Validation of Two Automatic Blood Pressure Monitors With the Ability

Original Paper

Validation of Two Automatic Blood Pressure Monitors With the

Ability to Transfer Data via Bluetooth

Madeleine Wetterholm

, MD; Stephanie Erika Bonn

, PhD; Christina Alexandrou

1,2

, MSc; Marie Löf

, PhD; Ylva

Trolle Lagerros

1,3

, MD, PhD

Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden

Department of Biosciences and Nutrition, Karolinska Institutet, Stockholm, Sweden

Obesity Center, Academic Specialist Center, Stockholm Health Services, Stockholm, Sweden

Corresponding Author:

Madeleine Wetterholm, MD

Clinical Epidemiology Unit

Department of Medicine Solna

Karolinska Institutet

Eugeniahemmet T2

Stockholm, SE 171 76

Sweden

Phone: 46 851779183

Fax: 46 851779304

Email: [email protected]

Abstract

Background: Patients with chronic diseases are in need of regular health controls. Diabetes mellitus type 2 is currently the most

prevalent chronic metabolic disease. A majority of diabetic patients have at least one comorbid chronic disease, where hypertension

is the most common. The standard for blood pressure (BP) measurement is manual BP monitoring at health care clinics.

Nevertheless, several advantages of self-measured BP have been documented. With BP data transfer from an automatic BP

monitor via Bluetooth to software, for example, a smartphone app, home measurement could effectively be integrated into regular

care.

Objective: The aim of this study was to validate two commercially available automatic BP monitors with the ability to transfer

BP data via Bluetooth (Beurer BM 85 and Andersson Lifesense BDR 2.0), against manual BP monitoring in patients with type

2 diabetes.

Methods: A total of 181 participants with type 2 diabetes were recruited from 6 primary care centers in Stockholm, Sweden.

BP was first measured using a manual BP monitor and then measured using the two automatic BP monitors. The mean differences

between the automatic and manual measurements were calculated by subtracting the manual BP monitor measurement from the

automatic monitor measurement. Validity of the two automatic BP monitors was further assessed using Spearman rank correlation

coefficients and the Bland-Altman method.

Results: In total, 180 participants, 119 men and 61 women, were included. The mean age was 60.1 (SD 11.4) years and the

mean body mass index was 30.4 (SD 5.4) kg/m

. The mean difference between the Beurer BM 85 and the manual BP monitor

was 11.1 (SD 11.2) mmHg for systolic blood pressure (SBP) and 8.0 (SD 8.1) mmHg for diastolic blood pressure (DBP). The

mean difference between the Andersson Lifesense BDR 2.0 and the manual BP monitor was 3.2 (SD 10.8) mmHg for SBP and

4.2 (SD 7.2) mmHg for DBP. The automatic BP measurements were significantly correlated (P<.001) with the manual BP

measurement values (Andersson Lifesense BDR 2.0: r=0.78 for SBP and r=0.71 for DBP; Beurer BM 85: r=0.78 for SBP and

r=0.69 for DBP).

Conclusions: The two automatic BP monitors validated measure sufficiently accurate on a group level, with the Andersson

Lifesense BDR 2.0 more often falling within the ranges for what is acceptable in clinical practice compared with the Beurer BM

85.

(J Med Internet Res 2019;21(4):e12772) doi:10.2196/12772

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KEYWORDS

blood pressure monitors; diabetes mellitus, type 2; hypertension; methods; mHealth; self-care; self-management

Introduction

In recent years, there has been a rapid development in

information and communication technology including the

availability of digital devices for self-measurements and health

promoting apps. Today, more and more patients are asking for

digital solutions. Despite this, apps and devices for home

measurement are seldom integrated into regular health care.

Given the importance of self-care in the therapy of most chronic

diseases, tools for self-measurement have the potential to play

a greater role than they do today. Furthermore, the use of new

technology such as mobile health, defined by the World Health

Organization as medical or public health practice that is

supported by mobile devices [1], could be a way to optimize

care as a large number of patients can be reached at a lower

cost.

Diabetes mellitus type 2 is currently the most prevalent chronic

metabolic disease, and the number of cases is increasing

worldwide. In 2015, the global prevalence of diabetes mellitus

in the adult population (20-79 years) was 8.8%, and it is

expected to rise to 10.4% by 2040 [2]. A majority of diabetic

patients have at least one comorbid chronic disease of which

hypertension, a powerful predictor of cardiovascular risk, is the

most common [3,4].

Today, the standard method for diagnosis of hypertension as

well as for blood pressure (BP) control in

antihypertensive-treated patients is manual BP monitoring at

health care clinics. Nevertheless, several advantages of

self-measured BP have been documented [5]. For example,

measurement at home can provide a more realistic appraisal of

habitual BP than that can be obtained at a health care clinic, that

is, eliminate the risk of the so-called white coat hypertension

when the BP is high only in the clinical setting [6]. In addition,

studies have also shown that the opposite, masked hypertension,

that is, normal BP when measured at a clinic, but high BP when

measured at home, is associated with an increased cardiovascular

risk similar to the risk of patients with persistent hypertension

[7,8]. As patients with diabetes have a high prevalence (47%)

of masked hypertension [9], the need for validated automatic

BP monitors in this specific population is of great importance.

Self-measurement at home could possibly improve patient

adherence to both BP controls and treatment [10,11]. However,

reporting of self-measured BP can be modified by the patients

if the values for some reason do not seem suitable to them [12].

With automatic data transfer via Bluetooth to software, for

example, a smartphone app, reporting bias as well as

misreporting can be avoided. However, commercial automatic

BP monitors are seldom validated, and to the best of our

knowledge, no automatic BP monitor with data transfer via

Bluetooth has been validated in patients with type 2 diabetes

previously. Thus, in this study, we set out to validate two on

the Swedish market commercially available automatic BP

monitors (Beurer BM 85 Bluetooth and Andersson Lifesense

BDR 2.0), with the ability to transfer data via Bluetooth, against

manual BP monitoring in patients with type 2 diabetes.

Methods

Recruitment of Participants

This study was performed using BP data collected at baseline

from all participants in the DiaCert-study, a randomized

controlled trial of patients with type 2 diabetes. The study design

has been described in detail previously [13]. A total of 181

participants were recruited from 6 primary care centers in

Stockholm, Sweden. Inclusion criteria were as follows: being

diagnosed with diabetes type 2, age above 18 years, being able

to read and understand Swedish, being able to walk, and having

access to and being able to use a smartphone. Overall, one

participant did not have data on BP. Due to battery discharge

or arm circumference larger than the recommended for the BP

monitor cuffs, that is, more than 36 cm for Beurer BM 85 and

more than 32 cm for Andersson Lifesense BDR 2.0, 11

participants did not have data from Beurer BM 85 and 25

participants did not have data from Andersson Lifesense BDR

2.0. In total, BP was measured using Beurer BM 85 in 169

participants and using Andersson Lifesense BDR 2.0 in 155

participants. All participants provided written consent before

participating in the study. The study was approved by the

Regional Ethical Review Board, Stockholm, Sweden (Dnr:

2016/2041-31/2; 2016/99-32; 2017/1406-32; 2018/286-32).

The Procedure

BP, weight, height, and waist circumference were measured by

study personnel at the baseline meeting. This has been described

in detail previously [13]. Smoking status (never, former, or

current) was assessed through a questionnaire. The BP

measurements were performed after at least 5 min of rest.

Participants were seated with their legs uncrossed in a quiet

room, and they were instructed to avoid talking during the

procedure. The upper left arm of each participant was used for

the BP measurement. BP was first measured once using the

manual BP monitor and then measured once using both

automatic BP monitors with no specific order.

The Automatic Monitors

The monitors Beurer BM 85 Bluetooth (Beurer GmbH. Ulm,

Germany) and Andersson Lifesense BDR 2.0 (Guangdong

Transtek Medical Electronics Co. Ltd. Zhongshan, China) are

automatic devices for measuring BP at the upper arm. Both

monitors can transfer data via Bluetooth to digital tools.

Beurer BM 85 has a pressure range of 0 to 300 mmHg and a

memory capacity of 60 measurements for 2 users. It can

calculate the average value of all saved measures as well as the

average of morning and evening measurements during the last

7 days. Systolic blood pressure (SBP) and diastolic blood

pressure (DBP) as well as the heart rate are displayed on a liquid

crystal digital (LCD) display. The monitor can identify an

irregular heartbeat, which is then displayed with a symbol on

the LCD screen. The included standard cuff for Beurer BM 85

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is applicable to arm circumferences ranging from 22 to 36 cm.

The dimensions of the device are 180×100×40 mm, and the

weight of the monitor without the cuff is 317 grams. The Beurer

BM 85 is equipped with a rechargeable lithium-ion battery (3.7

V/400 mAh) that has a battery life of approximately 50

measurements.

Andersson Lifesense BDR 2.0 has a pressure range of 0 to 300

mmHg and a memory capacity of 60 measurements for 2 users.

It can calculate an average value of the last 3 measurements.

SBP and DBP as well as the heart rate are displayed on an LCD

display. The monitor can identify an irregular heartbeat, which

is then displayed with a symbol on the LCD screen. The included

standard cuff for Andersson Lifesense BDR 2.0 is applicable

to arm circumferences ranging from 22 to 32 cm. The

dimensions of the device are 180×99×40 mm, and the weight

of the device without the cuff is 300 grams. For the Andersson

Lifesense BDR 2.0, 4 AAA-size alkaline batteries are needed.

The device has an approximate capacity of 300 measurements.

Statistical Analysis

We categorized the participants into low or high BP. Low BP

was defined as SBP less than 140 mmHg and DBP less than 90

mmHg. High BP was defined as SBP 140 mmHg or above or

DBP 90 mmHg or above. We used this classification as a BP

of 140/90 mmHg is the diagnostic cut-off for the definition of

hypertension in Europe [14]. Characteristics are presented as

mean (SD) and n (%) for continuous and categorical variables,

respectively. To assess whether there were any statistically

significant differences between participants with low and high

BP, Chi-square test was performed for categorical variables and

2-sided t tests were performed for continuous variables.

Differences between the automatic monitors and manual BP

measurements were calculated by subtracting the manual

measurement from the automatic ones. Participants were divided

into four categories classified by the differences according to

whether they were within 5, 10, 15, or more than 15 mmHg.

Separate variables were created for systolic and diastolic

pressure. We conducted a sensitivity analysis to see if the result

of Beurer BM 85 differed when including only the 155

participants in whom BP also was measured using Andersson

Lifesense BDR 2.0. The Bland-Altman method was used to

assess systematic differences in BP measurements between the

manual and automatic monitors and as a graphical evaluation

of the associations [15]. The difference in BP between the

automatic monitor and the manual monitor was plotted on the

y-axis and the mean of the two monitor measurements on the

x-axis. The limits of agreement, equal to ±2SD of the mean

difference, provide a measure of the variation. We assessed

Spearman rank correlation coefficients between automatic and

manual measurements to further examine the validity by

measuring the degree of association. The significance level was

set to .05. Analyses were performed using STATA 14 (Stata

Corporation, College Station, TX, USA).

Results

This study included 180 participants (119 men and 61 women)

with a mean age of 60.1 (SD 11.4) years. Characteristics of all

participants and according to low (n=83) and high BP (n=97)

are shown in Table 1. Participants with low BP and high BP

did not differ significantly with respect to age, gender, or

smoking status. However, there was a statistically significant

difference in body mass index (BMI; P=.02) between the high

and low BP groups with higher BMI in the high BP group. In

addition, there was a statistically significant difference in waist

circumference (P=.04) for men with greater waist circumference

in the high BP group. The mean BP values for all participants

with the manual monitor were 138 (SD 15.5) mmHg for SBP

and 83 (SD 9.7) mmHg for DBP. The Beurer BM 85 and

Andersson Lifesense BDR 2.0 mean BP values are shown in

Table 1.

The mean difference between the Beurer BM 85 and the manual

BP monitor was 11.1 (SD 11.2) for SBP and 8.0 (SD 8.1) for

DBP. The mean difference between the Andersson Lifesense

BDR 2.0 and the manual BP monitor was 3.2 (SD 10.8) for SBP

and 4.2 (SD 7.2) for DBP. The number of measurements that

differed from the manual measurements by 5, 10, 15 or less,

and more than 15 mmHg are shown in Table 2. For Beurer BM

85, 49.1% (83/169) of all measurements differed by 10 mmHg

or less in SBP and 30.8% (52/169) by 5 mmHg or less for DBP.

For Andersson Lifesense BDR 2.0, 69.7% (108/155) of all

measurements differed by 10 mmHg or less in SBP and 49.0%

(76/155) by 5 mmHg or less for DBP. In sensitivity analysis,

the results of Beurer BM 85 did not differ when including only

the 155 participants in whom BP was measured using both

automatic BP monitors (data not shown).

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Table 1. Characteristics of study participants by categories of low and high blood pressure.

P value

High blood pressure; ≥140/or

≥90 mmHg (n=97)

Low blood pressure;

<140/<90 mmHg (n=83)

Total (N=180)Variable

.3660.8 (11.5)59.2 (11.2)60.1 (11.4)Age (years), mean (SD)

.7263 (52.9)56 (47.1)119 (66.1)Male, n (%)

.0231.3 (5.4)29.4 (5.1)30.4 (5.4)

Body mass index (kg/m

), mean (SD)

Waist circumference (cm), mean (SD)

.34108.5 (15.6)106.3 (13.7)107.5 (14.8)All

.04112.7 (15.4)107.3 (12.7)110.1 (14.4)Male

.33100.7 (12.8)104.3 (15.8)102.3 (14.2)Female

Smoking status, n (%) .54

37 (38.1)35 (42.2)72 (40.0)Never

41 (42.3)30 (36.1)71 (39.4)Former

9 (9.3)11 (13.3)20 (11.1)Current

10 (10.3)7 (8.4)17 (9.4)Missing

Systolic blood pressure (mmHg), mean (SD)

<.001148 (13.0)126 (8.7)138 (15.5)Manual

<.001159 (15.8)137 (12.2)149 (18.2)

Beurer BM 85

<.001151 (17.5)129 (11.0)140 (18.5)

Andersson Lifesense BDR 2.0

Diastolic blood pressure (mmHg), mean (SD)

<.00188 (9.6)78 (6.3)83 (9.7)Manual

<.00194 (10.6)87 (7.8)91 (10.1)

Beurer BM 85

<.00191 (10.4)82 (7.1)87 (10.2)

Andersson Lifesense BDR 2.0

P value from Chi-square test or t test between groups of low blood pressure and high blood pressure.

n=169.

n=155.

Table 2. Validation results of the Beurer BM 85 and Andersson Lifesense BDR 2.0 (the number of measurements that differed from the manual blood

pressure measurement by 5, 10, 15 or less, and more than 15 mmHg).

>15 mmHg≤15 mmHg≤10 mmHg≤5 mmHgVariable

Beurer BM 85

60 (35.5)109 (64.5)83 (49.1)47 (27.8)

SBP

, n (%)

23 (13.6)146 (86.4)105 (62.1)52 (30.8)

DBP

, n (%)

Andersson Lifesense BDR 2.0

26 (16.8)129 (83.2)108 (69.7)68 (43.9)SBP, n (%)

8 (5.2)147 (94.8)123 (79.4)76 (49.0)DBP, n (%)

SBP: systolic blood pressure.

DBP: diastolic blood pressure.

The differences in SBP and DBP in relation to the mean between

the automatic and the manual monitors are shown in

Bland-Altman plots in Figures 1 and 2. Most data points fall

within the limits of agreement (±2SD), although it should be

noted that the limits of agreement were wide and individual

differences are shown. The data points in all Bland-Altman plots

show a consistent horizontal pattern around the mean of the

y-axis, that is, no trend was identified, that is, the accuracy did

not seem to be impacted by the level of SBP or DBP. All of the

automatic BP measurements were significantly correlated with

the manual measurements. The Spearman correlation coefficient

was r=0.78 for SBP and r=0.71 for DBP for Andersson

Lifesense BDR 2.0, and r=0.78 for SBP and r=0.69 for DBP

for Beurer BM 85 (P<.001 for all).

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Figure 1. Bland-Altman plots of the differences between the Beurer BM 85 measurements and the manual measurements for systolic blood pressure

(a) and diastolic blood pressure (b). The difference in blood pressure between Beurer BM 85 and the manual monitor is plotted on the y-axis and the

mean of the two monitor measurements on the x-axis. Each data point represents one participant (n=169).

Figure 2. Bland-Altman plots of the differences between the Andersson Lifesense BDR 2.0 measurements and the manual measurements for systolic

blood pressure (a) and diastolic blood pressure (b). The difference in blood pressure between the Andersson Lifesense BDR 2.0 and the manual monitor

is plotted on the y-axis and the mean of the two monitor measurements on the x-axis. Each data point represents one participant (n=155).

Discussion

Principal Findings

The results of our study demonstrate that the mean difference

between the manual and the automatic BP monitors Andersson

Lifesense BDR 2.0 and Beurer BM 85 was small on a group

level. The differences between the manual and automatic

measurements were larger on an individual level.

There is a lack of studies validating automatic BP monitors in

patients with type 2 diabetes. However, Masding et al [16]

compared automatic home BP measurement and manual BP

measurement with a previously validated 24-hour ambulatory

BP monitor, which measured BP every 30 min during the day

and every 60 min during the night, in 55 patients with type 2

diabetes. They found automatic home-measured BP superior to

clinically measured BP. The mean difference between the

automatic BP and the 24-hour ambulatory BP was 8.2 and 3.7

mmHg for SBP and DBP, respectively. The manual BP monitor

compared with the 24-hour ambulatory BP monitor showed a

mean difference of 10.9 and 3.8 mmHg for SBP and DBP,

respectively. In our study, Andersson Lifesense BDR 2.0 showed

a lower mean difference in SBP (3.2 mmHg).

Masding et al [16] have also predefined ranges for differences

in BP that would be acceptable in clinical practice to be 10

mmHg for SBP and 5 mmHg for DBP. Comparing the results

from our study, the Andersson Lifesense BDR 2.0 falls within

these ranges more often than the Beurer BM 85. Although 69.7%

(108/155) of automatic measurements performed using the

Anderson Lifesense BDR 2.0 was within 10 mmHg from the

manual measurement for SBP, only 49.1% (83/169) of automatic

measurements with Beurer BM 85 were within this limit. For

DBP, 49.0% (76/155) and 30.8% (52/169) were within 5 mmHg

of difference for Andersson Lifesense BDR 2.0 and Beurer BM

85, respectively. On a group level, Andersson Lifesense BDR

2.0 meets the clinical ranges with a mean difference of 3.2

mmHg for SBP and 4.2 mmHg for DBP. Although their patient

group was similar to ours, it should be noted that the studies

differ in a number of aspects. First, in their study, BP was

measured with the manual BP monitor at 3 different visits to

the health clinic. Thereafter, the patients were instructed to use

the automatic BP monitor at home at 3 specified times on 4

consecutive days, comparing it with the 24-hour ambulatory

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BP monitor [16]. In our study, BP was measured manually and

by automatic monitors on 1 occasion only.

Several automatic BP monitors without a Bluetooth connection

have been validated in the general population [17-21]. Takahashi

et al [17] validated three different automatic BP monitors against

manual BP monitoring. All three of them showed better accuracy

than the two monitors we validated in this study. In our study,

the percentage of measurements that differed from the control

measurements by 5, 10, and 15 mmHg or less for the monitor

with the best accuracy, Andersson Lifesense BDR 2.0, were

43.9% (68/155), 69.7% (108/155), and 83.2% (129/155) for

SBP and 49.0% (76/155), 79.4% (123/155), and 94.8%

(147/155) for DBP. For one of the monitors validated by

Takahashi et al, the corresponding numbers were 72%, 92%,

and 98% for SBP and 82%, 98%, 100% for DBP. However,

they only included 33 participants from the general population

and BP was measured with each of the monitors at 3 times on

each participant, giving a total of 99 measurements [17]. These

differences make it difficult to compare results across studies.

Furthermore, in our study, the automatic BP measurements were

significantly, with correlation coefficients of .69 or higher,

correlated with the manual BP measurements. However, to the

best of our knowledge, no correlation analysis has been

conducted in any validation study of automatic BP monitors

compared with manual BP measurement.

The large sample size is a notable strength of our study.

Furthermore, the participants were recruited from 6 primary

care centers located in different areas with diverse populations

and levels of socioeconomic status. With a mean age of 60 years,

the participants are younger than the general patients with type

2 diabetes in Sweden (68 years old) [22], which may be due to

the inclusion criteria of having a smartphone. However, 8 of 10

Swedes have a smartphone [23]. Our study also includes a larger

number of men compared with women. This may primarily be

a reflection of the higher prevalence of diabetes type 2 among

men compared with women in Sweden [24,25]. Nevertheless,

this study includes more women than any previous studies

validating automatic BP monitors [16,17].

There is a lack of automatic BP monitors validated in the large

population of patients with type 2 diabetes who are likely to use

automatic BP monitors in practice. Not only are patients with

diabetes often familiar with digital devices that help them with

better management, for example, devices for self-monitoring

of blood glucose, they are also in need of controls for

comorbidities, such as hypertension, on a regular basis. Today,

the routine practice for screening of hypertension consists of

multiple visits to the health care clinic for repeated BP

measurement. Including home measurements in the decision

making would not only be more cost-efficient but also provide

more reliable measurements with white coat hypertension and

masked hypertension in mind. The fact that BP measurements

in our study were performed in a clinical setting and not in a

home setting, and only once using each monitor, may be a

limitation of our study. Though, as the aim was to validate the

automatic monitors against the standard method for BP

measurement, the manual and the automatic measurements were

performed on the same occasion at a health care clinic.

Digital solutions could meet the needs and expectations of

patients by making health care more accessible. Validated

devices also ensure the quality of the care. However, if the BP

monitors’ ability to transfer BP data via Bluetooth is to be used

in future health care, it is important to emphasize that transfer

of data to, for example, an electronic health record has to be

compliant with security regulations and without the risk of

privacy invasion of stored health data on the cloud. In addition,

offering tech support, for example, an in-app chat-support, for

various issues such as data transfer and uploading data could

potentially increase consumer confidence in digital

self-measurement devices. Gamification techniques such as

visual feedback messages or a platform allowing communication

could have potential to further increase the motivation of the

patients to engage in their own health care [26]. For future

patients, the BP data together with other variables could possibly

allow for personalized lifestyle recommendations.

Conclusions

In conclusion, no previous studies have validated automatic BP

monitors with a Bluetooth connection in patients with type 2

diabetes. Our study shows that although the difference between

the manual and the automatic BP monitors was greater on an

individual level, the monitors are sufficiently accurate on a

group level. Moreover, the Andersson Lifesense BDR 2.0 is

more often falling within the BP ranges for what is acceptable

in clinical practice compared with the Beurer BM 85.

Acknowledgments

The authors would like to acknowledge the personnel at participating primary care centers for the help in recruitment of study

participants and, in particular, Klara Wiklander, Julia Ragnö, Kristin Hjörleifsdottir Steiner, and Monica Flodin. This study was

supported by Stockholm County Council and Karolinska Institutet (4D) as well as through grants from the Swedish Research

Council for Health, Working life, and Welfare (Dnr: 2016–00985) and funding from the strategic research area in care sciences

(SFO-V) to SEB. The funders had no role in the design, analysis, or writing of this study.

Conflicts of Interest

None declared.

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Abbreviations

BMI: body mass index

BP: blood pressure

DBP: diastolic blood pressure

LCD: liquid crystal digital

SBP: systolic blood pressure

Edited by G Eysenbach; submitted 15.11.18; peer-reviewed by K Anderson, M Lozano-Lozano, B Chaudhry; comments to author

16.01.19; revised version received 29.01.19; accepted 30.01.19; published 21.03.19

Please cite as:

Wetterholm M, Bonn SE, Alexandrou C, Löf M, Trolle Lagerros Y

Validation of Two Automatic Blood Pressure Monitors With the Ability to Transfer Data via Bluetooth

J Med Internet Res 2019;21(4):e12772

URL: https://www.jmir.org/2019/4/e12772/

doi:10.2196/12772

PMID:

in the Journal of Medical Internet Research (http://www.jmir.org), 21.03.2019. This is an open-access article distributed under

the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted

use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet

Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/,

as well as this copyright and license information must be included.

J Med Internet Res 2019 | vol. 21 | iss. 4 | e12772 | p.8https://www.jmir.org/2019/4/e12772/

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