Review of TempraMed VIVI Cap 1: Reusable Insulin Cooler Cap

The TempraMed VIVI Cap 1 is a reusable insulin cap cooler that promises to keep your insulin safe in extreme weather – protecting it from both hot and cold. Your insulin won’t overheat, and it won’t freeze. This is a great tool for the hot summer months or the dead of the winter. Wouldn’t you like to stop worrying about your insulin and just live in the moment?

What Does It Do?

This device offers supercharged insulation for your insulin pen.

The VIVI Cap 1 is scientifically proven to keep your insulin at room temperature, which allows you to spend time in extreme weather conditions without worrying about your insulin going bad. With a built-in temperature sensor and a temperature indicator, you can rest assured that your insulin will stay cool and safe.

VIVI Cap 1 is a simple solution that is easy to use and requires no maintenance. Just discard the cap that comes with your regular insulin pen, and slide the pen into the VIVI Cap 1. It will click into place, and you’re ready to take it along as you would normally. It doesn’t require any re-charging, no water, no ice – you’re good to go! When you’re done with your pen, just slide a new one into the cap.

How Can I Get VIVI Cap 1 and How Much Does it Cost?

You can purchase TempaMed’s VIVI Insulin Cap Cooler directly off their website. You can also make use of your FSA/HSA when purchasing this product.

VIVI Cap 1 costs $95 dollars and comes with a 30-day money-back guarantee if you are not pleased. It also comes with a 3-year warranty.

The company graciously offered our readers a 15% off each purchase discount code: DDAILY

The VIVI cap is compatible with many different insulin pens:

Pre-Filled Pens

  • FlexPen
  • NovoLog | NovoLog Mix | Levemir | Victoza |  NovoRapid | Insulin Aspart | Novolin R
  • FlexTouch
  • NovoLog |  NovoRapid | Tresiba (Degludec)  | Fiasp | Levemir U-100 & U-200 | Saxenda | Ryzodeg | Xultophy | Ozempic
  • KwikPen
  • Humalog | Humalog U-100 & U-200 | Humalog Jr | Humalog Mix |  Basaglar | Humulin Mix | Humulin | Humalog R U-500 | Lyumjev U-100 & U-200 | Insulin Lispro U-100
  • Solostar
  • Apidra | Lantus | Admelog | Soliqua

Refillable Pens

  • Eli Lilly
  • Luxura | Luxura HD | Ergo II | Savvio
  • Novo Nordisk
  • NovoPen 4 | NovoPen 5 | NovoPen Echo
  • Sanofi
  • ClickSTAR
  • Medtronic / Companion Medical
  • InPen

My Review

I think VIVI Cap 1 is a great product for anyone using pens for multiple daily injections. I’ve tried other insulin insulation products, but most require ice packs, water, batteries, or cords, all minor annoyances that I’d strongly prefer to do without. This product is extremely lightweight and can easily fit into a small purse or pocket, no problem. It was easy to set up and didn’t add any fuss.

Sometimes my blood sugar is erratic, and when I troubleshoot I realize that my insulin has lost effectiveness due to extreme temperature exposure. This product can help avoid that issue and save you money and a headache as well! I highly recommend giving this product a try!

Source: diabetesdaily.com

Debate at the ADA: Should Athletes with Diabetes Go Low-Carb, or High-Carb?

By Maria Muccioli and Ross Wollen

***

Do you need carbohydrates to optimize athletic performance? Or can athletes with diabetes do even better when they fuel their bodies with protein and fat?

By now it’s clear that the low-carb approach to diabetes has largely gained clinical acceptance, for people with both type 2 and type 1 diabetes (T1D). But some questions remain about when carbohydrate restriction is and isn’t appropriate.

One of those big questions: athletics. It’s long been conventional wisdom that athletes – whether elite professionals or weekend warriors – absolutely need carbs to fuel performance. But when you’ve got diabetes, “carb loading” the night before a big race is a tricky proposition.

At this year’s ADA Scientific Sessions, two experts went head-to-head in a debate on “Carbohydrate Intake and Its Impact on Athletics and Health.”

Read on to hear what happened – and who, in our opinion, won the debate.

The Case for a High-Carb Diet

In his presentation titled “High/Normal Carbohydrate Intake Optimizes Performance and Glycemia,” James P. Morton, PhD argued in favor of a normal-to-high carbohydrate approach for athletic performance and blood glucose management. Morton is a professor of exercise metabolism at Liverpool John Moores University.

Morton focused his talk on the importance of fueling high-energy expenditure for elite athletes, such as those on multi-week bicycle races. He presented some data showing that people who consumed a high-carb load were able to exercise for longer periods of time than those who consumed a placebo solution. Morton pointed out that for professionals, even tiny differences can make the difference between victory and defeat.

As an example, Morton presented a case study of Tour de France winner Chris Froome. In 2018, Froome made a very dramatic comeback on the 19th day of a multi-week cycling race. He ate an incredible amount of carbohydrates that day and the day previous, which Morton believes contributed significantly to his victory.

How do carbs fuel performance? The primary explanation centers around the availability of glycogen (branched glucose molecules) in the liver and muscle. The higher the glycogen levels, the more glucose is readily available to power activity.  Morton also presented evidence that those who eat high-carb delay the point at which they begin burning fat for energy, and claimed that delaying this crossover point was important for top performance in endurance athletes.

In addition, Morton cited personal testimonies from some elite endurance athletes, such as audio of interviews from his podcast, claiming that support of high-carb for athletic performance is “unanimous.”

Unfortunately, little of this presentation had much to do with the unique challenges of athletes with diabetes. And for that matter, its focus on truly elite professionals may be of limited relevance to even the most avid part-time athletes. Morton has never worked directly with athletes with type 1 diabetes, but referred to the opinions of his “friend and colleague” Sam Scott, PhD, a researcher at Novo Nordisk. Scott has plenty of firsthand experience with high-performing diabetic athletes: he works with Novo Nordisk’s inspiring all-diabetes pro cycling team.

Morton invited the audience to read Scott’s recent publication concerning type 1 diabetes, carbohydrate intake, and athletic performance. In that paper, Scott concludes that low-carb diets “represent an effective strategy to improve glycaemic control and metabolic health in people with T1D,” but that their effect on athletic performance is basically unknown:

Despite low carbohydrate training being one of the most widely debated topics amongst athletes, coaches and sport scientists, there is very little published research specific to athletes with T1D.

Some evidence suggests that people with type 1 diabetes might especially benefit from “train low” strategies – basically, limiting carbohydrate intake during regular training, and increasing carb consumption for competitions. Beyond that, however, there simply isn’t enough evidence to make concrete claims.

Leaning on his experience with non-diabetic athletes, Morton concluded:

Regardless of whether you have normal glycemic responses or you have type 1 diabetes, the principle of ensuring high carbohydrate availability should always be upheld, because carbohydrate will certainly make you go faster.

The Case for a Low-Carb Diet

In his presentation titled “Low Carbohydrate Intake Optimizes Performance and Glycemia”, Dominic D’Agostino, PhD argued that because low-carbohydrate diets are optimal for blood glucose control, they are therefore also optimal for athletic performance.

D’Agostino, a molecular pharmacologist, is something of a minor rock star in the keto community. He’s a frequent guest on podcasts and Youtube shows, and has a fair personal understanding of keto athletic achievement: he’s an impressive powerlifter to boot.

D’Agostino started by acknowledging that we do not really know the best level of carb intake for athletes. But in his telling, practices even among the elite are far from unanimous, with athletes experimenting with a variety of strategies, ranging broadly from carb restriction to carb loading.

Many athletes choose a low-carb diet because they like the way that it feels – some claim, for example, that keto results in more consistent energy throughout competition, making them much less likely to “bonk” or hit the wall. But for people with diabetes, the primary point in favor of a low-carb diet is the degree to which it optimizes glucose control.

A very low-carb or ketogenic diet doesn’t just steady blood sugar – it also appears to result in some measure of “hypoglycemic resilience”. This isn’t a small matter for diabetic athletes. Hypoglycemia during exercise or competition won’t just ruin athletic performance: it can be very dangerous.

Not only does ketosis protect against hypoglycemia, he explained, but recent research also shows additional benefits of ketosis, such as reduction of oxidative stress. D’Agostino also noted that increased fat utilization can lead to “glycogen sparing”, and that a low-carb diet does not cause glycogen depletion in the muscle. These features may confer additional athletic advantages.

Photo by Adobe Stock

While Morton’s presentation was largely founded on the assumption that athletes with diabetes are fundamentally like athletes without diabetes, D’Agostino emphasized a different principle:

Normal glycemia is optimal for health, performance and recovery.

Of course, normal blood glucose levels are very difficult to achieve for people with type 1 diabetes, especially during exercise. But the low-carb diet has been validated as perhaps the best method of doing so.

D’Agostino explained that his own thoughts on the subject were formed partially by the experience of his former Ph.D. student, Andrew Koutnik, who lives with type 1 diabetes. Initially, D’Agostino believed that type 1 diabetes was “the one condition that I thought you would want to stay away from low-carbohydrate nutrition,” but Koutnik’s success first convinced him otherwise.

I reached out to Koutnik, now a research scientist at Florida Institute for Human and Machine Cognition.

He stressed that most studies comparing high- and low-carb athletic results show mixed or neutral results; when there is a difference, the difference “is often of little meaningful impact to most individuals engaging in physical activity.”

Dr. Koutnik argues that any nutritional program that doesn’t consider glycemic control is missing the most important factor: “Very few will debate that poor health leads to poor performance. Additionally, few will debate that normoglycemia is likely to lead to better performance than hyper- or hypoglycemia.” Therefore, for the T1D athlete, performance is a “consequence” of health.

Who Won the Debate?

Here are our thoughts:

At a diabetes conference, the focus should remain on diabetes. Although Morton presented some evidence to support the performance benefits of high-carbohydrate intake in elite athletes without diabetes, it’s a mistake to assume that the same benefits would occur in athletes with diabetes, or that they wouldn’t be counterbalanced by the known downsides of high-carb consumption. Glycemic management is a huge issue during exercise, and both low and high blood sugars can have dramatic effects on performance.

exercise woman

Photo by Andrew Tanglao (Unsplash)

Most of Morton’s talk also focused on elite endurance athletes. But what we learn from the best athletes on the planet may not be very useful for the rest of us.

In our opinion, D’Agostino showed a better understanding of the balancing act that athletes with diabetes (especially type 1 diabetes) need to perform.

Even if we accept that carb loading can provide a perceptible boost to serious athletes, we have to acknowledge that those carbs (and any accompanying insulin) also make it more likely for the athlete to experience hypo- or hyperglycemia, which can instantly ruin any sports outing. And the more predictable and stable your blood sugar, the more confident you can be, and the less mental space you’ll have to waste on monitoring and micromanaging glycemic changes. And if a ketogenic diet really does provide some protection against hypoglycemia, that’s just even more reason to choose a very low carb diet.

If you’re actually an elite athlete, maybe carbohydrates can help push you to the peak of performance. But maybe not – the scientific evidence is not overwhelming. For the rest of us, blood sugar control remains of paramount importance. It seems to me that a low-carbohydrate diet is more likely to deliver confident performances and strong athletic results.

What are your thoughts on this debate?

Source: diabetesdaily.com

Insulin at 100, Part 3: Insulin’s Uncertain Future

This content originally appeared on diaTribe. Republished with permission.

This is Part 3 of James S. Hirsch’s exploration of the riveting history of insulin, on the occasion of its 100th birthday.

Part 1: The Discovery

Part 2: Failed Promises, Bold Breakthroughs

Insulin’s Uncertain Future

Insulin

Image source: Emily Ye, Diabetes Daily

As further refinements in insulin occurred, the insulin narrative should have become even more powerful – that insulin not only saves people, but in reaching new pharmacological heights, it is allowing patients to live healthier, better, and more productive lives. These should be insulin’s glory days – as well as days of unprecedented commercial opportunity. According to the International Diabetes Federation, in 2019, the global population of people with diabetes had increased a staggering 63 percent in just nine years – to 463 million patients.

Insulin sales should be booming, with a new generation of Elizabeth Evans Hughes and Eva Saxls to tell the story. In fact, insulin sales are declining, and insulin has no spokespeople. Reasons vary for these developments, but one fact is undeniable: insulin has lost its halo.

Insulin is still essential for any person with type 1 diabetes, though even with type 1 patients, insulin is sometimes under-prescribed as doctors fear getting sued over a severe hypoglycemic incident. The belief is that patients are responsible for high blood sugars, doctors for low blood sugars.

Where insulin has lost its appeal is with type 2 patients, which has driven the diabetes epidemic in the U.S and abroad. According to the CDC, from 2000 to 2018, America’s diabetes population surged 185 percent, from 12 million to 34.2 million, and an estimated 90 percent to 95 percent of that cohort has type 2. (The global percentage is similar.) These patients have long had options other than insulin – metformin, introduced in 1995, remains the ADA’s recommended first-line agent. But as a progressive disease, type 2 diabetes, in most cases, will eventually require a more intensive glucose-lowering therapy. Nothing achieves that objective better than insulin, but insulin is delayed or spurned entirely by many type 2 patients.

Some concerns are longstanding; namely, that insulin can lead to weight gain because patients now retain their nutrients. Some type 2 patients wrongly associate insulin with personal failure surrounding diet or exercise, so they want to avoid the perceived stigma of insulin. Some people just don’t like injections. Meanwhile, other patients associate insulin with the medication that an ailing patient takes shortly before they die: insulin as a precursor to death. Some clinicians who care for Hispanic patients refer to insulin pens as las plumas to avoid using a word that carries so much baggage.

What’s striking is how dramatically the cultural narrative has changed, from insulin the miracle drug to insulin the medical curse. And where are the commercials, the movies, the documentaries, and the splashy publicity campaigns about the wonders of insulin? They don’t exist.

The greatest impact on insulin use in type 2 diabetes has been the emergence of a dozen new classes of diabetic drugs. These include incretin-based therapies known as GLP-1 agonists and DPP-4 inhibitors (introduced in the 2000s) as well as SGLT-2 inhibitors (introduced in 2014). diaTribe has covered these therapies extensively, and their brands are all over TV: Trulicity, Jardiance, Invokana, and more. They all seem to have funky names, and like insulin, they can all lower blood sugars but – depending on which one is used – some have other potential advantages, such as weight loss. (Some have possible disadvantages as well, including nausea.)

The expectations for these drugs were always high, but what no one predicted was that GLP-1 agonists and SGLT-2 inhibitors have been shown to reduce the risk of both heart and kidney disease – findings that are a boon to type 2 patients, who are at higher risk of these diseases. These findings, however, were completely accidental to the original mission of these therapies.

Insulin, the miracle drug, has been eclipsed by drugs that are even more miraculous!

Consider Eli Lilly, whose Humalog is the market-leading insulin in the United States. In 2020, Humalog sales fell 7 percent, to $2.6 billion, while Trulicity, its GLP-1 agonist, saw its sales increase by 23 percent, to $5 billion.

That’s consistent with the global insulin market. Worldwide insulin sales in 2020 declined by 4 percent, to $19.4 billion, marking the first time since 2012 that global insulin sales fell below $20 billion.

It’s quite stunning. Amid a global diabetes epidemic, and with the purity, stability, and quality of insulin better than ever, insulin sales are falling. (Pricing pressures from insurers and government payers have also taken a revenue toll.) In 2019, Sanofi announced that it was going to discontinue its research into diabetes, even though its Lantus insulin had been a blockbuster for years. More lucrative opportunities now lay elsewhere.

Falling sales may not be the insulin companies’ biggest problem. Public scorn is. Though the insulins kept getting better, the prices kept rising, forcing many patients to ration their supplies, seek cheaper alternatives in Canada or Mexico, or settle for inferior insulins. Some patients have died for lack of insulin. According to a 2019 study from the nonprofit Health Care Cost Institute, the cost of insulin nearly doubled for type 1 patients in the United States between 2012 and 2016 – they paid, on average, $5,705 a year for insulin in 2016, compared to $2,864 in 2012.

Many patients are outraged and have used social media to rally support – one trending hashtag was #makeinsulinaffordable. Patient advocates have traveled to Eli Lilly’s headquarters to protest. In March of this year, nine Congressional Democrats demanded that the Federal Trade Commission investigate insulin price collusion among Eli Lilly, Novo Nordisk, and Sanofi, asserting they “are using their stranglehold on the market to drive up costs.” The letter notes that as many as one in four Americans who need insulin cannot afford it, and at least 13 Americans have died in recent years because of insulin rationing.

The criticism has been unsparing. In April 2019, in a hearing for the U.S. House of Representatives on insulin affordability, Democrats and Republicans alike pilloried the insulin executives. At one point, Rep. Jan Schakowsky (D-Illinois) said to them, “I don’t know how you people sleep at night.”

Insulin is hardly the only drug whose price has soared, but as the Washington Post noted last year, insulin is “a natural poster child of pharmaceutical greed.”

In response, the insulin companies have adopted payment assistance programs to help financially strapped consumers. They also blame the middlemen in the system – the PBMs, or the Pharmaceutical Benefit Managers – for high insulin prices, who in turn blame the insulin companies, and everyone blames the insurers, who point the finger at the companies and the PBMs.

Drug pricing in America is so convoluted it’s impossible for any patient to accurately apportion blame, but the history of insulin explains in part why the companies have come under such attack. When Banting made his discovery, he sold the patent to the University of Toronto for $1. He said that insulin was a gift to humankind and should be made available to anyone who needs it. Insulin was always profitable for Eli Lilly and the few other companies who made it, and critics have complained that the companies found ways to protect their patents by making incremental improvements in the drug.

But for years, those complaints were easily dismissed. The companies were revered for their ability to mass produce – and improve – a lifesaving drug that symbolized the pinnacle of scientific discovery while doing so at prices that were affordable.

When prices became unaffordable – and regardless of blame – the companies were seen as betraying the very spirit in which insulin was discovered and produced, and their fall from grace has few equivalents in corporate history.

Is the criticism fair?

Hard to say, but even the companies would acknowledge that they’ve squandered much good will. Personally, I’m the last person to bash the insulin companies – they’ve kept me and members of family alive for quite some time. Collectively, my brother, my son, and I have been taking insulin for 117 years, so I feel more regret than anger: regret that at least one insulin executive didn’t stand up and say loudly and clearly:

“Insulin is a public good. No one who needs it will be without it. And we will make it easy for you.”

Insulin

Image source: Emily Ye, Diabetes Daily

Whatever that would cost in dollars would be made up for in good will – and such a public commitment would honor the many anonymous men, women, and children, before 1921 and after, who gave their lives to this disease.

The next chapter for insulin? It will almost certainly include continued improvements. Both Eli Lilly and Novo Nordisk are trying to develop a once-a-week basal insulin to replace the current once-a-day options – that would be a major advance is reducing the hassle factor in care. Research also continues on a glucose-sensitive insulin, in which the insulin would only take effect when your blood sugar rises. That would be a breakthrough, but investigators have spent decades trying to make it work.

Since its discovery, the ultimate goal of insulin has been to make it disappear, as that would mean diabetes has been cured. It turns out that insulin therapy may indeed disappear someday, even if no cure is found. Since its discovery, the ultimate goal of insulin has been to make it disappear, as that would mean diabetes has been cured. It turns out that insulin therapy may indeed disappear someday, even if no cure is found.

Stem-cell therapy has long held promise in diabetes – specifically, making insulin-producing beta cells from stem cells, which the body would either tolerate on its own (perhaps by encapsulating the cells) or through immunosuppressant drugs. Progress has been halting but is now evident. Douglas Melton began his research in this area in 1991, and in 2014, he reported that his lab was able to turn human stem cells into functional pancreatic beta cells. The company that Melton created for the effort was acquired by Vertex Pharmaceuticals, and earlier this year, Vertex announced that it had received approval to begin a clinical trial on a “stem-cell derived, fully differentiated pancreatic islet cell therapy” to treat type 1 diabetes. Another company, ViaCyte, also announced this year that it will begin phase 2 of a clinical trial using encapsulated cells in hopes that they will mature into insulin-secreting beta cells.

It may take 10 to 15 years, but leaders in the field are cautiously optimistic that a cell-based therapy will someday provide a better option than insulin.

Diabetes would survive, but the therapy once touted as its cure would be dead.

Because I have a soft spot for happy endings – and because so much of own life has been intertwined with insulin – I have my own vision for insulin’s last hurrah.

A group of researchers in Europe are conducting a clinical trial to prevent type 1 diabetes. Called the Global Platform for the Prevention of Autoimmune Diabetes, the initiative began in 2015, and researchers are testing newborns who are at risk of developing type 1 to see if prevention is possible.

And what treatment are they using?

Oral insulin.

Like the discovery of insulin itself, this effort is a longshot, but if it works, insulin will have eradicated diabetes – a fitting coda for a medical miracle.

I want to acknowledge the following people who helped me with this article: Dr. Mark Atkinson, Dr. David Harlan, Dr. Irl Hirsch, Dr. David Nathan, Dr. Jay Skyler, and Dr. Bernard Zinman. Some material in this article came from my book, “Cheating Destiny: Living with Diabetes.”

About James

James S. Hirsch, a former reporter for The New York Times and The Wall Street Journal, is a best-selling author who has written 10 nonfiction books. They include biographies of Willie Mays and Rubin “Hurricane” Carter; an investigation into the Tulsa race riot of 1921; and an examination of our diabetes epidemic. Hirsch has an undergraduate degree from the University of Missouri School of Journalism and a graduate degree from the LBJ School of Public Policy at the University of Texas. He lives in the Boston area with his wife, Sheryl, and they have two children, Amanda and Garrett. Jim has worked as a senior editor and columnist for diaTribe since 2006.

Source: diabetesdaily.com

Insulin at 100, Part 2: Failed Promises, Bold Breakthroughs

This content originally appeared on diaTribe. Republished with permission.

By James S. Hirsch

Insulin

Image source: diaTribe

The discovery of insulin in 1921 was heralded as the cure for diabetes. The reality was different.

Insulin, to be sure, could temporarily lower blood sugars to near-normal ranges, but it could also cause hypoglycemia – blood sugars that are too low – that could lead to shakiness and confusion or, in extreme cases, seizures, loss of consciousness, or death. Insulin was a daily, self-administered drug, but if used incorrectly, it could kill a patient just as well as it could save a patient. No self-administered therapy, before or since, has quite those same attributes.

What’s more, insulin’s therapeutic powers were overestimated. Yes, insulin lowered blood sugars, but maintaining near-normal levels was still very difficult – and elevated blood glucose over time was still dangerous. As a result, by the middle of the 1930s, patients who were taking insulin began developing serious complications caused by elevated glucose levels, including damage to the eyes, kidneys, nerves, and heart. Insulin hadn’t cured anything but had turned diabetes from a deadly condition into a chronic condition, and a perilous one at that. At the dawn of the insulin age and for many decades thereafter, even those who understood the importance of maintaining near-normal blood sugars did not have the tools to do so. Blood sugar levels were measured by proxy through urine tests, in which samples had to be boiled for three minutes. Simpler methods were developed by the 1940s, but home glucose monitoring was not available until the late 1970s.

Until then, patients – unaware of their blood sugar levels – gave themselves insulin doses flying blind.

But few people outside the diabetes world knew about the daily rigors and risks of the disease – not only because it affected a relatively small percentage of people but also because the insulin narrative was too powerful.

Diabetes, after all, had been cured or at least resolved. That’s what all the pictures showed. That’s what the headlines blared. And that’s what the ads promoted.

Eli Lilly’s ads, for example, initially touted insulin as “An Epoch in the History of Medicine” and later featured a beautiful bride on her wedding day, kissing her beaming father, with the tagline, “Our favorite picture of insulin.”

Even that picture paled in comparison to the astonishing newspaper and magazine stories about insulin, and not just those about Elizabeth Evans Hughes. Insulin was a redemptive tale about science and survival.

Eva and Victor Saxl were Czech immigrants who fled to Shanghai during World War II. There, Eva was diagnosed with diabetes, and when her insulin supplies ran short, Victor, a textile engineer, found a book that described how to make insulin and, using the animal organs from a nearby slaughterhouse, brewed up enough insulin for his wife to survive. After the war, they immigrated to the United States, and when their story was discovered, they soon found themselves on numerous radio and television shows, including Edward R. Murrow’s, and a movie was also produced – about a husband’s devotion to his wife, expressed through the salvation of insulin.

Other life-saving medical breakthroughs occurred – antibiotics in the 1940s, the polio vaccine in the 1950s – and these would treat more people than insulin. But the unique circumstances of insulin’s discovery, with the young, untested scientists finding the potion that would bring children back from the brink of death, was too dramatic to ignore. In 1988, that story was the subject of a television movie on Masterpiece Theater called “Glory Enough for All,” based on Michael Bliss’s definitive book, “The Discovery of Insulin.”

I watched the movie on PBS when it was released, and it featured the brawling Toronto researchers – Banting and Collip literally came to blows over control of the experiments. But ultimately, the movie was about the triumph of medical science in saving dying children, and among the researchers, there was “glory enough for all.”

And then the movie ended.

There was nothing about living with diabetes – about the wildly fluctuating blood sugars, about the relentless demands, about the injections and the doctor visits and the complications, about the dietary restrictions, about the stigma and the isolation and the limitations of insulin.

“Glory Enough for All” was introduced by Alistair Cooke. An American-born Brit with a silver tongue, Cooke was enthralled not only by insulin’s inspirational story but also by the phrase “islets of Langerhans,” used to describe the island of pancreatic cells discovered by Paul Langerhans. “Islets of Langerhans” just rolled off Alistair Cooke’s tongue. To him, insulin was not just a miracle. It was poetry.

The lyrical beauty of insulin was lost on patients. Many of them, in fact, were frustrated that their own stories weren’t being heard. The parents of young patients were frustrated as well.

In 1970, a professional singer in Philadelphia, Lee Ducat, had a 10-year-old boy with type 1 diabetes, and she was miffed by the breezy disregard of his doctor, who told her that “insulin was the cure.” Ducat knew that wasn’t true, so with several other parents, she formed the first chapter of the Juvenile Diabetes Foundation (which is now the JDRF). Other parents soon opened chapters in New York, Washington, New Jersey, and Miami, and their mission was to educate the public about the stark challenges of diabetes in hopes of raising money and finding a cure.

They had no use for the American Diabetes Association, which was founded in 1940 and for many years was little more than a social club and referral service for physicians. As far as the parents were concerned, the ADA was complicit in perpetuating the jaunty insulin narrative that had hurt the cause for decades. Unless the truth about diabetes was known, how could lawmakers, regulators, philanthropists, and journalists – not to mention clinicians – do what had to be done to improve the lives of people with diabetes?

That question was driven home when the JDF chapter in Miami bought a full-page newspaper ad in 1972 to publicize its cause. The ad featured a little boy in a crib holding a glass syringe, and it described the many complications that could arise from diabetes, including blindness and amputations. The headline read, “The Quiet Killer.”

On the day the ad appeared, Marge Kleiman, whose son has type 1, was working in the JDF office, and the phone rang.

“I’m Charles Best,” the caller said, “and I discovered insulin.”

Now retired, Best had become an icon who, after Fred Banting died in 1941, carried the mantle for the Nobel-winning team that had discovered insulin. Best had been praised by the pope, the queen of England, and other heads of state, and he had given the keynote address at the ADA’s first meeting and later served as its president. He happened to be in Miami on the day the JDF ad appeared, and he was outraged.

“What kind of propaganda are you using?” he screamed. “You’re frightening people! This is not the way it is!”

Kleiman knew better. “Dr. Best, what you did was wonderful,” she said. “It allowed people to live longer. But we’re not trying to frighten people. If you tell the truth, maybe they can avoid these complications. Please don’t tell us to keep quiet.”

The JDRF, now a massive international organization focused primarily on type 1,  has continued to tell the truth about diabetes – and fund research – ever since, but changing the insulin narrative was not going to be easy.

Patients could at least take solace that the insulins kept getting better. The first extended-action insulins were introduced in 1936 and continued with widely used NPH insulin (1946) and the Lente insulins (1951). But the real improvement came in the 1970s, spurred by concerns about actual insulin supply. Meat consumption was declining, and slaughterhouses were cutting production, while the number of people with diabetes had been rising steadily (in 1976, there were about 5 million Americans with the disease). At some point, insulin demand could outstrip the animal-based supply.

As described in the book Invisible Frontiers: The Race to Synthesize a Human Gene, by Stephen S. Hall and James D. Watson, the specter of an insulin shortage triggered a race to develop genetically engineered insulin using recombinant DNA technology. Investigators succeeded by inserting the insulin gene into bacteria, which produced insulin that was chemically identical to its naturally produced counterpart.

The first human insulins, Humulin (made by Eli Lilly) and Novolin (made by Novo Nordisk), were introduced in the 1980s. Whether they were superior to animal-based insulins is a matter of debate, but they alleviated fears about an impending global insulin shortage.

Moreover, researchers soon discovered that changing the order of two amino acids in the human insulin molecule created a faster-acting formulation, and that led to the introduction of Humalog (1996) and Novolog (1999). Known as “insulin analogs” because they are more analogous to the body’s natural release of insulin, they were considered clear advancements. Another huge leap came with long-lasting basal insulin analogs, specifically Lantus (by Sanofi in 2000) and Levemir (by Novo Nordisk in 2005). These insulins keep blood sugar levels consistent during periods of fasting and, typically taken once a day, replicate the insulin release of a healthy pancreas. They were immensely popular and also used by many type 2 patients – Lantus was a $5 billion a year drug by 2011.

The improved insulins changed how patients cared for themselves, as the new formulations led to “basal-bolus” therapy – a 24-hour insulin complemented by a mealtime insulin – and that became the standard of care for type 1 diabetes. (Insulin pumps use the same basal-bolus framework.)

A new era of diabetes care, thanks to these insulin breakthroughs, appeared to beckon.

Stay tuned for part three of this riveting story next week!

I want to acknowledge the following people who helped me with this article: Dr. Mark Atkinson, Dr. David Harlan, Dr. Irl Hirsch, Dr. David Nathan, Dr. Jay Skyler, and Dr. Bernard Zinman. Some material in this article came from my book, “Cheating Destiny: Living with Diabetes.”

About James

James S. Hirsch, a former reporter for The New York Times and The Wall Street Journal, is a best-selling author who has written 10 nonfiction books. They include biographies of Willie Mays and Rubin “Hurricane” Carter; an investigation into the Tulsa race riot of 1921; and an examination of our diabetes epidemic. Hirsch has an undergraduate degree from the University of Missouri School of Journalism and a graduate degree from the LBJ School of Public Policy at the University of Texas. He lives in the Boston area with his wife, Sheryl, and they have two children, Amanda and Garrett. Jim has worked as a senior editor and columnist for diaTribe since 2006.

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

Why #insulin4all Advocates Targeted Beyond Type 1

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

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

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

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

LD673

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

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

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

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

The Letter

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

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

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

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

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

Are PAPs Really Good Enough?

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

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

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

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

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

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

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

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

Online Reaction

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

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

source: @miss__diabetes

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

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

BT1’s About-Face

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

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

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

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

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

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

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

 

Source: diabetesdaily.com

New Dexcom Update: Your G7 Questions Answered

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

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

There is no calibration, correct?

“This is correct.”

What about pharmacy vs. supplier distribution for the G7?

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

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

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

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

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

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

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

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

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

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

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

Dexcom G7

Image source: Dexcom

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

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

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

Source: diabetesdaily.com

Mandy Marquardt: Redefining Diabetes Through Racing

Mandy Marquardt is a Track Cyclist for the USA Cycling National Team and Team Novo Nordisk, the world’s first all-diabetes professional cycling team. Their mission is to inspire, educate and empower everyone affected by diabetes. Mandy has been part of the team since 2010 and believes what the team does really makes a difference to the people in our community – racing and inspiring everyone around the world affected by diabetes is something that brings her great joy.

Thank you so much Mandy for taking the time to answer our questions! We know you are an inspiration to many and would love to share your story!

At what age were you diagnosed with type 1 diabetes?

I was diagnosed with type 1 diabetes at the age of 16 while racing and living in Mannheim, Germany with my father.

What were your symptoms?

I surprisingly didn’t have any symptoms that I was aware of and the diagnosis was a shock. There were signs now that I look back at what I thought were some odd incidents. For example, I would take forever to warm up and felt this overwhelming feeling of exhaustion and tiredness frequently. I thought it could have been from the stress of school and training hard.

Along with my type 1 diagnosis, I shortly after found out I have hypothyroidism too, so having that all discovered and learning to get it under control was such a good feeling.

Being diagnosed as a child is hard, how did you handle your diagnosis? Were you quiet about it or were you vocal and welcomed the opportunity to educate?

When I was first diagnosed, I didn’t know anyone else living with type 1 diabetes. While hospitalized for two weeks, a doctor told me I would never be able to compete at a high level again in the sport of cycling. I was heartbroken, but my parents were my biggest supporters, and helped me get back on the bike. I always knew it was my happy place. I started riding again, and just training for fun and told myself, we’ll see what happens.

Joining Team Novo Nordisk in 2010, racing amongst other athletes with type 1 diabetes and learning how to talk about my diagnosis gave me hope.

At what point in your life did you get active with fitness and more specifically, cycling?

I was born in Mannheim, Germany and moved to South Florida at the age of 6. My parents got me involved with the local swim team and I started playing tennis. I picked up running and was interested in competing in triathlons. In 2002 at the age of 10, my dad came across The Brian Piccolo Velodrome, which was a short drive from our home and was a safe place to learn to ride competitively. A year later, my parents and I drove to Texas to compete in the 2003 U.S. Junior Women’s 10-12 Road National Championships and I won two gold medals in the criterium and time trial and a silver in the road race – I was hooked.

I continued to race both the road and track discipline for years. My success on the track has currently led to 18 U.S. National titles and 3 American National Records (records all with type 1 diabetes).

Photo credit: Team Novo Nordisk

At what point did you decide to do it professionally?

After I graduated from the Pennsylvania State University – Penn State Lehigh Valley commonwealth campus in the Spring of 2014, I was invited to a USA Cycling camp that fall.

Afterwards I was invited to go represent the United States at my first UCI Track World Cup in Guadalajara, Mexico. I was so terrified to compete at that level, but now, six years later, I’m right up there with the world’s best, ranked 12th in UCI World Sprint ranking and one step closer to hopefully competing at my first Olympic Games. It’s been a slow and steady process, but if diabetes has taught me anything, it is consistency, patience and resilience.

In June of 2020, I was honored that USA Cycling named me as a member of the Long Team for Women’s Track Cycling. The final selection will be made next year, since the Tokyo Games have been rescheduled for July 23-August 8, 2021.

Did type 1 diabetes ever come in the way of your training or races?

Oh absolutely. It can be a challenge at times and the race doesn’t pause for me. Training and racing at this level, I’ve conditioned and adapted my body to handle the stress and workload, but occasionally the body will do what it wants. Of course, sometimes, it’s still frustrating when my blood sugars aren’t cooperating, like [when]  training and competing at altitude, going through different periods of my training cycle, juggling time zones and everything life throws at me.

I work closely with a sports psychologist and my team’s diabetes educator. Through a lot of trial and error, I’ve found what routine and nutritional habits work best for me and I’m still always learning and improving.

What do you use to help you manage your diabetes? Do you use a pump or do you prefer injections? Do you use a continuous glucose monitor (CGM) to help you monitor your blood sugar levels?

I use a continuous glucose monitor and take injections. It’s helpful to have real-time data around training, racing and traveling to better my diabetes management and performance – getting the most out of my training and recovery. Plus, I want to live a long healthy life, without complications!

Photo credit: Team Novo Nordisk

Photo credit: Team Novo Nordisk

What do you recommend to other athletes when it comes to managing your blood sugars during this type of activity?

Whether competing at a high level or just going out to exercise, always be prepared. I love my snacks! My favorites are the Honey Stinger waffles, performance chews, and protein snack bars! It’s important to be mindful about nutrition and fueling, and incorporating more protein, and eating consistently through the day. Most importantly, be patient and seek resources. My team, Team Novo Nordisk has many great resources and tips on their website too!

I know you are very active within the community, what are some of the things you’ve been up to lately?

I love my cycling career, but I think it’s important to have a balance between my personal and professional life. I recently partnered with Mammoth Creameries, a yummy keto-friendly ice cream founded by Tim Krauss, who is living with type 1 diabetes – it’s a pretty sweet partnership!

I also recently launched my logo and merchandise. The diabetes community has always been inspiring and supportive. I feel that my logo really puts my journey and the connection with the diabetes community in perspective. The blue circle is the global symbol for diabetes – that we are all connected in a special way and my initials subtly share a story that we are all greater than our highs and lows. For my merchandise highlighted with my logo, I wanted to create a wide range of awesome and high quality clothing and products that people can feel inspired and connected with.

Where do you see yourself both personally and professionally in 5-10 years?

Well, currently training hard in hopes of being selected for my first Olympic Team! I’d like to aim for the 2024 Olympic Games in Paris. So, in 5-10 years, I’d love to hopefully be a 2-time Olympian. Personally, I’d like to continue my education and earn my Masters Degree. I have an undergraduate degree in Business Management and Marketing from The Pennsylvania State University – Penn State Lehigh Valley (’14) commonwealth campus. I want to continue to prove to myself what I’m capable of as an athlete and what is possible with diabetes.

What would you say to the children out there, living with type 1 diabetes, who aspire to do great things when it comes to sports and fitness?

Go for it! Never limit yourself and your own capabilities. Use your platform to create awareness and inspire and connect with others affected by diabetes. The Founder and CEO of Team Novo Nordisk, who is also living and racing with diabetes says, “Diabetes only chooses the champions.”

Mandy, thank you for taking the time to answer our questions! We will continue to follow your journey and can’t wait to see more great things from you! We wish you all the best!

Source: diabetesdaily.com

REVIEW: Companion Medical’s InPen, A Smart Delivery System

Companion Medical’s smart insulin delivery, the InPen, is a reusable injector pen plus user-friendly mobile device which allows individuals to improve their diabetes management. I choose multiple daily injections (MDI) over a pump for various reasons, but I cannot deny that a pump allows for more precise calculations. With InPen, people on multiple daily injections can achieve the same accuracy plus so much more!

What Is It?

The InPen is a reusable injector pen that not only helps you calculate your doses but also keeps a log of insulin data for up to a year. The InPen connects, via Bluetooth, to the smartphone app, and keeps track of all your insulin deliveries.

InPen is now approved for all ages (7 and over, or under the supervision of an adult), who are insulin-dependent. The pen can deliver between .5 units to 30 units of insulin, dialed in half-unit increments. The pen is compatible with the Lily Humalog, Novo Nordisk Novolog and Fiasp U-100 3.0 ml insulin cartridges.

InPen is compatible with all Apple iOS devices that support iOS 10 or greater. It is also compatible with Android (more info about compatibility here).

What Does It Do?

I made sure to use this pen for about a month before writing my review. I am in awe of how easy this pen makes my management. Up to now, to be quite frank, I am guilty of a lot of “WAGS” (wild a** guesses) and then winding up too high or too low. I also really never kept tabs on when my last insulin dose was, so would find myself stacking quite often. Thanks to InPen, a lot of this carelessness has been eliminated. Here are all the amazing things it can do:

1. Insulin delivery information

The InPen connects to the app via Bluetooth which allows the app to store your insulin delivery information and shows you how much insulin you have taken and how much you have on board. There have been so many times when I would correct a high, not realizing I still had insulin on board, which led to episodes of hypoglycemia. As you can see here, your information appears in real time from your lock screen.

InPen Screenshot 1

Screenshot from Companion Medical

2. Built-in calculator

The InPen has a built-in calculator to help you get the most accurate dose possible. Your physician enters your settings, and it will give a recommendation on how much to dose. It takes into account your previous insulin delivery, your current blood sugar and the number of carbs you are eating. Since I have been using this feature, my blood sugars have improved greatly.

InPen Screenshot 2

Screenshot from Companion Medical

3. Reminders

It also has a reminder to take your long-lasting insulin. There have been so many times when I can’t remember if I took my Tresiba. I know this is a common problem for people on daily injections. This takes the burden off of the individual and has proven to be one of my favorite features.

InPen Screenshot 3

Photo credit: Companion Medical

4. Reports

The InPen generates reports that you can share with your healthcare team. These comprehensive reports will allow for easier decisions regarding changes to your diabetes management.

Screenshot from Companion Medical

5. Temperature alerts

The InPen comes complete with temperature alerts! It will notify you anytime your pen is in temperatures too hot or too cold which could make your insulin ineffective. This will come in handy during my next vacation or even if I leave my bag in the car for too long.

6. Syncing to Dexcom

InPen can sync up to the Dexcom continuous glucose monitor, via the Health app. This allows you to see your continuous glucose monitor graph on your logbook and reporting feature of the app.

Screenshot from Companion Medical

How Can I Get the InPen?

Many commercial insurance companies cover InPen, you can fill out this form and a representative will contact you about your copay. They also have a copay assistance program.  Commercially insured InPen customers will not have to pay more than $35 dollars a year which is a small price for better control.

Conclusion

I think InPen is a game-changer for anyone on multiple daily injections. With all of the capabilities the InPen offers, I can achieve better blood sugar numbers. I feel more in control of my diabetes because now I am confident that I am administering the right doses. I am also avoiding stacking insulin, which means fewer blood sugar roller coasters, and now I also have reminders to take my long-lasting insulin.

InPen can also help empower children to make better choices and manage their own diabetes. You can even sync two different pens if a child wanted to leave one pen at school and one at home.

Using InPen has helped me take back some control of my diabetes. It allows me to feel more in control and allows me to spend less time thinking about my condition. I can’t imagine going back to MDI without InPen in my toolbox and highly recommend this to anyone else who prefers injections over the pump.

Source: diabetesdaily.com

Can You Manage Diabetes Well Without Lots of Money?

If you live in a country like the United States, where the majority of health insurance is privatized and there is no strong social safety net, it can feel as though managing a chronic disease like diabetes requires nothing but lots of money. And it does. As of 2017, diabetes cost the United States a staggering $327 billion dollars per year on direct health care costs, and people with diabetes average 2.3x higher health care costs per year than people living without the disease.

Diabetes is also devastatingly expensive personally: the cost of insulin has risen over 1200% in the past few decades, with no change to the chemical formula. In 1996, when Eli Lilly’s Humalog was first released, the price for a vial of insulin was $21. In 2019, that same vial costs around $275. Studies show that 1 in 4 people ration insulin simply due to cost. Diabetes Daily recently conducted a survey study, with almost 2,000 participants, of which an overwhelming 44% reported  struggling to afford their insulin.

So where does this leave patients who don’t have tons of money to spend on insulin and supplies, or who don’t have adequate health insurance coverage for the technology to help prevent complications? Can you manage diabetes well without lots of money? The short answer is yes. The long answer is a bit more complicated.

Best Practices for Managing with Less

If you have insurance coverage, but are unable to afford a continuous glucose monitor (CGM) or insulin pump, it’s advisable to follow best practices for optimal diabetes management. According to the Mayo Clinic, one should test their blood sugar:

  • Upon waking
  • Before meals and snacks
  • Before and after exercise
  • Before bed
  • More often during illness
  • More often when traveling or changing a daily routine
  • More often if on a new medication

One study has even shown that following a lower carbohydrate diet can improve health outcomes, reduce complications, and cut down on medication costs for people living with diabetes.

The study goes on to say that, “…insulin dependent diabetics can expect to half or third their insulin requirements. Less insulin injected results in more predictable blood sugars and less hypoglycemia.” However, no patient should ever feel pressured to follow a low carbohydrate diet solely to control the cost of their medications. There can be more effective ways to manage the cost of medications and supplies.

Photo credit: Adobe Stock

No Matter What You Think, Get Coverage

People with diabetes need health insurance coverage. In the short term, this makes sense, as insulin and things like insulin pumps, continuous glucose monitors, syringes, and test strips are expensive. But it also makes sense long term as well. People with diabetes can face serious complications as they age: diabetes is the leading cause of adult blindness and amputations, and is a leading cause of stroke, kidney failure, heart disease and premature death in its sufferers. Having health insurance helps pay for things like surgery, preventive screenings, doctors’ appointments and follow-up care, and any additional medicine and needs that’s needed.

It may seem cheaper to forego coverage, but don’t. Check to see if you’re eligible for Medicaid in your state. If you are, this comprehensive coverage will help you access affordable medication, doctors’ visits, emergency and preventive care. If Medicaid is not an option, see if you qualify for a tax subsidy on the federal or your state’s health exchange. There, you can find a range of affordable options that will cover your diabetes care and (especially) insulin prescriptions.

Get Help Paying for Insulin

Even if you have health insurance coverage, the cost of your insulin may be prohibitively high. According to the CDC, between 2007 and 2017, the percentage of adults aged 18-64 enrolled in a high deductible health plan rose from 10.6% to 24.5%. These plans have a high dollar amount that consumers must meet before their plan kicks in to help pay for things like prescriptions or hospital stays. Some high deductible health plans have deductibles as high as $10,000. This means that someone with diabetes could potentially pay the full $275 a vial for their insulin, every time they fill their prescription, until they reach their $10,000 deductible. These types of plans are cheaper monthly (have lower premiums), but don’t offer great coverage.

If you need help paying for your insulin, you can get low cost insulin through these assistance programs:

  • Eli Lilly’s $35 Co-Pay Program: Launched in early April in response to the COVID-19 crisis, Eli Lilly is introducing their Lilly Insulin Value Program, which allows anyone with commercial insurance and anyone without insurance to fill their monthly prescriptions of insulin for $35.
  • Novo Nordisk: Novo Nordisk has recently launched a $99 program, where people needing insulin assistance can purchase up to three vials or two packs of FlexPen®/FlexTouch®/Penfill® pens or any combination of insulins from Novo Nordisk Inc. for $99.
  • Sanofi: Launched in 2019, Sanofi’s program allows people living with diabetes in the United States to pay $99 for their Sanofi insulins (with a valid prescription), for up to 10 boxes of pens and/or 10 mL vials per month.
  • Medicare: Medicare recently unveiled a pilot program that would cap the cost of insulin. The Medicare Part D Senior Savings Model would cap insulin co-payments to $35 per month, starting in January 2021. Seniors must sign up for a plan that will qualify under the pilot during the open enrollment period, which is October 15 through December 7.
  • Buy a State-Regulated Health Plan: If you live in Colorado ($100 per prescription per month), Illinois ($100 per 30 day supply), Delaware ($100 per 30 day supply), New York ($100 per 30 day supply), Utah ($30 per 30 day supply), West Virginia ($100 per 30 day supply), Maine ($35 per 30 day supply), New Mexico ($25 per 30 day supply), Virginia ($50 per 30 day supply), Washington ($100 per 30 day supply), or New Hampshire ($30 per 30 day supply) and you buy a state-regulated health plan, you are eligible for a copayment cap on insulin (implementation dates pending, but Colorado was the first bill to be implemented and it went into effect January 1st, 2020).

Check the fine print of any health insurance plans on the federal or your state’s exchange to see if they are eligible for the copayment cap. More states are introducing legislation in 2021, so keep an eye out for a bill proposing some similar changes in your state!

Get Help Paying for Supplies

Several companies have launched affordability programs in response to the COVID-19 pandemic. A few new programs are:

  • Dexcom: Is offering up to two shipments of 90-days of Dexcom G6 Continuous Glucose Monitoring System supplies, with each shipment consisting of one transmitter and three boxes of three sensors for $45 per 90-day supply shipment. For existing customers only, if you qualify.
  • Omnipod: Is offering a six-month supply of products (60 pods) free of charge. The program is focused on current US customers who have lost jobs and health insurance as a result of the pandemic.
  • One Drop: This online subscription package charges the consumer a monthly fee, and you get access to cheaper test strips, online personal health coaching, and a mobile app to track your progress. If your health insurance doesn’t adequately cover test strips, this can be an affordable and effective way to go.
diabetes advocacy

Photo credit: T1International Instagram

Advocate for Change

If you see or are experiencing injustice, you should always try and advocate for change. This means writing letters to your elected officials, calling your members of Congress, petitioning your health insurer, testifying for bills that support better health care coverage, and raising your voice to improve policies that will benefit all people living with diabetes. Get involved in the diabetes online community on Facebook or Twitter. Sign up to become an advocate with T1International. Donate to your favorite diabetes charity who’s working to make things better.

Show up at your state capitol and talk to people about what it’s like to live with diabetes, how expensive it is, and how crucial good coverage and affordable medications really are. You can live a great life with diabetes, but coverage, laws, regulations, and policies can always be better. And things won’t improve until we have everyone at the table, advocating for change.

How are you able to manage well with less to spend? What policies or changes would you like to see in the US healthcare system that would make management easier for you? Share this post and your story, below!

Source: diabetesdaily.com

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