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Accepted for/Published in: JMIR mHealth and uHealth

Date Submitted: May 13, 2019
Open Peer Review Period: May 16, 2019 - Jun 28, 2019
Date Accepted: Jan 27, 2020
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

An Automated Blood Pressure Display for Self-Measurement in Patients With Chronic Kidney Disease (iHealth Track): Device Validation Study

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Calvo-Lobo C, Rodríguez-Sanz D, Martínez-Jiménez EM, Palomo-López P

An Automated Blood Pressure Display for Self-Measurement in Patients With Chronic Kidney Disease (iHealth Track): Device Validation Study

JMIR Mhealth Uhealth 2020;8(4):e14702

DOI: 10.2196/14702

PMID: 32238337

PMCID: 7163421

Validation of the iHealth Track Automated Blood Pressure Display for Self-Measurement in Patients with Chronic Kidney Disease: A Descriptive Investigation

  • Victoria Mazoteras-Pardo; 
  • Ricardo Becerro-De-Bengoa-Vallejo; 
  • Marta Elena Losa-Iglesias; 
  • Daniel López-López; 
  • César Calvo-Lobo; 
  • David Rodríguez-Sanz; 
  • Eva María Martínez-Jiménez; 
  • Patricia Palomo-López

ABSTRACT

Background:

Hypertension is a global population public health issue closely related to chronic kidney disorder (CKD). In people with CKD, strict checkpoint of blood pressure (BP) is a kingpin of therapy.

Objective:

The objective of this research was determine to validate the iHealth Track monitor for BP surveillance in CKD patients conformable by the institution of the Hypertension International in European Society following of the protocol 2010 (HI-ES2010).

Methods:

Thirty-three patients who received hemodialysis in Plasencia participated in the study. Nine successive records were made conformable to the HI-ES2010. We calculated the differences between the reference standard device (Omron M3 Intellisense) and the test device (iHealth Track) for BP and heart rate (HR) values. For 99 total comparisons of paired measurements, we assorted differences into various categories (≤5 mmHg, ≤10 mmHg, and ≤15 mmHg for BP; ≤3 mmHg, ≤5 mmHg, and ≤8 mmHg beats per minute for HR).

Results:

In 90 of 99 systolic BP and 89 of 99 diastolic BP comparisons between devices, measurement differences were within 5 mmHg. In 81 of 99 HR comparisons between devices, measurement differences were within 3 bpm. The mean differences between the test and reference standard readings were 3.27 (SD 2.99) mm Hg for systolic BP, 3.59 (SD 4.55) mm Hg for diastolic BP, and 2.18 (SD 2.75) bpm for HR. We also observed that for both systolic and diastolic BP, 31 of 33 participants had at least two of three comparisons between devices with measurement differences less than 5 mmHg. For HR, 28 of 33 individuals had at least two of three comparisons between devices with measurement differences less than 3 bpm.

Conclusions:

To our knowledge, this is the novel study to show that iHealth Track meets the requirements of the HI-ES2010 in CKD patients. Therfore, the iHealth Track is suitable for use in renal patients. Clinical Trial: Not Applicable


 Citation

Please cite as:

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Calvo-Lobo C, Rodríguez-Sanz D, Martínez-Jiménez EM, Palomo-López P

An Automated Blood Pressure Display for Self-Measurement in Patients With Chronic Kidney Disease (iHealth Track): Device Validation Study

JMIR Mhealth Uhealth 2020;8(4):e14702

DOI: 10.2196/14702

PMID: 32238337

PMCID: 7163421

Per the author's request the PDF is not available.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.