An Intraperitoneal Insulin Delivery System for Management of Type 1 Diabetes

用于治疗 1 型糖尿病的腹膜内胰岛素输送系统

• 批准号: 10584462
• 负责人: Daniel Rogers Burnett
• 金额: $ 104.81万
• 依托单位: PERIKINETICS INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10584462
• 关键词: Adoption; Advanced Development; Adverse event; Affect; Agitation; American; Animal Model; Animals; Attention; Body Temperature; Bolus Infusion; Brittle diabetes; Catheters; Characteristics; Chemicals; Clinical; Collaborations; Continuous Infusion; Custom; Devices; Disease; Drug Kinetics; Endocrine; Ensure; Esthetics; Europe; Evaluation; Excision; FDA approved; Family suidae; Feasibility Studies; Glucose; Goals; Health; High Pressure Liquid Chromatography; Histology; Hospitalization; Hour; Human; Hypoglycemia; Implant; Implantable venous access port; In Vitro; Infection; Infection prevention; Inflammation; Infusion procedures; Insulin; Insulin Infusion Systems; Insulin, Lispro, Human; Insulin-Dependent Diabetes Mellitus; Kinetics; Life; Liver; Location; Mechanics; Methods; Modeling; Modernization; Monitor; Needles; Obstruction; Operative Surgical Procedures; Patients; Pharmacodynamics; Phase; Physiological; Portal System; Positioning Attribute; Precipitation; Pump; Quality of life; Recombinants; Recurrence; Research; Risk; Safety; Small Business Innovation Research Grant; System; Testing; Time; Tissues; Visual; absorption; analog; biomaterial compatibility; blood glucose regulation; commercialization; cytotoxicity; delivery vehicle; design; diabetic; diabetic patient; experimental study; glycemic control; implantation; improved; in vivo; infection rate; innovation; intraperitoneal; intraperitoneal infusion; irritation; nephelometry; preclinical development; preclinical safety; research study; response; satisfaction; seal; stability testing; subcutaneous; systemic toxicity

ABSTRACT Perikinetics’ intraperitoneal (IP) insulin delivery system for the management of Type 1 diabetes (T1D) utilizes an innovative implantable port-catheter system accessed by a proprietary external infusion set to provide a safe and effective means of tight glycemic control. For the 1.6 million Americans living with T1D, modern technological advances have improved glucose sensing and insulin delivery, however, achieving tight glycemic control remains challenging. The IP cavity presents a superior location for insulin delivery for T1D patients. IP insulin delivery better mimics physiological delivery by providing a higher insulin concentration in the portal system, enabling rapid absorption by the liver, and a more effective response to glycemic disturbances and reduced hypoglycemic episodes. Continuous IP insulin infusion (CIPII) systems developed to date have demonstrated dramatic improvement in glucose regulation but, unfortunately, suffer from catheter obstruction, infection, and aesthetic disfigurement. No FDA approved CIPII systems are currently available in the U.S. Improving the safety and clinical utility of IP insulin devices would enable commercialization of a superior option for glycemic control within a tighter monitoring range. Perikinetics (PK) has developed the PK Insulin Delivery Conduit (IDC), an implantable port-catheter system accessed by a proprietary external infusion set for IP insulin delivery. In our Phase I equivalent research studies, we established feasibility of the system through in vitro flow characterization, implant viability, and mechanical integrity testing. The overall objective of this proposal is to demonstrate that the PK IDC can safely and effectively deliver basal and bolus insulin in a T1D animal model. In Specific Aim 1, we will assess insulin stability on the bench to ensure that injected insulin will not be adversely affected by the device or delivery method. In Specific Aim 2, we will conduct a pilot animal study to validate safety, efficacy, and clinical utility of the PK IDC. Successful completion of these aims will position the device for IDE-enabling studies and, ultimately, de novo 510(k) clearance as the first IP insulin delivery vehicle using a subcutaneous port to reduce infection and improve quality of life.

抽象的 Perikinetics 用于治疗 1 型糖尿病 (T1D) 的腹膜内 (IP) 胰岛素输送系统采用 创新的植入式输液港导管系统通过专有的外部输液器进行访问，以提供安全的 对于 160 万患有 T1D 的美国人来说，现代技术是严格控制血糖的有效手段。 进步已经改善了葡萄糖传感和胰岛素输送，但是，实现严格的血糖控制仍然存在 IP 腔为 T1D 患者提供了优越的胰岛素输送位置。 通过在门静脉系统中提供更高的胰岛素浓度，更好地模拟生理输送，从而使 肝脏快速吸收，对血糖紊乱有更有效的反应，降低低血糖 迄今为止开发的连续腹膜内胰岛素输注（CIPII）系统已表现出戏剧性的效果。 改善血糖调节，但不幸的是，会遭受导管阻塞、感染和美观问题 目前美国尚无 FDA 批准的 CIPII 系统。 IP 胰岛素装置的临床应用将使血糖控制的最佳选择商业化 Perikinetics (PK) 开发了 PK 胰岛素输送导管 (IDC)，这是一种可植入的监测范围。 在我们的第一阶段，通过专有的外部输注装置连接端口导管系统，用于腹膜内胰岛素输送。 等效研究，我们通过体外流动特性、植入物确定了系统的可行性 该提案的总体目标是证明 PK。 IDC 可以在 T1D 动物模型中安全有效地输送基础胰岛素和推注胰岛素。在具体目标 1 中，我们将。 评估工作台上的胰岛素稳定性，以确保注射的胰岛素不会受到设备的不利影响 在具体目标 2 中，我们将进行一项试点动物研究，以验证安全性、有效性和临床效果。 PK IDC 的实用性将成功完成这些目标，并将该设备用于支持 IDE 的研究，并且 最终，de novo 510(k) 作为第一个使用皮下端口的 IP 胰岛素输送工具获得批准，以减少 感染并提高生活质量。