Top Ten Myths About Peer Programs

I have been living with type 1 diabetes for almost 30 years (this October 19th marks my 30th diaversary) and I’ve worked in the diabetes industry for over 20 years. I’ve primarily focused my career on community education and peer programs and have seen time and time again how beneficial they are. But I’ve also heard, for a variety of reasons, that many are reluctant to take part in a community or join a group. And we think it might be due to some misconceptions or myths about peer programs. Here’s our list of the top ten myths about peer mentorship!

Myth #1: My healthcare team is the most important part of my diabetes management. 

YOU are the most essential part of your diabetes management. You manage your diabetes for 525,600 minutes per year. While your healthcare team is vital, research suggests that a peer community is just as important as an educated healthcare team.

Fisher et al. conducted a systematic review that analyzed data from peer support for diabetes management studies and concluded that,

“across diverse settings, including under-resourced countries and health care systems, PS [peer support] is effective in improving complex health behaviors in disease prevention and management including in diabetes.” 1

If you visit your diabetes healthcare provider (HCP) once per month for 20 mins, that’s only 240 minutes per year. Yah, it’s all you. Give yourself a high five – this is hard work! Regardless of the type of program, a peer community can help you in so many different ways. Emotional support, stress relief, guidance, learn to advocate for yourself, exposure to various management tools, techniques, devices, and medications, and the list goes on! Being around like-minded people going through the same thing – just.makes.sense.

Myth #2: I don’t need it – my diabetes is well managed. 

That’s awesome and we’re excited to hear that! Over the years, I’ve often heard the comment, “I didn’t know I needed it until I was there.” A peer program, whether that be an event or group, can fill a gap you didn’t know existed.

We can learn things from our peers that we just can’t from our team of doctors and nurses. For example, you might not be aware of specific tips and tricks that people with diabetes use concerning their devices, medications, insurance plans, or assistance programs. Peer groups can also help us fine-tune our diabetes management in different ways than our healthcare teams can. They are there when the going gets tough, and you need someone who “gets it.”

A good friend of mine, doing well and happily managing his diabetes, had no desire to use CGM (continuous glucose monitoring) technology. He attended an event and saw his friends using one and realized he could fine-tune things even more. It was because he saw others using it and was able to speak to them about their experiences; he decided to give one a try. Six years later, he’s still using one and doing better than ever.

Myth #3: I only need a peer community or mentor when first diagnosed.

Having someone walk you through what to expect or be there with you as learn can be impactful. But diabetes is lifelong, and that means it can change over time. Life ebbs and flows, and so can our management and ability to focus on it. Having people who “get it” and you can turn to can be beneficial at any stage!

Myth #4: A peer program is all about complaining. I don’t want to be part of a pity fest. 

We hope not! I know in my peer group I can post funny anecdotes (those things that only people living with diabetes would get a laugh out of), ask questions, figure out what to make for dinner, but yes, also vent if I need to.

The way I’ve managed my diabetes has changed over time throughout my life, and my peer group has been so helpful and empowering along the way. We hope our peer mentorship program will be a source of positive relationships and interactions.

Myth #5: My diabetes will be reversed if I join a mentorship program.

We wish this were always true. According to a small study 3, people diagnosed less than four years ago with type 2 diabetes found that drastic calorie reduction normalized blood glucose and insulin resistance. Thus, stopping diabetes in its tracks. However, this study did not include anyone using medication and had strict exclusion criteria. Therefore this result may not be true for everyone. Alongside lifestyle changes (nutrition, exercise, sleep, and stress reduction), sometimes medication is needed to help the body work more effectively and efficiently. Joining a program or group can help you find the resources and support you need to make those necessary changes and stay the course.

Myth #6: I will be shamed or judged for my choices or medications I’m using or not using.

We’re sorry to hear if that’s the experience you’ve had previously! For many communities and programs (including Facebook groups), most have guidelines each person must adhere to in order to participate. In our forum, there are Community Guidelines (rules for posting). Our Peer Mentorship Program encourages empowering language and not “shoulding” each other (“You should or shouldn’t do this.”) Instead, we speak from our own experiences, what has and has not worked. Each person is on their journey, and it takes time to reach your goals. What works for one person doesn’t necessarily mean it will work for you (diabetes would be SO much easier if we could all do the exact same thing and get the same results!) Most times, you’ll need to experiment to find the combination of things that work for you, whatever those things may be. One step forward at a time.

Myth #7: It’s too much time. I don’t want to spend more time talking about diabetes.

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We totally get it! Joining any program involves a time commitment, but what you put in, you get out. We know that talking about our experiences creates a sense of connection and belonging, which can help us cope during difficult times. It can also be more efficient to talk about options and choices with real-life users before starting something new or making changes. Sharing what is going on, asking questions, learning from other’s challenges, and helping others can pay you back in dividends.

Myth #8: These types of programs don’t work.

We hope they do, and research shows they do work! Peer programs are an option or piece of a larger puzzle. It’s one area that can help you manage your diabetes, but you have to show up and participate. Specifically, in the Diabetes Daily peer mentorship program, we ask that you set some goals to work towards them and use the community for help. You create the goals, and they can be as small or grand as you like.

See what our previous program participants had to say:

“I really enjoyed my time chatting with others and seeing how others managed their diabetes. It [the program] gave different perspectives but I always felt very supported. I felt I also helped my mentor with their diabetes.” 

 

“I learned so much from my mentor! He had tons of knowledge and I changed a lot of my lifestyle based on information from my mentor and the group.” 

 

“I learned about diabetes technology that I would have not known about.” 

 

“I was very introverted and not ready to accept my diabetes. This program made me realize how important it is and that I can’t ignore it.” 

Myth #9: All of these programs are the same.

Every program is different and unique. Take Weight Watchers; for example, it previously focused on in-person group weigh-ins and meetings. Now, the program uses an app and online support to help members reach their weight loss goals. Alcoholics Anonymous (AA) is composed of in-person group meetings and a one-on-one sponsor relationship. Cancer support groups often meet in person with a social worker, mental health professional, or facilitator to discuss their experiences, feelings, and emotions. Diabetes Daily has an anonymous online forum where you can freely post your questions and answer other people’s. The re-launch of our mentorship program is more similar to AA, where you have a partner to connect one-on-one with and group sessions where you can learn from others’ experiences and stories.

Myth #10: It’s a diabetes education program.

Yes and no. It’s what we call peer support and peer education. By listening to others’ successes and their challenges, you learn about real-life experiences. For example, it’s invaluable to hear about a medication’s common side effects and address these with your doctor before trying something new. Not everyone will react the same, but we know sharing your tips and tricks can help others. Continuing to work with your healthcare team is vital as they are the ones who will address medications and any changes to those.

To learn more or join our peer mentorship for people living with type 2 diabetes, head to our Mentorship page. Registration closes August 28th, 2020, and the program begins September 1st. We hope you’ll join us!

References

1. Fisher, EB, Boothroyd, RI, Elstad, EA; “Peer support of complex health behaviors in prevention and disease management with special reference to diabetes: systematic reviews” (2017) Clinical Diabetes and Endocrinology DOI: 10.1186/s40842-017-0042-3  Accessed: 8/21/2020 https://clindiabetesendo.biomedcentral.com/articles/10.1186/s40842-017-0042-3  

2. Warshaw H and Edelman D; “Building Bridges Through Collaboration and Consensus: Expanding Awareness and Use of Peer Support and Peer Support Communities Among People With Diabetes, Caregivers, and Health Care Providers” (2018) Journal of Diabetes Science and Technology DOI: 10.1177/1932296818807689 Accessed: 8/21/2020 https://journals.sagepub.com/doi/full/10.1177/1932296818807689#

3. Lim, E.L., Hollingsworth, K.G., Aribisala, B.S. et al. “Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol” (2011) Diabetologia 54 DOI: 10.1007/s00125-011-2204-7 Accessed: 8/21/2020  https://link.springer.com/article/10.1007/s00125-011-2204-7#citeas

Source: diabetesdaily.com

Teenage Boy Receives Novel Stem Cell Therapy

Editor’s note: This article was updated on 7/31/2020 for accuracy regarding the specific stem cell treatment used. 

A lot of research is ongoing to develop novel therapies for type 1 diabetes. Many investigators are now focusing on the potential of various stem cells therapies. One approach involves using mesenchymal stromal cells (MSCs) (which can be obtained from the umbilical cord) and directly injecting them into the pancreas in an effort to induce insulin production. These kinds of treatments are still in the early experimental stages, with some clinical trials ongoing.

Seeking an Experimental Treatment Abroad

Just last week, Vera and her son Aaron set out to have the procedure done at Cryovida in Mexico. After having a difficult time managing his diabetes, Vera vowed to do whatever it took to lessen the burden for both her son and herself. Since Vera first posted about their upcoming journey, the diabetes online community became intrigued. Vera even started a Facebook page where people could learn and ask their questions. I thought it would be good to hear from Vera about the whole experience and how Aaron is doing now.

At what age was Aaron diagnosed with type 1 diabetes?

He [had] just turned 15.

How have Aaron and your family been managing with his diabetes leading up to this life-changing procedure?

Probably the hardest time in our lives. In the honeymoon stage, my son’s attitude was almost impossible to deal with. As he got used to monitoring and stabilizing, he improved. My son is on the spectrum, so he was always difficult. He would forget to take his long-lasting insulin, not cover for the junk he would eat, and his sugars were almost always over 500. It was living in hell. Six months ago, my son came to live with me in Mexico (he was living with my mom in NJ, because he wanted to finish school, and we moved to Mazatlan, Mexico 3 years ago). When he came his blood work was so bad that the doctor didn’t know how he was walking. His A1C was over 20, his triglycerides were over 700! The doctor immediately changed his insulin. He said they had him on such a low dose, no wonder we could never control it, and put him on cholesterol meds, which my son never took. Just two months later my son’s triglycerides went down to normal (and he never took a single med for it; It is just the fresh food here), and his A1C was down to 18. By the time we went for the procedure, his A1C was down to 15.9. My son still doesn’t listen, and eats tons of junk, does not cover for it. I have to be on top of him 24/7 to check his blood and take his insulin. So, if this works I may retire from my position of a drill sergeant.

What prompted you to start looking for possible cures or treatments? How did you hear about Stem Cell Educator Therapy?

My son [was] almost dying, and his dream to go into the military was taken away from him. My husband is a retired Vet, his father is a retired Vet, my grandfather was a retired Vet. We are a military family. This may give him the opportunity to serve, which is all he wants. I heard about it from research. I started googling diabetes cures and ran across different articles for stem cells. I always read everything, I rarely follow what is being pushed by news or politicians. I sit and read.

What are the benefits of this procedure for a patient living with type 1 diabetes? And what are the risks involved?

Well, ultimately a full cure, but for those that do not get cured, it lowers their need for insulin substantially. Risks… honestly not much [from] the procedure itself, but the normal risk, possible bleeding, pain in the area. Long term, diabetes can come back. Scientists still have not figured out how to protect the new beta cells from being attacked again by your immune system. For me, that is a risk I can live with. Even if he gets a year diabetes-free, I would pay and do the procedure again. The longest known case has been diabetes-free for 3 years now.  I am hoping [the]  next huge development will be scientists figuring out how to protect the new beta cells.

How did Aaron feel about it? Was he nervous? Excited? Or a little bit of both?

OMG, he was a mess. At first, he was stoked about it. He couldn’t wait. Then came time for the procedure, and he was like, “nope”. He was sitting in the huge cat scan room where they were doing the procedure saying “no, I don’t want it”. I had to tell the anesthesiologist to get him sedated ASAP, or my son was about to run out of the hospital in the gown down the street!

How was it dealing with Renu and Cryovida? How were the doctors? Were they able to speak English so they could communicate with Aaron?

First, I am lucky enough to live in Mexico, but I speak horribly. We were able to set up the full thing in one week. The reps did everything. They spoke perfect English. Once at the hospital, the doctors spoke English, Went through every piece of paper I signed, explained everything to me and my son. Let my husband and I be in the room until the procedure started (even though the hospital had a rule; one person per family due to COVID). After the procedure, all the doctors came in, explained everything. Gave me all the paperwork. The reps from Renu came with us from Mazatlan to Guadalajara, a six-hour drive, and stayed the whole full three days with us to make sure everything was okay. It was an overall great experience.

Image credit: Vera Mazatlan

How long did the procedure take and generally speaking, how is it done?

They were done in an hour, but most of the time was prep. The actual procedure takes 10 minutes. They make a hole in the femoral artery and lead a scope into the pancreas, where they then inject the cells.

How does Aaron feel now after the procedure? Did he have a lot of pain right after?

He feels amazing. The first thing he noticed is that his eyesight was no longer blurry. He was only in pain on the first day. Now he is back to his crazy self. He also has tons of energy. He was so sluggish before. That is the biggest change.

Have you noticed any changes to his blood sugars yet? Do you notice any fewer peaks and valleys? Has he tried experimenting with new foods or is this too soon?

When can he expect to see some results? I have noticed his blood sugar is lower, even after he eats junks. He is 17, controlling him to eat right is IMPOSSIBLE! They said I should start seeing a real difference in about 45 days to 6 months. Depends on each person.

Now that is it over and behind Aaron, how is his perspective looking forward to living with this disease? Is he glad he did it? I bet he can’t wait to see the results!

He is beyond grateful to possibly be given a chance to be diabetes-free. He still wants to go into the military. To him, this is a gift he would never get. I made him a promise [that]  if there was a way to cure him, I would pay any amount of money, and go anywhere to do it. I have fulfilled my promise.

What would you share with our community who has been so intrigued by your story, any advice you could share having gone through this with your own child?

Never give up hope, and never take no for an answer. If the doctor is not giving you the answer you want, get a second, third, fourth, doesn’t matter how many opinions. There is always hope and new science out there. Yes, it can be expensive, but ask yourself, what is your child’s health worth to you? Also, READ EVERYTHING. Science changes monthly. Keep reading, keep joining groups, keep reaching out. Forget what you hear on the news and from politicians, you are the advocate for your child. Go against the grain, and be a trendsetter. Those are the people that make a difference.

Vera, thank you so much for sharing both you and your son’s experience. We wish Aaron nothing but health and happiness and we will continue to follow his journey!

What are your thoughts on this kind of experimental treatment? Is this something you would consider? Share and comment below!

Source: diabetesdaily.com

Did a Virus Trigger Your Type 1 Diabetes?

Type 1 diabetes is an autoimmune disease– that is, a disease resulting from the immune system attacking the body. In the case of type 1 diabetes, the immune system mistakenly attacks the beta cells in the pancreas that produce insulin, and without insulin-producing beta cell function, one develops type 1 diabetes, and quickly. Researchers still are not 100% sure what causes type 1 diabetes, but many believe that a virus can “trigger” the body into attacking itself, resulting in disease.

Why does this happen? When a virus invades the body, the immune system starts to produce a response to fight the infection. T-cells are central to recognizing and fighting off the virus. However, if the virus has some of the same antigens as the pancreatic beta cells (in the case of type 1 diabetes), the T cells sometimes actually start attacking the body’s own beta cells. Once all of the body’s beta cells have been destroyed, type 1 diabetes is developed and diagnosed.

It can take more than a year for the body’s T-cells to destroy the majority of the beta cells, but that original viral infection is hypothesized to be a trigger in the development of type 1 diabetes.

A recent study showed that kids exposed to enteroviruses are more likely to develop type 1 diabetes. Enteroviruses are a group of viruses that usually cause mild symptoms, similar to that of the common cold. Certain strains, such as the poliovirus or hand, foot, and mouth disease, can cause more serious complications.

Researchers in Finland tested more than 1,600 stool samples from 129 children who had recently developed type 1 diabetes and 282 children without diabetes for enterovirus RNA (a marker of previous exposure to infection). They found a significant difference: 60% of the control group showed signs of prior infection (without diabetes), versus 80% of the group with type 1 diabetes.

The results also showed that children who developed type 1 diabetes were exposed to the enterovirus more than a year before their diabetes diagnosis; taking this lag time into account, the researchers proved that children with diabetes are exposed to three times more enteroviruses than children without diabetes.

vaccine against enterovirus

A vaccine against enteroviruses may help prevent type 1 diabetes. | Photo credit: Adobe Stock

Researchers are hopeful about current trials, showing vaccines against enteroviruses could potentially prevent 30-50% of new cases of type 1 diabetes, but not all infections can be prevented.

Jessica Dunne, PhD, director of discovery research at JDRF, is excited by the current research. “Enteroviruses are not the only trigger for diabetes, so it’s important to note that even if we prevented all enterovirus infections we probably wouldn’t be able to prevent all cases of type 1 diabetes. I think it would go a long way,” Dunne said.

Clearly, other genetic and environmental facts are at play in the development of type 1 diabetes, but a growing amount of research is pointing to a virus as a common trigger. Other studies have shown that pregnant mothers with antibodies from enteroviruses go on to have children who develop type 1 diabetes.

Not every virus can trigger this reaction ending in disease. The virus must have antigens that are similar enough to the antigens in beta cells (and thus could easily be confused by the immune system); those viruses include:

  • B4 strain of the coxsackie B virus
  • German measles
  • Mumps
  • Rotavirus

There is even new, mounting evidence that the current COVID-19 (SARS-CoV-2 virus) pandemic could be triggering a new wave of type 1 diabetes diagnoses now and into the future.

There is still much debate in the medical community over the exact cause of type 1 diabetes, and most researchers believe it to be a mix of genetics and environmental factors, but the theory of enterovirus-triggered diabetes is gaining support from physicians and researchers alike. There is still much to be explored in the development of type 1 diabetes, but research like this is promising for the eventual development of a vaccine to help prevent new type 1 cases worldwide. Understanding viruses and their connection to the immune system can help unravel the medical mystery of type 1 diabetes without an apparent cause.

What was your experience when you were diagnosed with type 1 diabetes? Were you extremely sick with a viral illness, several months or even years before diagnosis? Do you think a virus could have triggered your diabetes? Share this post and comment with your story, below! We love hearing from our readers.

Source: diabetesdaily.com

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

This content originally appeared on diaTribe. Republished with permission.

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

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

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

Diabetes Technology

Diabetes Drugs

Nutrition, Exercise, and Mindset

Access to Care and Policy

Diabetes Technology

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

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

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

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

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

Graph

Image source: diaTribe

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

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

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

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

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

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

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

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

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

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

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

Image source: diaTribe

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

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

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

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

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

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

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

A1C ethnicity

Image source: diaTribe

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

Messages

Image source: diaTribe

SENCE

Image source: diaTribe

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

CITY

Image source: diaTribe

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

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

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

CGM

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

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

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

Parent Perspectives on DIY Closed-Loop

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

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

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

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

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

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

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

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

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

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

Early CGM use can help kids and predict T1D progression

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

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

Diabetes Drugs

VERTIS-CV Trial of Steglatro and Heart and Kidney Health

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

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

Read more about the trial in our full article here.

New Data Shows Teplizumab Delays Diagnosis of Type 1 Diabetes

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

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

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

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

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

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

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

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

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

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

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

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

Weekly Basal Insulin – The Wave of the Future?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A Debate on the Use of Sulfonylureas in Type 2 Diabetes

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

Benefits of SUs:

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

Challenges of SUs:

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

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

The Debate on Metformin and Insulin Use During Pregnancy Continues

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

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

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

Nutrition, Exercise, and Mindset

New Physical Activity Recommendations for Adults and Children

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

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

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

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

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

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

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

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Food as Medicine! Geisinger’s Fresh Food Farmacy

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

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

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

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

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

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

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

A Sneak Peek into the Film Blood Sugar Rising

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

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Image source: diaTribe

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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Image source: diaTribe

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

Breaking Updates from TrialNet (ADA 2020)

TrialNet is a research effort that seeks to identify preventative and treatment strategies for type 1 diabetes. New data was just released at the American Diabetes Association (ADA) 80th Scientific Sessions. Here are the major highlights:

1. The optimal age for screening children at risk for type 1 diabetes

It is possible to screen at-risk individuals for the development of autoantibodies that are predictive of T1D development. This can reduce the likelihood of health complications due to a late diagnosis as well as allow patients to enroll in clinical trials aimed at preventing or delaying T1D onset. Researchers recently evaluated the sensitivity, specificity and predictive values based on the screening ages of children at risk for developing T1D. They concluded that it was best for two separate screenings to occur; one around the age of 2-3 years and another at around the age of 5-6 years. “Our data represent a starting point for these considerations that should be customized based on the population’s underlying disease characteristics and public health infrastructure,” they added.

2. Identifying those at risk

How do we identify those who are most at risk for developing T1D? Currently, beta cell function analysis, utilizing glucose tolerance tests and other, more invasive measures, are used. New research demonstrates that using a validated (in type 2 diabetes) mathematical tool may be able to help make this assessment for those at risk for type 1 diabetes from “fasting glucose and insulin measurements from a single time point.” This could afford a fast and relatively non-invasive way to predict risk in the future.

3. Antibody-positive individuals with very slow progression to type 1 diabetes

It is established that people can develop T1D at different rates, after the initial appearance of autoantibodies. New research aimed to characterize the features of “long-term non-progressors.” Interestingly, data revealed that those whose disease onset did not progress long after autoantibody detection, still had a decline in beta cell function, but nevertheless exhibited largely stable glucose profiles and c-peptide levels. Researchers speculate that glucose tolerance testing in those with autoantibodies may help identify those who are less likely to progress to T1D.

4. Pancreas volume and type 1 diabetes progression

New research demonstrates that not only is pancreas size at the onset of T1D and in those at risk smaller, pancreas size is also predictive of T1D risk. The study evaluated those with “stage 1” T1D (those who have two or more autoantibodies, but normal glucose tolerance) and found that their pancreas volume was significantly smaller than that of healthy controls (but significantly larger than those with “stage 3” T1D (showing autoimmunity and hyperglycemia, with symptoms). Although the sample size was relatively small, the data indicate that pancreas size (as measured by MRI) could be a predictive indicator of T1D development.

5. Oral insulin for those at risk of developing type 1 diabetes

Relatives of people with type 1 diabetes (T1D) who were identified as “high-risk” for also developing the condition participated in a prevention trial that used oral insulin (OI) in this population. While overall, the treatment did not appear to be effective in preventing T1D in initial analyses, a further analysis of patient subgroups revealed an interesting trend. Among those who were identified as being at the highest risk for developing T1D (high auto-antibody levels; hindered first-phase insulin response), data indicate that OI can “slow insulin decline”.

Read more about TrialNet and the work they’re doing here:

New Treatment Delays Type 1 Diabetes

Please share this article and stay tuned for more news from the ADA Scientific Sessions.

Source: diabetesdaily.com

Updates on the Environmental Triggers of Type 1 Diabetes (ADA 2020)

The onset of type 1 diabetes (T1D) usually entails a genetic predisposition to developing the condition, as well as an “environmental trigger” (such as a viral infection, or another exposures). As we previously reported, a multi-center international research effort called TEDDY (The Environmental Determinants of Diabetes in the Young) has been investigating potential environmental triggers that may induce the onset of type 1 diabetes in children since 2004.

As described in the most recent press release:

“TEDDY is aiming to discover viruses and nutritional factors that interact with genes to “trigger” immune destruction of the beta cells, marked by the appearance of islet autoantibodies. The study enrolls infants identified as “at-risk” for developing T1D and follows them for 15 years to look for the appearance of various beta-cell autoantibodies and diabetes. TEDDY has also studied biomarkers that can predict faster or slower progression to diabetes after the autoimmune destruction has begun.”

Now, new data on environmental connections between type 1 diabetes as well as celiac disease were just presented today at the American Diabetes Association (ADA) 80th Scientific Sessions. Dr. Marian Rewers, MD, PhD from the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine, along with other presenters, provided the new research updates.

Key Takeaways

Here are the major highlights:

  • It appears that beta cell destruction often begins very early in life; as early as in the first two years of life.
  • There may be two distinct subtypes of type 1 diabetes that are characterized by differences in their genetics, immune system, and various metabolomic markers.
  • The value of HbA1c as a predictive factor for developing type 1 diabetes may differ between youth and adults who develop the condition.
  • Presence of enterovirus B in stool samples is predictive of islet autoimmunity development in children.
  • The gut microbiome composition tends to be different in children who develop islet autoantibodies as compared to those who do not. The use of probiotics may help to mitigate this risk.
  • Use of antibiotics WAS NOT shown to be related to autoimmunity.
  • Vitamin D, vitamin C, and polyunsaturated fats may carry preventative benefits against autoimmunity, although this needs to be validated in further studies.

Another interesting update was concerning the environmental determinants of celiac disease. There is some overlap in the genetic factors that are associated with the development of type 1 diabetes and celiac disease. Interestingly, recent research has identified a link between the consumption of gluten early in childhood and an increased risk for developing celiac disease among those with a genetic predisposition.

Dr. Rewers had this to say in summary:

“While T1D and celiac disease share a lot of genetic characteristics, there are intriguing differences in the ways these diseases develop and progress,” added Dr. Rewers. “TEDDY is contributing exciting clues for design of future trials to prevent both T1D and celiac disease.”

Conclusions

The multidisciplinary international TEDDY research effort continues to uncover important pieces of the complex puzzle to explain exactly how and why certain individuals develop type 1 diabetes and other autoimmune conditions. Understanding the relationships between genetic predispositions to autoimmune disease and how they may be triggered is critical to the development of effective preventative strategies in the future.

Stay tuned for more research updates from ADA 2020!

Source: diabetesdaily.com

New Therapy Shows Promise in Children with Newly-Onset Diabetes (ADA2020)

Research is ongoing around the world concerning the delay of progression and the prevention of type 1 diabetes. The etiology of the disease has been extensively characterized, but all the events and processes that drive and maintain autoimmune attack on the insulin-producing cells are still not fully understood.

One avenue of current investigation involves the clinical application of Tregulatory (Treg) cells. This population of immune cells have many functions, and importantly, serve to help the body recognize the self (“self-tolerance”) and to prevent aberrant attack on healthy tissues (autoimmune disease).

Dr. Piotr Trzonkowski, M.D., Ph.D from the Medical University of Gdansk in Poland has focused his career on investigating, developing, and applying cell-based therapeutic approaches. He presented his most recent work as part of the late-breaking poster session in the Diabetes Prevention category at the American Diabetes Association (ADA) 80th Scientific Sessions this weekend.

The research focuses on utilizing Treg cell therapy in combination with an antibody against a molecule called CD20. This molecule is expressed by immune cells populations (B cells) that are involved in mediating autoimmune disease (read more about anti-CD20 therapies here and about targeting B cells for type 1 diabetes therapy here).

Study Design

This phase II clinical trial utilized the combinational treatment (TrCD20) as part of a study that enrolled 36 children with a recent type 1 diabetes diagnosis. The participants were divided into three groups: control , Treg therapy alone, or the combinational therapy (TrCD20). All patients were followed for a period of two years, and various clinical parameters, such as blood glucose levels and beta cell function, were evaluated and compared between the groups.

Major Outcomes

The main finding in this study was that patients who received the combinational therapy fared better than the other groups with respect to multiple parameters, including fasting and stimulated c-peptide levels (c-peptide is a measurement of insulin production). Also, patients in both treatment groups exhibited lower HbA1c levels and lower fasting blood glucose levels throughout the study. The researchers noted that:

“TrCD20 group was in partial remission defined as insulin dose below 0.5 IU/kg up to +21 months. The longest insulin independent follow up lasted 18 months. The end of the remission in Tr group was noted at +18 month and in controls at +12 months. At the +24 months daily insulin requirement and HbA1c levels were significantly lower in TrCD20 as compared to control group.”

Conclusions

This phase II clinical trial demonstrated increased efficacy of combining cell-based therapy and antibody treatment to achieve longer beta-cell function in children with newly-diagnosed type 1 diabetes. Importantly, in addition to the potential glycemic management benefits, delaying the progression of type 1 diabetes at the early stages may also allow for the clinical application of several novel therapies aimed at halting disease progression.

For example, consider the following research that we have reported on over the last year:

Personalized Therapies for Type 1 Diabetes Take Center Stage 

TrialNet Updates: New Treatment Delays Type 1 Diabetes Onset 

“Inverse Vaccine” to Treat Type 1 Diabetes Passes Phase I Clinical Trial

We will continue to keep you posted of ongoing developments and promising new approaches. Please stay tuned for our ongoing coverage of the most recent research presented at the ADA Scientific Sessions.

Source: diabetesdaily.com

“Inverse Vaccine” to Treat Type 1 Diabetes Passes Phase I Clinical Trial

In people with type 1 diabetes (T1D), the immune system destroys the insulin-producing cells in the pancreas, leading to high blood glucose levels, which are deadly if left untreated. All people with type 1 diabetes rely on insulin injections or infusions to regulate their blood glucose levels. Individual insulin requirements are affected by many factors and tailoring the dosing regimen around the clock requires a lot of mental effort, with many patients finding it difficult to consistently achieve their target ranges.

The search for better clinical approaches for type 1 diabetes is ongoing, with many labs around the world focusing on better treatments and the ever-elusive “diabetes cure”. Most recently, researchers at the City of Hope described the first-ever human phase I clinical trial of a “inverse vaccine” to treat type 1 diabetes patients.

We previously reported on this novel potential treatment approach when it was still in its pre-clinical stages at the ADA Scientific Sessions last June. Now, we have reconnected with the lead researcher, Dr. Bart Roep, Ph.D., the Chan Soon-Shiong Shapiro Distinguished Chair in Diabetes at City of Hope and director of The Wanek Family Project for Type 1 Diabetes, to learn about the outcomes of the first-ever human trial.

What Is an “Inverse Vaccine”?

When we think of a vaccine in a traditional sense, we are usually referring to the stimulation of the immune system to develop an immunity and prevent illness from a particular microbe. An “inverse vaccine”, on the other hand, is designed to stop a specific immune response (e.g., the unwanted autoimmune response that destroys beta cells in patients with type 1 diabetes).

How Does the Treatment Work?

This treatment aims to retrain the patient’s immune system to self-tolerate the insulin-producing beta cells in the pancreas. First, specific immune cells (called dendritic cells, DCs) are collected from the patient’s blood and are specifically treated, in particular, with pro-insulin peptide and vitamin D. When the stimulated cells are injected back into the patients, in a series of “vaccinations”, they can elicit a specific subset of the patient’s T cells (regulatory T cells, or Tregs), which should, in turn, act to regulate the unwanted autoimmune response seen in type 1 diabetes.

Dr. Roep explained more:

“We want to negotiate with the immune system rather than bombard it into submission, because the latter may affect your chances of fighting off cancer and infections, including coronavirus.”

First Clinical Trial Results Show Promise

The novel vaccine was recently tested to assess safety and tolerability in nine patients with type 1 diabetes of long duration (at baseline, only three patients had detectable C-peptide levels, indicating some degree of insulin production). The results of the study were just published last week.

The treatment “passed the test” with respect to serious adverse events. The researchers describe that,

“Most importantly, there were no signs of systemic immune suppression, no induction of allergy to insulin, no interference with insulin therapy, and no accelerated loss in beta-cell function in patients with the remaining C-peptide. In conclusion, generation and intradermal administration of [the treatment] appears feasible and safe.”

Clinicians monitored various other health parameters throughout the trial, including glycemic management, which remained stable for all participants. Notably, Dr. Roep stated that,

“With regard to the unexpected clinical benefits: while we told the participating patients that it was a safety and feasibility trial, they have all-time low HbA1c years after our therapy (long after the trial ended) and on average, 13 years after their diagnosis. This is bizarre, and could point to beta-cell regeneration (perhaps once you stop the immune attack) or possibly waking up hibernating beta cells that came out of hiding after the immune system got back in check. Speculation, of course, but tantalizing observation nonetheless, in the preferred direction.”

Why were patients with long-standing diabetes selected for this initial investigation? Dr. Roep explained:

“There are two reasons why we involved patients with long-term disease.

First, to build-in extra safety precautions in this first in-human trial, we selected patients with long-term disease whose condition is less likely to worsen. After all, we injected a vaccine built on their pancreatic islets, so in theory, this could aggravate islet autoimmunity.

The other reason is a frustration that I share with my stakeholders, the diabetes patients: all efforts to intervene in the disease are biased toward a short period after diagnosis. We just learned that most patients keep beta cells for most of their lives, so it is worth protecting those beta cells and serving patients with longstanding T1D at the same time. Our novel strategy is also perfectly suited to do so: perhaps it is even smarter to negotiate with the immune system once the medical emergency is over and remaining beta cells (and the immune system) get some rest. All other strategies so far bombarded the immune system into submission; this big hammer is probably better justified early on.”

You can read even more about the study, including the patient selection process and the specific treatment protocol here.

What’s Next?

Based on the success of the phase I trial that evaluated the safety and tolerability, the research group expect to conduct more human testing:

“Our results warrant subsequent clinical testing in patients with a shorter diagnosis of type 1 diabetes and with preserved C-peptide production, to assess whether this novel immune intervention strategy is able to delay or halt progressive loss of beta-cell function. Further testing would tell whether [the treatment] protects beta cells from autoimmune destruction and can act as curative therapy for type 1 diabetes.”

Dr.  Roep and colleagues are optimistic about the future:

“Our research brings us one step closer to finding a vaccine against type 1 diabetes, an ambitious quest at City of Hope, and the hope of many patients with this disease.”

Of course, there is a long road ahead before we can know for sure whether this type of therapy will be truly effective. Moreover, the way that type 1 diabetes develops differs between patients, and it is likely that immunotherapies will have to be tailored to different patient subsets, as we previously discussed with Dr. Roep.

Nevertheless, such a tailored approach constitutes a previously unexplored form of treatment for type 1 diabetes patients, which could lead to effective therapies, and perhaps even a cure. We will continue to follow this research and provide updates as more research is conducted.

Read the official press release about this clinical trial from the City of Hope here.

Source: diabetesdaily.com

Research Trends with Dr. Maria: Beta Cells, Botox, and More

Dr. Maria Muccioli holds degrees in Biochemistry and Molecular and Cell Biology and has over ten years of research experience in the immunology field. She is currently a professor of biology at Stratford University and a science writer at Diabetes Daily. Dr. Maria has been living well with type 1 diabetes since 2008 and is passionate about diabetes research and outreach.

In this recurring article series, Dr. Maria will present some snapshots of recent diabetes research, and especially exciting studies than may fly under the mainstream media radar.

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Even Very Slightly Elevated Blood Glucose May Impact Beta Cells

When diabetes first develops, a reduction in insulin production initially results in just a slight elevation of blood glucose. A just-published study by researchers at the Joslin Diabetes Center employed cell culture and mouse models to assess how very slight elevations in blood glucose levels might affect the beta cells. Interestingly, the scientists discovered that even slight perturbations in glycemia (*as little as “being only 11 mg/dL higher than controls) could result in gene expression changes in the beta cells. The major conclusion of the investigation was that “mild glucose elevations in the early stages of diabetes lead to phenotypic changes that adversely affect beta cell function, growth, and vulnerability.” Continuing to investigate exactly how the early stages of diabetes may affect disease progression may aid in the development of treatments aimed at slowing or halting disease progression by preserving or improving beta cell function. This study also underscores the importance of early diabetes detection and treatment.

Different Subtypes of Type 1 Diabetes Classed by Age at Diagnosis

The pathophysiology of type 1 diabetes is complex, although it is generally accepted that in most cases, a genetic predisposition and an environmental trigger result in disease onset. A research study that was recently published in the journal Diabetologia aimed to investigate different subsets (endotypes) of type 1 diabetes by evaluating the level of insulin production from recently-diagnosed patients. Interestingly, the authors report that in patients who were diagnosed prior to age 30, “there are distinct endotypes that correlate with age at diagnosis”. Specifically, the new research showed that those who were diagnosed at a very young age (before seven years old) exhibited more defective insulin processing as compared to those diagnosed at age 13 and older. The scientists believe that stratifying type 1 diabetes cases by endotype will prove useful in the most appropriate design of immunotherapies to treat the condition.

Male and Female Offspring May Be Differently Affected by Maternal Diabetes

Hyperglycemia during pregnancy can negatively affect the offspring. A study published in April 2020 in the journal Brain, Behavior, & Immunity – Health indicates that the effects of hyperglycemia on central nervous system development may affect male and female offspring differently. Notably, the authors concluded that while hyperglycemia could cause developmental defects in males in females, when it came to “impairments in recognition memory,” specifically, it was found that only the females were negatively affected. Although this research was performed in rodents, it offers valuable insights into how maternal diabetes may affect offspring development in a sex-specific way. Notably, it was also demonstrated that insulin administration to achieve strict glycemic control mitigated the negative effects, once again highlighting the importance of optimal glycemic management before and during pregnancy.

Botox Injection Plus High-Protein Diet for Obesity Treatment

Interestingly, the injection of botulinum toxin (Botox) has been shown effective in the treatment of obesity. A research study recently published in the journal Obesity Surgery evaluated the efficacy of botulinum toxin injections alongside a calorie-restricted, high-protein diet for weight loss. Participants were assigned to one of three groups: 1) botulinum toxin treatment only; 2) botulinum toxin treatment + calorie-restricted/high-protein diet; or 3) calorie-restricted/high-protein diet alone. Excitingly, the results showed that patients who received botulinum toxin treatment prior to initiating the diet protocol achieved faster weight loss and experienced more positive effects in improving comorbidities. The authors theorize that botulinum toxin treatment may help “facilitate adaptation to the new diet style”.

“Kitchen Intervention” in Type 2 Diabetes Education Helps Improve Outcomes

Several educational intervention programs aimed at improving glycemic management in patients with type 2 diabetes were compared in a recent initiative by the Milwaukie Family Medicine center in Oregon. A traditional diabetes education class was implemented for one group of patients, while a second group was assigned to the traditional education program, along with a “health-focused, budget-friendly cooking class” provided by the Providence Milwaukie Community Teaching Kitchen. Hemoglobin A1c measurements were acquired at baseline, and at several months post-intervention. The recently published results demonstrated that patients who participated in the cooking class intervention, lowered their A1c levels more, on average, than those who attended the traditional education program alone. Although this initiative was a small one and yields very preliminary results, the outcomes suggest that intervention programs focused on real-life applications (like budgeting and cooking) may afford better patient outcomes.

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Please share your thoughts with us and stay tuned for more recent research updates!

Source: diabetesdaily.com

Research Trends with Dr. Maria: Cholesterol Benefits & More

Dr. Maria Muccioli holds degrees in Biochemistry and Molecular and Cell Biology and has over 10 years of research experience in the immunology field. She is currently a professor of biology at Stratford University and a science writer at Diabetes Daily. Dr. Maria has been living well with type 1 diabetes since 2008 and is passionate about diabetes research and outreach.

In this recurring article series, Dr. Maria will present some snapshots of recent diabetes research, and especially interesting studies than may fly under the mainstream media radar. Check out our first-ever installment of “Research Trends with Dr. Maria”!

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Allergen in Diabetes Tech Adhesives

Diabetes technologies, like insulin pumps and continuous glucose monitors, are steadily gaining popularity, especially among patients with type 1 diabetes. While the technological advances have shown considerable benefit in improving patient outcomes and quality of life, one common issue is the unfavorable reactions to adhesives. A recent study published in Diabetes Technology & Therapeutics identified that a common culprit of these allergic reactions to adhesives may be a chemical called colophonium, a commonly-used adhesive, which was shown to be an allergen in over 40% of patients in the small study. Read more about the study and the use of this adhesive in medical products here.

Bariatric Surgery May Worsen Retinopathy

Retinopathy (eye disease) is a common complication of diabetes, and can be serious, leading to severe visual impairment and even blindness, especially when left untreated. A recent study published in Acta Ophthalmologica has uncovered a potential link between patients who undergo weight loss surgery and worsening retinopathy. Researchers adjusted for confounding variables, including glycemic control (A1c) and found that those who underwent bariatric surgery experienced worse retinopathy outcomes. Although the sample size was small, the data showed a significant worsening of eye disease in those who underwent surgery as compared to controls. Learn more about the study and outcomes here.

Super Healthy Probiotic Fermented Food Sources

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Benefits of Probiotics for Type 2 Diabetes

The relevance of the gut microbiome in various health conditions, including diabetes, is gaining more and more attention. A recently published meta-analysis in The Journal of Translational Medicine discusses what we currently know about the effects of probiotic supplementation in patients with type 2 diabetes. Excitingly, probiotics can improve insulin resistance and even lower A1c! Learn more about exactly what the clinical trials have shown here.

Herbal Therapies Gaining Attention

With most modern medicines derived from plant compounds, it is not surprising that more research is being geared toward examining the effects of various herbal remedies on blood glucose levels and insulin sensitivity. A recent review published in The World Journal of Current Medical and Pharmaceutical Research summarizes the effects of some medicinal plants with potential anti-diabetic properties. Learn more about what is known about commons herbs and how they may be beneficial for glycemic control here.

Low HDL Cholesterol Linked to Beta Cell Decline

Research has previously suggested that higher HDL cholesterol levels may be protective of beta-cell function. A longitudinal study recently published in Diabetes Metabolism Research and Reviews indicated that patients with lower levels of HDL cholesterol were more likely to experience beta cell deterioration and develop type 2 diabetes than those with higher HDL cholesterol levels. Learn more about this study here.

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Please share your thoughts with us and stay tuned for more recent research updates!

Source: diabetesdaily.com

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