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NCT Number: NCT06949306

Intervention Study on Digital Health Management

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology,Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Age 18-65 years old; 2. Meet one of the following three conditions:

  • Diastolic hypertension (systolic blood pressure < 140 MMHG and diastolic blood pressure ≥90mmHg)
  • Glycosylated hemoglobin (6.0-6.5)
  • Obesity (BMI≥28kg/m²)
  • 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

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

Treatment and study plan

Bracelet, assistant, APP: the "golden triangle" of smart life

Other

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.

Primary outcomes

  1. Changes in diastolic blood pressure after 24 weeks

    Time frame: 24 weeks following intervention

Secondary outcomes

  1. Values for changes in Hba1c or BMI or CAI after 24 weeks

    Time frame: 24 weeks following intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Zhang

CONTACT

[email protected]

18917686332

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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