Development of a Low-Profile Dual Hormone Patch Pump with Novel Occlusion Sensor Project Summary:
The Specific Aim of this project is to develop a discrete, low-profile, dual hormone drug delivery system using SFC Fluidics? enabling microfluidic technologies. A DualPump? will be developed in which one proprietary ePump body will independently and accurately deliver both insulin and glucagon from two separate reservoirs. Latching safety valve sets will independently and safely control the delivery of each hormone and a dispense confirmation sensor will notify the user of any dosing errors resulting from occlusions or electrical/mechanical failures. Phase II will see the integration of all components into an accurate, discrete, low-profile wearable pod, extensive benchtop testing and initial testing in swine. The end goal of Phase II is production of a DualPump module that has been introduced to the FDA and is ready to be integrated with all other components required for a dual hormone artificial pancreas. During Phase IIB, SFC Fluidics will work with manufacturers of continuous glucose monitors, control algorithms and stable drug formulations to develop an FDA-approved, robust, and reliable dual hormone artificial pancreas.
The proposed DualPump-APTM system will improve glycemic control as compared to an insulin-only Artificial Pancreas by providing the ability to correct a hypoglycemic condition. The DualPump-AP will have the necessary safety features and low dose precision to meet the need for insulin and glucagon delivery for people with Type 1 diabetes, especially children, adolescents, and individuals that are hypoglycemic unaware.
