c levels (4).

As always, in the grand scheme of diabetes therapy solutions, the measuring stick has always been the almighty HbA1c. As technology improves, doctors are seeing the added benefits of reading telehealth data from sensors to measure Time-In-Range as well (TIR) (5).With both of these in mind, a new treatment option can succeed or fail based on the ability to improve HbA1c ranges consistently or provide greater time in optimal blood glucose range. This seems to be no struggle for telemedicine.

The benefits of telemedicine in diabetes distance care are so promising that the CDC (Centers for Disease Control and Prevention) ran a 2-year study in rural Alabama and Georgia (6). The outcome showed decreased hemoglobin A1c as well as average reduced travel time of over 78 minutes per visit. Based on their findings, the CDC declared that “diabetes care delivered via telemedicine was safe and was associated with time savings, cost savings, high appointment adherence rates, and high patient satisfaction.”

Additionally, another study found lower HbA1c levels as well as improved blood pressure and cholesterol levels after just one year of telemedicine (7).

These studies might seem great on paper, but you might be asking yourself…

“How can telemedicine help me manage my diabetes?”

Well, I’m so glad you asked. Welcome to “Telediabetes”!

We all know that diabetes is a chronic disease that requires regular and constant monitoring. Some providers wish to see their patients bi-annually, while others request quarterly or even monthly check-ups. The practical challenges of regular office visits can sometimes prove challenging, and in the gap of in-office care and at-home management, the person with diabetes flounders. This gap is precisely where telemedicine shines.

4 Reasons Why Real-time Feedback No Longer Requires Face-Time Appointments

  • Is the driving distance to your endocrinologist office making those quarterly visits hard to squeeze into your lunch hour? Transmit your health records and let telemedicine connect you for guidance in basal rates adjustments or dosing tweaks with less time off work.
  • Is prohibitive weather keeping you from talking with your mental health practitioner about diabetes challenges? Log into a portal and send a message detailing your snow-day concerns straight away. They can respond via email or video conference to provide real-time support and encouragement.
  • Are school absences piling-up making it hard for your child to miss another half-day for their monthly appointment? Simply log-in, upload the latest chart data you’ve been keeping, and let their doctor analyze the trends and suggest small changes. These tweaks can make a big impact in keeping them at optimal health while keeping them in school and learning (8).
  • Have travel challenges made your food dosing questionable? Send a message to your certified diabetic educator (CDE) and let them guide you to healthier solutions and safer swagging.

Whatever reason you have to miss out on those essential office visits, telemedicine doesn’t judge. Telemedicine understands.

With Great Tech, Comes Great Responsibility

The rapid advances of tracking devices and sensors mean we can readily gather reliable glucose data in a fairly simple manner. But that’s not the full picture your healthcare team will need. We all know that taming the diabetes monster requires a multi-faceted approach. The rise of newer and better diabetes management technology has perfectly poised the diabetic community to benefit from telemedicine and all it has to offer including lifestyle modifications, mental health checks, and more. But we must have solid data to reap those benefits.

The best way to take advantage of all the rewards of telemedicine is to provide good and useful data. The more data you can afford, in a succinct and readable format, the better distance care your provider can give. Utilizing technology means you should be able to provide food records, insulin doses, basal and bolus rates (for our pump-loving friends) as well as activity, health events, and other biometrics like Ketones, HbA1c readings, weight and body measurements.

Beyond the tracking of data itself, presentation also matters. Clearly you can’t courier-pigeon over a stack of origami-worthy paper logs and in this day and age, you shouldn’t have to. Organize your logs into a format that is easily accessible for your healthcare provider. If they need CSV, Excel sheets, or PDFs, provide what they can read.

How mySugr PDF Reports Makes Data Sharing Easy

If you are reading this and genuinely shocked to learn that you need to log things like insulin dosing and food intake, allow us to usher you out from under your rock and into the age of technology by introducing the reporting feature in the mySugr app! Indeed we believe you are the captain of your pancreas. As such, the ability to harness all your well-tracked data into usable information for you and your doctor is a key focus of our app. Using the reports feature you can quickly:

  • View your own data at a glance, anytime, to see trends.
  • Select your own time period to see only the data you wish to discuss. No more information overload or sifting through months of records needlessly.
  • Send preferred data to your doctor via email for quick communication about necessary formula changes. Even select from one of our three output formats for optimal communication.
  • Stay in constant communication and more!

Using the data in these reports, you can truly be the master of your own fate. The reports are meant to empower you as you discuss your treatment decisions with your provider, making the conversation more constructive and putting you back in the driver’s seat of your care.


And for our US friends in the diabetic online community (DOC), we still have our fabulous bundle! mySugr has over 2 million registered users to-date and a 4.6+ rating on the App Store and Google Play. The mySugr Coaching service is second-to-none and utilizing our monthly subscription gets you:

  • Blood glucose meter
  • Lancing device (with a box of refills…so that’ll last you basically forever, amiright)
  • Unlimited test strips (new shipments arrive before you even run out!)
  • The mySugr Pro App (that includes the ability to estimate the HbA1c!)
  • Diabetes coaching (with a pretty top-notch team)
  • Free shipping

And all the tech-support a person could need!

Indeed, we believe telemedicine is here to stay (9) and with good reason!

People living with diabetes can find more freedom and a better quality of life with the rising accessibility of a healthcare team armed and ready to interpret and predetermine the many responses to all the data we track.

As always, mySugr stands on the edge of change ready to help usher in this new age with open arms and glucometers for all Rise up mighty warriors and embrace the freedom of “telediabetes”!


(1) Wicklund E. Leveraging Primary Care Telehealth for Convenience and Quality. https://mhealthintelligence.com/features/leveraging-primary-care-telehealth-for-convenience-and-quality(2) White LA, Krousel-Wood MA, Mather F. Technology meets healthcare: distance learning and telehealth. Jan. 2001. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116779/

(3) eVisit: The Ultimate Telemedicine Guide | What Is Telemedicine? 2018. https://evisit.com/resources/what-is-telemedicine/

(4) Hompesch M, Kalcher K, Debong F, Morrow L. Significant improvement of blood sugar control in a high risk population of type 1 diabetes using a mobile health app – A retrospective observational study. Poster presentation at ATTD 2017, Paris, France.

(5) Beck R, Bergenstal R, Riddlesworth T, Kollman C, Li Z, Brown A, Close K. Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials. March 2019.

(6) Xu T, Pujara S, Sutton S, Rhee M. Telemedicine in the Management of Type 1 Diabetes. 2018. http://dx.doi.org/10.5888/pcd15.170168

(7) Steven Shea, MD, Ruth S. Weinstock, MD, PhD, Justin Starren, MD, PhD, Jeanne Teresi, EdD, PhD, Walter Palmas, MD, Lesley Field, RN, MSN, Philip Morin, MS, Robin Goland, MD, Roberto E. Izquierdo, MD, L. Thomas Wolff, MD, Mohammed Ashraf, BA, Charlyn Hilliman, MPA, Stephanie Silver, MPH, Suzanne Meyer, RN, Douglas Holmes, PhD, Eva Petkova, PhD, Linnea Capps, MD, Rafael A. Lantigua, MD, PhD, for the IDEATel Consortium. A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus. Jan-Feb. 2006. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1380195/

(8) Please note that all mySugr products have a minimum age limit of 16 years for the mySugr Logbook and 18 years for the mySugr Bolus Calculator (for more details please read mySugr’s General Terms & Conditions).

(9) Klonoff David C., M.D. Using Telemedicine to Improve Outcomes in Diabetes—An Emerging Technology. July 2009. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769943/

Source: diabetesdaily.com

Homemade Keto Alfredo Sauce Recipe

This content originally appeared on Low Carb Yum. Republished with permission.

If you’ve never made your own white pasta sauce, you’ll be surprised how easy it is. You can make a simple cream sauce with butter, heavy cream, parmesan cheese, and cream cheese. Those are the four basic ingredients I use to make homemade keto Alfredo sauce.

I like to add a few more ingredients to mine to enhance the flavor. For me, garlic is one of the best seasonings ever so I add in a few freshly minced cloves. I also add in a few shakes of fresh ground black pepper.

There’s very little preparation needed to make homemade sauce. And, it’s much better to make it yourself because commercially prepared ones always contain unnecessary ingredients that up the carbs.

Print

Low-Carb Alfredo Sauce

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Cook all the ingredients together in a saucepan until smooth. Then serve this easy low-carb cream cheese sauce over zoodles or keto-friendly fettuccine.
Course Side Dish
Cuisine Italian
Keyword alfredo sauce, zucchini
Prep Time 5 minutes
Cook Time 10 minutes
Total Time 15 minutes
Servings 16 people
Calories 321kcal

Ingredients

  • 1/2 cup butter
  • 2 cloves garlic minced
  • 2 ounces cream cheese
  • 1 1/2 cup parmesan cheese shredded
  • 2 cups heavy whipping cream
  • dash ground black pepper

Instructions

  • Melt butter in a medium saucepan over medium heat. Sauté garlic in hot butter until fragrant.
  • Blend in remaining ingredients and simmer for about 10 minutes or until the sauce has thickened.

Notes

Sauce will thicken as it cools and will become very thick if stored in the refrigerator. Simply heat the sauce up for it to be pourable.

Nutrition

Serving: 0.25cup | Calories: 321kcal | Carbohydrates: 2g | Protein: 15g | Fat: 28g | Saturated Fat: 18g | Polyunsaturated Fat: 1g | Monounsaturated Fat: 7g | Cholesterol: 87mg | Sodium: 706mg | Potassium: 65mg | Sugar: 1g | Vitamin A: 950IU | Calcium: 490mg | Iron: 0.4mg


Please note that the nutritional information may vary depending
on the specific brands of products used. We encourage everyone to check specific
product labels in calculating the exact nutritional information.

Homemade Keto Alfredo Sauce Recipe

Source: diabetesdaily.com

What Should I Do If I Have Symptoms of COVID-19?

As the global viral outbreak continues, you may be wondering what special considerations there are for people with diabetes to keep in mind. In particular, what should you do if you begin to experience symptoms consistent with the infection? This article reviews the most common COVID-19 symptoms, discusses potential issues specific to people with diabetes, and provides a guideline of how to respond if you become sick.

Symptoms of COVID-19

Be on the lookout for the following most common symptoms of COVID-19:

  • Fever
  • Coughing (especially dry)
  • Shortness of breath

Other symptoms may include fatigue, body aches, and sore throat, among others.

Special Considerations for People with Diabetes

You may have heard that people with certain medical conditions, including those with diabetes, are considered to be in the high-risk group for developing more serious symptoms of the disease, and have been reported to have a significantly higher mortality rate than those without underlying conditions. While these statistics are both relevant and can be scary, it is also important to keep in mind that your individual risk will vary widely depending on your specific health status, regardless of your diabetes diagnosis. Your age, other related and unrelated health conditions, and blood glucose management profile, all play a role in determining your overall risk. So, while as a whole population, people with diabetes are at higher risk for complications, your individual risk could be much lower than that.

For instance, as per the JDRF, those who have type 1 diabetes are  “not necessarily at higher risk of developing serious complications from the disease. Those at greatest risk are those who have another, or second chronic disease (such as a compromised immune system, heart disease or renal failure).

Talk to your healthcare provider to better understand your individual risk level and recommendations.

Have a Plan of Action If Symptoms Arise

Being adequately prepared ahead of time can help you feel calmer and more empowered if you do get sick. Consider taking the following steps today, if you haven’t already:

  • Take preventative measures. Stay home. Practice social distancing (note: if you already have symptoms, self-isolate!)
  • Wash your hands. Avoid touching your face. Disinfect “high-touch” surfaces regularly.
  • Make sure that your medication refills are up-to-date so that you have the supply you need if you will stay in your home for a long period of time (e.g., at least several weeks). Make sure that you consider supplies used for diabetes management as well as any other medications that you use.
  • Check that you have medications on hand that you would typically use to treat a viral infection, such as a fever-reducing agent, like acetaminophen (Tylenol). Consult with your healthcare provider for advice about their specific recommendations.
  • Have enough food and water in your home in case you stay home for a prolonged period of time (e.g., several weeks).
  • Review the “Sick Day Rules” for people with diabetes. COVID-19 causes mild symptoms in most of the people who are infected. This means most likely, you will be treating your symptoms at home. However, any illness can make blood glucose levels more challenging to manage. It is important to be aware of how illness can affect your management plan and make adjustments as needed, with the help of your healthcare provider, to keep yourself safe during the illness. You can find the standard “Sick Day Rules” as described by the Joslin Diabetes Center here, but discuss your specific recommendations with your healthcare provider.

So, what should you actually do (and not do) if you develop symptoms of COVID-19?

  1. Don’t panic.
  2. Self-isolate. Don’t go to urgent care or the emergency room, unless instructed to do so or you experience serious symptoms (see below). Stay home.
  3. Call your doctor and follow their advice closely.
  4. Keep a close eye on blood sugar levels. Work with your healthcare provider to make adjustments to medications, if needed, to help stay in the target glycemic range as much as possible. Keeping blood glucose levels in check as much as possible can go a long way to helping you avoid complications during any illness.
  5. Manage your specific symptoms (e.g., fever). Ask your healthcare provider for specific at-home treatment advice.
  6. Stay hydrated. This can help you keep your blood sugar levels in the target range and avoid complications.
  7. Be on the lookout for serious symptoms, including those of diabetic ketoacidosis (DKA), as well as the following “COVID-19 emergency warning signs”:
  • Difficulty breathing
  • Chest pain
  • Confusion or difficulty waking
  • Blue tint to the skin (on the lips or face, in particular)

If you experience these any of these symptoms, promptly seek medical care. Wear a mask if out in public.

  1. Continue to wash your hands and clean surfaces regularly.
  2. Continue to avoid contact with others (humans and pets).
  3. Do not discontinue isolation until you get the “all clear” from your healthcare provider.

***

For even more detailed information on what to do if you are ill, read these guidelines from the CDC:

What to Do if You’re Sick

Guidelines for At-Risk Populations

Also, learn even more about COVID-19 illness with diabetes from the American Diabetes Association (ADA) here.

Source: diabetesdaily.com

Keto Pecan Pie Cookies

This content originally appeared on Caroline’s Keto Kitchen. Republished with permission.

Legendary Foods Pecan Pie Flavored Almond Butter is one of my favorites, so I knew I had to bake with it quickly before I ate the whole jar. These cookies semi-defeated the purpose since they are equally as addicting (I mean, how can a cookie not be with a giant glob of this nut butter in it!?), but the good news is I had one and the rest are in my freezer. I feel like these would be a great Thanksgiving dessert, but I’m all for pecan pie year-round!

Keto Pecan Pie Cookies

Print

Keto Pecan Pie Cookies

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Pair this low-carb cookie with your afternoon tea or coffee, or have one as a dessert after your meal.
Course Dessert
Cuisine American
Keyword low carb cookies
Prep Time 20 minutes
Cook Time 20 minutes
Total Time 40 minutes
Servings 12
Calories 164kcal

Equipment

  • oven
  • Microwave

Ingredients

  • 10 tbsp Legendary Foods Pecan Pie Flavored Almond Butter
  • 4 tbsp salted butter softened
  • 1/3 cup granulated Swerve
  • 1 tsp liquid monk fruit juice concentrate
  • 1 tsp vanilla
  • 1/8 tsp salt
  • 1 egg large
  • 6 tbsp lupin flour
  • 2/3 cup almond flour
  • 1/4 tsp baking soda
  • 2 tbsp sugar-free chocolate chips
  • 1 tsp coconut oil

Instructions

  • First we'll make the pecan pie centers. I highly recommend having frozen centers before you stuff them into the cookies, or else you might get a bit of a nut butter mess. To get frozen centers, scoop out 12 spoonfuls of refrigerated Legendary Foods Pecan Pie Flavored Almond Butter onto a cutting board covered in wax paper and freeze overnight. (I used 10 tbsp of nut butter total for my 12 centers, so slightly less than 1 tbsp per cookie).
  • Pre-heat oven to 350 degrees.
  • In a large bowl, cream together the butter, vanilla and sweeteners.
  • Mix in the salt, egg, lupin flour, almond flour, and baking soda until a dough forms.
  • On a cookie sheet, form 12 discs of cookie dough and make a "thumbprint" in each center. This is where your filling will go, so it should roughly match the size of your pecan pie centers.
  • Bake the cookies for 5 minutes at 350 and then remove from oven.
  • Remove the frozen pecan pie centers from the freezer and stuff them inside each thumbprint.
  • Return to oven for about 11 minutes or until done.
  • Allow cookies to cool fully before removing from cookie sheet.
  • Melt chocolate chips with coconut oil in the microwave, stir, and use an icing bag to drizzle chocolate over the cookies.

Nutrition

Calories: 164kcal | Carbohydrates: 5g | Protein: 6g | Fat: 15g | Saturated Fat: 4g | Polyunsaturated Fat: 1g | Monounsaturated Fat: 3g | Cholesterol: 26mg | Sodium: 30mg | Potassium: 77mg | Fiber: 3g | Sugar: 1g


Please note that the nutritional information may vary depending
on the specific brands of products used. We encourage everyone to check specific
product labels in calculating the exact nutritional information.

Keto Pecan Pie Cookies Recipe>

Source: diabetesdaily.com

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