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

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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.