An Evaluation of the Approaches Used to Manage and Treat Type II Diabetes
By: Stanley J. Moore
28 May 2008
For: Dr. Andrew Feldman
University Maryland University College
The evidence is clear, convincing, and irrefutable that treatment and management of Type II diabetes in this country has been an utter failure. The majority of people with Type II diabetes are unsuccessful in achieving and maintaining proper glucose control. This lack of good glucose control is extremely problematic. As a consequence, complications from the disease are soaring causing untold problems in people’s lives, as well as over-taxing the medical community. In addition diabetes adds billions to the cost of health care. In order to correct this downward trend, there needs to be more education provided for the diabetic patient and the medical community. The standard medical approaches in use today may be grossly insufficient to effectively treat the large numbers of people with the disease. Typically, the standard medical approach for treating Type II diabetes is initially by modifying lifestyle by making changes to the diet and beginning an exercise program. Assuming that diet and exercise fails, as the overwhelming majority of the evidence shows to be the case, the next course of action is to take drugs, and/or administer daily insulin injections. The cases of diabetes are rising so dramatically that the impact from the disease will have far-reaching and potentially overwhelming consequences on our society. As such it is imperative that the effective approaches and strategies for treating and managing diabetes be identified and implemented as quickly as possible to help reverse the trend with the emerging epidemic of Type II diabetes.
Since the management of Type II diabetes has not been very successful, this paper examines just how effective traditional approaches have been with treating Type II diabetes, and discusses some of the limitations and barriers to successful treatment as well as some of the aternative therapies that show some promise in treating the disease. This paper however, does not address other types of diabetes such as Type I, or gestational diabetes.
Thesis: Cases of diabetes are rising so dramatically that the impact from the disease will have far-reaching and potentially overwhelming consequences on our society, if we continue the current path that we are headed.
II. Literature Review Synopsis
III. Overview of Diabetes
IV. Oral Medications
V. Insulin Therapy
VI. Other Emerging and Innovative Treatment and Management Alternatives
The statistics on diabetes are so alarming that no one should consider it solely someone else’s problem. The cases of diabetes are rising so dramatically that the impact from the disease will have far-reaching and potentially overwhelming consequences on our society as a whole. To put it bluntly, there has generally been utter failure with management of the diabetes, and there needs to be some significant changes so that more effective diabetes treatment can be realized. Therefore, there needs to be some serious re-thinking of the current approaches used to combat diabetes. From review of the literature, it is clear that maintaining the status quo will not work, and moreover it is not acceptable. The solution to this problem then is that the medical community, as well as diabetic patients must become better educated as to what are the most effective treatment regimes. Physicians must also become more aggressive in using the available tools to manage the diabetic patient, and what is more they must institute the appropriate treatment regimes in a more timely and appropriate manner based on the patient’s specific history and background. Thus, the purpose of this paper is to examine and evaluate the effective treatment approaches and strategies for Type II diabetes, and explore some of the barriers to successful management of the diabetes. We note that there are some very serious impacts of the disease on society. Two of the most significant impacts from diabetes are, loss of worker productivity, and the enormous costs to our health care system. For example, the total costs associated with diabetes in 2002 were $132 billion, of which $92 billion was direct medical costs. Further, $40 billion was from indirect costs such as disability, work loss, and premature mortality (Centers for Disease Control. n.d.).
Literature Review Synopsis
A literature review was undertaken to identify and assess what the scholarly literature shows with respect to effective treatment practices for Type II diabetes. The following is a brief synopsis of what the literature review revealed. With respect to treatment regimes for diabetes, assuming diet and exercise has not worked, oral medication is the starting point. Researchers found that there appears to be some consensus that oral medications have similar levels of effectiveness, with no single medicine shown to be distinctly superior to the others (Bolen, Wilson, Vassy, Feldman, Yeh, & Marinopoulos, 2007). These researchers found that the recent classes of the new oral medications were generally no more effective in treating diabetes than the existing sulfonylureas, and biguanides, which have been around for more than 50 years (Nathan, D.M., 2007). Some proponents of oral medications assert that oral medicines alone can be effective at controlling the disease. The proposition that the use of oral medications alone is sufficient to treat diabetes however; has wide disagreement among the medical establishment. After oral medications, the standard protocol in the diabetic treatment regime is insulin therapy. In fact several studies show that there is a need for physicians to use insulin at much earlier intervals in the patient’s treatment regime (Meneghini, L., 2007). Research has conclusively demonstrated that there is a clear need for the use of insulin therapy much earlier in the course of managing the disease (Bob, Hollander, Poul, Sherwyn, Richard, & William, 2003). Other proponents for the use of insulin have espoused the use of inhaled insulin as a delivery system. They report that its efficacy is only slightly less than that of subcutaneous injected insulin, but nonetheless comparable. The preponderance of the available literature shows that the use of inhaled insulin for treating Type II diabetics was effective in improving glycemic control. However, it is important to note that there appears to be some data gaps with the safety of inhaled insulin. More long-term safety data is needed on inhaled insulin, especially in pregnant adult women (Ceglia, Lau, & Pittas, 2006). Some researchers believe that inhaled insulin is not very effective, and it may have some significant safety concerns due to the fact that there is limited delivery of approximately just 10% insulin. Consequently, there has to be much larger doses provided to compensate for this problem. Thus, larger more in depth studies are necessary in order to get definitive answers to the safety concerns with inhaled insulin (Nathan, D.M., 2007).
Following insulin therapy, there is other more aggressive treatment alternatives and options. These options include the insulin pump, insulin pills and capsules, and gastric surgical procedures that target the obesity issue. Again, obesity is a major causative factor with the majority of Type II diabetics. The insulin pump for one is a mechanical device that delivers a continuous prescribed amount of insulin depending on the needs of the patient. The data shows that this type of delivery system is effective in ensuring that blood glucose levels remain at fairly constant levels throughout the day, thereby avoiding dangerous spikes in blood glucose levels. However, there was not a significant amount of data found on the efficacy of the use of the insulin pump therapy in patients with Type II diabetes, as most of the data on the insulin pump was for Type I diabetics. There were however some problems noted with increased incidence of infections at the infusion site, and more incidents of irritation and inflammation. Beyond the insulin pump is a relatively new approach that targets the obesity issue, and it entails gastric surgerical procedures such as stomach stapling, stomach reductions, and gastric lap banding. The data show that these types of procedures can have a major impact on treating Type II diabetes because they directly address one of the major contributors to the disease, which is obesity. Moreover, these procedures also appear to help with improving insulin sensitivity in many patients so that the body can more effectively utilize the available insulin. However, overall there is significant agreement within the medical community that there needs to be more effective management of the disease to prevent the many complications that are all too frequent. One team of researchers stated that “conventional therapies for diabetic mellitus are not effective in preventing the progression from early diabetic nephropathy (DN) to end-stage renal disease” (Dongqing, Guangsheng, Shu-Yuan Xiao, Wu, & Ruhan, 2006). Therefore, we acknowledge that there is much agreement within the medical and scientific community that there needs to be substantial improvement in the treatment of Type II diabetes.
Overview of Diabetes
So what exactly is diabetes? Diabetes mellitus in short, is a condition where the body does not produce enough insulin, or the available insulin has a diminished effect on regulating blood sugar i.e., insulin insensitivity. Diabetes is a progressive and life long condition that must be monitored daily and managed effectively to avoid the many complications from the disease. We should also note that the focus of this paper is specifically with Type II diabetes, which is known more commonly as adult-onset diabetes or otherwise known as non-insulin dependent diabetes mellitus (NIDDM). There are of course other types of diabetes such as Type I, that is essentially the childhood form of the disease where there is a complete shut down of the pancreas and no insulin is produced at all. As a result, in Type I diabetes daily insulin injections are a must to sustain life. There is also gestational diabetes, which is usually a temporary condition that occurs in pregnant women. We note that gestational diabetes is found more frequently among African Americans, Hispanic/Latino Americans, and American Indians. Obese women and women with a family history of diabetes are also more prone to gestational diabetes. We also note that for those women that come down with gestational diabetes after their pregnancies 5 to 10 percent of these women will later develop Type II diabetes. Further, these women who have had gestational diabetes will also have a 20 to 50 percent chance of developing Type II diabetes in the next 5 to 10 years (National Diabetes Information Clearinghouse, n.d.). The complications from poor glucose or blood sugar control can cause some pretty serious problems with one’s health. A few of the many complications from diabetes include: increased incidents of heart attacks and stokes; blood circulation problems that often lead to amputations; vision difficulties and blindness; foot ulcers; kidney problems and ultimately premature death. Type II diabetes is so prevalent and widespread in the United States and throughout the world that it is on the verge of reaching epidemic proportions. Type II diabetes is often more associated with older age, however, due to the obesity problems with children, more and more children are coming down with the disease. Type II diabetes is also linked to family history, a history of gestational diabetes, impaired glucose metabolism, a lack of physical activity, and race/ethnicity. With respect to race and ethnicity, African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Native Hawaiians or other Pacific Islanders are at a particularly high risk for Type II diabetes and its complications (National Diabetes Information Clearinghouse, n.d.). Further, the Centers for Disease Control’s statistics show that Type II diabetes represents 90% to 95% of all diabetics. (Centers for Disease Control, 2005). As noted above, Type II diabetes is so strongly linked to obesity, that roughly 80% of Type II diabetics are obese. Also, we should also note that the American Diabetes Association (ADA) has recently revised its position as to when a person should be classified as diabetic. According to the ADA, the current criteria states that diabetes is diagnosed if a person has a fasting plasma glucose level that is greater than or equal to 126 mg/dl (7.0 mmo/l). The other criteria is that diabetes is also diagnosed if a person has a 2-hour plasma glucose level greater than or equal to 200 mg/dl during an oral glucose tolerance test. Finally, a person is diagnosed to be diabetic if he or she has any single blood glucose measurement that is greater than or equal to 200 mg/dl, and a person has symptoms of diabetes. Some of the symptoms include excessive thirst, frequent urination, unusual weight loss, fatigue, blurry vision, extreme hunger, and irritability. With respect to the numbers of people that have the disease, in 2005 the Centers for Disease Control reported that in the U.S. there were 20.8 million people (7.0% of the population with the disease). Fourteen million and six hundred people had been diagnosed with the disease, while 6.2 million people have yet to be diagnosed with the disease (Centers for Disease Control, n.d.). Chart one below shows the breakdown for the total prevalence of diabetes among people aged 20 years or older in the U.S. in 2005. The chart shows that for the age group 20 years or older, 20.6 million, or 9.6% of all people in this age group have diabetes.
Chart 1 - Estimated Total Prevalence of Diabetes in People Aged 20 Years or Older, by Age Group in the United States in 2005
(Source: Centers for Disease Control, n.d.)
For the age group 60 years or older, 10.3 million, or 20.9% of all people have diabetes. In terms of trends with diabetes, according to the Centers for Disease Control, from 1980 through 2005 the number of people in the United States with diabetes increased from 5.6 million to 15.8 million (Centers for Disease Control, 2007). This upward trend represents a three-fold increase over 25 years, and what is worse; the future trends show continued escalation in the numbers. The data on the effectiveness of managing diabetes is not very good. Again, and we can not over state the fact that the statistics show that less than half of the adults with Type II diabetes are achieving proper glucose control (Saydah, and Eberhardt, 2007).
Oral medications are for most Type II diabetics the starting point for treatment, assuming that diet and exercise have failed to achieve proper blood sugar (glucose) control. There are several types of oral medicines used to treat Type II diabetes, and new medicines are constantly being presented to the Federal Drug Administration for consideration and approval. Table 1 below shows the available oral medications used to treat Type II diabetes. Physicians will typically prescribe oral medications for patients that have generally been diabetics for relatively short periods of time, and where the pancreas is still producing some amount of insulin. There are six classes of oral medicines (shown below) for treating diabetes and they include sulfonylureas, meglitinides, biguanides, thiazolidinediones, DPP-4 inhibitors, and alpha-glucosidase inhibitors. These drugs are commonly referred to as Oral Antidiabetic Drugs (OADs), and they all have different mechanisms by which they work. The first of these drugs is the sulfonylureas. They have been available since the 1950s and they work by stimulating pancreatic beta cells to release more insulin. The first generation of sulfonylureas includes the drug chlorpropamide (brand name Diabinese), and it is the only first-generation sulfonylureas drug still in use today. More recently there are what is called second-generation sulfonylureas,
and they are used in smaller doses and include drugs such as glipizide (brand names Glucotrol and Glucotrol XL), glyburide (Micronase, Glynase, and Diabeta), and glimepiride (Amaryl)
Table 1 - Oral Antidiabetic Drugs Used to Treat Type II Diabetes
Drug Class Drug Name Brand Name Mechanism of Action
Glucotrol® Glucotrol XL®
Micronase® Diabeta® Glynase® Increase insulin secretion by pancreatic beta cells
Starlix® Increase insulin secretion by pancreatic beta cells
Biguanides Metformin Glucophage® Inhibit glucose production by the liver
Thiazolidinediones (TZDs) Pioglitazone
Avandia® Increase glucose uptake by skeletal muscle
DPP-4 Inhibitors Sitagliptin Januvia® Prolongs the activity of proteins that block DPP-4
Alpha-glucosidase inhibitors Acarbose
Glyset® Inhibit carbohydrate absorption in the small intestine
(Source: U.S. Department of Health & Human Services, 2005)
(American Diabetes Association, n.d.). Second is the class of OADs named Meglitinides, and they also work by stimulating pancreatic beta cells to release insulin. Two of the most commonly used meglitinides include repaglinide (brand name Prandin) and nateglinide (Starlix). The third group of OADs is the Biguanides that work on diabetes by decreasing the amount of glucose produced by the liver. They also in some cases help to make the body’s muscle tissue more sensitive to insulin so that the available glucose can be absorbed more effectively. The most popular used Biguanides is the drug Metformin (Glucophage). The fourth class of OADs is the Thiazolidinediones, which include the drugs Rosiglitazone (Avandia) and Pioglitazone (ACTOS). These drugs work by helping the body’s available insulin work better in the muscles and fat. They also help to reduce the amount of glucose that is produced by the liver. We note however, that another Thiazolidinediones drug i.e., Troglitazone (Rezulin) was removed from the market because it was found to cause liver problems in some patients (American Diabetes Association, n.d.). A fifth class of OAD is Dipeptidyl Peptidase 4 Inhibitors (DPP-4). This drug works to prevent the breakdown of a naturally occurring compound called GLP-1, and allows it to remain active in the body and help lower blood glucose levels. The drug Sitagliptin (Januvia) is currently the only DPP4-inhibitor on the market. Lastly, there is a class of OADs called Alpha-glucosidase inhibitors that helps to lower the body’s blood glucose levels by blocking the breakdown of starches, in the intestine. This class of drugs also helps to slow down the breakdown of some sugars, thereby decreasing dangerous spikes in blood sugar levels. Some types of Alpha-glucosidase inhibitors are, Acarbose (Precose) and Miglitol (Glyset). We also note that the literature suggests that many of these drugs can be combined with one another because they have different chemical mechanisms by which they work. Thus, combining different oral medications can usually help improve blood glucose control versus taking only a single pill when proper glucose control is not achieved. Further, we note that in general, switching from one OAD to another OAD is not as effective as adding another type of OAD. We point out that the consensus among researcher is that although there may be different mechanisms by which the OADs work, there is no OAD that is distinctly superior to the others. We also think that it is important to point out however, that there are some questions and data gaps on the effectiveness of OADs, as most studies on the subject have lasted only a year or less. Therefore, the long-term effectiveness is not fully understood at this point in time. There are also some specific concerns about whether there are side effects from these OADs to include cardiovascular disease, kidney disease, nerve damage, etc. Also, it is not sufficiently understood whether the safety and effectiveness with these OADs vary significantly among people of different races and ethnicities, age groups, or with people that have other coexisting medical conditions (U.S. Department of Health and Human Services, 2005).
No matter how effective the oral diabetes medications are, over time the effectiveness of an oral medicine treatment regime will start to decline, and the diabetic patient will have to be started on insulin therapy. Thus, we turn our attention to the next course of action in the diabetic treatment regime, which for Type II diabetics is insulin therapy. First, it is necessary to understand what insulin is and the role that it plays in the human body. Insulin is a hormone
that is made by the islets of langerhans in the pancreas. When we eat food, insulin is released from the pancreas into the blood stream. The glucose that is produced from the breakdown of food is then moved from the blood stream to the muscles where it can be used as energy. However, in diabetics, there is either not enough insulin produced, or the available insulin does
not work properly due to insulin insensitivity. Thus, people who require insulin therapy must inject insulin into their bodies. Table 2 below shows some of the various types of insulin preparations that are currently being used to treat diabetes. The insulin is taken from pigs
Table 2 - Various Types of Insulin Preparations
Insulin Examples Onset of
Action Peak of Action Duration
Rapid-acting Humalog (lispro) - Eli Lilly 15 min 30-90 min 3-5 hours
NovoLog (aspart) Novo Nordisk 15 min 40-50 min 3-5 hours
Short-acting (Regular) Humulin R -Eli Lilly; Novolin R –Novo Nordisk 30-60 min 50-120 min 5-8 hours
Intermediate-acting (NPH) Humulin N - Eli Lilly; Novolin N -Novo Nordisk 1-3 hours 8 hours 20 hours
Humulin L -Eli Lilly; Novolin L- Novo Nordisk 1-2.5 hours 7-15 hours 18-24 hours
Intermediate- and short-acting mixtures Humulin 50/50; Humulin 70/30;Humalog Mix 75/25; Humalog Mix 50/50 -Eli Lilly; Novolin 70/30;Novolog Mix 70/30 - Novo Nordisk The onset, peak, and duration of action of these mixtures would reflect a composite of the intermediate and short- or rapid-acting components, with one peak of action.
Long-acting Ultralente -Eli Lilly 4-8 hours 8-12 hours 36 hours
Lantus (glargine)- Aventis 1 hour none 24 hours
(Source: U.S. Food and Drug Administration, January – February 2002)
and cows, or it is artificially manufactured in the laboratory. Insulin must be injected and cannot be taken orally because the digestive process would destroy it. The literature shows that there are about 20 or more different types of insulin products on the market. Some are made to act for long periods of time, while others have fast acting mechanisms. Insulin therapy is highly effective for achieving and maintaining good blood glucose control in diabetic patients; however, the insulin treatment regime has to be uniquely tailored to fit the needs of the patient. Insulin treatment regimes that are successful at optimizing glucose control will usually require vigorous and dedicated participation by the diabetic patient and physicians. Consistent administration of insulin, and timely and frequent monitoring are absolutely critical to ensure effectiveness. Studies have shown that often patients with Type II diabetes do not reach optimal glycemic control even though control was possible because there was a need for practitioners to be more pro-active and aggressive, but cautious when prescribing insulin. The researchers, however, recommend that physicians should strive to treat their patients to the recommended specific target goals in accordance with their history and background. Researchers have asserted that " In the past, there was often a prolonged time from the onset of Type II diabetes to the initiation of insulin therapy. This delay may be attributed to the practitioner's lack of knowledge regarding a switch from oral therapy to insulin therapy" (Appel, Wright, & Ovalle, 2007). With respect to insulin, there are three types of insulin preparations, and they are premixed, basal, and prandial. The premixed preparation is usually taken twice a day and can be used by both Type I and Type II diabetics. Basal insulin is the amount of insulin needed to suppress glucose production by the liver, and it is designed to maintain proper glucose levels between meals. Prandial insulin is used to cover the rise in blood glucose levels after a meal. Often physicians prescribe a combination of basal-prandial insulin therapy to closely mimic the natural actions of the pancreas (Appel, Wright, & Ovalle, 2007). Thus physicians are able to prescribe insulin or a combination of different types of insulin to effectively regulate blood glucose levels in their patients.
The overall treatment of diabetes is accomplished either with the use of oral medicine or with injectable insulin. Below in Chart 2 is a breakout showing the use of oral medicine versus that of injectable Insulin. More recently, there have been other injectable drugs that have been approved by the Food and Drug Administration (FDA) to treat Type II diabetes. One of these new drugs is named Pramlintide (brand name Symlin). This is a synthetic drug that is much like the hormone amylin that is also produced along with insulin in the pancreas to maintain normal glucose levels. Pramlintide has been shown to have moderate effects on improving blood glucose levels, and it does not cause episodes of low blood sugar levels. In addition, Pramlintide has been shown to promote a modest weight loss is some patients, and it’s primary side effect appears to be just nausea. The other new drug is called Exenatide (brand name Byetta); it is a very promising new injectable drug that has been shown to be very effective in treating Type II diabetes.
Chart 2 – Breakout of the Use of Oral Medicine and or Insulin Therapy
(Source: Centers for Disease Control, n.d.)
Byetta is also a synthetic drug that has some similarities to the saliva of the Gila monster. It works by stimulating the pancreas to produce more insulin. The literature shows that it has been a very effective drug, and there are minimal risks of low blood sugar (hypoglycemia) because it only works when the body’s blood sugar levels are elevated. It has very little side effects such as nausea; however, some people cannot tolerate the nausea and discontinue its use. It has also been shown to promote moderate weight loss in some patients (American Diabetes Association, n.d.).
Although insulin and the other above-mentioned injectable drugs are very effective in treating diabetes, one of the main hurdles with these drugs is that they need to be injected on a
daily basis, and many people fear needles. Thus, the effectiveness of using this treatment regime is often significantly reduced due to the fear and dislike of needles. As such, researchers are also studying and evaluating other delivery systems for delivering insulin, and some have already been implemented. Inhaled insulin is one such approach that has been used with some degree of success; however, it still has a ways to go to achieve full effectiveness. This delivery system requires the patient to inhale powdered insulin through the mouth where it is passed directly into the lungs and then it is absorbed into the bloodstream. Also, we note that there is some disagreement with respect to its efficacy and safety. In fact, while some researchers have shown that inhaled insulin works, there are those that are not fully convinced of its effectiveness. One of the concerns with inhaled insulin is that because it is inhaled, it requires much larger doses to compensate for its limited uptake by the body. There clearly is a need for some more study on inhaled insulin, such that a definitive assessment can be made on both its effectiveness and its safety (Nathan, D.M., 2007). The insulin patch is another alternative insulin delivery system under development. The insulin patch is placed on the skin, and it provides a continuous delivery of low doses of insulin to keep the body’s blood glucose at the desired levels. A tab on the patch can be opened and closed to make dose adjustments at specified time intervals throughout the day. This delivery system is still being developed, and as such there is little or no data available on its efficacy, or even more its safety.
Another alternative device for insulin delivery are insulin pens. Insulin pens are essentially pens with cartridges in them containing insulin. They have very small needles in them that are barely felt by the patient during injections. Some models require placing new cartridges with every use, while other models are one time throw away versions. The patient will still need to inject him or herself, but since the pain associated with injections is substantially reduced, there is more consistency with its use. Thus, these alternative insulin delivery devices should result in more consistent and efficient glucose control.
However, the bottom line with the use of injectable insulin therapy lies with the commitment to inject oneself on a consistent and routine basis in order to achieve effective blood glucose control. Researchers are in agreement on the need for this commitment by the patient for the traditional multiple daily injections of basal-prandial insulin therapy. The inconsistency with the use of insulin by the patients was noted as a major cause of many patients poor blood glucose control. “Practitioners need to consider the newer and varied options for insulin delivery in an attempt to optimize the patient's insulin regime, compliance, control, and, ultimately, outcome” (Appel, Wright, & Ovalle, 2007). Once these alternative insulin delivery systems are optimized and made fully available, there should be much-improved efficacy with the use of insulin as patients become more consistent with administering their daily-required insulin.
Other Emerging and Innovative Diabetes Treatment and Management Alternatives
The above discussion on diabetes treatment regimes that consists of oral medications and insulin therapies are standard medical approaches. The scientific and medical literature shows that effective control is possible for managing Type II diabetes when oral medicine and insulin are timely and properly implemented. However, even though these therapies work, there are situations that will require the use of other alternative methods, such as more innovative and aggressive approaches to fight the disease. Below we present some of these other options for treating and managing diabetes. Note that this discussion does not include all of the possible alternatives available, but it includes those that are considered to have the most potential, and those that have either undergone some clinical trials or in fact have been fully demonstrated and are currently being used on some level.
Thus we note that gastric surgical procedures are now frequently being used to treat obesity. However, these gastric procedures are also effective in treating diabetes as well. These gastric surgeries include stomach stapling, stomach reductions and lap banding. These procedures limit the amount of food that a person can consume, which results in dramatic weight loss in patients. In-turn the weight loss causes remarkable improvements in the diabetic condition. The lap band procedure has the major benefit of being less invasive since it involves the use of laparoscopic instruments to place an adjustable band around the tube that leads to the stomach. An Australian study found that the average weight loss for lap band patients was around 60 to 70 pounds in the first year after the procedure (Unknown, 2007). More importantly patients show substantial improvements with their diabetes management, and insulin sensitivity is improved due to enhanced beta cell functioning. Beta cells are specialized cells in the pancreas that make and release insulin. Thus the enhanced beta cell functioning causes the body to better utilize the available insulin. The procedure is thought to interfere with a signal that is sent from the duodenum to the pancreas that causes insulin insensitivity (Unknown, 2007). The lap band procedure results in “significant improvements in all measures of glucose control, with remission of diabetes in 64 % of the patients and major improvement in glucose control in 26 % of the patients.” Added benefits from the surgery include, improvement in triglycerides levels, HDL cholesterol, hypertension, sleep, and depression (Life Clinic Management Systems, 2008).
Other diabetes management alternatives involve insulin pumps, insulin pills, and insulin capsules. Insulin pumps in particular have been around for 25 years or so, however, newer more effective models are now being developed. The external insulin pump is a small device that the patient wears around their waist, and it can deliver prescribed amounts of insulin throughout the day. Figure 1 below shows a picture of the insulin pump as well as some of the devices used for daily glucose monitoring.
Figure 1 – Blood Glucose Testing and Picture of the Insulin Pump
(Source: Medline Plus, 2008)
There also is an internal implantable version of the insulin pump being developed. This device is surgically placed just below the skin to measure blood sugar levels and deliver the exact amount of insulin needed. Once fully developed and optimized, researchers expect that the implantable insulin pump will allow for accurate mimicking of the natural actions of the pancreas with respect to how insulin is released into the body. Also, the insulin pill is another alternative under development. The challenge however, is to produce a polymer substance to coat the pill so that the insulin can avoid destruction by the digestive system and be absorbed into the bloodstream. The testing to date has been conducted only with animals, and there are many researchers that are concerned about its safety for use in humans since precision and exactness is required with insulin delivery systems (Roberts, R., n.d.) Beyond that, researchers are trying to develop an insulin capsule. The insulin capsule will also be implantable, and it will provide for a continuous release of insulin. These capsules will “contain insulin-secreting cells that borrow nutrients from the body to keep producing insulin indefinitely” (Life Clinic Management Systems, 2008). The insulin pill will therefore provide another effective alternative for to provide a more effective diabetes treatment regime.
Recently, gene therapy has come into focus as an avenue to be explored further with respect to its applicability in treating diabetes. Gene therapy is in the early stages of research, but it seems to be providing significant interest among the medical and scientific community. It will certainly require a lot of hard work, as it will involve figuring out the complex actions of genes to decode the human genome. So far researchers have identified a specific gene called the SHIP2 gene that is thought to play a key role in the regulation of insulin in the body. This
finding of the SHIP2 gene will certainly be the focus of much attention as scientists attempt to utilize gene therapy for treatment of diabetes (Life Clinic Management Systems, 2008).
Self-monitoring of blood glucose levels is a critical part of proper diabetes management because diabetic patients need to accurately know what their blood sugar levels are throughout the day. Diabetics have to routinely sample their blood several times daily to determine whether they are within the acceptable ranges. Figure 1 above shows a picture of the required daily self-monitoring process for diabetics. With respect to target blood sugar levels, the ADA states that the target range for blood glucose levels is, before meals - 90 to 130 mg/dl; 2 hours after a meal - less than 180 mg/dl. Also, sometimes diabetics may experience very low blood sugar levels or “diabetic shock” (hypoglycemia), which according to the ADA are blood sugar levels below 70 mg/dl. Low blood sugar levels can be very dangerous conditions, and could be fatal if not promptly corrected. Hypoglycemia often occurs due to sickness, or when incorrect doses of either oral medicine or insulin were taken. Symptoms of low blood sugar can include one or more of the following: hunger, anxiousness, nervousness, shakiness, weakness, tiredness, sleepiness, mental confusion, light-headedness, and difficulty speaking. When low sugar episodes occur, the diabetic must eat or drink something with a high sugar content to raise the blood sugar level to within the normal range (ADA, 2004).
The diabetic patient should get a blood test every three months or so to measure their 2-3-month average reading. This test is called the HbA1C test, and it is a test that measures the amount of glycosylated hemoglobin in the blood. Glycosylated hemoglobin is a molecule in red blood cells that attaches to glucose (blood sugar). The higher the levels of glycosylated hemoglobin in the blood, the less glucose control is being achieved. The target goal according to the ADA for HbA1C is 7% or lower. Table 3 below shows the comparison of the HbA1C values to blood glucose levels.
Table 3- Comparison of HbA1C Levels to Blood Glucose Levels
HbA1C Levels Blood Glucose Levels
(Source: American Diabetes Association, 2004)
To reiterate, elevated blood glucose levels causes devastating damage to the body. Blindness, kidney failure, amputations, heart attacks and strokes are just a few of the major complications. The bottom line is that poor glucose control will lead to health problems, a decrease in the quality of life, and eventually premature death. Thus, daily self-monitoring is critical in order to properly assess blood glucose levels. To accomplish daily monitoring, diabetics will have to use a device to prick their finger, or alternative sites on the body with the newer models to obtain a small blood sample. The blood sample is then transferred to a meter that will give a readout of the blood glucose level. The monitoring of blood glucose levels requires steadfast diligence on the part of the diabetic patient, and failure to do so can lead to significant problems in achieving proper glucose control. Many researchers have observed that the more frequent the testing of blood sugar levels; the diabetic patient will achieve tighter control of their blood sugar levels. However, oftentimes the required finger prick to obtain a blood sample can be somewhat painful, and as such it is to some degree a deterrent to regular testing. Accordingly, there have been a number of new testing devices that have been developed to provide for less painful and alternative sampling sites. For example, the Federal Drug Administration has recently approved a wristwatch-like device that should aid in the required blood glucose monitoring by diabetics. This device is called the GlucoWatch Biograph, and it augments the fingertip sampling method. The GlucoWatch Biographer works by extracting fluid through the skin by sending out tiny electric currents. It can be worn for up to 12 consecutive hours, and it will produce 3 monitor readings every hour. It will even sound an alarm if the patient’s blood sugar drops too low (Life Clinic Management Systems, 2008). Other pain free glucose testing devices are currently under development, and these new pain free devices should have a substantial impact on minimizing the reluctance of some individuals that are put off by the pain associated with testing.
The problems caused by diabetes are extremely serious, and urgent attention is required because it will not go away anytime soon. The data clearly shows that the rates of the disease are soaring and will continue to soar unless there are more aggressive approaches and strategies implemented to help treat and manage this disease. This paper has shown that there are effective tools available to effectively treat diabetes. However, the challenge lies with the timely implementation of the most effective course of action in a patient’s treatment regime. The solution then will require more rigorous examination of the patient’s records and implementing the appropriate treatment program to maintain the patient’s glucose levels to within acceptable levels. The oral medicines, insulin, and the other alternative options discussed in this paper provide for a comprehensive medical toolbox to accomplish effective treatment. However, the challenge is to decide what is working and when to change course in a patient’s treatment regime. This paper should provide a consensus on a road map forward in treating the disease. This road map can then lead to more effective diabetes management where the proper treatment regimes are timely identified and implemented. This roadmap can in-turn be used as a guide or a reference for physicians and patients alike in selecting and optimizing the diabetic treatment regime. This initial effort can then be used to initiate more comprehensive and expansive efforts in the future for treatment of Type II diabetes. These actions, if undertaken, will be a powerful step forward in correcting a situation that can surely be corrected. This paper has shown that the tools are available, thus we need to only sustain a focus, determination, and commitment to improving the situation and accomplishing goals that are clearly achievable.
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