Use of Dose Safety Controller (DSC) Artificial Pancreas in Subjects with Hypoglycemia Unawareness

在无意识的低血糖受试者中使用剂量安全控制器 (DSC) 人工胰腺

• 批准号: 8823019
• 负责人: Richard Scott Mauseth
• 金额: $ 76.16万
• 依托单位: DOSE SAFETY COMPANY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8823019
• 关键词: Activities of Daily Living; Adoption; Algorithms; Applications Grants; Arrhythmia; Artificial Pancreas; Awareness; Behavior; Blood Glucose; Brain Death; Businesses; Cardiac; Chronic; Clinical Research; Clinical Trials; Cognition; Cognitive; Communication; Computer software; Devices; Diabetes Mellitus; Dose; Emotional; Engineering; Event; Exercise; Feasibility Studies; Food; Fright; Fuzzy Logic; Glucose; Goals; Health; Home environment; Hormones; Hospitals; Hour; Hypoglycemia; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Insurance; Ischemia; Lead; Location; Measurable; Measurement; Measures; Medical; Medical Device; Monitor; Morbidity - disease rate; Normal Range; Outpatients; Participant; Patient Outcomes Assessments; Patients; Performance; Persons; Prevention; Provider; Quality of life; Research; Research Institute; Risk; Running; Safety; Self Care; Signal Transduction; Symptoms; System; Testing; Time; Trauma; Visit; blood glucose regulation; cognitive function; design; emotional distress; experience; glycemic control; hypoglycemia unawareness; improved; mortality; programs; prototype; psychologic; public health relevance; response; restoration

 DESCRIPTION (provided by applicant): The objective of this project is to demonstrate that the Dose Safety Controller (DSC) improves the health and lives of persons with Type-1 diabetes (T1D) that have become unaware of hypoglycemia. This research aims to show that an artificial pancreas (AP) device using the DSC will 1) safely & effectively control blood glucose for T1D patients with hypoglycemic unawareness, 2) restore awareness of hypoglycemia & cognitive performance after 3 weeks and maintain awareness at 3 months and 3) improve the quality of life & emotional symptoms to the end of the study. This is accomplished through studies conducted at three locations: a) in a hospital clinical research center (CRC), b) in a guarded outpatient setting and c) in an unguarded outpatient setting at home. Five study scenarios will be used: 1) a 24-hour CRC study using the DSC with constant medical & engineering monitoring with controlled food & exercise, 2) followed for 3 weeks without use of the DSC on self-care to establish statistical control, 3) closely monitored for 3 days in a hotel using the DS, 4) followed for 18 days of guarded study at home using the DSC, 5) followed for the remainder of 3 months in an unguarded outpatient setting at home using the DCS. Through this progression it is expected that the DSC will automatically keep the participant's blood glucose level within near normal range, which is expected to restore the participant's awareness of the onset of hypoglycemia. Restoration of hormone response to low blood glucose will be tested using the hypoglycemia unawareness assessment (HUA) prior to use of the DSC at 3 weeks (end of study 2) at the end of the guarded study at home (study 4) and at 3 months (end of study 5). Patient Reported Outcomes and Cognitive Function will be assessed at the same times. It is expected that improved glucose control provided by the DSC will be reflected in increased awareness of the onset of hypoglycemia. The ultimate business goal of Dose Safety is the incorporation of the DSC software in a commercialized AP device. These studies could validate the use of an AP by a specific group of patients, which could lead to acceptance by the medical field and insurance companies of its use by those who have lost their awareness of hypoglycemia. It is expected that the successful completion of these studies will validate the use of the DSC software in subsequent pivotal trials of a prototype commercial AP device.

 描述（由申请人提供）：该项目的目标是证明剂量安全控制器 (DSC) 可以改善尚未意识到低血糖的 1 型糖尿病 (T1D) 患者的健康和生活。本研究旨在表明，使用 DSC 的人工胰腺 (AP) 装置将 1) 安全有效地控制无低血糖意识的 T1D 患者的血糖，2) 3 周后恢复低血糖意识和认知能力，并在 3 个月时保持意识，3) 改善生活质量和情绪症状直至研究结束。这是通过在三个地点进行的研究来完成的：a）在医院临床研究中心（CRC），b）在有人看守的门诊环境中，以及c）在无人看守的家中门诊环境中。将使用五种研究方案：1) 使用 DSC 进行 24 小时 CRC 研究，并持续进行医学和工程监测，并控制饮食和运动；2) 在自我保健方面不使用 DSC 进行 3 周的随访，以建立统计控制；3) 使用 DS 在酒店中密切监测 3 天；4) 使用 DSC 在家中进行 18 天的监护研究；5) 在家里无人看守的门诊环境中使用 DSC 进行剩下的 3 个月。 直流控制系统。通过这一进展，预计 DSC 将自动将参与者的血糖水平保持在接近正常范围内，这有望恢复参与者对低血糖发作的意识。在使用 DSC 之前，将在 3 周（研究 2 结束）、在家防护研究结束（研究 4）和 3 个月（研究 5 结束）时使用低血糖无意识评估 (HUA) 来测试激素对低血糖反应的恢复情况。患者报告的结果和认知功能将同时进行评估。预计 DSC 提供的血糖控制的改善将反映在对低血糖发生的认识的提高上。 Dose Safety 的最终业务目标是将 DSC 软件集成到商业化的 AP 设备中。这些研究可以验证特定患者群体对 AP 的使用情况，这可能会导致医疗领域和保险公司接受那些失去低血糖意识的患者使用 AP。预计这些研究的成功完成将验证 DSC 软件在原型商用 AP 设备的后续关键试验中的使用。