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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.

BackgroundHypertension is a global public health issue and is closely related to chronic kidney disorder (CKD). In people with CKD, strict monitoring of blood pressure is an important part of therapy. ObjectiveThe aim of this research was to validate the iHealth Track blood pressure monitoring device for patients with CKD according to the European Society of Hypertension International Protocol 2010 (ESH-IP2). MethodsIn total, 33 patients who received hemodialysis in Plasencia participated in the study. There were 9 successive measurements made, which conformed to the ESH-IP2. We calculated the differences between the standard reference device (Omron M3 Intellisense) and the test device (iHealth Track) for blood pressure and heart rate values. For 99 total comparisons of paired measurements, we classified differences into various categories (≤5 mmHg, ≤10 mmHg, and ≤15 mmHg for blood pressure; ≤3, ≤5, and ≤8 beats per minute for heart rate). ResultsIn 90 of 99 systolic blood pressure and 89 of 99 diastolic blood pressure comparisons between the devices, measurement differences were within 5 mmHg. In 81 of 99 heart rate comparisons between the devices, measurement differences were within 3 beats per minute. The mean differences between the test and reference standard measurements were 3.27 (SD 2.99) mmHg for systolic blood pressure, 3.59 (SD 4.55) mmHg for diastolic blood pressure, and 2.18 (SD 2.75) beats per minute for heart rate. We also observed that for both systolic and diastolic blood pressure, 31 of 33 participants had at least two of three comparisons between the devices with measurement differences less than 5 mmHg. For heart rate, 28 of 33 patients had at least two of three comparisons between the devices with measurement differences less than 3 beats per minute. ConclusionsTo our knowledge, this is the first study to show that iHealth Track meets the requirements of the ESH-IP2 in patients with CKD. Therefore, the iHealth Track is suitable for use in renal patients.

BackgroundHigh blood pressure is one of the most common reasons why patients seek assistance in daily clinical practice. Screening for hypertension is fundamental and, because hypertension is identified only when blood pressure is measured, accurate measurements are key to the diagnosis and management of this disease. The European Society of Hypertension International Protocol revision 2010 (ESH-IP2) was developed to assess the validity of automatic blood pressure measuring devices that are increasingly being used to replace mercury sphygmomanometers. ObjectiveWe sought to determine whether the iHealth Track blood pressure monitor meets ESH-IP2 requirements for self-measurement of blood pressure and heart rate at the brachial level and is appropriate for use in the general population. MethodsThis study was a descriptive investigation. ESH-IP2 requires a total number of 33 participants. For each measure, the difference between observer and device blood pressure and heart rate values is calculated. In all, 99 pairs of blood pressure differences are classified into 3 categories (≤5, ≤10, and ≤15 mm Hg), and 99 pairs of heart rate differences are classified into 3 categories (≤3, ≤5, and ≤8 beats/min). We followed these protocol procedures in a convenience sample of 33 participants. ResultsiHealth Track fulfilled ESH-IP2 requirements and passed the validation process successfully. We observed an absolute difference within 5 mm Hg in 75 of 99 comparisons for systolic blood pressure, 78 of 99 comparisons for diastolic blood pressure, and 89 of 99 comparisons for heart rate. The mean differences between the test and standard readings were 4.19 (SD 4.48) mm Hg for systolic blood pressure, 3.74 (SD 4.55) mm Hg for diastolic blood pressure, and 1.95 (SD 3.27) beats/min for heart rate. With regard to part 2 of ESH-IP2, we observed a minimum of 2 of 3 measurements within a 5-mm Hg difference in 29 of 33 participants for systolic blood pressure and 26 of 33 for diastolic blood pressure, and a minimum of 2 of 3 measurements within a 3-beat/min difference in 30 of 33 participants for heart rate. ConclusionsiHealth Track readings differed from the standard by less than 5, 10, and 15 mm Hg, fulfilling ESH-IP2 requirements. Consequently, this device is suitable for use in the general population.

BackgroundObesity and high blood pressure (HBP) pose high cardiovascular risks, and they are frequent causes of cardiovascular disease. ObjectiveThe aim of this study was to validate the mobile app QardioArm for high blood pressure monitoring in obese subjects (body mass index ≥30 kg/m2) according to guidelines in the European Society of Hypertension-International Protocol 2 (ESH-IP2). MethodsWe recruited 33 obese subjects and measured their blood pressure using QardioArm (test device) and Omron M3 Intellisense (Omron Healthcare, Kyoto, Japan; standard device). We compared systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) according to the ESH-IP2. ResultsA total of 95 of 99 differences for SBP and 91 of 99 for DBP displayed absolute differences within 10 mm Hg. A total of 98 of 99 differences for SBP and 98 of 99 for DBP exhibited absolute differences within 15 mm Hg. This result satisfied requirements for part 1 of the ESH-IP2. A total of 27 out of 33 individuals for SBP and 30 out of 33 individuals for DBP had a minimum of 2 of 3 comparisons within 5 mm Hg difference. None of the subjects had 3 differences outside 5 mm Hg for SBP and DBP, satisfying part 2 of the ESH-IP2. For HR measurements, a total of 90 of 99 differences had absolute differences within 3 beats per minute (bpm), and a total of 94 or 99 differences had absolute differences within 5 bpm. A total of 98 of 99 differences had absolute differences within 8 bpm. Therefore, the test device satisfied part 1 of ESH-IP2 criteria for HR. For part 2 of ESH-IP2, 31 of 33 individuals had a minimum of 2 of 3 comparisons within 3 bpm difference for HR. Only 1 of 33 subjects had 3 differences outside 3 bpm. ConclusionsTo the best of our knowledge, this was the first study to show that an app that measures blood pressure and HR meets the requirements of the ESH-IP2 in an obese population. We believe the ESH-IP2 should publish explicit criteria for validation of blood pressure devices in specific populations.

Background: Hypertension is considered as a main risk factor for chronic kidney disease development and progression. Thus, the control and evaluation of this disease with new software and devices are especially important in patients who suffer from chronic kidney disease., Objective: This study aimed to validate the QardioArm mobile device, which is used for blood pressure (BP) self-measurement in patients who suffer from chronic kidney disease, by following the European Society of Hypertension International Protocol 2 (ESH-IP2) guidelines., Methods: A validation study was carried out by following the ESH-IP2 guidelines. A sample of 33 patients with chronic kidney disease self-measured their BP by using the QardioArm and Omron M3 Intellisense devices. Heart rate (HR), diastolic BP, and systolic BP were measured., Results: The QardioArm fulfilled the ESH-IP2 validation criteria in patients who suffered from chronic kidney disease., Conclusions: Thus, this study is considered as the first validation using a wireless upper arm oscillometric device connected to an app to measure BP and HR meeting the ESH-IP2 requirements in patients who suffer from chronic kidney disease. New validation studies following the ESH-IP2 guidelines should be carried out using different BP devices in patients with specific diseases., (©Victoria Mazoteras-Pardo, Ricardo Becerro-De-Bengoa-Vallejo, Marta Elena Losa-Iglesias, Daniel López-López, David Rodríguez-Sanz, Israel Casado-Hernández, Cesar Calvo-Lobo, Patricia Palomo-López. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.12.2019.)