Efficient use of the TM-2441 ambulatory blood pressure measurement device in patients with diabetes.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2024-11-14 DOI:10.1097/MBP.0000000000000734

Sebastiano Cicco, Marialuisa Sveva Marozzi, Gabriella Schirosi, Francesco Corvasce, Daniele Egidio Romano, Angelo Vacca, Pietro Nazzaro

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Abstract

Background and objective: Ambulatory blood pressure monitoring (ABPM) requires automatic measurement and the use of a validated device, according to current guidelines and international standardization. The TM-2441 (A&D Co. Ltd, Tokyo, Japan) ABPM device is small, lightweight, and suitable for use in ambulatory settings. It was validated against the ISO 81060-2:2013 standard in the general population. This study investigated the reliability of the ABPM device for patients with type 2 diabetes.

Methods: Individuals aged more than 12 years affected with type 2 diabetes were recruited by our outpatient clinic. The blood pressure assessment was performed using the opposite limb simultaneous measurement according to the updated ISO 81060-2:2018.

Results: Forty-five subjects were included in the clinical investigation. The mean difference between blood pressure values measured by the TM-2441 ABPM device and the reference sphygmomanometer was within limits allowed by the ISO standard. Bland-Altman plots of the measurements and differences between the values obtained from the study device and those from the reference device showed no systematic variations in error. It was not possible to perform a stress test in most patients due to refusal or poor physical condition.

Conclusion: The TM-2441 ABPM device fulfilled all the requirements of the ISO standard for ambulatory testing not only in a general population but also in the subgroup of subjects with type 2 diabetes.

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在糖尿病患者中有效使用 TM-2441 非卧床血压测量设备。

背景和目的：非卧床血压监测 (ABPM) 需要根据现行指南和国际标准化要求进行自动测量并使用经过验证的设备。TM-2441（A&D 有限公司，日本东京）非卧床血压监测设备体积小、重量轻，适合在非卧床环境中使用。该设备根据 ISO 81060-2:2013 标准在普通人群中进行了验证。本研究调查了 ABPM 设备对 2 型糖尿病患者的可靠性：方法：我们的门诊部招募了年龄超过 12 岁的 2 型糖尿病患者。根据最新的 ISO 81060-2:2018，使用对侧肢体同时测量法进行血压评估：45名受试者参与了临床调查。TM-2441 ABPM 设备和参考血压计测量的血压值之间的平均差在 ISO 标准允许的范围内。研究设备和参照设备测量值之间的测量值和差值的 Bland-Altman 图显示，误差没有系统性变化。由于大多数患者拒绝或身体状况差，无法进行压力测试：结论：TM-2441 ABPM 设备不仅在普通人群中，而且在 2 型糖尿病患者亚群中，都能满足 ISO 标准对非卧床测试的所有要求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.