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Is Continuous Glucose Monitoring Underappreciated in the UK? 持续血糖监测在英国被低估了吗?
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.76
Christopher G Parkin, Melissa Holloway, Jeffrey Truesdell, Tomas C Walker

Introduction: Information about continuous glucose monitoring (CGM) use in the UK is limited. We conducted an online survey of a representative sample of current CGM users in England, Scotland and Wales to address this deficit.

Methods: The 29-item online survey was conducted between 29 December 2016 and 25 January 2017. Persons with type 1 diabetes (T1D) and caregivers of T1D children/adolescents were recruited from mailing lists, using Nielsen and Harris Polling databases.

Results: 315 patients and caregivers responded to the survey - 170 adult patients and 145 caregivers. Among respondents, 144 received full funding for CGM use, 72 received partial funding and 83 received no funding. Most reported improvements in glycated haemoglobin (HbA1c) (67.0%), fewer hypoglycaemia episodes (70.2%), improved hypoglycaemia awareness (77.5%) and better diabetes management (92.4%). Self-funders reported significantly higher CGM use (76.1%) than those who were fully funded (58.9%) and/or partially funded (65.9%), p=0.0008. Fewer than 50% of all respondents reported receiving guidance in interpreting CGM data from their diabetes care team; 30.1% of self-funders reported receiving no CGM support from their diabetes team compared with fully funded (2.8%) and partially funded (1.4%) respondents, p<0.0001.

Conclusions: Patients with T1D and their caregivers are realising benefits from CGM use but are largely unsupported by the UK healthcare system.

简介:关于连续血糖监测(CGM)在英国使用的信息是有限的。我们对英格兰、苏格兰和威尔士的当前CGM用户的代表性样本进行了一项在线调查,以解决这一问题。方法:于2016年12月29日至2017年1月25日进行29项在线调查。使用尼尔森和哈里斯民意调查数据库,从邮件列表中招募1型糖尿病患者(T1D)和T1D儿童/青少年的照顾者。结果:315名患者和护理人员回应了调查- 170名成年患者和145名护理人员。在答复者中,144人获得了CGM使用的全额资助,72人获得了部分资助,83人没有获得资助。大多数报告糖化血红蛋白(HbA1c)改善(67.0%),低血糖发作减少(70.2%),低血糖意识改善(77.5%)和糖尿病管理改善(92.4%)。自筹者报告的CGM使用率(76.1%)明显高于全额资助者(58.9%)和部分资助者(65.9%),p=0.0008。不到50%的应答者报告从他们的糖尿病护理小组获得了解释CGM数据的指导;与全额资助(2.8%)和部分资助(1.4%)的受访者相比,30.1%的自资者报告没有从他们的糖尿病团队获得CGM支持。结论:T1D患者及其护理人员正在从CGM使用中获益,但在很大程度上没有得到英国医疗保健系统的支持。
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引用次数: 4
An Economic Evaluation of Continuous Glucose Monitoring for People with Type 1 Diabetes and Impaired Awareness of Hypoglycaemia within North West London Clinical Commissioning Groups in England. 英国伦敦西北部临床调试组对1型糖尿病患者持续血糖监测和低血糖认知受损的经济评价
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.81
Shraddha Chaugule, Nick Oliver, Brigitte Klinkenbijl, Claudia Graham

To assess the economic impact of providing real time continuous glucose monitoring (CGM) for people with type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) within North West (NW) London clinical commissioning groups (CCGs).

Methods: The eligible population for CGM and inputs for the economic budget impact model developed were derived from published data. The model includes cost of CGM; cost savings associated with lower hypoglycaemia related hospital admissions, accidents and emergency visits; self-monitoring of blood glucose (SMBG) strip usage; and glycated haemoglobin (HbA1c) reduction-related avoided complications and insulin pump use.

Results: The cost of CGM for T1D-IAH (n=3,036) in the first year is £10,770,671 and in the fourth year is £11,329,095. The combined cost off-sets related to reduced hypoglycaemia admissions, SMBG strip usage and complications are £8,116,912 and £8,741,026 in years one and four, respectively. The net budget impact within the NW London CCGs is £2,653,760; £2,588,068 in years one and four respectively.

Conclusions: Introduction of CGM for T1D-IAH patients will have a minimal budget impact on NW London CCGs, driven by cost of CGM and offsets from lower hypoglycaemia-related costs, reduced SMBG strip usage, avoided HbA1c-related complications and lower insulin pump use.

评估在伦敦西北(NW)临床调试组(ccg)中为1型糖尿病(T1D)和低血糖意识受损(IAH)患者提供实时连续血糖监测(CGM)的经济影响。方法:符合CGM的人口和经济预算影响模型的输入来自已发表的数据。该模型包括CGM的成本;与低血糖相关的住院、事故和急诊就诊减少相关的成本节约;自我监测血糖试纸使用情况;糖化血红蛋白(HbA1c)降低相关的避免并发症和胰岛素泵的使用。结果:T1D-IAH (n=3,036)第一年的CGM费用为10,770,671英镑,第四年为11,329,095英镑。在第一年和第四年,与降低低血糖入院率、SMBG条使用率和并发症相关的综合成本抵消分别为8,116,912英镑和8,741,026英镑。NW伦敦CCGs的净预算影响为2,653,760英镑;第一年和第四年分别为2,588,068英镑。结论:在T1D-IAH患者中引入CGM将对NW伦敦CCGs的预算影响最小,这是由于CGM的成本和较低的低血糖相关成本、减少的SMBG条带使用、避免hba1c相关并发症和较低的胰岛素泵使用所抵消的。
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引用次数: 10
Antihyperglycemic Medications and Cardiovascular Risk Reduction. 降糖药物与降低心血管风险。
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.86
Sarah L Anderson, Joel C Marrs

Cardiovascular disease (CVD) remains a leading cause of death in patients with type 2 diabetes (T2D). In addition to glycemic control, a major focus of diabetes treatment involves cardiovascular (CV) risk reduction. In 2008, the US Food and Drug Administration (FDA) instituted a new requirement that new drugs developed and studied for the treatment of T2D must undergo CV safety testing. Since the advent of this new policy, canagliflozin, empagliflozin, liraglutide and semaglutide have demonstrated superior CV event reduction - via a composite of reduction in CV death, nonfatal myocardial infarction (MI), and nonfatal stroke - compared with placebo in patients with T2D and existing CVD, or at high risk of CVD. Multiple studies are underway to evaluate the CV outcomes of other antihyperglycemic agents. In a time when there are numerous drugs in the T2D armamentarium, positive CV outcomes data influence drug selection and aids practitioners in making more individualised therapeutic recommendations for their patients.

心血管疾病(CVD)仍然是导致 2 型糖尿病(T2D)患者死亡的主要原因。除了控制血糖,糖尿病治疗的一个重点是降低心血管疾病(CV)风险。2008 年,美国食品和药物管理局 (FDA) 提出了一项新要求,即开发和研究用于治疗 T2D 的新药必须经过心血管安全性测试。自这项新政策出台以来,与安慰剂相比,卡格列净、恩帕格列净、利拉鲁肽和赛马鲁肽已在患有 T2D 和现有心血管疾病或心血管疾病高风险的患者中,通过降低心血管疾病死亡、非致命性心肌梗死(MI)和非致命性中风的复合指标,证明了它们在降低心血管疾病风险方面的优势。目前正在进行多项研究,以评估其他降糖药物对心血管疾病的影响。在 T2D 药物种类繁多的今天,积极的 CV 结果数据会影响药物的选择,并帮助医生为患者提出更个性化的治疗建议。
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引用次数: 0
Beta-cell Insufficiency. β细胞功能不全。
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.51
Sanjay Kalra, Yashdeep Gupta

'Beta-cell failure' is a frequently used term to describe the structural and functional inability of the cells to fulfil their metabolic responsibility. This editorial reviews the anatomy and physiology of the beta cell, and describes factors which regulate this. The authors focus on semantics, comparing the phrases 'beta-cell failure', 'functional mass', and 'beta-cell insufficiency'. They suggest the use of 'beta-cell insufficiency', with descriptors such as 'partial' and 'complete', or 'reversible' and 'irreversible', to convey betacell dysfunction in type 2 diabetes. A three-phase taxonomic structure: beta-cell sufficiency, partial/reversible beta-cell insufficiency and complete/irreversible beta-cell insufficiency, is proposed as a tool to understand pathophysiology and facilitate therapeutic decision-making.

“β细胞衰竭”是一个常用的术语,用来描述细胞在结构和功能上无法履行其代谢职责。这篇社论回顾了β细胞的解剖学和生理学,并描述了调节这一点的因素。作者着重于语义,比较了“β细胞衰竭”、“功能团”和“β细胞不足”这三个短语。他们建议使用“β细胞功能不全”,加上“部分”和“完全”,或“可逆”和“不可逆”等描述符,来表达2型糖尿病患者的β细胞功能障碍。三阶段的分类结构:β细胞充分性,部分/可逆性β细胞不足和完全/不可逆性β细胞不足,被提出作为理解病理生理和促进治疗决策的工具。
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引用次数: 2
The Vildagliptin Experience - 25 Years Since the Initiation of the Novartis Glucagon-like Peptide-1 Based Therapy Programme and 10 Years Since the First Vildagliptin Registration. 维格列汀的经验——诺华胰高血糖素样肽-1治疗项目启动25年,维格列汀首次注册10年。
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.56
James E Foley, Bo Ahrén

The discovery of the incretin hormone glucagon like peptide-1 (GLP-1), and its usefulness in the treatment of type 2 diabetes mellitus (T2DM) followed by the finding that dipeptidyl peptidase-4 (DPP-4) inhibition prevents GLP-1 inactivation, led to the discovery of DPP-728. In 1999, studies with DPP-728 established the first proof-of-concept that DPP-4 inhibition improves glycaemic control in patients with T2DM. Further efforts to improve the binding kinetics of DPP-728 resulted in the discovery of vildagliptin (LAF237). In the last 20 years, a plethora of studies conducted by Novartis in collaboration with external investigators has demonstrated the mechanism of action of vildagliptin and its efficacy as monotherapy and as an add-on therapy for patients with T2DM. The studies establish that vildagliptin is a selective DPP-4 inhibitor that blocks GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) inactivation, thereby prolonging their action, resulting in improved glycaemic control. This review aims to discuss the discovery and development of vildagliptin, with an emphasis on mechanism of action and clinical efficacy.

胰高血糖素样肽-1 (GLP-1)的发现及其在治疗2型糖尿病(T2DM)中的作用,以及二肽基肽酶-4 (DPP-4)抑制可阻止GLP-1失活的发现,导致DPP-728的发现。1999年,对DPP-728的研究首次证实了抑制DPP-4可改善T2DM患者血糖控制的概念。进一步努力改善DPP-728的结合动力学导致vildagliptin (LAF237)的发现。在过去的20年里,诺华公司与外部研究人员合作进行了大量的研究,证明了维格列汀的作用机制,以及它作为单一疗法和附加疗法对T2DM患者的疗效。研究证实,维格列汀是一种选择性DPP-4抑制剂,可阻断GLP-1和葡萄糖依赖性胰岛素性多肽(GIP)失活,从而延长其作用,从而改善血糖控制。本文综述了维格列汀的发现和发展,重点介绍了维格列汀的作用机制和临床疗效。
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引用次数: 7
Call for Submissions. 征集作品。
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.49
Abd Tahrani
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引用次数: 0
Continuous Glucose Monitoring Adoption in the United Kingdom - An Economic and Policy Perspective. 持续血糖监测在英国的应用——从经济和政策的角度。
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.73
Nick Oliver

Continuous glucose monitoring (CGM) technology provides real-time glucose concentration data to people with diabetes. The data enable timely treatment decisions that can lead to avoidance or mitigation of hypoglycaemia, with potential cost savings. This commentary discusses CGM implementation and funding policies in the UK, and regional disparities that confront many people with diabetes who could benefit from the technology.

连续血糖监测(CGM)技术为糖尿病患者提供实时血糖浓度数据。这些数据有助于及时做出治疗决策,从而避免或缓解低血糖,并可能节省成本。这篇评论讨论了英国CGM的实施和资助政策,以及许多糖尿病患者面临的地区差异,这些糖尿病患者可以从这项技术中受益。
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引用次数: 5
Dipeptidyl Peptidase-4 Inhibitor Development and Post-authorisation Programme for Vildagliptin - Clinical Evidence for Optimised Management of Chronic Diseases Beyond Type 2 Diabetes. 二肽基肽酶-4 抑制剂维达列汀的开发和授权后计划--优化 2 型糖尿病以外慢性疾病管理的临床证据。
Q2 Medicine Pub Date : 2017-08-01 Epub Date: 2017-08-22 DOI: 10.17925/EE.2017.13.02.62
William David Strain, Päivi M Paldánius

The last decade has witnessed the role of dipeptidyl peptidase-4 (DPP-4) inhibitors in producing a conceptual change in early management of type 2 diabetes mellitus (T2DM) by shifting emphasis from a gluco-centric approach to holistically treating underlying pathophysiological processes. DPP-4 inhibitors highlighted the importance of acknowledging hypoglycaemia and weight gain as barriers to optimised care in T2DM. These complications were an integral part of diabetes management before the introduction of DPP-4 inhibitors. During the development of DPP-4 inhibitors, regulatory requirements for introducing new agents underwent substantial changes, with increased emphasis on safety. This led to the systematic collection of adjudicated cardiovascular (CV) safety data, and, where 95% confidence of a lack of harm could not be demonstrated, the standardised CV safety studies. Furthermore, the growing awareness of the worldwide extent of T2DM demanded a more diverse approach to recruitment and participation in clinical trials. Finally, the global financial crisis placed a new awareness on the health economics of diabetes, which rapidly became the most expensive disease in the world. This review encompasses unique developments in the global landscape, and the role DPP-4 inhibitors, specifically vildagliptin, have played in research advancement and optimisation of diabetes care in a diverse population with T2DM worldwide.

在过去的十年中,二肽基肽酶-4(DPP-4)抑制剂在 2 型糖尿病(T2DM)的早期管理中起到了观念转变的作用,将重点从以血糖为中心的方法转移到全面治疗潜在的病理生理过程。DPP-4 抑制剂强调,必须认识到低血糖和体重增加是 T2DM 优化治疗的障碍。在 DPP-4 抑制剂问世之前,这些并发症是糖尿病治疗不可或缺的一部分。在 DPP-4 抑制剂的开发过程中,引入新药的监管要求发生了重大变化,更加注重安全性。这导致了系统性地收集经裁定的心血管 (CV) 安全性数据,以及在无法证明 95% 的置信度为无害的情况下进行标准化的 CV 安全性研究。此外,全球范围内对 T2DM 发病率的认识不断提高,这就要求临床试验的招募和参与方式更加多样化。最后,全球金融危机使人们对糖尿病的健康经济学有了新的认识,糖尿病迅速成为世界上最昂贵的疾病。本综述涵盖了全球范围内的独特发展,以及 DPP-4 抑制剂(尤其是维达列汀)在研究进展和优化全球不同 T2DM 患者的糖尿病护理方面所发挥的作用。
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引用次数: 0
Pilot Study of a Web-based Decision Tool on Post-operative Use of Radioactive Iodine. 基于网络的术后放射性碘使用决策工具的初步研究。
Q2 Medicine Pub Date : 2017-04-01 Epub Date: 2017-04-03 DOI: 10.17925/EE.2017.13.01.26
Shrujal S Baxi, Rachel Kurtzman, Anne Eaton, Eliza Dewey, Craig Bickford, Stephanie Fish, Leonard Wartofsky, R Michael Tuttle

Background: The Thyroid Cancer Care Collaborative developed a web-based clinical decision-making module (CDMM) to inform risk-adjusted decisions on post-thyroidectomy radioactive iodine (RAI) use in papillary thyroid cancer (PTC). Methods: In a pilot study, we evaluated the CDMM in 19 PTC cases representing low- (five), intermediate- (seven) and high-risk (seven) disease. Two PTC experts and 10 PTC physicians reviewed cases and assigned risk level and RAI recommendation. The experts used a standard approach while the others used the CDMM. We assessed agreement between responses using a weighted Kappa. Results: Between experts, risk-assignment was concordant in 100%, 57% and 86% of low-, intermediate- and high-risk cases, respectively. Between CDMM users, risk-assignment was concordant in 100%, 29% and 14% in low-, intermediate- and high-risk cases, respectively (p=0.01). CDMM-assigned risk agreed with the expert-assigned risk in 100%, 25% and 0% of low-, intermediate- and high-risk cases, respectively (Kappa=0.69). For RAI use, the experts agreed in 15 cases while CDMM users agreed in eight. On further analysis, interpretation of extrathyroidal extension and lymph node staging led to discrepancies with the CDMM. Conclusions: For a web-based CDMM to accurately inform appropriate use of RAI in PTC, standard pathological and surgical reports are necessary.

背景:甲状腺癌护理协作开发了一个基于网络的临床决策模块(CDMM),为甲状腺切除术后放射性碘(RAI)在乳头状甲状腺癌(PTC)中的使用提供风险调整决策。方法:在一项初步研究中,我们评估了19例低危(5例)、中危(7例)和高危(7例)PTC病例的CDMM。两名PTC专家和10名PTC医生审查了病例,并分配了风险水平和RAI建议。专家们使用标准方法,而其他人使用CDMM。我们使用加权Kappa来评估回答之间的一致性。结果:专家之间的风险分配在100%、57%和86%的低、中、高风险病例中是一致的。在CDMM使用者之间,低、中、高风险病例的风险分配分别为100%、29%和14% (p=0.01)。cdmm分配的风险与专家分配的风险分别在100%、25%和0%的低、中、高风险病例中一致(Kappa=0.69)。对于RAI的使用,专家们同意了15个案例,而CDMM用户同意了8个案例。进一步分析,甲状腺外展和淋巴结分期的解释导致与CDMM的差异。结论:为了使基于网络的CDMM准确地告知在PTC中正确使用RAI,标准的病理和手术报告是必要的。
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引用次数: 1
Progress and Problems in Bone and Mineral Disorders. 骨与矿物质疾病的研究进展与问题。
Q2 Medicine Pub Date : 2017-04-01 Epub Date: 2017-04-03 DOI: 10.17925/EE.2017.13.01.19
Neil Gittoes

A number of new drugs are moving through the osteoporosis therapy pipeline. Some show great promise for patients while one has fallen by the wayside at the last hurdle. New, effective therapies are warmly welcomed but there are still uncertainties around management of osteoporosis with currently available drugs that are contributing to what is commonly being referred to as the 'treatment gap'; a differential between those patients who would benefit from treatment versus those who actually are receiving it. Furthermore, in parallel to the common public health disease of osteoporosis, there have been tangible developments in therapies available for some rare bone and calcium diseases.

许多新药正在通过骨质疏松症的治疗管道。有些显示出对病人的巨大希望,而另一个则在最后的障碍中失败了。新的、有效的治疗方法受到热烈欢迎,但目前可用的药物在骨质疏松症的管理方面仍然存在不确定性,这导致了通常被称为“治疗缺口”的现象;那些从治疗中受益的患者和那些实际接受治疗的患者之间的差异。此外,在骨质疏松这一常见的公共健康疾病的同时,一些罕见的骨病和钙病的治疗方法也有了切实的发展。
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引用次数: 0
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European Endocrinology
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