Transcultural Diabetes Care in The United States – A Position Statement by the American Association of Clinical Endocrinologists

The American Association of Clinical Endocrinologists (AACE) has created a transculturalized diabetes chronic disease care model that is adapted for patients across a spectrum of ethnicities and cultures. AACE has conducted several transcultural activities on global issues in clinical endocrinology and completed a 3-city series of conferences in December 2017 that focused on diabetes care for ethnic minorities in the U.S. Proceedings from the “Diabetes Care Across America” series of transcultural summits are presented here. Information from community leaders, practicing health care professionals, and other stakeholders in diabetes care is analyzed according to biological and environmental factors. Four specific U.S. ethnicities are detailed: African Americans, Latino/Hispanics, Asian Americans, and Native Americans. A core set of recommendations to culturally adapt diabetes care is presented that emphasizes culturally appropriate terminology, transculturalization of white papers, culturally adapting clinic infrastructure, flexible office hours, behavioral medicine—especially motivational interviewing and building trust—culturally competent nutritional messaging and health literacy, community partnerships for care delivery, technology innovation, clinical trial recruitment and retention of ethnic minorities, and more funding for scientific studies on epigenetic mechanisms of cultural impact on disease expression. It is hoped that through education, research, and clinical practice enhancements, diabetes care can be optimized in terms of precision and clinical outcomes for the individual and U.S. population as a whole.Lay AbstractThe American Association of Clinical Endocrinologists (AACE) has created a diabetes care model for patients of different backgrounds. AACE led meetings in New York, Houston, and Miami with health care professionals and community leaders to improve diabetes care. Information from these meetings looked at biological and environmental diabetes risks. Four American patient groups were studied: African Americans, Latinos, Asian Americans, and Native Americans. Diabetes care should use culturally appropriate language and search for better ways to apply science and clinic design. Talking to patients more clearly can improve their diabetes control. There are many other needed changes in the American health care system discussed in this paper. It is hoped that through better education, research, and practice, diabetes care can be improved for the entire U.S. population. This means that important differences among patients' ethnic and cultural backgrounds are addressed.Executive Summary

• Cultural adaptation of evidence-based recommendations is a necessary component of optimal diabetes care.
• Biological factors that contribute to the pathophysiology of diabetes vary according to race and ethnicity and can be affected by social determinants that vary with culture.
• The “Transcultural Diabetes Nutrition Algorithm” was developed in 2010 to optimize diabetes nutrition care globally and represents a validated methodology where evidence-based recommendations from a source culture can be adapted and implemented in a different culture using a toolkit.
• The 2015 AACE Pan-American Workshop examined diabetes care in 9 Latin American nations and concluded that there should only be one level of diabetes care for a population and that level should be “excellent;” also, that A1C measurements should be utilized and that more educational and nutritional options are needed to optimize diabetes care.
• The “Diabetes Care Across America – A Series of Transcultural Summits” was an AACE program conducted in 2017 in New York, Houston, and Miami to examine cultural factors that influence diabetes care domestically; the findings of this program are presented here.
• The African American, Hispanic/Latino, Asian American, and Native American populations are each comprised of different ancestries, anthropometrics/body compositions and physical appearances, and cultures and degrees of acculturation, with a significant evidence base that associates specific gene variants with specific phenotypic traits affecting diabetes care.
• For each ethno-cultural population, health messaging and diabetes care will need to consider issues of potential distrust of health care professionals, history of discrimination, religious practices, food preferences, attitudes toward physical activity, and despite the full range of socio-economics, the impact of poverty on engagement, self-monitoring, adherence with lifestyle and medical recommendations, and recruitment for clinical trials.
• Diabetes care should be as precise as possible, incorporating clinical trial evidence that best reflects the ethno-cultural attributes of a specific patient, with particular emphasis on cardiovascular disease risk mitigation, technology to assess the effects of eating patterns on glycemic status, adjusting traditional eating patterns to more healthy options that are still acceptable to the patient, flexibility in lifestyle and medication recommendations that take into account cultural factors, and the utilization of community-based resources to improve implementation.
• Pragmatic first steps to prepare a diabetes practice for an ethno-culturally diverse patient population include: learning more about biological-cultural interactions; gaining experience with lifestyle and behavioral medicine, especially motivational interviewing; creating a safe and immersive clinical environment; incorporating translation services, social prescribing, wearable technologies, web-based resources, and community engagement; and establishing referral networks with clinical trialists in diabetes research to improve recruitment of different populations.

ABSTRACTAbbreviations: A1C = hemoglobin A1c; AACE = American Association of Clinical Endocrinologists; ABCD = adiposity-based chronic disease; BMI = body mass index; CPA = clinical practice algorithm; CPG = clinical practice guideline; DBCD = dysglycemia-based chronic disease; DPP = Diabetes Prevention Program; GWAS = genome-wide association study; HCP = health care professional(s); IHS = Indian Health Service; LDL = low-density lipoprotein; MetS = metabolic syndrome; T2D = type 2 diabetes mellitus; tDNA = transcultural Diabetes Nutrition Algorithm; TG = triglyceride; WC = waist circumference     

American Association of Clinical Endocrinologists and American College of Endocrinology – Clinical Practice Guidelines for Developing A Diabetes Mellitus Comprehensive Care Plan – 2015 — Executive Summary

The American Association of Clinical Endocrinologists/American College of Endocrinology Medical Guidelines for Clinical Practice are systematically developed statements to assist healthcare professionals in medical decision making for specific clinical conditions. Most of the content herein is based on literature reviews. In areas of uncertainty, professional judgment was applied. These guidelines are a working document that reflects the state of the field at the time of publication. Because rapid changes in this area are expected, periodic revisions are inevitable. We encourage medical professionals to use this information in conjunction with their best clinical judgment. The presented recommendations may not be appropriate in all situations. Any decision by practitioners to apply these guidelines must be made in light of local resources and individual patient circumstances.Abbreviations: A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACCORD = Action to Control Cardiovascular Risk in Diabetes ACE = angiotensin-converting enzyme ADA = American Diabetes Association AER = albumin excretion rate ApoB = apolipoprotein B ARB = angiotensin II receptor blocker ASCVD = atherosclerotic cardiovascular disease BEL = best evidence level BMI = body mass index CDC = Centers for Disease Control and Prevention CDE = certified diabetes educator CGM = continuous glucose monitoring CKD = chronic kidney disease CPAP = continuous positive airway pressure CPG = clinical practice guideline CSI = continuous subcutaneous insulin infusion CVD = cardiovascular disease DPP-4 = dipeptidyl peptidase 4 DSME = diabetes self-management education DSPN = distal symmetric polyneuropathy EL = evidence level ESRD = end-stage renal disease FDA = U.S. Food and Drug Administration FPG = fasting plasma glucose GDM = gestational diabetes mellitus GFR = glomerular filtration rate GLP-1 = glucagon-like peptide 1 HBV = hepatitis B virus HDL-C = high-density lipoprotein cholesterol HR = hazard ratio ICU = intensive care unit IFG = impaired fasting glucose IGT = impaired glucose tolerance ISF = insulin sensitivity factor LDL-C = low-density lipoprotein cholesterol LDL-P = low-density lipoprotein particles MDI = multiple daily injections MNT = medical nutrition therapy NPH = neutral protamine Hagedorn OGTT = oral glucose tolerance test OSA = obstructive sleep apnea PG = plasma glucose POC = point-of-care PPG = postprandial glucose PTH = parathyroid hormone Q = clinical question R = recommendation RAAS = reninangiotensin-aldosterone system RCT = randomized controlled trial SFN = small-fiber neuropathy SGLT2 = sodium glucose cotransporter 2 SMBG = self-monitoring of blood glucose T1D = type 1 diabetes T2D = type 2 diabetes TZD = thiazolidinedione     

American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis — 2016--Executive Summary

Abbreviations:AACE = American Association of Clinical EndocrinologistsAFF = atypical femur fractureASBMR = American Society for Bone and Mineral ResearchBEL = best evidence levelBMD = bone mineral densityBTM = bone turnover markerCBC = complete blood countCI = confidence intervalDXA = dual-energy X-ray absorptiometryEL = evidence levelFDA = U.S. Food and Drug AdministrationFLEX = Fracture Intervention Trial (FIT) Long-term ExtensionFRAX® = Fracture Risk Assessment ToolGFR = glomerular filtration rateGI = gastrointestinalHORIZON = Health Outcomes and Reduced Incidence with Zoledronic Acid Once YearlyIOF = International Osteoporosis FoundationISCD = International Society for Clinical DensitometryIU = international unitsIV = intravenousLSC = least significant changeNBHA = National Bone Health AllianceNOF = National Osteoporosis Foundation25(OH)D = 25-hydroxy vitamin DONJ = osteonecrosis of the jawPINP = serum carboxy-terminal propeptide of type I collagenPTH = parathyroid hormoneR = recommendationRANK = receptor activator of nuclear factor kappa-BRANKL = receptor activator of nuclear factor kappa-B ligandRCT = randomized controlled trialRR = relative riskS-CTX = serum C-terminal telopeptideSQ = subcutaneousVFA = vertebral fracture assessmentWHO = World Health Organization     

Invasive Breast Cancer After Initiation of Testosterone Replacement Therapy in A Man—A Warning To Endocrinologists

ObjectiveTo alert fellow endocrinologists of a rare side effect of testosterone therapy, for which men with hypogonadism must receive appropriate counseling and monitoring.MethodsWe present clinical features, laboratory data, and histopathologic findings in a man with hypogonadism who received testosterone replacement therapy.ResultsA 61-year-old man was referred to an endocrinologist after presenting to his general practitioner with erectile dysfunction and low libido. He had no history of hypothalamic, pituitary, or testicular disorders. There were no other illnesses or medications to account for low testosterone levels. Physical examination was unremarkable. There was no family history of malignant disease. Biochemical investigations confirmed the presence of primary hypogonadism, for which no cause (including Klinefelter syndrome) was identified. Testosterone therapy was initiated to improve sexual function and preserve bone density. Five weeks later, the patient returned to his general practitioner, complaining of a gradually enlarging lump in his right breast. When biopsy showed breast cancer, testosterone therapy was discontinued. Right mastectomy and axillary node clearance were performed. Further histologic examination revealed estrogen receptor-positive, invasive carcinoma, without nodal involvement. The patient remains on tamoxifen therapy and is undergoing follow-up in the breast clinic. After 6 months of treatment, estradiol levels were undetectable, and testosterone levels remained low.ConclusionAlthough breast cancer has been described in men with hypogonadism receiving long-term testosterone replacement therapy, to our knowledge this is the first report of breast cancer becoming clinically manifest after a short duration (5 weeks) of testosterone treatment. This case should remind clinicians that men receiving testosterone therapy should be warned of the risk of not only prostate cancer but also breast cancer. Patient self-monitoring and breast examinations by the attending physician are recommended. (Endocr Pract. 2008;14: 201-203)     

American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis— 2020 Update Executive Summary

Objective: The development of these guidelines is sponsored by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs).Methods: Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols.Results: The Executive Summary of this 2020 updated guideline contains 52 recommendations: 21 Grade A (40%), 24 Grade B (46%), 7 Grade C (14%), and no Grade D (0%). These detailed, evidence-based recommendations allow for nuance-based clinical decision-making that addresses multiple aspects of real-world care of patients. The evidence base presented in the subsequent Appendix provides relevant supporting information for the Executive Summary recommendations. This update contains 368 citations: 123 (33.5%) evidence level (EL) 1 (highest), 132 (36%) EL 2 (intermediate), 20 (5.5%) EL 3 (weak), and 93 (25%) EL 4 (lowest). New or updated topics in this CPG include: clarification of the diagnosis of osteoporosis, stratification of the patient according to high-risk and very-high-risk features, a new dual-action therapy option, and transitions from therapeutic options.Conclusion: This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of post-menopausal osteoporosis.     

Cell Replacement Therapy in Parkinson’s Disease—History of Development and Prospects for Use in Clinical Practice

Molecular Biology - Parkinson’s disease is a widespread neurodegenerative disease, which is characterized by the death of dopaminergic neurons in the substantia nigra of the midbrain....     

American Association of Clinical Endocrinologists and American College of Endocrinology Disease State Clinical Review: Management of Acromegaly Patients: What is the Role of Pre-Operative Medical Therapy?

Objective: Acromegaly is a complex disease characterized by growth hormone (GH) excess originating in most cases from a pituitary tumor. The goals of treatment include removing the tumor or reducing tumor burden, normalizing GH secretion and insulin-like growth factor 1 levels, and preserving normal pituitary function if possible. Surgery by an experienced neurosurgeon is still considered first-line therapy, especially in cases with small tumors. In the last few decades, significant progress in the development of selective pharmacologic agents has greatly facilitated the management of active acromegaly, with agents such as somatostatin-receptor ligands (SRLs), GH-receptor antagonists, and dopamine agonists. In addition to adjuvant treatment, pre-operative medical therapy and primary therapy in de novo patients are increasingly employed.Methods: A United States National Library of Medicine PubMed search (through July 2014) was conducted for the following terms: acromegaly, pre-operative medical therapy, somatostatin-receptor ligands, and somatostatin analogs. Articles not in English and those not in peer-reviewed journals were excluded. In reviewing pertinent articles, focus was placed on biochemical and other postoperative outcomes of medical therapy.Results: An analysis of the full effect of pre-operative use of SRLs on surgical outcomes (remission rates and peri-operative complications) is limited by heterogeneity of methodology, low overall surgical cure rates, and different study designs. The assumption that SRL use prior to surgery reduces peri-operative surgical risk has yet to be proven. A variable degree of tumor shrinkage with preoperative SRLs is observed. Likewise, SRL treatment 3 months before surgery may improve surgical remission rates in the short term; however, positive results do not persist in the long term.Conclusion: We consider that medical therapy before surgery could play a role in carefully selected patients, but treatment should be individualized. Primary medical therapy with a SRL may be considered in patients with macroadenomas without local mass effects on the optic chiasm, as SRLs have been shown to reduce tumor size and control GH hypersecretion. However, the data are insufficient to support general use of a SRL prior to surgery in order to improve post-surgery biochemical outcomes. Theoretically, patients with severe cardiac and respiratory complications due to acromegaly could potentially benefit from pre-operative SRLs in order to reduce peri-operative morbidity. Further investigation and investment in large randomized long-term clinical trials are needed to define the precise role and duration of pre-surgical medical treatment in acromegaly patients.Abbreviations: GH = growth hormone IGF-1 = insulin-like growth factor 1 MRI = magnetic resonance imaging SRL = somatostatin-receptor ligand     

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2018 Executive Summary

Abbreviations: A1C = hemoglobin A1C; AACE = American Association of Clinical Endocrinologists; ACCORD = Action to Control Cardiovascular Risk in Diabetes; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure; ACEI = angiotensin-converting enzyme inhibitor; ADVANCE = Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation; AGI = alpha-glucosidase inhibitor; apo B = apolipoprotein B; ASCVD = atherosclerotic cardiovascular disease; BAS = bile acid sequestrant; BCR-QR = bromocriptine quick release; BMI = body mass index; BP = blood pressure; CCB = calcium channel blocker; CHD = coronary heart disease; CKD = chronic kidney disease; CVD = cardiovascular disease; DASH = Dietary Approaches to Stop Hypertension; DPP4 = dipeptidyl peptidase 4; eGFR = estimated glomerular filtration rate; ER = extended release; FDA = Food and Drug Administration; GLP1 = glucagon-like peptide 1; HDL-C = high-density lipoprotein cholesterol; IMPROVE-IT = Improved Reduction of Outcomes: Vytorin Efficacy International Trial; LDL-C = low-density lipoprotein cholesterol; LDL-P = low-density lipoprotein particle; Look AHEAD = Look Action for Health in Diabetes; NPH = neutral protamine Hagedorn; OSA = obstructive sleep apnea; RCT = randomized controlled trial; SU = sulfonylurea; SGLT2 = sodium glucose cotransporter-2; SMBG = self-monitoring of blood glucose; T2D = type 2 diabetes; TZD = thiazolidinedione; VADT = Veterans Affairs Diabetes Trial     

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2019 Executive Summary

Abbreviations: A1C = hemoglobin A1C; AACE = American Association of Clinical Endocrinologists; ACCORD = Action to Control Cardiovascular Risk in Diabetes; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure; ACE = American College of Endocrinology; ACEI = angiotensin-converting enzyme inhibitor; AGI = alpha-glucosidase inhibitor; apo B = apolipoprotein B; ARB = angiotensin II receptor blocker; ASCVD = atherosclerotic cardiovascular disease; BAS = bile acid sequestrant; BMI = body mass index; BP = blood pressure; CCB = calcium channel blocker; CGM = continuous glucose monitoring; CHD = coronary heart disease; CKD = chronic kidney disease; DKA = diabetic ketoacidosis; DPP4 = dipeptidyl peptidase 4; eGFR = estimated glomerular filtration rate; EPA = eicosapentaenoic acid; ER = extended release; FDA = Food and Drug Administration; GLP1 = glucagon-like peptide 1; HDL-C = high-density-lipoprotein cholesterol; HeFH = heterozygous familial hypercholesterolemia; LDL-C = low-density-lipoprotein cholesterol; LDL-P = low-density-lipoprotein particle; Look AHEAD = Look Action for Health in Diabetes; NPH = neutral protamine Hagedorn; OSA = obstructive sleep apnea; PCSK9 = proprotein convertase subtilisin-kexin type 9 serine protease; RCT = randomized controlled trial; SU = sulfonylurea; SGLT2 = sodium-glucose cotransporter 2; SMBG = self-monitoring of blood glucose; T2D = type 2 diabetes; TZD = thiazolidinedione     

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2020 Executive Summary

Abbreviations: A1C = hemoglobin A1C; AACE = American Association of Clinical Endocrinologists; ABCD = adiposity-based chronic disease; ACCORD = Action to Control Cardiovascular Risk in Diabetes; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure; ACE = American College of Endocrinology; ACEI = angiotensin-converting enzyme inhibitor; AGI = alpha-glucosidase inhibitor; apo B = apolipoprotein B; ARB = angiotensin II receptor blocker; ASCVD = atherosclerotic cardiovascular disease; BAS = bile acid sequestrant; BMI = body mass index; BP = blood pressure; CCB = calcium channel blocker; CGM = continuous glucose monitoring; CHD = coronary heart disease; CKD = chronic kidney disease; DKA = diabetic ketoacidosis; DPP4 = dipeptidyl peptidase 4; eGFR = estimated glomerular filtration rate; EPA = eicosapentaenoic acid; ER = extended release; FDA = Food and Drug Administration; GLP1 = glucagon-like peptide 1; HDL-C = high-density-lipoprotein cholesterol; HeFH = heterozygous familial hypercholesterolemia; LDL-C = low-density-lipoprotein cholesterol; LDL-P = low-density-lipoprotein particle; Look AHEAD = Look Action for Health in Diabetes; NPH = neutral protamine Hagedorn; OSA = obstructive sleep apnea; PCSK9 = proprotein convertase subtilisin-kexin type 9 serine protease; RCT = randomized controlled trial; SU = sulfonylurea; SGLT2 = sodium-glucose cotransporter 2; SMBG = self-monitoring of blood glucose; T2D = type 2 diabetes; TZD = thiazolidinedione     

Protocol for Development of American Association of Clinical Endocrinology Clinical Practice Guidelines and Consensus Statements: Summary of Methodology,Process, and Policy – 2023 Update

ObjectiveThis 2023 updated protocol summarizes the American Association of Clinical Endocrinology’s (AACE’s) new framework for the development of clinical practice guidelines and other guidance documents that includes changes to methodology, processes, and policies.MethodsAACE has critically reviewed its development processes for guidance documents over the last several years against the National Academy of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines and the Council of Medical Specialty Societies Principles for Development of Specialty Society Clinical Guidelines to determine areas for improvement.ResultsThe new AACE framework for development of guidance documents incorporates many changes, including a revised conflicts of interest (COI) policy; strengthened commitment to collection of disclosures and management of relevant COI during development; open calls to membership for authors; new requirements for authors; new diversity, equity, and inclusion (DEI) policy; new empanelment process that incorporates consideration of DEI; and adoption of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to increase the quality of evidence assessment and standardize recommendation grades and statements, among other improvements.ConclusionsAACE has revised its policies and adopted a completely new methodology for guideline development in support of the mission to elevate the practice of clinical endocrinology to improve patient care. With the use of an evidence-based medicine framework and by continually assessing and improving its processes for development of guidance, AACE strives to deliver trustworthy, unbiased, and up-to-date information that ensures clinician and patient confidence in AACE content. Further, AACE hopes that these enhancements foster a more collaborative approach to development and increase engagement with the worldwide medical community to improve global health.     

American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm – 2023 Update

ObjectiveThis consensus statement provides (1) visual guidance in concise graphic algorithms to assist with clinical decision-making of health care professionals in the management of persons with type 2 diabetes mellitus to improve patient care and (2) a summary of details to support the visual guidance found in each algorithm.MethodsThe American Association of Clinical Endocrinology (AACE) selected a task force of medical experts who updated the 2020 AACE Comprehensive Type 2 Diabetes Management Algorithm based on the 2022 AACE Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan and consensus of task force authors.ResultsThis algorithm for management of persons with type 2 diabetes includes 11 distinct sections: (1) Principles for the Management of Type 2 Diabetes; (2) Complications-Centric Model for the Care of Persons with Overweight/Obesity; (3) Prediabetes Algorithm; (4) Atherosclerotic Cardiovascular Disease Risk Reduction Algorithm: Dyslipidemia; (5) Atherosclerotic Cardiovascular Disease Risk Reduction Algorithm: Hypertension; (6) Complications-Centric Algorithm for Glycemic Control; (7) Glucose-Centric Algorithm for Glycemic Control; (8) Algorithm for Adding/Intensifying Insulin; (9) Profiles of Antihyperglycemic Medications; (10) Profiles of Weight-Loss Medications (new); and (11) Vaccine Recommendations for Persons with Diabetes Mellitus (new), which summarizes recommendations from the Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention.ConclusionsAligning with the 2022 AACE diabetes guideline update, this 2023 diabetes algorithm update emphasizes lifestyle modification and treatment of overweight/obesity as key pillars in the management of prediabetes and diabetes mellitus and highlights the importance of appropriate management of atherosclerotic risk factors of dyslipidemia and hypertension. One notable new theme is an emphasis on a complication-centric approach, beyond glucose levels, to frame decisions regarding first-line pharmacologic choices for the treatment of persons with diabetes. The algorithm also includes access/cost of medications as factors related to health equity to consider in clinical decision-making.