1



The podiatric practitioner must have a strong working knowledge of not only the pedal complications of Diabetes Mellitus but also other systemic morbidity associated with this disease. It is no secret that Americans are getting more and more obese and with this increase obesity the concomitant rise in the prevalence of diabetes, especially type 2, is no coincidence. The purpose of this talk is to present an overall perspective of this disease from diagnosis through complications and management principals. If there is one essential take home message it would be that medicine today is not an individual pursuit, it is interdisciplinary and requires close communication and cooperation of patients, their families and the many health care providers that seek to control this disease and limit its complications.



2



Each year the American Diabetes Association publishes its Clinical Practice Recommendations which we will use as a reference. The most recent document is listed here and was released in January of 2004. This document is a compilation of hundreds of individual references that represent the most recent evidence and expert opinion. As new ADA Clinical Practice Recommendations are released I strongly encourage that you read over the changes made to the previous document.



3



At the outset it is essential today that health care providers understand the strength of the evidence upon which they are making management decisions. For this reason, the ADA has established a grading system to define those relative strengths.



A Level evidence indicates clear evidence from well-controlled, generalizable, randomized controlled trials that are adequately powered



B Level Evidence indicates Supportive evidence from well conducted cohort studies



C Level Evidence indicates Supportive evidence from poorly controlled or uncontrolled studies and



E Level Evidence indicates Expert consensus or clinical experience



It should be noted that the strength of this evidence helps us to define where our knowledge is lacking and should help direct research efforts in the future.



4



Lets begin with a general overview of diabetes as a systemic disease. As defined by the ADA“, Diabetes is a group of metabolic diseases involving carbohydrates, lipids and proteins. It is characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction and failure of various organs, especially the eyes, kidneys, nerves, heartand blood vessels.



5



The persistent hyperglycemiais caused by either an absolute deficiency (where the pancreas does not produce any insulin) or ineffective insulin (where there is either an underproduction or "insulin resistance.”)



6



The podiatric physician must be cognizant of the major complications of diabetes. The two most serious acute complications are ketoacidosis and hyperosmolar hyperglycemia. The mortality rates for ketoacidosis is around 5% and for hyperosmolar hyperglycemia around 15%. The most common precipitating factor for DKA or HHS is infection, others include stroke, alcohol abuse, pancreatitis, myocardial infarction, trauma and drugs. For both DKA and HHS the classic symptoms include polyurua, polydipsia, polyphagia, weight loss, vomiting, abdominal pain (in DKA) dehydration, weakness, mental status changes and finally coma. Hypoglycemia is a common complication in patients with diabetes that may present in your office. It is from a relative low blood sugar either from too much insulin or failure to eat properly. It is not uncommon for patients to lose consciousness in the office setting when hypoglycemic It is essential for the clinician to quickly determine if the loss of consciousness is due to hyperglycemia which is quickly reverses with oral glucose or the more serious diabetic ketoacidosis or hyperosmolar hyperglycemia. Infection is common in patients with diabetes and may be due to a decrease in the ability of white blood cells to fight infection. It is believed that prolonged periods of hyperglycemia may cause a decrease chemotaxis to the site, a decreased ability to phagocytize which results in decreased intracellular killing of bacteria



7



It is well know that cardiovascular diseases such as myocardial infarction, hypertension and stroke are more common in patients with diabetes. In fact the risk of Heart disease and Stroke is is 2-4 x greater in patients with diabetes and 73 % of all patients with diabetes have blood pressures 130/80 or above

Diabetes is the leading cause of blindness accounting for 12,000-24,000 new cases yearly and accounts for 43% of all Kidney disease. We are all well aware that 60% of non-traumatic amputations are seen in patients with diabetes which is estimated at 87,000 amputations from 1999-2001. The reason for this high amputation rate is due to the Negatively Synergistic Diabetes Foot Complications which include Ischemia, Neuropathy, and infection. Keep in mind that 85% of all non traumatic amputations were preceded by a foot ulceration



8



The standards for making the diagnosis of diabetes involves the evaluation of plasma glucose. Physiologically Insulin helps to metabolize glucose and transport it in a usable form of energy to the cells of the body. Without insulin, glucose can't be stored -- which results in a rise in the level of glucose in the blood. A blood glucose level of 126 milligrams per deciliter (mg/dL) or more after an overnight fast is considered abnormal. The diagnosis of diabetes is make when a fasting blood glucose level of 125mg/dl is confirmed on a subsequent day by either another fasting glucose, classic symptoms of polyuria, polydypsia and polyphagia and a glucometer reading of 200mg.dl or higher or a 2 hour fasting blood glucose of 200 mg/dl or greater in a 75gm oral glucose tolerance test



9



The two most common types of diabetes are type 1 and type 2

Type 1 diabetes occurs because the insulin-producing cells or beta cells of the pancreas are damaged and as a result they produce little or no insulin. People with type 1 diabetes must use insulin injections to control their blood glucose.

The damage to the insulin-producing cells in type 1 diabetes occurs over a period of years. However, the symptoms of type 1 diabetes may occur over a period of days to weeks. Type 1 diabetes most commonly starts in people under the age of 20, but may occur at any age. Unlike type 1 diabetes, people with type 2 diabetes produce insulin. The insulin they produce however is either in small quantities or doesn't work properly in the body. As a result glucose can't get into the body's cells. Type 2 diabetes is the most common form, affecting almost 17 million Americans. While over 91% of these cases can be prevented, it remains for adults a major cause of related complications. Type 2 diabetes usually starts in people over age 40 who are overweight; but can also occur in people who are not overweight. Sometimes referred to as "adult-onset diabetes,” type 2 diabetes has started to appear in children because of the rise in obesity in young people.



Gestational Diabetes. Gestational diabetes is triggered by pregnancy. Hormone changes during pregnancy can affect insulin's ability to work properly, resulting in high blood glucose levels. Pregnant women who have an increased risk of developing gestational diabetes are those who are over 25 years old, are above their normal body weight before pregnancy, have a family history of diabetes or are Hispanic, black, Native American, or Asian. Usually, blood glucose levels return to normal after childbirth. However, women who have had gestational diabetes have an increased risk of developing type 2 diabetes later in life. Other Specific Types of diabetes include genetic defects of beta cells or of insulin itself, disease of the pancreas, endocrinopathies, drugs or chemically induced diabetes and infections.



10



The 2002 Clinical Practice Recommendations has added a new classification of diabetes termed “pre diabetes” This new class is for patients with impaired fasting glucose defined by a fasting plasma glucose of 100-125mg/dl or impaired glucose tolerance define by a 2 hour post load glucose of 140-199mg/dl This class is not treated as diabetes but represent a significant risk factor of frank diabetes and cardiovascular disease



11

Symptoms of diabetes often occur suddenly and can be severe. They may include increased thirst, increased hunger, dry mouth, blurred vision, numbness or tingling of the hands and feet, loss of consciousness increased urination, frequent urination, unexplained weight loss, and fatigue. These symptoms usually develop quickly, over a few days to weeks. Occasionally symptoms are first noticed after an illness, such as the flu. The person may think the diabetes symptoms are related to the illness and not seek medical care early.



12



The blood sugar level may become very high before a person seeks medical care. Symptoms of very high blood sugar include:

Flushed, hot, dry skin.

Loss of appetite, abdominal pain, and vomiting.

A strong, fruity breath odor (similar to nail polish remover or acetone).

Fast and shallow breathing.

Restlessness, drowsiness, difficulty waking up, confusion, or coma.



13



Symptoms of type 2 diabetes are essentially the same as those seen in type 1 but will develop more gradually

Other symptoms may include:

Slow-healing sores or cuts

Itching of the skin (usually in the vaginal or groin area)

Yeast infections

Recent weight gain



14



The management principals for diabetes mellitus are directed at control rather than cure. It is essential to maintain as near to normal blood glucose levels as possible by balancing food intake with medication and activity. Maintain blood cholesterol and triglyceride levels as near their normal ranges as possible by decreasing the total amount of fat to 30% or less of total daily calories and by reducing saturated fat and cholesterol. Control blood pressure at or below 130/80. These principals are designed to slow or possibly prevent the development of diabetes-related health problems such as retinopathy, nephropathy, vascular and neurologic changes and of course the pedal manifestations of diabetes.



15



Effective treatment can only be gained when the patient and the physician effectively communicate expectations and realistic goals.

The first principal is proper diet and weight control involving planning what’s eaten in a balanced meal plan. Next is regular exercise. It is of interest that exercise has been viewed as so important and issue in the fight against obesity that it is being added to the U.S. Government’s Food Pyramid. If required oral agents or insulin or both are prescribed, and patients must closely follow guidelines dosage and timing.. This requires close monitoring of blood glucose at home. All this must be maintained via frequent follow-up with laboratory testing and the health care provider.



16



The following chart is a summary of the goals of therapy for patients with diabetes based on the ADA 2003 Clinical Practice Recommendations Hemoglobin A1C should be keep less that 7% Preprandial plasma glucose levels should be between 90-130mg/dl Postprandial plasma glucose levels should be less that 180mg/dl Blood pressure should be less than 130/80 Low density lipoproteins should be less that 100mg/dl Tryglycerides should be less than 150 mg/dl and high density lipoproteins should be greater than 40mg/dl



17



The new recommendations from the 2004 Clinical Practice Recommendations are for a hemoglobin A1C less that 6 verses last years value of less than 7



18



The hypertension recommendations for blood pressures less than 130 systolic and over 80 diastolic haven’t changed however the 2004 recommendations recommend behavioral therapy alone for a period of 3 months and then adding medication if not effective. The strength of the evidence upon which this is bases is an E level recommendation and for blood pressures over 140 systolic and over 90 diastolic both behavioral and drug treatment. The strength of the evidence upon which this is bases is an A level recommendation



19



The new recommendations regarding lipids include lifestyle modification-decreased saturated fat and cholesterol, weight loss, exercise, smoking cessation and pharmacologic therapy: with statins, fibrates or combinations both based on A level evidence.



20



New recommendations regarding anti platelet therapy include Daily aspirin 75-162 mg/day for secondary prevention for MI, Vascular bypass, stroke, TIA, PVD, claudication and/or angina and Daily aspirin 75-162 mg/day for the primary prevention for MI, Vascular bypass, stroke, TIA, PVD, claudication and/or angina base on A level evidence



21



New recommendations regarding retinopathy include patients with diabetes should have a initial dilated eye examination shortly after diagnosis and Subsequent exams should be repeated annually unless an eye care professional advises less frequent exams (2-3 years) Both are based on B level evidence.



22



New recommendations regarding footcare include Annual foot exam

More frequent in high risk foot Patients with neuropathy should have a visual inspection every visit Neurologic exam in low-risk foot should include sensory exam with a 5.07 Semmes-Weinstein monofilament and Initial visit for PVD should include history of claudication, pedal pulses and an ABI It is interesting to note that these are all E level recommendation indicating the need for more research into the efficacy of these recommendations.



23



Lets turn our attention to an overview of the principal of treatment. The first principal of treating patients with diabetes is to control diet and maintain an appropriate level of physical activity. Ironically this is the least expensive and least followed management strategy as it requires significant effort on the part of the patient often requiring behavior modification



24



The overall goal of diabetes management is to attain and maintain optimal metabolic outcomes so that Normal blood glucose levels, appropriate lipid and lipoprotein levels, and Normal blood pressure levels can be maintained. I cannot overemphasis the need to prevent obesity. Ultimately we should all Make healthier food choices



25



There is strong evidence A – level recommendations for incorporating Whole grains, vegetables, and low fat milk into the diet. This is based on the findings that Total carbohydrates are more important than source or type, Sucrose does not need to be restricted but needs to be covered with extra glucose lowering medications And Non-nutritive sweeteners are safe consumed in acceptable levels.



26



There is some evidence at the B-level that adjusting pre-meal insulin based on carbohydrate content of meals may be effective and that Patients with diabetes need not take fiber in amounts greater than those recommended for non-diabetic persons however there is Insufficient evidence that low-glycemic diets provide any long term benefit



27



There is only limited evidence at the C level that insulin takers should try to be consistent in day to day carbohydrate intake



28



In the absence of significant controlled studies expert and consensus opinion at the E level suggest that Carbohydrate and monounsaturated fat should make up 60-70% of diet and that Sucrose and sucrose containing foods should be eaten in the context of a healthy diet.



29



There is fair evidence that B- Level that Protein ingestion does not increase plasma glucose concentration And that Protein requirement may be greater in poorly controlled patients



30



There is No evidence that protein intake should be modified if renal function is normal that said the Long term effects of high protein, low carbohydrate diets are unknown. This is based on E level evidence



31



Regarding fat intake there is strong evidence A level to suggest that saturated fat should not exceed 10% of energy intake and that daily cholesterol intake should be less than 300mg per day. There is fair evidence B level that patients should reduced saturated fat or replace with monounsaturated fat when weight loss is a goal or carbohydrates if weight loss is not a goal.



32



There is fair evidence B level that patients with diabetes should limit intake of transfats and that reduced fat diets may result in modest weight loss and improvement in dyslipedemia



There is poor evidence C- level that polyunsaturated fat intake should account for 10% of energy intake



33



Obesity is the number one public health issue in the united states and is associated with every chronic degenerative disease including diabetes. As such there is strong evidence that A- level

Reduced energy intake and modest weight loss improve insulin resistance in the short term.

Lifestyle changes of diet and exercise can produce long term weight loss

Exercise and behavior modification are the most useful strategies for maintaining weight loss

And Standard diets used alone are unlikely to result in long term weight loss.



34



There is fair evidence B-level that there is no clear evidence about the benefit of vitamin and mineral supplementation, and that routine long term antioxidant supplementation is not advised. There is fair evidence however that limiting alcohol to one drink per day for woman and two drinks per day for men should be recommend.



35



All of us need regular physical activity to maintain ideal weight and achieve a maximum functional potential, for patients with diabetes it needs to be a prescribe part of their daily activity.



36



The benefits of exercise are well established .Exercise Improves insulin metabolism, Helps to decrease and control weight, Improves muscle strength,Increases bone density and strength, Lowers blood pressure, helps to protect against heart and blood vessel disease by lowering overall cholesterol , it May raise HDL, or "good" cholesterol it enhances work capacity by increases energy level. Reduces stress, promotes relaxation, and releases tension and anxiety. Once again this is a low cost strategy that should be encourage and facilitated by providing a list of health clubs and community based programs that patients can participate in at low or no cost.



37



Before you prescribe an exercise program for your patients with diabetes they should Check with their primary care physician for cardiovascular risk, make any Adjustments to their medicine schedule or meal plan if necessary, make sure they Start slowly and gradually increase their endurance



To ensure exercise programs become a life long pursuit patients should Choose an activity that is enjoyable. Finally Exercise should be done at least three to four times per week for 20 to 40 minutes each session



38



The podiatrist is consulted by patients with diabetes to advise on exercise options based on their individual foot health status.



For patients where weight bearing exercise is not advisable, water exercise can be suggested due to the reduction of almost 80% of weight stress via buoyancy.



Standard recommendations by the ADA include 5 to 10-minute warm-up, 15 to 30 minutes of continuous aerobic exercise followed by a 5-minute cool down. To reduce the risk of hypoglycemia, the best time to exercise is 30 to 60 minutes after eating.



39



Further advise your patients that Prolonged or strenuous exercise can cause blood glucose to rise. Exercise is best completed when their medicine is reaching its peak effect. Patients should not ignore pain, pain is the only way the body has to tell us something’s wrong



Prevent dehydration by Drinking water before, during, and after exercise

Recommend Testing blood glucose before and after exercise



Patients should always carry a glucose source while exercising in case of hypoglycemia



40



If diet and exercise have not reduced obesity and controlled blood sugars, oral agents may become necessary.



41



Oral diabetes medicines help control blood glucose levels in people whose bodies still produce some insulin this includes the majority of people with type 2 diabetes). These drugs are NOT insulin, and are usually prescribed to people with diabetes along with recommendations for making specific dietary changes and getting regular exercise. Often, several of these drugs are used in combination to achieve optimal blood glucose control.



Remember that people with type 2 diabetes tend to have two problems that lead to increased glucose in the blood stream:



·Number 1They don't make enough insulin to move glucose into cells where it belongs.

And Number 2 The body's cells become "resistant" to insulin (know as insulin resistance), meaning they don't take in glucose as well as they should



42



What Types of Oral Diabetes Medicine Are Available?

Diabetes medications are grouped in categories based on medication type. There are several categories of oral diabetes medicine -- each works differently

Oral Agents

Sulfonylureas include: First generation medicine -- Dymelor, Diabinese, Orinase, Tolinase - and second generation medicine - Glucotrol, Glucotrol XL, DiaBeta, Micronase, Glynase PresTab, and Amaryl. These drugs lower blood glucose by stimulating the pancreas to release more insulin.



43



Biguanides, include Glucophage, Glucophage XR and metformin. These drugs improve insulin's ability to move glucose into cells especially in the liver.



44



Sulfonylureas and biguanide combination, including Glucovance. This drug stimulates the pancreas to release more insulin, improves insulin's action in the body, and lowers the amount of glucose released by the liver.



45



Thiazolidinediones, Actos and Avandia. These drugs improve insulin's effectiveness (improving insulin resistance) and lower the amount of glucose made by the liver.



46



Alpha-glucosidase inhibitors, including Precose and Glyset. These drugs block enzymes that help digest starches, slowing the rise in blood glucose. These drugs may cause diarrhea or gas.



47



Meglitinides, including Prandin and Starlix. These medicines lower blood glucose by stimulating the pancreas to release more insulin.



48



Finally the insulin replacement is always needed in Type 1 patients and may be needed in Type 2 patients in combination with an oral agent



49



BLANK



50



The following chart display’s the various types of insulin. It is not within the purview of this talk to delve in any great detail on this subject except to say that the three major groups include short acting, intermediate acting and long acting. Medical management of the systemic disease of diabetes is out of the scope of practice for podiatric physicians however close coordination of care with the primary care physician is essential to maintain good glycemic control. In addition in the surgical realm it is essential to modify the insulin dose to account for the effects of the trauma of surgery. This should be coordinated with the primary care physician.



51



In summary both the incidence and prevalence of diabetes is on the rise in the United States. As a result we are seeing a lot more of the morbid complications such as retinopathy, neuropathy, nephropathy, heart disease, and of course diabetic foot complications of neuropathy, ischemic and immunopathy.

It is essential that the podiatric physician be prepared to not only manage the pedal manifestation of the diabetes but must also play a role on the interdisciplinary management team by encouraging good glycemic control and appropriate diet and exercise.



52