Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
For last decade, the innovation of mobile health platform has brought new opportunities for disease management. Previous studies have shown that health management programs based on mobile platforms for patients with diabetes can improve patients' glucose control, self-management ability and quality of life. Type 1 diabetes mellitus (T1DM) due to its characteristics needs long-term linkage care throughout the lifespan cycle of patients. Therefore, this study intends to construct a prospective and open T1DM cohort based on mobile application and platform, to deliver home-community-hospital joint management for patients, and to provide follow-up online or offline every 3 months lasting for 10 years. Mainly, the objective of this study is to observe the blood glucose control outcome of T1DM patients. Secondly, the control of comprehensive metabolic indicators such as blood pressure and blood lipid, occurrence and progression of acute and chronic complications, and psychosocial status were included as well, expecting to provide scientific evidence for continuously improving the quality of T1DM management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years old;
- •Diagnosed as type 1 diabetes according to World Health Organization (WHO) criteria in 1999;
- •Be able to use smart mobile phones;
- •Informed consent and voluntary participation.
排除标准
- •Secondary diabetes;
- •Complicated with malignant diseases, such as cancer, hepatic and renal failure;
- •Complicated with cognitive impairment or mental illness;
- •Be pregnant or lactating at the time of enrollment.
结局指标
主要结局
HbA1c
时间窗: Outcome evaluation at 10 years.
HbA1c is one of the indicators that reflects the level of blood glucose control overall. Blood sample will be required and tested.
Time in range (TIR)
时间窗: Outcome evaluation at 10 years.
TIR is one of the indicators that reflects the level of blood glucose control from the point of view of target time. Continuous glucose monitoring (CGM) devices will be used.
Incidence of hypoglycemia
时间窗: Outcome evaluation at 10 years.
Incidence of hypoglycemia is one of the indicators that reflects the level of blood glucose control. Hypoglycemia is defined as blood glucose lower than 3.9mmol/L with or without symptoms. Incidence of hypoglycemia is occurence times per month according to patients self-reported.
次要结局
- Anxiety condition.(Outcome evaluation at 10 years.)
- Comprehensive metabolic control(Outcome evaluation at 10 years.)
- Occurrence of Diabetes-related complications.(Outcome evaluation at 10 years.)
- Progression of Diabetes-related complications.(Outcome evaluation at 10 years.)
- Depression condition.(Outcome evaluation at 10 years.)
- Life quality.(Outcome evaluation at 10 years.)