Type 2 diabetes mellitus with elevated blood pressure
Conditions
Interventions
Comprehensive strategic interventions for monitoring wearable devices and digital remote management group:Comprehensive intervention strategy based on wearable device monitoring and digital remote man
Digital monitoring intervention of wearable devices group:Digital monitoring based on wearable devices
Regular Management group:Regular Management
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at least 35 years old and less than 80 years old; 2. Diagnosed with primary hypertension, with both office blood pressure and 24-hour ambulatory blood pressure uncontrolled prior to randomization. The former is defined as an average office systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg, and the latter is defined as an average 24-hour ambulatory systolic blood pressure >=130 mmHg and/or diastolic blood pressure >=80 mmHg; 3. Diagnosed with type 2 diabetes; 4. Owns and regularly uses a smartphone, and can use WeChat mini programs; 5. Voluntarily participates in the study and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes; 2.During the screening, if the systolic blood pressure in the examination room was >= 180 mmHg and/or the diastolic blood pressure was >=110 mmHg, or the 24-hour average systolic blood pressure was >= 180 mmHg and/or the diastolic blood pressure was >= 110 mmHg, then the person would be considered as having hypertension; 3.Diagnosed or suspected secondary hypertension, such as hypertension caused by kidney diseases, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial diseases, drug-induced conditions, or rare monogenic genetic disorders. 4.Currently taking more than three types of blood pressure-lowering medications (refractory hypertension); 5.Cannot be used in conjunction with wearable devices, or in situations that affect the normal operation of the devices, including cognitive dysfunction, visual impairment, hearing impairment, limb movement impairment, disability, burns, tattoos, skin diseases, allergies to device materials, after implantation of a cardiac pacemaker, after implantation of a cardioverter defibrillator, after implantation of an artificial cochlea, etc; 6.There was a clear history of atrial fibrillation in the past; 7.Acute myocardial infarction or acute cerebral stroke occurred within the previous 3 months randomly; 8.Including dilated cardiomyopathy, hypertrophic cardiomyopathy, rheumatic heart disease, congenital heart disease, severe heart valve disease (severe valve stenosis and/or regurgitation), or the presence of other structural heart diseases; 9.Severe liver or kidney diseases, alanine aminotransferase or aspartate aminotransferase exceeding three times the upper limit of normal, dialysis, end-stage kidney disease or eGFR 2.5 mg/dL; 10.Symptomatic heart failure or left ventricular ejection fraction less than 40% occurred within the past 6 months; 11.Having severe physical illnesses with an expected survival time of less than 12 months, such as malignant tumors; 12.Any history of organ transplantation; 13.In the acute stage of a disease supported by clinical evidence; 14.Currently pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study period; 15.Having a history of alcohol or drug abuse within the past 12 months; 16.Clinical diagnosis: Severe anxiety disorder; 17.Refused to take any blood pressure-lowering medication during the research period; 18.Significant concerns from one's spouse, close relatives, or family members regarding participation in the research; 19.Currently participating in other clinical studies; 20.According to the researchers' assessment, it was determined that the subjects were unable to follow the trial procedures, or there were other reasons preventing them from participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average systolic blood pressure from 24-hour dynamic blood pressure monitoring;Average systolic blood pressure from 24-hour dynamic blood pressure monitoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average diastolic blood pressure from 24-hour dynamic blood pressure monitoring; | — |
Countries
China
Contacts
Public ContactYufang Bi
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed