FDA Propels Insulin Affordability with Semglee

This content originally appeared on diaTribe. Republished with permission.

By Karena Yan, Joseph Bell, and Arvind Sommi

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

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

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

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

But what exactly is a biosimilar drug?

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

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

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

Source: diabetesdaily.com

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

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 Lose Weight and Be Active With Type 1 Diabetes

Editor’s Note: Cliff Scherb, Founder of the Glucose Advisors Consulting community and Tristar Athletes LLC, is a nutrition, health, and dosing expert. He consults virtually through the Glucose Advisors University, teaching the Scherb Method decision support system for insulin management, nutrition, weight loss, and activity. To inquire about program openings, courses, and general questions working with Cliff or Glucose Advisors, join the community or email him directly at cliff@glucoseadvisors.com.

Most of my career as a health expert, I have had the privilege of helping others. In the type 1 diabetes  (T1D) spotlight, I am one who walks the walk and talks the talk when it comes to general health and well being. Yes, most of my career has been spent as a more extreme endurance athlete – yet these days most of my endurance is spent behind a computer teaching others how to achieve their T1D goals, still active but more inclined to also be happily chasing my 1.5 year old daughter as she grows up.

Cliff Scherb

Photo credit: Cliff Scherb

Sitting more regularly and burning less energy overall each day has had some meaningful changes to my management methods. Let’s face it, if I continued to eat the same amounts of calories each day such as when I was racing and training, I would blow up like a balloon!

I have always maintained what I will call a “normal” lifestyle and stayed true to what most do in life who do not have T1D. Meaning I don’t bend my will to T1D and I’m not afraid of carbohydrates or feel compelled to eat only fats. I believe that you can do what’s best for you, and if it makes you happy to join one of these extremes, by all means do it.

The internet is full of advice for people with T1D and never before have we had the wealth of information at just a fingertip-length away. How you put that information together and use it to your benefit is what is not so easy to do. Knowing what is worth your time and what is not can mean the difference between brilliant blood sugar control and avoiding longer term complications. The following tips we use have helped our students stay on track.

Here are five things you can do as a person with T1D that can help to improve your blood sugar and to help maintain a lean body composition:

1. Consider an Insulin Pump

If you have the option and ability, the pump allows you to lower and raise your total daily insulin dose more easily. When there are periods of your day that do not include insulin, there is a greater opportunity to process fat stores. If you are using multiple daily injections you may want to speak with your doctor about moving away from long-acting insulins such as Lantus, which have close to a 24-hour duration. On an insulin pump, only short-acting insulin is used, which is out of the body more quickly and may help lower the total daily insulin dose.

2. Choose More Fiber

Consuming an adequate amount of fiber in your diet can help not only by giving you the feeling of fullness but also by not requiring any extra insulin. Considered a carbohydrate, it does not generally impact blood sugars and can be subtracted out of your total carbohydrate count at meals.

3. Choose Lean Proteins

Proteins are great at promoting blood sugar stability and also have fewer total calories per gram when compared to fats. Fat grams, while having the benefit of blood sugar stability, can promote insulin resistance (increased insulin demand) and have nearly twice as many calories.

4. Time Your Carbohydrates Earlier in the Day vs. Later at Night

This means having a larger carbohydrate-loaded breakfast to supercharge your energy during the day and setting it up so that your insulin levels overnight are lower. This is a great way to lower your total daily insulin dose. You should also try to limit insulin prior to activity and time it post-activity when you are more sensitive and need less insulin overall.

5. Create Insulin Sensitivity

Being active is a great way to introduce a higher level of insulin sensitivity. This sensitivity will lower your total daily dose overall, aiding in total reductions in body fat. When timed with an appropriate meal plan and diet it can be a recipe for success!

Keep in mind, anything worth doing takes work! What is one of the biggest obstacles to T1D management success? It certainly isn’t a lack of desire. No, it’s just one thing…

Follow-through.

All the tools in the world don’t matter if you aren’t implementing what you learn. Practicing your nutrition timing and activity can help you to create greater insulin sensitivity which lowers your total daily dose. Ultimately, when you track the total daily insulin dose, this can help lead to longer-term weight loss and happiness with enhanced blood sugars.

Source: diabetesdaily.com

Mark Andrews: A Tight End with Type 1 Diabetes

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

By Katie Doyle

The Baltimore Ravens didn’t choose just any offensive lineup during the 2018 NFL draft – a key part of their strategy is Mark Andrews, a tight end from the University of Oklahoma who has been managing his type 1 diabetes since before he started playing football and into his rookie season.

Beyond Type 1 spoke with Mark about his pre-game rituals, how technology like the Dexcom G6 helps him stay on top of type 1 on long Sunday afternoons, and why it’s important to use his high-profile career to educate and advocate with National Diabetes Awareness month coming up.

How have you managed your diabetes through major life changes, like going away to college, playing a division 1 sport, or going through the NFL draft?

I was diagnosed at 9 years old, and it was the first time I ever saw my dad cry. At that moment, I knew it was serious because it wasn’t something my dad did very often. And since then, my family has been my rock. I was lucky enough to have a dad who was also a doctor and had an understanding of diabetes when I first was diagnosed.

Personally, I wasn’t very nervous. I knew that one day I wanted to move out, play football at a Division 1 level and ultimately play in the NFL. It’s something I was always very diligent about. I wasn’t going to let my nerves or anything else get in the way of that. My mom probably worried most, but my dad was instrumental in instructing my whole family in what to expect and what to know. I rely on them a ton. Using a CGM allows them to be a part of it and know my numbers at all times. It gives them peace of mind to be able to check in on me.

Mark

Image source: Beyond Type 1

How does your family support you from across the country?

My mom will always be my mom, so she still checks on me regularly. Last week, she texted me and said, ‘Hey, I don’t think you have enough complex carbs on board, you’ve been going low and trending low a lot. Just want you to eat something that gives you more complex carbs. I love you, hope you’re having a good week; I’ll talk to you soon!”

It’s awesome to get a text message like that and know my family has my back. After that, I ate a peanut butter and jelly sandwich just to have that background complex carb and went about my day. It’s always good having people look out for you — the more eyes you have on someone with diabetes, the better.

I’ve got a teammate right now named Orlando Brown whose dad had diabetes so he’s incredibly well-informed. He was my college teammate and now he’s my NFL teammate with the Ravens. He’s always wondering what my numbers are, and I actually share my numbers with him from my Dexcom.

When did you feel comfortable enough to talk to your friends and teammates about diabetes?

At first, I remember feeling a little bit reserved and not being totally open about it. I’d go hide in a corner to test. I also remember the first time my friends saw me testing my blood sugar. I was 10 or 11 years old, and they saw blood and thought it was cool. I was kind of in the spotlight because they were so interested in what I was doing.

That opened me up to be more vocal and to share what I’m doing and how I deal with things. After that, I became really comfortable sharing what I deal with having T1D and how I deal with it and sharing with others. I was very open talking to my coaches, and I had my parents to help me out with that, and they still do that to this day. Ever since then, I’ve always wanted to talk about it and shed light on what people with diabetes have to do.

Tell us about your pre-game ritual.

I do something a little bit different: I wear a pump, so I use that for basal (25%) and I use Lantus for my other type of basal (75%) on a normal day. But on a game day, I’ll go 100% Lantus — that allows me to be off the pump for long periods of time but not have to worry.

Knowing your body is key. Knowing what I put in my body and how it will affect me is something that I feel has been instrumental for my health. I’m a big fan of complex carbs; I eat peanut butter and jellies, especially on game days or the day before a game, just allowing myself to have that complex carb to hold me over while I’m exerting a lot of energy.

Having my Dexcom, and the way it allows me to see my blood glucose trends and see what foods react a certain way has been huge for me. There’s a lot that goes into diabetes management, and I think it’s incredible that I can rely on Dexcom and not have to prick my fingers all the time. It really sets me up for success on the field.

Who are your role models?

I didn’t know anyone else with diabetes growing up, but I have my dad, who is extremely knowledgeable and always researching different things. He’s the reason I went to 100% Lantus for game days.

I can remember, at a young age, having diabetes and seeing Jay Cutler in the League, and being able to tell myself that it’s possible. I adopted a mindset that this disease is a part of who I am, but it’s not going to define me and it’s never going to stop me in achieving my dreams. Football is my passion, it’s what I love, but now it’s my job, and diabetes is something I refuse to let affect my job.

You seem like you have a ritual down for games, but how about during the NFL draft? How were you feeling then?

There’s so much work that had been put into that moment, from my mom driving me to soccer practice, to all those hard hours put in on the field, it all lead to that moment of actually playing in the NFL. It was kind of scary to know that that you’re putting your future into someone else’s hands — into 32 organizations’ hands — but this has been my dream for a very, very long time.

Why is it important for young athletes with type 1 to have role models?

To be put on this stage, I’ve always wanted to give back and for me, that’s with diabetes — that hits home for me. Helping kids with diabetes is something that I’ve found has given me the most reward: raising awareness and talking to people about how I use technology and what I do with it, it’s to help people with everyday life and share some of that.

I’m going to work as hard as I can to be the best tight end that I can be, and hopefully one of the premiers tight ends in the League. I want kids to see where I’m at today, like I saw Jay Cutler, and I hope it inspires them to go out there and play sports and be active — to follow their dreams, no matter what they may be. A professional football player? Great! Go out and achieve it. Or if anything else, you know, This guy’s playing football at the highest level, then I can do anything else!

Source: diabetesdaily.com

Semglee, A Low-Cost Basal Insulin, Comes to the US

This content originally appeared on diaTribe. Republished with permission.

By Karena Yan and Joseph Bell

A more affordable alternative to Lantus (insulin glargine) will cost $148 for five pre-filled insulin pens

Mylan and Biocon Biologics announced last month the long-awaited US launch of Semglee, a new insulin aiming to be deemed “biosimilar” to insulin glargine (basal insulin) by the FDA. A biosimilar drug is a biological product that is highly similar in structure and function to a product already approved by the FDA, known as the reference product. Semglee is said to be similar to Sanofi’s basal insulin Lantus; it has the same protein sequence and has a similar glucose-lowering effect. The FDA has yet to classify Semglee as “biosimilar” or “interchangeable” to Lantus due to the need for additional review – so for now, Semglee should be considered a new basal insulin option for people with diabetes. Semglee was previously approved in 45 countries, including Australia, Europe, Japan, and South Korea. We aren’t positive how “interchangeable” will go – would someone using Tresiba or Toujeo “next-generation basal” insulin want to go with Semglee instead? This is unlikely in our view.

Semglee is currently available by prescription in either a pen or a vial and can be used by people with type 1 or type 2 diabetes. It costs $147.98 for five 3 mL pre-filled pens or $98.65 for one 10 mL vial. Semglee is reported to be the cheapest available insulin glargine-equivalent on the market, with a 65% discount from the list price of Lantus. That calculation is a bit misleading as does not take into account discounts and rebates available with a variety of insulin brands; actual out-of-pocket costs can differ dramatically for individuals.

Happily for people who don’t qualify for patient assistance programs, Semglee represents a far more affordable option for people with type 1 and type 2 diabetes who take basal insulin. While biosimilars are usually not as inexpensive as “generic” versions of drugs, because biosimilars are more expensive to manufacture, they do provide cheaper alternatives to brand name drugs, in this case, Lantus (and Levemir, Tresiba, and Toujeo). Further, because Semglee is thought to be essentially equivalent to Lantus, it should provide an important and practical option for basal insulin users who are concerned about insulin costs and do not have a route to pay less – this is far more people than often considered.

It’s also key to note that Semglee is not technically considered a “biosimilar” drug – it is currently under FDA review to gain approval of this designation. The biosimilar designation would mean that Semglee officially has bioactivity and clinical efficacy that are not different from Lantus, but are not necessarily exactly the same. If it earns an “interchangeability” designation, pharmacists would be able to substitute Semglee for Lantus without consulting the prescribing healthcare professional. Semglee might also be substituted for Tresiba or Toujeo, two “next generation” more stable basal insulins.

Two biosimilar insulins are currently approved in the US: Basaglar, a basal insulin glargine approved in 2016, and Admelog, a rapid-acting insulin lispro approved in 2018. If Semglee gains an FDA biosimilar designation, it will become the third biosimilar insulin available in the US.

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

Source: diabetesdaily.com

Is Healthcare Provider Knowledge of Diabetes Lacking?

People’s experiences with healthcare providers can vary widely. When it comes to living with diabetes, many people expect that their healthcare providers, even if they’re not specialists, will be at least somewhat knowledgeable about their health condition. Many have found however, that while endocrinologists and diabetes education specialists tend to be more attuned to the ins and outs of diabetes management, even their knowledge can be outdated, while the knowledge of other providers, is sometimes starkly lacking.

Meanwhile, two informal polls in two separate diabetes social media groups, highlighted that over 85% of people with diabetes expect any healthcare provider (even if not a diabetes specialist) to have a basic working understanding of diabetes, at the very least the two major types and general treatment options.

Nevertheless, when the asked to share their own experiences, many reported a lot of confusion and uneducated statements about diabetes from various healthcare providers. The consensus during the crowdsourcing research tended to be “while we expect it, we do not routinely see it.”

We asked people to share some of the comments that they received about diabetes from healthcare providers. Here are some surprising responses and stories to ponder:

“When did you have your insulin pump surgery?”

“Type 1 diabetes develops over 2-3 days, not months.”

“He was a big baby so clearly he’s was a diabetic when he came out.”

“You will kill your child with this low carb nonsense… I will not stand by and watch you do that… I’m sure one of the other doctors will call CPS with this.”

“Diabetics like you are only allowed 4 eggs a week. Period.”

“You should eat more carbs, it’ll stabilize your blood sugars.”

“Do not correct under 13 mmol/L [~234 mg/dL].”

“You need to eat a minimum of 45 g carbs per meal.”

“If you don’t like seeing high fasting blood sugar numbers in the morning, don’t test your blood sugar then.”

“You will likely be dead from diabetes by age 30. If by some miracle you are still alive, you will be blind, on kidney dialysis, and in a wheelchair due to amputations.”

“Are you sure you have type 1?”

“It’s probably best if you stop sports and strenuous exercise.”

“If you go low-carb, you’re going to kill yourself.”

“An A1c below 6.5 is dangerous.”

“You don’t have to bolus for corn or peas, they are freebies.”

“Your insides are destroyed from having diabetes so long.”

One woman shared the following story:

“When my daughter was diagnosed at age 2 (I had diagnosed her and had to fight with her pediatrician to test her blood, because her urine test was normal. We already ate low-carb, so I had to feed her a high-carb meal and take her back and storm the pediatrician’s office and force them to give her a test, which came back at around 500, at which point they finally sent us to the ER). After diagnosis, the endo told us she needed at least 100 g carbs for each meal (at age 2!!!), plus 30–50 g snacks in between meals. Insanity! They had her on massive amounts of Lantus, NPH, and Novolog. They told me to feed her lots of ice cream before bed every night to hold her steady at around 200, which was a great night-time number for a kid that age! I swear I still have PTSD from that whole experience! Nightmare! I had to fight with them every step of the way!”

Such stories amassed very quickly, with many nodding their heads at having similar experiences. Is there perhaps a gap in basic diabetes education, in particular for non-specialists?

Image credit: Haidee Merritt. Republished with permission. Please visit her Etsy store for more original work and gifts. 

Almost all will likely agree – while we cannot expect every healthcare provider to be fully attuned to the latest developments in diabetes diagnostics and treatment, an accurate knowledge of the basics should be a requirement – especially with the high number of diabetes diagnoses, and undiagnosed or misdiagnosed patients.

Moreover, ensuring better understanding of diabetes and its management across the board, for all providers, is highly likely to improve patient outcomes in various situations, including recovery from illness and surgery, and more effective prevention of numerous diabetes-associated complications.

***

What are your thoughts on this issue? Have you ever had a surprising conversation about diabetes with a healthcare provider?

Source: diabetesdaily.com

The Biggest News in Diabetes Technology, Drugs, and Nutrition: Highlights from ADA 2020

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler, Jimmy McDermott, Matthew Garza, Divya Gopisetty, Frida Velcani, Emily Fitts, Karena Yan, Joseph Bell, and Rosalind Lucier

The diaTribe team attended the 2020 ADA 80th Scientific Sessions to share several of the greatest highlights from the virtual conference!

The American Diabetes Association (ADA) 80th Scientific Sessions was full of exciting news on advances and studies in diabetes technology, treatments, and nutrition. Click on the links below to learn more!

Diabetes Technology

Diabetes Drugs

Nutrition, Exercise, and Mindset

Access to Care and Policy

Diabetes Technology

The Next Generation of Automated Insulin Delivery Systems for People with Type 1 Diabetes – Updates from Four New Clinical Trials

The first day of ADA featured data on four clinical trials of the newest automated insulin delivery (AID) systems. In what was a packed (virtual) room, the session began with three highly anticipated presentations of studies on Medtronic’s MiniMed 780G Advanced Hybrid Closed Loop System (AHCL). Dr. Bruce Bode, presented the US adult pivotal trial. Here are the main results:

  • Big news – nearly 80% of participants achieved a time in range of more than 70% without an increase in hypoglycemia.
    • On average, AHCL therapy increased time in range to nearly 75% from a baseline of 68.8%.
    • Among adolescents, time in range increased to over 72% from a baseline of 62.4%.
  • AHCL therapy improved average A1C from 7.5% to 7.0%. This is what is sometimes called a “high quality A1C” in the field – hypoglycemia is low, and therefore not contributing to a “better” number.
  • How were these results achieved? Experts said that the lower algorithm target of 100 mg/dl (vs. 120 mg/dl) helped, along with an active insulin time (AIT) setting of 2-3 hours. If you use a pump, check what you have for this setting and talk to your healthcare professional about it to see if you can make changes (regardless of whether your pump can deliver insulin automatically).

Following Dr. Bode, International Diabetes Center’s Dr. Rich Bergenstal shared data from FLAIR, a trial comparing MiniMed 780G Advanced Hybrid Closed Loop (AHCL) with the 670G Hybrid Closed Loop (HCL) in adolescents and youth with type 1 diabetes (ages 14-29). This is the first ever head-to-head comparison of an AID system with a commercially available AID system. The study also had broad entry criteria: at start, 20% of participants were on multiple daily injections of insulin (MDI), 38% were not using CGM, and 25% had a baseline A1C above 8.5%.

  • Time in range over 24 hours increased from 57% at baseline to 63% with the 670G and to 67% with the 780G. Notably, 6% greater time in range totals nearly an hour and a half more time in range per day.
  • Compared to baseline, the number of participants achieving the international time in range consensus target of more than 70% was nearly two times higher with the 670G and almost three times higher with the 780G (22% and 32% of participants, respectively, compared to a baseline of 12%; see slide below).
  • This was the first time that a study measured participants meeting the combined metric of both time in range greater than 70% and time below 54 mg/dL less than 1% (see slide below). This is important since all therapy – and particulary automated insulin delivery – aims to decrease hyperglycemia and hypoglycemia.

Graph

Image source: diaTribe

  • From a baseline average of 7.9%, those on the 670G achieved an average A1C of 7.6%, and those on the 780G had A1Cs that fell to 7.4% on average.
  • Both the 670G and 780G were considered safe when evaluating severe hypoglycemia or diabetic ketoacidosis (DKA).
  • Participants satisfaction favored the 780G over the 670G.

Today’s MiniMed 780G data finished with Dr. Martin de Bock’s study, which served as the clinical trial supporting 780G’s CE-Mark submission (and today’s announced approval in Europe). In a study of 59 people (ages 7-80 years, with an average age of 23) who had never used an insulin pump:

  • Average time in range increased to over 70% from 58% (a change of 12.5%) when using the 780G compared to a sensor augmented pump.
  • Overnight time in range increased to 75% from 59% when using the 780G compared to the sensor augmented pump.
  • The improvement in time in range was primarily driven by a 12.1% decrease in time in hyperglycemia (high blood sugar) with the 780G.

It was warming on Twitter to see Dr. de Bock with his three small children while also engaging in Q&A/Chat from their breakfast table. If you’re on social media, follow Dr. De Bock here.

The session concluded with Stanford’s Dr. Bruce Buckingham who presented data on Insulet’s Omnipod 5 Automated Glucose Control System, powered by Horizon. What fantastic data! The study assessed the safety and effectiveness of the fully on-body system over 14 days of use before starting the three-month pivotal study. Interestingly, this study was conducted during the winter holiday season when some of the lowest time in range is observed (typically a three percent drop); the system performed remarkably well in both children and adults, even during this challenging time period.

  • In adults, time in range increased to 73% on the hybrid closed loop system, up from 65.6% using standard therapy – this is the same as nearly two hours more time in range per day.
  • In youth, time in range increased to 70% on the hybrid closed loop system, up from 51% using standard therapy – what an increase, nearly five hours more per day.

These reductions in time in range were mostly driven by a decrease in hyperglycemia. Hypoglycemia was also very low to start. Dr. Buckingham eloquently emphasized, “… this is so important for families and people at night to go to sleep and not worry about hypoglycemia … for a number of kids, they got to go on their first sleepover during this study. It was really decreasing a lot of the burden and a lot of the thinking about diabetes.”

Tandem’s Control-IQ Real-World Data: Time in Range Increases 2.4 Hours Per Day

Tandem presented two posters featuring very positive real-world data from early Control-IQ users. Control-IQ was cleared in December 2019 and officially launched in January 2020.

The first poster, Control-IQ Technology in the Real World: The First 30 daysincluded at least 30 days of pre- and post-Control-IQ data from 1,659 participants. During the first 30-days of Control-IQ use:

  • Time in range increased by 2.4 hours a day (compared to pre-Control-IQ data) to 78%
  • The time in range improvement was driven by a 9.5% decrease in time spent above 180 mg/dl (that’s 2.3 hours less per day in hyperglycemia – wow!).
  • Average glucose levels fell from 161 mg/dL to 148 mg/dL.
  • Glucose management indicator (or GMI, an estimate of A1C) fell from 7.2% to 6.9%.
  • Users spent 96% of time in closed loop!
Teplizumab graph

Image source: diaTribe

The second poster, Glycemic Outcomes for People with Type 1 and Type 2 Diabetes Using Control-IQ Technology: Real-World Data from Early Adopters, looked at 2,896 participants with type 1 diabetes and 144 participants with type 2 diabetes, using at least 14 days of pre- and post-Control-IQ data.

  • Time in range was improved by 2.1 hours per day in the type 1 group to 77%
  • Time in range was improved by 1.4 hours per day in the type 2 group 79%
  • Both groups spent 96% of time in closed loop.

We learned so much at ADA about improving time in range, and we were moved by the power of automated insulin delivery in doing so, since it shows much greater time in range with what sounds like so less work for people and their healthcare teams.

To learn more about Control-IQ, check out the following articles:

A1C vs. Time in Range – Which Should be Used for Children with Diabetes?

A panel discussion of leading experts, moderated by JDRF CEO Dr. Aaron Kowalski, focused on the pros and cons of using A1C and time in range as primary metrics in diabetes care and management for children. As they debated the best marker of glucose management, they attempted to define the ultimate “goal” of diabetes care: is it preventing complications, spending less time in hyperglycemia and hypoglycemia, or improving mental and emotional wellbeing?

Dr. William Winter presented extensive evidence that A1C can predict a person’s risk of developing complications (kidney disease, heart disease, retinopathy, and neuropathy). While lower time in range has been associated with microvascular complications, experts agree that more studies are needed to determine its predictive accuracy for long-term outcomes. Dr. Thomas Danne presented results from the SWEET project that furthered the case for A1C as a measure of population outcomes: setting ambitious targets based on A1C could lead to significant improvements in outcomes for children with type 1 diabetes.

A1C ethnicity

Image source: diaTribe

Experts discussed cases in which A1C can be misleading and time in range may emerge as a more reliable measure of glucose control. Dr. Winter explained that population A1cs differ among racial and ethnic groups, leading to misdiagnosis (for example, African Americans have a higher A1c on average compared to white people). Very importantly, as diaTribe has reported on for many years in Beyond A1C research, A1C also does not demonstrate hypoglycemia, hyperglycemia, or glucose variability. According to Dr. Danne, healthcare professionals find CGM reports more helpful in identifying daily highs and lows and in adjusting therapy. This technology allows them to better work alongside families to set individual and measurable goals based on time in range – it is terrific to hear about this continued teamwork.

Messages

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SENCE

Image source: diaTribe

Though Dr. Danne acknowledged the issue of access and affordability, he believes CGM use will continue to increase among children who are tech savvy. Dr. Daniel DeSalvo presented data from the SENCE and CITY to further support use of CGM among children with type 1 diabetes.

CITY

Image source: diaTribe

Young children (two to seven years old) enrolled in the SENCE study saw their hypoglycemia (blood glucose under 70 mg/dL) and time spent over 300 mg/dL reduce by 40 minutes per day – that’s nearly five hours a week. Teens and young adults (ages 14 to 24) in the CITY study saw a 7% increase in time in range, which is almost two more hours per day spent in range – 100 minutes, to be exact!

The Use of CGM in Type 2 Diabetes — Is There Value?

Continuous glucose monitoring (CGM) has been a revolutionary tool; it gives people real-time updates on their blood glucose levels that can help to increase time in range (TIR). For most providers in diabetes, the value of CGM is now nearly universally supported (either “real-time” or “professional CGM”) even if all people with diabetes can’t get it. Reimbursement throughout much of the world has reinforced the value of CGM in type 1 diabetes almost everywhere, though the value of CGM for people with type 2 diabetes is still being explored.

CGM

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Dr. Philis-Tsimikas argued for CGM for type 2 diabetes given the technology’s ability to offer remote solutions for care management, provide direct feedback of behavior modification, and allow evidence-based changes to drug therapies. Dr. Philis-Tsimikas shared data from several CGM studies in people with type 2 diabetes on a variety of therapies (basal insulin alone, and oral and other medications), highlighting the improvement in clinical and behavioral outcomes. In what could be the most exciting set of results, people with type 2 diabetes who used real-time CGM (RT-CGM) intermittently for 12 weeks showed an average A1C reduction of 1 percentage point at the end of 12 weeks (compared to a 0.5 percentage point reduction in the blood glucose meter control group). During the 40-week follow up period, A1C was still significantly lower in the RT-CGM group.

Dr. Elbert Huang gave what we felt was a less persuasive view. He argued that in most cases, CGM use is not valuable for people with type 2 diabetes, on the basis of cost. Howerver this is based on outdated data – just yesterday at ADA, there was striking Late-Breaker data presented that showed very meaningful reductions in A1c by Dr. Eden Miller and Dr. Gene Wright (he’ll be speaking at the TCOYD/diaTribe Forum Monday night!) The study showed very meaningful A1C reductions in thousands of people with diabetes – starting A1C was 8.5%, which fell to 7.6% to 7.9% depending on the population. Dr. Huang presented two studies that showed that the cost ratio of CGM was different depending on the assumptions of costs related to the quality and quantity of lives impacted by type 2 diabetes. A QALY, by the way, is a “quality adjusted life year” that measures both quantity and quality (based on disease burden) of life years. We also strongly believe that many people become more engaged in their diabetes management due to a variety of factors that reduce stigma (no fingerstick tests required, etc.) and enable them to focus on how data and technology can work together to improve their results.

Dr. Huang suggests that less costly treatments (such as the use of ACE inhibitors to avoid high blood pressure or to prevent kidney disease) might be better areas of focus and certainly all experts would agree that focus here is important as well. He also mentioned potential negative psychological effects of constantly checking blood glucose readings using CGM and the fact that this technology may only work if it is shared with a person’s healthcare team – we agree integration with healthcare teams where available is a valuable point and also emphasize our learnings from ADA 2020 from many providers that emphasize, as Dr. Diana Isaacs did on Saturday, that CGM enables greater interest in diabetes management by people. While the technology is extremely important, Dr. Huang also expressed that it could be more valuable if the price of CGM declines or if it is shown to improve glucose management while also reducing the need for costly medicines, among other factors – these factors of cost are extremely important. CGM is going down in price on average and global pricing of $109/month is already available from FreeStyle Libre all over the world. While no one should have to pay $3/day on their own, we believe many more health systems are interested in investing more here due to the positive results they are seeing. We’ll be back with more data from the ADA 2020 Scientific Sessions on this and related fronts!

Parent Perspectives on DIY Closed-Loop

An observational study on Loop, a do-it-yourself (DIY) automated insulin delivery system (AID), used focus groups to gather the attitudes and experiences of parents and children using Loop. The study followed people using an AID system, continuous glucose monitor (CGM) readings, and a communications bridge device, called “RileyLink.”

Overall, parents felt that Loop had a positive impact on their family’s lives. They reported the following outcomes:

  • Improvements in emotional health as a result of a greater sense of security and normalcy, increased quality of life, and decreased parental stress.
  • Improvements in other areas of life, including management of children’s diabetes at school, quality of sleep, confidence in caregivers, and children’s ability to explore extracurriculars without supervision.

Dr. Anastasia Albanese-O’Neill presented survey results on what parents expect of school and diabetes camp staff to help their children manage their DIY closed-loop system. School nurses were also surveyed on their opinions regarding DIY. Here are some highlights:

  • 29% of parents expect that school staff will assist children with delivering a bolus.
  • Expectations of diabetes camp staff were lower than school staff – 23% of parents expect school staff to assist with carbohydrate counting and timing of bolus, while only 13% of parents expect diabetes camp staff to do those things.
  • Though 46% of school nurses had never heard of DIY before participating in the survey, 33% of them agreed that school staff should help students using DIY who cannot manage it independently.

This suggests a need for training on DIY and diabetes technology for school and camp staff.

Is Technology the Solution to Hypoglycemia? Dr. Bergenstal and Dr. Wilmot Debate

Dr. Richard Bergenstal from the International Diabetes Center (IDC) emphasized the advantages of using continuous glucose monitoring (CGM) for reducing episodes of hypoglycemia (low blood sugar) and other health complications in this debate with Dr. Wilmot. Both doctors are highly regarded, and we took this as a big opportunity to learn lots more rather than land only on one size, though it’s certainly hard to avoid saying yes to this question, from diaTribe’s perspective. Dr. Bergenstal eloquently explained that, on average, hypoglycemia is the biggest barrier to optimal blood glucose management, pointing to the fact that A1C levels increase when people fear going low (what he called the “ripple effect of hypoglycemia”). Luckily, with CGM reports, people can finally detect patterns in hypoglycemia and understand exactly how much time they are spending with blood glucose levels under 70 mg/dL in a day.

Evidence shows that closed-loop technology can reduce and even prevent hypoglycemia. In a study of 124 people with diabetes that Dr. Bergenstal shared, the use of automated-insulin delivery systems (AID) completely eliminated hypoglycemia. This was a historic win – previous studies (see slide below) using low glucose suspend systems (LGS) reduced hypoglycemia by 38%, while predictive low glucose suspend systems (PLGS) reduced hypoglycemia by 59%.

ada 1 1

Image source: diaTribe

Dr. Emma Wilmot argued that while these findings are exciting, technology is only part of the solution. Technology does reduce the risk of hypoglycemia, but is not available to all (particularly those from underserved populations) and is not suited to all. She said that unless CGM is also paired with structured education, it will not provide the significant and lasting improvements in hypoglycemia awareness that the diabetes community needs. We know, of course, how important education is – and diaTribe will be coming back to discuss this in an upcoming piece about a new article just published in Diabetes Care earlier this week (Diabetes Sisters’ CEO Anna Norton was a key author in the new consensus report)!

Early CGM use can help kids and predict T1D progression

The use of CGM across different populations – including people of various ages and different stages of type 1 diabetes – shows that CGM can accurately predict the progression of type 1 diabetes for people at risk. For those transitioning from “stage 2” to “stage 3”, continuous monitoring can also help prevent DKA, which many people with type 1 have at diagnosis. While there are no clinical guidelines at the moment for how to manage “stage 2” type 1 diabetes, the TESS study is currently evaluating the benefits of CGM use in this population. “Staging” of type 1 diabetes is fairly new and we will be thinking about this more as we consider how to further improve education about type 1 diabetes.

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Experts all agreed that earlier use of CGM could result in better diabetes management later on. Dr. Jan Fairchild studied the start and continued use of CGM in a pediatric population with early “stage 3” type 1 diabetes. Kids who started CGM at diagnosis had slightly higher CGM wear at 24 months, compared to kids who started within the first two years of diagnosis (78% vs. 66%, respectively), though this result was not significant. All children using CGM ultimately benefitted – they demonstrated a median A1C of 7.7% at 24 months, which was less than the clinic median A1C of 8.1%. Dr. Fairchild also mentioned the educational role that early CGM use could play, especially with a focus on time in range.

Diabetes Drugs

VERTIS-CV Trial of Steglatro and Heart and Kidney Health

Dr. Samuel Dagogo-Jack and Dr. Christopher Cannon presented highly anticipated results from the VERTIS-CV trial, which studied the effects of Merck/Pfizer’s SGLT-2 inhibitor Steglatro (ertugliflozin) on over 8,000 participants with type 2 diabetes and cardiovascular disease (CVD). The trial found that treatment with Steglatro reduced average A1C by 0.5 percentage points, lowered average weight by nearly five pounds, and reduced blood pressure compared to standard diabetes treatment. Steglatro also improved kidney function, as measured by eGFR, and reduced the number of study participants with heart failure.

The researchers agreed that the VERTIS-CV results confirm the current guidance on the use of SGLT-2 inhibitors to prevent and treat heart failure and diabetes-related kidney disease. As a reminder, the current ADA Standards of Care advise using SGLT-2 inhibitors in people with type 2 diabetes for reducing hyperglycemia (high blood sugar), improving blood pressure, and facilitating weight loss. SGLT-2 inhibitors have also been shown to improve heart and kidney health in people with and without diabetes.

Read more about the trial in our full article here.

New Data Shows Teplizumab Delays Diagnosis of Type 1 Diabetes

At last year’s ADA, we were very excited to report on trial results that showed teplizumab (pronounced Tep-pli-ZU-mab!) delayed type 1 diabetes diagnosis by two years, compared to placebo. The study enrolled 76 participants (55 children and 21 adults) who were the relatives of people with type 1 diabetes and did not have diabetes, and were at high risk for developing the condition (they had unstable blood glucose levels and at least two diabetes-related antibodies). On average, time to diagnosis of type 1 diabetes for the teplizumab group was four years, compared to two years with placebo. At the end of the trial, 53% of the teplizumab-treated group did not have type 1 diabetes, compared to 28% of the placebo group.

New follow up data, presented by Dr. Emily Sims (Indiana University), showed sustained reduction in the onset of type 1 diabetes. Previously, teplizumab had been proven to delay clinical onset by only two years in high-risk people; however, these new data support a delay of as much as three years, compared to placebo.

Furthermore, people who were treated with teplizumab showed a “striking reversal” in C-peptide decline (this is a common measure of type 1 diabetes) in the six months following treatment, after which C-peptide levels seemed to stabilize. These data suggest that the treatment helped stabilize beta cell function (the cells in the pancreas that make insulin) and that repeated teplizumab treatment at key time points may be able to further extend, delay, or even prevent diagnosis of type 1 diabetes. While not a cure, three years of living without daily diabetes management is certainly a meaningful outcome.

When will teplizumab become available? With an estimated six-month review time if Priority Review is granted, an FDA decision could be expected as soon as mid-2021.

SGLT-2 Inhibitors and GLP-1 Agonists to Prevent Heart Disease

Dr. Mikhail Kosiborod (University of Missouri-Kansas City) and Dr. Darren McGuire (University of Texas Southwestern Medical Center) debated the use of SGLT-2 inhibitors and GLP-1 agonists in primary prevention of heart disease (called cardiovascular disease, or CVD).

As background, primary prevention is using medication in people who do not have CVD in order to prevent CVD. This is different from secondary prevention in which a person who is diagnosed with CVD uses a medication to prevent progression of the disease.

Dr. Kosiborod started the session with a strong “yes” – SGLT-2 inhibitors and GLP-1 agonists should be used for primary prevention. However, primary prevention is difficult to prove: larger and longer trials are needed. Dr. Kosiborod believes that we do have enough evidence.

  • A meta-analysis of SGLT-2 inhibitor trials suggests that:
    • SGLT-2 therapy works to prevent heart failure regardless of whether a person has established CVD (based on hospitalizations for heart failure).
    • SGLT-2 therapy protects kidney health regardless of whether a person has established CVD.
  • The FDA has approved SGLT-2 inhibitor Farxiga for people with type 2 diabetes and established CVD, and those with risk factors for CVD. That is primary prevention!
  • REWIND showed that GLP-1 agonist Trulicity prevents major adverse cardiovascular events (MACE, which includes stroke, heart attack, and cardiovascular death) in people with and without established CVD.
  • The FDA agrees again here – Trulicity is approved for people with type 2 diabetes with CVD and those with risk factors for CVD.
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Next, Dr. Kosiborod looked at the population level. Worldwide, primary prevention with SGLT-2s and GLP-1s will significantly reduce cardiovascular events (compared to secondary prevention alone) because there are many people who are not diagnosed with CVD.

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Dr. Kosiborod believes this primary prevention is cost-effective and essential, given the high risk to the population. And many SGLT-2s and GLP-1s will become generic in the future.

Dr. McGuire argued that we are not ready for SGLT-2s and GLP-1s to be used in primary prevention. He pointed to a meta-analysis that showed no benefit of SGLT-2 inhibitors and GLP-1 agonists in atherosclerotic cardiovascular disease (ASCVD) outcomes compared to placebo in people without established ASCVD. In his analysis of REWIND, Dr. McGuire pointed to an absolute risk difference of 0.3% in people without established CVD taking Trulicity versus placebo (1.7 events for every 100 patient years, vs. 2.0 events for every 100 patient years). This would mean that you would need to treat 333 people without CVD to prevent one MACE – which would be $3.4 million in drug costs.

Both speakers agreed that SGLT-2 inhibitors have shown strong effects in primary prevention for heart failure and kidney outcomes. There was no significant debate on this point, as the data speak for themselves regarding the profound effect of SGLT-2 treatment in reducing these outcomes.

Weekly Basal Insulin – The Wave of the Future?

New types of insulin – once-weekly basal insulin injections – are being tested in clinical trials and may bring major developments to how people take insulin. In this session, Professor Philip Home, Dr. J. Hans DeVries, and Dr. Stefano Del Prato discussed the pros and cons and recent results from clinical trials of weekly basal insulin.

Prof. Home explained that weekly insulin could reduce hurdles in starting or maintaining insulin therapy for people with diabetes, especially those who are:

  • Afraid of injections
  • Hesitant to start insulin due to the change in lifestyle or impact on quality of life
  • Wary about handling devices
  • Already on a weekly injectable GLP-1 agonist

Weekly insulin could help people adhere to their prescribed therapy – but it will likely make dose titration and adjustments more challenging. One of the major challenges of weekly insulin is that people can’t modify insulin doses according to life disruptions (for example, sick days or increased physical activity).

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Dr. DeVries and Dr. Del Prato reviewed the various weekly insulins that companies are studying to evaluate their safety and how they affect diabetes outcomes in comparison to existing insulins. Dr. Del Prato highlighted results from a recent study that compared Novo Nordisk’s weekly insulin (icodec) to Glargine U100 (Lantus) in people with type 2 diabetes:

  • Both insulins showed a similar reduction in A1c.
  • Icodec showed improved glucose profiles for self-monitored blood glucose (SMBG).
  • Rates of hypoglycemia were low for both insulins.
  • Weight gain, which is common when starting insulin, was the same for both insulins.
  • Icodec did not show any new safety issues.

Research is still to come on weekly basal insulin, but it looks promising.

Farxiga for Diabetes Prevention? New Analysis of DAPA-HF Trial

Yale’s Dr. Silvio Inzucchi presented an analysis of the landmark DAPA-HF trial, suggesting that along with the heart health benefits of SGLT-2 inhibitor Farxiga, an additional benefit of preventing type 2 diabetes also exists.

As background, DAPA-HF examined the heart health effects of Farxiga (spelled Forxiga in Europe) in people with and without type 2 diabetes. The trial showed that:

  • Farxiga reduced heart-related death or worsening heart failure by 26% compared to placebo (a “nothing” pill).
  • The heart benefits were the same in people with diabetes and without diabetes.

Dr. Inzucchi’s new analysis showed that for participants who did not have type 2 diabetes at the start of the trial, treatment with Farxiga reduced the risk of developing type 2 diabetes by a whopping 32% compared to placebo. After 18 months, 4.9% of the Farxiga group had been diagnosed with diabetes compared to 7.1% of the placebo group. This is a big deal and anyone you know at high risk of type 2 diabetes should learn about these results and talk to their doctor or healthcare team.

We’re glad to see this important benefit – type 2 diabetes prevention – may be conveyed to people with heart failure who can now take Farxiga regardless of whether or not they have type 2 diabetes. As a reminder, Farxiga is the first SGLT-2 inhibitor drug to be approved for a non-diabetes specific population.

Metformin, GLP-1 agonists, and SGLT-2 inhibitors in Type 1 Diabetes

UCSD’s Dr. Jeremy Pettus moderated a session with three expert presenters from across the world: Dr. Irene Hramiak (Western University), Dr. Tina Vilsboll (Steno Diabetes Center Copenhagen), and Dr. Chantal Mathieu (University Hospital Gasthuisberg Leuven).

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Dr. Hramiak kicked things off discussing the current challenges and risks of insulin therapy, including hypoglycemia, weight gain, glucose variability, and diabetic ketoacidosis (DKA). According to data from the T1D Exchange, average A1C levels have not improved in the last decade, and adolescents continue to be a difficult group for glycemic management, despite increased use of pumps and continuous glucose monitors (CGM). How can adjunctive therapies (added to insulin) help?

The REMOVAL study looked at the effects of metformin in people with type 1 diabetes (40 years of age or older). Over three years, participants taking metformin saw the following benefits compared to those taking a placebo:

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  • A decrease in A1C of 0.13 percentage points
  • A reduction in insulin dose by 1.2 units
  • No change in the rate of minor or severe hypoglycemia
  • From a baseline body weight of 193 lbs (87.7 kg), a weight loss of 2.6 lbs (1.17 kg)
  • A reduction in LDL (“bad”) cholesterol by 0.13 mmol/L (5 mg/dL)

These data suggest that metformin did not have a clinically meaningful impact on glycemic management but may improve cardiovascular health in adults with type 1 diabetes. That’s disappointing, but something we’ve all wondered for years – now we know!

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Dr. Vilsboll continued the conversation by discussing GLP-1 agonists for type 1 diabetes. She reminded that adjunctive therapy has several important goals but does not replace insulin – which is the main treatment for people with type 1 diabetes.

Dr. Vilsboll provided an overview of the effect of GLP-1 drugs in the pancreas (on insulin-producing beta cells), liver, brain, kidneys, and other organs before sharing data from a trial on GLP-1agonists in type 1 diabetes.

The LIRA-1 Study evaluated 24 weeks of GLP-1 agonist use in people with type 1 diabetes and excess weight and found that GLP-1 treatment:

  • Did not have a statistically significant (meaningful) reduction in A1C compared to placebo.
  • Reduced body weight by 13.4 lbs (6.1 kg) compared to placebo (from a baseline of about 205 lbs, or 93 kg).
  • Increased gastrointestinal side effects (nausea, diarrhea).
  • Did not decrease the amount of bolus insulin required but reduced basal insulin by about five to six units per day.

The ADJUNCT trial was the longest such trial, involving 1,400 people with type 1 diabetes with an A1C between 7%-10%. In this trial, participants taking GLP-1 agonists experienced:

  • A clinically significant reduction in A1C of 0.54 percentage points compared to a baseline of 8.2% after 52 weeks.
  • A reduction in body weight that correlated with the dose of GLP-1 agonist: 10.8 lbs (4.9 kg) of weight loss with a 1.8 mg dose of GLP-1 agonist; 7.9 lbs (3.6 kg) with a 1.2 mg dose; and 4.9 lbs (2.2 kg) with a 0.6 mg dose.
  • An increased rate of symptomatic hypoglycemia, but no increase in severe hypoglycemia or DKA.
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In a more recent trial, MAG1C, researchers examined the use of GLP-1 agonist exenatide (Byetta) over 26 weeks in adults with type 1 diabetes. Researchers found that compared to placebo, the GLP-1 agonist did not decrease A1C but did decrease insulin dose and body weight. Researchers concluded that the GLP-1 agonist does not have a future as an add-on treatment to insulin in type 1 diabetes. We are not certain this is the correct answer, because it seems like TIR would’ve been useful to measure – but, there’s no fighting city hall.

The session concluded with Dr. Chantal Mathieu discussing the role of SLGT-2 inhibitors in people with type 1 diabetes. She pointed to three main trials: DEPICT with Farxiga, InTANDEM with Zynquista, and EASE with Jardiance.

Compared to placebo, participants taking Farxiga (either 5mg or 10mg dose) experienced:

  • Approximately a 0.45 percentage point drop in A1C by 24 weeks, and 0.2 to 0.3 percentage point decrease in A1C after 52 weeks.​
  • time in range increase of about 10% – a gain of almost two more hours of time in range per day

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  • A 10% decrease in both basal and bolus insulin.
  • A decrease in body weight of about 5.5 lbs (2.5 kg) with a 5mg dose, and about 7.7 lbs (3.5 kg) with a 10mg dose (from a baseline of 179 lbs, or 81 kg).
  • An increased risk of genital infection and urinary tract infections.
  • No increase in hypoglycemia.
  • An increased risk of DKA that rises with a larger dose.

The inTandem trial also showed a drop in A1C: after 24 weeks, participants taking Zynquista experienced a 0.5 percentage point drop in A1C compared to those taking placebo. Time in range also increased with Zynquista. There was a 77-minute increase in time in range with the 200 mg dose, and almost a three-hour increase for people taking the 400mg dose. The increased risks of DKA and genital infections were also observed in this trial.

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The EASE trial provided evidence that supported the effects of SGLT-2 inhibitors on the reduction of A1C – about 0.3-0.4 percentage points after 52 weeks. This study also used a much lower dose of 2.5 mg, which offered an intermediate effect – lowering A1C by about 0.2 percentage points and reducing body weight by 4 lbs (1.8 kg). Interestingly, there was no difference in DKA with the 2.5 mg dose compared to placebo.

Dr. Mathieu concluded by sharing her “bottom line” on the use of SGLT-2 inhibitors in type 1 diabetes and preventing DKA.

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To learn more about off-label drugs in type 1 diabetes, check out this article from Kerri Sparling.

What Therapies Are Best for People with Type 2 Diabetes at Risk of Heart Disease?

The world of diabetes is now focusing more than ever on preventing diabetes-related health complications. Not only is the treatment of diabetes about blood sugar (measured by A1C or time in range), but it is also about heart health, kidney health, and so much more. In 2019, data from large trials showed that GLP-1 agonists and SGLT-2 inhibitors have heart and kidney protection benefits.

As such, experts strongly emphasized using GLP-1 or SGLT-2 drugs for individuals at high-risk for heart attack, stroke, heart failure, or chronic kidney disease. They also named that GLP-1 and SGLT-2 therapies should become more accessible and affordable to people living with diabetes.

Studies have not yet evaluated the heart and kidney health benefits of metformin, compared to those of GLP-1s and SGLT-2s. However, trials have shown that metformin helps lower blood glucose and body weight, comes with a low risk of hypoglycemia, and is cost-effective.

If your healthcare professional has not brought up additional therapy options for you, we recommend you ask them to read this article and discuss your options.

A Debate on the Use of Sulfonylureas in Type 2 Diabetes

Sulfonylureas, or SUs (drugs like glimepiride, glipizide, gliclazide), are a commonly prescribed low-cost drug for people with type 2 diabetes across the world. At ADA 2020, experts Dr. Sophia Zoungas and Dr. Carol Wysham debated the role of SUs in the treatment of type 2 diabetes. While the two endocrinologists differed on how to interpret data from various studies, we came away from the debate with several important take-aways.

Benefits of SUs:

  • Like many other compounds available today, SUs can help lower A1C, especially at the beginning of use in diabetes management.
  • SUs are low-cost and can be an economical method of managing diabetes, at least in the short term.
  • The CAROLINA study demonstrated that sulfonylurea glimepiride is safe for the heart in people with type 2 diabetes.

Challenges of SUs:

  • The CAROLINA study showed that SUs lead to a greater risk of hypoglycemia than other type 2 diabetes medications (not including insulin).
  • All SUs are associated with weight gain, which itself is associated with cardiovascular disease for many people with diabetes.
  • Not all SUs are created equally – each SU might have different health risks, so more research needs to be done on this front.
  • Preventing long-term complications is possible with GLP-1 agonists and SGLT-2 inhibitors – SUs confers no cardioprotective advantages.
  • Without the cost advantage in the short-term, no one would use SUs.
  • Clinical trial investigators are sometimes discouraged from using SUs in major trials, as we understand it.

If you do use an SU, and have experienced hypoglycemia or weight gain, we encourage you to ask your healthcare professional if there is an alternative. To increase safety, we encourage you to check blood sugar as often as you can (or start using a continuous glucose monitoring device, if you can get access – see here if you are on Medicare) to minimize the risk of hypoglycemia.

The Debate on Metformin and Insulin Use During Pregnancy Continues

Traditionally, healthcare professionals have been advised to use insulin to treat pregnant women who have type 2 diabetes or gestational diabetes (GDM). Now, there is debate about whether metformin or other medications are equally effective alternatives to insulin.

Dr. Denice Feig presented data showing that in pregnant women with GDM, metformin use resulted in less maternal weight gain, less preeclampsia (pregnancy-related high blood pressure), lower birth weight, and less neonatal hypoglycemia (low blood sugar). Additionally, there is no evidence that metformin causes any abnormalities in babies, and the drug may reduce insulin resistance in the fetus. During the first trimester of pregnancy, metformin may be a reasonable alternative, if not a first-line treatment equivalent, to insulin. It is also cheaper, easier to use, and poses less of a risk for hypoglycemia (low blood sugar) than insulin.

While the data are promising, both Dr. Feig and Dr. Linda Barbour pointed out that long-term effects on the baby due to exposure to metformin during pregnancy may include a greater risk of being overweight, developing obesity, and having a higher BMI. Unfortunately, the data did not include pregnant women with type 2 diabetes; an ongoing study, MiTy, is currently studying these effects. Both Dr. Feig and Dr. Barbour emphasized that we need more data to decide the best treatment for pregnant women with diabetes – that may well be, and we also hope that better screening is in the works, so that those at risk of gestational diabetes can learn about it earlier and work with their healthcare teams to live with it successfully, which is eminently possible. Learn more about gestational diabetes in our recent article by Cheryl Alkon.

Nutrition, Exercise, and Mindset

New Physical Activity Recommendations for Adults and Children

Dr. Katrina Piercy and Dr. Ronald Sigal presented the 2018 Physical Activity Guidelines for Americans, with updates to the age-specific guidelines and evidence of even more health benefits. These are the recommendations for each age group:

  • Children ages 3-5 should be physically active throughout the day to support their growth, development, and motor skills. Though the US guidelines do not include a specific amount of time, Australia, the United Kingdom, and Canada recommend three hours per day.
  • Children ages 6-17 should do at least 60 minutes a day of moderate or vigorous physical activity.
  • Adults (under age 55) should do at least 150 minutes (2.5 hours) to 300 minutes (5 hours) each week of moderate-intensity activity, or 75 minutes (1 hour and 15 minutes) to 150 minutes (2.5 hours) each week of vigorous-intensity aerobic physical activity. Adults should also do muscle-strengthening activities at least twice a week. We were slightly surprised not to see adults urged to exercise every day like former head of CMS/FDA Dr. David Kessler does in his recent acclaimed book, Fast Carbs, Slow Carbs.
  • Older adults (above age 55) should do the recommended aerobic and muscle-strengthening activities for adults. They should also incorporate balance and functional training, such as standing on one foot or ballroom dancing.

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How do you determine the intensity of exercise? Dr. Piercy recommends the “talk test”: someone doing moderate-intensity aerobic activity can talk, but not sing, during the activity, while a person doing vigorous-intensity activity cannot say more than a few words without pausing for breath.

The speakers noted that while the most health benefits come with at least 150-300 minutes of moderate physical activity per week, any activity is beneficial: any time spent sitting that is swapped out for exercise (even light activity,) can lead to short-term and long-term health benefits. Read more about the guidelines here.

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Diabetes Self-Management Education and Support (DSMES) 2020 Consensus Report Recommendations

A group of educators made a strong case for the greater use of diabetes self-management education and support (DSMES). The benefits are many, including improvements in clinical, behavioral, and psychosocial outcomes, and greater diabetes knowledge and self-care behaviors. Dr. Margaret Powers stressed that compared to other treatments prescribed by healthcare professionals, DSMES and medical nutrition therapy produce few to no negative side effects for people with diabetes and are low cost.

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The experts discussed low DSMES participation rates across the nation and the factors that reduce referrals to diabetes education. Evidence shows that less than 5% of people newly diagnosed with diabetes who have Medicare insurance, and 6.8% of privately insured people with diabetes, have used DSMES services. The 2020 DSMES Consensus Report was created to address these concerns by outlining steps healthcare professionals can take to help people access DSMES services. The report recommends that healthcare professionals make referrals and encourage participation in DSMES at four critical times in someone’s diabetes journey: (1) diagnosis, (2) annually or when not meeting treatment targets, (3) when complicating factors develop, and (4) when transitions in life and care occur. It also suggests that awareness of, and access to, DSMES must be expanded (culturally and geographically), and financial support should be provided for use of DSMES services.

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Food as Medicine! Geisinger’s Fresh Food Farmacy

Michelle Passaretti (Geisinger Health System) presented data on the success of the Fresh Food Farmacy initiative. Fresh Food Farmacy was developed to meet the health needs of people with diabetes in Pennsylvania who do not have access to healthy foods (also known as being food insecure). diaTribe interviewed two leaders from Geisinger in 2018, Dr. Andrea Feinberg and Allison Hess; now, Fresh Food Farmacy has provided 482,219 total meals.

The data speaks to the power of food as medicine! The program participants had a:

  • 2 percentage point reduction in A1C from a baseline of 9%
  • 27% reduction in fasting glucose
  • 13% reduction in cholesterol (including a 9.9% reduction in “bad” LDL cholesterol)
  • 15% reduction in triglycerides

Fresh Food Farmacy also led to increased use of preventive care: flu shots increased by 23%, annual eye exams increased by 17%, and annual foot exams increased by 33%.

Compared to eligible individuals who did not participate, Fresh Food Farmacy participants saw:

  • 49% lower hospital admissions rates
  • 13% decrease in emergency department visits
  • 27% more primary care visits
  • 14% more endocrinologist visits

Participant surveys show significant improvements in quality of life, with 31% of people in the program rating their overall health as very good, compared to just 6% before participation. Additionally, 44% of Fresh Food Farmacy participants now rate their emotional and mental health as very good, compared to just 9% before the program. Passaretti emphasized that Fresh Food Farmacy is not a diet, but a lifestyle change, and that support for the individual’s entire household is necessary for success.

A Sneak Peek into the Film Blood Sugar Rising

Blood Sugar Rising is a film that powerfully articulates the need for a war on diabetes. During this panel moderated by our own Kelly Close, we heard from ADA CEO Tracey Brown, Rise and Root urban farmer Karen Washington, social media influencer and film star Nicole Egerer, film director David Alvarado, and incoming ADA Chief Scientific & Medical Officer Dr. Robert Gabbay.

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Many myths exist in diabetes. One is that if you get diabetes, it is your fault. Blood Sugar Rising dismantles some of these false narratives by showing the complexity of the disease and amplifying diverse voices of people in the diabetes community. Watch the film here if you are in the US and here if you are outside the US.

Tracey Brown ended with a powerful call to action: “What will we do when the burning bush stops burning? We need to move from words into action. We get one point for saying and nine points for doing. Each of us can use our voice, our monetary power, and our ears, and reach across the aisle to collaborate. This is what we need to do to bring diabetes down. We can make it happen, but only together. I’m full up of hope and courage that tomorrow is going to be better than today.”

Lifestyle Interventions for Type 2 Diabetes Remission

In a fascinating session on type 2 diabetes remission, several leaders in the field introduced data on how specific lifestyle interventions (diet and exercise) may help put type 2 diabetes into remission.

Alison Barnes presented data from the DiRECT trial, which focused on low-calorie diets (LCD). The trial compared an intervention group on an LCD (between 800-900 calories per day) to a control group receiving typical diabetes care. Remission was defined as achieving an A1C below 6.5% and stopping all diabetes medications. Results from the DiRECT trial were promising:

  • At one year: 4% remission in control group and 46% remission in the intervention group.
  • At two years: 3% remission in control group and 36% remission in the intervention group.
  • 64% of participants who lost more than 22 lbs (10 kg) were in remission at two years.
  • The intervention group dropped from 75% of participants on diabetes medications at baseline to 40% at two years (compared to 77% at baseline and up to 84% in the control group).
  • Average A1C decreased by 0.6 percentage points in the intervention group at 2 years.
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We thoroughly recommend Dr. Roy Taylor’s book Life Without Diabetes: The Definitive Guide to Understanding and Reversing Type 2 Diabetes – he provides a major connection to the DiRECT trial.

Next Dr. William Yancy spoke on low-carbohydrate diets (classified as less than 130 g carbs per day, with no overall calorie restrictions). In an analysis that compared the effects of nine different diets on glycemic outcomes in type 2 diabetes, the low-carb diet was ranked as the most effective dietary approach for lowering A1C.

Finally, Dr. Kristian Karstoft presented the U-TURN study on how exercise alone, or exercise and diet, may play a role in type 2 diabetes remission. U-TURN had two groups, one receiving standard care and one receiving intensive lifestyle intervention, which included diet and exercise components.

  • After 12 months, 37% of participants in the intervention group stopped using glucose-lowering medication and maintained glucose levels below the criteria for type 2 diabetes (effectively achieving remission).
  • Of the participants who achieved remission, the majority of them came from the group that consistently exercised the most.

The Need for a Personalized Approach to Obesity Treatment

Experts shared the latest data on different treatments for obesity. They focused on three approaches:

1. Lifestyle interventions:

  • The Look AHEAD trial tested whether reducing calories and exercising regularly would lead to diabetes remission. After one year, 11.5% of participants achieved diabetes remission with an average weight loss of 19 pounds (8.6 kilos). After four years, 7.3% of participants were able to maintain remission with an average weight loss of 10 pounds (4.5 kilograms).
  • The Diabetes Remission Clinical Trial (DiRECT) tested whether calorie restriction alone had an effect on diabetes remission. After one year, 46% of people in this study with type 2 diabetes achieved remission; after two years, 70% of the people who had achieved remission were able to maintain remission.

Participants in Look AHEAD had more advanced diabetes than in DiRECT, leading to the big difference in remission rates. The speakers emphasized that the longer someone has been diagnosed with diabetes, the harder it is to achieve diabetes remission.

2. Obesity medication:

  • Just 2% of people living with obesity are managing the disease with medication. However, many obesity medications can lead to weight loss, prevention of diabetes, and diabetes remission.
  • Combination therapy has shown success for managing obesity and type 2 diabetes. A study testing tirzepatide (a dual GLP-1 and GIP receptor agonist) in people with type 2 diabetes found a 1.7-2% decrease in A1C and an average weight loss of 12 pounds in just 12 weeks.

3. Bariatric surgery:

  • Experts agreed that bariatric surgery should be considered as a treatment option for people with a BMI greater than 35. Bariatric surgery can also lead to sustained weight loss and a decrease in diseases associated with obesity, including sleep apnea and heart disease.
  • It’s clear that obesity treatments must be determined at individual levels – we know that so much more is possible for people with diabetes to reach healthier weights and will be returning to this topic. In the meantime, if changing your weight is of interest, talk to your doctor about how to do this in the best way for you.

How Might Type 1 Diabetes Affect the Gut Microbiome? How Can We Use the Gut Microbiome to Treat Type 1 Diabetes?

Though the science is not yet conclusive, research continues on the relationship between the gut microbiome (made up of all the bacteria that live in the human digestive tract) and type 1 diabetes autoimmunity. Dr. Eric Triplett reviewed studies of the gut microbiome in babies with high genetic risk for type 1 diabetes. Three of the studies (DIPP, Babydiet, and DIABIMMUNE) showed an association between the species of bacteria living in the gut and the onset of type 1 diabetes. He then presented a study using data from the general population in Sweden (ABIS), which compared the gut microbiome of children with low, neutral, or high genetic risk for type 1 diabetes. The study found that high genetic risk for type 1 diabetes is associated with changes in the gut microbiome early in life.

Dr. Emma Hamilton-Williams shared unpublished research on the effect of high-fiber dietary supplements on gut microbiome composition and diabetes management in 18 adults with type 1 diabetes. Fibrous food breaks down into short-chain fatty acids (SCFAs) when digested. SCFAs are known to support gut health and regulate the immune system. The study found that the high-fiber supplements affected the species of bacteria living in the gut as well as their function (though these returned to baseline after the diet ended). Participants with better-managed diabetes at baseline had a stronger response to the dietary change – and experienced changes in their glycemic management: A1C levels decreased and less daily insulin was required. Further research on short-chain fatty acid supplements could shed lead on diabetes treatment and prevention.

Real World Stories: Supporting People at Different Stages of Diabetes

Dr. Neesha Ramchandani presented her work on young adults living with diabetes (ages 18 to 30). Through interviews, she found four main challenges: finding a balance between diabetes and life, feeling in control of diabetes, navigating the hidden burden of diabetes within their social circles, and wanting a better connection with their diabetes healthcare professional. One participant said, “Diabetes is like having a full-time job… you can’t 100% turn off. It always has to be a part of your thought process.” diaTribe has resources for teens here.

We then heard from Dr. Della Connor and Dr. Gary Rothenberg on the need to care for people who are living with diabetes post-kidney transplants and post-amputations. In all three talks, the experts emphasized the need to:

  • Build trust and comfort between people with diabetes and healthcare professionals.
  • Incorporate perspectives based on gender, race, and ethnicity into care.
  • Recognize the importance of a team approach, including care-partners.

Access to Care and Policy 

Soda Taxes: Are They Working?

Dr. Lisa Powell (University of Illinois at Chicago) presented compelling evidence in support of sugar-sweetened beverage (SSB) taxes and their ability to reduce soda consumption. Evidence suggests that taxes do reduce the consumption of sugary beverages – a 38 percent reduction in Philadelphia, PA and 21 percent reduction in Seattle, WA, for example – and incentivize soda companies to decrease the amount of sugar in their products, especially when the tax is dependent on the drink’s sugar content. Research also shows that while some consumers replace sodas and sugary drinks with other forms of sugar, such as candy or chocolate milk, the most common substitute is water.

day 2 1

Image source: diaTribe

Dr. Martin White (University of Cambridge) and Dr. Rafael Meza (University of Michigan) presented promising data on how SSB taxes are working in the United Kingdom and Mexico, respectively. UK consumers overall have been switching to drinks with less sugar and most companies have been reducing levels of sugar in their products; however, taxes have not had a dramatic negative impact on the sugary beverages industry’s revenues overall. Similarly, Dr. Meza showed that Mexico’s overall sugar consumption has decreased since the implementation of the SSB tax, having the largest influence on people who drink lots of sugary drinks, and he noted that the current tax, which is about 10% of the beverage price, would have a significantly larger impact if doubled.

Dr. Powell pointed out that the most effective taxes require careful design. To significantly curb consumption of sodas, the SSB tax should be added into the shelf price, rather than applied at the register, and the tax ought to apply to a broad base of sugary-drinks (including sodas, juices, sports drinks, etc.) to avoid substitutions. Moreover, researchers must be mindful of cross-border shopping – this is when consumers purchase their beverages in places where the SSB tax doesn’t apply. This tax avoidance can heavily impact the effectiveness of the tax: for example, in Philadelphia, PA, consumers buying SSBs outside of Philly reduced the the impact of the tax from a 51% reduction in SSB sales to a 38% reduction.

Effects of Health Policy on Diabetes Care

Professor Rebecca Myerson (from the University of Wisconsin) shared key findings of a study on the impact of Medicaid expansion for people with diabetes:

  • Medicaid prescriptions for insulin increased by about 40%, even with rising insulin prices, meaning that more people with diabetes are receiving treatment.
  • Prescriptions for metformin also increased, suggesting that more people are getting treatment for early-stage diabetes.
  • About one-third of the other prescriptions are for newer medicines (such as SGLT-2 inhibitors and GLP-1 agonists) – promising trends for preventing diabetes complications and saving significant costs down the road.

Dr. Kasia Lipska from Yale School of Medicine discussed the importance of coverage for essential medicines and pre-existing conditions – two health policy issues that are front of mind for many Americans as the November election approaches. In addition to Medicaid expansion, the Affordable Care Act (ACA, or Obamacare) provided coverage for “Essential Health Benefits,” which includes prescription drugs, mental health services, emergency services and hospital care, preventive services and chronic disease management, and more. Dr. Lipska shared a study that found the ACA reduced the percent of income spent on family medical costs for people ages 18-64 with diabetes. This reduction was especially true for people whose family income was in the lowest bracket ($0-34,999 per year).

Income

Image source: diaTribe

Importantly, ACA also prohibited health insurance companies from denying people coverage or charging higher costs to people who have “pre-existing conditions,” including diabetes. Given the significant improvements in coverage and care, Dr. Lipska emphasized that getting rid of the pre-existing conditions provisions would be “a disaster for people with diabetes” – presumably diaTribe readers in the US would agree! Over half of those surveyed were in favor of expanding Medicaid programs in their state – this doesn’t surprise us, since there are so many states that do not have favorable diabetes care programs (for example, see our article on CGM coverage for people on Medicaid; although this was not part of the ACA, many cite it as helping improve care quickly for those that are able to access the benefit). She shared results of a Kaiser Family Foundation survey that emphasized the need for ACA provisions:

ACA

Image source: diaTribe

Whole-Population Interventions Aim to Prevent Type 2 Diabetes

As type 2 diabetes rises in the United States (and around the world), organizations are working to prevent new cases and improve the health and wellness of entire communities. Simon Neuwahl (RTI International) showed models of the benefits of proposed changes, which includied soda taxes, worksite health promotion, and bike lanes. The models suggest that the introduction of these three societal reforms can reduce the rate of type 2 diabetes by 17% over the next ten years. In 2018, 1.4 million people were diagnosed with type 2 diabetes in the, US so a 17% decrease would prevent 2.4 million cases over ten years.

There is still a long way to go. The CDC is aiming for the rate of type 2 diabetes to drop by 21% by 2025. The efficacy of some reforms, like the soda tax, are well proven. But, experts like Professor Nicholas Wareham (University of Cambridge, England) believe that no single intervention can make a difference. Decreasing rates of type 2 diabetes will require societal and individual lifestyle reforms.

Thankfully, diverse groups recognize the need for holistic approaches to diabetes prevention. The CDC’s National Diabetes Prevention Program coordinates with both public and private organizations to connect people with diabetes or prediabetes to lifestyle change resources and programs. Neuwahl’s cost-effective model is adaptable to national, state, and local communities hoping to implement whole-population interventions. Together, his three proposed population-level reforms could directly improve the lives of 2.4 million people.

Source: diabetesdaily.com

How to Safely Transition to Multiple Daily Injections (MDI)

As the reality of living during a pandemic slowly starts to sink in, people are changing their expectations for what 2020 (and beyond!) looks like. Some people have delayed their weddings, or put plans for a baby on hold, and many people have lost their jobs.

In the US, where health insurance is so intimately tied to employment, which also, unfortunately, means that many people are currently without health insurance and are quickly searching for a plan that will work for them. This is infinitely more complicated when you’re living with diabetes, as health insurance is even more essential for your health and well-being, but this can also cause problems.

Coverage for diabetes supplies varies by insurance carrier. For example, many Medicaid programs across the United States do not have an adult CGM benefit, and some health insurance plans on the federal and state health exchanges will not cover the type of insulin pump you need and are used to. These transitions have many people considering a switch to MDI, or multiple daily injections. Here’s how to transition safely, if this is you.

Reasons for Switching to MDI

People may switch from their insulin pump back to multiple daily injections for any number of reasons, but some may include:

  • Needing a mental health or “tech” break
  • Diabetes burnout 
  • Not wanting pump sites and tubing during the summertime (when lots of heat, humidity, pool, and beach time can cause many headaches with sites coming out more frequently)
  • Losing health insurance, and new insurance doesn’t cover your preferred pump
  • Saving money (a 2019 study found that annual costs are ~$4,000 higher for pump therapy than for MDI therapy: $12,928 vs. $9,005, respectively)
  • Experiencing frequent pump and/or cannula malfunctions
  • Experiencing sensitive skin and adhesive issues at your pump site
  • Absorption issues with insulin pump therapy

Some people switch pretty frequently between insulin pump therapy and daily shots, while others stay strictly in one camp or the other for years, and only switch when they absolutely have to. Remember that you don’t have to justify your reasons to anyone.

Talk to Your Doctor

Once you’ve decided to switch back to MDI, you should contact your primary care physician or endocrinologist (or any other provider who you regularly see for diabetes care). They can help you develop a plan to convert your basal (pump) settings to a long acting insulin injection (Lantus, Levemir, and Tresiba are common brands). Additionally, they can help you navigate the transition for bolus doses, as well as help you figure out your insulin sensitivity and correction factors.

Stock Up on Supplies

Once you’ve spoken to your doctor (and have gotten some prescriptions for long-acting insulin), it’s time to stock up on supplies. You’ll need both short and long-acting insulins (for bolus and basal insulin replacements), syringes or pen needles, and alcohol swabs. It’s helpful to have plenty of low snacks, like juice and glucose tablets, on hand as well. A silver lining of MDI is that there are way fewer supplies you’ll need, and they cost less money.

Buckle Up for the Roller Coaster

Switching back to MDI after using an insulin pump will not be without issues. You may experience both more frequent high and low blood sugars as you navigate the transition, and figure out both how much and how frequent you need to dose insulin. Don’t be surprised if you find that you need much more insulin on injections than you needed on a pump (or vice versa). Everyone is different, and having a little patience (and plenty of low snacks handy) can go a long way.

Listen to Your Heart

It’s important to remember that people living with diabetes can have excellent control whether or not they use an insulin pump. Multiple daily injections is a form of diabetes therapy that works wonderfully for millions of people. That being said, you may have family or friends who will try and change your mind about switching back to MDI. Be let’s be clear: if you need a pump break (for ANY reason), listen to your heart. Don’t let people talk you out of it. Diabetes is for the long-haul, and sometimes taking a break (or going back to insulin injections permanently) is just what can be needed to achieve better physical and emotional health.

You Can Always Change Your Mind

Made the switch to MDI, and can’t stand it after 2 weeks? Remember, your diabetes management is just that, yours! No one will judge you if you are ready to go back on insulin pump therapy sooner than you anticipated. You are allowed to change your mind as many times as necessary to find the best therapy that will fit your lifestyle and meet your needs most effectively.

Have you made the switch to multiple daily injections from insulin pump therapy recently? How was your experience? Any advice to share? Please share your story below; we love hearing from our readers!

Source: diabetesdaily.com

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