type 1 diabetes

1 型糖尿病
  • 文章类型: Journal Article
    目的:了解医疗保健提供者使用GlucoGuide的经验,一种模型工具,它将视觉数据分析与算法见解集成在一起,以支持临床医生使用患者从1型糖尿病设备生成的数据。
    方法:这项定性研究分三个阶段进行。在第1阶段,11名临床医生在一次大声思考的数据演练活动中使用商业糖尿病平台审查数据,然后进行半结构化访谈。在阶段2中,开发了GlucoGuide。在第3阶段,相同的临床医生在大声思考活动中使用GlucoGuide审查数据,然后进行半结构化访谈。归纳主题分析用于分析第1阶段和第3阶段的大声思考活动和访谈的笔录。
    结果:3个高级任务,8个子任务,在第一阶段确定了4个挑战。在阶段2中,确定了对GlucoGuide的3个要求。第3阶段结果表明,与第1阶段使用的商业糖尿病数据报告相比,临床医生发现GlucoGuide更易于使用,并且认知负担更低。此外,GlucoGuide解决了第一阶段所面临的挑战。
    结论:该研究表明,在实现数据接口的功能时,分析任务和特定任务的可视化策略的知识可以产生降低与数据互动的感知负担的工具。此外,通过对相关数据的视觉分析,支持临床医生将算法洞察情境化,可以积极影响临床医生利用算法支持的意愿.
    结论:结合多种数据驱动方法的任务对齐工具,例如可视化策略和算法见解,可以提高临床医生审查设备数据的经验。
    OBJECTIVE: To understand healthcare providers\' experiences of using GlucoGuide, a mockup tool that integrates visual data analysis with algorithmic insights to support clinicians\' use of patientgenerated data from Type 1 diabetes devices.
    METHODS: This qualitative study was conducted in three phases. In Phase 1, 11 clinicians reviewed data using commercial diabetes platforms in a think-aloud data walkthrough activity followed by semistructured interviews. In Phase 2, GlucoGuide was developed. In Phase 3, the same clinicians reviewed data using GlucoGuide in a think-aloud activity followed by semistructured interviews. Inductive thematic analysis was used to analyze transcripts of Phase 1 and Phase 3 think-aloud activity and interview.
    RESULTS: 3 high level tasks, 8 sub-tasks, and 4 challenges were identified in Phase 1. In Phase 2, 3 requirements for GlucoGuide were identified. Phase 3 results suggested that clinicians found GlucoGuide easier to use and experienced a lower cognitive burden as compared to the commercial diabetes data reports that were used in Phase 1. Additionally, GlucoGuide addressed the challenges experienced in Phase 1.
    CONCLUSIONS: The study suggests that the knowledge of analytical tasks and task-specific visualization strategies in implementing features of data interfaces can result in tools that lower the perceived burden of engaging with data. Additionally, supporting clinicians in contextualizing algorithmic insights by visual analysis of relevant data can positively influence clinicians\' willingness to leverage algorithmic support.
    CONCLUSIONS: Task-aligned tools that combine multiple data-driven approaches, such as visualization strategies and algorithmic insights, can improve clinicians\' experience in reviewing device data.
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  • 文章类型: Journal Article
    探讨混合巴西人群中HLA等位基因和单倍型与1型糖尿病(T1DAgeD)诊断年龄之间的潜在关系。这项全国性的研究是在巴西12个城市的公共诊所进行的。我们收集了1600名T1D患者的人口统计学和遗传数据。DNA样品用于确定基因组祖先(GA)并对DRB1,DQA1和DQB1进行HLA分型。我们探索了按T1DAgeD类别分组的患者的等位基因和单倍型频率和GA(<6年,≥6-<11年,≥11-<19年和≥19年),通过单变量和多变量分析以及主要成分分析。此外,我们考虑了自我报告的肤色种族,并确定了一级亲属中常见的T1D病史.DRB1~DQA1~DQB1单倍型的纯合性指数在T1DAgeD群体中表现出最高的变异,撒哈拉以南非洲和欧洲祖先的百分比在主成分分析(PCA)分析中显示出相反的趋势。关于等位基因和单倍型与T1DAgeD的关联,风险等位基因,如HLA-DQB1*03:02g,-DQA1*03:01g,-02:01g,DRB1*04:05g和-04:02g在具有早期疾病发作的T1D患者中更频繁地观察到杂合性或纯合性。相反,等位基因如DRB1*07:01g,-13:03g,DQB1*06:02g和DQA1*02:01在老年T1D患者中更为普遍。DR3/DR4.5组合与早期疾病发作显著相关。然而,性别,GA,熟悉的T1D病史和自我报告的肤色种族身份与T1D的发作没有显着关联。值得注意的是,非常常见的风险单倍型DRB1*03:01g~DQA1*05:01g~DQB1*02:01g没有区分T1DAgeD组。在混合的巴西人口中,高危单倍型DRB1*04:05~DQA1*03:01~DQB1*03:02在6岁以前诊断的个体中更为普遍.相比之下,保护等位基因DQA1*01:02g,DQB1*06:02g,DRB1*07:01g和DRB1*13:03g和单倍型DRB1*13:03g〜DQA1*05:01g〜DQB1*03:01g和DRB1*16:02g〜DQA1*01:02g〜DQB1*05:02g在成年期诊断的患者中更常见。值得注意的是,这些关联与性别等因素无关,经济地位,GA,熟悉的T1D历史和巴西的出生地区。这些等位基因和单倍型有助于我们对疾病发作异质性的理解,并且当检测到与众所周知的T1D基因组风险或保护因子相关时,可能对早期干预有影响。
    To investigate the potential relationship between HLA alleles and haplotypes and the age at diagnosis of type 1 diabetes (T1DAgeD) in an admixed Brazilian population. This nationwide study was conducted in public clinics across 12 Brazilian cities. We collected demographic and genetic data from 1,600 patients with T1D. DNA samples were utilised to determine genomic ancestry (GA) and perform HLA typings for DRB1, DQA1 and DQB1. We explored allele and haplotype frequencies and GA in patients grouped by T1DAgeD categories (<6 years, ≥6-<11 years, ≥11-<19 years and ≥19 years) through univariate and multivariate analyses and primary component analyses. Additionally, we considered self-reported colour-race and identified a familiar history of T1D in first-degree relatives. The homozygosity index for DRB1~DQA1~DQB1 haplotypes exhibited the highest variation among T1DAgeD groups, and the percentages of Sub-Saharan African and European ancestries showed opposite trends in principal component analysis (PCA) analyses. Regarding the association of alleles and haplotypes with T1DAgeD, risk alleles such as HLA-DQB1*03:02g, -DQA1*03:01g, -02:01g, DRB1*04:05g and -04:02g were more frequently observed in heterozygosity or homozygosity in T1D patients with an early disease onset. Conversely, alleles such as DRB1*07:01g, -13:03g, DQB1*06:02g and DQA1*02:01 were more prevalent in older T1D patients. The combination DR3/DR4.5 was significantly associated with early disease onset. However, gender, GA, familiar history of T1D and self-reported colour-race identity did not exhibit significant associations with the onset of T1D. It is worth noting that the very common risk haplotype DRB1*03:01g~DQA1*05:01g~DQB1*02:01g did not differentiate between T1DAgeD groups. In the admixed Brazilian population, the high-risk haplotype DRB1*04:05~DQA1*03:01~DQB1*03:02 was more prevalent in individuals diagnosed before 6 years of age. In contrast, the protective alleles DQA1*01:02g, DQB1*06:02g, DRB1*07:01g and DRB1*13:03g and haplotypes DRB1*13:03g~DQA1*05:01g~DQB1*03:01g and DRB1*16:02g~DQA1*01:02g~DQB1*05:02g were more frequently observed in patients diagnosed in adulthood. Notably, these associations were independent of factors such as sex, economic status, GA, familiar history of T1D and region of birth in Brazil. These alleles and haplotypes contribute to our understanding of the disease onset heterogeneity and may have implications for early interventions when detected in association with well-known genomic risk or protection factors for T1D.
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  • 文章类型: Journal Article
    背景:证据表明,患有1型糖尿病的月经女性的血糖水平在整个月经周期中发生变化,在黄体期达到峰值。1型糖尿病运动倡议(T1DEXI)研究提供了评估月经周期早期和晚期之间的血糖指标的机会,以及差异是否可以用锻炼来解释,胰岛素,和碳水化合物的摄入量。
    方法:分析了一百六十二名成年女性。血糖指标,碳水化合物的摄入量,胰岛素需求,和运动习惯在早期与月经周期的晚期阶段(即2-4天后vs.报告月经开始日期前2-4天)进行比较。
    结果:平均血糖从卵泡早期的8.2±1.5mmol/L(148±27mg/dL)增加到黄体晚期的8.6±1.6mmol/L(155±29mg/dL)(p<0.001)。平均时间百分比(3.9-10.0mmol/L[70-180mg/dL])从73±17%降至70±18%(p=0.002),时间中位数>10.0mmol/L(>180mg/dL)从21%增加到23%(p<0.001)。平均每日总胰岛素需求从卵泡早期的37.4个单位增加到黄体晚期的38.5个单位(p=0.02),平均每日碳水化合物消耗量从127±47g略微增加到133±47g(p=0.05)。但是卵泡早期的平均葡萄糖与黄体晚期不能用运动持续时间的差异来解释,每日总胰岛素单位,或报告的碳水化合物摄入量。
    结论:黄体晚期的血糖水平高于月经周期的卵泡早期。这些血糖变化表明,1型糖尿病女性的血糖管理可能需要在月经周期的背景下进行微调。
    BACKGROUND: Evidence suggests that glucose levels in menstruating females with type 1 diabetes change throughout the menstrual cycle, reaching a peak during the luteal phase. The Type 1 Diabetes Exercise Initiative (T1DEXI) study provided the opportunity to assess glycemic metrics between early and late phases of the menstrual cycle, and whether differences could be explained by exercise, insulin, and carbohydrate intake.
    METHODS: One hundred and sixty two adult females were included in the analysis. Glycemic metrics, carbohydrate intake, insulin requirements, and exercise habits during the early vs. late phases of the menstrual cycles (i.e. 2-4 days after vs. 2-4 days before reported menstruation start date) were compared.
    RESULTS: Mean glucose increased from 8.2±1.5 mmol/L (148±27 mg/dL) during the early follicular phase to 8.6±1.6 mmol/L (155±29 mg/dL) during the late luteal phase (p<0.001). Mean percent time-in-range (3.9-10.0 mmol/L [70-180 mg/dL] ) decreased from 73±17% to 70±18% (p=0.002), and median percent time >10.0 mmol/L (>180 mg/dL) increased from 21% to 23% (p<0.001). Median total daily insulin requirements increased from 37.4 units during the early follicular to 38.5 units during the late luteal phase (p=0.02) and mean daily carbohydrate consumption increased slightly from 127±47 g to 133±47 g (p=0.05), but the difference in mean glucose during early follicular vs. late luteal phase was not explained by differences in exercise duration, total daily insulin units, or reported carbohydrate intake.
    CONCLUSIONS: Glucose levels during the late luteal phase were higher than the early follicular phase of the menstrual cycle. These glycemic changes suggest that glucose management for females with type 1 diabetes may need to be fine-tuned within the context of their menstrual cycles.
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  • 文章类型: Journal Article
    目的:运动是1型糖尿病(T1D)治疗的推荐部分,高体力活动水平改善健康结果。然而,许多患有T1D的人不符合体育活动建议。这项研究的目的是确定影响T1D患者身体活动水平的因素。
    方法:这项基于问卷的研究包括来自英国1个门诊诊所和丹麦2个门诊诊所的T1D成人。运动特点,评估了动机和障碍。使用Saltin-Grimby体力活动水平量表测量体力活动水平。受访者分为三个活动组:不活动,轻度活跃和适度活跃。
    结果:在332名受访者中,8.4%的人认为自己不活跃,48%的轻度活动和43%的中度至剧烈活动。78%的不活跃和轻度活跃的患者表示希望变得更加活跃。53%的受访者接受了糖尿病团队关于运动/体力活动的指导。是男性,接受了指导,与较高的体力活动水平有关。锻炼/身体活动的重要动机是改善身心健康和血糖控制,而最常见的障碍是忙于工作/私人生活和缺乏动力。担心葡萄糖远足,成本,缺乏知识,在最不活跃的人群中,与健康相关的原因是更普遍的障碍。
    结论:这项研究发现,78%的不活跃和轻度活跃的受访者表示希望变得更加活跃。接受有关运动/身体活动的指导与较高的身体活动水平有关,但只有53%的受访者获得了糖尿病团队的支持.
    OBJECTIVE: Exercise is a recommended part of type 1 diabetes (T1D) treatment, as high physical activity levels improve health outcomes. However, many people with T1D do not meet physical activity recommendations. The aim of this study was to identify factors influencing physical activity levels in people with T1D.
    METHODS: This questionnaire-based study included adults with T1D from 1 outpatient clinic in the UK and 2 in Denmark. Exercise characteristics, motivators and barriers was assessed. Physical activity level was measured using Saltin-Grimby Physical Activity Level Scale. Respondents were categorized into three activity groups: inactive, light active and moderate-to-vigourous active.
    RESULTS: Out of 332 respondents, 8.4% rated themselves as inactive, 48% light active and 43% moderate-to-vigorous active. 78% of inactive and light active repondents expressed a desire to become more physically active. 53% of respondents had received guidance concerning exercise/physical activity from their diabetes team. Being male and having received guidance, was associated with higher physical activity level. Important motivators for exercising/being physically active were improved mental and physical health and glycaemic control, while most frequent barriers were busyness with work/private life and lack of motivation. Worries about glucose excursions, costs, lack of knowledge, and health related reasons were more prevalent barriers in the least active groups.
    CONCLUSIONS: This study found that 78% of inactive and light active respondents reported wishing to become more physically active. Receiving guidance about exercise/physical activity was associated with higher physical activity level, but only 53% of respondents had received support from their diabetes team.
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  • 文章类型: Journal Article
    背景:患有慢性病的人经常在网上搜索健康信息。糖尿病在线社区(DOC)是一个活跃的社区,成员可以交流健康信息;但是,很少有研究检查DOC中的健康信息中介。
    目的:本研究的目的是在1型糖尿病(T1D)成人样本中开发和验证在线寻求健康信息的态度(ATSHIO)量表。
    方法:通过DOC招募T1D患者,特别是Facebook和Twitter。为他们提供了Qualtrics链接以完成调查。这是一项混合方法研究,使用主题分析以及现有理论和形成性研究来设计定量ATSHIO量表。
    结果:共有166名T1D患者参与了这项研究。验证性因素分析确定了具有良好收敛效度和判别效度的2因素量表(在DOC中信任和评估在线健康信息以及在DOC中参与在线健康信息)。社会支持之间存在相关性,在线健康信息搜索,糖尿病困扰,和疾病管理。
    结论:ATSHIO量表可用于调查糖尿病患者如何使用互联网获取健康信息,这在远程医疗和健康2.0时代尤其重要。
    BACKGROUND: Individuals with chronic diseases often search for health information online. The Diabetes Online Community (DOC) is an active community with members who exchange health information; however, few studies have examined health information brokering in the DOC.
    OBJECTIVE: The aim of this study was to develop and validate the Attitudes Toward Seeking Health Information Online (ATSHIO) scale in a sample of adults with type 1 diabetes (T1D).
    METHODS: People with T1D were recruited through the DOC, specifically Facebook and Twitter. They were provided with a Qualtrics link to complete the survey. This was a mixed methods study that used thematic analysis along with existing theory and formative research to design the quantitative ATSHIO scale.
    RESULTS: A total of 166 people with T1D participated in this study. Confirmatory factor analyses determined a 2-factor scale (Trusting and Evaluating Online Health Information in the DOC and Engaging With Online Health Information in the DOC) with good convergent validity and discriminant validity. Correlations were found between social support, online health information-seeking, diabetes distress, and disease management.
    CONCLUSIONS: The ATSHIO scale can be used to investigate how people with diabetes are using the internet for obtaining health information, which is especially relevant in the age of telehealth and Health 2.0.
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  • 文章类型: Journal Article
    目的:对新诊断的1型糖尿病患者的β细胞丢失率的异质性了解甚少,这对设计和解释改变疾病的临床试验造成了障碍。对1型糖尿病诊断后获得的基线多组学数据的综合分析可以提供对1型糖尿病诊断后疾病进展的不同速率的机械见解。
    方法:我们在一个泛欧洲联盟中收集了样本,该联盟对来自97名新诊断患者的数据中的五种不同的组学模式进行了协同分析。在这项研究中,我们使用多组学因素分析来鉴定与以空腹C肽测量的β细胞质量诊断后下降相关的分子特征.
    结果:两个分子特征与空腹C肽水平显著相关。一个特征显示与中性粒细胞脱颗粒相关,细胞因子信号,淋巴细胞和非淋巴细胞相互作用以及G蛋白偶联受体信号事件与β细胞功能的快速下降呈负相关。第二个特征与翻译有关,而病毒感染与β细胞功能的变化成反比。此外,免疫组学数据揭示了与β细胞快速衰退相关的自然杀伤细胞特征.
    结论:β细胞质量缓慢和快速下降的个体之间的不同特征在分期和预测疾病进展速度方面可能是有价值的,因此可以实现更智能(更短和更小)的试验设计用于疾病修饰疗法以及提供治疗效果的生物标志物。
    OBJECTIVE: Heterogeneity in the rate of β-cell loss in newly diagnosed type 1 diabetes patients is poorly understood and creates a barrier to designing and interpreting disease-modifying clinical trials. Integrative analyses of baseline multi-omics data obtained after the diagnosis of type 1 diabetes may provide mechanistic insight into the diverse rates of disease progression after type 1 diabetes diagnosis.
    METHODS: We collected samples in a pan-European consortium that enabled the concerted analysis of five different omics modalities in data from 97 newly diagnosed patients. In this study, we used Multi-Omics Factor Analysis to identify molecular signatures correlating with post-diagnosis decline in β-cell mass measured as fasting C-peptide.
    RESULTS: Two molecular signatures were significantly correlated with fasting C-peptide levels. One signature showed a correlation to neutrophil degranulation, cytokine signalling, lymphoid and non-lymphoid cell interactions and G-protein coupled receptor signalling events that were inversely associated with a rapid decline in β-cell function. The second signature was related to translation and viral infection was inversely associated with change in β-cell function. In addition, the immunomics data revealed a Natural Killer cell signature associated with rapid β-cell decline.
    CONCLUSIONS: Features that differ between individuals with slow and rapid decline in β-cell mass could be valuable in staging and prediction of the rate of disease progression and thus enable smarter (shorter and smaller) trial designs for disease modifying therapies as well as offering biomarkers of therapeutic effect.
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  • 文章类型: Journal Article
    确定获得糖尿病技术的不平等以及社会经济因素对1型糖尿病儿童家庭的影响。
    在这项多中心横断面研究中,1型糖尿病儿童的父母填写了一份关于家庭社会人口统计学特征的问卷,最新的HbA1c值,连续血糖监测(CGM)和胰岛素泵使用儿童,父母的教育和工作状况。这些特征在技术使用之间进行了比较(仅限CGM,唯一的泵,CGM+泵,不使用技术)。
    在882个家庭中,仅限CGM用户,仅泵用户,与CGM+泵用户相比,无技术用户,调整年龄,性别,区域,教育水平,有工作的父母,和家庭收入。与生活在最发达地区的儿童相比,生活在最不发达地区的儿童仅有CGM(OR=0.20,95CI0.12-0.34)和有CGM+泵(OR=0.07,95CI0.03-0.22)的几率较低。与父母未完成高中学业的孩子相比,只有CGM(母亲:OR=0.36,95CI0.19-0.66;父亲:OR=0.32,95CI0.18-0.60)或同时使用CGM泵(OR=0.27,95CI0.11-0.64;父亲:OR=0.34,95CI0.15-0.79)而不是没有技术。家庭收入每增加840美元,只有CGM(OR=1.05,95CI1.02-1.09)和CGM+泵(OR=1.05,95CI1.01-1.08)的几率就会增加5%。
    社会经济因素,如教育,regions,收入与获取技术的不平等有关。不平等在获得CGM方面更为突出,而CGM对血糖控制的贡献更大。
    UNASSIGNED: To determine inequalities in access to diabetes technologies and the effect of socioeconomic factors on families with children with type 1 diabetes.
    UNASSIGNED: In this multicenter cross-sectional study, parents of children with type 1 diabetes completed a questionnaire about household sociodemographic characteristics, latest HbA1c values, continuous glucose monitoring (CGM) and insulin pump use of children, the education and working status of parents. These characteristics were compared between technology use (only-CGM, only-pump, CGM+pump, no technology use).
    UNASSIGNED: Among 882 families, only-CGM users, only-pump users, and CGM+pump users compared with no technology users, adjusting for age, sex, region, education levels, number of working parents, and household income. Children living in the least developed region had lower odds of having only-CGM (OR=0.20, 95%CI 0.12-0.34) and having CGM+pump (OR=0.07, 95%CI 0.03-0.22) compared with those living in the most developed region. Children with parents who had not finished high school had lower odds of having only-CGM (Mothers: OR=0.36, 95%CI 0.19-0.66; fathers: OR=0.32, 95%CI 0.18-0.60) or both CGM+pump (OR=0.27, 95%CI 0.11-0.64; fathers: OR=0.34, 95%CI 0.15-0.79) rather than no-technology compared to children whose parents has a university degree. Every $840 increase in the household income increased the odds by 5% for having only-CGM (OR=1.05, 95%CI 1.02-1.09) and CGM+pump (OR=1.05, 95%CI 1.01-1.08).
    UNASSIGNED: Socioeconomic factors such as education, regions, and income were associated with inequality in access to technologies. The inequalities are more prominent in access to CGM while CGM had a bigger contribution to glycemic control.
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  • 文章类型: Journal Article
    背景:MedtronicMiniMed™780G(MM780G)系统使用包括自动校正推注(AB)递送的算法。这项研究评估了省略餐团和系统设置的影响,葡萄糖目标和主动胰岛素时间(AIT),在AB上。
    方法:对我们医疗保健领域所有MiniMed780G用户上传的数据进行回顾性观察研究,通过远程监控平台CareConnect获得,2023年4月至8月。不包括传感器使用时间<95%的下载。
    结果:分析了235个用户的235个下载。与其他设置(2.25-4h)(26.43±13.2%)相比,在2hAIT(36.08±13.17%)时的AB递送显着更高(p<0.001)。没有发现基于葡萄糖目标的AB差异。每天少于3次的患者的AB分娩率较高(46.91±19.00%vs27.53±11.54%)(p<0.001),并且血糖参数较差(GMI7.12±0.45%,TIR67.46±12.89%与GMI6.78±0.3%,TIR76.51±8.37%)(p<0.001)。然而,2小时AIT组呈现相似的TAR,TIR和GMI不考虑餐粉的数量。
    结论:用户发起的推注越少,接收到的自动校正越大。2小时的主动胰岛素时间需要更主动的自动校正模式,这使得可以更有效地补偿餐团的遗漏而不会增加低血糖。
    BACKGROUND: The Medtronic MiniMed™ 780G (MM780G) system uses an algorithm that includes autocorrection bolus (AB) delivery. This study evaluates the impact of omitted meal boluses and the system settings, glucose target and active insulin time (AIT), on the AB.
    METHODS: Retrospective observational study on data uploaded by all MiniMed 780G users in our healthcare area, obtained through the remote monitoring platform Care Connect, from April to August 2023. Downloads with a sensor usage time <95% were excluded.
    RESULTS: 235 downloads belonging to 235 users were analysed. AB delivery was significantly higher at 2 h AIT (36.08 ± 13.17%) compared to the rest of settings (2.25-4 h) (26.43 ± 13.2%) (p < 0.001). AB differences based on the glucose target were not found. Patients with <3 meal boluses per day had higher AB delivery (46.91 ± 19.00% vs 27.53 ± 11.54%) (p < 0.001) and had more unfavourable glucometric parameters (GMI 7.12 ± 0.45%, TIR 67.46 ± 12.89% vs GMI 6.78 ± 0.3%, TIR 76.51 ± 8.37%) (p < 0.001). However, the 2-h AIT group presented similar TAR, TIR and GMI regardless of the number of meal boluses.
    CONCLUSIONS: The fewer user-initiated boluses, the greater the autocorrection received. The active insulin time of 2 h entails a more active autocorrection pattern that makes it possible to more effectively compensate for the omission of meal boluses without increasing hypoglycaemias.
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  • 文章类型: Journal Article
    比较1型糖尿病(T1D)患者在COVID-19大流行之前和期间的体重和血糖控制变化。
    在来自德国糖尿病前瞻性随访注册(DPV)的47,065名T1D患者中,我们比较了2018年3月至2022年2月4个时期的BMI-Z评分和HbA1c的校正平均变化,以及按性别和年龄组(4-<11,11-<16,16-50岁)的个体变化分布.
    在人口水平上,唯一显著的大流行效应是青春期前儿童的BMIZ评分略有增加(女孩:在第一个COVID年为+0.03,而不是之前,P<0.01;男孩:0.04,P<0.01)以及所有亚组的HbA1c稳定,甚至女性改善(-0.08%,P<0.01)。在个人层面,然而,异质性显著增加(p<0.01),尤其是儿童。更多的青春期前儿童体重增加(女孩:45%vs.COVID前35%;男孩:39%33%)。更多青春期女孩体重减轻(30%vs.21%)和较少的体重增加(43%vs.54%)。更多儿童的HbA1c下降(青春期前组:29%vs.22%;青春期女孩:33%vs.28%;青春期男孩:32%vs.25%)和更少的有递增值。更多的女性有稳定的HbA1c,更少的女性有增加的值(30%vs.37%)。在男人中,没有观察到显著的变化。
    这项现实世界的分析显示,前两个COVID年对T1D的平均体重和HbA1c没有不利影响,但揭示了,超越平均趋势,在个人层面上有更大的可变性。
    UNASSIGNED: To compare the changes in body weight and glycemic control before and during the COVID-19 pandemic in people with type 1 diabetes (T1D).
    UNASSIGNED: In 47,065 individuals with T1D from the German Diabetes Prospective Follow-up Registry (DPV), we compared the adjusted mean changes in BMI-Z-scores and HbA1c as well as the distribution of individual changes between four periods from March 2018 to February 2022, by sex and age group (4- < 11, 11- < 16, 16-50 years).
    UNASSIGNED: At population level, the only significant pandemic effects were a slight increase in BMI Z-score in prepubertal children (girls: + 0.03 in the first COVID year vs. before, P < 0.01; boys: + 0.04, P < 0.01) as well as a stabilization of HbA1c in all subgroups or even improvement in women (- 0.08%, P < 0.01). At individual level, however, heterogeneity increased significantly (p < 0.01), especially in children. More prepubertal children gained weight (girls: 45% vs. 35% before COVID; boys: 39% vs. 33%). More pubertal girls lost weight (30% vs. 21%) and fewer gained weight (43% vs. 54%). More children had a decreasing HbA1c (prepubertal group: 29% vs. 22%; pubertal girls: 33% vs. 28%; pubertal boys: 32% vs. 25%) and fewer had increasing values. More women had stable HbA1c and fewer had increasing values (30% vs. 37%). In men, no significant changes were observed.
    UNASSIGNED: This real-world analysis shows no detrimental consequences of the two first COVID years on weight and HbA1c in T1D on average, but reveals, beyond the mean trends, a greater variability at the individual level.
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  • 文章类型: Journal Article
    先进的混合闭环(AHCL)系统具有改善血糖并减轻1型糖尿病(T1D)患者负担的潜力。儿童和青年,特别容易发生血糖脱靶的人,可能会从AHCL中获得最大收益。然而,以前没有尝试专门针对HbA1c非常高的这一年龄组的随机对照试验(RCT).因此,CO-PILOT试验(在1型糖尿病和高风险血糖控制的儿童和青少年中的封闭式lOoP)旨在评估AHCL在该组中的疗效和安全性.
    预期,多中心,平行组,开放标签RCT,将MiniMed™780GAHCL与标准护理(每日多次注射或持续皮下胰岛素输注)进行比较。80名年龄在7-25岁的T1D参与者,a当前HbA1c≥8.5%(69mmol/mol),和幼稚的自动胰岛素输送将随机分配给AHCL或对照(标准护理)13周。主要结果是基线和13周之间的HbA1c变化。次要结果包括标准连续血糖监测血糖指标,社会心理因素,睡眠,平台性能,安全,和用户体验。此RCT之后将是一个持续阶段,控制臂交叉到AHCL,所有参与者再使用AHCL39周以评估长期结果。
    这项研究将评估AHCL在该人群中的疗效和安全性,并有可能证明AHCL是T1D患者血糖控制不达标和糖尿病负担相当大的儿童和青少年的金标准。
    该试验于2022年11月14日在澳大利亚新西兰临床试验注册中心(ACTRN12622001454763)和世界卫生组织国际临床试验注册平台(通用试验编号U1111-1284-8452)进行了前瞻性注册。
    在线版本包含补充材料,可在10.1007/s40200-024-01397-4获得。
    UNASSIGNED: Advanced hybrid closed loop (AHCL) systems have the potential to improve glycemia and reduce burden for people with type 1 diabetes (T1D). Children and youth, who are at particular risk for out-of-target glycemia, may have the most to gain from AHCL. However, no randomized controlled trial (RCT) specifically targeting this age group with very high HbA1c has previously been attempted. Therefore, the CO-PILOT trial (Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control) aims to evaluate the efficacy and safety of AHCL in this group.
    UNASSIGNED: A prospective, multicenter, parallel-group, open-label RCT, comparing MiniMed™ 780G AHCL to standard care (multiple daily injections or continuous subcutaneous insulin infusion). Eighty participants aged 7-25 years with T1D, a current HbA1c ≥ 8.5% (69 mmol/mol), and naïve to automated insulin delivery will be randomly allocated to AHCL or control (standard care) for 13 weeks. The primary outcome is change in HbA1c between baseline and 13 weeks. Secondary outcomes include standard continuous glucose monitor glycemic metrics, psychosocial factors, sleep, platform performance, safety, and user experience. This RCT will be followed by a continuation phase where the control arm crosses over to AHCL and all participants use AHCL for a further 39 weeks to assess longer term outcomes.
    UNASSIGNED: This study will evaluate the efficacy and safety of AHCL in this population and has the potential to demonstrate that AHCL is the gold standard for children and youth with T1D experiencing out-of-target glucose control and considerable diabetes burden.
    UNASSIGNED: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 November 2022 (ACTRN12622001454763) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1284-8452).
    UNASSIGNED: The online version contains supplementary material available at 10.1007/s40200-024-01397-4.
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