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Intervention Study on Digital Health Management

Intervention of a Digital Health Management Program in Patients With Cardiometabolic Disorders: a Real-world Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06949306
Enrollment
300
Registered
2025-04-29
Start date
2025-07-01
Completion date
2030-12-31
Last updated
2025-04-29

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

Conditions

Hyperlipidemia, Hypertension

Keywords

Cardiometabolic abnormalities, Digital Interventions

Brief summary

The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of monitor-feedback-optimization based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from generalized intervention to precise regulation. By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of digital therapy can be promoted for the prevention and control of chronic diseases in China

Interventions

OTHERBracelet, assistant, APP: the golden triangle of smart life

The lifestyle intervention was carried out through the bracelet, Little Assistant and Keyhealth APP for 24 weeks, and the daily data synchronization of the APP and weekly AI feedback were performed. After 24 weeks, blood glucose, blood lipid, blood pressure, CAI and other indicators were monitored.

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-65 years old; 2. Meet one of the following three conditions: 1. Diastolic hypertension (systolic blood pressure \< 140 MMHG and diastolic blood pressure ≥90mmHg) 2. Glycosylated hemoglobin (6.0-6.5) 3. Obesity (BMI≥28kg/m²) 4. Mild hyperlipemia: total cholesterol (TC) ≥5.2 mmol/L and \< 6.2 mmol/L, or low-density lipoprotein cholesterol (LDL-C) ≥3.4 mmol/L and \< 4.1 mmol/L 3. Antihypertensive or lipid-lowering medications have not been started 4. Use a smartphone and volunteer

Exclusion criteria

1. Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease 2. Previous cardiovascular and cerebrovascular events 3. Diastolic blood pressure ≥99mmHg 4. Glycated hemoglobin ≥6.5 5. Other life expectancy such as cancer is less than 5 years 6. Participate in other clinical trials

Design outcomes

Primary

MeasureTime frame
Changes in diastolic blood pressure after 24 weeks24 weeks following intervention

Secondary

MeasureTime frame
Values for changes in Hba1c or BMI or CAI after 24 weeks24 weeks following intervention

Countries

China

Contacts

Primary ContactYi Zhang
yizshcn@gmail.com18917686332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026