Validation of Two Automatic Blood Pressure Monitors With the Ability to Transfer Data via Bluetooth
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Madeleine Wetterholm1, Stephanie Erika Bonn1, Christina Alexandrou1,2
1Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Insights
Two Bluetooth-enabled automatic blood pressure (BP) monitors were validated for patients with type 2 diabetes. The Andersson Lifesense BDR 2.0 demonstrated greater accuracy within clinical ranges compared to the Beurer BM 85.
Area of Science:
- Cardiology
- Endocrinology
- Medical Devices
Background:
- Type 2 diabetes is the most common metabolic disease, often accompanied by hypertension.
- Regular health monitoring is crucial for patients with chronic conditions like diabetes.
- Bluetooth-enabled automatic blood pressure (BP) monitors offer potential for integrating home measurements into routine care.
Purpose of the Study:
- To validate two commercial automatic BP monitors (Beurer BM 85, Andersson Lifesense BDR 2.0) against manual BP monitoring.
- To assess the accuracy of Bluetooth-enabled BP monitors in patients with type 2 diabetes.
Main Methods:
- 181 participants with type 2 diabetes were recruited from 6 primary care centers.
- Blood pressure was measured manually, then using the Beurer BM 85 and Andersson Lifesense BDR 2.0.
- Validation involved calculating mean differences, Spearman rank correlation, and Bland-Altman analysis.
Main Results:
- 180 participants (119 men, 61 women; mean age 60.1 years) were analyzed.
- The Andersson Lifesense BDR 2.0 showed smaller mean differences for systolic (3.2 mmHg) and diastolic (4.2 mmHg) BP compared to manual measurements.
- Both monitors showed significant correlations with manual BP measurements (r=0.69-0.78).
Conclusions:
- The validated automatic BP monitors are sufficiently accurate for group-level measurements.
- The Andersson Lifesense BDR 2.0 performed better, more frequently falling within clinically acceptable BP measurement ranges than the Beurer BM 85.
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/m2. 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.
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