Advanced Development of Gemini-DHAP

Gemini-DHAP的高级开发

• 批准号: 10760050
• 负责人: Forrest Payne
• 金额: $ 100万
• 依托单位: SFC FLUIDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-25 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10760050
• 关键词: Adolescent; Adult; Advanced Development; Algorithms; Amendment; Animal Model; Artificial Pancreas; Bluetooth; COVID-19 risk; Catheters; Chemicals; Clinical Trials; Collaborations; Computer software; Continuous Glucose Monitor; Detection; Development; Devices; Diabetes Mellitus; Dose; Drug Stability; Endocrinology; Evaluation; Failure; Freezing; Funding; Future; Glucagon; Government; Health Sciences; Hormones; Hypoglycemia; Individual; Infection; Injections; Insulin; Insulin-Dependent Diabetes Mellitus; Mechanics; Medical; Metabolic Diseases; Methods; Modification; National Institute of Diabetes and Digestive and Kidney Diseases; Notification; Oregon; Pancreatic Hormones; Patients; Persons; Phase; Phase I Clinical Trials; Positioning Attribute; Preparation; Pump; Recommendation; Regulatory Pathway; Safety; Site; Sterilization; Syringes; System; Testing; United States Food and Drug Administration; Universities; Work; biomaterial compatibility; commercialization; cost; design; efficacy testing; glycemic control; hypoglycemia unawareness; improved; in vivo; in vivo evaluation; manufacturability; manufacture; meetings; microfluidic technology; phase 2 testing; preclinical study; prevent; prototype; response; sensor; simulation; stability testing; subcutaneous; usability; web based software; wireless

Advanced Development of GeminiTM-DHAP Project Summary: The Specific Aim of this Direct to Phase II project is to develop a discrete, low-profile, dual hormone artificial pancreas device, the GeminiTM-DHAP, using SFC Fluidics' enabling microfluidic technologies to deliver both insulin and glucagon as recommended by a dual-hormone algorithm in response to continuous glucose monitor readings. The Gemini pod uses one proprietary DualPumpTM body to independently and accurately deliver both insulin and glucagon from two separate reservoirs. Safety valve sets independently and safely control the delivery of each hormone, and a dispense confirmation sensor notifies the user of any dosing errors resulting from occlusions or electrical/mechanical failures. Phase II will focus on optimization and design freeze of the Gemini pod followed by integration of the Gemini pod with a CGM and dual-hormone algorithm into a DHAP system and extensive benchtop and animal model testing. The project will culminate with an IDE submission in preparation for future clinical trials. Throughout the project SFC will collaborate with its university subcontractors, established medical, regulatory and manufacturing consultants, GMP-compliant pod component manufacturing partner, and the Food and Drug Administration to streamline commercialization of the Gemini-DHAP. By the end of Phase II, SFC Fluidics will be well positioned to raise the additional funding necessary for early- stage clinical trials and subsequent pivotal trials to obtain PMA-approval of the Gemini-DHAP. This project is in direct response to the National Institute of Diabetes and Digestive and Kidney Diseases, Division of Diabetes, Endocrinology and Metabolic Diseases for “development of improved insulin and other pancreatic hormone delivery devices and methods” and is particularly relevant in 2023 due to the increased risk for Covid 19 and other infections that results from poor glycemic control.

GeminiTM-DHAP的进阶发展 项目概要： 这个直接进入第二阶段项目的具体目标是开发一种分立的、低调的、双通道的 激素人工胰腺装置 GeminiTM-DHAP，采用 SFC Fluidics 的支持 微流体技术可按照双激素的建议输送胰岛素和胰高血糖素 Gemini pod 使用一种算法来响应连续血糖监测读数。 专有的 DualPumpTM 主体可独立准确地输送胰岛素和胰高血糖素 来自两个独立的储罐的安全阀组独立且安全地控制输送。 每种激素，分配确认传感器会通知用户由此产生的任何剂量错误 第二阶段将重点关注优化和设计。 冻结 Gemini pod，然后将 Gemini pod 与 CGM 和双激素整合 该项目将把算法引入 DHAP 系统并进行广泛的台式和动物模型测试。 最终提交 IDE，为整个项目的未来临床试验做准备。 SFC 将与其大学分包商、已建立的医疗、监管和 制造顾问、符合 GMP 的烟弹组件制造合作伙伴以及食品 和药物管理局简化 Gemini-DHAP 的商业化。 第二阶段，SFC Fluidics 将处于有利地位，可以筹集早期所需的额外资金。 阶段临床试验和随后的关键试验以获得 Gemini-DHAP 的 PMA 批准。 该项目是对国家糖尿病、消化和肾脏研究所的直接响应 疾病、糖尿病、内分泌和代谢疾病科“发展 改进的胰岛素和其他胰腺激素输送装置和方法”，特别是 由于贫困导致 Covid 19 和其他感染的风险增加，因此 2023 年相关 血糖控制。