Your Brain and Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Brett Goerl and Matthew Garza

Recent studies have shown a link between brain diseases like Alzheimer’s and Parkinson’s and diabetes.  Unfortunately, these conditions are becoming more common as our population grows older. Find out more and ways to improve brain health.

What are neurodegenerative diseases?

The term “neurodegenerative diseases” refers to a range of diseases in which the cells in our brains break down and can no longer perform their designated functions associated with movement or mental ability, according to the EU Joint Programme – Neurodegenerative Disease Research. The most common neurodegenerative diseases that affect people with diabetes are mild cognitive impairment (MCI) and dementia, which includes Alzheimer’s disease.

As we age, it is completely normal for our memory, thinking, and judgment to slightly decline. However, MCI occurs when our mental abilities decline faster than expected and begin to interfere with our daily lives. Age is by far the biggest risk factor for MCI, but diabetes, smoking, high blood pressure and cholesterol, obesity, and depression can further increase a person’s risk of developing MCI.

In around 10-15% of cases each year, the mental decline seen in MCI may progress further, making it difficult for us to carry out a healthy and happy life. When this happens, it is called dementia. The two most common types of dementia that affect people with diabetes are Alzheimer’s disease (AD) and vascular dementia.

While the symptoms of AD and vascular dementia are similar, they are caused by two different processes that occur in our brains. AD is thought to be caused by the abnormal build-up of proteins in the brain. One protein is “amyloid,” which clumps together in spaces around brain cells. The other protein is “tau,” which get tangled up inside brain cells. Vascular dementia, on the other hand, occurs when the blood vessels in our brain become narrow or start to bleed. This reduces the brain’s ability to get the oxygen it needs to keep brain cells healthy and for the brain to function properly. In both cases, brain cells become damaged, leading to a wide range of problems such as memory loss, worsened judgment, and personality changes.

AD is the most common form of dementia in the US, making up 60-70% of dementia cases. In the US, an estimated 5.4 million people of all ages are affected by AD, and one in eight people 65 years and older suffer from it. Considering the 14.3 million adults aged 65 and older in the U.S. who have diabetes, and it is easy to see why Alzheimer’s disease and diabetes are two of the most common diseases of aging. And recent research has suggested that they may be linked in various ways.

How do neurodegenerative diseases like Alzheimer’s and vascular dementia relate to diabetes? 

We often think of diabetes as a problem with our metabolism since the lack of insulin (in type 1 diabetes) or insulin resistance (in type 2 diabetes) affects our body’s ability to maintain normal blood glucose levels. However, our brain consumes the most glucose compared to any other organ in our body. While the brain accounts for roughly 2% of our body weight, it uses almost 20% of the sugars we eat or release from our body’s stores.

An increasing amount of research shows that people with AD and other forms of dementia experience insulin resistance in the CNS (central nervous system, which includes the brain and the spinal cord), similar to what people with type 2 diabetes experience in other areas of the body, such as the muscles, the liver, and the fat. Scientists have yet to determine exactly what the relationship between diabetes and AD or other forms of dementia may be caused by, but there are a few theories that have been proposed.

  • One of these theories focuses on brain insulin resistance, which is when brain cells stop responding normally to insulin, leading to problems related to the ways our brain cells communicate, use energy, and fight infection.
    • Insulin receptors can be found in many areas of the brain, where they are involved with brain cell growth, communication, and survival. While insulin levels are lower in the brain than in the bloodstream, all the insulin that makes its way to the brain comes from the same insulin produced in the pancreas – it crosses over what is known as the blood-brain barrier (or BBB). This barrier prevents unwanted things from the bloodstream from entering the brain. However, injected insulin does not cross the BBB. The reduced transport of insulin across the BBB may be why brain insulin levels are lower when the body experiences insulin resistance (such as in pre-diabetes and type 2 diabetes) and in diseases such as AD.
    • Insulin in the brain is known to help control our metabolism in certain other organs of the body, like the liver and fat tissue. The hypothalamus, the part of our brain that controls hunger, thirst, and emotions, is highly sensitive to levels of insulin in the brain. The association between type 2 diabetes and brain health may be due to problems with insulin’s actions in the hypothalamus, increasing a person’s likelihood of developing whole-body insulin resistance.
  • Diabetes also increases the risk for damaged blood vessels, leading to heart disease and stroke. Damaged blood vessels can starve the brain of oxygen, leading to cognitive decline and vascular dementia.
  • Diabetes disrupts how our bodies produce amylin, a hormone related to insulin that helps our bodies digest food. People with obesity and pre-diabetes often have high amounts of amylin, some of which can circulate and cross into the brain. Studies have shown that amylin can interact with the same protein deposits in the brain known to cause AD.
  • Experiencing hyperglycemia for long periods of time can degrade the myelin sheath (a protective layer that surrounds your neurons). This leads to issues in how your nerves send and receive signals to your body. It can also lead to your brain cells dying.

Type 1 diabetes could be a risk factor for dementia for many of the same reasons as type 2 diabetes. In particular, the cardiovascular complications such as heart disease and stroke that are associated with type 1 diabetes could provide an explanation for its relationship with vascular dementia. Additionally, higher rates of cognitive dysfunction for those with type 1 diabetes could be related to frequent cases of hyperglycemia and hypoglycemia. Indeed, severe hypoglycemic and hypoglycemic events are associated with increased dementia risk for older adults with type 1 diabetes.

Is diabetes a risk factor for developing neurodegenerative disease? 

On average, people with diabetes experience slightly more cognitive difficulties associated with MCI across their lifespan, but experiencing cognitive difficulty does not mean you will eventually get diagnosed with dementia or AD. The prevalence of type 2 diabetes and neurodegenerative diseases, however, both increase with age, meaning it is more common for older people (65+ years) with type 2 diabetes to get diagnosed with vascular dementia or AD.

Data suggests that people with diabetes have a 73% increase in the risk of developing any type of dementia and 56% increase in the risk of developing AD compared to people who do not have diabetes. This makes diabetes one of the strongest risk factors for getting dementia aside from aging. Health measures like A1C, cholesterolhigh blood pressure(or hypertension), and eGFR are negatively impacted by diabetes and may also be associated with cognitive performance and neurodegenerative diseases.

  • In the ACCORD-MIND trial, the largest and most rigorous study on diabetes and the brain to date, higher A1C levels were associated with lower cognitive function in people with diabetes. Similarly, another study found that the risk for dementia increased as a person’s A1C level increased, regardless of whether or not the person had type 2 diabetes.
  • A recent analysis of over 100 studies found that higher levels of LDL cholesterol (known as “bad cholesterol”) was an independent risk factor for the development of AD.
  • High blood pressure in middle-aged people has been linked to future cognitive decline and dementia, and in particular, vascular dementia. This may be due to high blood pressure in the brain causing damage to blood vessels, such as small blockages and bleeding.
  • In a study on kidney health and dementia recently published recently, researchers found that lower rates of kidney filtration (as measured by eGFR) were associated with higher risk of onset of both vascular dementia and AD.

What about Parkinson’s Disease?

Parkinson’s Disease (PD) is another neurodegenerative disease associated with aging. In PD, the cells in your brain deteriorate and begins to affect a person’s ability to perform daily activities associated with movement. Symptoms can include tremors (rhythmic shaking), muscle stiffness and rigidity, and PD can even slow your movement in a process called bradykinesia. It can also lead to other symptoms not associated with movement such as disrupting sleep, constipation, anxiety, depression, and fatigue.

As with other neurodegenerative diseases, research has been conducted to identify if there is a link between diabetes and PD. In particular, one study from 2018 showed an association between the two conditions. The researchers looked at the English National Hospital Episode Statistics and Mortality Data from 1999-2011 and divided the data into two cohorts, those with type 2 diabetes (2,017,115 people) at the time of hospital admission and those without (6,173,208 people). It was found that those with diabetes had a 30% higher chance of developing PD than those without, and the younger a person was with diagnosed type 2 diabetes, the more likely their chance of developing PD.

Though researchers do not yet understand the exact way that diabetes and PD are related, they do have a few hypotheses. Namely, there is the chance that certain genetic abnormalities that lead to diabetes may also lead to PD; even if one of these conditions does not directly cause the other, people who have one may be more likely to also have the other. In addition, when diabetes and PD coexist in a person, they may create a more hostile environment in the brain, leading the neurodegenerative processes underway in PD to speed up and be more severe.

What are strategies to reduce the risk of developing a neurodegenerative disease?

There is evidence that leading a healthy lifestyle can reduce your risk of developing diabetes-related complications like dementia or PD. For example, heart attacks and stroke can increase the risk of developing vascular dementia; therefore, lifestyle modifications that help you maintain an ideal blood pressure and levels of cholesterol for your age and health status are important. This can be accomplished by exercising regularly and consuming a diet low in saturated fat, salt, and sugar.

Below are some other tips for improving brain health, which can go a long way in reducing the risk of neurodegenerative diseases like AD. The good news is that many of these strategies are also recommended for managing diabetes.

  • Take control of your blood glucose levels by aiming for a greater time-in-range (TIR). To learn more about time-in-range goals, click here.
  • Smoking is associated with higher rates of dementia. In a recent review, smokers were 40% more likely to develop AD than non-smokers. Given that people with diabetes are at an increased risk of developing dementia, smoking is likely to increase this risk further. If you smoke or experience nicotine addiction, talk to your healthcare professional about a plan to quit or cut back.
  • Keep blood pressure at the target discussed with your health care provider (which might be 130/80 mmHg or less, if you are at high risk of cardiovascular disease) by exercising regularly and eating a diet low in salt (aim for less than 2,300 mg of sodium each day)
  • Take your diabetes medications consistently and as directed by your healthcare team. Some early evidence shows that certain diabetes drugs, like GLP-1 receptor agonists, may be beneficial for brain health. In fact, exenatide, a GLP-1 receptor agonist, is currently in clinical trials for treating PD.
  • A very active area of research focuses on the dementia-preventing effects of having an active and stimulating mental life and rich social networks. Working to maintain an active and socially rich lifestyle could help prevent some of the effects of diabetes on dementia risk.

If you are 65 years of age or older and have memory concerns or other cognitive complaints (i.e., brain fog, depression, personality change), talk to your healthcare provider about getting a cognitive assessment. Learn more here.

Source: diabetesdaily.com

Diabetes Community Survey Shows Drug Costs Still Ranks Highest Access Concern

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

By Beyond Type 1 Team

In early 2021, Beyond Type 1’s advocacy division surveyed almost two thousand people living with or caring for someone with diabetes to determine key healthcare access issues faced by members of the Beyond Type 1 community throughout 2020. While other surveys on access have been conducted within the diabetes community, it was important to Beyond Type 1 to hear directly from the community they serve on issues faced, both throughout the COVID-19 pandemic and generally.

The survey follows ongoing advocacy work from Beyond Type 1 addressing the rising cost of insulin and other healthcare access issues such as implicit bias and equitable technology access, Medicare and Medicaid access, drug pricing and rebate reform, and more.

The survey ran in English and Spanish, was anonymous, and included survey respondents both within and outside of the United States. The survey was run independently by Beyond Type 1 and specific methodology can be found at the bottom of this article.

Key Learnings

Access + Cost

A majority of respondents (56%) ranked access to affordable insulin and diabetes drugs as their most important access issue. This aligns with data reported from studies such as the 2018 Yale report showing that one in four insulin-dependent people ration insulin due to cost, while also nodding toward the high cost of other diabetes medications like SGLT2 inhibitors and GLP-1 receptor agonists.

Almost half of respondents (40%) ranked access to diabetes supplies as the second most important access issue (8.5% of respondents ranked access to supplies as their most important access issue), while nearly the same amount of respondents (36%) ranked access to affordable healthcare coverage as their third most important access issue. Just 6% of respondents ranked access to new therapies that cure, treat, or prevent diabetes as their top access issue (75% of respondents ranked it as their least important access issue).

Health Insurance

In the United States, 66.4% of respondents indicated they used employer-based health insurance to access healthcare in 2020. This is slightly higher than the 2019 U.S. population health insurance coverage data provided by the Current Population Survey Annual and Social Economic Supplement (CPS ASEC) and the American Community Survey (ACS), which calculated 55.4%.

Of the remaining third of respondents:

  • 8.1% received 2020 health coverage through Medicaid
  • 7.7% through Healthcare.gov / State Marketplace
  • 5.8% through Medicare
  • 5% reported no insurance coverage in 2020,
  • and 4.6% indicated ‘other’, which could include either a combination of coverage options, catastrophic care plans, COBRA, and/or other temporary plans

While two-thirds of respondents reporting employer-based health insurance could be seen as a positive—that access to healthcare is the norm rather than the exception—40.4% of respondents indicated they incur a deductible of more than $1500 per person for their insurance coverage. This indicates that over a third of respondents are covered by High-Deductible Healthcare Plans (HDHPs), a rising trend across American healthcare that, for those with chronic health needs, creates excessive financial burden.

HDHPs create a scenario in which a person often must pay full price for medications or supplies until the healthcare plan’s deductible is met, creating a significant out-of-pocket cost at the start of every calendar year. For people living with chronic conditions such as diabetes, this economic burden can create avoidance of healthcare treatment, unaffordability of life-essential medications, and inability to purchase or utilize supplies needed.

Out of Pocket Costs

Survey respondents reported excessive out of pocket expenses not only for medications, but for diabetes supplies (such as insulin pump or glucose monitoring supplies).

  • 55% of respondents stated they have paid more than $100 out-of-pocket in any month for any diabetes medication
  • 64% of respondents paid more than $100 out-of-pocket in any month for diabetes supplies

Global Issues

While the American healthcare system often creates an undue financial burden for people living with diabetes, access abroad remains a major issue as well.

  • 55% of respondents could not get supplies
  • 18.3% of respondents had run out of medications or rationed due to cost
  • 23% of respondents made a decision between bills and diabetes supplies

The Impact of COVID-19

Of course, the COVID-19 pandemic exacerbated healthcare issues across the globe. For those living with diabetes or caring for individuals with diabetes,

  • 30.7% of respondents did not see a healthcare professional or have lab work completed in 2020 due to fear of contracting COVID-19
  • 38.4% of respondents experienced mental health issues related to the COVID-19 pandemic
  • 7.8% of respondents experienced employment discrimination due to COVID-19 in relation to diabetes during 2020

The Bottom Line

Living with diabetes creates a major financial burden for many—the added medical cost of living with diabetes in the United States has been estimated at an average of $9,071 annually per individual—and the financial decisions that many are forced into making create short- and long-term consequences. Among survey respondents:

  • 21.6% ran out of medications or rationed due to cost
  • 15.0% skipped specialist visits or other healthcare to pay for diabetes care or supplies
  • 16.8% did not see a medical professional due to cost
  • 14.1% “borrowed” insulin or other diabetes supplies because of cost
  • 20.1% utilized a copay card for any diabetes medication
  • 22.8% made a decision between bills and diabetes supplies

These survey responses will continue to shape ongoing work being done by Beyond Type 1 ensuring everyone impacted by diabetes — type 1, type 2, and beyond — has a right to the best care possible for their unique situation. To learn more about Beyond Type 1’s advocacy work and to lend your voice to legislative actions, click here.

Details on Methodology

The Beyond Type 1 Diabetes Experiences Survey was created on Formsite, a secure platform for processing and hosting sensitive survey data in both English and Spanish versions. Both versions were identical in ranking questions, response offers, and language. The survey was logic mapped to offer additional questions for those who identified as individuals living outside the United States.

Questions were created by employees of Beyond Type 1 living with diabetes, with careful attention paid to plain, inclusive language in demographic self-identification inquiries.

The Beyond Type 1 Diabetes Experiences Survey was shared online through different avenues from mid-January to mid-February in English and mid-January to mid-March in Spanish through the Beyond Type 1 website (English and Spanish), the Beyond Type 2 website (English and Spanish), a targeted email from Beyond Type 1, and both organic and paid posts on Twitter, Facebook, and Instagram. There was no paper version available to print out; it was online responses only.

Respondents self-identified as people living with diabetes or caring for an individual living with diabetes.

The survey was completely voluntary; no one was paid to provide responses. All responses were mandatory for a survey to be deemed complete. If an individual did not click submit at the bottom of the survey, no results were recorded. A statement before the beginning explained that the survey results were anonymized, and only aggregate data and key learnings would be shared publicly.

1924 individuals fully completed the survey, with 1850 identifying as living in the United States.

Noted Limitations

The sample size of 1924 individuals is a small section of the global diabetes population, although larger than many similar surveys in the space. Additionally, respondents cannot be assumed as indicative of all people living with diabetes – 93% of respondents lived with or were caretakers of someone with type 1 diabetes, 91% lived in the United States, 85% were white, and 83% were female. Just 3.2% were 65+. All respondents had access to the internet and were either already following or in some way connected to Beyond Type 1 channels.

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

Olympian Laurie Hernandez, Her Dad, and Diabetes

Laurie Hernandez is an elite athlete. To keep up her Olympics-quality form, she needs to take her lifestyle decisions, like diet and exercise, very seriously.

Anthony Hernandez is similarly mindful. He’s not an elite athlete – he’s Laurie’s dad. He takes care of his health because he has type 2 diabetes.

“I’ve always watched him take care of himself. It was just something he did because he had to do it. For me and gymnastics, going to physical therapy, and doing preventative bodywork, and eating the right things … all of those are key things that I’ve watched him do.”

Photo by Harry How/Getty Images

Laurie, a gymnast, won both individual silver and team gold in the 2016 Summer Olympics in Rio. 

I spoke to Laurie only days after she had sustained an unfortunate injury that put her Olympic return in doubt. A hyperextended knee forced Laurie to withdraw from the U.S. Gymnastics Championships, a critical competition that helps determine which athletes can make the team for the upcoming Tokyo games. In the days after our talk, Laurie decided not to petition for a spot on the Tokyo team – potentially ending her career as a competitive gymnast.

We talked about gymnastics and the Olympics, but we mostly talked about her dad. Anthony’s had diabetes for as long as Laurie can remember, but he never made a big deal about it.

“He wanted things to appear as normal as possible, so it wasn’t a big topic. It was just something that he did. He would prick his finger, and he would take his medication.”

Laurie’s grandmother also had diabetes – little Laurie would watch her take insulin shots. As her grandmother got older and more unsteady, Laurie would help her with her injections. Everyone helped out like that.

“I didn’t see it like an odd thing. ‘Oh, here are two people taking care of themselves. That’s my family!’”

I was struck by the contrast, but similarity, between Laurie and her dad. They’re in very different stages of life, but each is similarly motivated to take their health seriously, and each inspires good decisions in the other. Growing up in a household where diabetes was an everyday fact of life gave Laurie early models of self-care.

“I had that representation of somebody taking care of themselves.

“This gymnastics training is crazy, but let me show you how I learned all the in-betweens, how I learned to take care of myself. A big part of that comes from my dad. Watching him do that and set that example for me and my siblings.”

Anthony still manages his diabetes in a subtle way, and isn’t one to draw much attention to himself. But over the years, he’s gotten more in tune with his body and addressed his condition in a little bit more depth.

He’s also been more open about how his children helped inspire him to improve his control. He didn’t want his disease to force him to miss out on their lives, especially Laurie’s superlative athletic career.

“He would say, ‘I wanna be there for those things.’”

I spoke to Laurie because she’s the newest spokesperson for Trulicity, a GLP-1 agonist approved for type 2 diabetes. Trulicity is a once-weekly injection that studies have shown can confer both improved glucose control and weight loss. It also may help reduce the likelihood of major cardiovascular events.

Laurie told me that representing a diabetes medication “resonated” with her.

“I get to talk about my dad and show all the hard work that he’s done in quiet. It’s life, it’s something that he takes care of every single day. He doesn’t really have a choice! So to give him grace and kudos for that, I do think it’s important.”

If anyone’s curious why Laurie, who doesn’t have diabetes, decided to represent Trulicity, she has a simple answer: “It’s my dad. That’s my family, that’s my core, he’s a big part of who I am.

“I’m so proud of him. He talks about how proud he is of me, all the time, but now I have an opportunity to tell everyone how proud I am of him.”

Diabetes care can be a team effort for the Hernandezes.

“My mom would always carry snacks with her, you know, just in case he ever got low. It didn’t click for me, up until the last few years, that she was doing that to take care of him. I thought, you know, that’s just mom being mom, but it was always for him. It was a way to keep an eye out.”

Even when she’s on the other coast, she makes an effort to keep up with her dad as much as possible:

“I make sure to check in and see that he’s doing ok. Just give him an encouraging word or call. Me and my siblings, we have a big family group chat, and we’ll let him know that we’re so proud of him. If he does have an off day, not reprimanding him for it, but letting him know, hey, everybody’s got an off day. Lots of love and support.”

In a remarkable coincidence, Laurie’s roommate Charlotte Drury, also an Olympic hopeful, was recently diagnosed with Type 1 diabetes. Performing at an elite athletic level while dealing with newly diagnosed type 1 diabetes can’t be easy, but Laurie reports that Charlotte “is kicking major butt.” She certainly lucked out in having Laurie as a roommate. Laurie has accompanied her to the doctor’s office, and is happy to run and grab a juice box when Charlotte’s blood sugar goes low.

It’s been a strange year for Laurie, as it has for everyone, but the pandemic did bring some benefits. Laurie usually trains in California, far away from her hometown in New Jersey, but after her gym closed down she switched for about six months.

“I got to spend a lot of time with my family, got to watch my nephew grow, which was awesome. There was a lot of family time that I should not have gotten but did, so that was a huge silver lining.”

What advice does the high achiever and devoted daughter have for other people with diabetes?

“The biggest thing is just to do your best, to not let it stop you from doing things you really want to do. From watching my dad be a good dad and do his best to show up for all my different meets, diabetes did not get in the way of that. I’m sure it was a challenge for him, but he constantly showed up.”

“I’m really proud of all of you. You’re strong because you have to be, but you are strong.”

 

Source: diabetesdaily.com

Drink to That: How to Safely Consume Alcohol with Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Cheryl Alkon

We’re already thinking about carbs and calories all the time, and adding alcohol into the mix makes things more complex. ­Experts share their best advice on how to safely drink when living with diabetes.

People who choose to drink alcohol typically do so for a few main reasons: to cope with challenges, to be sociable, or just because they enjoy having a drink. But while alcohol may make some people feel more comfortable, drinking can be especially complicated for people with diabetes. If you’re choosing to drink with friends or loved ones, let’s talk about how you can do so safely with diabetes.

First, alcohol is a drug, and it can be highly addictive. If you don’t drink now, there’s no reason to start. In fact, avoiding alcohol is the healthiest choice for people with or without diabetes. Drinking more than is healthy for the body has been linked to issues in the brain, heart, liver, pancreas, and immune system and is associated with several kinds of cancer, according to the National Institute on Alcohol Abuse and Alcoholism. Drinking is also connected to other health problems, such as unintentional injuries (car accidents, falls, drownings), domestic violence, alcohol use disorders, and fetal alcohol spectrum disorders, per the Centers for Disease Control and Prevention.

So, with all that said, how can you best manage your diabetes if you choose to drink?

What happens in the body when you drink?

Your liver works to create glucose when your blood sugar levels are low, but it also processes any alcohol present in your body, says Sandra Arevalo, a certified diabetes care and education specialist and spokesperson for the Academy of Nutrition and Dietetics. More specifically, “Alcohol gets broken down by your liver. The liver is also in charge of making sugar when your blood sugar levels are low, by converting stored glycogen into glucose, and releasing that glucose into your bloodstream. When you drink, your liver is busy processing the alcohol and has a hard time producing glucose,” she said.

This process “puts people with diabetes at high risk of low blood sugar when they drink,” Arevalo said. “If you are on basal insulin, you may not make enough glucose for the amount of basal insulin you have taken, and you may suffer a hypoglycemic episode.” This applies primarily to people with type 1 diabetes, but people with type 2 diabetes are still at risk for low blood glucose levels when they drink.

What’s in a drink?

That’s a tricky question. What you are drinking and how much of it you choose to drink can make a big difference. Like most things with diabetes, there aren’t simple answers.

According to the CDC, moderate drinking is defined as two drinks or less per day for men, or one drink or less per day for women. The US Dietary Guidelines Advisory Committee recommends one drink or fewer per day for people of any gender. It is illegal for people under 21 to drink alcohol in the United States.

Drinking

Image source: diaTribe

What does the CDC classify as “a drink?” One drink contains 14 grams, or 0.6 ounces, of pure alcohol, which normally equates to 12 ounces of beer, 8 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of hard liquor or spirits such as gin, rum, vodka or whiskey.

What influences your intoxication?

Several factors – including diabetes medications, food, and exercise – can all make things even more complicated, said Carrie S. Swift, a dietician and spokesperson with the Association of Diabetes Care & Education Specialists. “Overall, alcohol intake leads to less predictable blood glucose whether you have type 1 or type 2 diabetes,” she said. But “the impact of alcohol on blood glucose isn’t always the same.”

This can be caused by:

  • Carbohydrate content of drinks: Beer and sweet wines contain a lot of carbohydrates, and can increase your blood sugar level despite the alcohol content. On the other hand, quickly cutting down your intake of these drinks, or quickly making the switch to dry wine or spirits, can carry a high risk of hypoglycemia.
  • Diabetes drugs: Insulin and sulfonylurea medications such as glipizide, glyburide, and glimepiride – all of which help to lower blood glucose levels – “are more likely to cause low blood glucose when alcohol is consumed,” said Swift. Insulin and alcohol work similarly whether you have type 1 or type 2 diabetes. If you take metformin, pay attention to these specific symptoms when you are drinking: weakness, fatigue, slow heart rate, muscle pain, shortness of breath, or dark urine. “Excessive alcohol intake while taking metformin may increase the risk of a rare, but dangerous condition, called lactic acidosis. If you have these symptoms – get medical help right away,” she said. There are no specific or predictable ways that blood glucose levels react when taking other oral diabetes medications or GLP-1 medications, Swift added.
  • Food: “If you drink on an empty stomach, you are more likely to experience hypoglycemia,” said Swift. Yet, eating while drinking “may also increase your blood glucose, especially if you eat more than usual or make less healthy food choices when you drink.”
  • Exercise: If you are physically active either before or after drinking alcohol, it can cause your blood sugars to drop and lead to hypoglycemia.

What and how are you drinking?

If you have diabetes and choose to drink, what should you keep in mind?

  • Alcoholic drinks can have as much added sugar as some desserts, so think about what kinds of drinks you are having. “It’s best not to choose alcohol mixed with punches or soft drink mixers, such as Pepsi, Sprite, or Coke, daiquiris, margaritas, or sweetened liquors like Kahlua or Bailey’s Irish Cream,” said Swift. Regular beer and sweet wines are also higher in carbohydrates. “These drinks not only add carbohydrate, but excess calories from the added sugars,” she said.
  • If you have a continuous glucose monitor (CGM), use it. While you are drinking, you can see where your glucose is at all times and if it drops quickly. If you don’t have a CGM, “test your blood sugar more often,” said Arevalo. “Mainly if you are not feeling well, you want to know if your sugar is dropping, or if you are getting drunk. Even though both feel equally bad, you will want to know if your sugars are low so you can correct them quickly.”
  • Never drink on an empty stomach. Instead, “Have a good meal before or during drinking,” said Arevalo. But know the carb count of what you are eating and work with your healthcare professional to determine how to take medication for that meal along with the alcohol you are consuming.
  • Exercise and alcohol can make your numbers plummet. “Avoid drinking while dancing or exercising,” said Arevalo. “Physical activity helps to reduce blood sugar levels, and if the liver is not able to keep up with the production of glucose, the risk of hypoglycemia is even higher.”
  • Have your supplies handy, such as a hypoglycemia preparedness kit. Always bring your blood glucose testing kit and enough supplies for you to test frequently. It’s a good idea to have extra test strips, alcohol swabs, lancets, as well as fast-acting forms of glucose, including emergency glucagon in case your blood sugar level doesn’t come up with food or glucose.
  •  If you take basal insulin in the evening, it’s not an easy answer on what to do if you plan to consume alcohol that evening, said Swift. “Depending on what type of diabetes the person has, and other factors, the results of drinking and taking a long-acting insulin before going out, may contribute to a different result,” she said. If you have type 1 and you take your usual amount of long-acting insulin and then you drink alcohol, “It may contribute to delayed hypoglycemia when drinking too much alcohol,” she said. If you have type 2 diabetes and are overweight or have significant insulin resistance, “Taking your usual amount of long-acting insulin may be a good strategy to avoid high blood glucose numbers,” she said. “No matter what your type of diabetes, frequent blood glucose checking will help you take the right action to avoid high or low blood glucose when choosing to drink alcohol.”
  • If you use an insulin pump or a CGM, make sure you check that they are working properly before you leave the house, without any low-power indicators. If you need to fill your pump with insulin or change out either your infusion set or CGM sensor, do it before you begin drinking or get drunk. As Dr. Jeremy Pettus and Dr. Steve Edelman say in this video, “Protect yourself from drunk you as much as you possibly can.”

It’s important for everyone to avoid getting drunk to the point of not being able to protect yourself. For people with diabetes, this includes protecting yourself from hypoglycemia.

Navigating social situations

If you find yourself in situations where people around you are drinking, or your friends like to party, there are ways to fit in without feeling left out:

  • “It’s okay to choose sparkling water with lemon or a diet soda instead of an alcoholic drink in a social setting,” said Swift. “If you do choose to drink alcohol, have a glass of water, or another no-calorie beverage between alcohol-containing drinks.” It’s also okay to hold a drink and not consume it, if that makes you more comfortable.
  • Tell a trusted friend ahead of time where you keep your supplies, such as your blood glucose monitor or CGM reader, how to get glucose tabs or juice if you need it, and, if necessary, how to give emergency glucagon, either by injection or by nasal inhalation, said Arevalo. It’s also good to have a designated non-drinker in your group, who can watch out for everyone’s safety. And be sure the group you are with knows that the signs of a low blood sugar and the signs of being drunk are the same, said Swift: slurred speech, blurry vision, dizziness, confusion, lack of coordination, irritability, and potentially, loss of consciousness.
  • Make sure you’re hanging out with people you want to be with, and consider where drinking fits in to your health goals and your life. “Friends are only friends if they accept you the way you are and help to take care of you,” said Arevalo. “If you feel peer-pressured to drink, let them know that you have to take care of yourself because of your diabetes. Good friends will respond in a positive way, and will understand and help you. If you want to have a good time and don’t want to keep an eye on how much you are drinking, alert your friends about your diabetes. Let them know where you have your supplies, how to use them, and who to call and what to do in case of an emergency.” Remember, never drive if you (or your driver) have been drinking.

Finally, if you’re going to drink, be smart about it. Always start with a blood glucose level that’s at a healthy, in-range level, sip—don’t chug—your alcohol, and avoid drinking to excess. Your body, your brain, and your diabetes will all be easier to manage once you’re done drinking, either for the evening, the event, or for good.

About Cheryl

Cheryl Alkon is a seasoned writer and the author of the book Balancing Pregnancy With Pre-Existing Diabetes: Healthy Mom, Healthy Baby. The book has been called “Hands down, the best book on type 1 diabetes and pregnancy, covering all the major issues that women with type 1 face. It provides excellent tips and secrets for achieving the best management” by Gary Scheiner, the author of Think Like A Pancreas. Since 2010, the book has helped countless women around the world conceive, grow and deliver healthy babies while also dealing with diabetes.

Cheryl covers diabetes and other health and medical topics for various print and online clients. She lives in Massachusetts with her family and holds an undergraduate degree from Brandeis University and a graduate degree from the Columbia University Graduate School of Journalism.

She has lived with type 1 diabetes for more than four decades, since being diagnosed in 1977 at age seven.

Source: diabetesdaily.com

Getting Started with Insulin if You Have Type 2 Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Frida Velcani

New to insulin? Learn about insulin dosing and timing and how often to test your blood sugar levels if you have type 2 diabetes.

If you have type 2 diabetes, it is likely that your treatment regimen will change over time as your needs change, and at some point, your healthcare professional may suggest that you start taking insulin. While this might feel scary, there are millions of others living with type 2 diabetes and taking insulin, so it’s definitely manageable.

Click to jump down:

Why do some people with type 2 diabetes need to take insulin?

Type 2 diabetes can progress with time, which means that it gets more difficult for a person’s body to regulate glucose levels. The body’s many cells become less responsive to insulin (called increased insulin resistance), and the specific cells in the pancreas that produce insulin make less of it (called beta cell insufficiency). This is not necessarily related to a person’s diabetes management, and it is likely not possible to prevent.

For many people, adjusting lifestyle factors such as a reduced calorie diet and increased physical activity are key to keeping blood glucose levels stable and in a target range. Healthcare professionals may also recommend that people with type 2 diabetes take additional medications like metforminDPP-4 inhibitorsSGLT-2 inhibitors, or GLP-1 agonists to their treatment plan to improve glucose management, reduce A1C, lose weight, or support heart and kidney health.

When do people with type 2 diabetes start insulin?

After 10 to 20 years, many people with type 2 diabetes will begin insulin therapy, although every person’s journey with type 2 diabetes is different. This happens when lifestyle changes and medications aren’t keeping your glucose levels in your target range. It is important that you start treatment as early as possible to avoid persistent hyperglycemia (high blood sugar), which can lead to long-term health complications affecting your heart, kidneys, eyes, and other organs.

What are the different types of insulin?

The key to transitioning to insulin is knowing your options. Some people taking insulin need to use both a basal (long-acting) and a prandial (rapid-acting or “mealtime”) insulin each day, while others may only need to use basal insulin. Learn about your options here.

  • Basal (long-acting) insulins are designed to be injected once or twice daily to provide a constant background level of insulin throughout the day. Basal insulins help keep blood sugars at a consistent level when you are not eating and through the night but cannot cover carbohydrates (carbs) eaten for meals or snacks or glucose spikes after meals.
    • Some people use other medications, like GLP-1 agonists, to help cover mealtimes. GLP-1/basal combination treatments for people with type 2 diabetes combine basal insulin with GLP-1 agonist medication in one daily injection. This combination can effectively lower glucose levels while reducing weight gain and risk of hypoglycemia (low blood sugar). Learn more here.
  • Prandial (rapid-acting or “mealtime”) insulins are taken before mealtime and act quickly to cover carbohydrates eaten and bring down high sugar levels following meals. Ultra-rapid-acting prandial insulins can act even more rapidly in the body to bring down glucose levels. Rapid and ultra-rapid insulins are also taken to correct high glucose levels when they occur or are still persistent a few hours after a meal.
  • Basal and prandial insulins are both analog insulins, meaning they are slightly different in structure from the insulin naturally produced in the body. Analog insulins have certain characteristics that can be helpful for people with diabetes. Human insulins, on the other hand, were developed first and are identical to those produced by the human body. Human insulins are classified as regular (short-acting insulin) or NPH (intermediate-acting). These are generally cheaper than analog insulins and can be bought without a prescription at some pharmacies.

Although many people use both basal and prandial insulin – which is called multiple daily injections of insulin (MDI) and consists of one or two injections of basal insulin each day as well as prandial insulin at meals – people with type 2 diabetes who are beginning insulin therapy may only need basal insulin to manage their glucose levels. Basal insulin requires fewer injections and generally causes less hypoglycemia. For these reasons, many healthcare professionals recommend basal insulin when you first start insulin therapy.

How do I take and adjust my insulin doses?

It is important to learn the different methods of taking insulin and what kinds of insulin can be delivered through each method. There are several ways to take insulin – syringe, pen, pump, or inhalation – though injection with a syringe is currently the most common for people with type 2 diabetes. There are many apps that can help you calculate your insulin doses.

  • Insulin pens are considered easier and more convenient to use than a vial and syringe. There are different brands and models of insulin pens available. Smart pens are becoming increasingly common and can help people manage insulin dosing and tracking. They connect to your smartphone and help you remember when you took your last dose, how much insulin you took, and when to take your next one.
  • Insulin pumps are attached to your body and can be programmed to administer rapid-acting insulin throughout the day, to cover both basal and prandial insulin needs. When you need to take insulin for meals or to correct high glucose, calculators inside the pump can help determine the correct dosage after you’ve programmed them with your personal insulin pump settings.
  • Inhaled insulin is ultra-rapid acting insulin and can replace insulin used for mealtime and corrections of high glucose. It is taken through an inhaler and works similarly to injected prandial insulin. People with diabetes who do not want to inject prandial insulin might use this, but it’s not for people who only use basal insulin. The only approved inhaled insulin on the market is the ultra-rapid-acting mealtime insulin Afrezza.

Your insulin regimen should be tailored to fit your needs and lifestyle. Adjusting your basal insulin dosage and timing will require conversations and frequent follow-up with your healthcare team. When initiating insulin therapy, you may be advised to start with a low dose and increase the dose in small amounts once or twice a week, based on your fasting glucose levels. People with diabetes should aim to spend as much time as possible with glucose levels between 70-180 mg/dl. Insulin may be used alone or in combination with oral glucose-lowering medications, such as metformin, SGLT-2 inhibitors, or GLP-1 agonists.

One of the most important things to consider is the characteristics of different insulin types. To learn more, read “Introducing the Many Types of Insulin – Is There a Better Option for You?” and discuss with your healthcare team.

In order to dose insulin to cover meals or snacks, you have to take a few factors into consideration. Your healthcare team should help you determine what to consider when calculating an insulin dose. Prandial insulin doses will usually be adjusted based on:

  • Current blood sugar levels. You’ll aim for a “target” blood sugar, and you should know your “sensitivity” per unit of insulin to correct high blood sugar levels.
    • Insulin sensitivity factor (ISF) or correction factor:  how much one unit of insulin is expected to lower blood sugar. For example, if 1 unit of insulin will drop your blood sugar by 25 mg/dl, then your insulin sensitivity factor is 1:25. Your ISF may change throughout the day – for example, many people are more insulin resistant in the morning, which requires a stronger correction factor.
  • Carbohydrate intake. Insulin to carb ratios represent how many grams of carbohydrates are covered by one unit of insulin. You should calculate your carbohydrate consumptions for each meal.
    • Insulin to carbohydrate ratio:  the number of grams of carbs “covered” by one unit of insulin. For example, a 1:10 insulin to carbohydrate ratio means one unit of insulin will cover every 10 grams of carbohydrates that you eat. For a meal with 30 grams of carbohydrates, a bolus calculator will recommend three units of insulin.
  • Physical activity. Adjust insulin doses before, and possibly after, exercise – learn more about managing glucose levels during exercise here.

Learning to adjust your own insulin doses may be overwhelming at first, especially given the many factors that affect your glucose levels. Identifying patterns in your glucose levels throughout the day may help you optimize the timing and dosing of your insulin. Your healthcare professional, a certified diabetes care and education specialist, or insulin pump trainer (if you use a pump), can help guide you through this process. Do not adjust your insulin doses without first talking to your healthcare team.

How often should I test my blood sugar?

The frequency of testing will depend on your health status and activities during the day. Initially, you may be advised to check your blood glucose three to four times a day. As a starting point, check in with your healthcare team about how often to check your blood sugar. Many people test before meals, exercise, bedtime, and one to two hours after meals to ensure that they bolused their insulin correctly. Over time, your fasting, pre-meal, and post-meal blood glucose levels will help you figure out how to adjust your insulin doses.

Continuous glucose monitors (CGM) are particularly useful for tracking changes in glucose levels throughout the day. Some CGM devices also connect with an insulin pump to automatically adjust insulin delivery. After you start a treatment plan, the goal for most people is to spend as much time as possible in their target range. Talk with your healthcare professional about starting CGM and developing glucose targets.

What else do I need to know about taking insulin?

It’s common to experience minimal discomfort from needle injections or skin changes at the insulin injection site. You may also experience side effects of insulin therapy, which can include some weight gain and hypoglycemia. In some people, insulin increases appetite and stops the loss of glucose (and calories) in the urine, which can lead to weight gain. Hypoglycemia can occur if you are not taking the right amount of insulin to cover your carb intake, over-correcting high glucose levels, exercising, or consuming alcohol. Treating hypoglycemia also adds more calories to your daily intake and can further contribute to weight gain. Contact your healthcare professional to adjust your insulin dose if you are experiencing hypoglycemia, or call 911 if you experience more serious side effects, such as severe low blood sugar levels, serious allergic reactions, swelling, or shortness of breath.

Staying in contact with your healthcare team is the best way to make the transition to insulin therapy. Though the first few days or weeks will be challenging, with the right support, you’ll find a diabetes care plan that works for you.

If you were recently diagnosed with type 2 diabetes, check out more resources here.

Source: diabetesdaily.com

The Latest Heart Health and Diabetes Guidelines from the American College of Cardiology

This content originally appeared on diaTribe. Republished with permission.

By Joseph Bell

New SGLT-2 inhibitor and GLP-1 agonist diabetes medication recommendations for people with type 2 diabetes

The American College of Cardiology (ACC) updated its guidance in mid-August for heart health in people with type 2 diabetes. These recommendations are supported by the American Diabetes Association (ADA), and ACC similarly supported ADA’s 2020 Standards of Care for heart disease.

What’s New?

Compared to the 2018 ACC guidelines, the 2020 update gives more attention to preventing diabetes complications, rather than treating them once they have already developed. If a person with type 2 diabetes has heart disease, kidney disease, or heart failure – or is at high risk of heart disease – the ACC recommends discussing SGLT-2 inhibitor or GLP-1 agonist medications with their healthcare professional. Unlike the 2019 European Society of Cardiology guidelines, however, the ACC does not make a specific recommendation about SGLT-2 inhibitors or GLP-1 agonists as first-line drug therapies.

Additionally, in 2018, the ACC recommended Victoza as the preferred GLP-1 agonist and Jardiance as the preferred SGLT-2 inhibitor. However, with abundant clinical research since then, the ACC now recommends additional therapies, all equally:

  • For GLP-1 receptor agonists: TrulicityOzempic (injectable once-weekly GLP-1), and Victoza (once-daily GLP-1). Of these, only Trulicity is recommended for people with multiple risk factors for heart disease. The ACC also suggested that Rybelsus (oral GLP-1) may be included in these recommendations after more research is completed.
  • For SGLT-2 inhibitors: FarxigaInvokana, and Jardiance. The ACC also mentioned the potential heart and kidney benefits of Steglatro, given results from the VERTIS CV study.

Importantly, the ACC noted that starting either an SGLT-2 inhibitor or GLP-1 agonist medication should not be dependent on a person’s A1C levels; rather, it should be based on whether they would benefit from the drugs’ heart and kidney benefits. Many people with diabetes on an SGLT-2 or GLP-1 medication also see weight loss, reduced hypoglycemia, and lower A1C – even though heart health and kidney health are the reason that the therapies are prescribed. The ACC also recommended either drug class on top of existing metformin therapy. We look forward to a future stance on SGLT-2/GLP-1 combination therapy, although no guidance has been provided so far.

The American Heart Association (AHA) just made its own statement on SGTL-2 and GLP-1 inhibitors here – it’s technical language but check out the “Conclusion and Next Steps” section at the end.

Source: diabetesdaily.com

What Are SGLT-2 Inhibitors and How Can They Help Your Heart?

This content originally appeared on diaTribe. Republished with permission.

By Mary Barna Bridgeman

SGLT-2 inhibitors can protect your heart! This type of medicine is recommended for people with type 2 diabetes who have heart disease or risk factors related to heart disease. Learn about the use of these medicines, including side effects, their effect on A1C, and their role in supporting heart health

Diabetes is a risk factor for heart disease: people with diabetes are twice as likely to have heart disease or a stroke compared to those without diabetes. Heart disease is often a “silent” condition, meaning that symptoms are not necessarily present until a heart attack or a stroke actually happens. It is important for people with diabetes to realize they may be at risk – click to read more about the link between diabetes and heart disease from Know Diabetes By Heart.

There are many ways to take care of your heart and to reduce the risk of heart disease while living with diabetes. New medicines, including sodium-glucose cotransport 2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) agonists, have been shown to protect the heart and reduce the risk of many specific heart-related outcomes. This article will focus on SGLT-2 medications, and our next article will focus on GLP-1 medications.

Heart diseases

Image source: diaTribe

Click to view and download diaTribe’s helpful infographic on preventing heart disease.

What are SGLT-2 inhibitors?

There are currently four medicines that are categorized as SGLT-2 inhibitors:

These medicines help people with type 2 diabetes manage their glucose levels: they work in the kidneys to lower sugar levels by increasing the amount of sugar that is passed in the urine. SGLT-2s increase time in range and reduce A1C levels while also lowering blood pressure and supporting weight loss. For people with diabetes who have had a heart attack or are at high risk of heart disease, or who have kidney disease or heart failure, these medicines could be considered regardless of A1C level. While SGLT-2 medications are expensive, some assistance programs are available to help with cost – see one of diaTribe’s most popular articles, “How to Get Diabetes Drugs For Free.”

What do you need to know about SGLT-2 inhibitors?

SGLT-2s have a low risk of causing hypoglycemia (low blood sugar levels). Because they increase sugar in the urine, side effects can include urinary tract infections and genital yeast infections in men and women. Dehydration (loss of fluid) and low blood pressure can also occur. Symptoms of dehydration or low blood pressure may include feeling faint, lightheaded, dizzy, or weak, especially upon standing.

Before starting an SGLT-2 inhibitor, here are some things to discuss with your healthcare team if you have type 2 diabetes:

  • How much water to drink each day
  • Ways to prevent dehydration and what to do if you cannot eat or you experience vomiting or diarrhea (these are conditions that may increase your risk of developing dehydration)
  • Any medicines you take to treat high blood pressure

When prescribed for people with type 2 diabetes, SGLT-2s rarely cause diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition. For people with type 1 diabetes, DKA is a well-known risk when SGLT-2s are prescribed. Call your healthcare professional if you have warning signs of DKA: high levels of ketones in your blood or urine, nausea, vomiting, lack of appetite, abdominal pain, difficulty breathing, confusion, unusual fatigue, or sleepiness. When you are sick, vomiting, have diarrhea, or cannot drink enough fluids, you should follow a sick day plan – see Dr. Fran Kaufman’s article on developing your sick day management plan. Your healthcare professional may instruct you to test your urine or blood ketones and stop taking your medication until symptoms go away.

If you have type 1 diabetes or chronic kidney disease, depending on your level of kidney function, these medicines may not be for you. Additionally, SGLT-2s are associated with increased risk of lower limb amputation.

SGLT-2 inhibitors are usually taken as a pill once a day – often in the morning before breakfast – and can be taken with or without food.

What do SGLT-2 inhibitors have to do with heart health?

Results from clinical studies suggest SGLT-2 inhibitors may play an important role in lowering heart disease risks.

Jardiance was the first SGLT-2 inhibitor to show positive effects on heart health in the EMPA-REG OUTCOME trial. In this study, more than 7,020 adults with type 2 diabetes and a history of heart disease were followed. Participants received standard treatment for reducing heart disease risk – including statin medications, blood pressure-lowering drugs, aspirin, and other medicines – and diabetes care, plus treatment with Jardiance. Over a four-year period, results from the study showed that, compared to placebo (a “nothing” pill), Jardiance led to:

  • a 14% reduction in total cardiovascular events (heart attacks, strokes, heart-related deaths)
  • a 38% reduction in risk of heart-related death
  • a 32% reduction in overall death
  • a 35% reduction in hospitalizations from heart failure

Read diaTribe’s article on the results here.

Similarly, the heart protective effects of Invokana have been shown in two clinical studies, CANVAS and CANVAS-R. These two studies enrolled more than 10,140 adults with type 2 diabetes and a high risk of heart disease, randomly assigned to receive either Invokana or placebo treatment. In the CANVAS studies, treatment with Invokana led to the following:

  • a 14% reduction in total cardiovascular events (heart attacks, strokes, heart-related deaths)
  • a 13% reduction in risk of heart-related death
  • a 13% reduction in overall death
  • a 33% reduction in hospitalizations from heart failure

Read diaTribe’s article on the results here.

Farxiga may also reduce heart disease risks. In the DECLARE-TIMI 58 study, more than 17,000 people with type 2 diabetes received Farxiga; 40% of participants had known heart disease and 60% had risk factors for heart disease. Importantly, more than half of the people included in this study did not have existing heart disease. While Farxiga was not found to significantly reduce total cardiovascular events (heart attacks, strokes, heart-related deaths) compared with placebo, its use did lead to a 17% lower rate of heart-related death or hospitalization for heart failure. Read diaTribe’s article about the results here.

More recently, the DAPA-HF study evaluated the use of Farxiga for treating heart failure or death from heart disease in people with or without type 2 diabetes. The study included more than 4,700 people with heart failure; about 42% of those enrolled had type 2 diabetes. Farxiga was shown to reduce heart-related death or worsening heart failure by 26% compared to placebo, both in people with type 2 diabetes or without diabetes. Learn more about these results here.

All of the available SGLT-2 inhibitors have evidence suggesting benefits of this class of medications for people with established heart failure. Click to read diaTribe’s article on SGLT-2 Steglatro and heart health.

Other possible benefits of SGLT-2 inhibitors

InvokanaFarxiga, and Jardiance have also been shown to reduce the progression of kidney disease. Learn more about diabetes and kidney disease here.

SGLT-2s have been studied in people with type 1 diabetes, but are not yet approved for use by the FDA – you can learn about SGLT-2s for people with type 1 diabetes here.

What’s the bottom line?

You can reduce your risk of heart disease and promote heart health while living with diabetes. You and your healthcare team should develop a personalized plan to determine what ways are best for reducing your risk of heart disease. According to the latest evidence and treatment recommendations, SGLT-2 inhibitors may be most useful for people with type 2 diabetes and heart disease or at high risk of heart disease.

About Mary

Mary Barna Bridgeman, PharmD, BCPS, BCGP is a Clinical Professor at the Ernest Mario School of Pharmacy at Rutgers University. She practices as an Internal Medicine Clinical Pharmacist at Robert Wood Johnson University Hospital in New Brunswick, New Jersey.

This article is part of a series to help people with diabetes learn how to support heart health, made possible in part by the American Heart Association and American Diabetes Association’s Know Diabetes by Heart initiative.

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.

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  • 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!
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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.

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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.

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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.

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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.

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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%.

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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.

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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).

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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:

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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

Rybelsus, the First GLP-1 Pill, Approved for Type 2 Diabetes in Europe

This content originally appeared on diaTribe. Republished with permission.

By Frida Velcani

Rybelsus, a GLP-1 agonist pill already approved in the US, received positive feedback from the European Medicines Agency (EMA) in January and was just approved on Saturday!

In exciting news for the type 2 diabetes community, the first GLP-1 agonist pill for type 2 diabetes has not only been recommended for approval in Europe, it has just been approved by the European Medicines Agency (EMA)! Rybelsus (formerly known as oral semaglutide in clinical trials) is a pill version of Ozempic, a GLP-1 agonist injection for type 2 diabetes. Rybelsus was approved in the US in September 2019, and was met with incredible enthusiasm from the diabetes community, particularly due to its availability and accessibility in the US. For a Rybelsus savings card, text READY to 21848, or go to saveonr.com.

Rybelsus, a once-daily pill, can be taken alone or in combination with other treatments for type 2 diabetes. Currently, GLP-1 agonists in Europe are available only as injections (which, depending on the medication, are taken twice-daily, once-daily, or once-weekly). This approval provides more options for people interested in starting GLP-1 treatment. The EMA approval was great news for giving people more options – the once-weekly injections have also been widely embraced.

The EMA added data to the Rybelsus label confirming that it lowers blood glucose and improves heart health – although it doesn’t say “primary prevention,” the label indicates that heart attacks are prevented in people with and without established heart disease. Clinical trials show that both Rybelsus and Ozempic reduce the risk of heart attack, stroke, and heart-related death. This is important because people with type 2 diabetes are at substantially higher risk of heart disease than those without diabetes. Click here to learn more about the benefits of Rybelsus.

Novo Nordisk has not released information about pricing for Rybelsus in Europe. Our hope is that everyone who can benefit from a GLP-1 agonist will be able to access it as early as possible.

There are more social safety nets in the EU than in the US, and many parts of the EU are more focused on prevention and preparedness than the US, so we have high hopes for accessibility in the EU. The European Society of Cardiology recommends that those with type 2 diabetes begin taking GLP-1 or SGLT-2 medications directly after diagnosis. This is good news for people with type 2 diabetes, as the recommendation should enable greater awareness among healthcare professionals. It will also help the field get less caught up in what has previously been called “clinical inertia.”

If you have type 2 and would like to learn more about a pill that has the benefits of GLP-1 – heart disease prevention, weight loss, lower A1C, and less hypoglycemia (and many experts associate also associate improved time in range with GLP-1) – chat with your doctor or a member of your healthcare team. If you like the idea of a pill, mention Rybelsus, or if you like the idea of a once-weekly injection, mention BydureonOzempic, or Trulicity.

Source: diabetesdaily.com

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