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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