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Clinical Trial on the Accuracy of Blood Pressure Measurement in Diabetic Patients Using the YE680B Arm-Cuff Electronic Blood Pressure Monitor by Yuyue

Clinical Trial on the Accuracy of Blood Pressure Measurement in Diabetic Patients Using the YE680B Arm-Cuff Electronic Blood Pressure Monitor by Yuyue

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116214
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Gold Standard:This study mainly used a mercury column sphygmomanometer to verify the validity period of wrist electronic sphygmomanometer for measuring blood pressure. Mercury column blood pressure ha
Index test:Blood pressure is mainly measured and diagnosed through traditional mercury sphygmomanometers

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as a diabetic patient (either previously diagnosed as a diabetic, or those whose laboratory test results meet the diagnostic criteria for diabetes. The diagnostic criteria are as follows: having typical symptoms of diabetes (such as excessive thirst, frequent urination, excessive hunger, and unexplained weight loss), meeting fasting venous plasma glucose >= 7.0 mmol/L, or 2-hour venous plasma glucose after oral glucose tolerance test >= 11.1 mmol/L, or glycosylated hemoglobin >= 6.5%, or random venous plasma glucose >= 11.1 mmol/L, can be diagnosed as diabetes. Without typical symptoms of diabetes, diagnosis can only be made when two blood glucose indicators at the same time point or two blood glucose indicators at different time points reach or exceed the diagnostic cut-off points. When the test results of two different blood glucose indicators are inconsistent, that is, one blood glucose indicator reaches or exceeds the diagnostic cut-off point while the other does not, it is necessary to retest the blood glucose indicator that reaches or exceeds the diagnostic cut-off point, and at the same time, factors that may affect the test results of blood glucose indicators need to be considered for diagnosis.) 2. Age requirement: Children and adults aged 3 years and above 3. Gender requirement: At least 30% of the subjects should be male and at least 30% should be female 4. Blood pressure distribution requirement: >= 5% of the subjects have systolic blood pressure (readings from the control group) = 5% of the subjects have systolic blood pressure (readings from the control group) >= 160 mmHg; >= 20% of the subjects have systolic blood pressure (readings from the control group) >= 140 mmHg; >= 5% of the subjects have diastolic blood pressure (readings from the control group) = 5% of the subjects have diastolic blood pressure (readings from the control group) >= 100 mmHg; >= 20% of the subjects have diastolic blood pressure (readings from the control group) >= 85 mmHg; Other blood pressure distributions are within these limit values (here, the blood pressure values are calculated based on the readings from the mercury sphygmomanometer) 5. The arm circumference of the subjects should be within the cuff range of 17 cm - 52 cm 6. Voluntary participation in this clinical trial and signing the informed consent form or having the guardian sign the informed consent form 7. Good compliance, able to cooperate to complete the entire clinical trial

Exclusion criteria

Exclusion criteria: 1. Those with mental disorders or those who cannot cooperate calmly (speaking/moving during the measurement process); or subjects whose blood pressure measurement may be difficult due to skin or limb conditions. 2. Those undergoing dialysis treatment or having upper limb arteriovenous fistula, severe lymphedema, or as determined by the researcher, a risk of deep vein thrombosis in the upper limbs. 3. Those whose arm circumference exceeds the size range of the cuff or who have difficulty measuring blood pressure in a seated position. 4. Patients with arrhythmia. 5. Patients with peripheral arterial disease and those with diseases that may affect arterial compliance. 6. Those who smoked, drank coffee within 30 minutes before the measurement, or had not emptied their bladder. 7. Other situations deemed unsuitable for inclusion by the doctor.

Design outcomes

Primary

MeasureTime frame
Accuracy of electronic blood pressure monitor measurement;

Secondary

MeasureTime frame
Relative error of pulse frequency;The relationship between wrist circumference and measurement error;

Countries

China

Contacts

Public ContactLuo Li

The First Affiliated Hospital of Anhui Medical University

89200398@qq.com+86 551 6292 2821

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026