SBIR-STTR Award

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 dual ePump® will be developed in which a single ePump body will independently and accurately deliver both insulin and glucagon from two separate reservoirs. Latching micro-valve sets will independently and safely control the delivery of each hormone and a flow confirmation sensor will identify dosing errors from either occlusions or electrical/mechanical failures. Phase I will see the development of an early prototype with control system, and a dosing accuracy of +/- 5% (for nL to ?L dosing volumes) will be targeted. During Phase II, SFC Fluidics will work closely with clinicians and drug formulation, glucose sensor and control algorithm developers to develop a robust and reliable artificial pancreas.

Public Health Relevance Statement:


Project narrative:
The proposed dual drug delivery system will have the necessary safety features and low dose accuracy to meet the need for insulin and glucagon dual-hormone delivery to type 1 diabetics, including children and adolescents, to greatly improve the quality of life for this significant and growing at-risk group.

Project Terms:
Adolescent; Advanced Development; Algorithms; Artificial Pancreas; blood glucose regulation; Child; clinically relevant; Development; Dose; Drug Delivery Systems; Drug Formulations; Equilibrium; Evaluation; Failure; Feedback; Formulation; Glucagon; glucose sensor; Government; Guidelines; Hormone use; Hormones; improved; In Vitro; in vivo; Insulin; Measurement; Measures; Mechanics; meetings; meter; Microfluidics; novel; Persons; Pharmaceutical Preparations; Phase; Protocols documentation; prototype; Pump; Quality of life; Randomized; Reading; Reporting; Risk; Safety; sensor; Side; Syringes; System; Technology; Testing; Time; type I diabetic; Water; Work

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.

Thesaurus Terms:
Adolescent; Algorithms; Artificial Pancreas; Biocompatible Materials; Biomaterial Compatibility; Blood Glucose; Bluetooth; Cannulas; Child; Cost; Design; Development; Devices; Dose; Drug Carriers; Drug Contamination; Drug Delivery Systems; Drug Formulations; Dyes; Electronics; Ensure; Evaluation; Failure; Family Suidae; Fda Approved; Formulation; Glucagon; Glucose Monitor; Glycemic Control; Goals; Government; Guidelines; Hand; Hormones; Hour; Hypoglycemia; Improved; In Vitro Testing; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Liquid Substance; Manuals; Manufacturability; Manufacturer Name; Measurement; Measures; Mechanics; Meetings; Methods; Microfluidic Technology; Next Generation; Novel; Persons; Pharmaceutical Preparations; Phase; Power Sources; Production; Protocols Documentation; Prototype; Pump; Response; Safety; Sensor; Series; Syringes; System; Techniques; Testing; Update; Wireless Technology; Work;