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

Q: 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).

Victoria Mazoteras‐Pardo; Ricardo Vallejo; Marta Elena Losa‐Iglesias; Eva María Martínez‐Jiménez; César Calvo‐Lobo; Carlos Romero‐Morales; Daniel López‐López; Patricia Palomo‐López

doi:10.2196/19781

July 24, 2020Journal of Medical Internet ResearchOpen Access

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

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Key result

QardioArm blood pressure monitor meets ESH-IP2 validation requirements in patients with type 2 diabetes.

n=33

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Why the study?

Home blood pressure monitoring benefits populations prone to high blood pressure, but the QardioArm mobile device had not been validated in individuals with noninsulin-dependent type 2 diabetes under European Society of Hypertension guidelines.

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?

Study Design

Type

Observational (n=33)

Multicenter

No

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?

P

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.

I

Intervention

QardioArm automatic home blood pressure measurement monitoring device

C

Comparator

Omron M3 Intellisense digital sphygmomanometer (reference standard)

O

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.
Consecutive sampling bias (simple random sampling might be more appropriate)
Arterial stiffness was not assessed
Findings should not be extrapolated to other populations with other diseases

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Implication

Supports QardioArm for home BP monitoring in type 2 diabetes; leaves open need for outcome trials.

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.

Discussion

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Cite This Study

Mazoteras‐Pardo et al. (2020) conducted an observational in Noninsulin-dependent type 2 diabetes (n=33). QardioArm blood pressure monitoring device vs. Omron M3 Intellisense was evaluated on Device validation according to the European Society of Hypertension International Protocol 2 (ESH-IP2). 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.

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

Figures

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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

Figures

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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