A Growing Problem of Diabetes

An area of research of considerable importance is adult and embryonic stem cell research. Studying stem cells have contributed to breakthroughs in type one diabetes, and embryonic stem cells in mice were able to be isolated for study about thirty-five years ago, and the same happened for human embryonic stem cells in 1998. Embryonic stem cells help research because they help scientists understand the causes and triggers of the disease, and they contribute to research in replacement therapies with beta cells, a type of islet cell that produces insulin.

Additionally, the stem cell research has assisted with regenerative medicine, and it has increased understanding of cell development, drug testing, and cell differentiation, the ability of a cell to turn into another type of cell. Furthermore, through adult stem cell research in mice, scientists were able to permanently reverse type one diabetes. To do this, the scientists killed the cells that caused the disease, and then the stem cells were able to re-create the missing insulin-producing cells (Metcalf 85-91).

Stem cell research in mice has also proven to help other autoimmune diseases, such as sickle-cell anemia, Parkinson's disease, and hemophilia. More recently, this research has led to several major therapies for type one diabetes. Some of these therapies are: islet cell transplantation, regeneration therapy, and various ways to deliver insulin. Because of these breakthroughs in type one diabetes research, the study of stem cells has proven to be a critical endeavor in the pursuit for a cure (Ara?±a, Miriam, et al). One area of research, brought about by studying stem cells, that may lead to a breakthrough in curing type one diabetes, is islet cell transplantation. The method of islet cell transplantation, called allo-islet cell transplantation, is in its final stage of the clinical trial. The process of the procedure is placing donated human islet cells, which come from the pancreas, into the liver. When the cells have embedded in the liver's blood vessels, most of the time, they start producing insulin. To complete this procedure, the patient receiving the transplant has to take immunosuppressive drugs because the body may reject the foreign cells. This is similar to organ transplants, but islet cell transplantation does not involve major surgery; the patient receiving the transplantation only needs to be lightly sedated while the surgeon injects the cells, and the procedure may last from thirty minutes to two hours.

When this procedure is successful, the patient will be able to create enough insulin to be independent from administered insulin, and blood sugar levels will be kept in a healthy, or close-to-healthy range. When the procedure is partially but not completely successful, the patient will produce some insulin on his or her own and will need to administer fewer amounts of insulin and will have more stable blood sugar levels. Four of these transplantations have been completed since 2000 at the Schulze Diabetes Institute, part of the University of Minnesota health system, and none of the patients experienced serious side-effects. Further, over eighty percent of the patients had not experienced severe low blood sugar for five years after the procedure, ninety percent of the patients produced enough insulin to live without administering it, and fifty percent of patients have continued to produce enough insulin five years after the procedure; this treatment has changed the lives of people with type one diabetes. Though there have been many positive outcomes with the procedure, it is still experimental; however, the process has begun to obtain FDA approval to make the procedure available as a mainstream treatment, and therefore, improve the lives of many more type one diabetics (University of Minnesota).

Another area of research inspired by stem cell research is beta cell regeneration therapy. JDRF, the world's largest non-profit diabetes research organization, has a goal of possessing the ability to make beta cells multiply, promoting their survival, and improving their function, as part of their Beta Cell Regeneration Program. JDRF has been running trials to try and meet their goals. One outcome from a trial attempting to preserve remaining insulin-producing beta cells was able to preserve the insulin production in a newly-diagnosed patient for over a year. JDRF's research in cell regeneration began in 2015, which brought the discovery of a new area of research in drugs that could potentially "stimulate the creation of new beta cells." In 2016, two researchers have been able to convert one type of cell, called an alpha cell, into beta-like cells in mice; this research suggests that it may be possible to do the same in humans. In 2017, the use of the cancer drug, imatinib, administered to newly diagnosed trial participants, was shown to increase beta cell function and decrease the need for as much insulin administration. Finally, in 2018, it was found that a blood pressure drug may slow the disease's progression. In just three years, beta cell regeneration research has come a long way, and because of this, further progress is inevitable. With further progress, there is a higher probability of discovering a cure (JDRF Research). A third avenue of research originating from the study of stem cells is insulin innovation. Innovations in insulin administration have improved treatments and lives of diabetic patients. The diabetic patient must administer two types of insulin: a long-acting dose, which constantly works to lower blood sugar levels in the background, and a fast-acting dose, which is given to match consumed carbohydrates.

The oldest, and still commonly used today, form of insulin administration is through insulin injections, either via syringe or pre-filled pens. The patient would inject his or herself once every twenty-four hours with the long-acting dose and fifteen minutes prior to any consumption of carbohydrates with the fast-acting dose. The fast-acting dose is also used to correct blood glucoses that are too high (Nathan). The first discovered alternative for administering insulin is inhalable insulin. The first inhalable insulin was called Exubera, which came in a powder form to be measured out and taken about ten minutes before a meal. Exubera, however, did not replace long-acting doses of insulin, but it would provide patients with the option of fewer injections (Metcalf 20). A more recent option for inhalable insulin, called Afrezza, has been developed as well. This option works in the same way as Exubera and is FDA approved for those of at least eighteen years of age (JDRF Technology). The latest mainstream available insulin therapy option is the insulin pump. Insulin pumps are small devices that are worn in replacement of injections. The pumps are able to provide fast-acting doses of insulin, and they slowly provide long-acting doses throughout the day each day they are worn. Pumps are convenient to the user, as they are very accurate in dosing on a level that cannot be obtained through injections; as said in a handbook for type one diabetic patients by JDRF and a global pharmaceutical company, Novo Nordisk, "pumps provide a high degree of accuracy and can be set to pump out as little as one-tenth of a unit (0.1 unit) of insulin per hour" (Novo Nordisk, and JDRF).

An insulin syringe is measured in only as little as one-half of a unit, and pre-filled insulin pens are measured in whole units (Clausen). Insulin pumps also commonly provide features that help the user calculate the amount of insulin needed for meals with a pre-programmed carbohydrate ratio so the user has to complete fewer calculations before he or she eats. Additionally, pumps help to decrease a build-up of insulin in the body due to over-corrections of high blood sugar. The pumps calculate the corrective doses depending on how long it has been since the user last administered a correction, thus protecting against hypoglycemia, also known as low blood sugar, from corrections being given too often. These innovations have provided patients with more treatment options, and the advancement with the insulin pump creates a higher level of safety and convenience (Beasley, Shannon, et al). In contrast, while huge strides have been made with diabetes research, there have been outcomes where research has not proven to significantly improve treatments or provide the possibility of leading to a cure. One of these is the drug Symlin. Symlin, also known as pramlintide acetate, is a recently approved drug that helps patients who have a difficult time controlling high blood sugar with insulin alone. It helps glucose control because it slows down the release of food into the intestines and restrains the release of glucagon, a sugar-releasing hormone. It may allow helpful additional care for those who use it, but it has downsides in some areas of safety and convenience (Symlin).

The inconveniences that it provides are that it adds more injections to a person using injectable insulin, and the different standard of dosing may be confusing. Because the user has to measure the drug on his or her own and the units are not the same for insulin syringe units, confusion in the dosing may occur for the user and the prescriber (Metcalf 23). The downsides in safety of the drug are the side-effects. The most serious side-effect is severe hypoglycemia. Severe hypoglycemia may occur with the drug even if it is properly administered. Other common side-effects are nausea, vomiting, decreased appetite, stomach pain, and headache (Symlin). This drug may be helpful to some, but because of its many side-effects, it does not significantly improve the lives or treatment of type one diabetics, nor has it contributed to the possibility for a cure. Another discovery whose significance has been disputed is the use of chromium supplements. It has been proven that chromium increases the action of insulin, so researchers decided to look into possible benefits of chromium supplements. Results found that its ability to increase insulin action helped people with type two diabetes, and further, as USDA chromium researcher Richard Anderson, Ph.D. stated, "'Even people with type 1 diabetes show improvement with chromium supplements.'" Studies have also suggested higher chromium levels are good for heart health and depression, but these claims lack significance in the volume of data. Conflicting conclusions from other studies also question the credibility of the claims. For example, as authors Tom and Gena Metcalf stated in their book, Diabetes, "According to the American Diabetes Association (ADA), only patients with very low chromium levels experience problems; for most people, chromium supplements offer no known benefits."

However, the disputing side also lacks a volume of credible evidence; several tests have been conducted with results concluding that there was no significant benefit from chromium, but many of the testing methods were of questionable credibility. For example, in one study, men and women from the United States who were healthy or glucose intolerant were randomly selected to either take 924 milligrams per deciliter of chromium or a placebo. They also all participated in resistance training twice a week, and at the end of the twelve-week study, statistics showed that there was no significant benefit to the chromium supplements on blood sugar; however, this study was described as having "moderate methodological quality." Also, per a letter of enforcement from the FDA, all chromium supplements must be labeled with, "'One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes,'" and they have concluded that the issue remains uncertain.

Moreover, while there is evidence that both support and dispute claims of chromium supplement benefits, there is a lack of information that leads to an overall uncertain conclusion on its benefits (Metcalf 59-69). Some research outcomes have proven to have minute or no significance in diabetes research; however, as further developments in research and technology show, these outcomes are a minority. Significant developments in type one diabetes research and technology are plentiful. One such example of developing technology for patients with type one diabetes is the artificial pancreas. The artificial pancreas takes care of blood glucose monitoring and insulin administration so that the person with the disease does not have to manually monitor blood glucose and administer insulin. JDRF is working towards creating an artificial pancreas that is small in size; has an "open" system where continuous glucose monitors and insulin pumps can communicate, regardless of the brand; and that can automatically control blood sugar. Though not all of JDRF's goals for the product have been met, such as open systems, there is an artificial pancreas system available. A type one diabetic, Sara, has an artificial pancreas, and she is quoted, Before I had my artificial pancreas system, I would constantly check my blood glucose levels to make sure I wasn't getting too low or too high.

Now, my artificial pancreas does it for me, and provides insulin as a result of its readings. Because of this, I think about T1D a fraction of the time, leading me to focus my efforts on more important things. If the system of pumps and continuous glucose monitors became unified and was offered as a mainstream treatment, it could greatly improve the quality of life for those with type one diabetes (JDRF Technology). Studies involving blood glucose control have improved the lives of people with the disease as well. More intensive glucose control, different from traditional practices for glucose control, greatly lowers the risk of developing complications such as kidney disease and retinopathy, an eye disease that can lead to blindness. This was proven through a trial known as the Diabetes Control and Complications Trial, or DCCT, funded by the National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK. The trial compared long-term results from participants who had followed intensive glucose control, which was defined as three or more doses of insulin a day and glucose self-monitoring at least four times a day, and those who had followed traditional glucose control, which was defined as one to two doses of insulin a day and daily self-monitoring through urine or blood glucose tests. After ten years of the trial, it was proven that those who had undertaken intensive glucose control, to keep blood glucose levels close to normal, had significantly reduced his or her chances of developing eye, kidney, and nerve disease.

After this trial, there was a follow-up called the Epidemiology of Diabetes Interventions and Complications, EDIC, that continued to observe people that had participated in the DCCT for more than twenty years, and it found that the benefits of intensive glucose control had continued long-term. In addition to the reduced chances of complications, intensive glucose control was proven to lengthen the life of participants, and they have shown that regular eye exams decreased the necessity of frequent exams, which lowered patient costs, and provided earlier diagnosis and treatment of eye disease. Findings from these trials found several reductions in the risk of diabetes-related complications, some of which were a seventy-six percent decrease for the risk of diabetic eye disease, a fifty percent decrease of the risk for diabetic kidney disease, and a fifty-seven percent decrease of the risk for cardiovascular diseases and deaths. Because of these findings, the DCCT and EDIC have created a new standard of diabetes treatment for those with type one and type two diabetes (NIDDK). Studies about the importance of blood glucose monitoring are not the end to related research; there have also been innovations in glucose monitoring technology. Advancements in glucose monitoring technology have improved the quality of type one diabetes care and improved the lives of patients. The older way, presently used, of self-monitoring blood sugar is through multiple, daily finger pricks. The patient pricks his or her finger and places a drop of blood on a test strip connected to a meter, which reads the blood glucose level (Nathan).

However, there has been a recent opportunity for a different kind of glucose monitoring, using a device called the continuous glucose monitor, or CGM. A CGM is a device that may be worn by a patient twenty-four hours each day, and the device constantly measures blood glucose so that the patient does not have to prick his or her finger as often and may know what his or her blood sugar is at any time that the device is worn (Clausen). CGMs also provide additional information about blood sugar, such as if the blood sugar level is stable, heading higher, or heading lower. They also have an alarm function that can notify the user of high or low blood sugar. Continuous monitoring and blood sugar alarms provide greater protection from hyperglycemia, also known as high blood sugar, and hypoglycemia, and they can provide greater help in adjusting insulin levels, particularly for those who have changing or active schedules. The protection against low blood sugar is also particularly useful for those who have the condition called hypoglycemia unawareness, a condition that happens to patients who frequently have low blood sugar to the point where he or she no longer notices the symptoms of it (Beasley, Shannon, et al 79). The latest option in CGMs is the Dexcom G6. In addition to all of the other common features, this continuous glucose monitor is smaller than others and does not require finger pricks, which makes it even more desirable for patients (Dexcom).

Many improvements have been focused on improving the treatment for and lives of people with type one diabetes, but there is also research being conducted for those who are at risk for the disease. Researchers are testing methods involving the prevention and delay of the early stages of type one diabetes. This research, conducted by the research organization Type One Diabetes TrialNet, is testing the drug hydroxychloroquine, or HCQ. This drug has been approved by the FDA and has been used to treat other autoimmune diseases such as rheumatoid arthritis and lupus. The research is very new, as it is the first study examining the potential of HCQ to prevent or delay type one diabetes. Along with other participant requirements, the study is conducted with participants who are in stage one of the disease. Stage one is identified when the body begins attacking beta cells, but there are not yet any blood glucose problems, and there are no symptoms of the disease. Study participants undergo several months of monitoring and blood tests, several months of taking the drug, and a few eye exams. For those who progress to stage two of the disease, when the body shows signs of abnormal glucose tolerance, he or she will no longer take the drug but may choose to continue monitoring until the end of the study. If successful, this study will prevent or delay the progression of type one diabetes. It is also beneficial to those participating in the study that become diagnosed with the disease because they will have been closely monitored, and the disease will likely be caught before symptoms of it arise. Further, the risk of developing diabetic ketoacidosis, a serious condition from prolonged high blood glucose, at diagnosis is reduced from thirty percent to three percent (TrialNet)

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