APTITUDE MEDICAL SYSTEMS INC — Department of Health and Human Services SBIR Phase II: 200

Description

AbstractIn the United Statesmillion children and adults have diabetes andmillion have pre diabetesInsulin therapy is critical in TypeDiabetes and now understood to be an inevitable therapeutic component for TypeDiabetes in order to achieve adequate glycemic controlHowevernone 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 variabilityThis results in unpredictable blood glucose excursions and risk of hypoglycemia due to insulin stackingAdapting insulin therapy based on personal measures of insulin pharmacokinetics can overcome this limitationhoweversince insulin currently must be measured in a lab facilityextending these benefits to themillion individuals using insulin therapy is not possibleThusthere is critical unmet need for a personal device that measures insulin on the spotTo address this need we developed a novel aptamer based devicethe INSIGHT Insulin Sensorwhich measures the concentration of insulin on the spot in real time in an episodic manner and supports compatibility with the established glucose motioning technologiesIn this Phase II workAptitude will collaborate with researchers at Yale School of Medicineto 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 settingsOur team will compare the device to the current standard labbased assay and measure personal insulin pharmacokinetics in patientsand assess the capability to improve insulin pumpsThrough measures of personal insulin pharmacokineticsINSIGHT has the potential to augment existing insulin delivery devices to improve glucose control during challenging real life scenariosand will support proliferation of artificial pancreas systems through safer and more effective glucose controlWe expect to form a product co development partnership with leaders in the diabetes device market for commercialization within three years