Intervention Study on Digital Health Management

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Other: Bracelet, assistant, APP: the "golden triangle" of smart life

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Zhang; Phone Number: 18917686332; Email: yizshcn@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, China
      • Department of Cardiology,Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiovascular digital management group; Participants used a bracelet and an APP assistant for lifestyle interventions	Other: Bracelet, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in diastolic blood pressure after 24 weeks	24 weeks following intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Values for changes in Hba1c or BMI or CAI after 24 weeks	24 weeks following intervention

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 13, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Digital Interventions; Cardiometabolic abnormalities
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias
• Other Study ID Numbers: NSS_3.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No