Abstract
BackgroundHome blood pressure monitoring has many benefits, even more so, in populations prone to high blood pressure, such as persons with diabetes.ObjectiveThe purpose of this research was to validate the QardioArm mobile device in a sample of individuals with noninsulin-dependent type 2 diabetes in accordance with the guidelines of the second International Protocol of the European Society of Hypertension.MethodsThe sample consisted of 33 patients with type 2 diabetes. To evaluate the validity of QardioArm by comparing its data with that obtained with a digital sphygmomanometer (Omron M3 Intellisense), two nurses collected diastolic blood pressure, systolic blood pressure, and heart rate with both devices.ResultsThe analysis indicated that the test device QardioArm met all the validation requirements using a sample population with type 2 diabetes.ConclusionsThis paper reports the first validation of QardioArm in a population of individuals with noninsulin-dependent type 2 diabetes. QardioArm for home monitoring of blood pressure and heart rate met the requirements of the second International Protocol of the European Society of Hypertension.
Highlights
Devices that automatically measure blood pressure have gradually evolved to replace the standard mercury sphygmomanometer, as the risk of mercury toxicity outweighed any potential benefits of its use
This paper reports the first validation of QardioArm in a population of individuals with noninsulin-dependent type 2 diabetes
We performed an observational concordance study to validate the QardioArm device for measurement of heart rate, diastolic blood pressure, and systolic blood pressure, in individuals with noninsulin-dependent type 2 diabetes according to European Society of Hypertension-International Protocol 2 (ESH-IP2) [9] and STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria [33]
Summary
Devices that automatically measure blood pressure have gradually evolved to replace the standard mercury sphygmomanometer, as the risk of mercury toxicity outweighed any potential benefits of its use. It is a necessary requirement that these devices have been validated by standardized protocols, such as the European Society of Hypertension-International Protocol 2 (ESH-IP2) [9], the British Hypertension Society protocol [10], or the protocol of the Association for the Advancement of Medical Instrumentation [11]. If this validation is essential in the general population, it is even more important in at-risk populations, such as patients with diabetes, where reliability and accurate blood pressure measurement are essential to avoid the disease’s progression. Home blood pressure monitoring has many benefits, even more so, in populations prone to high blood pressure, such as persons with diabetes
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