What is the clinical evidence from this study?

Study design: Observational. Population: Noninsulin-dependent type 2 diabetes (n=33). Intervention: QardioArm blood pressure monitoring device vs. Omron M3 Intellisense. Primary outcome: Device validation according to the European Society of Hypertension International Protocol 2 (ESH-IP2).

July 24, 2020Open Access

QardioArm Blood Pressure Monitoring in a Population With Type 2 Diabetes: Validation Study

Key Result

The QardioArm blood pressure monitoring device successfully met all validation requirements of the European Society of Hypertension International Protocol 2 in patients with type 2 diabetes.

Study Design

Type

Observational (n=33)

Multicenter

Structured PICO

Does the QardioArm device accurately measure blood pressure and heart rate compared to a standard digital sphygmomanometer in patients with noninsulin-dependent type 2 diabetes?

Population

33 adults (>25 years) diagnosed with noninsulin-dependent type 2 diabetes, mean age 65.9 years, 17 men and 16 women, recruited from a single center in Spain. Exclusion criteria: arrhythmia or using insulin as treatment.

Intervention

QardioArm automatic home blood pressure measurement monitoring device

Comparator

Omron M3 Intellisense digital sphygmomanometer (reference standard)

Outcome

Device accuracy for measurement of systolic blood pressure, diastolic blood pressure, and heart rate according to the European Society of Hypertension-International Protocol 2 (ESH-IP2)surrogate

The QardioArm mobile blood pressure monitoring device is valid and accurate for home monitoring of blood pressure and heart rate in patients with noninsulin-dependent type 2 diabetes.

Limitations

Consecutive sampling bias was present; a simple random sampling process might be more appropriate.
Arterial stiffness, which is common in people with type 2 diabetes, was not assessed.
Findings should not be extrapolated to other populations with other diseases.

Abstract

BACKGROUND: Home blood pressure monitoring has many benefits, even more so, in populations prone to high blood pressure, such as persons with diabetes. OBJECTIVE: The purpose of this research was to validate the QardioArm mobile device in a sample of individuals with noninsulin-dependent type 2 diabetes in accordance with the guidelines of the second International Protocol of the European Society of Hypertension. METHODS: The sample consisted of 33 patients with type 2 diabetes. To evaluate the validity of QardioArm by comparing its data with that obtained with a digital sphygmomanometer (Omron M3 Intellisense), two nurses collected diastolic blood pressure, systolic blood pressure, and heart rate with both devices. RESULTS: The analysis indicated that the test device QardioArm met all the validation requirements using a sample population with type 2 diabetes. CONCLUSIONS: This paper reports the first validation of QardioArm in a population of individuals with noninsulin-dependent type 2 diabetes. QardioArm for home monitoring of blood pressure and heart rate met the requirements of the second International Protocol of the European Society of Hypertension.

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