Continual cuffless blood pressure monitoring in children: agreement and feasibility compared with ambulatory blood pressure monitoring.

Background

Cuffless wearable technologies enable continual blood pressure (BP) monitoring and may improve tolerability compared with conventional cuff-based methods. Pediatric data comparing cuffless devices with ambulatory blood pressure monitoring (ABPM) remain limited.

Methods

In this prospective observational study, children with well controlled type 1 diabetes mellitus and normal office BP underwent simultaneous 24-h monitoring using a wrist-worn cuffless optical device and conventional ABPM. Between-method differences were assessed for averaged 24-h, daytime, and nighttime systolic and diastolic BP. Equivalence was evaluated using the two one-sided tests procedure with a prespecified exploratory ± 10 mmHg margin, whereas individual-level agreement was assessed using Bland-Altman analysis.

Results

Twenty-one participants were included (mean age 14.7 ± 2.6 years). Mean differences (Aktiia - ABPM) were -4.5 mmHg for 24-h systolic BP and -0.8 mmHg for 24-h diastolic BP. The 90% confidence intervals were fully contained within the ±10 mmHg margin for 24-h and nighttime systolic BP and for diastolic BP across all periods, but not for daytime systolic BP. Bland-Altman analysis showed modest mean bias but wide limits of agreement, particularly for systolic BP. Nocturnal systolic and diastolic BP dipping was attenuated with cuffless monitoring.

Conclusions

In this selected pediatric cohort, continual cuffless BP monitoring was feasible and showed group-level comparability with ABPM for averaged 24-h BP values. However, it should not be considered interchangeable with ABPM for individual clinical decisions or assessment of nocturnal dipping. Larger studies in more diverse pediatric populations are required before broader clinical implementation.