Network Control of Diabetes: Aligning Artificial Pancreas Design with Physiology

糖尿病的网络控制：使人工胰腺设计与生理学保持一致

• 批准号: 8641036
• 负责人: BORIS P KOVATCHEV
• 金额: $ 344.1万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8641036
• 关键词: 20 year old; Adolescent; Adult; Age; Algorithms; Architecture; Artificial Pancreas; Awareness; Behavior Therapy; Behavioral; Blood Glucose; Bolus Infusion; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Cognitive; Communication; Controlled Study; Data; Deposition; Deterioration; Development; Devices; Diabetes Mellitus; Disease; Dose; Elements; Endocrinology; Engineering; Ensure; Epinephrine; Exposure to; Family; Feedback; France; Frequencies; Fright; Glosso-Sterandryl; Glycosylated hemoglobin A; Health; Hospitals; Hypoglycemia; Incidence; Individual; Instruction; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Italy; Learning; Link; Measures; Medical; Medical Device; Metabolic Control; Modeling; Monitor; Operating System; Outpatients; Parents; Participant; Patients; Pattern; Perception; Persons; Philosophy; Physicians; Physiological; Physiological Processes; Physiology; Population; Population Study; Prevention; Process; Pump; Quality of life; Recording of previous events; Recruitment Activity; Relative (related person); Risk; Running; Safety; Services; Signal Transduction; Software Design; System; Systems Development; Technology; Telemedicine; Telephone; Testing; Time; Universities; Virginia; Work; aged; base; clinical practice; control trial; design; diabetes control; diabetes mellitus therapy; engineering design; flexibility; glycemic control; hypoglycemia unawareness; improved; indexing; operation; prevent; prototype; response; restoration; sensor; success; technology development

DESCRIPTION (provided by applicant): This project is an interdisciplinary and inter-institutional effort of physicians, mathematicians, and engineers from the University of Virginia (UVA) and Stanford University, dedicated to development and testing of a new network-control artificial pancreas (AP) concept: optimization of glycemia in type 1 diabetes by alignment of engineering control functions with physiologic and behavioral processes in a modular design. The vehicle for implementation of this concept into the clinical practice will be the Diabetes Assistant (DiAs) - the first [worldwide] smart-phone AP system used in outpatient closed-loop control (CLC) trials. DiAs combines local patient services (e.g. hypoglycemia prevention, advice, CLC), and global services (e.g. real-time remote monitoring, telemedicine). The system development will utilize 15 years of extensive theoretical work, CLC studies, behavioral interventions, and cutting-edge engineering designs. Nevertheless, our basic philosophy is straightforward: in order to be successful, CLC needs to include a robust safety system reducing the risk for hypoglycemia and control algorithms learning from each individual's daily behavioral and basal/bolus patterns. (1) Technology development will include: (i) Structural Software design, based on our prototype Medical Android operating system (deposited in FDA Master File 2109), and adding a system hypervisor to enable seamless co-execution of critical CLC functions together with other non-critical processes (e.g. normal smart phone operation); (ii) Alignment of Advisory and CLC Algorithms with key physiological processes by incorporating modules specific to prevention of hypoglycemia, behavioral optimization of basal/bolus profiles to reflect each patient's daily patterns; and real-time fine-tuning of insulin delivery to safely intensify treatment. (2) Clinical Trials will include: (i) Study 1 demonstrating reversal of hypoglycemia unawareness with CLC, which will result from 1-month use of our hypoglycemia-preventing Unified Safety System (USS Virginia); (ii) Study 2 deploying an Advisory System comprised of local and global advisory modules, which will optimize each person's daily basal/bolus profiles by matching them to individual behavioral patterns. (iii) Study 3 bringing together Safety, Advisory, and CLC modules into a comprehensive network-control system. Specifically: the USS will safeguard against hypoglycemia - the primary barrier to optimal diabetes control - thereby allowing intensified treatment by Fully-Integrated CLC, which will adjust insulin delivery to fine-tune each person's behaviorally-optimized profile. The DiAs technology will be primarily developed by the UVA team. All clinical studies will be carried out in parallel at UVA (focusing on adult patients) and Stanford (focusing on pediatric population). Ultimately, this project will finalize and test extensively a modular portable AP system, making it ready for clinical deployment.

DESCRIPTION (provided by applicant): This project is an interdisciplinary and inter-institutional effort of physicians, mathematicians, and engineers from the University of Virginia (UVA) and Stanford University, dedicated to development and testing of a new network-control artificial pancreas (AP) concept: optimization of glycemia in type 1 diabetes by alignment of engineering control functions with physiologic and behavioral processes in a模块化设计。将此概念实施到临床实践中的工具将是糖尿病助理（DIAS） - 门诊闭环控制（CLC）试验中使用的第一个[全球]智能手机AP系统。 DIAS结合了当地患者服务（例如预防低血糖症，建议，CLC）和全球服务（例如实时远程监控，远程医疗）。系统开发将利用15年的广泛理论工作，CLC研究，行为干预和尖端的工程设计。但是，我们的基本理念很简单：为了成功，CLC需要包括一个可靠的安全系统，以降低低血糖的风险和控制算法从每个人的日常行为和基础/大量大型模式中学习。 （1）技术开发将包括：（i）基于我们的原型医疗Android操作系统（存放在FDA Master File 2109中）的结构软件设计，并添加系统管理程序以启用关键CLC功能的无缝共同执行以及其他非批评过程（例如，正常智能手机操作）； （ii）通过纳入预防低血糖症的模块，基础/注射概况的行为优化，以反映每个患者的日常模式，将咨询和CLC算法与关键生理过程的比对与关键的生理过程进行比对；以及对胰岛素递送的实时微调以安全加强治疗。 （2）临床试验将包括：（i）研究1证明CLC不认识低血糖的逆转，这将归因于1个月使用我们的低血糖统一安全系统（USS Virginia）； （ii）研究2部署由本地和全球咨询模块组成的咨询系统，该系统将通过将它们与个体行为模式匹配，从而优化每个人的每日基础/注射材料。 （iii）研究3将安全，咨询和CLC模块汇总到一个全面的网络控制系统中。具体来说：USS将保护低血糖 - 最佳糖尿病控制的主要障碍 - 从而可以通过完全集成的CLC进行加强治疗，这将调整胰岛素的递送以微调每个人的行为型在行为上精选的特征。 DIAS技术将主要由UVA团队开发。所有临床研究将在 在UVA（专注于成年患者）和斯坦福大学（专注于小儿种群）的平行线。最终，该项目将最终确定和测试一个模块化便携式AP系统，使其成为 准备临床部署。