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

Insulin Pump Therapy for Those Living with Type 2 Diabetes: Doris’s Story



LEARN MORE ABOUT THE MINIMED™ 630G SYSTEM

My name is Doris, and I am a wife, small business owner, volunteer and an Assistant Director at a non-profit agency. I’m always busy, which is why some are surprised that I also live with type 2 diabetes. Managing my diabetes hasn’t always been easy. In reading my story, I hope you can take away some of the lessons that it took me years to learn.

20 years ago, I noticed that I was feeling sick each morning and it was a struggle to get myself together. One morning, I arrived at work and was extremely tired and nauseous. A co-worker took me to the emergency room where I was diagnosed with type 2 diabetes. I was in my thirties then. At the time, I was dealing with other health challenges as well. Adding this serious disease to an already full plate was overwhelming to say the least. I knew very little about type 2 diabetes. I thought that diabetes was common and I could handle it, so I wasn’t really too worried. In my naivety, I thought if I just took the medication prescribed for me and avoided sugar, I would be just fine. Boy was I wrong! I learned very quickly that I needed to educate myself about the disease, causes, symptoms, treatments, and find a specialist.

I have been living with type 2 diabetes for over twenty years now. I have had so many changes in my drug therapy regimen, I can’t count. No matter what combination of medications and insulin I took, or changes I made to my diet or exercise, my A1C levels would not stay consistently at or below 7. I have been hospitalized twice due to elevated blood sugar levels. I even sought help from diabetes specialists, but I still wasn’t able to get control of my blood sugar the way I wanted. Throughout the years, I really struggled with always being tired and listless. Some days I couldn’t even make it out of bed. It was a struggle being able to do activities. My family and friends thought I was being lazy or anti-social because I would pass on so many events. They did not understand how I was being affected.

About 4 years ago, I had to change my primary doctor because of insurance coverage. The process of having to find a new doctor was always exasperating to me because I wanted to find someone that was truly solutions-based and took time with their patients. I ended up finding a family practice doctor near my home. I liked the fact that she was always very candid with me about my out of control blood sugar levels, high A1C, and the other medical complications I was dealing with due to type 2 diabetes. She was increasingly concerned as the test results showed that I was heading toward serious complications with my kidneys. One day, I visited her office to review my test results, and we had a serious discussion on what my prognosis looked like. She felt it was important to discuss my options. I began crying because I felt so defeated and helpless. She spoke to me about insulin pump therapy. I knew very little about it. I thought it was only offered to patients that have type 1 diabetes. She gave me some literature and told me to think about it and let her know if I wanted to pursue it further. I went home and discussed it with my husband and other family members. I was depressed about the situation because the quality of my life looked bleak. I did some research on insulin pump therapy but couldn’t find much information about it or how it was used with type 2 diabetes patients.  I called my doctor and asked her to give me some more details of what the therapy consisted of. My level of apprehension was pretty high at this point, so she scheduled some time for me to meet with a nurse who specialized in insulin pump therapy.

I spoke to Shelly, a nurse from Medtronic, who was able to give me better insight into what the therapy would involve and how I could benefit from it. Her knowledge about the therapy, the disease, and her willingness to answer what felt like a million of my questions gave me some hope. After that conversation and further research, I knew that I had to try insulin pump therapy. I put my initial skepticism away and without further hesitation, I told my doctor to sign me up.

When my MiniMedTM 630G pump arrived, I met with Shelly for my product training. I initially thought it was complicated. There were too many parts and too many steps for me to get this right! I became nervous, but I knew how important it was for me. I took a deep breath, concentrated, and with Shelly’s guidance, was able to successfully start insulin pump therapy. I still had a lot of questions concerning the pump. Shelly’s number was on speed dial for a while. The more I used the pump, the more my confidence with handling the pump grew. I was so amazed at this technology and how the device could adapt to my changing needs.

After a month of using the pump, my blood tests results came back and I was ecstatic. My A1C level had dropped and I was seeing much better blood sugar levels. I do the happy dance every time I get a blood sugar level under 100.

I have been using the pump for over 3 years, and have had such a positive experience using the pump. I can’t believe the difference it has made in my live. Most notable to me is more energy— I don’t feel tired and sluggish anymore. I’m able to be more active and participate more in daily activities. When it comes to my blood sugar levels, they are more stable now and my A1C level is at 7.1! I could have never imagined that happening before.

I am no longer a home body either. I am always busy, on the go, and wanting to do more. I look at my life 3 years ago and I was facing a totally different scenario. Things that I had put on hold, I am now pursuing. Using the pump has changed my life drastically. I no longer see just dark days ahead of me— I see the chance to live my best life. I get so emotional when I speak about my experience with the pump. It’s motivated me to figure out what I could be doing to help others. I believe in the product so much that I signed up to be an Ambassador for Medtronic, so I can share my journey with others.

As I reflect on my experiences researching and ultimately using the pump, one of my major takeaways is that you must be committed and dedicated to the process. Although I have certainly grown accustomed to using the pump, it was a bit of a struggle for the first few months. Even now, I have to always remember small things like having additional batteries and pump supplies on hand. In addition, I plan my schedule to ensure that I can continuously use the therapy, even when I travel.

Another takeaway is that it’s important to talk with someone that’s living with type 2 diabetes and using insulin pump therapy. Although I received excellent information form the nurse, nothing beats speaking to someone who has firsthand knowledge.

Finally, be proactive and learn about the coverage that your medical insurance provides when it comes to the cost of the pump and the supplies.

Overall, my experience using insulin pump therapy as a diabetes management tool has definitely benefitted me and what I do in my life. Things don’t always happen the way you plan them, but when you have the right information and know where to go to find answers, your possibilities keep growing and for that I am thankful!

LEARN MORE ABOUT THE MINIMED™ 630G SYSTEM

The testimonial above relates an account of an individual’s experience with 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.

Important Safety Information: MiniMed 630G System with SmartGuard Technology

Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Both systems require a prescription. Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick using a CONTOUR®NEXT LINK 2.4 meter is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK 2.4 meter, to ensure the glucose result shown agrees with the glucose results shown on the meter. Do not calibrate your CGM device or calculate a bolus using a result taken from an Alternative Site (palm) or a result from a control solution test. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. The MiniMed™ 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

WARNING: The SmartGuard™ Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again, resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard™ feature, it is important to read the SmartGuard™ feature information in the User Guide and discuss proper use of the feature with your healthcare provider.

See www.medtronicdiabetes.com/importantsafetyinformation and the appropriate user guides for additional important details.

Source: diabetesdaily.com

Should You Be Afraid of Insulin?

It’s an all-too-common fear for people with diabetes. There is the completely natural fear of needles, but depending on the messages they’ve received from their care providers along with the experiences with insulin from other people in their family or circle, they can feel like insulin is the last resort or that they’ve failed on everything else. We’ll dive into all of that.

Topics

  • What is insulin
  • Why is it prescribed
  • Common messages and fears
  • Should you be afraid of insulin?

Transcript

Scott K. Johnson – Hey, thanks for tuning in to another episode of Coaches Corner. It is great to see you again. Let me know where you’re watching from today. I’d love to hear that. Post it in the comments. One small way that mySugr is giving back is by hosting the short conversations with our diabetes coaches, to talk about staying healthy in body and mind. We really appreciate you sharing some time with us. Now I do have to give the standard disclaimer. We cannot provide medical advice. Please contact your doctor directly for specific questions about your care. Today my sugar coaches Kristen and Maggie, talk about if insulin is something to be afraid of. Let’s take a look. And hi Maggie. Today we are talking about being afraid of insulin which is something that is quite common, especially for those who are new to diabetes, don’t really understand some of how it all works. But maybe we should start with some of the basics. So what is insulin?

Maggie Evans – Yeah, great, great start. So it is always useful to break down the basics. So we hear in the word insulin quite a bit. So I agree kind of, you know, understanding what that is. Insulin is a hormone that’s created by our pancreas or pancreas, it’s kind of right next to our stomach, and insulin is released in response to a meal. So when we eat a meal that’s broken down, and it tends to raise our blood sugar. So when that blood sugar response increases, that’s when insulin is released into the bloodstream. Now, when we explain the mechanism, mechanism of insulin, it’s helpful to use a term of just like a lock in a key. So imagine there’s a bunch of little locked doors on the outside of a cell, and insulin is that key to unlock the door to allow glucose into the cell. So when glucose is allowed in, that helps us create energy and helps us live our lives and do our thing. So thinking of insulin in that way, that it’s just simply a hormone that our bodies already make, I think can kind of help break down that barrier a little bit more too in terms of if it is something that ends up being prescribed.

Scott K. Johnson – Yeah, great point. So let’s from there, ask the question, why is insulin prescribed? If our body is already making it, what leads us to then need it as far as a prescription?

Kristen Bourque – Yeah, so Scott, I think, when we talk a little bit about first the differences between type one and type two, and we’ll talk more about this in our conversation. But essentially, insulin is provided as a treatment for diabetes. So with type one, our pancreas is no longer producing insulin. So there are multiple types of insulin that are provided to help essentially regulate the blood sugar right? With type two, generally what happens over time is the pancreas produces less insulin. So maybe additional insulin might be needed along with the use of oral medications to help regulate blood sugar.

Scott K. Johnson – And it’s, there’s actually quite a few misconceptions about insulin right? Can we dive into some of those? So especially, and I think this is one that’s, that I hear most common is the feeling of, of being a failure, right? Or the doctor saying, all right, let’s try with type two diabetes, as you mentioned, let’s try this this and this, and there’s always this phrase that if that doesn’t work, then we’ll start on insulin right, so it can be a hard step for people to take.

Kristen Bourque – And I think that you bring up such a great point Scott ’cause unfortunately sometimes we hear this kind of being almost used as a maybe a scare tactics sometimes for patients as well. If you don’t follow this and that insulin will be put on your regimen. And so I think there is a lot of unfortunately, negative kind of connotation around insulin. But the important thing to remember is with type two diabetes especially is over time. Again, as I mentioned, the pancreas produces less insulin, it can be up to 75%. So even if we’re doing, you know, diet, exercise, oral medications, we still might not get those numbers that we’re striving for. So yes, it’s very important to kind of wash away those ideas of feeling inadequate or like a failure because what we’re doing and those behavior changes may only sometimes bring us so far. So this is important to remember, is to rely on your healthcare team to find a way of providing you with various options for medications and whatnot to kind of find the best thing for you and ultimately, our goal is right to manage our blood sugar. So insulin may be put on the table, as just another option for you and it does nothing to mean that you did anything wrong in your management of your diabetes at all.

Maggie Evans – I think also emphasizing the fact that just like everybody’s body is different, everybody’s diabetes is different. And that your management of diabetes is going to look different than your neighbor with diabetes or someone else with diabetes. So recognizing that your body’s response to somethings just like what Kristen said, might be different than other people, and you just might well, need insulin. And yet again, breaking down the barrier to that and just recognizing that it is simply that hormone that we already produce, and sometimes we just need a little extra help along the way.

Scott K. Johnson – I love that. There’s a one of my good friends. His name is Bennet. And he has a catchphrase that he says that your diabetes may vary. And it really what it comes down to is right, whatever it takes to manage your blood sugars in a way that works for you. And so you’re able to meet your diabetes management goals, and also your quality of life goals. And it’s different for everybody. So I’m so glad that you mentioned that. What are some other misconceptions around insulin?

Maggie Evans – I think there can tend to be a fear of injections or a fear of needles, fairly common for a lot of people with diabetes. But recognizing that now there’s so many different options and the technology in the diabetes world is just advancing. I feel like every day I hear something new. But there’s other ways around giving yourself insulin injections either every day or with every meal. Now we have pumps that are available. So the pump system uses a little smaller needle that tends to just go right under the skin and barely noticeable. But that can be another way to reduce the amount of injections that you’re given throughout the day or throughout the week. And also knowing that the syringes now, the advancement in the needles is much better, they’re much smaller, they’re thinner, so you can barely feel them. So that makes it much less painful. I’ve even had people tell me that their actual insulin injections are much less painful than just their finger pricks for their, for their glucose checks, so, really interesting to hear that. But just knowing that there are other options and now they’re even coming out with an inhalable insulin, which is very effective as well. So if there is that fear of needles or fear of it being painful, reach out to your providers, reach out to your diabetes care team, let them know these concerns. And there’s always going to be options available. So just as long as you let people know what you’re feeling that can help us and your team kind of direct you in the right direction.

Scott K. Johnson – I’m glad you mentioned that, that open conversation. So if my provider has prescribed insulin, but I’m struggling to take that insulin because of the fear of needles, which, by the way, is completely normal, there is nothing normal about poking yourself with sharp objects, so but like you say, maybe talking with your, your team about the challenges that you are facing in doing what they ask of you, that makes a big difference. So what else are we dealing with?

Kristen Bourque – Oh, when I was going to just add to that kind of what you and Scott, Maggie you mentioned is kind of that fear of the unknown. I think too, with that, with the injection piece of it too. So, like you mentioned, Scott is talking to your healthcare team. But also a lot of times especially when initially prescribed that they’ll do a demonstration with you. So that kind of fear of the unknown, maybe having someone kind of walk it through with you, versus just kind of sending you home on your way, also will, I think help kind of minimize that fear over time too. So yeah, the next thing I would say, of course, is the fear of weight gain, we always kind of get this. And this would also be, the case of certain oral medications as well. But I think that insulin and weight gain are oftentimes associated together. But it’s important to remember that some patients will experience this overall, it helps the body to use food more efficiently. But again, this is going back to is everyone’s different, this isn’t going to be a for sure, side effect that happens. But it is again, going back to talking to your health care team about some of these fears or concerns that you have, in regards to I don’t want to gain weight once I go off, go on insulin. So just kind of let your doctor know, but important to still maintain, healthy diet and activity and all those things as well, to help kind of mitigate that as well, too.

Scott K. Johnson – Great, yeah, that makes a lot of sense. So if we, if we were to kind of wrap this question of should I be afraid of insulin? In a summary, few points, what would that look like?

Kristen Bourque – Of course, no. But just to kind of go off of some other reviews that we’ve mentioned, is that, I think, again, it’s very important to talk with your healthcare team about your concerns about your fears about this. They’re there to get, provide support and be there with you through this journey, but let them know kind of what your thoughts are around it, and see if they can kind of help you to feel more comfortable. But and then kind of just going off of what Maggie had mentioned is there’s so many different options for insulin nowadays, too. So this is another conversation to have with your provider is what you feel more comfortable with. Some people like to use a pump. Some people like to use insulin injections. So again, these are great options that we have that we did not have years ago. So you can ask someone that has had diabetes for quite some time, the differences in the technology and the needles and everything. So, you know, it’s great to know that there’s options available as well, so.

Scott K. Johnson – That’s great, that’s great. And I think that, it’s a very, very useful tool in the diabetes management toolbox. And if you’re struggling to meet your goals on the therapies that you’re using now, and the idea of insulin is there, it might be a way that you finally feel successful in doing what you need to do to get your blood sugars where they need to be. So I think it’s a very powerful tool, and not something to be afraid of. So thank you, thank you for breaking that down a bit.

Kristen Bourque – Yeah, and I think it’s like you said, Scott, it’s, and it’s an important thing to remember that it’s, it will get you closer to your goal. And that’s of course, what we want to focus on, is to manage our diabetes to manage it well. So insulin is just one of those other therapy options that’s available to us. And it’s a great option. So something to be again, a little bit less fearful and more open-minded if it comes up in conversation with your doctor.

Scott K. Johnson – Makes sense, great. Thank you. Well, with that, let’s wrap this session up and we’ll be back again soon. All right, I hope that was helpful. Carol, great to hear that this helps with your expectations, should insulin become a thing for you. Today was actually our last live episode of Coaches Corner. We have really enjoyed our time together. And for those of you who are using the mySugr bundle, I encourage you to continue asking great questions to your coach. They are there for you and happy to support you in your journey of living well with diabetes. If you would like to review any of the information in past episodes, we’ve pulled everything together into a single place, and we’ll put the link here for you. With that stay well, have a great weekend, and I hope to see you again sometime soon.

Source: diabetesdaily.com

FDA Approves Lyumjev – A New Rapid-Acting Mealtime Insulin

This content originally appeared on diaTribe. Republished with permission.

By Frida Velcani

Lyumjev reduces blood glucose spikes and can be taken at the beginning of a meal, or even 20 minutes into the meal; available through Lilly’s insulin affordability program

A new rapid-acting mealtime insulin has been approved by the FDA to reduce high blood sugar after meals and keep blood glucose levels in-range. The insulin is rapid-acting, meaning that it is absorbed into the bloodstream and the body more quickly. This approval provides another important mealtime insulin option for adults with type 1 or type 2 diabetes. Lilly’s Lyumjev was approved in Japan and Europe in March 2020, and the company is working to make Lyumjev available to people in the United States as quickly as possible.

Lyumjev will be offered at the same price as Humalog. Lilly will also offer Lyumjev through its newly launched Insulin Value Program, which makes the therapy available at $35 per month for people who are uninsured or have commercial insurance. The $35 cap applies regardless of the number of insulin doses required.

This approval was granted based on the results from the 2019 phase 3 PRONTO-T1D and PRONTO-T2D trials. The data showed that, compared to Humalog, Lyumjev reduced blood glucose spikes (hyperglycemia) one hour and two hours after a meal in people with type 1 and type 2 diabetes. The drug did not affect A1C reduction. In people with type 1 diabetes, Lyumjev reduced hypoglycemia four hours after meals, whereas in people with type 2 diabetes, the insulin slightly increased hypoglycemia both one to two hours and two to four hours after a meal.

Lyumjev can be taken at the beginning of a meal or 20 minutes after starting it. This flexibility is due to the faster onset and offset of the insulin. That said, it is still strongly recommended that whenever possible, people should take Lyumjev before the start of the meal.  Lyumjev by Lilly joins Fiasp by Novo Nordisk as the two faster acting insulins available giving people with diabetes more flexibility in mealtime insulin dosing.

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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Image source: diaTribe

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

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

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

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

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

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

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

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

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

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

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

Image source: diaTribe

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

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

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

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

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

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

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

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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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SENCE

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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.

CITY

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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.

CGM

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

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

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

Parent Perspectives on DIY Closed-Loop

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

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

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

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

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

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

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

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

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

ada 1 1

Image source: diaTribe

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

Early CGM use can help kids and predict T1D progression

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

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

Diabetes Drugs

VERTIS-CV Trial of Steglatro and Heart and Kidney Health

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

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

Read more about the trial in our full article here.

New Data Shows Teplizumab Delays Diagnosis of Type 1 Diabetes

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

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

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

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

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

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

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

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

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

GLP1

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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

Creative Bolus Strategies Result in Better Glycemic Control (ADA 2020)

At the American Diabetes Association (ADA) 80th scientific sessions on Friday afternoon, Margaret Pellizzarri, RN, MS, MBA, CDE along with the Integrated Diabetes Services team, including Gary Scheiner, MS, CDE delivered a unique presentation on clever insulin bolusing techniques for people living with diabetes who use a pump or multiple daily injections, when dosing for high-protein and high-fat meals.

Bolus Options

  • Normal bolusing–delivers insulin all at once and is used for most meals
  • Square bolusing–delivers insulin over a period of time. This is especially useful in situations where there is a buffet or you are eating over a longer period of time. Patients with gastroparesis also can benefit from square bolusing since their digestion is slowed down.
  • Combination or dual-wave bolus–delivers a portion of the insulin as a normal bolus and the rest as an extended or square bolus. This can be particularly helpful with meals that are high in fat, high in both fat and carbs, as well as for high-protein meals.

Insulin Dosing for Protein and Fat: Studies and Strategies

Studies conducted in both people living with type 1 and type 2 diabetes indicate that fat slows down gastric emptying and slows down glucose absorption. This can result in hypoglycemia for patients after a fat-laden meal. Several studies demonstrate that both high-fat and high-protein meals require more insulin to achieve target postprandial blood glucose levels. Furthermore, glycemic responses vary depending on the specific macronutrient profile of the meal, with higher-protein meals tending to cause prolonged hyperglycemia (if not accounted for). Altogether, this indicates that the insulin delivery strategy must be optimized in dose and timing to achieve the most optimal results when consuming such meals. 

Here are the highlights from the presentation:

  • One study showed that high-protein, high-fat meals required 30% more insulin over 6 hours and suggested using a glucose meter or continuous glucose monitor (CGM) to adjust as needed.
  • Another investigation demonstrated that consuming a mixed protein mixed meal (36 g protein, 30 g carbs, 5 g fat) when dosing only for the carb content, resulted in higher postprandial glucose values. By using a protein-fat insulin dosing algorithm, they suggested that adding 66% more insulin delivered in a combination bolus over three hours resulted in improved glucose levels. The impact of a meal that was higher in protein and fat, showed to be additive to postprandial glucose levels.
  • One study showed that mealtime doses for individuals with type 1 diabetes need to be individualized. For high-fat meals (more than 40 g), patients should consider additional mealtime insulin, around 30-35% of the initial dose. For individuals using pumps, it is recommended to try a combination bolus with half the dose before eating and half delivered over 2-2.5 hours after eating.
  • One investigation suggested that high-protein and high-fat meals require a >60% ICR (insulin-carb ratio) as a standard bolus before the meal with an additional ICR up to 70% in an extended bolus starting at 1.5-5 hours after the meal.

Conclusions

  • Experts suggest altering your insulin dosing and changing the timing of insulin delivery can help better navigate tricky meals that are high in fat and/or protein.
  • Using the bolus techniques presented above, those on an insulin pump can experiment to achieve what works best (Note: If low blood glucose occurs, it is recommended to extend the duration of the remainder of the extended dose.)
  • Those using multiple daily injections can also vary the timing and dose of their insulin according to the specific meal (although this may be more tedious). You could also consider different insulin based on their activity profiles (make sure to discuss any changes with your healthcare provider!).
  • Despite the manufacturer’s recommendations of dosing insulin within 15 minutes of meal consumption or immediately after, research shows that best postprandial glycemic results are achieved when taking the specific macronutrient distribution of the meal into account and adjusting both insulin amounts and timing to best match that food profile.
  • Recent research shows that injecting 15-20 minutes before meals is safe, and results in 30% lower glucose levels and less post-meal hyperglycemia when premeal glucose levels were in range.

Whether you use a pump and can take advantage of the special bolusing features or are on multiple daily injections, there are strategies to try when consuming high-protein, high-fat meals. With some trial and error, we can all benefit these creative tactics to strive for improved postprandial glucose levels when it comes to the always challenging high-protein, high-fat meals. Be sure to always consult your healthcare provider before making any changes to your insulin dosing regimen.

***

What are your thoughts on the subject? Do you use any of these strategies? How do you navigate complex meals?

Stay tuned for more from the ADA 80th scientific sessions!

Source: diabetesdaily.com

Advancements in Treatment: The Use of Adjunctive Therapies in Type 1 Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Paresh Dandona and Megan Johnson

Read on to learn about the research around GLP-1, SGLT-2, and combination therapy use in type 1 diabetes. Dr. Paresh Dandona is a Distinguished Professor and Chief of Endocrinology at the University of Buffalo, and Megan Johnson is a fellow on his team

For people living with type 1 diabetes, new treatments are finally on the horizon. The University at Buffalo (UB) Endocrinology Research Center is helping to revolutionize the treatment of this condition. Among the most promising new therapies are two non-insulin medications currently used in type 2 diabetes, SGLT-2 inhibitors and GLP-1 receptor agonists.

SGLT-2 inhibitors, such as Farxiga, act the kidney to help the body excrete more glucose in the urine. Meanwhile, GLP-1 receptor agonists like Victoza work in several different ways: increasing the body’s natural insulin production, decreasing the release of the glucose-raising hormone glucagon, slowing the emptying of the stomach, and curbing excess appetite. Some people with type 1 diabetes take these medications as an addition to insulin treatment as an “off-label” drug. To learn more about off-label, check out the article: Can “Off Label” Drugs and Technology Help You? Ask Your Doctor.

Why consider these medications?

In people without diabetes, the body is constantly releasing more or less insulin to match the body’s energy needs.  People with type 1 diabetes do not make enough insulin on their own and have to try to mimic this process by taking insulin replacement – but it isn’t easy.

People with type 1 diabetes often have fluctuations in their blood sugars, putting them at risk for both low blood sugars (hypoglycemia) and high blood sugars (hyperglycemia). Many individuals are unable to manage their blood sugars in a healthy glucose range with insulin alone. In fact, less than 30% of people with type 1 diabetes currently have an A1C at the target of less than 7%.

Can GLP-1 agonists be safely used in type 1 diabetes?

Over the past decade, the endocrinologists at the University at Buffalo and other research groups have been conducting studies to see whether GLP-1-receptor agonists can safely be used in type 1 diabetes.

  • The first of these was published in 2011 and showed a decrease in A1C within just four weeks of GLP-1 agonist treatment. Importantly, people given GLP-1 agonists plus insulin also had much less variation in their blood sugars, as measured by continuous glucose monitors (CGM).
  • Another study involved 72 people with type 1 diabetes who took GLP-1 agonist or placebo (a “nothing” pil) in addition to insulin for 12 weeks. The GLP-1 group had decreases in A1C, insulin requirements, blood sugar fluctuations, and body weight. People in this group did report more nausea – a common side effect of GLP-1 agonists.
  • Since then, multiple studies, some involving over 1000 people and lasting up to 52 weeks, have shown that GLP-1 treatment in people with type 1 diabetes can reduce A1C and body weight, along with insulin dosages.

Many of these studies, but not all, have suggested that GLP-1 agonists can do this without increasing the risk for hypoglycemia or diabetic ketoacidosis (DKA). There is also some evidence that GLP-1 agonists can improve quality of life in type 1 diabetes.

Who should consider GLP-1’s?

The effects of GLP-1 agonists seem to be especially strong in individuals who are still able to make some insulin on their own, although it also works in people who do not.

In one notable study, researchers gave a GLP-1 agonist to 11 people with type 1 diabetes who were still able to produce some insulin. To get an estimate of insulin production, they measured levels of a molecule called C-peptide, which is produced at the same time as insulin. In these 11 individuals, C-peptide concentrations increased after GLP-1 treatment. By the 12-week mark, they had decreased their insulin dosage by over 60%. Incredibly, five people were not requiring any insulin at all. Even though the study was very small, the results were exciting, because it was the first study to suggest that some people with type 1 diabetes had sufficient insulin reserve and thus, could – at least temporarily – be treated without insulin.

Can SGLT-2 inhibitors be used in type 1 diabetes?

SGLT-2 inhibitors like Farxiga have also shown tremendous potential. In two large studies called DEPICT-1 and DEPICT-2, adults with type 1 diabetes were randomly assigned to take either placebo or SGLT-2 inhibitor in combination with insulin. Over 700 people from 17 different countries participated in DEPICT-1, and over 800 people with type 1 diabetes participated in DEPICT-2. At the end of 24 weeks, people taking dapaglifozin had a percent A1C that was lower, on average, by 0.4 compared to people who had received placebo, and it was still lower, by over 0.3, at 52 weeks. The number of hypoglycemic events was similar in both groups.

As with GLP-1 agonists, people taking SGLT-2 inhibitors had weight loss and decreased insulin requirements. People taking SGLT-2 inhibitor, however, did have an increased risk of diabetic ketoacidosis (DKA). If individuals consider this therapy, they should be cautious about not missing meals or insulin, and not drinking large amounts of alcohol, as these behaviors can lead to increased ketone production.

Several other research groups, in trials recruiting up to 1000 individuals, have seen similar results when using this class of medications.  Researchers have been conducting additional studies to try to determine how best to minimize the risks associated with them. Farxiga (called Forxiga in Europe) has now been approved as the first oral agent as an adjunct treatment for type 1 diabetes in Europe and Japan.

Promising Combination Therapy

Now, endocrinologists are also looking at whether GLP-1 agonist and SGLT-2 inhibitor combination therapy could increase the benefits of each of these treatments. A study conducted on a small number of people showed that GLP-1 agonists can help prevent ketone production, so it is theoretically possible that this medication could reduce the risk of DKA that was seen with SGLT-2 inhibitors.

In an early study involving 30 people with type 1 diabetes who were already on GLP-agonist and insulin were randomly assigned to take SGLT-2 inhibitor or placebo, as well. People who received both drugs saw an 0.7% reduction in A1C values after 12 weeks, without any additional hypoglycemia. People on the SGLT-2 inhibitor did make more ketones, though, and two individuals in the combination group experienced DKA. Larger studies are now being conducted to expand on these results and learn more about how to give these drugs safely. The hope is that non-insulin therapies will soon be approved for type 1 diabetes. By unlocking the potential of these therapies, we can do more than manage blood glucose levels – we can improve people’s lives.

Source: diabetesdaily.com

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