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1 Diabetes: The Search for a Cure Student Name Program Name or Degree Name (e.g., Bachelor of Science in Psychology), Brigham Young University - Idaho COURSE XXX: Title of Course Instructor Name Month XX, 202X

2 Diabetes: The Search for a Cure Imagine this: you are a young mother or father with a happy, healthy 17-month-old boy. He is eating solid foods, walking like a champ, and is generally a joy to be around as his personality is rapidly developing. Then something frightening occurs. Your baby wakes up in the night crying; he has wet the bed through his diaper, and he is sweating profusely. Over the next few weeks, events like this become a nightly occurrence, and your son starts losing weight rapidly. Every day he is so thirsty that he attempts to even drink the tabasco sauce off the restaurant table. He has now lost so much weight that his once strong tiny body that was covered in baby fat resembles an exhausted skeleton. Every rib is visible on his tiny body and he has lost all of his strength. Finally, one night you wake up and you know something is very wrong. Bursting into the nursery, you find your child’s skin is the color of ash, his eyes are sunken deep into their sockets, and his tongue is white . Your baby is too weak to even cry. You rush to the emergency room and plead to God that your son's life may be spared. The doctors spring into action, and a few hours later, they have your son hooked up to an I.V. and are giving him insulin in miniscule doses. You are told your son's blood sugar was over 900 and that he shouldn’t be alive. He has type 1 diabetes, and he will have it for the rest of his life. This is the story of my mother. I am the baby who was diagnosed with type 1 diabetes almost 18 years ago. Unfortunately, our story isn’t unique, and in some cases, people aren’t as lucky as we were. According to the American Diabetes Association (2020), 1.6 million Americans had type 1 diabetes (or juvenile diabetes) in 2018. 187,000 of those with type 1 diabetes are children or adolescents. To bring awareness to the plight of those with type 1 diabetes, this paper will 1) explain what diabetes is, 2) recount its history, 3) examine current treatments and potential cures, and 4) advocate for further research in hopes of changing the lives of millions world-wide.

3 Understanding Type 1 Diabetes Type 1 diabetes (T1D) is an autoimmune disorder one's immune system mistakenly attacks the beta cells in the pancreas. Beta cells are the cells that produce a hormone called insulin. Insulin is what allows your body to process carbohydrates into energy by allowing them through your body's cell membranes (see Fig. 1). Because all the beta cells are destroyed by the immune systems of type 1 diabetics, this natural energy process can’t occur in the body. This means type 1 diabetics can starve to death on a cellular level while eating a five-course meal every hour of every day. Thankfully insulin can be used to prevent these outcomes, but insulin therapy is never an exact science. Exercise, growth, metabolism, diet and a million other factors make the treatment of diabetes extremely difficult to control. The History of Diabetes To understand where we are in the development of a cure for diabetes, we first must understand the history of diabetes and how far we have come. Diabetes is a disorder that occurs naturally through gene mutation and has dogged humanity since ancient times. The very first descriptions of diabetic symptoms date back to the times of Hesy-Ra, an Egyptian physician in 1552 BC, who documented frequent urination as a symptom of a mysterious disease that also caused the patient's urine to become sweet (McCoy et al, n.d.). Urine became the number one symptom of diagnosing diabetes, prompting British author, Robert Tattersall (2017), to title his Fig. 1. Cellular Energy Production with Insulin Contrasting Normal People with Diabetics ( Diabetes Mellitus, n.d.)

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4 comprehensive history of diabetes The Pissing Evil , a coarse but apt name for the effects high glucose has on the body. Early treatments of diabetes included starvation therapy, bloodletting, the consumption of rancid animal food, the use of opium and other narcotics, and the wearing of flannel or silk (Wu, 2019). The unfortunate truth is that for the vast span of human history, diabetes has been a death sentence for those who have it. The Development of Insulin The landscape of diabetes changed in the early 1900s when insulin was discovered and began to be harvested from pigs. This was rudimentary research and was not sustainable because of the amount of insulin that would need to be harvested to treat all diabetics couldn’t be maintained by pigs alone. It was, however, a groundbreaking discovery because for the first time in over 3400 years of knowing about diabetes, there was a way that it could be treated. Death was no longer a guarantee, and research could be done to find a sustainable treatment. That sustainable treatment came in 1923 when Fredrick Banting and his scientist co-workers found a way to synthesize insulin from recombinant DNA (Belluz, 2019). This new lab created insulin could be made cheaply and in much larger quantities than could reasonably and humanely be harvested from pigs. Equally hopeful news was that Banting's coworkers, James Collip and Charles Best, “sold the insulin patent to the University of Toronto for a mere $1. They wanted everyone who needed their medication to be able to afford it” (Belluz, 2019). Now insulin was not only available but affordable through the larger lab production that the University of Toronto could provide. Thanks to Banting and his colleagues, thousands of people across the globe (myself included) are alive because we inject ourselves daily with synthesized insulin from a lab. The Price of Insulin

5 Unfortunately, the dream of Banting and his colleagues to create an affordable and life- saving medication came only partially true. You could say that the treatment of diabetes today looks much the same as it did in the 1920s, with one major exception: expense. The price of insulin has become so costly that some diabetics are missing out on life-saving doses of insulin simply because they cannot afford it. According to a study done by the Health Care Cost Institute, type 1 diabetics in the United States spend an average of $5,705 on insulin every year as of 2016. That is double the amount that was spent by the same group on insulin just four years before in 2012 (Biniek and Johnson, n.d.). This trend has continued to make it difficult for even reasonably well-off individuals to pay for the drugs that could save their lives. According to a recent article in the U.S. News and World Report , there are two main reasons for the exorbitant price of insulin in America: 1) manufacturers can set their own prices for their product without limitations, and 2) there are currently no competitors in the insulin industry, so name-brand insulin costs aren’t offset by a generic brand (Gordon, 2019). Attempts have been made to make the price of insulin drop, but these efforts inevitably get bogged down and the price of insulin continues to go up. The economic considerations of type 1 diabetes--in addition to its day-to-day suffering--has led myself along with many other individuals to campaign for research to find a cure. Future Technologies for the Cure of Type 1 Diabetes Artificial Pancreas The first and most promising attempt at curing diabetes is a combination of several existing technologies into a harmonious artificial pancreas. This pancreas would be on the outside of your body and would be less of a “cure-all” and more of a diabetes regulator. It would do this by combining an insulin pump with a CGM and some very clever software engineering.

6 An insulin pump works by inserting a tube into the bloodstream and attaching that tube to a miniature pump. That pump would then pump insulin into the body when calibrated to do so, sometimes on a continuous basis. The second technology that would be integrated into this artificial pancreas would be a CGM, or a continuous glucose monitor. CGMs are a fairly recent technology that are based on the idea that rather than using a machine to draw out a blood sample to be tested every time the patient wants to know their blood sugar, a small devise could be hooked up to the bloodstream to send continuous blood glucose readings to an app on the patient’s phone. The idea for the artificial pancreas is that by combining these two technologies, a diabetic regulation system could be created that would make it so the patient wouldn’t even have to worry about what they ate or what they did because the system could take care of the patient's blood glucose levels independently. According to Micheal T. Swinyard (2019), an M.D in endocrinology from the University of Utah, “I would be surprised if there were not some form of mechanical cure for diabetes in the next 10 years.” This is an exciting prediction, but as with most good things in this world, there is a caveat; the price of this device would be enormous. Not only would this device still rely on the same synthesized insulin that is financially driving diabetics into the ground, but it would also involve the added cost of a CGM that can easily add hundreds of dollars to a diabetic’s bill every week. The problem is magnified by the fact that an artificial mechanical pancreas would be developed by a private company, and the demand for such a cure would be enormous. This would mean that the company that develops the cure first could drive the cost of such a device even higher to make profit. While an artificial pancreas would be a major step forward in the treatment of diabetes, it wouldn’t be a panacea as diabetes would continue to play a role in the patient's life--or at least their pocket books--long after they got their artificial pancreas .

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7 Islet Transplantation Another treatment method for diabetes that has been tested since the 1990s while technically curing diabetes but doesn't cut diabetes out of the patient's life. That method is called pancreatic or islet transplantation. Islet transplantation attempts to cure diabetes in the same way that other organ failures are cured: by replacing the organ tissue responsible for producing insulin. There are several reasons this method hasn’t taken off as the next miracle in diabetic technology. The first and most obvious is that islet transplantation suffers from the same thing that all other transplant patients suffer from--the number and match of organ donors. There are simply not enough organ donors to keep up with the number of diabetic cases. According to research published in The New England Journal of Medicine , even if there were enough donors for the number of diabetics, there are still many restrictions and limitations to this treatment. Problems include, “a restricted transplant-tissue volume, bleeding with placement of the transplant, exposure to high levels of immunosuppressive drugs after transplantation, and the triggering of an immediate blood-mediated inflammatory response” (Baidal et al., 2017). This laundry list of problems is enough to drive most diabetics away from this supposed cure, but the real nail in the coffin comes from the nature of type 1 diabetes itself. Because diabetes is caused by the immune system attacking the beta cells in the pancreas, simply replacing the pancreas or the beta cells in it does not prevent the same thing from happening again. According a study from National Center for Biotechnology Information, 80% of the transplanted patients were cured, or at least didn’t need insulin supplements at 1 year, but only 10% remained at an insulin-free status after 5 years (Figliuzzi et al., 2017). This means that while islet transplantation is promising in the short-term, it is not a sustainable cure and comes with some very high risks.

8 Encapsulation Theory In order to create a more sustainable cure while still using the basis of islets transplantation, researchers developed the encapsulation theory. The goal of encapsulation theory is to perform a form of islet transplantation with the twist of shielding immature pancreatic beta cells with body neutral capsules that would then be surgically implanted into the abdomen. Those beta cells would then develop inside the body into fully functioning islets that would be protected from the body's immune system by the capsules while still allowing the islets to be nourished by the body. The struggle to make this cure work comes from two different things. The first is developing a capsule material that the body doesn't reject while making it porous enough to allow nutrients through that the beta cells need to survive. At the same time, this material must prevent the immune system from being able to get through to attack the cells inside the capsules. The second struggle this therapy faces is that the cells that are used inside the capsules are embryonic stem cells that are genetically turned into beta cells. The only way to obtain these stem cells is through harvesting human fetuses, and that is a topic that has people torn ethically, politically, and morally all across the nation. With these obstacles and the inherent dangers of surgery, it seems unlikely that encapsulation will take over as the leading method of curing diabetes. Nonetheless, promising progress is being made as JDRF (the Juvenile Diabetes Research Foundation) and Living Cell Technologies have developed alginate capsules that are proven to be safe in the first phase of clinical testing and are now being tested for their effectiveness at helping diabetics with their glucose levels in their phase two trials. Immunotherapy

9 While the development for a cure for type 1 diabetes continues, huge strides are being made to improve the lives of newly diagnosed diabetics and in preventative measures against diabetes. One of the most exciting methods that is being employed to help newly diagnosed patients and prevent diabetes in the first place is called immunotherapy. Diabetic immunotherapy is a treatment that reprograms the immune system to not attack the pancreas’s beta cells. If diabetes is caught in the early stages and given the immunotherapy treatment immediately, it is possible to slow or even prevent the progression of diabetes and the deterioration of the insulin- making cells in the pancreas. Researchers from King’s College, London and Cardiff University tested 27 adults that had been diagnosed with type 1 diabetes in the past 100 days using a new immunotherapy drug (Peakman et al., n.d.). The participants were split into three groups: two groups were given the treatment injection either every two weeks and four weeks, while the final group was given a placebo. After six months, the researchers found that those taking the immunotherapy drug were able to preserve what was left of their bodies’ insulin production. Those that were on the placebo, however, had a 50% increase in usage of synthesized insulin as the remaining insulin-producing beta cells in their pancreases were destroyed (Peakman, et al., n.d.). This is the first big step in the prevention of diabetes and can reduce the amount of insulin that newly diagnosed patients will have to rely on, dramatically improving these patients' lives and their experience with diabetes. Conclusion Since the discovery of diabetes thousands of years ago, diabetic treatment has made huge progress, but there is still a long way to go. In order to prevent any more lives being hijacked or lost to diabetes, we all must promote the development of a real cure. Pharmaceutical companies will bleed diabetics and their families dry if they are given the chance, so we must also find a

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10 way to prevent diabetes from happening in the first place. Unfortunately, even if the treatments that have been discussed are completely successful, they do not entirely remove the disease. Research on autoimmune disorders will continue, and maybe someday we will live in a world without them. You would think after 18 years of treating my diabetes that it would be easy or inconsequential in my life. While I have made large strides in this long journey, I still find myself fighting to maintain control and unable to forget that my life, along with millions of others, is constantly at risk. References Baidal, D. A. et al. (2017, May 11). Bioengineering of an intraabdominal endocrine pancreas.” The New England Journal of Medicine , 376 (19). Belluz, J. (2019, November 7). “The Absurdly High Cost of Insulin, Explained.” Vox , Vox. Biniek, J., & Johnson, W. (n.d.) “Spending on Individuals with type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices.” Spending on Individuals with type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices – HCCI . Disease Graphics, Videos & Images on Diabetes Mellitus. (n.d.). DiseaseFix .

11 Figliuzzi, M., et al. (2014, April 26). Mesenchymal stem cells help pancreatic islet transplantation to control type 1 diabetes.” World Journal of Stem Cells , Baishideng Publishing Group Co., Limited. Gordon, S. (2019). Why are insulin prices still so high for U.S. patients? USNews and World Report . Healthday. Juvenile Diabetes Research Foundation. (n.d.) Encapsulation. JDRF, the type 1 Diabetes Charity , jdrf.org.uk/our-research/about-our-research/cure-research/encapsulation/. McCoy, K. et al. (n.d.). The history of diabetes - Diabetes Center - Everyday health. EverydayHealth.com . Peakman, M. et al. (n.d.). New immunotherapy treatment shows promise in first clinical trial. JDRF, the type 1 Diabetes Charity . American Diabetes Association. (2020). Statistics about diabetes. Diabetes.org. Swinyard, M. (2019, March 4). Personal interview. Tattersall, R. (2017). The Pissing Evil, A Comprehensive History of Diabetes . Swan and Horn. Wu, B. (2019, April 26). History of diabetes: Early science, early treatment, insulin. Medical News Today , MediLexicon International.

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