Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode
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
- 否
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
YunFeng Shen
professor
Second Affiliated Hospital of Nanchang University
