Validation of the Microlife BP A3 PC upper arm blood pressure monitor in patients with diabetes mellitus according to the ANSI/AAMI/ISO 81060-2: 2013 protocol.

Objective: The aim of the present study was to validate the blood pressure (BP) measurement device, Microlife BP A3 PC, in patients with diabetes mellitus, according to the ANSI/AAMI/ISO 81060-2:2013 protocol.

Patients And Methods: In 85 individuals aged 56-88 years, with predefined criteria for diabetes mellitus, BP measurements on the upper arm were performed alternately using the Microlife BP A3 PC and a standard mercury reference sphygmomanometer. A total of 333 comparisons were included for analysis.

Results: The mean difference between the Microlife BP A3 PC and the reference was -1.5±6.3 mmHg for systolic BP (SBP) and -1.3±5.2 mmHg for diastolic BP (DBP) according to criterion 1 of the protocol. For SBP, a total of 209 of the 333 measurements were within the range of 5 mmHg (62.8%), whereas the corresponding numbers for DBP were 232 of 333 (69.7%). For criterion 2, the intraindividual differences for the test device and the reference were -1.50±4.73 mmHg for SBP and -1.30±4.55 mmHg for DBP, thus being within the defined ranges provided by the protocol.

Conclusion: The Microlife BP A3 PC fulfilled the requirements of criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 protocol and can also be recommended for BP measurement in diabetic patients.