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（由适用提供）：我们已经在患有1型糖尿病（T1D）的受试者的住院和现实门诊研究中构建并广泛测试了我们的生物荷尔群化繁殖胰腺（BP）。 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（在糖尿病营地）。在BU，MGH，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的合作中，我们完成了一项为期11天的bionic胰腺胰腺多中心门诊在成人中，T1D在家庭中和工作场所的iPhone iPhone版本中，无需进行活动或运动的限制。最近，我们根据III类医疗设备标准建立了一个新的生物轴向BP设备平台，该标准整合了一个微精制双输入泵，（（1）（1）单独提供胰岛素和胰高血糖素，（2）作为FDA被清除的连续葡萄糖监测器（CGM）的接收器，包括我们的临床上的Algities Algities，（3）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，该解决方案将标准化，简化和改善T1D疗法。在这里，我们建议进行bionic胰腺体育蛋白pivotal试验（BPPT），该试验将招募480名具有T1D的儿童和成人（8岁及8岁以上，HBA1C <11％），以测试BP的完全集成版本，并提供所有临床数据，以提供所有临床数据，以便（PMA）对FDA进行批准（PMA）应用。我们建议通过以下特定目的实现这一目标：（1）根据研究结果评估人体因素研究中BP的可用性，以根据研究结果来修复设备和用户界面，并在小型门诊可行性研究（Bionic Pancreas Pancreas Bridging研究）中鉴定其功能。 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 glu​​cose 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 glycagon administration sufficient for a该设备的新使用指示。