Viocare, Inc. — Department of Health and Human Services SBIR Phase I: 200

Description

More thanmillion U Sadults with typediabetesT DMdo not meet American Diabetes AssociationADAglycemic targets for glucose controlHealthcare costs related to diabetes were estimated at $billion inincluding $billion in direct medical costsPoorly regulated dietary intakewhich often results in chronic hyperglycemia and elevated HbA c levelscontributes substantially to this costAs suchmedical nutrition therapy is an integral part of diabetes managementAccording to the ADAthe primary goals of nutrition therapy for adults with T DM is to promote and support healthful eating patterns to maintain glycemic controlHoweverdetermining what to eat and following a food plan is the most challenging part of treatment for patientsparticularly when access to diabetes educators and trained dietitians is limitedPatients are most often left to self monitor food intake and post meal glucose levels to inform future dietary decisionsHoweverthe vast majority of people are unable to sustain a level of self monitoring to experience such meaningful insightsWhile multiple diet and glucose tracking technologies have been developed for self monitoringnone of these tools merge dietary data with glucose data to optimize personalized diabetes self managementMobile technology that complements traditional medical nutrition therapy and is personalized to an individual s biological response to foods is long overdueThe time has come for a patient friendlymobile dietary guidance systemmDGSfor diabetes management that lessens the burden of self monitoring while producing meaningful dietary feedback about what to eat and what to avoid with the goal of improving one s glycemic controlIn responsewe are proposing a new mobile dietary assessment approach that integrates continuous glucose monitoringCGMdata with a mobile diet tracker to predict diet related hyperglycemic events and provide dietary guidance to prevent these events in the futureWe will accomplish this by automating the selfmonitoring of post meal glucose levels in a manner consistent with ADA glucose targetsthereby reducing the burden of self monitoring by more thanand improving a user s glycemic controlTo achieve these goalswe will build off of our preliminary data byAimdeveloping algorithms that use CGM data to predict postmeal hyperglycemia andAimdesigningprototypingand testing the usability of CGM integrated mobile dietary guidance system interfacesPhase II will complete mDGS as a fully functional CGM integrated dietary guidance system for the management of T DM in partnership with CGM device companiesPost Phase IIwe plan for a clinical trial to test the effectiveness of mDGS under free living conditionsIn the commercialization phaseViocare will seek FDA approval for mDGStarget primary care practicescertified diabetes educatorsAccountable Care Organizationsand payers treating people with T DMViocare will start by offering mDGS licenses to its current customer base of overhealthcare organizationswhich include Mayo Clinicthe Baylor Diabetes Prevention Program groupGeisingerand the Ohio State University Dietary intake self monitoring is an instrumental but burdensome aspect of diabetes self management despite recent advances in mobile technologyHerewe propose a new dietary assessment and intervention approach thatfor the first timeintegrates continuous glucose monitoringCGMdata with a mobile diet tracker to automate personalized dietary guidanceThis CGM integrated mobile dietary guidance system will be the first to use biological data to reduce the burden of dietary self monitoring with the aim of improving glucose control in people with typediabetes