hybrid closed loop

混合闭环
  • 文章类型: Journal Article
    与围绕计划和自发运动管理葡萄糖水平相关的挑战和恐惧会影响1型糖尿病患者的结果和生活质量。技术的进步,包括连续血糖监测,用于1型糖尿病运动管理的开环胰岛素泵治疗和混合闭环(HCL)系统,解决其中一些挑战。在这次审查中,三名研究或临床专家,每个人都患有1型糖尿病,利用已发表的文献、临床和个人经验,将研究结果转化为简化,以患者为中心的战略。了解胰岛素药代动力学的局限性,个体对有氧运动和无氧运动的不同反应,以及技术的特点,提出了六个步骤来指导临床医生有效地将简化的操作更有效地传达给1型糖尿病患者.从根本上说,六个步骤集中在两个方面。首先,无论胰岛素治疗类型,特别是自发运动所需要的,我们提供了葡萄糖进入活动肌肉的估计值,这些活动肌肉打算作为额外的碳水化合物消耗用于运动(\'ExCarbs\';一个常见的例子是成人每小时0.5g/kg体重,青年每小时1.0g/kg体重)。第二,对于使用开环泵治疗或HCL系统的计划锻炼,我们还建议在运动开始前90分钟(1-2小时)开始使用先发制人的基础胰岛素减少或使用HCL运动模式,直至运动结束.讨论了有氧运动和无氧运动的修改。先发制人的基础胰岛素减少和ExCarbs消耗的负担是HCL系统的局限性,这可能会被未来的创新所克服,但无疑是当前可用系统所必需的。
    Challenges and fears related to managing glucose levels around planned and spontaneous exercise affect outcomes and quality of life in people living with type 1 diabetes. Advances in technology, including continuous glucose monitoring, open-loop insulin pump therapy and hybrid closed-loop (HCL) systems for exercise management in type 1 diabetes, address some of these challenges. In this review, three research or clinical experts, each living with type 1 diabetes, leverage published literature and clinical and personal experiences to translate research findings into simplified, patient-centred strategies. With an understanding of limitations in insulin pharmacokinetics, variable intra-individual responses to aerobic and anaerobic exercise, and the features of the technologies, six steps are proposed to guide clinicians in efficiently communicating simplified actions more effectively to individuals with type 1 diabetes. Fundamentally, the six steps centre on two aspects. First, regardless of insulin therapy type, and especially needed for spontaneous exercise, we provide an estimate of glucose disposal into active muscle meant to be consumed as extra carbohydrates for exercise (\'ExCarbs\'; a common example is 0.5 g/kg body mass per hour for adults and 1.0 g/kg body mass per hour for youth). Second, for planned exercise using open-loop pump therapy or HCL systems, we additionally recommend pre-emptive basal insulin reduction or using HCL exercise modes initiated 90 min (1-2 h) before the start of exercise until the end of exercise. Modifications for aerobic- and anaerobic-type exercise are discussed. The burden of pre-emptive basal insulin reductions and consumption of ExCarbs are the limitations of HCL systems, which may be overcome by future innovations but are unquestionably required for currently available systems.
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  • 文章类型: Case Reports
    在肠内营养的糖尿病患者中,血糖管理的实现具有挑战性。在这种情况下,关于混合闭环系统的功效的文献有限。我们描述了1例1型糖尿病患者通过先进的混合闭环肠内营养治疗,血糖管理令人满意。
    The achievement of glycemic management is challenging in patients with diabetes on enteral nutrition, limited literature exists on hybrid closed-loop systems\' efficacy in such a situation. We described the case of a patient with type 1 diabetes treated by advanced hybrid closed loop on enteral nutrition with satisfactory glycemic management.
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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: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    这篇叙述性综述评估了自动胰岛素输送(AID)系统在儿科人群中管理1型糖尿病(PWD)患者中的使用。它概述了当前的研究,目前市场上各种AID系统之间的差异和面临的挑战,并讨论了该领域进一步发展的潜在机会。此外,叙述性综述包括各种专家意见,内容涉及在胰岛素需求快速变化的挑战中如何使用不同的AID系统.这些包括例子,例如在胰岛素需求增加或减少的疾病期间以及在不同强度或持续时间的身体活动期间。案例描述给出了根据所使用的AID系统类型添加用户启动操作的场景示例。作者还讨论了在这些情况下如何使用另一个AID系统。
    This narrative review assesses the use of automated insulin delivery (AID) systems in managing persons with type 1 diabetes (PWD) in the pediatric population. It outlines current research, the differences between various AID systems currently on the market and the challenges faced, and discusses potential opportunities for further advancements within this field. Furthermore, the narrative review includes various expert opinions on how different AID systems can be used in the event of challenges with rapidly changing insulin requirements. These include examples, such as during illness with increased or decreased insulin requirements and during physical activity of different intensities or durations. Case descriptions give examples of scenarios with added user-initiated actions depending on the type of AID system used. The authors also discuss how another AID system could have been used in these situations.
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  • 文章类型: Journal Article
    在过去的十年里,糖尿病患者及其亲人开发的技术增加了糖尿病管理的选择。一个这样的例子是自动胰岛素输送(AID)算法的例子。这是在商业系统首次可用之前,由1型糖尿病(T1D)患者作为开源创建和共享的。现在,在一些国家存在许多商业系统的选择,然而,成千上万的糖尿病患者仍在选择开源AID(OS-AID),以前称为“自己动手”(DIY)系统,它们是这些开源AID系统的非商业版本。在这篇文章中,我们提供关于1)安全性和有效性的观点和对立面观点;2)监管和支持;3)用户选择和灵活性;4)访问和负担能力,和5)患者和提供者教育,用于开源和商业AID系统。这里反映的观点包括一个生活在T1D中的人使用并开发了OS-AID系统,一位在美国进行临床试验以支持商业AID系统的开发,并支持糖尿病患者使用所有类型的AID,和T1D的内分泌学家使用两种系统并使用所有类型的AID治疗糖尿病患者。
    In the last decade, technology developed by people with diabetes and their loved ones has added to the options for diabetes management. One such example is that of automated insulin delivery (AID) algorithms, which were created and shared as open source by people living with type 1 diabetes (T1D) years before commercial systems were first available. Now, numerous options for commercial systems exist in some countries, yet tens of thousands of people with diabetes are still choosing Open-Source AID (OS-AID), previously called \"do-it-yourself\" (DIY) systems, which are noncommercial versions of these open-source AID systems. In this article, we provide point and counterpoint perspectives regarding (1) safety and efficacy, (2) regulation and support, (3) user choice and flexibility, (4) access and affordability, and (5) patient and provider education, for open source and commercial AID systems. The perspectives reflected here include that of a person living with T1D who uses and has developed OS-AID systems, a physician-researcher based in the United States who conducts clinical trials to support development of commercial AID systems and supports people with diabetes using all types of AID, and an endocrinologist with T1D who uses both systems and treats people with diabetes using all types of AID.
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  • 文章类型: Journal Article
    临床试验证明了混合闭环(HCL)系统的有效性和安全性,然而,很少有研究比较现实世界中的结果。
    这项回顾性研究分析了2018年1月1日至2022年11月18日期间学术内分泌学实践的患者。纳入标准为I型糖尿病(T1D)的诊断代码,>18岁,任何HCL系统的新功能[美敦力670G/770G(MT),串联控制IQ(CIQ),或Omnipod5(OP5)],并在三个月内下载泵。结果包括70至180毫克/分升范围内的时间百分比(TIR),在90天时低于范围(TBR)<70mg/dL的时间百分比,和HbA1c91至180天。
    在176名参与者中,47是MT,74CIQ,55OP5。中位数(25%,75%)HbA1c变化为-0.1(-0.8,0.3),-0.6(-1.1,-0.15),MT为-0.55(-0.98,0)%,CIQ,和OP5,分别(P=.04)。TIR为70(57,76),67(59,75),和68(60,76)%(P=.95)在90天,而TBR为2(1,3),1(0,2),和1(0,1)%,分别,(P=.002)。自动递送时间%与TIR和HbA1c变化相关。在控制其他因素(包括自动交付时间百分比)之后,HCL类型不是HbA1c或TIR变化的独立预测因子,但仍然是TBR的重要预测因子。
    在CIQ和OP5中HbA1c显著降低。不同泵的TIR相似,但MT的TBR最高。自动递送的%时间可能解释了HbA1c变化的差异,但不能解释HCL系统之间的TBR变化。
    UNASSIGNED: Clinical trials have demonstrated the efficacy and safety of hybrid closed-loop (HCL) systems, yet few studies have compared outcomes in the real-world setting.
    UNASSIGNED: This retrospective study analyzed patients from an academic endocrinology practice between January 1, 2018, and November 18, 2022. The inclusion criteria were diagnosis code for type I diabetes (T1D), >18 years of age, new to any HCL system [Medtronic 670G/770G (MT), Tandem Control IQ (CIQ), or Omnipod 5 (OP5)], and availability of a pump download within three months. The outcomes included %time in range (TIR) of 70 to 180 mg/dL, %time below range (TBR) <70 mg/dL at 90 days, and HbA1c for 91 to 180 days.
    UNASSIGNED: Of the 176 participants, 47 were MT, 74 CIQ, and 55 OP5. Median (25%, 75%) change in HbA1c was -0.1 (-0.8, 0.3), -0.6 (-1.1, -0.15), and -0.55 (-0.98, 0)% for MT, CIQ, and OP5, respectively, (P = .04). TIR was 70 (57, 76), 67 (59, 75), and 68 (60, 76)% (P = .95) at 90 days while TBR was 2 (1, 3), 1 (0, 2), and 1 (0, 1)%, respectively, (P = .002). The %time in automated delivery was associated with TIR and change in HbA1c. After controlling other factors including %time in automated delivery, HCL type was not an independent predictor of change in HbA1c nor TIR but remained a significant predictor of TBR.
    UNASSIGNED: There were significant reductions in HbA1c in CIQ and OP5. TIR was similar across pumps, but TBR was highest with MT. The %time in automated delivery likely explains differences in change in HbA1c but not TBR between HCL systems.
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  • 文章类型: Journal Article
    目的:调查2至6岁儿童3个月自动胰岛素给药(AID)对血糖结局的积极影响是否持续了很长时间,以及AID治疗如何影响紧范围内的时间(TITR)。定义为3.9-7.8mmol/L
    方法:我们分析了18个月的非随机随访数据,prospective,2021年至2023年进行的单臂临床试验(n=35)。主要结果指标是时间范围(TIR)的变化,糖化血红蛋白(HbA1c),高于范围的时间(TAR),TITR,和平均传感器葡萄糖(SG)值在随访期间(0,6,12和18个月)。SmartGuard模式下的MiniMed780GAID系统使用了18个月。父母的糖尿病困扰在3个月和18个月与糖尿病父母的验证问题区域进行评估,修订(PAID-PR)调查。
    结果:在0到6个月之间,TIR和TITR增加,和HbA1c,平均SG值和TAR显著下降(p<0.001);随访18个月后,该良好效果持续.在3到18个月之间,PAID-PR评分显著下降(0个月:平均评分37.5;3个月:平均评分28.6[p=0.06];18个月:平均评分24.6[p<0.001])。
    结论:AID治疗可显著增加幼儿的TITR和TIR。6个月后观察到的AID对血糖控制的积极作用持续了18个月的随访。同样,在18个月的随访期间,父母的糖尿病困扰仍然减轻.这些发现令人放心,并表明在延长的18个月随访中,AID治疗可以改善幼儿的血糖控制并减少父母的糖尿病困扰。
    OBJECTIVE: To investigate whether the positive effects on glycaemic outcomes of 3-month automated insulin delivery (AID) achieved in 2- to 6-year-old children endure over an extended duration and how AID treatment affects time in tight range (TITR), defined as 3.9-7.8 mmol/L.
    METHODS: We analysed 18 months of follow-up data from a non-randomized, prospective, single-arm clinical trial (n = 35) conducted between 2021 and 2023. The main outcome measures were changes in time in range (TIR), glycated haemoglobin (HbA1c), time above range (TAR), TITR, and mean sensor glucose (SG) value during follow-up visits (at 0, 6, 12 and 18 months). The MiniMed 780G AID system in SmartGuard Mode was used for 18 months. Parental diabetes distress was evaluated at 3 and 18 months with the validated Problem Areas in Diabetes-Parent, revised (PAID-PR) survey.
    RESULTS: Between 0 and 6 months, TIR and TITR increased, and HbA1c, mean SG value and TAR decreased significantly (p < 0.001); the favourable effect persisted through 18 months of follow-up. Between 3 and 18 months, PAID-PR score declined significantly (0 months: mean score 37.5; 3 months: mean score 28.6 [p = 0.06]; 18 months: mean score 24.6 [p < 0.001]).
    CONCLUSIONS: Treatment with AID significantly increased TITR and TIR in young children. The positive effect of AID on glycaemic control observed after 6 months persisted throughout the 18 months of follow-up. Similarly, parental diabetes distress remained reduced during 18 months follow-up. These findings are reassuring and suggest that AID treatment improves glycaemic control and reduces parental diabetes distress in young children over an extended 18-month follow-up.
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  • 文章类型: Journal Article
    目的:比较使用混合闭环(HCL)与每日多次胰岛素注射(MDI)加连续血糖监测的1型糖尿病(T1D)妇女的血糖控制和母婴结局。方法:西班牙T1D孕妇的多中心前瞻性队列研究。我们评估了HbA1c和在(TIR)内花费的时间,下面(TBR),和以上(TAR),妊娠特异性葡萄糖范围为3.5-7.8mmol/L。调整后的模型用于不良妊娠结局,包括基线产妇特征和中心。结果:112名妇女被纳入(HCLn=59)。HCL组的女性患糖尿病的时间更长,孕前护理的发生率更高。在所有三个月中,HbA1c没有组间差异。然而,在妊娠中期,MDI用户的HbA1c下降幅度更大(-6.12±9.06与-2.16±7.42mmol/mol,P=0.031)。HCL和MDI使用者之间的TIR(3.5-7.8mmol/L)和TAR没有差异,但妊娠中期总胰岛素剂量较高[+0.13IU/kg·day)]。HCL治疗与怀孕期间母亲体重增加增加相关(β调整=3.20kg,95%置信区间[CI]0.90-5.50)。关于新生儿结局,HCL使用者的新生儿更有可能有更高的出生体重(β调整=279.0克,与MDI使用者相比,95%CI39.5-518.5)和巨大儿(OR调整=3.18,95%CI1.05-9.67)。当模型中包括母体体重增加或妊娠晚期HbA1c时,这些关联消失了。结论:在现实世界中,HCL使用者在怀孕期间体重增加,新生儿比MDI使用者大,同时在HbA1c和TIR方面实现相似的血糖控制。
    Aims: To compare glycemic control and maternal-fetal outcomes of women with type 1 diabetes (T1D) using hybrid closed loop (HCL) versus multiple daily insulin injections (MDI) plus continuous glucose monitoring. Methods: Multicenter prospective cohort study of pregnant women with T1D in Spain. We evaluated HbA1c and time spent within (TIR), below (TBR), and above (TAR) the pregnancy-specific glucose range of 3.5-7.8 mmol/L. Adjusted models were performed for adverse pregnancy outcomes, including baseline maternal characteristics and center. Results: One hundred twelve women were included (HCL n = 59). Women in the HCL group had a longer duration of diabetes and higher rates of prepregnancy care. There was no between-group difference in HbA1c in any trimester. However, in the second trimester, MDI users had a greater decrease in HbA1c (-6.12 ± 9.06 vs. -2.16 ± 7.42 mmol/mol, P = 0.031). No difference in TIR (3.5-7.8 mmol/L) and TAR was observed between HCL and MDI users, but with a higher total insulin dose in the second trimester [+0.13 IU/kg·day)]. HCL therapy was associated with increased maternal weight gain during pregnancy (βadjusted = 3.20 kg, 95% confidence interval [CI] 0.90-5.50). Regarding neonatal outcomes, newborns of HCL users were more likely to have higher birthweight (βadjusted = 279.0 g, 95% CI 39.5-518.5) and macrosomia (ORadjusted = 3.18, 95% CI 1.05-9.67) compared to MDI users. These associations disappeared when maternal weight gain or third trimester HbA1c was included in the models. Conclusions: In a real-world setting, HCL users gained more weight during pregnancy and had larger newborns than MDI users, while achieving similar glycemic control in terms of HbA1c and TIR.
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  • 文章类型: Journal Article
    在临床实践中引入连续葡萄糖监测(CGM)系统可以更详细地了解1型糖尿病(T1D)患者的每日和每日血糖波动。然而,CGM测量的葡萄糖控制指标有时可能不准确。这项研究旨在评估T1D儿童和青少年队列中葡萄糖管理指标(GMI)和糖化血红蛋白(HbA1c)(ΔGMI-HbA1c)之间的差异。探讨其与其他CGM指标和血细胞计数参数的相关性。在这个单一中心,横断面研究,我们收集了人口统计学和临床数据,包括血细胞计数参数,HbA1c值,和CGM指标,来自128名患有T1D的儿科受试者(43%为女性;平均年龄,13.4±3.6年)。我们的发现显示,在ΔGMI-HbA1c>0.3%的受试者中,变异系数(CV)(p<0.001)和超过250mg/dL(p=0.033)的时间较高。在血细胞计数参数和ΔGMI-HbA1c之间没有观察到相关性。总之,尽管CGM系统取得了进步和广泛采用,HbA1c仍然是评估血糖控制的重要参数,特别是在代谢控制欠佳和血糖变异性极高的个体中。
    The introduction of continuous glucose monitoring (CGM) systems in clinical practice has allowed a more detailed picture of the intra- and interdaily glycemic fluctuations of individuals with type 1 diabetes (T1D). However, CGM-measured glucose control indicators may be occasionally inaccurate. This study aims to assess the discrepancy between the glucose management indicator (GMI) and glycated hemoglobin (HbA1c) (ΔGMI-HbA1c) within a cohort of children and adolescents with T1D, exploring its correlation with other CGM metrics and blood count parameters. In this single-center, cross-sectional study, we gathered demographic and clinical data, including blood count parameters, HbA1c values, and CGM metrics, from 128 pediatric subjects with T1D (43% female; mean age, 13.4 ± 3.6 years). Our findings revealed higher levels of the coefficient of variation (CV) (p < 0.001) and time above range > 250 mg/dL (p = 0.033) among subjects with ΔGMI-HbA1c > 0.3%. No association was observed between blood count parameters and ΔGMI-HbA1c. In conclusion, despite the advancements and the widespread adoption of CGM systems, HbA1c remains an essential parameter for the assessment of glycemic control, especially in individuals with suboptimal metabolic control and extreme glycemic variability.
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