讲义参考教案proteus clinical development studies jan14.pptxVIP

Proteus Digital Health Feedback SystemClinical Development Studies7 January 2014Clinical Development OverviewCommenced in 2008Focus on safety and performance to date17 studies, over 500 subjectsTested in diverse populationsTB HFHypertensionDiabetesSchizophreniaBipolar disorderRenal transplantationSeniors with fragile skinAdvanced BMIHealthy volunteersThe system has a low rate of AEs; no SAEs or UADEs The system measures and delivers data accurately reliablyStudied in Diverse PopulationsStudyDatesDesignPurposeEMITTER 1.0 Healthy volunteersJan-Aug 2008N=30, 2 daysValidate tec