Document text
Principal Investigator: Forrest Payne
Organization: SFC FLUIDICS, LLC
Fiscal Year: 2024
Award: $944,944
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
Advanced Development of GeminiTM-DHAP
Project Summary:
The Specific Aim of this Direct to Phase II project is to develop a discrete, low-profile, dual
hormone artificial pancreas device, the GeminiTM-DHAP, using SFC Fluidics' enabling
microfluidic technologies to deliver both insulin and glucagon as recommended by a dual-hormone
algorithm in response to continuous glucose monitor readings. The Gemini pod uses one
proprietary DualPumpTM body to independently and accurately deliver both insulin and glucagon
from two separate reservoirs. Safety valve sets independently and safely control the delivery of
each hormone, and a dispense confirmation sensor notifies the user of any dosing errors resulting
from occlusions or electrical/mechanical failures. Phase II will focus on optimization and design
freeze of the Gemini pod followed by integration of the Gemini pod with a CGM and dual-hormone
algorithm into a DHAP system and extensive benchtop and animal model testing. The project will
culminate with an IDE submission in preparation for future clinical trials. Throughout the project
SFC will collaborate with its university subcontractors, established medical, regulatory and
manufacturing consultants, GMP-compliant pod component manufacturing partner, and the Food
and Drug Administration to streamline commercialization of the Gemini-DHAP. By the end of
Phase II, SFC Fluidics will be well positioned to raise the additional funding necessary for early-
stage clinical trials and subsequent pivotal trials to obtain PMA-approval of the Gemini-DHAP.
This project is in direct response to the National Institute of Diabetes and Digestive and Kidney
Diseases, Division of Diabetes, Endocrinology and Metabolic Diseases for “development of
improved insulin and other pancreatic hormone delivery devices and methods” and is particularly
relevant in 2023 due to the increased risk for Covid 19 and other infections that results from poor
glycemic control.
Terms: <21+ years old><Adolescent><Adolescent Youth><Adult><Adult Human><Advanced Development><Algorithms><Amendment><Animal Model><Animal Models and Related Studies><Antidiabetic Hormone><Artificial Pancreas><Bluetooth><Brittle Diabetes Mellitus><COVID-19 related risk><COVID-19 risk><COVID-19 risk factor><Catheters><Chemicals><Clinical Trials><Collaborations><Computer software><Continuous Glucose Monitor><Detection><Development><Devices><Diabetes Mellitus><Dose><Drug Stability><Early-Stage Clinical Trials><Endocrine Gland Secretion><Endocrinology><Evaluation><Failure><Food and Drug Administration><Freezing><Funding><Future><Glucagon><Glukagon><Government><HG-Factor><Health Sciences><Hormones><Humulin R><Hyperglycemic-Glycogenolytic Factor><Hypoglycemia><IDDM><In vivo analysis><Individual><Infection><Injections><Insulin><Insulin-Dependent Diabetes Mellitus><Juvenile-Onset Diabetes Mellitus><Ketosis-Prone Diabetes Mellitus><Mechanics><Medical><Metabolic Diseases><Metabolic Disorder><Metabolism and Endocrinology><Methods><Modification><NIDDK><National Institute of Diabetes and Digestive and Kidney Diseases><Notification><Novolin R><Oregon><Pancreatic Hormones><Patients><Persons><Phase><Phase 1 Clinical Trials><Phase I Clinical Trials><Position><Positioning Attribute><Preparation><Pump><Recommendation><Regular Insulin><Regulatory Pathway><Safety><Site><Software><Sterilization><Sudden-Onset Diabetes Mellitus><Syringes><System><T1 DM><T1 diabetes><T1D><T1DM><Testing><Therapeutic Hormone><Thesaurismosis><Type 1 Diabetes Mellitus><Type 1 diabetes><Type I Diabetes Mellitus><USFDA><United States Food and Drug Administration><Universities><Work><adulthood><biocompatibility><biomaterial compatibility><commercialization><continuous blood glucose monitor><continuous blood sugar monitor><continuous glucose measurement><continuous sugar monitor><coronavirus disease 2019 risk><coronavirus disease 2019 risk factor><cost><design><designing><developmental><diabetes><efficacy testing><glycemic control><hypoglycemia unawareness><hypoglycemic><hypoglycemic episodes><improved><in vivo><in vivo evaluation><in vivo testing><insulin dependent diabetes><insulin dependent type 1><juvenile><juvenile diabetes><juvenile diabetes mellitus><juvenile human><ketosis prone diabetes><manufacturability><manufacture><mechanic><mechanical><meeting><meetings><metabolism disorder><microfluidic technology><model of animal><online software><pancreas hormone><phase 2 evaluation><phase 2 testing><phase I protocol><phase II evaluation><phase II testing><pre-clinical study><preclinical study><preparations><prevent><preventing><prototype><response><risk associated with COVID-19><risk factor associated with COVID-19><risk factor related to COVID-19><risk related to COVID-19><sensor><simulation><stability testing><subcutaneous><subdermal><type I diabetes><type one diabetes><usability><web based software><web software><wireless><µfluidic technology>