ViTrack: Wearable, accurate, continuous blood pressure monitor to improve outcomes in hypertensive diseases of pregnancy

Abstract: We have developed ViTrack™, a cuffless, wrist-wearable device that uses a fundamentally new method to accurately and non-invasively measure BP continuously. ViTrack’s beat-to-beat accurate measurements, irrespective of patient movement or wrist level to the heart, provide the patient’s circadian BP pattern, including 24-hr mean BP, nighttime BP, and BP variability (BPV). In addition, ViTrack also measures heart rate and respiratory parameters and advanced hemodynamics. The hypertensive diseases of pregnancy (HDP) are a significant cause of morbidity and mortality. The current standard for measuring BP in pregnant women is the periodic use of oscillometric arm-cuff devices. The oscillometric devices indirectly estimate systolic (SBP) and diastolic BPs (DBP) based on artery wall oscillations during cuff-deflation. Measurement errors inherent to this indirect method, patient posture/movement, and wrong cuff size lead to unreliable BP measurements in 50% of routine office visits. Oscillometric device errors are compounded in pregnant women due to hemodynamic and vascular changes that reduce oscillations of the arterial wall, resulting in BP underestimation. In contrast, these hemodynamic changes will have less impact on ViTrack measurements because it utilizes pressure-dependent spatiotemporal skin displacement to measure SBP and DBP directly. In addition, random clinic measurements during antenatal visits lead to a 30% wrong diagnosis of HDP due to white coat or masked hypertension. In addition, there is a need for remote and continuous accurate measurement of BP for prediction and early deduction of preeclampsia. The 24-hour BP parameters, such as 24-hr mean SBP, nighttime BP, and BPV, are better predictors of preeclampsia than clinic BP measurements. ViTrack, the first standalone, wearable, connected device, can provide remote, accurate circadian BP data for correct diagnosis and enable predictive monitoring for better outcomes. Our objectives in this Phase II study are: (1) to assess the accuracy of ViTrack SBP and DBP measurements in pregnant women and as well as in women with severe preeclampsia; (2) to evaluate patient tolerance (i.e., comfort) and reliability of ViTrack’s beat-to-beat 24-hr BP measurements, and assess usability; (3) to compare the 24-hr BP profile in pregnant women with and without HDP; and (4) to compare the number of hypotensive/hypertensive episodes with ViTrack continuous measurements vs. the current standard of care of intermittent cuff measurements. The data generated will validate ViTrack as the first standalone wearable technology for accurate and continuous monitoring of BP during pregnancy.