Advanced Artificial Pancreas Systems to Enable Fully Automated Glycemic Control in Type 1 Diabetes Mellitus

先进的人工胰腺系统可实现 1 型糖尿病的全自动血糖控制

• 批准号: 10276560
• 负责人: MARC D BRETON
• 金额: $ 68.6万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-12 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10276560
• 关键词: Address; Adverse event; Algorithm Design; Algorithms; Architecture; Artificial Pancreas; Automation; Behavior; Blood Glucose; Bolus Infusion; Carbohydrates; Clinical; Clinical Research; Clinical Trials; Computer Simulation; Data; Databases; Deterioration; Devices; Diabetes Mellitus; Disease Management; Dose; Eating; Ecosystem; Exposure to; FDA approved; Formulation; Foundations; Glucose; Glycosylated hemoglobin A; Home; Hour; Hybrids; Hyperglycemia; Hypoglycemia; Insulin; Insulin-Dependent Diabetes Mellitus; Kinetics; Laws; Legal patent; Length; Manuals; Measures; Medical Device; Outcome; Outpatients; Participant; Patient Outcomes Assessments; Patients; Pattern; Pattern Recognition; Performance; Pilot Projects; Randomized; Randomized Controlled Trials; Research; Risk; Safety; Source; Speed; Supervision; System; Technology; Testing; Therapeutic; Time; Translations; Work; algorithm development; analog; attenuation; basal insulin; burden of illness; design; glycemic control; improved; in silico; indexing; novel; predictive modeling; satisfaction; subcutaneous; success; tool

PROJECT ABSTRACT Despite advancements in automated insulin delivery systems that demonstrate superior glycemic outcomes, challenging clinical issues remain with the continued need for accurate carbohydrate counting and meal announcement combined with slow-acting subcutaneous insulin that contribute to repeated occurrences of postprandial hyperglycemia. This clinical gap in glycemic control is addressed by the proposed project. We intend to leverage our existing advancements in pattern recognition and anticipation to refine and test a fully automated closed-loop system that does not require meal announcements. This system is unique in that it relies on pattern recognition, particularly surrounding meals, in an anticipatory manner so that insulin action is taken in advance of an expected meal rather than the predominantly reactive solutions that are often proposed. We intend to further test and tune this system within the context of accelerated insulins to further improve glycemic outcomes and remove barriers to use of these systems by lowering burden of disease management. We have already developed the foundational tools needed for a fully automated closed-loop and will plan for further refinement by leveraging data from our accumulated clinical studies database. We plan to conduct 2 pilots studies followed by a larger, 7-month main study to evaluate the following specific aims of this proposal: 1) We hypothesize that novel faster acting insulin analogs can be safely used to provide more effective fully automated closed-loop control. Our first pilot will test the differences between Fiasp and a novel formulation of aspart (AT247) in a supervised trial. This trial results will inform the selection of the insulin used in the subsequent trials. 2) We hypothesize that, with a design adapted to these new insulin formulations, fully automated closed-loop control is a valid clinical alternative to hybrid closed-loop systems, the current state- of-the-art systems. 3) Lastly, we hypothesize that further adding glycemic disturbance anticipation (e.g. generally surrounding meals) to this fully automated closed-loop control system will further improve glycemic outcomes compared with a fully automated closed-loop system without disturbance anticipation.

项目摘要 尽管自动胰岛素输送系统取得了进步，显示出优越的血糖水平 随着对准确碳水化合物的持续需求，挑战性的临床问题仍然存在 计数和进餐通知结合慢效皮下胰岛素 导致餐后高血糖反复发生。这种血糖的临床差距 拟议项目解决了控制问题。我们打算利用我们现有的进步 在模式识别和预期中完善和测试全自动闭环系统 不需要用餐公告。该系统的独特之处在于它依赖于模式 以预期的方式识别，特别是围绕膳食，以便胰岛素作用 在预计进餐之前服用，而不是主要反应性的解决方案 经常提出。我们打算在加速的背景下进一步测试和调整这个系统 胰岛素进一步改善血糖结果并消除使用这些系统的障碍 减轻疾病管理负担。 我们已经开发了全自动闭环和 将利用我们积累的临床研究数据库中的数据来计划进一步完善。 我们计划进行 2 项试点研究，然后进行一项更大规模的、为期 7 个月的主要研究，以评估 该提案的具体目标如下： 1) 我们假设新型速效胰岛素类似物可以安全地用于提供更多作用 有效的全自动闭环控制。我们的第一个试点将测试 Fiasp 之间的差异 以及一项监督试验中的天冬氨酸（AT247）新配方。该试验结果将告知 选择后续试验中使用的胰岛素。 2) 我们假设，通过适应这些新胰岛素配方的设计，完全自动化 闭环控制是混合闭环系统的有效临床替代方案，目前的状态 最先进的系统。 3）最后，我们假设进一步增加血糖紊乱预期（例如，通常 周围的饭菜）到这个全自动闭环控制系统将进一步改善 与无干扰的全自动闭环系统相比，血糖结果 预期。