Objective
The proposed research aims to develop an orally delivered glucose-responsive insulin prototype, addressing several major obstacles associated with the current development of glucose-responsive insulin and oral drug formulations, respectively.
Background Rationale
The PI previously developed a uniquely designed glucose-responsive insulin (supported by JDRF) and a novel drug carrier enabling high oral absorption efficacy. They promise to address barriers to GRI development and oral delivery, respectively, and support the scientific premise for the proposed oral GRI.
Description of Project
Exogenous insulin treatment remains indispensable for type 1 diabetic (T1D) patients. Currently, insulin is administered subcutaneously through syringes or infusion pumps. Despite advancements in insulin analogs, improved automatic design of pumps, and introduction of continuous glucose monitoring (CGM), disease management remains challenging and burdening for the patients, as suggested by clinical data and epidemiological analyses on the control of glucose and HbA1c levels, incidences of hypoglycemia and diabetic ketoacidosis (DKA), and resulting complications. In addition, frequent blood glucose monitoring and insulin administration and being concerned about poor management and complications could cause mental health comorbidities. This project aims to develop a novel orally delivered glucose-responsive insulin (GRI) that transforms the treatment of T1D. With significantly improved compliance, the oral formulation provides pancreas-like blood glucose control, avoids hypo- and hyperglycemic events, and eliminates the need for a nearly full-time commitment to diabetes management.
Anticipated Outcome
Completing this project will achieve proof of concept for a novel orally delivered GRI by understanding the mechanics and developing an oral pill prototype showing efficacy in animal studies.
Relevance to T1D
The oral GRI formulation is expected to transform the treatment of T1D by providing effective pancreas-like blood glucose control, avoiding dangerous hypo- and hyperglycemic incidences, reducing the need for blood glucose monitoring, minimizing dietary restrictions, and improving compliance.