Community-Engaged Research (CEnR) to Address Gaps in Chronic Kidney Disease Education among Underserved Latines-The CARE Study.

Ensuring equitable chronic kidney disease (CKD) education for Latine patients with low health literacy and low English proficiency stands as a critical challenge, and the "Caridad Awareness and Education" (CARE) initiative represents our ongoing effort to address this imperative issue. In collaboration with twenty-three patients living with CKD, diabetes and/or hypertension and twelve trained Community Health Workers (CHWs) from diverse Latine subgroups, we conducted a research initiative funded by the National Kidney Foundation. Our primary objective was to co-design and test culturally tailored patient education materials (PEMs) for underserved Latine adults at risk for or diagnosed with CKD. We effectively integrated Community-Engaged Research (CEnR) principles with a Human-Centered Design (HCD) approach to create a range of CKD-PEM prototypes in Spanish. Patient preferences for printed educational materials were clear. They favored printed materials that incorporated visual content with concise text over digital, email, texts, or online resources and personalized phone outreach and the involvement of CHWs. Additionally, patients identified their unwavering commitment to their families as a forceful motivator for caring for their kidney health. Currently, a culturally and linguistically tailored CKD flipchart for one-on-one education, led by CHWs, is undergoing a pilot testing phase involving a sample of one hundred Latine patients at risk for or diagnosed with CKD. This innovative approach signifies a commitment to amplifying the insights and expertise of the Latine community afflicted by kidney health disparities, effectively embracing a CEnR to forge meaningful and impactful CKD-PEMs.

Are residents receiving the training needed within their residency programs to optimally manage patients with diabetes?

Objective: Diabetes is a prevalent and growing problem in the United States (U.S.); primary care physicians need to be prepared to initiate and progressively advance treatment. The objective of this study was to understand how diabetes management is taught in U.S. Family Medicine (FM) and Internal Medicine (IM) residency programs.Methods: Invitations to complete an online survey were sent via postal mail to U.S. FM and IM residency programs in 2019.Results: Directors/associate directors from 68 FM residencies and 66 IM residencies completed the online survey out of 645 (10.5%) and 505 (13.1%) programs, respectively. Most respondents rated cardiovascular disease and risk management in diabetes as 'very important' (90%), but only about half (47%) did so for newer generation insulin analogs and 27% for digital health technologies. About two-thirds of programs cover non-insulin options for type 2 diabetes (66%) and types of insulin (63%) to a great extent, but only about one-third of programs cover social determinants of health (36%) and pre-diabetes (35%) to this degree. Many programs report plans to expand training on cardiovascular disease and diabetes (59%), but only 32% plan to expand training on digital technology for diabetes care. Lack of faculty time and competing priorities are cited as being the biggest barriers to expanding diabetes training.Conclusions: Our study found that the current U.S. FM and IM residency program diabetes curricula are dominantly oriented toward cardiovascular disease and 'traditional' insulins. A variety of training materials and resources could help overcome some of the current barriers to curriculum expansion of other important components of diabetes care that may help future physicians successfully manage diabetes with newer generation insulin and glucose monitoring technologies.Abbreviations: U.S: United States; PCP: Primary Care Physician; FM: Family Medicine; IM: Internal Medicine; CGM: Continuous Glucose Monitor; AAFP: American Academy of Family Physicians; ACGME: Accreditation Council for Graduate Medical Education; U/mL: units per milliliter; CME: Continuing Medical Education.

Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo.

Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA), recently approved in the USA and other countries. This paper reviews data from clinical trials (PIONEER 1, 2, 3, and 7) comparing oral semaglutide (once-daily doses of 3, 7, or 14 mg) with either once-daily placebo, empagliflozin 25 mg, or sitagliptin 100 mg. After 26 weeks in PIONEER 1, patients randomized to 3, 7, or 14 mg doses of oral semaglutide monotherapy had statistically significant reductions in glycated hemoglobin (HbA1 c) of 0.9%, 1.2%, and 1.4%, respectively, versus 0.3% with placebo. In the active-comparator studies, oral semaglutide 14 mg provided better glycemic control than empagliflozin or sitagliptin after 26 weeks, with durable effects. Body weight reductions were significantly greater with oral semaglutide than with placebo and sitagliptin. However, body weight reductions with oral semaglutide 14 mg versus empagliflozin 25 mg were not significantly different. Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time. Across these trials, 5-13% and 15-20% of patients experienced nausea with oral semaglutide 7 and 14 mg, respectively, and 2.3-3.4% and 5.1-8.0%, respectively, discontinued treatment due to gastrointestinal AEs. Severe or blood glucose-confirmed symptomatic hypoglycemia occurred infrequently with oral semaglutide and was seen most often in patients taking concomitant sulfonylureas. Findings from these trials indicate that the addition of oral semaglutide reduces HbA1 c and body weight and is associated with a low risk of hypoglycemia. Oral semaglutide represents an additional option for treating people with type 2 diabetes in primary care, with the potential to expand the numbers of patients benefiting from GLP-1RAs beyond that currently seen with injectable formulations.

The non-medical switching of prescription medications.

Non-medical switching of medication, whereby a patient's treatment regimen is changed for reasons other than efficacy, side effects, or adherence, is often related to drug formulary changes aimed at reducing drug costs. In the era of health care reform, while cost-cutting measures are important, there is considerable evidence that non-medical switching, particularly when applied to medication used to treat chronic conditions such as diabetes, may impact patient outcomes, medication-taking behavior, and use of health care services. Ultimately, overall costs may be increased, as savings by insurers are cancelled out by higher costs to the health care system as a whole, such as extra administration, treatment failure from new medicines, and increased adverse events. The emergence of biosimilar and follow-on biologic treatments raises further questions among patients receiving biologic treatments, with patient advocacy groups calling for clear legislation to ensure that patients with complex or chronic conditions continue to receive effective, evidence-based medications for their disease. This article will discuss non-medical switching in the US, taking into account the different parties involved, such as patients, health care providers, pharmacists, payers, and pharmacy benefit managers, with the aim of providing a detailed overview of this complex and evolving topic.

A GUIDE TO FOLLOW-ON BIOLOGICS AND BIOSIMILARS WITH A FOCUS ON INSULIN.

OBJECTIVE: Many healthcare providers in the U.S. are not familiar with follow-on biologics and biosimilars nor with their critical distinctions from standard generics. Our aim is to provide a detailed review of both, with a focus on insulins in the U.S. regulatory system. METHODS: Literature has been reviewed to provide information on various aspects of biosimilars and a follow-on biologic of insulin. This will include structure, efficacy, cost, switching, and legal issues. RESULTS: Biologic products are large, complex molecules derived from living sources. Follow-on biologics are copies of the original innovator biologics. It is not possible to copy their structure exactly, leading to possible differences in efficacy and safety. Thus, regulations involving biologics are complex. Follow-on biologics are regulated under two Federal laws until March 23, 2020: the Public Health Service Act (PHS Act) and the Federal Food, Drug, and Cosmetic Act. Biosimilars are follow-on biologics which have been approved via the PHS Act. They consist of those which are "highly similar" to the reference drug and those which are "expected" to produce the same clinical result as the reference drug (interchangeable biosimilars). Interchangeable biosimilars have been determined by the U.S. Food and Drug Administration to be substitutable by the pharmacist "without the intervention" of the prescriber. From the patient perspective, switching to a follow-on biologic may necessitate a change in delivery device, which may create issues for patient adherence and dosing. CONCLUSION: Although they present several challenges in terms of regulation and acceptance, follow-on biologics have the potential to significantly reduce costs for patients requiring insulin therapy. ABBREVIATIONS: BLA = biologics license application EU = European Union FDA = Food and Drug Administration FD&C = Food, Drug, and Cosmetic HCPCS = Healthcare Common Procedure Coding System INN = internatinal nonproprietary name NDA = new drug application PHS = Public Health Service.

Use of oral combination therapy for type 2 diabetes in primary care: Meeting individualized patient goals.

The management of type 2 diabetes mellitus (T2DM) by primary care physicians (PCPs) has become increasingly complex due to limitations on consultation time, an increasing array of drug treatment options, and issues of comorbidities and polypharmacy. Diabetes is a progressive condition and treatment with a single glucose-lowering agent can only address limited pathophysiologic targets and does not provide adequate glycemic control in many cases. Consequently, most patients with T2DM will eventually require treatment with multiple glucose-lowering medications. Oral combination therapy in T2DM may be given as multiple-pills, or as single-pill, fixed-dose combinations (FDCs), the latter of which offer convenience, ease of administration, and a reduction in the medication burden. Therefore, FDCs can potentially improve patients' treatment adherence and optimize achievement and maintenance of glycemic targets. However, cost factors also need to be considered. An understanding of the issues associated with the use of combination therapy in T2DM will help PCPs to guide patient-centered decision making and promote the effective management of T2DM.

Recognizing and minimizing hypoglycemia: The need for individualized care.

Hypoglycemia is a condition known to disrupt many everyday activities and is associated with increased risks of hospitalization, falls, motor vehicle accidents and mortality. Many patients with diabetes have an increased risk of hypoglycemia due to interventions targeting glycemic control. In these patients, hypoglycemia and fear of hypoglycemia may further reduce adherence to glucose-lowering regimens, contributing to the further aggravation of diabetes-related complications. Avoiding hypoglycemia should be one of the principal goals of any treatment strategies employing agents that can induce hypoglycemia in order to prevent the occurrence of associated symptoms and consequences. The education of patients and their families is an important feature of individualized management strategies in order to prevent, mitigate and treat hypoglycemic episodes. Patients with diabetes need to be made aware of how to recognize the signs of hypoglycemia and of the simple, highly effective steps that they can take to self-manage hypoglycemic episodes. Clinicians should be familiar with the risk factors for hypoglycemia, especially the profiles of the different classes of glucose-lowering medications such as the sulfonylureas and insulin. This article aims to review the risk factors for hypoglycemia and its implications for patients and healthcare systems, and provide practical advice for minimizing the risk of hypoglycemia and its consequences.

What options are available when considering starting insulin: premix or basal?

Several large studies in diabetes have shown that early initiation of intensive therapy is better for the prevention of long-term complications and suggest that patients with more advanced disease may be at increased risk of adverse cardiovascular events. Despite these findings, insulin initiation is often delayed in patients with type 2 diabetes, typically until A1C exceeds 8.5%. Barriers to the use of insulin are many, arising from both a patient and a physician perspective, and the decision to initiate insulin treatment can be influenced by cost, risk of hypoglycemia, convenience, and the potential for weight gain. Choosing when to initiate insulin and which insulin/treatment regimen to adopt in patients with type 2 diabetes is key, and the importance of tailoring treatment to the patient is widely acknowledged. However, there is currently no universal consensus on the optimal course of action. Once-daily basal insulin and twice-daily premix insulin are commonly used for insulin initiation. Relatively few studies have directly compared these starter treatment regimens, although general findings suggest that, although glycemic control appears to be similar with once-daily basal insulin and twice-daily premix, the lower hypoglycemia rates, lower weight gain, simplicity, and convenience associated with basal insulin support its first-line use as a starter insulin regimen in patients failing on oral antidiabetes agents. Variables such as age, body mass index, and bedtime or post-breakfast plasma glucose levels may alter the efficacy of the chosen treatment regimen, further supporting the need to tailor treatment to meet individual patient's requirements.

Type 2 diabetes mellitus: practical approaches for primary care physicians.

The incidence and prevalence of type 2 diabetes mellitus (T2DM) have reached epidemic proportions in the United States. In addition to growing numbers of individuals in whom T2DM has been diagnosed, in numerous others T2DM or prediabetes remains undiagnosed or is likely to develop in the near future. Identification of individuals at risk for T2DM, as well as those who may already have the disease but in whom it has not yet been diagnosed, is a key element in reducing the overall burden of this disease. Early initiation of treatment can prevent or delay disease progression and reduce the risk for diabetes-related complications. Achieving evidence-based clinical goals by implementing effective management strategies substantially reduces the risk of morbidity and mortality and ultimately improves patient outcomes. A review of the latest and most effective approaches to T2DM management and practical suggestions for implementing treatment strategies in order to provide optimal T2DM care will be presented.

Improving glycemic control and cardiometabolic risk through integrated treatment plans.

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular complications. This increased risk is present even before the diagnosis of diabetes is made. Therefore, it is imperative that physicians are aware of risk factors for diabetes and actively screen high-risk patients and diagnose the condition as early as possible. Patients with prediabetes must be counseled on interventions to prevent the progression to diabetes. Integrated treatment plans that address all aspects of disease must be implemented. Patients with diabetes should be examined for dyslipidemia, overweight or obesity, and hypertension. Treatment for patients with T2DM should include lifestyle interventions and should address any other comorbidities for which the patient may be at risk.

Effective switch from premixed to basal-prandial insulin to achieve glycemic goals in type 2 diabetes.

OBJECTIVE: This article describes a patient with type 2 diabetes mellitus achieving glycemic control after transitioning from premixed to basal-prandial insulin. METHODS: A case report illustrates the challenges of achieving glycemic control in type 2 diabetes, and results of a literature search regarding premixed and basal-prandial insulins are presented. RESULTS: A 52-year-old obese man with type 2 diabetes for 10 years initiated therapy with 2 oral antidiabetic drugs (OADs). When OAD therapy no longer maintained glycemic targets, and the addition of exenatide proved intolerable, he started premixed insulin aspart 70/30. However, lapses in exercise and irregular meal patterns led to a loss of glycemic control and nocturnal hypoglycemia. Switching to a basal-prandial regimen, starting with basal insulin glargine and then adding prandial insulin glulisine, subsequently resulted in a glycated hemoglobin level of 6.7%. CONCLUSION: The patient benefited from the addition of 1 or more prandial insulin injections to a once-daily basal insulin analog.

How to obtain appropriate type 2 diabetes control in the first 180 days of treatment initiation.

Good control of diabetes provides meaningful microvascular risk reduction; yet, patients with type 2 diabetes mellitus commonly languish at unsatisfactory levels of glycated hemoglobin (HbA1c) for protracted periods. A variety of factors contribute to this clinical inertia, as clinicians tend to be too conservative in their treatment of patients who are not achieving glycemic control. Available clinical data suggest the near-maximal blood glucose reduction achievable with use of most antidiabetic agents typically occurs within several weeks of treatment initiation. Based on this time course of action, we propose that optimal glycemic control can be attained within 180 days of treatment initiation by advancing antihyperglycemic therapy more rapidly than typical current practice. Our approach builds on current recommendations, though it seeks to redefine standard management of type 2 diabetes by placing greater emphasis on the timing of treatment intensification. We recommend the total period patients spend with uncontrolled hyperglycemia be minimized by shortening the number of steps along the treatment intensification ladder. This can be achieved by establishing combination therapy early in cases where baseline HbA1c levels are markedly elevated, including the prompt addition of basal insulin therapy when it becomes apparent that oral agents alone are unlikely to attain glycemic goals.

Treating hyperglycemia and diabetes with insulin therapy: transition from inpatient to outpatient care.

CONTEXT: Intensive insulin therapy is recommended to control glucose elevations in the critically ill and has been shown to significantly improve outcomes among hospital inpatients with acute hyperglycemia or newly diagnosed diabetes. Once discharged, the hyperglycemic patient may require ongoing outpatient care, most often under the attention of a primary care physician. EVIDENCE ACQUISITION: The purpose of this review is to provide a background of in-hospital hyperglycemia management and discharge planning in preparation for continued outpatient care. Primary data sources were identified through a PubMed search (1990-2007) using keywords, such as diabetes, hyperglycemia, in-hospital, discharge, and insulin. EVIDENCE SYNTHESIS: Hyperglycemia protocols with strict glycemic goals have been shown to improve morbidity and mortality among critically ill inpatients. Discharge planning should prepare patients for self-care and give them the survival skills necessary to maintain glycemic control. In preparation for discharge, patients are usually transitioned from insulin infusions to subcutaneous insulin administered through an appropriate basal-prandial regimen. CONCLUSION: A thorough understanding of hyperglycemia history and treatment will allow the primary care physician to deliver optimal diabetes care and thereby improve both short-term and long-term outcomes for those patients with critical illnesses and hyperglycemia or diabetes.