Intervention Study on Digital Health Management

Официальное название

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

Обзор

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

Вмешательства

• Другое 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.

Первичные конечные точки

• Changes in diastolic blood pressure after 24 weeks [Срок оценки: 24 weeks following intervention]

Вторичные конечные точки (1)

• Values for changes in Hba1c or BMI or CAI after 24 weeks [Срок оценки: 24 weeks following intervention]

Критерии участия

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Cardiology,Shanghai Tenth People's Hospital — Шанхай

Идентификаторы

NCT: NCT06949306 · NSS_3.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗