Validation of a Remote Monitoring Blood Pressure Device in Pregnancy

Abstract

Abstract Background The Ideal Life Blood Pressure Manager measures blood pressure (BP) and automatically transmits results to the patient’s medical record independent of internet access, but has not been validated. Our objective was to conduct a validation study of the Ideal Life BP Manager in pregnant women using a validation protocol. Methods Pregnant participants were enrolled into three subgroups per the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization protocol: normotensive (systolic blood pressure (SBP) < 140 and diastolic blood pressure (DBP) < 90), hypertensive without proteinuria (SBP ≥ 140 or DBP ≥ 90), and preeclampsia (SBP ≥ 140 or DBP ≥ 90 with proteinuria). Two trained research staff used a mercury sphygmomanometer to validate the device, alternating sphygmomanometer, and device readings for a total of 9 measurements. Results Among 51 participants, the mean SBP and DBP differences and standard deviations between the device and the mean staff measurements for all participants were 1.7 ± 7.1 and 1.5 ± 7.0 mm Hg, respectively. The standard deviations of the individual participant’s paired device and mean staff SBP and DBP measurements were 6.0 and 6.4 mm Hg, respectively. The device was more likely to overestimate rather than underestimate BP (SBP: mean difference = 1.67, 95% CI [−12.15 to 15.49]; DBP: mean difference = 1.51, 95% CI [−12.26 to 15.28]). Most paired readings had a difference of less than 10 mm Hg across averaged paired readings. Conclusion The Ideal Life BP Manager met internationally recognized validity criteria in this sample of pregnant women.