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Real-time Point of Care Insulin Monitoring Device for Improved Diabetes Management

Award Number: R44DK101280
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2015
PERIOD OF PERFORMANCE END DATE: 06/30/2021

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Real-time Point of Care Insulin Monitoring Device for Improved Diabetes Management - Abstract In the United States, 25.8 million children and adults have diabetes and 79 million have pre-diabetes. Insulin therapy is critical in Type 1 Diabetes and now understood to be an inevitable therapeutic component for Type 2 Diabetes in order to achieve adequate glycemic control. However, none of the available commercial insulin preparations are able to simulate normal secretion and current glucose monitoring and insulin delivery devices struggle to maintain euglycemia during periods of meal and alcohol consumption and during exercise because they cannot fully account insulin absorption variability. This results in unpredictable blood glucose excursions and risk of hypoglycemia due to insulin stacking. Adapting insulin therapy based on personal measures of insulin pharmacokinetics can overcome this limitation, however, since insulin currently must be measured in a lab facility, extending these benefits to the 6 million individuals using insulin therapy is not possible. Thus, there is critical unmet need for a personal device that measures insulin on the spot. To address this need we developed a novel aptamer-based device, the INSIGHT Insulin Sensor, which measures the concentration of insulin on the spot in real time in an episodic manner and supports compatibility with the established glucose motioning technologies. In this Phase II work, Aptitude will collaborate with researchers at Yale School of Medicine, to translate the proof of concept device developed in Phase I into a manufacture-ready prototype that is deployable in research labs and in clinical research settings. Our team will compare the device to the current standard lab- based assay and measure personal insulin pharmacokinetics in patients, and assess the capability to improve insulin pumps. Through measures of personal insulin pharmacokinetics, INSIGHT has the potential to augment existing insulin delivery devices to improve glucose control during challenging real-life scenarios, and will support proliferation of artificial pancreas systems through safer and more effective glucose control. We expect to form a product co-development partnership with leaders in the diabetes device market for commercialization within three years.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2018	APTITUDE MEDICAL SYSTEMS, INC.	125 CREMONA DR # 100	GOLETA	CA	93117	SANTA BARBARA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	11/27/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	APTITUDE MEDICAL SYSTEMS, INC.	2219 BATH ST	SANTA BARBARA	CA	93105	SANTA BARBARA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/1/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $640,326 )
2018	2018	APTITUDE MEDICAL SYSTEMS, INC.	2219 BATH ST	SANTA BARBARA	CA	93105	SANTA BARBARA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/21/2018	NON-COMPETING CONTINUATION	$640,326
														Subtotal = $640,326

Issue Date FY: 2017 ( Subtotal = $792,839 )
2017	2017	APTITUDE MEDICAL SYSTEMS, INC.	2219 BATH ST	SANTA BARBARA	CA	93105	SANTA BARBARA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	6/22/2017	COMPETING CONTINUATION	$792,839
														Subtotal = $792,839

Grand Total All Awards = $1,433,165

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Real-time Point of Care Insulin Monitoring Device for Improved Diabetes Management

Award Number: R44DK101280

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/16/2015

PERIOD OF PERFORMANCE END DATE: 06/30/2021

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