Final clinical studies for submission of a pre-market approval application to the FDA for a Bionic Pancreas that automates type 1 diabetes management

向 FDA 提交自动 1 型糖尿病管理仿生胰腺上市前批准申请的最终临床研究

• 批准号: 9055080
• 负责人: ROY W. BECK
• 金额: $ 149.83万
• 依托单位: BOSTON UNIVERSITY (CHARLES RIVER CAMPUS)
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-30 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9055080
• 关键词: 13 year old; Adolescent; Adult; Age; Algorithms; Behavioral; Bionics; Blinded; Blood Glucose; Blood specimen; Boston; CCL4 gene; Camping; Caring; Cellular Phone; Child; Chronic; Clinic; Clinic Visits; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Colorado; Computer software; Cross-Over Studies; Data; Devices; Diabetes Mellitus; Diabetic Ketoacidosis; Dose; Elderly; Enrollment; Evaluation; Exercise; Exposure to; Feasibility Studies; General Hospitals; Geographic Locations; Glucagon; Glucose; Glycosylated hemoglobin A; Goals; Health; Home environment; Human; Hypoglycemia; Incentives; Infusion Pumps; Infusion procedures; Inpatients; Insulin; Insulin-Dependent Diabetes Mellitus; Lead; Marketing; Massachusetts; Measurement; Medical Device; Medical center; Monitor; North Carolina; Outcome; Outpatients; Pancreas; Qualifying; Questionnaires; Randomized; Relative (related person); Reporting; Research; Research Design; Risk; Safety; Scheme; Site; Solutions; System; Technology; Testing; Therapeutic; Universities; Workplace; age group; base; clinical research site; cohort; design; diabetes management; diabetes mellitus therapy; glucose monitor; improved; laptop; prevent; primary outcome; psychosocial; public health relevance; safety testing; sample collection; sensor; treatment as usual; usability

 DESCRIPTION (provided by applicant): We have built and extensively tested our bihormonal bionic pancreas (BP) in inpatient and real-world outpatient studies in subjects with type 1 diabetes (T1D). Through an eight-year collaboration between Boston University (BU) and the Massachusetts General Hospital (MGH), we have completed three 1- and 2-day inpatient studies testing a laptop version of the BP and three 5-day outpatient studies testing an iPhone version of the BP in adults with T1D (in downtown Boston), adolescents with T1D (in a diabetes camp), and pre-adolescents with T1D (in a diabetes camp). In collaboration among BU, MGH, the University of Massachusetts Medical Center, Stanford University, and the University of North Carolina, Chapel Hill, we completed an 11-day Bionic Pancreas Multi-Center outpatient study in adults with T1D testing the iPhone version of the BP at home and in the workplace without restrictions on activity or exercise. We have recently built a new bihormonal BP device platform in accordance with Class III medical device standards that integrates a microprecision dual-infusion pump that (1) separately delivers insulin and glucagon, (2) acts as a receiver for an FDA-cleared continuous glucose monitor (CGM), and (3) includes our clinically tested suite of mathematical control algorithms that autonomously determines and commands doses of insulin and glucagon based on CGM glucose data. This new device platform provides a turnkey solution that will standardize, simplify, and improve T1D therapy. Here we propose to conduct the Bionic Pancreas Pivotal Trial (BPPT), which will enroll 480 children and adults with T1D (ages 8 and older, HbA1c <11%) to test and qualify the fully integrated version of the BP and to provide all of the clinical data necessary for a pre-market approval (PMA) application to the FDA. We propose to achieve this objective with the following specific aims: (1) to evaluate the usability of the BP in a human factors study, to refine the device and user interface, if necessary, based on the study results, and to qualify its functionality in a small outpatient feasibility study (the Bionic Pancreas Bridging Study); and (2) to conduct the BPPT to test the safety and efficacy of the final BP system in controlling glycemia (with co-primary outcomes of HbA1c and percentage of CGM glucose measurements < 60 mg/dl), to evaluate the behavioral and psychosocial impact of our technology relative to usual care, and to provide data on the safety of chronic glucagon administration sufficient for a new use indication for this device.

 描述（由申请人提供）：我们已经在 1 型糖尿病 (T1D) 受试者的住院和现实门诊研究中建立并广泛测试了我们的双激素仿生胰腺 (BP)。通过波士顿大学 (BU) 和马萨诸塞州总医院 (MGH) 之间长达八年的合作，我们完成了三项为期 1 天和 2 天的住院研究，测试笔记本电脑版本的 BP 和三项为期 5 天的门诊研究，测试 iPhone 版本的 BP，对象包括成人 T1D（在波士顿市中心）、患有 T1D 的青少年（在糖尿病营）和青春期前的患者。 T1D（在糖尿病营中）。我们与波士顿大学、麻省总医院、马萨诸塞大学医学中心、斯坦福大学和北卡罗来纳大学教堂山分校合作，完成了一项为期 11 天的仿生胰腺多中心门诊研究，对象是患有 T1D 的成人，在家中和工作场所测试 iPhone 版血压计，不限制活动或锻炼。我们最近根据 III 类医疗设备标准构建了一个新的双激素血压设备平台，该平台集成了微精密双输液泵，该泵 (1) 分别输送胰岛素和胰高血糖素，(2) 充当 FDA 批准的连续血糖监测仪 (CGM) 的接收器，(3) 包括我们经过临床测试的数学控制算法套件，可自主确定和命令剂量 基于 CGM 葡萄糖数据的胰岛素和胰高血糖素。这个新的设备平台提供了一个交钥匙解决方案，将标准化、简化和改进 T1D 治疗。在这里，我们建议进行仿生胰腺关键试验 (BPPT)，该试验将招募 480 名患有 T1D 的儿童和成人（8 岁及以上，HbA1c <11%）来测试和鉴定完全集成版本的 BP，并向 FDA 提供上市前批准 (PMA) 申请所需的所有临床数据。我们建议通过以下具体目标来实现这一目标：（1）评估 BP 在人为因素研究中的可用性，如有必要，根据研究结果改进设备和用户界面，并在小型门诊可行性研究（仿生胰腺桥接研究）中验证其功能； (2) 进行 BPPT 来测试最终 BP 系统在控制血糖方面的安全性和有效性（共同主要结果是 HbA1c 和 CGM 血糖测量百分比 < 60 mg/dl），评估我们的技术相对于常规护理的行为和心理社会影响，并提供足以用于新的长期胰高血糖素管理安全性的数据。 该设备的使用指示。