New Therapy to Treat Type 1 Diabetes Rolls Out Clinical Trial

Type 1 diabetes is an autoimmune condition whereby the person’s own immune system attacks the pancreatic cells that produce insulin. Insulin signals for glucose uptake into cells, a carefully regulated and important process, that when disrupted, can lead to an array of health complications, and without treatment, results in death. Many advances in the care of type 1 diabetes have been made in the last century; however, there is no cure for the condition, and patients rely on frequent blood glucose monitoring and insulin injection or infusion therapy to survive.

We have been closely following the work of Dr. Bart Roep and his colleagues at the City of Hope over the last several years. We first spoke to him at the 79th American Diabetes Association (ADA) Scientific Sessions in 2019.

“Dr. Roep has dedicated his professional life to trying to cure type 1 diabetes. Over an almost 30-year career, he has earned numerous prestigious awards and is perhaps most well-known for his work discovering how T-cells recognize specific antigens on beta cells in the context of type 1 diabetes pathogenesis. Currently, he is Chan Soon-Shiong Shapiro Distinguished Chair in Diabetes and the founding chair of the Department of Diabetes Immunology within City of Hope’s Diabetes & Metabolism Research Institute. Dr. Roep is also the director of the Wanek Family Project for Type 1 Diabetes.”

The immune system coordinates defenses against pathogens (like viruses and bacteria) via intricate cross-talk between different immune cells in the body. It is also able to recognize the host (self-tolerance) and under normal circumstances, should not attempt to destroy the person’s own cells (with the exception of special circumstances, like cancerous cells, for instance).

Photo by iStock

For the treatment of autoimmune conditions, like type 1 diabetes, much research is ongoing in an effort to “re-write” some of the “programming” and cellular cross-talk thought to be responsible for autoimmune attack. The “inverse vaccine” for the treatment of type 1 diabetes attempts to do just that in the following process:

  1. Immune cells are taken from patients and “re-educated” in the test tube to improve self- tolerance
  2. These cells are injected back into the patient, in hopes that they will not longer drive autoimmune attack, but rather “educate” the immune system to tolerate the person’s own beta cells

Last year, we reported that the initial safety and tolerability studies appeared promising.

Now, additional clinical trials are poised to begin:

“The vaccine is made using one’s own immune cells (dendritic cells) and a beta cell protein. The vaccine may teach the immune system to stop attacking the beta cells, which may help the beta cells recover and make enough insulin to control blood sugar levels. The vaccine may also help reduce future type 1 diabetes related complications.”

It is a very exciting time for type 1 diabetes as we move from just treating the symptoms to actually trying to stop the disease,” Roep remarked in a recent press release.

What are your thoughts on this research? Would you participate in the trial?

Source: diabetesdaily.com

Type 2 Diabetes and Insulin: What to Expect

Whether you’ve been newly diagnosed or have been living with type 2 diabetes for a long time, you may know that it is often a progressive disease. The longer someone lives with type 2, the more likely they are to need insulin therapy to manage their blood sugars. Often, but not always, people with type 2 diabetes start the management of their condition with exercise and diet alone, and then may progress to oral medications like Metformin, before finally (over the course of months or even years) requiring insulin to manage their blood sugar levels.

If this happens, you and your doctor will need to come up with a new treatment plan. But what can you expect? This article will describe what will and what won’t happen, and how to prepare when adding insulin therapy to your diabetes management.

There Is No Need to Panic

It’s important to remember that you haven’t done anything wrong if you get to a point where you need insulin therapy. Physicians used to prescribe insulin to people with type 2 diabetes as a last resort, but in recent years are prescribing it much sooner, due to the benefits of more stringent blood sugar management to prevent complications.

Since type 2 diabetes is often a progressive disease, many with the condition will require insulin at some point. You didn’t fail at diabetes management, and insulin is no punishment. Adding insulin therapy to your management toolkit is just another way to better meet HbA1c goals, enjoy better blood sugars, improve your quality of life, and even extend your life. Embrace it!

Insulin Does Not Inherently Make You Gain Weight

There is a common myth that insulin makes you gain weight. And this line of thinking is simply false. Here’s the connection between insulin and weight gain: When you take insulin, glucose from food is better able to enter your cells, making your blood sugar level drop. But if you take in more calories (eat more) than you need, your cells will also get more glucose than they need, and anything extra is stored as fat.

But this is obvious: the same process happens to people who do not have diabetes. People also believe that insulin causes weight gain because at diagnosis, people might be underweight (as a symptom of the disease), and finally getting the insulin they need into their bodies makes them gain the much-needed weight back. There are many side effects of insulin, but if you eat right, exercise, and take it as prescribed, extra weight gain is not one of them.

You Will Experience More Low Blood Sugars

One well-known and common side effect of insulin, however, is hypoglycemia. If you’ve traditionally managed your diabetes with exercise and diet alone, you may have rarely, if ever, experienced low blood sugar. Even oral diabetes medications, such as Metformin, rarely cause low blood sugars when taken on their own, but insulin is a whole different story.

You will need to work with your doctor to fine-tune your management, so you are able to take enough insulin to manage high blood sugars, while not taking too much where you will drop too low. It is a learning process, and it will take time.

Be better prepared by always carrying a snack on you, and making sure to check your blood sugar more often to prevent lows. Symptoms of low blood sugar include:

  • Dizziness
  • Slurred speech
  • Confusion
  • Extreme fatigue
  • Sweating
  • Rapid heartbeat

Symptoms of severe low blood sugar include:

  • Seizure
  • Loss of consciousness

Severe low blood sugar always requires immediate emergency medical attention and 911 should be contacted right away. Ask you doctor about a prescription for Glucagon,  an emergency injection that can be used to bring blood glucose levels up in case of an emergency.

Your Medical Bills Will Go Up

Diabetes is a costly disease, as of 2017, was the most expensive chronic disease in the United States, costing over $327 billion dollars per year. While diet, exercise, and even oral diabetes medications are cheaper ways to manage type 2 diabetes, insulin is one of the most expensive chronic disease medications on the market in the United States, averaging around $285 per vial.

Be prepared for higher costs at the pharmacy counter, especially if your physician prescribes you fast-acting, analog insulins like Humalog, Novolog, or Fiasp. Cheaper, human-insulins are available over the counter at places like Walmart, although they are much slower-acting, are much older, and their efficacy may not be as good as modern insulins.

Make sure to sign up for health insurance, and make sure your insurance plan will cover prescription insulin at a decent out-of-pocket cost. See if you are eligible for Medicaid or Medicare for more affordable coverage.

If available, make sure to take advantage of your employer’s Health Savings Account (HSA) and work with your doctor to make sure you have been prescribed insulin that you can comfortably afford for the long-haul. More resources for affording insulin can be found here.

You Will Need Additional Support

Adding insulin therapy to your diabetes management is a big decision. You will need extra emotional, mental, and even physical support during this time. Insulin therapy is expensive, and the toll of managing low blood sugars for the first time can be tough. Insulin injections can sometimes hurt, finding new injection sites can be hard without a second set of eyes, counting carbohydrates more closely is time-consuming, and fighting off stigma and shame is real and can be hard on everyone. It is a big adjustment.

Getting support from family and friends, joining a diabetes support group, or simply becoming more engaged in the diabetes community can really help during this time. Make sure to enlist friends and family to help you, and be open and honest with them about your worries and struggles. Adding insulin therapy to your management is meant to help, not hurt, but it’s easier when you’re not doing it alone.

Insulin Can Improve the Quality of Your Life

When taking insulin, it is crucial that you work with your doctor and follow your treatment plan to better meet your health goals. The transition from managing with diet and exercise alone or solely taking oral medications to insulin therapy can be challenging, but with a growth mindset and preparation for what lies ahead, you can thrive on insulin therapy and vastly improve the quality of your life.

Source: diabetesdaily.com

Virta Health: An Unparalleled Leader in Reversing Type 2 Diabetes

Type 2 diabetes is a condition characterized by high blood glucose levels due to the inability to effectively utilize insulin (insulin resistance). It is well-known that it is often possible to reverse type 2 diabetes by adjusting lifestyle factors, in particular, through dietary changes and sustained weight loss. However, many patients are not able to achieve this.

Virta is a company that was founded in 2014 and has made it their mission to help people reverse their type 2 diabetes. In their program, “most patients achieve blood sugar control while removing medications like insulin, often in a matter of weeks.”

The program centers around utilizing a very low-carbohydrate (ketogenic) diet, tailored specifically to meet each patient’s need. The dietary change can help facilitate both weight loss, and improve blood glucose levels, often quickly, allowing for discontinuation of various blood glucose medications under medical supervision.

In addition to a health coach”, blood sugar testing supplies, a “smart scale”, the company offers a variety of educational resources, community engagement among patients, and personalized advice provided by medical experts.

“Powered by technology and data science, physicians and nurses provide expert medical care, when and where patients need it, via Virta’s custom-designed app medical records system.”

One of the main reasons that a very low-carbohydrate diet can work so well for many people with diabetes is depicted below.

Photo credit: Virta Health

In fact, a very low-carbohydrate approach as an integral part of diabetes management is becoming more and more accepted and recommended by medical professionals and health organizations. Learn more about the most recent research and recommendations about low carb for diabetes here:

Low-Carb for Type 1 Diabetes

Low-Carb for Type 2 Diabetes

Low-Carb for Pre-Diabetes

Check out some of the very impressive Virta clinical study outcomes in patients who utilize the program:

Additionally, the researchers noted weight loss as a “side-benefit”, with patients losing an average of 30 lbs., or 12% of their body weight, a clinically-significant result that was maintained at the one-year mark since the start of the trial. Even more strikingly, participants experienced significant cardiovascular disease risk reduction, lower blood pressure levels, lower levels of inflammation, and lower risk for fatty liver disease.

Of course, all these health improvements also translate to cost savings for both patients and health insurance providers. Many employers and health plans are now working with Virta to increase patient access to this treatment approach. To get started, you can fill out a short form to schedule a free call to determine the next steps in the process.

With superior success to a traditional diabetes care approach already established, Virta aims to continue to broaden its reach with the challenging and very admirable goal of “reversing type 2 diabetes in 100 million people by 2025.

Have you heard of or participated in this program? What are your thoughts on carbohydrate restriction as a primary means to achieve weight loss and tighter blood sugar management? Please share your thoughts in the comments below!

Source: diabetesdaily.com

Great News: Trials Show Some Diabetes Drugs Can Actually Protect Your Kidneys

This content originally appeared on diaTribe. Republished with permission.

By Matthew Garza, Eliza Skoler, and Rhea Teng

More people with diabetes are taking drugs like Jardiance and Farxiga, originally developed to lower glucose in people with type 2 diabetes, because the latest data confirms that these drugs can protect your kidneys. A therapy still under investigation, finerenone, has been developed to protect the kidneys of people with and without diabetes

Recent research is showing that certain drugs can benefit your kidneys if you have type 2 diabetes. Diabetes is the leading cause of chronic kidney disease (CKD), and many people don’t receive adequate treatment for this condition, so advancements in therapy to treat and prevent kidney disease are important for the 800 million people worldwide who live with chronic kidney disease. We bring you some of the newest findings on finerenone, Jardiance, and Farxiga – three medications that have been shown to protect the kidneys in people with decreased kidney function, including those with diabetes and CKD.

Note: The latest results on Jardiance and Farxiga confirm earlier findings on two other SGLT-2 inhibitors – Invokana and Steglatro – which clearly show the kidney and heart benefits of this class of medication. As a result, SGLT-2 inhibitors are recommended for treating kidney disease in many people with diabetes. SGLT-2 inhibitors were a focus of the recent American Society of Nephrology’s virtual kidney conference. As research has shown an increased number of benefits of these medications – in terms of glucose levels, weight loss, hypoglycemia reduction, and heart and kidney health – new guidelines have rapidly developed (since 2013) for the use of these drugs in people with type 2 diabetes. And, in the case of Farxiga, SGLT-2s can also protect the kidneys in people without diabetes.

Finerenone

Finerenone is currently being tested to treat CKD in people with type 2 diabetes – it’s a new type of drug (called a non-steroidal MR antagonist) that interferes with the receptors that cause kidney cells to retain, or hold onto, excess salt and water. In the FIDELIO-DKD trial, almost 6,000 people with type 2 diabetes and kidney disease received either finerenone or placebo (a “nothing” pill) and were enrolled in the study for over two and a half years. The results from the trial demonstrated the benefits of finerenone:

  • Finerenone significantly reduced the risk of severe kidney outcomes by 18% over two and a half years.
  • Finerenone reduced the risk of severe heart outcomes by 14%, compared to the placebo.

The FIDELIO-DKD trial showed this medication to be helpful for people with type 2 diabetes. Given these positive results, finerenone has been submitted to the FDA and the European Medicines Agency for approval as a CKD treatment option for people with type 2 diabetes.

Jardiance

New findings from the EMPEROR-Reduced trial showed that Jardiance, an SGLT-2 inhibitor, improved heart and kidney outcomes in adults with heart failure with reduced ejection fraction (HFrEF, or a reduced ability to pump blood out of the heart), regardless of whether they had chronic kidney disease at the start of the trial. Of the 3,730 people enrolled in the trial – with or without type 2 diabetes – participants taking Jardiance showed:

  • A 22% reduced risk for severe heart outcomes among people with CKD, and a 28% reduced risk in those without CKD.
  • A 47% reduced risk for severe kidney outcomes in those with CKD, and a 54% reduced risk in those without CKD.

The variation in risk reduction was determined to be due to chance, rather than a difference in health outcomes between people with and without CKD. These results show that even though CKD increases a person’s risk for heart issues, Jardiance lowered that risk to the level of people without CKD.

Farxiga

New analysis of the DAPA-CKD trial found that Farxiga, another SGLT-2 inhibitor, protects the kidneys regardless of the cause of kidney disease, in people with or without type 2 diabetes. This builds on the positive results presented earlier this year on Farxiga’s ability to treat people with heart disease and CKD.

Why is this important?

More than 800 million people around the world live with chronic kidney disease, including 45 million people in the US (almost 14% of the US population). The need for effective medications that work for everyone, including those with or without diabetes, is high. Treatment with SGLT-2 inhibitors – or non-steroidal MR antagonists – could be key to helping these people.

Organizations like the American Diabetes Association and the European Association for the Study of Diabetes now recommend that people with type 2 diabetes and kidney issues be treated with SGLT-2 inhibitors or GLP-1 agonist medications. If you have diabetes or kidney disease, talk with your healthcare team about which of these treatment options may be helpful for you.

It’s important to catch kidney disease early so that it can be treated. If you have diabetes, ask your healthcare team to test your kidney function every year. To learn more about preventing kidney disease, view diaTribe’s helpful infographic. You can also read about UACR and eGFR, the two lab tests that are commonly used to evaluate kidney health.

Source: diabetesdaily.com

Injection Device Helping a Family Manage New Diabetes Diagnosis During COVID

Injection Port Device Help Family Whose Son Lives with Diabetes

Jennifer, like many others, has worried about her family’s health during the coronavirus pandemic.

In June, she was diagnosed with COVID-19. Shortly after, her 13-year old son Mason started feeling ill. Unsure if he too had contracted the virus, they visited their local emergency room. Soon after, the family was informed that Mason was living with type 1 diabetes. In this post, Jennifer discusses her family’s experience and the ways they are managing Mason’s diabetes during the global pandemic.

Mason came to me and said he didn’t feel right. Upset tummy, sinus issues, and a small headache. We took him to a local emergency room, and sure enough his rapid test was positive for COVID-19. The doctors also said that his sugar was pretty high. They asked if I could watch his levels at home over the next couple of days and if his sugars remained high, then I should call our family doctor. We left the ER on Tuesday evening. By Thursday, I called our doctor because his sugars never went below 200 mg/dL. We were put in touch with an endocrinologist, who advised us to take him to the hospital where he was diagnosed with diabetes. 

As a parent, all fears set in. I was worried that I didn’t know enough about diet and medication. I worried about if my son would ever feel normal again.

I was surprised that Mason was able to start giving his own insulin almost immediately, and he preferred it that way. In the three months since he was diagnosed, I have probably only given 10 shots! 

I was introduced to the i-Port Advance™ injection port through a Facebook page. I posted that we were having issues with him taking too much insulin before meals, and then he was too full to finish what he had dosed for. Several parents came back and suggested we try an injection port! I called my doctor’s office the next day and they were super excited to let him try it.

Almost immediately, Medtronic sent us a box of the i-Port Advance™ injection port to try at no-cost. I could not express my happiness! I was thankful the company was willing to let us try the port before we purchased. As a parent, this was such an amazing feeling and it was one of the first easy experiences we had since Mason was diagnosed! 

Mason fell in love with the injection port, and so did I! When he used the port, it was the first time since he was diagnosed that he didn’t feel like an outcast. Although he is incredibly diligent with what he eats and doesn’t take advantage of his insulin, he is a kid! He wants little treats, he wants to hang out with friends his age, and eat cupcake or have snow cones from time to time. All of which he had stopped because he hated sticking himself all the time and taking shots in front of people. Now, he can take a little extra insulin if he needs to. He can hang out with friends and not feel like an outsider because he can’t eat what they do! I’m also happy because he is building up less scar tissue with 1 stick every 3 days compared to 12-15 injections.

As a parent, I’ve been so happy to watch his outlook change. He knows that he can manage this disease and he isn’t constantly worried with taking another shot! 

Mason’s family enrolled in the 12-day evaluation program offered by Medtronic. To learn more, click below.

GET STARTED

The testimonial above relates an account of an individual’s experience using a Medtronic device. The account is genuine, typical and documented. However, this individual’s experience does not provide any indication, guide, warranty or guarantee as to the response or experience other people may have using the device. The experience other individuals have with the device could be different. Experiences can and do vary. Please talk to your doctor about your condition and the risks and benefits of Medtronic devices.

Safety Information: i-Port Advance injection port

i-Port Advance injection port is indicated for patients who administer or receive multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple injections without the discomfort of additional needle sticks. i-Port Advance injection port may be used on a wide range of patients, including adults and children. For more, please see http://www.medtronicdiabetes.com/important-safety-information.

Source: diabetesdaily.com

Marijuana as a Treatment for Neuropathy: Emerging Evidence

Marijuana, or cannabis, has a long history of human use. Although it remains federally illegal, many states have opened the door to medical, and even recreational use legislation. Notably, more and more research studies are being conducted on the medicinal properties of cannabis, and a growing body of evidence now supports the relevance and efficacy of this plant and its compounds in the treatment of various health conditions.

Here, I focus on a common diabetes complication, peripheral neuropathy, and the emerging scientific evidence for the use of marijuana to reduce pain associated with this condition. If you want to learn more about marijuana and diabetes in general, please check out our recently updated and comprehensive resource:

Marijuana and Diabetes: What You Need to Know

What is Neuropathy?

Over time, high blood glucose levels can damage blood vessels and affect nerve function. A common complication of long-standing diabetes, especially for those who have chronically high blood glucose levels, is neuropathy. Neuropathy occurs due to nerve damage from high blood glucose levels and patients often experience numbness, tingling, and pain (most often occurring in the legs and feet).

Common treatment strategies include optimizing glycemic management to help prevent disease progression, as well as pain management with medications like Lyrica (pregabalin), Neurontin (gabapentin), and sometimes with certain antidepressants.

Research Shows Cannabis Is a Promising Treatment

Recent research points to the potential benefits of cannabis for the treatment of peripheral neuropathy pain. According to Way of Leaf, nine states – Arkansas, Connecticut, Missouri, Montana, New Mexico, New York, North Dakota, Pennsylvania, and West Virginia – already list neuropathies as a “qualifying condition” for medical marijuana use.

Experts say that there is now “substantial evidence” that cannabis is effective in treating chronic pain. So far, at least three studies have evaluated the efficacy in the treatment of diabetic peripheral neuropathy.

For example, one preliminary randomized clinical trial conducted in 2015 identified a “dose-dependent reduction in diabetic peripheral neuropathy pain” in patients whose pain was not alleviated by other treatment strategies. This study focused on the effects of inhaled cannabis. Interestingly, another clinical trial that evaluated the efficacy of Sativex, an oral spay containing cannabis-derived ingredients (THC and CBD), did not find a significant improvement in pain reduction as compared to the placebo arm in their analysis.

It is possible that there are additional compounds that contribute or synergize with the known active compounds to deliver the therapeutic effects. Experts explain:

“Currently, there is a debate about the so-called “entourage effect” which refers to the idea that compounds other than cannabinoids in marijuana (i.e. terpenes and flavonoids) are important in its therapeutic effects. This idea has wide lay-popularity, but little scientific evidence to support it.”

Overall, while more research is needed, there is increasing evidence that cannabis can be useful for treating neuropathic pain:

“The scientific literature demonstrates some efficacy of medical marijuana/cannabis in the treatment of chronic neuropathic pain. Clinical trials of different routes of administration (sublingual, oral, smoked, and vaporized) have demonstrated analgesic benefit in the treatment of this costly and disabling condition and some treatment guidelines for neuropathic pain recommend consideration of cannabinoids as a second or third line agent.”

They also note the potential financial challenges that may come with using cannabis to treat neuropathy:

“As expenses for medical marijuana are not covered by health plans and are out-of-pocket, knowing the cost-effectiveness of medical marijuana may impact patients’ decisions regarding its use. Based on a recent published article, inhaled cannabis appears to be cost-effective when used as second or third-line treatment in chronic neuropathic pain.”

Summary

The medicinal properties of cannabis have been described for thousands of years, and now more and more modern research study outcomes suggest that cannabis and cannabis-based treatments are effective and well-tolerated for a variety of ailments. So far, several studies have shown that cannabis-based treatment approaches for neuropathy are effective, although additional investigation is warranted.

What do you think? Please share your thoughts on your experiences with neuropathy in the comments below. Have you tried or considered using this type of alternative treatment?

References

Heimerl K; “Medical Marijuana and Cannabidiol (CBD): Perception vs Facts” (2019) American Academy of Osteopathy (OMED 2019) http://files.academyofosteopathy.org/CME/OMED2019/Heimerl_MedicalMarijuana.pdf

Mechtler L, Ralyea C, Hart P, Bargnes V; “Medical Cannabis in the Treatment of Neuropathy” (2020) Neurology, 94(15S). https://n.neurology.org/content/94/15_Supplement/5020

Nemergut G; Marijuana (2019) Pain, pp. 315-319. https://link.springer.com/chapter/10.1007/978-3-319-99124-5_69#enumeration

Robinson-Papp J. and Dehbashi S; “Medical Marijuana for Peripheral Neuropathy” (2019) Neuropathy Hope Newsletter, Western Neuropathy Association. P.1 https://pnhelp.org/application/files/1415/6081/5051/WNAENews0719L.pdf

Wallace MS, Marcotte TD, Umlauf A; “Efficacy of Inhaled Cannabis on Painful Diabetic Neuropathy” (2015) Journal of Pain 16(7): 616-627. https://pubmed.ncbi.nlm.nih.gov/25843054/

Source: diabetesdaily.com

The Future of Insulin Therapy: New Tech For Better Outcomes

Advances in insulin types and delivery systems over the last few decades have aimed to improve blood glucose management and quality of life for people with diabetes. From improvements to insulin pumps and continuous glucose monitoring (CGM) systems, to new insulin formulations, and automation of insulin delivery, the technological developments in the diabetes world have been numerous and fast-paced.

What other new products and technologies can we expect in the future? The medical company Thermalin has many exciting ideas and ongoing developments on the horizon.

Thermalin was started approximately ten years ago by Michael Weiss, MD, PhD, Distinguished Professor and Chair of The Department of Biochemistry & Molecular Biology at the Indiana University School of Medicine. Dr. Weiss has decades of experience, and an extensive publication record, with a particular focus in insulin physiology. One of the primary goals of his company is to develop “new forms of insulin that will lower the burden of insulin use, increase patient adoption of and adherence to insulin therapy, improve patient lives and outcomes, and lower the cost.”

Products in Development

At this time, researchers are investigating several approaches that aim to lessen the burden of insulin therapy and improve outcomes. Some of the potential products and technologies they are working on include:

  • Small insulin pumps that will be about one-fourth the size of what is currently available. They are expected to have broad compatibility with a variety of smart devices and integrate with CGMs. Moreover, the pumps will come pre-filled and is expected to last for up to one week. Excitingly, a prototype has already been developed.
  • A variety of stable insulin preparations (no need for refrigeration). In particular, efforts on ultra-rapid and concentrated insulins are ongoing, with several products poised to begin clinical trials soon.
  • “Smart” basal insulin that will respond to changes in blood glucose levels. This product is still early in the stages of development.

Thermalin has recently announced that they received a grant from the NIH that should enable them to move forward with one of their ultra-rapid insulin candidates. Importantly, the development and approval of temperature-stable insulin will also allow for improvements to insulin pump technologies. Devices could then come pre-filled, and users could enjoy longer wear time without worrying about insulin integrity.

Altogether, temperature-stable insulin analog, along with smaller pumps that are technologically advanced but also less burdensome to wear, may help patients view pump therapy more favorably. The company points out a particular population that may benefit on their website:

“Many patients prefer to inject themselves privately before meals rather than wear a visible stigma of their disease. Good treatment habits are frequently developed in childhood but too often are lost in the teenage years; for body-conscious teenagers, a pump that is too visible just won’t be used. This means many patients will not adopt the new, automated pumps that can significantly improve blood sugar control.”

They also note the importance of shelf-stable insulin, and particularly in the developing world:

“In many parts of the developing world, patients do not have refrigerators and live long distances from clinics. Further, many of these clinics are not well served by “cold chain” distribution.  This means these patients do not have a reliable supply of needed insulin.”

We will continue to follow the development of these new products and update you as they begin to progress through clinical trials.

What do you think about these advances? What would you like to see come about in diabetes technology in the next decade? Please share your thoughts in the comments; we love hearing from our readers!

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

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

This content originally appeared on diaTribe. Republished with permission.

By Karena Yan and Joseph Bell

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

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

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

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

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

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

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

Source: diabetesdaily.com

Peripheral Artery Disease: Know Your Alternatives to Lower Leg Amputation

By Dr. Albert Chun, MD MBA, Managing Physician at Modern Vascular

Not long ago, a man, only 49 years old, was referred to us; he had already lost toes to amputation and just a week earlier, he was told he was also facing the amputation of his lower leg. He kept his leg, and today he is walking around, driving his car, and living his life in a way that the would have affected greatly.

This man was suffering from Peripheral Artery Disease (PAD), a circulatory ailment that affects as many as 12 million Americans; type 2 diabetes is one of the leading risk factors for PAD. This man’s story is not an isolated one; we see many just like this every month. What saved his leg was a minimally invasive outpatient procedure that is becoming a standard treatment option for PAD sufferers and their physicians to consider.

What Is PAD?

September is PAD Awareness Month, and while we have had much success saving limbs and restoring hope to hundreds of PAD sufferers, we still have work to do to raise awareness of this solution. What is PAD, specifically? It is the narrowing of peripheral arteries due to atherosclerosis (plaque buildup on arterial walls), decreasing blood flow to legs, feet, and toes. Left untreated, PAD complications include critical limb ischemia, gangrene, and amputation.

Aside from type 2 diabetes, risk factors that greatly increase the likelihood of developing PAD include increasing age, obesity, high blood pressure, high cholesterol, and smoking. In addition, PAD is more prevalent in African American and Native American populations.

Treatment: An Alternative to Amputation

While many PAD cases have traditionally resulted in amputation below the knee, new therapies are preventing that, giving patients a pathway that keeps them whole. Interventional Radiology is a minimally invasive, image-guided endoscopic procedure to treat vascular disease, down to the toe. These treatments pose minimal risk to the patient, reduce recovery time and lower costs versus Open Vascular Surgery. Who performs these procedures? Interventional Radiologists are medical doctors with 6 or 7 years of additional training following medical school. We are certified in both Diagnostic Radiology and Endovascular Procedures.

Endovascular Procedures differ from Open Vascular Surgeries in the following ways:

  • They are conducted in dedicated out-patient clinics rather than in a hospital setting
  • The procedures are minimally invasive procedures, vs open surgery performed by Vascular Surgeons
  • They tend to be shorter and have reduced recovery time, usually discharging the patient on the same day
  • They use moderate sedation or local anesthesia of patients while Open Vascular Surgeries often require general anesthesia

Both Interventional Radiologists and Vascular Surgeons have long-term patient relationships and will continue to see patients for follow-up care after treatment. Modern Vascular patients may follow up with their Interventional Radiology physician for follow up care 2-4 times per year.

Procedure Room Modern Vascular

A glance inside one of the procedure rooms | Photo credit: Dr. Albert Chun, M.D., M.B.A.

What You Should Do

For anyone at risk, particularly those with type 2 diabetes, there are a number of things you can do:

  • The ADA recommends that if you have diabetes and you are over 50, you should proactively get a screening test, such as a pulse check or ultrasound, to monitor for problems early.
  • Have periodic foot care at least once a year, to ensure you are not developing ulcers; often, people with diabetes will suffer from ulcers or other lower leg injuries without feeling them, and will not catch them until it’s too late- sometimes weeks later.
  • If PAD symptoms worsen to the point that amputation is recommended, ask your doctor about Interventional Radiology as an option.

There is a role for active surveillance for people in all risk categories, but people with type 2 diabetes, in particular, should be vigilant for symptoms. The good news is that if PAD symptoms do arise, there are real alternatives to amputation. For many, like the 49-year-old man I described above, PAD is not the end of life as they knew it – not anymore.

About the Author

Dr. Albert Chun, MD MBA, is a Vascular Interventional Radiologist and the Managing Physician at Modern Vascular in Fairfax. Dr. Chun is a board certified Vascular and Interventional Radiology specialist. He has been in practice for 15 years and previously served as Instructor of Radiology at Harvard University and Assistant Professor of Radiology and Surgery at George Washington University.

Source: diabetesdaily.com

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