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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.
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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.
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The A1C metric has been the gold standard for assessing glycemia for decades. This biologic assay, based on averaging, is fraught with limitations and may be giving way to more holistic approaches. This article reviews glycemic time in range as the new standard for assessing patients with continuous glucose monitoring data. Information from the International Consensus Group on Time in Range will be summarized.
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IN BRIEF Obstacles to realizing the clinical benefits of continuous glucose monitoring (CGM) for daily diabetes management are being overcome with more affordable, user-friendly technologies. This article describes a novel category of CGM known as "flash" that may allow more routine use of continuous data for greater numbers of patients treated in primary care.
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IN BRIEF Glucose variability is a potential independent risk factor of poor clinical outcome among people with diabetes, with adequate measurement technically difficult and cumbersome. For this study, a novel 14-day continuous sensor was used to assess glucose variability among people with type 2 diabetes (T2D). The aim was to characterize glucose profiles for up to 2 weeks in T2D and to survey device utilization in a standard clinical setting and its potential to collect clinically meaningful data.
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AIMS: Since 2005, several glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been approved to treat people with type 2 diabetes. These agents are considered for use at the same point in the treatment paradigm as basal insulins. A comprehensive comparison of these drug classes, therefore, can help inform treatment decisions. This systematic review and meta-analysis assessed the clinical efficacy and safety of GLP-1 RAs compared with basal insulins. MATERIALS AND METHODS: MEDLINE, EMBASE, CENTRAL and PubMed databases were searched. Randomized clinical trials (RCTs) of ≥16 weeks' duration comparing GLP-1 RAs vs basal insulins in adults with type 2 diabetes inadequately controlled with oral antihyperglycemic drugs were included. Data on the change from baseline to 26 weeks (±10 weeks) of treatment in hemoglobin A1c (HbA1c) and weight, as well as the proportion of patients experiencing hypoglycaemia, were extracted. Fixed-effect pairwise meta-analyses were conducted where data were available from ≥2 studies. RESULTS: Fifteen RCTs were identified and 11 were meta-analysed. The once-weekly GLP-1 RAs, exenatide long acting release (LAR) and dulaglutide, led to greater, statistically significant mean HbA1c reductions vs basal insulins (exenatide: -0.31% [95% confidence interval -0.42, -0.19], dulaglutide: -0.39% [-0.49, -0.29]) whilst once-daily liraglutide and twice-daily exenatide did not (liraglutide: 0.06% [-0.06, 0.18], exenatide: 0.01% [-0.11, 0.13]). Mean weight reduction was seen with all GLP-1 RAs while mean weight gain was seen with basal insulins. Interpretation of the analysis of hypoglycaemia was limited by inconsistent definitions and reporting. Because of the limited number of available studies sensitivity analyses to explore heterogeneity could not be conducted. CONCLUSIONS: Although weight reduction is seen with all GLP-1 RA's, only the once-weekly agents, exenatide LAR and dulaglutide, demonstrate significant HbA1c reductions when compared to basal insulins.
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Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Incretinas/administração & dosagem , Insulina/uso terapêutico , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/metabolismo , Exenatida , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Hemoglobinas Glicadas/metabolismo , Humanos , Hipoglicemia/induzido quimicamente , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Insulina Detemir/uso terapêutico , Insulina Glargina/uso terapêutico , Insulina de Ação Prolongada/uso terapêutico , Liraglutida/administração & dosagem , Peptídeos/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Peçonhas/administração & dosagemRESUMO
This podcast discusses innovations, advancements, and discoveries in continuous glucose monitoring that were presented at the American Diabetes Association 84th Scientific Sessions held in Orlando, Florida, June 2024. Specifically, the author will discuss sessions focused on (1) Equity and access to new technologies; (2) The role of the interdisciplinary team in technology onboarding in primary care; (3) New technologies for glucose monitoring and sensing; (4) New technologies for continuous glucose monitoring (CGM); and (5) CGM implementation in primary care.
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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.
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Diabetes Mellitus Tipo 2 , Guias de Prática Clínica como Assunto , Atenção Primária à Saúde , Insuficiência Renal Crônica , Humanos , Diabetes Mellitus Tipo 2/terapia , Insuficiência Renal Crônica/terapia , Atenção Primária à Saúde/normas , Estados Unidos , Fidelidade a Diretrizes , Médicos de Atenção PrimáriaRESUMO
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 hemoglobin A1c (HbA1c) between people acquiring GLP-1 with FSL (GLP-1+FSL) versus GLP-1 without FSL (GLP-1). Methods: This real-world study used 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 and 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 6 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 with 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%), nonintensive 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 suboptimally controlled T2D, initiating GLP-1 RA with FreeStyle Libre, had greater improvement in HbA1c compared with 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.
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Diabetes Mellitus Tipo 2 , Receptor do Peptídeo Semelhante ao Glucagon 1 , Hemoglobinas Glicadas , Hipoglicemiantes , Humanos , Feminino , Masculino , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/sangue , Pessoa de Meia-Idade , Hemoglobinas Glicadas/análise , Hipoglicemiantes/uso terapêutico , Hipoglicemiantes/administração & dosagem , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Glicemia/análise , Glicemia/efeitos dos fármacos , Adulto , Idoso , Peptídeo 1 Semelhante ao Glucagon/uso terapêutico , Quimioterapia Combinada , Insulina/uso terapêutico , Insulina/administração & dosagem , Exenatida/uso terapêuticoRESUMO
INTRODUCTION: Both glucagon-like peptide-1 receptor agonists (GLP-1 RA) and continuous glucose monitoring (CGM) improve glycemia in patients with type 2 diabetes (T2D). However, it is unknown whether adding CGM to GLP-1 RA therapy further improves A1c. We evaluated changes in A1c levels 6 months after initiation of FreeStyle Libre (FSL) in adults with sub-optimally controlled T2D already on GLP-1 RA therapy. METHODS: This retrospective, observational study used Optum's de-identified Market Clarity Data, a linked electronic health record-claims database to assess changes in A1c after FSL acquisition. Inclusion criteria were T2D diagnosis, ≥ 18 years, baseline A1c ≥ 8%, with the first FSL acquisition between 2018 and 2022. Patients were required to be on GLP-1 RA prior to FSL with at least one GLP-1 RA prescription within 90 days of FSL acquisition. GLP-1 RA initiation was defined as the earliest GLP-1 RA prescription from 2017 onwards. Paired changes in A1c were assessed at 6 months after initial FSL acquisition. RESULTS: The study cohort included 1454 adults with T2D (age 55 ± 10 years, 52% male, 38% with intensive insulin therapy, median 471 days from GLP-1 RA initiation to FSL, and baseline A1c 9.8 ± 1.5%). After FSL acquisition, patients experienced an A1c decrease of 1.5 ± 1.9% (p < 0.001). Patients with a baseline A1c > 10% had the largest reduction (n = 497, - 2.7 ± 2.2%, p < 0.001). Significant improvements were observed in subgroups based on insulin therapy and GLP-1 RA formulation. Those initiating GLP-1 RA therapy > 24 months before FSL acquisition also showed improvements in A1c (n = 478; - 1.3 ± 1.7%, p < 0.001). CONCLUSIONS: In a large, real-world study of adults with T2D, those on prior GLP-1 RA therapy experienced significant A1c improvements after acquiring FSL, irrespective of GLP-1 RA duration, GLP-1 RA formulation, or insulin therapy type. These findings support the use of FSL in adults with T2D treated with GLP-1 RA.
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Background: Connected insulin pens capture data on insulin dosing/timing and can integrate with continuous glucose monitoring (CGM) devices with essential insulin and glucose metrics combined into a single platform. Standardization of connected insulin pen reports is desirable to enhance clinical utility with a single report. Methods: An international expert panel was convened to develop a standardized connected insulin pen report incorporating insulin and glucose metrics into a single report containing clinically useful information. An extensive literature review and identification of examples of current connected insulin pen reports were performed serving as the basis for creation of a draft of a standardized connected insulin pen report. The expert panel participated in three virtual standardization meetings and online surveys. Results: The Ambulatory Glucose Profile (AGP) Report: Connected Insulin Pen brings all clinically relevant CGM-derived glucose and connected insulin pen metrics into a single simplified two-page report. The first page contains the time in ranges bar, summary of key insulin and glucose metrics, the AGP curve, and detailed basal (long-acting) insulin assessment. The second page contains the bolus (mealtime and correction) insulin assessment periods with information on meal timing, insulin-to-carbohydrate ratio, average bolus insulin dose, and number of days with bolus doses recorded. The report's second page contains daily glucose profiles with an overlay of the timing and amount of basal and bolus insulin administered. Conclusion: The AGP Report: Connected Insulin Pen is a standardized clinically useful report that should be considered by companies developing connected pen technology as part of their system reporting/output.
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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.
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Automonitorização da Glicemia , Glicemia , Humanos , TecnologiaRESUMO
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.
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Glicemia , Diabetes Mellitus , Humanos , Automonitorização da Glicemia , Estudos Prospectivos , Estudos Retrospectivos , TecnologiaRESUMO
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.
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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.
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Diabetes Mellitus Tipo 2 , Insuficiência Renal Crônica , Humanos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/terapia , Insuficiência Renal Crônica/epidemiologia , Comorbidade , ComunicaçãoRESUMO
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).
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Humanos , Adulto , Peptídeo Natriurético Encefálico , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Consenso , Biomarcadores , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/epidemiologiaRESUMO
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.
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Diabetes Mellitus Tipo 2 , Hipoglicemia , Adulto , Idoso , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Hemoglobinas Glicadas/análise , Custos de Cuidados de Saúde , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes , Insulina/uso terapêutico , Insulina Glargina , Masculino , Estudos RetrospectivosRESUMO
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.
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Automonitorização da Glicemia , Diabetes Mellitus Tipo 2 , Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêuticoRESUMO
Type 2 diabetes poses a major health challenge among African Americans. Older therapies are associated with shortcomings such as hypoglycemia and/or weight gain. In recent years the "incretin system" has become understood as offering great promise for drug development. Two drug classes-namely, the injectable glucagon-like peptide 1 (GLP-1) receptor agonists, which produce pharmacological GLP receptor activity, and the oral dipeptidyl peptidase-4 (DPP-4) inhibitors, which raise levels of endogenously produced GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) by preventing enzymatic degradation--have been available for several years. These drugs can be given as monotherapy or added to other antidiabetic drugs to lower blood glucose with very low risk of hypoglycemia without weight gain. In fact, GLP-1 receptor agonists may induce clinically significant reductions in weight and systolic blood pressure, as well as improve indices of beta-cell function. Although transient nausea occurs in some patients with GLP-1 receptor agonists, these agents are generally well tolerated, and the available clinical data are encouraging. Clinical experience shows that these treatments are acceptable to patients.