Smartphone / smartwatch-based cuffless blood pressure measurement : a position paper from the Korean Society of Hypertension

Lee, Hae Young; Lee, Dong-Ju; Seo, Jong-Mo; Ihm, Sang‐Hyun; Kim, Kwang Il; Cho, Eun Joo; Kim, Hyeon Chang; Shin, Jinho; Park, Sungha; Sohn, Il Suk; Chung, Wook‐Jin; Ryu, Sung Kee; Sung, Ki Chul; Kim, Juhan; Kim, Dae–Hee; Pyun, Wook Bum

doi:10.1186/s40885-020-00158-8

Cited by 37 publications

(41 citation statements)

References 29 publications

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“…Current guidelines recommend to measure blood pressure (BP) using a validated auscultatory or (semi)automatic upper-arm sphygmomanometer ( 2 , 3 ). While in the past BP measurement was mainly performed in the doctor’s office, nowadays it is known that the addition of out-of-office BP measurement provides better prognostic information than office BP measurement alone ( 4 , 5 ). New evolutions in development of BP monitors aim to increase convenience while preserving accuracy ( 6 ).…”

Section: Introductionmentioning

confidence: 99%

“…Advantages in using these methods are increased convenience as well as the possibility to easily increase the number of measurements per day, up to even continuous measurement. Other advantages are an increased role for the patient in managing their own health, possibly resulting in increased adherence to antihypertensive treatment ( 5 ).…”

Section: Introductionmentioning

confidence: 99%

“…While guidelines recommend only upper-arm inflatable cuff measurements of BP, commercial devices such as smartwatches capable of measuring BP using cuffless methods are already coming to market. In recent years, smartwatch devices first fulfilled the requirements for a medical device in the International Organization for Standardization (ISO) 81,060–2:2018 Non-invasive sphygmomanometers ( 5 ). However, it was recently emphasized that using these standards for new devices is inappropriate, and that new standards are needed ( 11 ).…”

Section: Introductionmentioning

confidence: 99%

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Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Falter

Scherrenberg

Driesen

et al. 2022

Front. Cardiovasc. Med.

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BackgroundNovel smartwatch-based cuffless blood pressure (BP) measuring devices are coming to market and receive FDA and CE labels. These devices are often insufficiently validated for clinical use. This study aims to investigate a recently CE-cleared smartwatch using cuffless BP measurement in a population with normotensive and hypertensive individuals scheduled for 24-h BP measurement.MethodsPatients that were scheduled for 24-h ambulatory blood pressure monitoring (ABPM) were recruited and received an additional Samsung Galaxy Watch Active 2 smartwatch for simultaneous BP measurement on their opposite arm. After calibration, patients were asked to measure as much as possible in a 24-h period. Manual activation of the smartwatch is necessary to measure the BP. Accuracy was calculated using sensitivity, specificity, positive and negative predictive values and ROC curves. Bland-Altman method and Taffé methods were used for bias and precision assessment. BP variability was calculated using average real variability, standard deviation and coefficient of variation.ResultsForty patients were included. Bland-Altman and Taffé methods demonstrated a proportional bias, in which low systolic BPs are overestimated, and high BPs are underestimated. Diastolic BPs were all overestimated, with increasing bias toward lower BPs. Sensitivity and specificity for detecting systolic and/or diastolic hypertension were 83 and 41%, respectively. ROC curves demonstrate an area under the curve (AUC) of 0.78 for systolic hypertension and of 0.93 for diastolic hypertension. BP variability was systematically higher in the ABPM measurements compared to the smartwatch measurements.ConclusionThis study demonstrates that the BP measurements by the Samsung Galaxy Watch Active 2 show a systematic bias toward a calibration point, overestimating low BPs and underestimating high BPs, when investigated in both normotensive and hypertensive patients. Standards for traditional non-invasive sphygmomanometers are not met, but these standards are not fully applicable to cuffless devices, emphasizing the urgent need for new standards for cuffless devices. The smartwatch-based BP measurement is not yet ready for clinical usage. Future studies are needed to further validate wearable devices, and also to demonstrate new possibilities of non-invasive, high-frequency BP monitoring.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Falter

Scherrenberg

Driesen

et al. 2022

Front. Cardiovasc. Med.

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show abstract

“…Last, we calibrated the test device in the opposite arm according to the guideline of the manufacturer, and it can minimize the temporal variation of the BP. However, the experts recommend calibrating the smartwatch device using the same-arm measurement of the BP after acquiring PPG-based pulse signals in the smartwatch sequentially ( 19 ). The calibration in the same arm can be useful, especially for patients with PD because we can use the less affected arm for both the smartwatch and the reference device.…”

Section: Discussionmentioning

confidence: 99%

Validation of Blood Pressure Measurement Using a Smartwatch in Patients With Parkinson's Disease

et al. 2021

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Objectives: We aimed to validate the accuracy of blood pressure (BP) measurement using a smartwatch in patients with Parkinson's disease (PD).Materials and Methods: We compared 168 pairs of BP (n = 56) measurements acquired by a smartwatch (SM-R850) with those measured by a sphygmomanometer (reference device).Results: Differences between the smartwatch BP and reference BP measurements were compared. The mean and standard deviation of the differences systolic BP (SBP) and diastolic BP (DBP), measured by smartwatch and reference device, fulfilled both criterion 1 (0.4 ± 4.6 and 1.1 ± 4.5 mm Hg for DBP and SBP, respectively) and criterion 2 (0.2 ± 2.5 and 0.9 ± 2.4 mm Hg for DBP and SBP, respectively) of the BP validation criterion of the International Organization for Standardization.Conclusion: BP measurement using a smartwatch with a photoplethysmography sensor is an accurate and reliable method in patients with PD.

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“…ISF-based glucose monitors developed in recent years have proven reliable and accurate in research studies 20 , 21 , but their relatively low level of integration limits their application beyond the benchtop. As activity tracking features (e.g., sleep patterns 22 , 23 , heart rate 24 , 25 , blood pressure 26 , 27 , and blood oxygen 28 , 29 ) become increasingly popular in wearable electronics, especially smartwatches and smart bands, ISF-based noninvasive glucose meters could be further consolidated and miniaturized into the form of a watch to better enable continual monitoring. A brief summary and comparison of representative glucose meters based on the same sample extraction mechanism are included in the supplementary material (Table S1 ).…”

Section: Introductionmentioning

confidence: 99%

Highly integrated watch for noninvasive continual glucose monitoring

Chang

Zhang

et al. 2022

Microsyst Nanoeng

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This article reports a highly integrated watch for noninvasive continual blood glucose monitoring. The watch employs a Nafion-coated flexible electrochemical sensor patch fixed on the watchband to obtain interstitial fluid (ISF) transdermally at the wrist. This reverse iontophoresis-based extraction method eliminates the pain and inconvenience that traditional fingerstick blood tests pose in diabetic patients’ lives, making continual blood glucose monitoring practical and easy. All electronic modules, including a rechargeable power source and other modules for signal processing and wireless transmission, are integrated onto a watch face-sized printed circuit board (PCB), enabling comfortable wearing of this continual glucose monitor. Real-time blood glucose levels are displayed on the LED screen of the watch and can also be checked with the smartphone user interface. With 23 volunteers, the watch demonstrated 84.34% clinical accuracy in the Clarke error grid analysis (zones A + B). In the near future, commercial products could be developed based on this lab-made prototype to provide the public with noninvasive continual glucose monitoring.

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Smartphone / smartwatch-based cuffless blood pressure measurement : a position paper from the Korean Society of Hypertension

Cited by 37 publications

References 29 publications

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Validation of Blood Pressure Measurement Using a Smartwatch in Patients With Parkinson's Disease

Highly integrated watch for noninvasive continual glucose monitoring

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