Hello, my name is Madhuri Vasudevan and I will be presenting to you the American Association of Clinical Endocrinology, Intensifying Diabetes Therapies to Achieve Personalized Treatment Goals. There are five outcome objectives of this educational activity. Number one, to review the latest evidence-based guidelines on implementing complication-centric treatment options in persons living with type 2 diabetes. Number two, to identify methods to intensify therapies in order to reach timely sustained glycemic targets and maintain weight or promote weight loss. Number three, to apply shared decision-making strategies with sustained glycemic targets and personalized weight management as our key goals in persons living with type 2 diabetes with the intent to prevent long-term health complications. Number four, to optimize glucose management to prevent the long-term health consequences of uncontrolled diabetes. And number five, to intensify diabetes therapies for patients who have already developed vascular complications related to uncontrolled diabetes, including chronic kidney disease and cardiovascular disease. And so, without further ado, let us begin. The content for this presentation is divided into two sections. The first addresses the importance of establishing shared decision-making strategies that is focused on building healthy and constructive patient communication methods. The second section focuses on highlighting evidence-based guidelines related to medical nutrition therapy counseling while addressing challenges related to diabetes distress and diabetes burnout. The objectives of this educational session are to build confidence with patient communication strategies, to recognize the importance of developing a personalized treatment goal for glycemic control in patients with type 2 diabetes, and to recognize the benefits of provider-directed medical nutrition therapy for the management of weight and cardiometabolic diseases. According to the Centers for Disease Control and Prevention National Diabetes Statistics Report, approximately 37.2 million adults in the United States have either been diagnosed with diabetes or have undiagnosed diabetes. That is nearly 40 million people with this diagnosis at this time. It is anticipated that up to 50 percent of patients diagnosed with diabetes have some form of diabetes distress, a condition that is independent of other ICD-10 mental health disorders including anxiety and depression. Diabetes distress, defined as an emotional response to diabetes, is characterized by extreme apprehension, discomfort, or dejection due to the perceived inability in coping with the challenges and demands of living with diabetes. The condition was first proposed in peer-reviewed literature by a group of psychiatrists and psychologists at the Joslin Diabetes Center in 1995 and refers specifically to the negative emotional experiences resulting from self-care demands in diabetes management. The researchers reported that diabetes distress was associated with self-care behavior and even predicted hemoglobin A1c at one-year follow-up. The pervasive symptomatology includes several characteristics such as denial, grief, frustration, fear, low motivation, defeat, and loneliness. Since 1995, one of the most consistent effects in literature is that diabetes distress is consistently associated with lower levels of self-care. Despite being well-known within the diabetes field, diabetes distress is not yet mentioned in the ICD-10 diagnosis code, nor is it listed in the DSM-5 criteria as an independent diagnosis. How do we, as diabetes providers, consistently and accurately identify diabetes distress in our patients? Furthermore, how would we distinguish diabetes distress from other mental health conditions that may warrant further mental health intervention and management? In 2020, a scoping database review was published that demonstrates three distinct entities in diabetes-associated negative psychological states. The first defined diabetes distress as the day-to-day experiences of living with diabetes. Depression was defined as the generic feeling of depressed affect not linked to a specific experience or condition. And diabetes burnout, a condition known to be associated with barriers to treatment and glycemic control. Patients with diabetes burnout often describe feeling drained and hopeless, having difficulty with self-care strategies, and often detaching themselves from support systems, thereby worsening isolationism and a sense of powerlessness. In 2022, a group of researchers identified modifiable factors that directly impacted diabetes distress. Greater hurried communication significantly worsened diabetes distress, while patient-centered decision-making and provider communication styles that included compassion and respect were associated with reduced diabetes distress. These relationships were independent of diabetes burden and reiterate the value of developing shared decision-making strategies while ensuring that the patient is playing an active role in self-care treatment plans. Let us begin with our first case. Meet Ms. G. Ms. G is a 54-year-old woman with a history of type 2 diabetes. She is referred to endocrinology by her primary care provider for uncontrolled diabetes, though she was unaware of the referral at the time. Upon chart review, her hemoglobin A1c historically had been between 6.5 to 7%, until the most recent lab value, which substantially elevated to 8.6%. The patient's family history is notable for a 27-year-old daughter with obesity and a 24-year-old daughter with no significant health issues. Her medications include metformin 1,000 mg twice daily and sitagliptin 100 mg once daily. Ms. G's vitals include a blood pressure of 136 over 85 mmHg, pulse 82 beats per minute, respirations 14 per minute, temperature 97.4 degrees Fahrenheit, weight of 125 pounds, and a height of 5 foot 2 inches with the BMI of 24. In general, she appears sad and quiet, with no other significant distress, and the physical exam is otherwise non-focal. Her labs are notable for a hemoglobin A1c of 8.6%, HDL cholesterol of 45, total cholesterol 210, LDL cholesterol 128, triglyceride 185, and GFR of 95 mLs per minute. Of note, one year prior, Ms. G's triglycerides were 130 and her LDL was 116. At that time, the primary care provider had discussed statin therapy, which the patient deferred, requesting time to improve her diet. What's next for Ms. G? Should we add another anti-hyperglycemic agent, inquire further about the reasons for the hyperglycemia trend, inquire into the reason that the patient appears sad, or recommend that the patient lose weight and discharge the patient from the endocrinology clinic? The recommendation is to inquire into the reason that the patient appears sad. The reason for the patient's sadness may be contributing to changes in self-care strategies. Additionally, it would be valuable to focus on patient-centered communication, as this may help reduce or potentially mitigate the burden of diabetes distress. Additionally, focusing on the patient's symptoms and her feelings is consistent with the shared decision model of personalized diabetes care. The specialist asks Ms. G, I notice you appear a little sad. Is there a particular reason for this? After an extended pause, the patient relates. I used to be able to take such good care of myself. I went for walks every day, ate healthy, and felt so proud of how I lived a healthy and balanced life. But one year ago, my husband was diagnosed with end-stage cancer. Over the six months that followed, I had to redirect all my waking hours to his doctor's appointments and care. Sadly, six months ago, he passed away, and I have not been able to get myself back on track. My daughter lives in another state, and she wants me to move in with her. I am hoping to do that in the months ahead. I admit that I have forgotten to take my medications, and I have not been eating the heart-healthy diet that I know works to keep my blood sugar under control. The specialist concluded that the recent rise in Ms. G's hemoglobin A1c was likely a reflection of situational depression as a result of the loss of her loved one. The specialist provided ongoing guidance to the patient that included inquiring and encouraging the patient to enlist the support of her family and community, and to consider mental health consultation for clinical support. Finally, when the patient appeared composed, the specialist inquired if she was ready to consider resuming self-care daily strategies that had been so successful for her in the years prior. Ms. G expressed a readiness to proceed. This case illustrates the value of establishing an open communication between patient and provider that allows the provider to gain greater insight into the reasons for the patient's current clinical state. The provider can then deliver ongoing support for the patient as she adapts to changes in her personal life, while encouraging her to resume consistent adherence to medications, increasing her activity, and resuming a heart-healthy approach to nutrition. Finally, the provider reiterates the importance of scheduling a follow-up appointment with pre-clinic labs to include a hemoglobin A1c. Before concluding the visit, the provider addresses the patient's recent lipid profile that includes an LDL cholesterol of 128 milligrams per deciliter and a triglyceride of 185 milligrams per deciliter. The provider explains to the patient that based on her atherosclerotic cardiovascular disease risk assessment, even if she resumes a heart-healthy diet, she would still benefit from the initiation of moderate-intensity statin for cardiovascular risk reduction benefit. Additionally, the provider explains that triglyceride levels greater than 150 milligrams per deciliter but less than 500 milligrams per deciliter warrant dietary modification and continued surveillance. Please review the American Association of Clinical Endocrinology guidance regarding treating hypercholesterolemia in persons with diabetes mellitus. In individuals with diabetes and an LDL cholesterol greater than or equal to 100 milligrams per deciliter, the patient should continue to receive ongoing counseling regarding optimization of enduring healthy lifestyles. In addition to this counseling, patients atherosclerotic cardiovascular disease, or ASCVD risk assessment should be assessed. If the patient's ASCVD 10-year risk is less than 10%, then moderate intensity statin therapy should be recommended and initiated with the goal to achieve an LDL cholesterol less than 100 milligrams per deciliter, a non-HDL cholesterol less than 130 milligrams per deciliter, and an apolipoprotein B level of less than 90 milligrams per deciliter. In individuals with the 10-year ASCVD risk greater than 10%, high intensity statin therapy is recommended with the goal to achieve an LDL cholesterol less than 70 milligrams per deciliter and an apolipoprotein B level less than 80 milligrams per deciliter. Let us move on with our second case. Meet Mr. K. Mr. K is a 64-year-old gentleman with a 15-year history of type 2 diabetes mellitus who had been initially started on oral agents for 8 years and then basal insulin was started. Four years later, mealtime insulin is initiated. The patient has struggled with dietary and medication adherence over the years. He admits to drinking sugar-concentrated, carbonated, and non-carbonated beverages on a daily basis despite frequent counseling about guidelines that recommend not to consume such substances. He primarily admits to missing mealtime insulin as it is not convenient with his busy lifestyle. The patient's problem list includes essential hypertension, hyperlipidemia, and chronic kidney disease stage 3 in addition to type 2 diabetes. The patient's medications include ACE inhibitor, high-intensity statin therapy, a basal insulin of 60 units once a day, and a mealtime insulin of 15 units three times a day with meals, including a sliding scale that delivers two units for every incremental increase of 50 points above a blood sugar of 150 milligrams per deciliter. The patient's exam is notable for a blood pressure of 149 over 86 millimeters of mercury, pulse of 85 beats per minute, respirations of 16 per minute, temperature of 98.9 degrees Fahrenheit, weight of 208 pounds, and a height 5 foot 8 inches with the BMI of 31. In general, the patient does not appear to be in any distress. His cardiac exam is notable for regular rate and rhythm. The abdominal wall is protuberant, non-tender, and his extremities demonstrate trace pretibial edema. Objective labs include a hemoglobin A1c of 10.5%, an HDL cholesterol of 39, total cholesterol 265, LDL cholesterol 185, triglycerides of 200, and a GFR of 55 mils per minute. What is the next best step for counseling Mr. K? Admonish the patient for dietary and medication non-adherence. Counsel the patient that if he doesn't follow recommendations, then he is increasing his risk for dying prematurely. Initiate concentrated insulin as the patient is unable to adhere to multiple daily injection regimen, or recommend initiation of continuous glucose monitoring to provide greater insight into the patient's glycemic trends, assist with medication decision-making, and provide guidance to optimize dietary strategies. Please review the American Association of Clinical Endocrinology guidance regarding matching glucose monitoring options to the complexity of anti-hyperglycemic regimens. Continuous glucose monitoring systems, or CGMS therapy, provide excellent support to patients with diabetes and should be considered for patients, particularly when the treatment regimen increases in complexity, including the initiation of insulin and mealtime insulin. In such patients, CGMS therapy can not only guide the patient in insulin dose titration, but can also be effective in guiding and changing dietary and lifestyle behaviors. Another specific population of patients that benefit from CGMS therapy include patients with diabetes who are at a higher risk for hypoglycemia. In this patient population, CGMS therapy can help to prevent and protect patients from hypoglycemia and its complications. In this case, please note the personalized approach to type 2 diabetes that includes the initiation of CGM therapy. In addition to CGM, the patient would benefit from ongoing support from a nutritionist. Additionally, the patient should be counseled to continue metformin, and the provider may consider adding additional pharmacologic therapy with either SGLT2 inhibitor or GLP-1 agonist therapy. Let us address the additional agents for diabetes optimization, as well as a personalized approach to lipid therapy. Please review the American Association of Clinical Endocrinology guidelines regarding anti-hyperglycemic therapy for persons with type 2 diabetes who also have a very high risk for atherosclerotic cardiovascular disease, heart failure, cerebral vascular disease, or chronic kidney disease. In all persons with type 2 diabetes, counseling should be provided to the patient to optimize cardiovascular disease risk factors. In patients with type 2 diabetes with existing atherosclerotic cardiovascular disease, or in patients who have a high risk for atherosclerotic cardiovascular disease, the addition of GLP-1 agonist and or SGLT2 inhibitor would be recommended. In patients with type 2 diabetes and heart failure, the provider may consider preferential add-on therapy with an SGLT2 inhibitor. In patients with a history of type 2 diabetes and cerebral vascular disease or stroke, the provider may consider additional therapy with either a GLP-1 agonist and or pioglitazone. And finally, in patients with type 2 diabetes and chronic kidney disease, the addition of an SGLT2 inhibitor may help to slow the progression in chronic kidney disease. In the case of Mr. K, his calculated atherosclerotic cardiovascular disease risk was defined as very high or a 10-year risk of greater than 10%. He would specifically benefit, therefore, from the addition of either a GLP-1 agonist or SGLT2 inhibitor and potentially the combination of both, barring any clinical contraindication to the addition of these agents. Let us review Mr. K's lipid profile once more. His HDL cholesterol is 39 milligrams per deciliter, total cholesterol 265 milligrams per deciliter, LDL cholesterol of 186 milligrams per deciliter, and triglyceride level of 200 milligrams per deciliter. The patient's atherosclerotic cardiovascular disease risk is calculated to be 42%. An ASCVD risk of greater than 10 but less than 20% would be defined as very high risk. However, patients with an ASCVD risk greater than 20% are defined as extreme 10-year risk for a cardiovascular disease event. Therefore, high-intensity statin therapy is recommended for this patient and additional pharmacologic therapies may be warranted to reduce the pro- atherogenic lipoprotein level. Additionally, the patient's triglyceride levels are noted to be elevated and should be optimized with both medical nutrition therapy and the addition of pharmacologic therapy. Again, please review the American Association of Clinical Endocrinology guidelines regarding the decision tree for treating hypercholesterolemia in patients with diabetes. For the case of Mr. K, his ASCVD risk is calculated at 42%, putting him in the extreme risk category. In these patients, high-intensity statin therapy is warranted and additional agents may be required to reduce the apolipoprotein B level to less than 70 milligrams per deciliter. Additional agents may include ezetimibe or PCSK9 inhibitor therapies. Please review the American Association of Clinical Endocrinology guidelines regarding the decision tree for hypertriglyceridemia in persons with diabetes. Patients with hypertriglyceridemia and diabetes benefit from provider-directed counseling regarding optimized glycemic control and reiteration of the recommended nutrition guidelines. The provider may also consider referring the patient to a registered dietitian for ongoing guidance and counseling. If a patient's fasting triglyceride level is greater than 150 but less than 500 milligrams per deciliter, then the patient should be counseled to begin a focused dietary regimen that includes the elimination of all carbonated drinks such as sodas as well as alcohol. The patient should be counseled to reduce fat consumption to no more than 20 to 25 percent of the daily caloric intake. If triglyceride levels remain elevated above 200 milligrams per deciliter, despite these treatment strategies and on maximally tolerated statin therapy, then the addition of fibrates or icosapent ethyl may be warranted to reduce the pro-atherogenic burden. If a patient's triglyceride level is equal to or greater than 500 milligrams per deciliter, then insulin therapy may be warranted not only for glycemic control but also to facilitate triglyceride metabolism. Patients should be recommended to continue maximally tolerated statin therapy and then add a fibrate or icosapent ethyl for continued pharmacologic reduction of triglyceride levels. Additional agents including niacin may be considered in exceptional situations in which the patient's fasting triglyceride level exceeds 1,000 milligrams per deciliter, a threshold above which the patient is at a higher risk for pancreatitis. Please review the American Association of Clinical Endocrinology Guidelines regarding the full recommendations for specific dietary patterns that have been studied and have demonstrated a clinically meaningful impact on cardiometabolic diseases. Of note, the Mediterranean diet is primarily comprised of more than five servings of vegetables per day as well as fruits, legumes, beans, a moderate intake of dairy products, and animal protein in the form of fish and poultry limited to no more than one serving per day. This approach to nutrition has been extensively studied in randomized controlled trials and demonstrates long-term benefits including a reduction in cardiovascular disease risk and mortality. Patients may consider a plant-strong approach to nutrition, considering the plethora of benefits when consuming a nutrient-dense diet that offers an excellent protein alternative to animal products while also increasing fiber and other essential vitamins and nutrients. Patients following a vegetarian or plant-based diet that focuses on whole foods with moderate consumption of healthy fats and avoidance of excessive saturated fats and processed foods demonstrates a further reduction in diabetes risk and can also help with weight loss and lowering the LDL cholesterol. The DASH diet or dietary approaches to stop hypertension diet not only reduces diabetes and lipids but also has been shown to reduce blood pressure. Thank you for your attention to this educational module. Through this session we hope that you have gained greater confidence with patient communication strategies, with developing personalized treatment goals for glycemic control in patients with type 2 diabetes, and appreciate the benefits of provider-directed medical nutrition therapy for the management of weight and cardiometabolic diseases. Thank you.

intensifying diabetes therapies

personalized treatment goals

evidence-based guidelines

glycemic control

shared decision-making strategies

glucose management