Capillary Biomedical, Inc. — Department of Health and Human Services SBIR Phase II: 200

Description

PROJECT SUMMARYABSTRACT Capillary Biomedical Incis developing an infusion setcatheter cannula inserterfor the treatment of diabetes mellitus with continuous subcutaneous insulin infusionCSIIThe Capillary infusion cannula has been reinvented to include kink resistancean internal reinforcing coilmultiple outlet portsan `effortlessandaposautomatic inserter and other performanceimproving design elementsThis combination of features will remove barriers to CSII therapy by increasing the infusion set replacement interval beyond the currenttoday standardIt will also substantially reduce the incidence of very commonand frustratingfailure modes that impact the health of diabetic personsincludinginfusion set failure upon insertionblocked insulin delivery due to kinking or occlusionand infusion site reactionsThis NIH phasegrant proposal addresses exploratory research objectives to study how the novel design of the Capillary infusion set reduces the failure rate and why it may be safe to extend continuous use of one Capillary infusion set for up todaysThis project consists of extensive in vitro and in vivo testing to ensure safety and reliability with the objectives ofFabricating Coil Reinforced Soft Polymer CSII Sets The Capillary CSII Set design and pilot scale production process will be finalized to produce a minimum ofcompleted infusion sets suitable for human useVerifying Insulin Compatibility OverDay Duration We will demonstrate the compatibility of our infusion set in non clinical testing with HumalogInsulin LisproLillyand NovologInsulin AspartNovoto prepare for the human trialClinical Trial to Assess the Capillary Infusion Set Performance in Humans A twenty five adult patient phaseb inpatient hyperinsulinemia euglycemia study in typediabetics will be conducted in a randomized sequencecross over design to explore bioavailability and dose response profiles of commercially available rapid acting insulin when delivered using a CSII pump plus investigational Capillary catheter vs a commercially available Tefloncatheter fordaysThe proposed primary endpoint is insulin bioavailabilityAUCon the day of insertion PROJECT NARRATIVEPUBLIC HEALTH STATEMENT Emerging artificial pancreas systems pair a continuous glucose monitor with an insulin pump and promise to simplify the lives of overM people with Typediabetes in the United StatesA key barrier to broader adoption of these systems is the day to day variability in insulin response and theday limit on use of current insulin infusion cathetersThis research aims to assess the relative bioavailability of subcutaneously infused insulin using Capillary Biomedicalandapos s investigational infusion set vsa commercially available infusion set as controlfor up todays extended use