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临床试验/NCT04973644
NCT04973644已完成不适用

Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode

Second Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
HbA1c concentration

研究概览

简要总结

This study intends to combining wearable technology to crate Internet+Digital Hospital-remote Home Type 2 Diabetes follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

详细描述

Background:The prevalence of T2DM in Chinese adults has exceeded 10%, and the prevalence of abnormal glucose metabolism has exceeded 40% in people older than 18 years. This will lead to a significant increase in the prevalence of DM complications in the next decade, and the disability and death caused by complications will also seriously affect the quality of life of patients and bring a huge social and economic burden.This randomized controlled trial intends to combining wearable technology to crate Internet+Digital Hospital-remote Home T2DM follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

Methods:The study was a parallel-group, randomised, controlled trial. the number of cases planned to be included in 200 cases. Participants were randomly assigned to the intervention or control group.The intervention group receives Internet + Digital Hospital-remote home management mode,including remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction, etc.The control group receives the traditional management mode, including routine dietary and exercise recommendations, education as well as monitor in the clinic.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with type 2 diabetes according to the World Health Organization criteria;
  • Aged between 18 and 70 years;
  • Glycosylated haemoglobin (HbA1C%) between 7% and 9%.

排除标准

  • Type 1 diabetes;
  • Gestational diabetes;
  • Other special types of diabetes;
  • Moderate-severe insufficiency of heart , liver, kidney and lung;
  • Complicated with acute disease or stress status.

结局指标

主要结局

HbA1c concentration

时间窗: Baseline, Week 12, Week 24

HbA1c concentration reflects the average blood glucose level

次要结局

  • Waist circumference(Baseline, Week 24)
  • BMI(Baseline, Week 24)
  • Serum uric acid(Baseline, Week 24)
  • FBG(Baseline, Week 24)
  • Fasting insulin(Baseline, Week 24)
  • Blood pressure(Baseline, Week 24)
  • Total cholesterol(Baseline, Week 24)
  • Triglycerides(Baseline, Week 24)
  • LDL-C(Baseline, Week 24)
  • HDL-C(Baseline, Week 24)
  • Weight(Baseline, Week 24)
  • Serum creatinine(Baseline, Week 24)
  • Urinary microalbumin / creatinine ratio(Baseline, Week 24)
  • Diabetes Treatment Satisfaction Questionnaire(Week 24)

研究者

发起方
Second Affiliated Hospital of Nanchang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

YunFeng Shen

professor

Second Affiliated Hospital of Nanchang University

研究点 (1)

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