STTR Phase I: Feasibility and proof of concept of a non-invasive treatment for type 2 diabetes inspired from bariatric surgery

该小企业技术转让（STTR）I期项目的更广泛影响/商业潜力是开发第一种针对2型糖尿病的非侵入性、基于器械的治疗方法，该方法模拟减肥手术的治疗益处。所提出的非侵入性肠衬里暂时改变小肠中的信号通路，以模拟减肥手术的代谢作用。2700万美国人和全球3亿2型糖尿病患者迫切需要恢复血糖控制的治疗，而不是目前的管理策略，如二甲双胍和胰岛素，它们只能减缓疾病的进展。该治疗的潜在商业影响是显著的，因为在美国诊断糖尿病的总估计成本超过2450亿美元，并且还在上升。总体而言，令人震惊的是，五分之一的美国医疗保健美元用于糖尿病患者的护理。主要的保险公司表示有兴趣报销所提议的替代方法，从而减轻国家的费用负担。拟议的项目需要在实验台和体内动物模型上进行概念验证实验，以解决该方法最相关的技术风险。第一个具体目标是开发和测试几种肠内膜制剂，并评估相关的性能特征。第二个目的是开发一种可摄取的输送方法，选择衬里局部部署。与领先的内分泌学家，胃肠病学家和材料科学家就减肥手术进行了磋商，指导了胃肠道内非常具体的递送靶点的选择。这些目标构成了具体目标2的成功标准。第三个也是最后一个具体目标是确定衬里是否可以在猪模型中递送并在小肠中保持功能2小时以改变营养吸收。这一目标将为整体方法提供概念验证，并推动NSF STTR 2期申请，其中将进行更严格和长期的安全性和有效性研究。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop the first non-invasive, device-based treatment for type 2 diabetes which mimics the therapeutic benefits of bariatric surgery. The proposed non-invasive intestinal lining temporarily alters signaling pathways in the small intestine to mimic the metabolic effects of bariatric surgery. The 27 million Americans and 300 million patients globally with type 2 diabetes are desperate for a treatment that reinstates glycemic control as opposed to current management strategies, such as metformin and insulin, which only slow the progression of the disease. The potential commercial impact of the treatment is significant as the total estimated cost of diagnosed diabetes in the US is upwards of $245 billion, and on the rise. Overall, an astounding 1 in 5 US health care dollars are used for the care of people with diabetes. Major insurers have expressed interest in the reimbursement of alternative approaches such as the one proposed, thereby lessening the national cost burden.The proposed project entails proof-of-concept experiments on the bench top and in-vivo animal model to address the most pertinent technological risks with the approach. The first specific aim is to develop and test several formulations of the intestinal lining and evaluate pertinent performance features. The second aim is to develop an ingestible delivery method of the selected lining for localized deployment. Consultation with leading endocrinologists, gastroenterologists, and material scientists regarding bariatric surgery has guided the selection of very specific delivery targets within the gastrointestinal tract. These targets form the success criteria for specific aim 2. The third and final specific aim is to determine if the lining can be delivered and remain functional in the small intestine for a period of 2 hours to modify nutrient absorption in a porcine model. This aim will provide proof-of-concept for the overall approach and motivate the NSF STTR phase 2 application, wherein more rigorous and long term safety and efficacy studies will be performed.