Closed-Loop Control Modalities in Type 1 Diabetes: Efficacy and System Acceptance

1 型糖尿病的闭环控制方式：功效和系统接受度

• 批准号: 8878487
• 负责人: BORIS P KOVATCHEV
• 金额: $ 69.9万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8878487
• 关键词: Address; Advocate; Algorithms; Artificial Pancreas; Blood Glucose; Bolus Infusion; Cellular Phone; Circadian Rhythms; Clinical; Clinical Trials; Companions; Cross-Over Trials; Data; Deterioration; Devices; Diabetes Mellitus; Ecosystem; Engineering; Enrollment; Equilibrium; Europe; Exercise; Focus Groups; Fright; Future; Genetic Crossing Over; Glucose; Glycosylated hemoglobin A; Goals; Group Interviews; Hour; Hyperglycemia; Hypoglycemia; Incidence; Inferior; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Interruption; Lead; Longitudinal Studies; Measures; Metabolic; Modality; Monitor; Outcome; Outpatients; Participant; Patients; Persons; Pilot Projects; Pump; Quality of life; Randomized; Recording of previous events; Research; Research Design; Risk; Running; Safety; Scheme; Sleep; Slide; System; Technology; Testing; Therapeutic; Time; United States National Institutes of Health; Virginia; Work; base; blood glucose regulation; design; diabetes mellitus therapy; digital; efficacy testing; engineering design; glucose monitor; glycemic control; hypoglycemia unawareness; improved; indexing; new technology; operation; preference; prevent; public health relevance; research clinical testing; sensor

 DESCRIPTION (provided by applicant): Closed-Loop Control Modalities in Type 1 Diabetes: Efficacy and System Acceptance In 2009 we initiated one of the first NIH studies dedicated to engineering and clinical testing of closed-loop control (CLC) of type 1 diabetes. Since then, we have achieved key milestones and derived conclusions which enabled further research in this rapidly growing field. Notably, we proposed the idea that the artificial pancreas is not a single all-in-one device but a network encompassing the patient in a digital treatment ecosystem that can offer and alter different treatment modalities in real time depending on the patient's clinical state. This new notion was reflected in: (1) Our modular engineering design of CLC algorithms, which now allows various treatment modalities to be initiated and swapped without interruption; (2) The Diabetes Assistant (DiAs) - the first portable CLC hub using a smart phone to run control algorithms and specifically designed to be operated by the patient, which is now used in a number of outpatient studies in the U.S. and in Europe, and (3) The Unified Safety System (USS Virginia) - the first CLC algorithm engineered to adapt its mode of operation during the course of every night, first mitigating after-dinner hyperglycemia and then sliding the patient to a target morning glucose of 120mg/dl, thereby resetting his/her metabolic state for a new day. Using these technologies, we now propose to compare in a randomized cross-over trial the long-term efficacy of three treatment modalities - sensor-augmented pump (SAP) vs. USS+SAP during the day(d) vs. USS+CLC(d). We plan to randomize 84 patients with type 1 diabetes into two different treatment sequences: SAP,USS+SAP(d),USS+CLC(d),USS+SAP(d) and USS+SAP(d),USS+CLC(d),USS+SAP(d),SAP. Each treatment modality will continue for 2 months - sufficient time to address the following specific aims: SA1: Overnight CLC achieved by USS+SAP(d) will be superior to SAP alone in terms of: (1) Improved HbA1c without increasing the risk for hypoglycemia; (2) Reduced incidence and risk for hypoglycemia overnight, and (3) Reduced fear of hypoglycemia and improved diabetes quality of life scores. SA2: CLC during the day achieved by USS+CLC(d) will preserve the benefits of USS+SAP(d) and will be superior to USS+SAP(d) in terms of: (1) Increased time within target range of 70-180mg/dl during the day; (2) Reduced risk for hypoglycemia during and after exercise, and (3) Reduced postprandial glucose variability. SA3: CLC system acceptance evaluated by focus-group interviews and technology acceptance scores will be: (1) Superior, for USS+SAP(d) compared to SAP alone, i.e. adding USS overnight will increase patients' acceptance of CLC, and (2) Marginally inferior, for USS+CLC(d) compared to USS+SAP(d); i.e. some patients would prefer SAP alone during the day due to perceived increased system complexity. Overall, we expect to establish that a distinct overnight CLC modality (USS Virginia) combined with SAP therapy during the day is a viable precursor to future adaptable therapeutic schemes, achieving glycemic control that is superior to SAP alone and optimal balance between system complexity and perceived benefits.

 描述（由适用提供）：1型糖尿病中的闭环控制方式：2009年的功效和系统接受度，我们启动了最早的NIH研究之一，该研究致力于1型糖尿病的闭环控制（CLC）的工程和临床测试。从那以后，我们实现了关键的里程碑并得出结论，这使得在这个快速增长的领域中进行了进一步的研究。值得注意的是，我们提出了一个想法，即人造胰腺不是一个多合一的设备，而是一个网络，包括数字治疗生态系统中患者的网络，可以实时提供和改变不同的治疗方式 状态。这个新的概念反映在：（1）我们的CLC算法的模块化工程设计，现在允许在不中断的情况下启动和交换各种治疗方式； （2）糖尿病助手（DIAS） - 使用智能手机运行控制算法的第一个便携式CLC集线器，并专门设计为患者操作，该算法现已用于美国和欧洲的许多门诊研究中，以及（3） 统一安全系统（USS Virginia） - 第一个设计用于在每晚进行调整其操作模式的第一个CLC算法，首先减轻饮料后高血糖，然后将患者滑到目标的早晨葡萄糖为120mg/dl，从而使他/她的代谢状态重新确定新的一天。使用这些技术，我们现在建议在一项随机交叉试验中比较三种治疗方式的长期有效性 - 传感器增强泵（SAP）与uss+SAP（d）与USS+CLC（D）。我们计划将84例1型糖尿病患者随机分为两个不同的治疗序列：SAP，USS+SAP（D），USS+CLC（D），USS+SAP（D）和USS+SAP（D），USS+CLC（D），USS+SAP（D），SAP，SAP。每种治疗方式将持续2个月 - 足够的时间来解决以下特定目标：SA1：USS+SAP（D）实现的CLC过夜将优于SAP：（1）改善HBA1C而不会增加低血糖的风险； （2）一夜之间降低了低血糖的事件和风险，以及（3）减少对低血糖的恐惧和改善糖尿病的生活质量评分。 SA2：USS+CLC（d）实现的白天CLC将保留USS+SAP（D）的好处，并且在以下方面将优于USS+SAP（D）：（1）在目标范围内增加70-180mg/dl的时间； （2）降低运动过程中低血糖的风险，以及（3）餐后葡萄糖变异性降低。 SA3：通过焦点组访谈和技术接受评分评估的CLC系统接受度将是：（1）与单独使用SAP相比，对于USS+SAP（D），与单独的SAP相比，与USS+CLC（D）相比，与单独的SAP相比，与USS+SAP（D）相比，将USS添加为night over night over night of Night of Sap（d）；即，由于系统的复杂性增加，白天有些患者希望单独使用SAP。总体而言，我们希望确定在白天结合使用SAP治疗的独特的过夜CLC模态（USS Virginia）是可行的前体，是未来适应性的治疗方案的可行先驱，从而实现了单独使用SAP的血糖控制和系统复杂性和可感知的好处之间的最佳平衡。