Making treatment guideline recommendations in chronic kidney disease and type 2 diabetes more accessible to primary care providers in the United States.

Clinical practice guidelines for the management of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) are designed to assist healthcare professionals with clinical decision making by providing recommendations on the screening, detection, management, and treatment of these conditions. However, primary care practitioners (PCPs) may have clinical inertia when it comes to routinely enacting CKD and T2D guideline recommendations in their clinical practices. Guideline developers have published a range of resources with the aim of facilitating easier access to guideline recommendations to support efficient and consistent implementation into clinical practice of PCPs. Challenges remain in providing strategies to reduce inertia in the application of guideline recommendations in primary care. In this review, we explore reasons behind the low level of awareness and poor uptake of published evidence-based care approaches to the optimal management of patients with T2D and CKD. Finally, we present suggestions on strategies to improve the implementation of guideline-directed recommendations in primary care.

Clinical practice guidelines for managing chronic kidney disease (CKD) for people who also have type 2 diabetes (T2D) provide healthcare providers with recommendations on how to identify, diagnose, and treat CKD. Although treatments cannot cure CKD, they can help to reduce the risk of CKD getting worse. The recommendations are based on results of clinical trials that tested how safe and how well a medication works among many people with CKD and T2D. If these clinical trials show that the medicine is beneficial for people with CKD and T2D, then it may be included in guideline recommendations. Most people living with T2D and early-stage CKD are treated by their primary care practitioner (PCP). If PCPs are not fully aware of guideline recommendations, then their patients may lose the opportunity to receive medications that can benefit them. PCPs have said that barriers to implementing guideline recommendations in their clinical practices include too many guidelines and that the guidelines are difficult to understand and use in their offices. Guideline developers have thought of ways to make the guidelines easier to access and use. This includes putting the guidelines onto mobile apps, providing online resources, making versions more relevant to PCPs, and combining multiple guidelines. These approaches are helpful, but more work is needed. This review article talks about the reasons why PCPs are not always aware of the most up-to-date guideline recommendations for CKD and T2D, how guideline developers have found different ways of sharing the guideline recommendations, and what more can be done.

Initiating GLP-1 Therapy in Combination with FreeStyle Libre Provides Greater Benefit Compared to GLP-1 Therapy Alone.

BACKGROUND AND AIM: Glucagon-like peptide-1 receptor agonists (GLP-1 RA) therapy provides glycemic benefits to individuals with type 2 diabetes (T2D). However, the effects of GLP-1 RA therapy in combination with FreeStyle Libre systems (FSL) are unknown. This study aimed to compare changes in HbA1c between people acquiring GLP-1 with FSL (GLP-1+FSL) vs. GLP-1 without FSL (GLP-1). METHODS: This real-world study utilized Optum's de-identified Market Clarity Data, a linked electronic health records (EHR)-claims database and included adults with T2D and HbA1c ≥8% who acquired their first GLP-1 RA medication between 2018-2022. GLP-1+FSL subjects acquired their first FSL within ±30 days of their first GLP-1 acquisition. Cohorts were matched 1:5 on baseline insulin therapy, age, sex, baseline HbA1c and GLP-1 type. Paired changes in HbA1c were compared between unmatched and matched groups at six months. RESULTS: The study included 24,724 adults in the unmatched cohort (GLP-1+FSL, n=478; GLP-1, n=24,246). The matched cohort included 478 GLP-1+FSL users and 2,390 GLP-1 users: mean age 53.5±11.8 and 53.5 ±11.3 years, HbA1c 10.25±1.68% and 10.22±1.69%, respectively. HbA1c reduction was greater in the GLP-1+FSL group compared to the GLP-1 group in the unmatched cohort (-2.43% vs. -1.73%, difference 0.70%, p<0.001, respectively) and in the matched cohort (-2.43% vs. -2.06%, difference 0.37%, p<0.001). GLP-1+FSL vs. GLP-1 treatment was associated with greater HbA1c reduction in the intensive insulin (-2.32% vs. -1.50%), non-intensive insulin (-2.50% vs. 1.74%), and noninsulin group (-2.46% vs. -1.78%), as well as in patients using semaglutide (2.73% vs. 1.92%) and dulaglutide (2.45% vs. 1.71%) GLP-1 RA, all p<0.001. CONCLUSIONS: Adults with sub-optimally controlled T2D, initiating GLP-1 RA with FreeStyle Libre, had greater improvement in HbA1c compared to those treated with GLP-1 RA only. These results suggest an additional glycemic benefit of FSL when used with a GLP-1 RA in T2D treatment.

Is Continuous Glucose Monitoring a Tool, an Intervention, or Both?

Studies that investigate use of diabetes technologies such as blood glucose monitoring (BGM) and continuous glucose monitoring (CGM) often report contradictory findings regarding efficacy and clinical utility. Whereas some studies of a given technology have shown no benefit, others have reported significant benefits. These incongruities derive from how the technology is viewed. Is it viewed as a tool, or is it an intervention? In this article, we discuss earlier studies that illustrate the contrast between use of BGM as a tool versus use as an intervention, compare and contrast the roles of BGM and CGM as tools and/or interventions in diabetes management, and suggest that CGM can function effectively as both.

Advancements in Diabetes Technology Are Outpacing the Evidence.

Diabetes technologies such as continuous glucose monitoring (CGM) continue to evolve at an increasingly rapid pace. Seventeen new CGM devices have been introduced to the market during the past decade. The introduction of each new system is supported by well-designed randomized controlled trials and real-world retrospective and prospective studies. However, translation of the evidence into clinical guidelines and coverage policies often lags. This article reviews the major limitations of the current approach to clinical evidence assessment and presents a more appropriate method for evaluating rapidly evolving technologies such as CGM.

Biomarkers for the Diagnosis of Heart Failure in People with Diabetes: A Consensus Report from Diabetes Technology Society.

Diabetes Technology Society assembled a panel of clinician experts in diabetology, cardiology, clinical chemistry, nephrology, and primary care to review the current evidence on biomarker screening of people with diabetes (PWD) for heart failure (HF), who are, by definition, at risk for HF (Stage A HF). This consensus report reviews features of HF in PWD from the perspectives of 1) epidemiology, 2) classification of stages, 3) pathophysiology, 4) biomarkers for diagnosing, 5) biomarker assays, 6) diagnostic accuracy of biomarkers, 7) benefits of biomarker screening, 8) consensus recommendations for biomarker screening, 9) stratification of Stage B HF, 10) echocardiographic screening, 11) management of Stage A and Stage B HF, and 12) future directions. The Diabetes Technology Society panel recommends 1) biomarker screening with one of two circulating natriuretic peptides (B-type natriuretic peptide or N-terminal prohormone of B-type natriuretic peptide), 2) beginning screening five years following diagnosis of type 1 diabetes (T1D) and at the diagnosis of type 2 diabetes (T2D), 3) beginning routine screening no earlier than at age 30 years for T1D (irrespective of age of diagnosis) and at any age for T2D, 4) screening annually, and 5) testing any time of day. The panel also recommends that an abnormal biomarker test defines asymptomatic preclinical HF (Stage B HF). This diagnosis requires follow-up using transthoracic echocardiography for classification into one of four subcategories of Stage B HF, corresponding to risk of progression to symptomatic clinical HF (Stage C HF). These recommendations will allow identification and management of Stage A and Stage B HF in PWD to prevent progression to Stage C HF or advanced HF (Stage D HF).

Optimizing Multidisciplinary Care of Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus.

Diabetes is the leading cause of chronic kidney disease (CKD), a condition associated with significant morbidity and mortality. As these patients have a high risk of developing cardiovascular disease and end-stage kidney disease, there is a need for early detection and early initiation of appropriate therapeutic interventions that slow disease progression and prevent adverse outcomes. Due to the complex nature of diabetes and CKD management, a holistic, patient-centered, collaborative care approach delivered by a coordinated multidisciplinary team (ideally including a clinical pharmacist as part of a comprehensive medication management program) is needed. In this review, we discuss the barriers to effective care, the current multidisciplinary approach used for CKD prevention and treatment, and the potential ways that the multidisciplinary management of CKD associated with type 2 diabetes mellitus can be refined to improve patient outcomes.

People living with type 2 diabetes mellitus are at risk of developing chronic kidney disease. Having chronic kidney disease means that over time the kidneys may not work as well as they should. Some people with chronic kidney disease will eventually need a new kidney (transplant) or will need to use a machine that does the job of their kidneys (dialysis). To slow the rate at which the kidneys get worse, chronic kidney disease needs to be detected and treated early. A multidisciplinary team of healthcare professionals is needed to help people with type 2 diabetes reduce their chances of getting chronic kidney disease, or to prevent their chronic kidney disease from getting worse. Some healthcare teams include a clinical pharmacist who makes sure medicines are given in the correct amount and at the correct time. It is important that the healthcare team members communicate well and include the person with type 2 diabetes and chronic kidney disease and their family members or caregivers (if needed) in the decision-making process to achieve better health results. Barriers stopping people with type 2 diabetes and chronic kidney disease from getting good healthcare include a shortage of nephrologists, not having enough healthcare insurance, limited access to healthcare, and poor understanding about what chronic kidney disease is and how it can be treated. This review article discusses the barriers to better healthcare in chronic kidney disease and how the current healthcare team approach could be changed to improve health results.

Early intervention and intensive management of patients with diabetes, cardiorenal, and metabolic diseases.

Increasing rates of obesity and diabetes have driven corresponding increases in related cardiorenal and metabolic diseases. In many patients, these conditions occur together, further increasing morbidity and mortality risks to the individual. Yet all too often, the risk factors for these disorders are not addressed promptly in clinical practice, leading to irreversible pathologic progression. To address this gap, we convened a Task Force of experts in cardiology, nephrology, endocrinology, and primary care to develop recommendations for early identification and intervention in obesity, diabetes, and other cardiorenal and metabolic diseases. The recommendations include screening and diagnosis, early interventions with lifestyle, and when and how to implement medical therapies. These recommendations are organized into primary and secondary prevention along the continuum from obesity through the metabolic syndrome, prediabetes, diabetes, hypertension, dyslipidemia, nonalcoholic fatty liver disease (NAFLD), atherosclerotic cardiovascular disease (ASCVD) and atrial fibrillation, chronic kidney disease (CKD), and heart failure (HF). The goal of early and intensive intervention is primary prevention of comorbidities or secondary prevention to decrease further worsening of disease and reduce morbidity and mortality. These efforts will reduce clinical inertia and may improve patients' well-being and adherence.

Living with Chronic Kidney Disease and Type 2 Diabetes Mellitus: The Patient and Clinician Perspective.

Comorbid type 2 diabetes mellitus (T2D) and chronic kidney disease (CKD) is associated with poor health outcomes and a high economic burden. Management of these conditions remains a significant challenge for current healthcare systems. The objective of this article is to describe the experiences of patients living with T2D and CKD and their thoughts on how communication between patients and their clinicians could be improved despite the multiple comorbidities that need to be addressed. We present the individual perspectives of three patient authors, followed by relevant discussion around the management of CKD in patients with T2D by clinician authors.Audio abstract available for this article. Audio Abstract. In this audio introduction, the authors Patrick Gee (a patient author) and Eugene Wright (a clinician author) provide a brief overview and discuss the key findings of their article titled "Living with Chronic Kidney Disease and Type 2 Diabetes Mellitus: The Patient and Clinician Perspective".

People living with type 2 diabetes mellitus (T2D for short) and chronic kidney disease (CKD for short) may have worse health over time. Managing long-term health conditions can be expensive for those living with the conditions and for healthcare systems. To optimize their quality of life, people with T2D and CKD need the necessary resources to better manage their conditions. Healthcare professionals desire the best outcomes for their patients. Currently, communication between healthcare professionals and their patients is suboptimal, and ineffective communication creates a barrier to effective optimal care. The aim of this article is to describe the experiences of three people living with T2D and CKD (patients), who are also authors of the article. They outline their thoughts on how communication between patients and healthcare professionals might be improved when managing multiple conditions. We also present responses from three healthcare professionals (clinicians), who are co-authors of this article, to the points made by the patients, as well as their views on how to manage these long-term conditions.

Management of NAFLD in primary care settings.

Non-alcoholic fatty liver disease (NAFLD) affects at least 25% of the general population and is an increasingly important cause of cirrhosis and hepatocellular carcinoma. Although it is the research focus of the hepatology field, it is clear that primary care physicians are seeing the majority of NAFLD patients and are in a pivotal position to provide quality care. In this article, we review the role of primary care in the management of NAFLD. NAFLD is common in patients with diabetes, obesity and other metabolic risk factors. Abdominal ultrasonography is the most commonly used method to diagnose fatty liver. Simple fibrosis scores have high negative predictive values in excluding advanced liver fibrosis and future liver-related events and can be used in primary care as initial evaluation. An abnormal result should be followed by subsequent workup or specialist referral. Primary care is the ideal setting to institute multidisciplinary care, especially the involvement of dietitians and physical activity trainers in lifestyle intervention, as well as initiating the discussion of bariatric surgery in patients with severe obesity. Although specific drug treatment for steatohepatitis would require a more precise diagnosis, metabolic drugs that improve both steatohepatitis and cardiovascular outcomes (e.g. glucagon-like peptide-1 receptor agonists) may be considered in patients with NAFLD.

Real-world persistence, adherence, health care resource utilization, and costs in people with type 2 diabetes switching from a first-generation basal insulin to a second-generation (insulin glargine 300 U/mL) vs an alternative first-generation basal insulin.

BACKGROUND: People with type 2 diabetes (T2D) who change their basal insulin (BI) may have variable persistence with therapy. Compared with first-generation (long-acting) BI analogs (insulin glargine 100U/mL [Gla-100]; insulin detemir [IDet]), second-generation (longer-acting) BI analogs (insulin glargine 300U/mL [Gla-300]; insulin degludec) have similar glycated hemoglobin (HbA1c) attainment and lowered hypoglycemia risk, which could impact treatment persistence. OBJECTIVE: To compare persistence, adherence, health care resource utilization (HRU), and costs for individuals switching from neutral protamine Hagedorn insulin or a first-generation BI analog with either the second-generation BI, Gla-300, or an alternative first-generation BI analog (Gla-100 or IDet). METHODS: We used Optum Clinformatics claims data from adults (aged ≥ 18 years) with T2D who had received BI (neutral protamine Hagedorn, Gla-100, IDet) in the 6-month baseline period, and switched to either Gla-300 or an alternative first-generation BI (Gla-100 or IDet; treatment switch = index date) between April 1, 2015, and August 31, 2019. Participants were followed for 12 months, until plan disenrollment, or until death, whichever occurred first. Cohorts were propensity score matched (PSM) on baseline characteristics. The primary outcome was the proportion who were persistent with therapy at 12 months. Secondary outcomes were adherence (proportion of days covered); change in HbA1c; and all-cause, diabetes-related, and hypoglycemia-related HRU and costs. RESULTS: PSM generated 3,077 participants/group (mean age: 68 years, 52% female). Cohorts were well balanced except for hospitalization, which was adjusted in models as a covariate. During the 12-month follow-up period, participants who received Gla-300 vs first-generation BI had greater persistence with (45.5% vs 42.1%; adjusted P = 0.0001), and adherence to (42.8% vs 38.2%; adjusted P = 0.0006), BI therapy and a statistically larger reduction in HbA1c at 12 months (-0.65% vs -0.45%; adjusted P = 0.0040). The proportion of participants achieving HbA1c less than 8% (47.2% vs 40.9%; P < 0.0001), but not less than 7% (21.2% vs 20.8%), was significantly higher for Gla-300 vs first-generation BI. All-cause (45.3 vs 65.9 per 100 patient-years [P100PY]) and diabetes-related (21.5 vs 29.1 P100PY), but not hypoglycemia-related, hospitalizations (1.0 vs 1.5 P100PY) were significantly (P < 0.0001) lower for Gla-300 vs first-generation BI. Similarly, all-cause (111.9 vs 148.8 P100PY), diabetes-related (54.8 vs 74.2 P100PY), and hypoglycemia-related (2.9 vs 5.7 P100PY) emergency department (ED) visits were significantly lower for Gla-300 (all P < 0.0001). Costs for all-cause hospitalizations and hypoglycemia-related ED visits were significantly lower for Gla-300 vs first-generation BI. Although pharmacy costs were significantly higher for Gla-300 vs first-generation BI, all-cause total health care costs were not significantly different: $41,255 vs $45,316 per person per year, respectively. CONCLUSIONS: In this claims-based analysis of people with T2D receiving BI, switching to Gla-300 was associated with significantly better persistence, adherence, and HbA1c reduction compared with switching to an alternative first-generation BI analog. All-cause HRU was significantly lower; despite significantly higher pharmacy costs, total health care costs were similar. DISCLOSURES: This study was funded by Sanofi US. Medical writing support was provided by Helen Jones, PhD, CMPP, of Evidence Scientific Solutions and funded by Sanofi US. Dr Wright is on the speakers' bureau and sits on the advisory boards for Abbot Diabetes, Bayer, Boehringer Ingelheim, Eli Lilly, and Sanofi; sits on the advisory board for Medtronic; and is a consultant for Abbot Diabetes, Bayer, Boehringer Ingelheim, and Eli Lilly. Dr Malone is on advisory boards for Novartis and Avalere and consults for Pear Therapeutics, Sarepta, and Strategic Therapeutics. Dr Trujillo sits on advisory boards for Novo Nordisk and Sanofi. Drs Gill, Zhou, and Preblick and Mr Li are employees and stockholders of Sanofi. Mr Huse is an employee of Evidera and a contractor for Sanofi. Dr Reid is a speaker and consultant for Novo Nordisk and Sanofi-Aventis and is a consultant for AstraZeneca and Intarcia.

Management of chronic kidney disease in type 2 diabetes: screening, diagnosis and treatment goals, and recommendations.

Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are at high risk of CKD progression and cardiovascular (CV) disease. Prevalence of CKD in patients with T2D is currently around 40% and continues to grow. The increasing number of people with CKD and T2D will ultimately have a significant impact upon health resource use and costs of care for people with T2D. Management of CKD in patients with T2D aims to preserve kidney function to reduce the risk of end-stage kidney disease, CV events, and mortality. Evidence-based recommendations for the treatment of patients with CKD and T2D are provided by several international and national organizations and recommend several lifestyle and pharmacological approaches to help prevent or delay the progression of CKD in patients with T2D. Guidelines include regular screening of patients with T2D for CKD using spot urine albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (at least annually and at least twice a year if UACR >300 mg/g). Additionally, assessment of vascular complications, together with interventions designed to improve glycemic control and lipid levels, maintain healthy body weight, and optimize blood pressure should be performed. Medications shown to slow progression of CKD include renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide 1 receptor agonists, and, more recently, selective, non-steroidal mineralocorticoid receptor antagonists. This review highlights the ongoing challenges facing primary care providers in the management of CKD in patients with T2D including the consideration of comorbidities, adoption of new treatment options, and implementation of individualized care. Achieving consensus for optimal treatment of this disease is critical in providing consistent and appropriate care for all patients. Strategies to improve outcomes should also include use of clear referral criteria, use of a multi-disciplinary approach, and patient education.

Post Hoc Analysis Evaluating the Impact of Antihyperglycemic Background Therapies on Attainment of A1C Targets Without Hypoglycemia in the ACHIEVE Control Pragmatic, Real-Life Study.

BACKGROUND: ACHIEVE Control, a prospective, open-label, randomized, pragmatic, real-life study in insulin-naive people with type 2 diabetes (A1C 8.0-11.0%), demonstrated superiority of insulin glargine 300 units/mL (Gla-300) versus first-generation standard-of-care basal insulin (SOC-BI; glargine 100 units/mL or insulin detemir) in achieving individualized A1C targets without documented symptomatic (glucose ≤3.9 mmol/L [≤70 mg/dL] or <3.0 mmol/L [<54 mg/dL]) or severe hypoglycemia (American Diabetes Association level 3) at 6 months. Noninsulin antihyperglycemic background therapies are commonly used; however, sulfonylureas may increase hypoglycemia risk. This post hoc analysis assessed outcomes according to background therapy. METHODS: Subgroup analyses were performed per concomitant use/nonuse of sulfonylureas, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase 4 inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors. End points (6 and 12 months) included A1C target attainment without documented symptomatic or severe hypoglycemia, A1C target attainment, and absence of documented symptomatic or severe hypoglycemia. RESULTS: Odds ratios (ORs) at 12 months mostly favored Gla-300 versus SOC-BI across subgroups except in analysis of SGLT2 inhibitors, in which ORs were similar. Among sulfonylurea users, ORs at 12 months strongly favored Gla-300 versus SOC-BI for all end points, particularly A1C target achievement without documented symptomatic hypoglycemia (glucose ≤3.9 mmol/L [≤70 mg/dL]; OR 1.25, 95% CI 1.02-1.53) or severe hypoglycemia and achievement of no documented symptomatic hypoglycemia (glucose <3.0 mmol/L [<54 mg/dL]; OR 1.25, 95% CI 1.02-1.52) or severe hypoglycemia. CONCLUSION: The results suggest that, in insulin-naive people with type 2 diabetes, Gla-300 is effective with a risk of hypoglycemia that is lower than or similar to that of SOC-BI regardless of background medication. Individuals receiving concomitant sulfonylureas were more likely to remain without symptomatic or severe hypoglycemia with Gla-300.

Flash CGM associated with event reduction in nonintensive diabetes therapy.

OBJECTIVES: We evaluated the effects of acquiring a flash continuous glucose monitoring (CGM) system in the population with type 2 diabetes (T2D) treated with basal or noninsulin therapy. STUDY DESIGN: This was a retrospective database analysis of the IBM MarketScan Commercial Claims and Medicare Supplemental databases that assessed rates of acute diabetes-related events (ADEs) and all-cause inpatient hospitalizations (ACHs) in a large population with T2D treated with basal insulin therapy or noninsulin medications. ADE and ACH rates 6 months prior to and 6 months post CGM acquisition were compared. METHODS: Inclusion criteria for analysis were diagnosis of T2D; age 18 years or older; treatment with long-acting, neutral protamine Hagedorn, or premixed insulin or noninsulin therapy; naïve to CGM; and acquisition of their flash CGM system between October 2017 and March 2019. Patients served as their own controls. Event rates were compared using weighted Cox regression with Andersen-Gill extension for repeat events. RESULTS: A cohort of 10,282 adults with T2D (mean [SD] age, 53.1 [9.6] years; 51.9% male) who met inclusion criteria were assessed. ADE rates decreased from 0.076 to 0.052 events per patient-year (HR, 0.68; 95% CI, 0.58-0.80; P < .001). ACH rates decreased from 0.177 to 0.151 events per patient-year (HR, 0.85; 95% CI, 0.77-0.94; P = .002). CONCLUSIONS: Acquisition of the flash CGM system was associated with significant reductions in outpatient and inpatient ADEs and ACHs. These findings provide compelling evidence that use of flash CGM in patients with T2D treated with basal insulin therapy or noninsulin therapy improves clinical outcomes and potentially reduces costs.

Clinical Care Pathway for the Risk Stratification and Management of Patients With Nonalcoholic Fatty Liver Disease.

Find AGA's NASH Clinical Care Pathway App for iOS and Android mobile devices at nash.gastro.org. Scan this QR code to be taken directly to the website.Nonalcoholic fatty liver disease (NAFLD) is becoming increasingly common, currently affecting approximately 37% of US adults. NAFLD is most often managed in primary care or endocrine clinics, where clinicians must determine which patients might benefit from secondary care to address hepatic manifestations, comorbid metabolic traits, and cardiovascular risks of the disease. Because NAFLD is largely asymptomatic, and because optimal timing of treatment depends on accurate staging of fibrosis risk, screening at the primary care level is critical, together with consistent, timely, evidence-based, widely accessible, and testable management processes. To achieve these goals, the American Gastroenterological Association assembled a multidisciplinary panel of experts to develop a Clinical Care Pathway providing explicit guidance on the screening, diagnosis, and treatment of NAFLD. This article describes the NAFLD Clinical Care Pathway they developed and provides a rationale supporting proposed steps to assist clinicians in diagnosing and managing NAFLD with clinically significant fibrosis (stage F2-F4) based on the best available evidence. This Pathway is intended to be applicable in any setting where care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.

Evolving Use of Continuous Glucose Monitoring Beyond Intensive Insulin Treatment.

Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) use in individuals with type 1 diabetes and type 2 diabetes (T2D) who are treated with intensive insulin therapy. A growing body of evidence suggests that CGM use may also confer similar glycemic benefits in T2D individuals who are treated with less-intensive therapies. Investigators are also exploring the potential use of CGM as an aid in weight management. This article reviews the continuing evolution of CGM, focusing on how CGM may be used to improve glycemic control and promote adoption of desired health behaviors within broader T2D and prediabetes populations.

Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy.

BACKGROUND: Glycemic control is suboptimal in many individuals with type 2 diabetes. Although use of flash continuous glucose monitoring (CGM) has demonstrated A1C reductions in patients with type 2 diabetes treated with a multiple daily injection or insulin pump therapy regimen, the glycemic benefit of this technology in patients with type 2 diabetes using nonintensive treatment regimens has not been well studied. METHODS: This retrospective, observational study used the IBM Explorys database to assess changes in A1C after flash CGM prescription in a large population with suboptimally controlled type 2 diabetes treated with nonintensive therapy. Inclusion criteria were diagnosis of type 2 diabetes, age <65 years, treatment with basal insulin or noninsulin therapy, naive to any CGM, baseline A1C ≥8%, and a prescription for the FreeStyle Libre flash CGM system during the period between October 2017 and February 2020. Patients served as their own control subject. RESULTS: A total of 1,034 adults with type 2 diabetes (mean age 51.6 ± 9.2 years, 50.9% male, baseline A1C 10.1 ± 1.7%) were assessed. More patients received noninsulin treatments (n = 728) than basal insulin therapy (n = 306). We observed a significant reduction in A1C within the full cohort: from 10.1 ± 1.7 to 8.6 ± 1.8%; Δ -1.5 ± 2.2% (P <0.001). The largest reductions were seen in patients with a baseline A1C ≥12.0% (n = 181, A1C reduction -3.7%, P <0.001). Significant reductions were seen in both treatment groups (basal insulin -1.1%, noninsulin -1.6%, both P <0.001). CONCLUSION: Prescription of the flash CGM system was associated with significant reductions in A1C in patients with type 2 diabetes treated with basal insulin or noninsulin therapy. These findings provide evidence for expanding access to flash CGM within the broader population of people with type 2 diabetes.

Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy.

Injectable therapies such as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin are high-efficacy options for people with type 2 diabetes (T2D) who require treatment intensification. In addition to high glycemic efficacy, GLP-1RAs offer weight loss benefits, and some agents have been shown to reduce cardiovascular risk. This article summarizes data from two clinical studies with the first oral GLP-1RA, oral semaglutide, in situations where injectable therapy is often considered, and provides guidance on use in primary care. PIONEER 4 compared oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo in patients uncontrolled on oral glucose-lowering therapies. PIONEER 8 compared oral semaglutide with placebo in patients with T2D already on insulin therapy. Treatment with oral semaglutide gave similar reductions in glycated hemoglobin (HbA1 c) compared with liraglutide at 26 weeks, and significantly greater reductions at 52 weeks. Changes in body weight with oral semaglutide were significantly greater compared with liraglutide after 26 and 52 weeks. Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA1 c and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage. Oral semaglutide was associated with low proportions of patients experiencing severe or blood glucose-confirmed symptomatic hypoglycemia when added to oral glucose-lowering therapies, and did not increase the incidence of such events when added to insulin. The tolerability profile of oral semaglutide was consistent with that seen for injectable GLP-1RAs, with gastrointestinal side effects seen most frequently; most were transient and tended to occur during dose escalation. For patients requiring treatment intensification after oral therapy or as add-on to insulin, oral semaglutide provides effective glucose lowering and body weight loss, with low risk of hypoglycemia, thus broadening the range of therapeutic options for treatment of T2D in primary care.

Integrating oral semaglutide into clinical practice in primary care: for whom, when, and how?

Oral semaglutide is the first US Food and Drug Administration-approved oral glucagon-like peptide-1 receptor agonist (GLP-1RA) for the treatment of type 2 diabetes (T2D). Prior articles within this supplement reviewed the PIONEER trial program, which demonstrated that oral semaglutide reduced glycated hemoglobin and body weight when given to patients with uncontrolled T2D on various background therapies, and had a safety profile consistent with subcutaneous GLP-1RAs. This article provides guidance on integrating oral semaglutide into clinical practice in primary care. Patient populations with T2D who may gain benefit from oral semaglutide include those with inadequate glycemic control taking one or more oral glucose-lowering medication (e.g. after metformin), patients for whom weight loss would be beneficial, patients at risk of hypoglycemia, those who would historically have been considered for treatment with a subcutaneous GLP-1RA, and those receiving basal insulin who require treatment intensification. Like other GLP-1RAs, oral semaglutide is contraindicated in those with personal/family history of medullary thyroid carcinoma, and in those with multiple endocrine neoplasia syndrome type 2, as noted in a boxed warning in the prescribing information. Oral semaglutide has not been studied in those with a history of pancreatitis, is not recommended in patients with suspected/confirmed pancreatitis, and is not indicated in type 1 diabetes. When initiating oral semaglutide, gradual dose escalation is recommended to minimize the risk of gastrointestinal adverse events. As food and excess liquid reduce oral semaglutide absorption, patients should swallow the tablet with up to 4 fl oz/120 mL of water on an empty stomach upon waking, and should wait at least 30 minutes before eating, drinking, or taking other oral medications. Those managing patients should be aware of the potential impact of these dosing conditions on concomitant medications. When counseling patients, it is important to discuss these administration instructions, realistic therapeutic expectations, and strategies for mitigation of gastrointestinal events. Oral semaglutide provides a new option for add-on to initial T2D therapy (or later in the treatment paradigm), with the potential to enable more patients to benefit from the improvements in glycemic control, reductions in body weight, and low risk of hypoglycemia afforded by GLP-1RAs.