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临床试验/NCT05539066
NCT05539066Unknown不适用

Application of AI Health Assistant in Out of Hospital Management of Patients With Type 2 Diabetes

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 196 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
196
主要终点
Blood pressure compliance rate

研究概览

简要总结

The developed health assistant has the functions of intelligent analysis of health data inside and outside the hospital, health reminder, etc. The advantages of AI health assistant management group compared with conventional management group in terms of comprehensive compliance rate, metabolic index level, hypoglycemia incidence rate was further studied.

详细描述

  1. The investigators have developed an AI health assistant suitable for diabetes patients, which has the functions of automatically uploading blood pressure, blood glucose data, intelligent reminder, automatic analysis of reports inside and outside the hospital, intelligent question and answer, etc. it is simple to operate, highly interactive, and maximizes the management level of diabetes patients outside the hospital.
  2. Through AI personal health assistant, 196 diabetes patients were managed to further improving the comprehensive compliance rate of metabolic indicators such as blood glucose and blood pressure of diabetes patients, improving the patients' self-management ability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The diagnostic criteria of T2DM patients are the diagnostic criteria of the 2017 China guidelines for the prevention and treatment of type 2 diabetes HbA1c 7.5-13% Age: 18-65y BMI 18.5-30kg/m2 The course of disease is less than 5 years Have good cognitive ability and can correctly use health assistants

排除标准

  • Acute complications of diabetes (diabetes ketosis, etc.) Diabetes complicating pregnancy or preparing for pregnancy HbA1c < 7.5% or > 13% Age < 18y or age > 65y Pre pregnancy BMI < 18.5 or > 30kg / m2 Severe liver and kidney dysfunction (ALT greater than 2.5 times the upper limit of normal, EGFR less than 45 ml / min / 1.73m2) Using drugs that may affect blood glucose are being used (including steroids, hydroxyprogesterone hexanoate, anti AIDS drugs, etc.)

结局指标

主要结局

Blood pressure compliance rate

时间窗: 6 months

Proportion of patients with blood pressure \< 130 / 80mmHg

Compliance rate of total cholesterol

时间窗: 6 months

Proportion of patients with total cholesterol \< 4.5mmol/l

Compliance rate of BMI (Body Mass Index)

时间窗: 6 months

Proportion of patients with BMI \< 24 kg/m2

HbA1c compliance rate

时间窗: 6 months

Compliance rate of HbA1c \< 7%

次要结局

  • Incidence of hypoglycemia(6 months)

研究者

发起方
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liping Gu

Deputy chief physician

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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