How I Crushed Type 2 Diabetes in Only Weeks and Completely Changed My Outlook on Life

Editor’s note: We found Rey’s remarkable story in the diabetes online community, and asked him if he would share it with us. Rey experienced extraordinary rapid success by following a precise diet and medication regimen immediately after diagnosis with type 2 diabetes. His improvement was incredible, but others making the same changes may not experience the same success. Please speak to your doctor or caregiver before enacting any major health changes of your own.

I’m Rey, and I’m a 44-year old male with a history of high blood pressure and being overweight, but until recently I had no major health issues. Only this past summer I learned that I had dangerously uncontrolled diabetes. Within the span of just a couple of months, I completely changed my diet, started and then stopped glucose-lowering medications, and got my blood sugar back into the normal, healthy range. Here’s my story.

My First Health Scare

My story is ultimately a diabetes story, but there were some bumps along the way that I think are worth including before I jump into the diabetes.

My adventure really began in the summer of 2020. After some stressful life events, I developed a rather constant state of anxiety, which seemed to be preventing me from getting good sleep. Even while using a sedative, I was up at least 4-5 times during the night, every night. I didn’t have a previous history of mental health problems, so this was all new to me. The especially challenging part was that as time passed, lying in bed became a trigger for the anxiety, which made the sleep even harder to come by. I felt like I was just going through the motions to get through life.

Fortunately, after months of stubbornness and sucking it up the best I could, I finally got to the bottom of things. I discovered it was sleep apnea, and started CPAP treatment. The result was truly life-changing, sleep returned to normal, and my anxiety went away 100%.

Life was great and I’d survived and handled my major mid-life health crisis…. or so I thought! Little did I know, but that relief would prove to be short-lived as in the coming months I started to experience a new set of symptoms.

I was at my highest weight yet and my BMI was creeping towards 30. Some reading this will scoff and think “30 is nothing, I’m well above that,” but everyone’s body is a little different and apparently 30 was my personal breaking point.

My fasting blood sugar was over 100 mg/dL, and my doctor said something about pre-diabetes, but she didn’t sound too concerned about it.

The Symptoms

I was again experiencing sleeplessness. Now I was finding that instead of sleep apnea waking me up during the night, my bladder was sure filling up and I was getting up to pee several times a night. Also, I was quite thirsty when this would happen. I did notice it was nights that I’d eat pizza or pasta for dinner that were the worst. Some combination of stubbornness and perhaps denial kept me from taking this too seriously, so I just kept on with things. Besides, this was March 2021 and you didn’t dare go into a medical clinic unless you were on your covid deathbed. Surely, this was no big deal, and getting checked out could wait.

Still, I sensed something was wrong and I reduced the amount of pizza and pasta I was eating for dinner (maybe twice a week instead of five nights a week), eating beans with rice and veggies for dinner instead. In hindsight, not great, but a minor improvement.

The next major symptom arrived in April: blurry vision. At first, I wasn’t worried. I’d gotten LASIK eye surgery done 12 years earlier, and this change seemed like a mild return of my nearsightedness. I was also in my mid-40s, which I’m told is a time where focusing becomes harder and your vision changes.

Then it got really bad: I was on a trip to Florida when I couldn’t read a menu board that was 8 feet in front of me. I had to resort to taking a picture of it with my phone and then looking at that picture to read the menu. Something was majorly wrong!

When I got back from Florida (after some real nerve-wracking and likely dangerous driving), I went in to get my vision checked and received a -2.0 diopters prescription. The optometrist was shocked that I had let my vision get that bad before getting glasses and made a comment about diabetes, but was also of the impression that my vision would change throughout the day as my blood sugar changed. That clearly wasn’t happening to me (turns out it’s more complicated than that).

The last major symptom was that I had been losing weight at a pretty decent clip (5-10 pounds a month). Obviously, this must have been due to cutting back on pizza and pasta, right? Curiously, past attempts at eating better had never been quite this effective, but why question such great progress when you’re on a roll! At this point, it was late April and the earliest I could get in for a check-up was mid-June, so why not ride out another month of weight loss and see how great my labs come back then?

My Diagnosis

A little over a week before the appointment I started researching diabetes online, since I was starting to wonder about what my doctor and optometrist had said. But surely that takes years to develop, right?

Obviously, my “diet” was working since I had now lost 25 pounds this year and weighed less than I did in my 30s. Who knew eating healthy was so easy!

After a little light reading, I quickly realized how wrong I was, that everything that had happened in the last few months was explained perfectly by diabetes, and that the weight loss might have been diabetes rather than my new diet. This was hard to process.

I picked up a blood sugar meter, and on a Friday night fumbled with the thing enough to figure out how to get a reading. I was shocked when the meter read 567 mg/dL. That can’t possibly be right! My girlfriend tried the meter and her result came in at 77 mg/dL. I tested mine again and this time it registered 596 mg/dL!

At this point, it was 11 PM on a Friday night, and my safest course of action would have been to go to the ER, but I figured if high blood sugar hadn’t killed me in the last 3-4 months, it probably wasn’t going to kill me that weekend. I decided to read more about diabetes, give myself a couple of days to get my wits about me, and go into urgent care on Monday. I also continued to test my blood sugar and it seemed to stay in the 300 to 450 mg/dL range that weekend, regardless of what I ate or whether I was eating.

At urgent care my A1c came in at 13.7%, and my fasting blood sugar was 449 mg/dL. Based on my history, I was more likely to have type 2 diabetes (and additional testing would later confirm that). I was prescribed metformin, and advised to take insulin, advice that I wasn’t ready to take.

Rey kept track of his blood sugar measurements from the moment he began testing, before he was diagnosed with diabetes. You can see his girlfriend’s healthy reading, 77 mg/dL, on the first day.

A New Diet

I now understood that the reason I had lost so much weight so quickly was my uncontrolled diabetes, at least 3 months of it!

I immediately cut most high-carb foods out of my diet and subsisted largely on a diet of full-fat cottage cheese, full-fat plain Greek yogurt, hard cheese, nuts, avocadoes, and canned beans with olive oil. I also kept some fruit and berries in my diet initially. Throughout the day I ate random combinations of these foods. I didn’t really prepare them or fancy them up at all with cooking (other than heating the beans in the microwave so they’d be warm).

I knew I had screwed things up, and if there was going to be any hope of reversing the damage I feared I had done to my body I needed to focus. Maybe I would be able to go back to eating pizza, pasta, and all those delicious carb-filled foods that I loved someday, but it was clear now wasn’t the time for that.

I’d certainly thrown in the towel on diets plenty of times before and gone back to eating like crap, but this time it felt like there was a gun held to my head, and quitting wasn’t an option. Perhaps I’m being overly dramatic about this, and perhaps it wasn’t the healthiest outlook, but it’s how I saw things and it got me through the first weeks where I was at my highest level of motivation.

I wasn’t using a particular diet system I had found on the internet or in a book, it was just me trying to think of all the foods (as a vegetarian) that I normally ate that were lower on the glycemic index, and sticking to those. Frustratingly, there seemed to be a lot of disagreement online in regards to what the “best” diet was for a diabetic, but I’ll come back to that later.

The Right Medications

With this diet and metformin, my blood sugar still ranged from about 250 to 400 mg/dL that first week. My blood sugar really needed to come down since the longer it remained elevated, the greater my risk for diabetes-related complications. Clearly, a week of my new diet and metformin wasn’t enough, and I was more open to exploring what else could be done.

When I saw my primary doctor after that week, she wanted to put me on insulin too, in order to stabilize my blood sugar. Although I knew that insulin would have rapidly brought my blood sugar down to normal levels, using it would have made it difficult for me to gauge if my dietary changes were getting the job done.

Through my research, I had become convinced that SGLT2 inhibitors were the only class of drugs that made any sense for a person with new uncontrolled type 2 diabetes to take (in addition to metformin). Normally in uncontrolled diabetes, your kidneys excrete sugar to your urine as a means of keeping your blood sugar from getting dangerously high, but that effect doesn’t really kick in until your blood sugar levels are way up there. With an SGLT2 inhibitor, your kidneys are just doing that all the time, keeping your blood sugar down in the process. The real beauty of this is instead of insulin, which causes your body to store that excess sugar (only delaying the problem), once you pee out the excess sugar, it’s gone forever.

I asked my doctor for a referral to an endocrinologist and a prescription for an SGLT2 inhibitor instead. She didn’t have much experience with SGLT2s and started talking about other drugs, but she could see I had a pile of notes with me on different drug classes, the research I had done on them. I think she also realized that although she was the one to write the prescription, that I was ready to argue my case.

As soon as I started taking the SGLT2 inhibitor my blood sugar came down almost immediately.

On Farxiga, within days my blood sugar dropped to the 100 to 150 mg/dL range. I had to pee a little more at first too, which suggested the drug was doing exactly what it was supposed to. After a few days, I found I wasn’t peeing any more than normal, which was probably due to my fairly low-carb diet.

[Editor’s note: Rey had an incredibly positive experience with SGLT2 inhibitors, but they are not for everyone, and do carry side effects and risks, especially when combined with low-carbohydrate diets. Please speak to your doctor about changing your medication.]

This was a great improvement over where I was before, but like every newly-minted diabetic I had dreams of reversing my diabetes and getting my blood sugar back to “normal.” I obviously wasn’t there yet and just because you want something doesn’t mean it’s possible or realistic, but I was holding onto that dream.

Remission is a very controversial topic. Most ADA and official-looking literature I found said that diabetes was a progressive disease. As time passes, more drugs are required to maintain the same degree of control, and some pretty awful complications occur as it gets worse and worse. That was a rather depressing outlook. If it all falls apart in the end, why not just go back to enjoying all those carb-rich foods that I love and enjoy whatever time I’ve got left? Fortunately, I didn’t fall into that trap, but I have to imagine many do.

Intermittent Fasting

I was aware of internet doctors out there on the fringes saying type 2 diabetes can be reversed and people can manage through diet alone, without drugs. Are they selling false hope, similar to new-age healers selling energy crystals to cure cancer? Most of them are talking about low-carb and “keto,” which I’d previously assumed to be just another random fad diet. “They’re obviously quacks,” I thought. I figured that American Diabetes Association was most certainly correct about diabetes being progressive, just giving me the cold hard truth. But just for the sake of argument, I decided to hear the quacks out first.

Of the doctors on Youtube, the first to really suck me in was Dr. Jason Fung, a Canadian nephrologist. He had a very intuitive model for explaining type 2 diabetes, and used research on treating the condition with gastric bypass surgery (which has been highly successful) as a starting point. He suggested a low-carb diet combined with fasting in various forms. Hey, I’m already doing the low-carb thing and it seems to be helping. Maybe fasting would be the next nudge I needed.

I started with 3 set meals a day (eating between 7:30 AM and 7:30 PM, and then fasting from 7:30 PM until 7:30 AM the next morning). Around the time I started Farxiga, I moved into the next phase of fasting, which was to skip breakfast and then eat only lunch and dinner (eat at 12 PM and then 8 PM). To my surprise, I no longer felt hunger when I wasn’t eating. I now know that’s a common benefit to the keto diet, but if someone had tried to tell me about that a year earlier, I would have thought they were crazy. Also, I didn’t really know I was doing keto. I was just doing a tighter version of the diet I’d explained earlier, with less fruit and no beans.

I completed my first full-day fast the weekend after starting Farxiga. I didn’t eat anything at all starting Friday after dinner until around 1 PM on Sunday, for a 40+ hour fast. Again, Farxiga had gotten my blood sugar down to under 150 mg/dL on a regular basis, but this was the kick that finally got me back under 100 mg/dL. Throughout Friday it was testing 130 to 150 mg/dL, Saturday morning I was at 144 mg/dL, but as Saturday dragged on and my fast continued I started getting multiple readings under 100 mg/dL. My Sunday morning fasting result was 96 mg/dL and, it got as low as 79 mg/dL on Sunday afternoon before I finally broke my fast. To my surprise, breaking my fast only bumped me to 119 mg/dL and 5 hours later my blood sugar was back down to 82 mg/dL. Seeing this progress felt truly amazing and it was only 16 days after finding out I had diabetes!

Maintenance

Rey’s blood sugars improved rapidly and remarkably with the right combination of diet and medication.

Of course, you don’t eat your way to diabetes in two weeks and you don’t undo your diabetes in two weeks either. I was taking 2,000 mg of metformin a day as well as the SGLT2 inhibitor. The week after my big fast, my fasting blood sugar readings would go back over 100 mg/dL, but I kept plugging away, only eating two larger meals a day during a narrow set of eating hours. I also tested the high-carb waters with a 6-inch Subway sandwich – it spiked my blood sugar to 190 mg/dL, which is much higher than a non-diabetic would likely hit from that meal. That helped knock me back down a peg and remind me that I still had diabetes, after all.

The next weekend I noticed that my blood sugar numbers were starting to come down to under 100 mg/dL without extended fasting. I also noticed that foods that previously spiked my blood sugar a great deal were now spiking it much less. On June 28th (day 24 of knowing I had diabetes and 13 days after starting my SGLT2) I decided to stop taking Farxiga and see what effect it would have. This was not a responsible decision, as you should always consult with your doctor before discontinuing medication, but with my improved blood sugar levels, I questioned if Farxiga was still doing anything for me. It turned out my guess was correct. There was no significant change in fasting or post-meal blood sugar readings in the days that followed, and my type 2 diabetes was now well-controlled via just diet and metformin!

About a week later I started wearing a Freestyle Libre 2 to get a broader picture of my blood sugar trends, and for convenience. My readings were still in the 80-90 mg/dL range throughout the day, with small bumps up over 100 mg/dL after a meal. When I finally was due for my appointment with an endocrinologist to discuss my diabetes treatment, the feel of the visit could best be summed up as “why are you here?” My data showed that my average blood sugar in the previous 10 days had been 95 mg/dL, which would extrapolate to a 4.9% A1C (compared to the 13.7% result when first tested). This is, of course, only an estimate. And my blood sugar had only been well controlled for 2-3 weeks at this point.

Blood sugar wasn’t the only improvement either over last year’s numbers: total cholesterol dropped from 238 mg/dL to 172 mg/dL, with HDL (“good cholesterol”) fairly steady from 64 to 62 mg/dL. LDL (calculated) dropped from 141 to 90 mg/dL. Triglycerides dropped from 165 to 102 mg/dL. The endocrinologist agreed that I no longer needed Farxiga and indicated there really wasn’t a reason for me to see her again, but that I was free to set up another appointment if things changed.

My Best Path Forward

Since then, I’ve done more reading on the keto diet and feel that’s my best path forward to continue to maintain my health, both in terms of diabetes and beyond. I’ve improved enough that I no longer wear a CGM or perform finger sticks to check blood sugar on a regular basis, only checking maybe once a week “just to be sure.” Although I’ve tested out eating some of my old high-carb favorites and been impressed by how much less they spike my blood sugar now, I’m no longer interested in eating them on a regular basis, which is surprising to me. I’ve also found I can sleep through the night just fine without my CPAP machine due to the 35 pounds of weight I have lost from my peak of 215 lbs. The sleep apnea isn’t completely gone, so I still wear the mask most nights, but it appears to be dialed back from severe to mild.

It’s a very weird feeling: when I first found out I had diabetes I wanted nothing more than to continue eating the foods I loved and found comfort in. I felt like something had been stolen from me and feared that my body was permanently broken. Why should other people be able to eat what they want to, and I can’t? It felt very unfair and I really wanted there to be a drug or a treatment that would let me eat how I wanted to. Now that I’ve immersed myself in a better understanding of just how bad those foods were for me, I view things very differently.

I share my story not to lord my results over you if you’ve been less successful with your diabetes. I got really lucky, finding good dietary advice quickly after my diagnosis. Sadly, much of the official guidance out there seems sure to fail. I was also lucky with my uncontrolled diabetes “helping” with the first 25-30 pounds of weight loss.

I no longer have aches and pains when I get up out of bed or have to roll a certain way to avoid them, my memory has improved quite a bit and I’m no longer struggling to recall things I was just told, as I did with high blood sugar levels. I have so much more energy and stamina rather than feeling lethargic or struggling to complete physical activities. It’s like I’m in my 20s all over again (except for a little gray hair)! The downside is I now know if I go back to a lifestyle of enjoying carbohydrate-rich foods, things will go poorly for me, but as long as I don’t, I get to enjoy life so much more than I had before. And there are plenty of delicious foods that aren’t packed with carbs that I’m free to enjoy.

I think diabetes has been a net positive for me, as strange as that sounds. The me of today is very different than the me of a year ago.

Source: diabetesdaily.com

Is Digital Diabetes Coaching Worth the Cost?

Does digital diabetes coaching really work? And is it worth the money?

While these programs were basically unknown only a few years ago, there is now a dizzying number of businesses claiming to offer personalized mobile diabetes coaching programs. A diaTribe guide to the services lists fifteen different options, a number which may only grow in coming years. (In a related phenomenon, there are also many new coaching services that utilize continuous glucose monitoring for people without diabetes).

What is digital coaching?

Digital coaching is not telemedicine or telehealth. A digital diabetes coaching service can only supplement, but not replace,  your doctor, endocrinologist, or diabetes educator. Digital diabetes coaching services cannot order prescriptions and cannot address more complicated health issues.

Digital diabetes coaching services aim to help “fill in the gaps” between regular visits with an existing care team, as a representative of MySugr, one of the better-known services, puts it:

I really see the benefits of having those touch points in between physician appointments because the day-to-day is what really matters with diabetes. If you’re just going in every several months it’s hard to make changes that stick. If you’re able to check in with a coach every so often without having to make an appointment, not only does it help the management, but it helps ease anxiety which is a huge part of diabetes too.

While the details will vary from one business to another, the basic idea is that the patient will share his or her data (blood sugar, insulin use, weight, etc) through a mobile app. The app provides feedback and advice, whether it’s delivered by an algorithm or a trained professional. Even if the mobile coach doesn’t deliver any revelations, the hope is that little check-ins and notifications will help keep patients more mindful of their condition and in a better frame of mind to apply themselves to their diabetes management, leading to improved results.

Some coaching platforms are paid for by insurers or employers. Others require patients to pay for them directly – a common price is about $50 per month.

The case against digital coaching

Digital coaching services have studies that show that their coaching programs deliver big results – improving HbA1c, weight loss, and reductions in insulin and other glucose-lowering medications. But in a recent debate at the American Diabetes Association’s Scientific Sessions conference, Dr. Kasia Lipska of the Yale School of Medicine expressed doubt about the quality of the evidence in favor of these programs.

After reviewing the clinical literature, Dr. Lipska noted that most studies of the services tend to be sponsored by the companies themselves. They are typically of very short duration, and some are barely up to good standards for clinical science.

She referred particularly to a study run by Omada Health of its own program. Among the problems with this study: no control group, no randomization (perhaps meaning that participants were highly motivated), and missing data, in addition to the obvious conflict of interest.

Omada has also run a randomized controlled trial, considered a far more thorough approach. Those results, which have only been made public in a press release thus far, were “relatively modest,” showing some weight loss but less than a 0.1% improvement in HbA1c. A similar trial, of the Noom coaching platform, had similar results, showing no difference in A1c and a relatively minor improvement in weight loss.

The best-designed study of digital coaching platforms that Dr. Lipska was able to find “did not demonstrate clinical effectiveness.”

“I think we have to squint a little bit to see a lot of evidence for clinically important significant outcomes,” she stated.

Dr. Lipska also expressed some personal skepticism about the programs.

“The thing that really bothers me is that they’re really not aligned with the healthcare team. Me as a clinician, I have no input into the feedback that my patient gets.”

The case in favor of digital coaching

Arguing the opposite case was Dr. Anne Peters, the director of the University of Southern California’s Clinical Diabetes Programs, and a much-honored diabetes advocate.

Dr. Peters took a broader view of the problems that digital coaching is meant to solve, noting that the healthcare costs of diabetes continue to spiral and that many people with diabetes still struggle to achieve the targets set by their doctors.

Even if patients enrolled in digital coaching services do not experience better outcomes, the programs may be worth the cost to insurers and employers if it helps reduce the frequency of in-person visits to the medical center. Some studies have found that digital coaching systems reduce patient medical spending and office visits, big benefits for patients, insurers, and medical practitioners alike.

Moreover, in Dr. Peters’ telling, patients can use all the help we can get them. Technology and medication have improved significantly in recent years, but they are not effective without training and professional assistance. For decades we have known that diabetes education improves outcomes – is there a good reason to doubt that education delivered through a smartphone would fail to do the same?

Both debaters agreed that digital coaching platforms were only likely to help a certain percentage of diabetes patients, those with a modicum of technical acumen and a willingness to commit to a more intensive management style. It’s possible that such patients are already highly motivated to pursue management success and are therefore less in need of help than others less likely to use such a service. While Dr. Lipska argued that this means that digital coaching services may exacerbate healthcare inequities, Dr. Peters took a more optimistic view of the matter, counting any new treatment options as a positive even if they do not serve all patients equally well.

Takeaways

Digital diabetes coaching hopes to supplement standard medical care for diabetes by filling in the gaps between visits to the doctor’s office. By offering advice and reminders, they hope to keep your mind on your condition, setting you up for diabetes management success.

The evidence in favor of digital diabetes coaching is mixed. The proof that these platforms actually lead to improved outcomes is meager, but there is better evidence that they may save money for insurers and employers that offer the programs by reducing the frequency of in-person visits.

Would a digital diabetes coaching service be worth the cost to you? For a certain type of person, especially a patient ready to take his or her glucose management to the next level and willing to keep up with frequent online check-ins, these programs may well be highly effective.

 

Source: diabetesdaily.com

FDA Propels Insulin Affordability with Semglee

This content originally appeared on diaTribe. Republished with permission.

By Karena Yan, Joseph Bell, and Arvind Sommi

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

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

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

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

But what exactly is a biosimilar drug?

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

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

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

Source: diabetesdaily.com

Islet Cell Transplants: How the USA Fell Behind the Rest of the World

The United States has fallen behind other countries in the effort to make pancreatic islet cell transplants available for patients with type 1 diabetes. As the technique grows in popularity through much of the developed world, in America innovation has come to a standstill.

Islet transplantation is an advanced treatment for type 1 diabetes. Briefly, doctors take a donor’s islets of Langerhans (the clusters of cells in the pancreas that contain the insulin-producing beta cells) and inject them into patients with diabetes, typically into the liver. When successful, patients can discontinue insulin use altogether, or greatly reduce it. Some transplant recipients have remained free of insulin therapy for many years following the procedure, with only minor side effects, although most patients require some insulin therapy at five years post-transplant.

Islet cells are harvested from the pancreas of a deceased organ donor, and immunosuppressive drugs are required to prevent rejection by the recipient’s immune system. These donor cells are scarce, and while there are many ongoing attempts to find other sources of usable islet cells (such as the use of pluripotent stem cells or even genetically engineered pigs), the procedure is not expected to become a mainstream treatment in the foreseeable future. But for patients with a dire need—for example, those with extreme glucose management challenges, hypoglycemia unawareness, or advanced kidney disease—islet transplantation can be a lifesaver.

Unfortunately, in the United States, the procedure has been “effectively halted,” according to an official report on the American Diabetes Association’s recent Scientific Sessions conference. While the technique was largely investigated and defined by scientists working in the US, it has never become available to the general public, and there is little hope that it will become available any time soon. Meanwhile, some medical centers in Canada, Australia, Europe, and Asia are now performing the technique routinely.

Dr. Camillio Ricordi, a leading researcher on the treatment with the University of Miami, blamed the issue on “outdated regulation” from the FDA. Because of a quirk in the National Organ Transplant Act of 1983, subparts of organs (such as the islets of Langerhans) don’t count as organs and are not covered by the network of rules and programs governing organ transplantation. Instead, transplanted islet cells are regulated as if they were drugs. Treating the cells as pharmaceuticals subjects them to standards for precision and consistency that they cannot meet.

Phase 3 trials have already proved that islet cell transplantation can deliver impressive results, and do so safely. And yet, America’s leading experts have agreed that it is all but impossible for a research institution to apply for and secure full approval for the technique.

Around the world, other medical authorities have taken a more practical stance. This has also allowed insurers to pay for the procedure, just as they would any other organ transplant. Most of the countries that lead the world in islet transplantations have robust social healthcare systems.

But islet transplantation is still considered purely experimental in the United States, and today can only be performed under the auspices of an official clinical trial. While the ADA and other advocates have pushed for change, so far, the regulation still stands in the way.

As islet transplantation becomes more available across the globe, the treatment is going nowhere fast in the USA.

 

Source: diabetesdaily.com

An Update from the Controversial Dr. Denise Faustman

Remember Dr. Denise Faustman? Dr. Faustman is about as close as the type 1 diabetes world comes to having a celebrity researcher. Her lab, based at Massachusetts General Hospital, has given people with diabetes a lot of hope—and also generated plenty of controversy.

The BCG Vaccine

In 2018, Dr. Faustman’s team released the first results from a Phase I trial of a novel but appealingly simple and non-invasive treatment that could make blood sugar management much easier for patients with type 1 diabetes. The treatment? The bacillus Calmette-Guérin (BCG) vaccine, which has been used to prevent tuberculosis for a century. The BCG vaccine is one the oldest, longest-studied and best-understood vaccines; it is inexpensive and considered very safe. It is administered to as many as 100 million newborns across the globe annually.

The early results were encouraging: patients with type 1 diabetes who received just two doses of the BCG vaccine, spaced four weeks apart, achieved markedly lower A1c levels when compared to a control group. This result was first observed three years after the vaccine administration and continued for the next five years of follow-up. Participants receiving the experimental treatment had an HbA1c of just 6.18%, significantly lower than participants who received a placebo (7.07%). These results understandably created a lot of enthusiasm in the diabetes community.

The Authorities Push Back

The good results, however, also attracted some pushback from important diabetes authorities. The American Diabetes Association and JDRF took the unusual and striking step of co-authoring a joint statement to highlight “limitations” to Dr. Faustman’s research. The study, according to the statement, was minuscule – “nine people at the five-year time point, and three people at the eight-year time point” – and did “not provide enough clinical evidence to support any recommended change in therapy at this time.” While couched in cautious and moderate language, the letter clearly hoped to smother the hype that the BCG study had kindled.

A 2021 profile in Healthline stated that Dr. Faustman has now been “effectively shunned by the research community.” She has had to seek funding outside of the usual sources – something she’s done with aplomb, raising millions from private donors.

How BCG Might Work

Dr. Faustman hasn’t been as much in the news too much lately, but rest assured, she’s still working. And at last month’s ADA Scientific Sessions conference, we received an update to her ongoing work on the BCG vaccine. The team is still learning how and why BCG appears to work the way that it does.

The BCG vaccine is old, but its proposed mechanism in treating type 1 diabetes is new and surprising. BCG does not appear to restore insulin production, nor does it improve insulin sensitivity. So, what could explain the purported improvements in glycemic control?

Many experts have theorized that our immune systems have become less robust because our society is so much cleaner than it used to be. This idea, the so-called ‘hygiene hypothesis,’ also seems like a pretty good explanation for why type 1 diabetes is more common than it used to be. Dr. Faustman believes that the vaccine may help kick parts of the immune system into action, a mechanism that used to happen naturally back when we had a messier society. In particular, BCG helps trigger the proper function of “Tregs,” immune cells that are known to be dysfunctional in people with type 1 diabetes. Over a period of three years, participants in the study saw their Treg function slowly return to normal. This change also causes the immune system itself to burn more blood glucose, a shift that creates big glycemic improvements.

Interestingly, the BCG vaccine seems effective in patients that developed T1D during childhood (< 21 years), but not those that developed the condition as adults.

More Trials Planned

Meanwhile, several other trials of BCG have begun. A Phase II study is happening right now, and will monitor the effects of the treatment in more detail and with more participants; if the good results are confirmed, it could help allay the concerns raised by the research community about Dr. Faustman’s work. In addition, the Faustman lab is targeting a larger pediatric trial, which will test the vaccine in 150 adolescents, some with well-established type 1 diabetes, some newly diagnosed. Perhaps younger patients have an even greater opportunity to benefit.

The appeal of the BCG vaccine is obvious—a simple jab or two that could confer years of significant blood sugar improvements? Who wouldn’t be excited? But it would be best to continue to evaluate Dr. Faustman’s results with caution, given the skepticism of other researchers. Even if she’s right that BCG is a kind of silver bullet that can deliver durable A1c improvements, it will be years before she’ll have the data to make the case.

Source: diabetesdaily.com

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

This content originally appeared on diaTribe. Republished with permission.

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

Part 1: The Discovery

Part 2: Failed Promises, Bold Breakthroughs

Insulin’s Uncertain Future

Insulin

Image source: Emily Ye, Diabetes Daily

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Is the criticism fair?

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

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

Insulin

Image source: Emily Ye, Diabetes Daily

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

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

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

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

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

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

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

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

And what treatment are they using?

Oral insulin.

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

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

About James

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

Source: diabetesdaily.com

Will Insulin in a Pill Soon Become a Reality?

Since insulin was first discovered and isolated for therapeutic use nearly 100 years ago, most everyone with insulin-dependent diabetes has had to rely on exogenous insulin, given in the form of injections, whether via an insulin pump or multiple daily shots every single day of their lives (inhalable insulin was approved by the FDA in 2014, but its use is not widespread).

While research and development have come a long way in that time, the reality for millions (and over 7 million people in the United States alone) has been thousands upon thousands of invasive injections, oftentimes causing scarring, bruising, and pain. However, that may be about to change.

Researchers from the New York University in Abu Dhabi have successfully developed a pill using nanomaterial layers that disseminate insulin in rats safely without being destroyed by their stomach acids. This could be life-changing for the millions of people around the world who rely on insulin to live.

“Imagine being able to take insulin in a pill instead of injecting it a couple of times a day,” said first author Farah Benyettou, a research scientist in the Trabolsi Research Group at the New York University in Abu Dhabi. “The insulin was loaded in a system that protects it from the acidic environment of the stomach. Once in the body, the system can sense the blood sugar level and can release the loaded insulin on demand.”

A pill form of insulin has the potential to radically change the daily management of diabetes for the better: It would make treatment easier for children and people with a fear of needles, safer for both patients and clinicians in hospital and clinic settings, more effective, and patient-friendly.

Nearly 30% of people with diabetes rely on insulin injections, and while it might not be for everyone, this revolutionary advancement would be the first of its kind in the world.

Other attempts at orally administering insulin have been made in the past but faced roadblocks in the gastrointestinal tract, where stomach acids and bile quickly destroy insulin and any effectiveness it has.

This is different from common type 2 diabetes drugs like Metformin that aren’t insulin but simply improve the efficacy of insulin that their body already makes.

The research team in Abu Dhabi thinks it has solved the problem of the insulin-destroying stomach bile issue by encapsulating insulin within nCOF nanoparticles in a capsule that is resistant to such acids but responsive to sugar, reacting quickly when it senses blood glucose in the body is rising but survives the dangerous journey down the G.I. tract to reach the bloodstream.

This new advancement also has the potential to reduce or eliminate low blood sugars, as the release of insulin shuts off as soon as it senses blood sugars have fallen. This creates a helpful feedback loop and prevents an overdose of insulin, which for many, is an almost a daily occurrence on injections, where people are constantly walking a balance beam to prevent both high and low blood sugars in a world of stress, meals, exercise, and normal everyday living.

While this is all excellent news, it’s important to remember that the study’s success was only observed in rats, and human bodies are very different. The team will next test different nanomaterials to see what may be appropriate for human trials, and potentially, widespread market availability.

“Our revolutionary technology developed at NYUAD will dramatically improve the well-being of diabetic patients worldwide in a very simple and straightforward way,” says senior author Ali Trabolsi, an associate professor of chemistry at the New York University in Abu Dhabi.

While taking a daily insulin pill may is far from a functional cure, managing diabetes could become easier than ever, especially if the threat of low blood sugars is greatly reduced or eliminated.

The team hopes that diabetes management can soon be a lot less stressful, painful, and dangerous for the millions of people around the world who currently rely on insulin.

Source: diabetesdaily.com

The Latest on Eylea: A Leading Treatment for Diabetes-Related Retinopathy

This content originally appeared on diaTribe. Republished with permission.

By Kira Wang

New results on Eylea, a treatment for diabetes-related retinopathy, show that the therapy reduces the risk of more serious eye complications when used for prevention.

Key findings were recently published on Eylea, a common therapy in the US used to treat several eye conditions including diabetes-related eye disease. According to Dr. Jennifer Sun (co-chair of the Diabetic Retinopathy Clinical Research Network), 60% of patients may not know they have some form of early-stage diabetes-related retinopathy which may not affect one’s ability to see. The clinical trial was focused on prevention: does early Eylea treatment of diabetes-related retinopathy result in better vision later on? The answer may not yet be clear – while Eylea was found to reduce specific vision-threatening complications, it did not meaningfully improve vision outcomes in the published study.

Eylea is an approved treatment for diabetes-related macular edema and diabetes-related retinopathy, two of the eye complications associated with diabetes. Eylea is an anti-VEGF therapy, meaning that the drug blocks VEGF, a protein that is necessary for new blood vessel growth. The medication is injected into the eye by an ophthalmologist every four to 16 weeks, depending on the severity of the eye disease.

The trial looked at 328 adults with early-stage diabetes-related retinopathy (also called non-proliferative diabetes-related retinopathy) and excellent vision. At the beginning of the study, about half of the eyes received Eylea injections every 16 weeks, and the other half received a placebo injection (which included no medication). The preliminary data were reported through two years. The study will continue for a total of four years.

The researchers were studying two main outcomes in these eyes:

  • Changes in the anatomy of the retina (for evidence of either a more advanced stage of diabetes-related retinopathy, called proliferative diabetes-related retinopathy, or the development of swelling called center-involved diabetes-related macular edema). These can be thought of as structural changes in the eye.
  • A functional difference in participants’ ability to see, known as their visual acuity. See below for key findings after two-years:

The trial found that Eylea led to improved anatomical outcomes and reduced the risk of more serious eye complications:

  • Eylea reduced the risk of developing complications by 68% when compared to the placebo. The probability of developing any complication was 16% in the Eylea group and 44% in the placebo group.
  • Individually, participants taking Eylea were 66% less likely to develop more advanced stages of diabetes-related retinopathy (proliferative diabetes-related retinopathy) and 64% less likely to develop macular edema with vision loss.
  • People receiving placebo injections were five times more likely to need additional treatment (with Eylea) with worsening of the eye disease.
  • There was no difference in the vision quality of either group after two years (excellent vision in 75% of the treatment group and 72% of the placebo group).

The four-year results of the trial will be important in determining whether the higher rate of complications in the placebo group might eventually lead to more vision loss in that group. If this is the case, treating diabetes-retinopathy in its earliest stages with Eylea may present a long-term benefit for vision.

There are several treatment options for diabetes-related eye disease, including oral medications, laser treatments for the eyes, and therapies like Eylea. Increasingly, surgical techniques are being used for less advanced stages of diabetes-related eye disease. Other novel strategies are also being investigated to avoid needing regular injections into the eye.

More information is needed before Eylea can be considered for use as a widespread tool to prevent worsening of diabetes-related retinopathy. Dr. Sun’s bottom line for clinicians and patients? “With regular follow-up and rigorous evaluation, the chances of continuing to have good vision, even with severe non-proliferative diabetic retinopathy and moderate non-proliferative diabetic retinopathy, are excellent. I don’t think this study says that early treatment should be routinely given yet. It is important to hang tight and wait for four-year results.”

The most important action people with diabetes can take is to have an annual dilated eye exam, in addition to managing glucose, blood pressure, and cholesterol levels. If diabetes-related eye disease worsens, there a number of options that can be used to prevent vision loss. To learn more about protecting your eyes and treating eye disease, check out our series: Caring For Your Eyes.

Source: diabetesdaily.com

Amylin: The Forgotten Hormone

Most everyone knows that when someone has type 1 diabetes, their pancreas lacks the ability to produce the hormone insulin (or their pancreas doesn’t make enough insulin, as in the case of type 2 diabetes). What isn’t so well known is that the pancreas also produces another helpful hormone called amylin that people with diabetes also lack! A crucial hormone that was once unknown and not prescribed for diabetes management is now recommended for most people with diabetes to take via injection. So, what is it? This article will describe what Amylin is and why it is important.

What Is Amylin?

Amylin is an amino acid polypeptide hormone that is released by the pancreas at the same time as insulin, although in much smaller quantities (at a ratio of approximately 1:100).

Amylin is a crucial hormone that acts as a sidekick to insulin in people without diabetes. It is produced by the pancreas and helps inhibit glucagon secretion, preventing the rapid spike in blood sugar, and also helps slow gastrointestinal emptying and curbs appetite.

The hormone assists insulin in controlling postprandial blood sugars. Unfortunately, people with diabetes not only lose the ability to produce insulin, but they also lose the ability to produce amylin as well.

Why Is Amylin Important?

People without diabetes don’t have to worry as much about controlling their appetite, managing hormonal levels, or juggling their blood sugars because they naturally produce both insulin and amylin. Amylin inhibits the release of glucagon when eating (preventing blood sugar spikes), slows the digestion of food from the stomach, and curbs appetite.

People with diabetes can sometimes struggle with these issues due to lacking both hormones, but for patients in the United States, amylin analogs are available (via a daily or weekly injection before meals) to mimic the functions of this important hormone.

The Benefits of Amylin Analogs

Amylin analogs, like Symlin (approved in 2005 for use in the United States), have been shown to cause weight loss, lower HbA1c levels, and reduce the average amount of insulin needed to manage blood sugars in people with diabetes. Amylin analogs can be used to treat both type 1 and type 2 diabetes in conjunction with insulin therapy. Although not approved for use in children, several studies have shown that amylin analogs are safe and effective when taken by adolescents. Doctors may prescribe amylin analogs off-label to children under the age of 18.

People with diabetes can take injectable amylin analogs before meals to help with postprandial blood sugar levels and help manage both appetite and weight gain.

Potential Side Effects

The most common side effects of amylin are:

  • Nausea
  • Vomiting
  • Headache
  • Hypoglycemia (especially if used in conjunction with insulin)

These side effects typically occur at the beginning of treatment and decline as the body adjusts to the medication.

Research shows that the regular use of amylin analogs in people with diabetes lowers HbA1c levels, fasting blood glucose levels, triglycerides and cholesterol levels, increases time-in-range (TiR), and helps people with diabetes manage their appetite and lose weight. It also reduces blood sugar variability, helping to prevent long-term complications. Talk with your doctor about whether incorporating amylin analogs into your diabetes management therapy is a good choice for you

Source: diabetesdaily.com

New Therapy to Treat Type 1 Diabetes Rolls Out Clinical Trial

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

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

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

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

Photo by iStock

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

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

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

Now, additional clinical trials are poised to begin:

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

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

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

Source: diabetesdaily.com

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